the food safety modernization act (fsma) and what it means ... · a major food safety incident in...
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The Food Safety Modernization Act (FSMA) and What It Means to You
Larisa PavlickVP Global Regulatory amp ComplianceUnited Natural Products Alliance
GOED Exchange 2018February 6 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Key words prevention proactive scientific
Summary
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Signed on January 4 2011
bull ldquoIt aims to ensure the US food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing itrdquo
Seven parts of FSMA also known as foundational rules1 Preventive Controls for Human Food2 Foreign Supply Verification Programs3 Produce Safety Rule4 Preventive Controls for Animal Food5 Sanitary Transport of Human and Animal Food6 Intentional Adulteration7 Accredited Third Party Certification
Food Safety Modernization Act (FSMA)
UNPA copy 2018
Federal Food Drug and Cosmetic Act 1938
President Franklin D Roosevelt June 24 1938
UNPA copy 2018
UNPA copy 2018
Changes 1938-2011
Trends Foodborne Disease Outbreak Surveillance SystemSource Centers for Disease Control FoodNet (2006)
Science
Technology
Trending of data
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Key words prevention proactive scientific
Summary
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Signed on January 4 2011
bull ldquoIt aims to ensure the US food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing itrdquo
Seven parts of FSMA also known as foundational rules1 Preventive Controls for Human Food2 Foreign Supply Verification Programs3 Produce Safety Rule4 Preventive Controls for Animal Food5 Sanitary Transport of Human and Animal Food6 Intentional Adulteration7 Accredited Third Party Certification
Food Safety Modernization Act (FSMA)
UNPA copy 2018
Federal Food Drug and Cosmetic Act 1938
President Franklin D Roosevelt June 24 1938
UNPA copy 2018
UNPA copy 2018
Changes 1938-2011
Trends Foodborne Disease Outbreak Surveillance SystemSource Centers for Disease Control FoodNet (2006)
Science
Technology
Trending of data
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Signed on January 4 2011
bull ldquoIt aims to ensure the US food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing itrdquo
Seven parts of FSMA also known as foundational rules1 Preventive Controls for Human Food2 Foreign Supply Verification Programs3 Produce Safety Rule4 Preventive Controls for Animal Food5 Sanitary Transport of Human and Animal Food6 Intentional Adulteration7 Accredited Third Party Certification
Food Safety Modernization Act (FSMA)
UNPA copy 2018
Federal Food Drug and Cosmetic Act 1938
President Franklin D Roosevelt June 24 1938
UNPA copy 2018
UNPA copy 2018
Changes 1938-2011
Trends Foodborne Disease Outbreak Surveillance SystemSource Centers for Disease Control FoodNet (2006)
Science
Technology
Trending of data
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Seven parts of FSMA also known as foundational rules1 Preventive Controls for Human Food2 Foreign Supply Verification Programs3 Produce Safety Rule4 Preventive Controls for Animal Food5 Sanitary Transport of Human and Animal Food6 Intentional Adulteration7 Accredited Third Party Certification
Food Safety Modernization Act (FSMA)
UNPA copy 2018
Federal Food Drug and Cosmetic Act 1938
President Franklin D Roosevelt June 24 1938
UNPA copy 2018
UNPA copy 2018
Changes 1938-2011
Trends Foodborne Disease Outbreak Surveillance SystemSource Centers for Disease Control FoodNet (2006)
Science
Technology
Trending of data
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Federal Food Drug and Cosmetic Act 1938
President Franklin D Roosevelt June 24 1938
UNPA copy 2018
UNPA copy 2018
Changes 1938-2011
Trends Foodborne Disease Outbreak Surveillance SystemSource Centers for Disease Control FoodNet (2006)
Science
Technology
Trending of data
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
UNPA copy 2018
Changes 1938-2011
Trends Foodborne Disease Outbreak Surveillance SystemSource Centers for Disease Control FoodNet (2006)
Science
Technology
Trending of data
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Changes 1938-2011
Trends Foodborne Disease Outbreak Surveillance SystemSource Centers for Disease Control FoodNet (2006)
Science
Technology
Trending of data
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
httpswwwmenshealthcomhealthstomach-flu-survival-guide
Your Stomach Bug Survival GuideBY CHRISTA SGOBBA DECEMBER 22 2014
ldquoYep yoursquove got whatrsquos commonly known as the stomach flu but what medical professionals more studiously call ldquoacute gastroenteritisrdquo
Thatrsquos the official term for expelling the contents of your stomach violently through both ends and to feel like death while doing sordquo
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
RegulationsFood Safety Modernization Act (FSMA)Foodborne Illness
ScienceSymptoms of most organisms causing food borne illnessbull Diarrhea stomach cramps upset stomach low grade
feverbull Vomitingbull Blurred visionbull Nauseabull Fatigue
UNPA copy 2018
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
FSMA The evolution of modern food regulations
2009-2010 Foodborne Disease Outbreaksbull 94 million foodborne illnesses annuallybull 1527 outbreaks
bull 2009 675bull 2010 852
bull 29494 illnessesbull 1184 hospitalizationsbull 23 deaths
S10UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History since FSMA
httpswwwfdagovFoodRecallsOutbreaksEmergenciesOutbreaksucm272351htmUNPA copy 2018
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Outbreak Score Card
2009-2010 Outbreaks Hospitalizations Deaths
Norovirus X (42) X (9) 1
Salmonella X (30) X (49) 9
E ColiE Coli 0157 X X (16) 0157 = 4
Listeria x 9
Clostridium botulinum x 5
Clostridium perfringens 3
Shigella 1
Shown in descending order
This CDC report did not include the PCA peanut outbreak (9 deaths) caused by Salmonella
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
RegulationsFood Safety Modernization Act (FSMA)FDA Regulatory History
httpswwwhealthlinecomhealthworst-foodborne-illness-outbreaksemsalmonellaemUNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
RegulationsFood Safety Modernization Act (FSMA)Consequences of an outbreak
bull Warning Letterbull Recallbull Seizurebull Injuctionbull Criminal prosecution and finesbull Import alert
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
RegulationsFood Safety Modernization Act (FSMA)
copy 2017 UNPA
Consequences of an outbreak
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
FSMA The evolution of modern food regulationsMelamine recalls 2007-2009
ldquoSince March 16 2007
more than 150 brands of pet
food have been voluntarily
recalled by a number of
companiesrdquo FDA
UNPA copy 2018
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Food Safety Modernization Act (FSMA)Melamine
The Melamine Incident Implications for International Food and Feed SafetyCeacuteline Marie-Elise Gossner et al
Abstract
Background
A major food safety incident in China was made public in September 2008 Kidney and urinary tract effects
including kidney stones affected about 300000 Chinese infants and young children with six reported deaths
Melamine had been deliberately added at milk-collecting stations to diluted raw milk ostensibly to boost its protein
content Subsequently melamine has been detected in many milk and milk-containing products as well as other
food and feed products which were also exported to many countries worldwide
Objectives
The melamine event represents one of the largest deliberate food contamination incidents We provide a description
and analysis of this event to determine the global implications on food and feed safety
Gossner CM-E Schlundt J Ben Embarek P et al The Melamine Incident Implications for International Food and Feed Safety Environmental Health Perspectives 2009117(12)1803-1808 doi101289ehp0900949
UNPA copy 2018
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
UNPA copy 2018
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
What does this mean to us
Food Safety Modernization Act (FSMA)
UNPA copy 2018
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
RegulationsFood Safety Modernization Act (FSMA)
21 CFR Part 110
cGMP for Human Food
June 19 1987 ndashSept 17 2018
FSMA
The seven new FSMA foundations rules introduce a modern preventive science based food safety system including new food Good Manufacturing Practices (GMPs)
UNPA copy 2018
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Food Safety Modernization Act (FSMA)
bull PCHF or PC
bull Referred to as the Preventive Controls for Human Food regulation
Current Good Manufacturing Practice Hazard Analysis and Risk-based Preventive Controls for Human Food (21 CFR Part 117)
UNPA copy 2018
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
hellipis intended to ensure safe manufacturingprocessing packaging and holding of food products for human consumption in the US
Compliance Dates o Large (gt500 employees) September 2016 o Small (lt500 employees) September 17 2017o Very small (lt$1Myear) September 2018
FSMA PCHF
UNPA copy 2018
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Food Safety Modernization Act (FSMA)Preventive Controls for Human Food (PCHF)
Who is subject to PCHF
bull A foreign or domestic facility
bull Who manufactures processes packs or holds human
food for consumption in the United States
o Any food facility required to register with the FDA
under section 415 of the FDampC Act (Registration of
Food Facilities) Retail is exempt from registration
o Unless subject to an exemption
UNPA copy 2018
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Applicability of FSMA
Other examples Meal replacements shakes nutritional powders or greens
Also includes bars gummies drinks or any product marketed with a nutritional label
Food including raw materials used in food products and dietary ingredients used in dietary supplements
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
All subparts are applicable to raw material suppliers and dietary ingredients including
ndash Subpart A General
ndash Subpart B Good Manufacturing Practice (GMP)
ndash Subpart C Hazard analysis and risk-based Preventive Controls
ndash Subpart D Modified Requirements
ndash Subpart E Withdrawal of Qualified Facility
ndash Subpart F Records
ndash Subpart G Supply Chain ProgramUNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
httpswwwaccessdatafdagovscriptscdrhcfdocscfCFRCFRSearchcfmCFRPart=117UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Preventive Controls Qualified Individual (PCQI)
ldquoA qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety systemrdquo -- 21 CFR Part 1173
UNPA copy 2018
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Preventive Controls Qualified Individual (PCQI)
ldquo hellipstandardized curriculum recognized as adequate by FDAhelliprdquo
16 chapters 6 appendices and 469 pagesUNPA copy 2018
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
16 chapters 6 appendices and 469 pages
UNPA copy 2018
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
cGMP Hazard Analysis and Risk-based Preventive Controls for Human Food ( CFR Part 117)
Responsibilities of the PCQI include overseeing or performing
1 Preparation of the Food Safety Plan (FSP)
2 Validation of the preventive controls
3 Records review
4 Reanalysis of the Food Safety Plan and other activities as appropriate for the food
21 CFR Part 117180
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Example Hazard Analysis for Fish Oil
Chemical Physical Biological
Allergens Metal (processing equipment)
Pathogen survival cross contact
Histamine Glass (packaging) Parasites (Cod and Squid)
Environmental contaminant like
Pesticides PCBs (oil soluble)
UNPA copy 2018
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
GMPs and Other Prerequisite Programs
Preventive Food Safety Systems
Food Safety Plan
Recall Plan
Hazard Analysis
Process Control
Supply-chain
ProgramAllergen Control
Sanitation Control
Including procedures formonitoring corrective actionand verification as appropriate
From PCQI instructor slidesUNPA copy 2018
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Dietary Supplement Exception from Subparts C amp G only
21 CFR section 1175(e) and reads in part DS are exempt from
bull Subpart C (hazard analysis and preventive controls
requirements) andhellip
bull Subpart G (supply-chain program requirements)
ifhellip
UNPA copy 2018
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
DS Exceptions (cont)
hellipin compliance with the requirements of
bull 21 CFR part 111 (Current Good Manufacturing Practice
in Manufacturing Packaging Labeling or Holding
Operations for Dietary Supplements) andhellip
bull Serious Adverse Event Reporting for Dietary
Supplements [Section 761 of the FDampC Act (21 USC
section 379aa-1)]
UNPA copy 2018
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
bull ldquohellipshifting the focus of federal regulators from responding to contamination to preventing itrdquo
bull Foodborne Illness
bull Preventive Controls Qualified Individual (PCQI)
bull Food Safety Plans
bull Take away modernization prevention proactive scientific risk-based
Summary PCHF
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs (FSVP)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs (FSVP)
ldquoThe final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs (FSVP)
Applicability
Human food imported food products for consumption in the US including
bull DI bull Raw material used in DS bull Dietary supplementbull And food products marketed with a Nutritional Facts panel
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs (FSVP)
Who
Importers
This rule requires importers of human food to verify
1 Their foreign suppliers are producing the imported food in a manner which meets the expectations of US safety standards and hellip
2 Is not adulterated
3 Or misbranded (allergens)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull Initial compliance date May 30 2017
bull Several roll out sub-categoriesoIf not subject to PC rule (AKA DS)oIf subject to PC rule (RM DI food products)
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs (FSVP)
When Compliance Dates
bull If not subject to PC rule (AKA DS FP) May 30 2017
bull If subject to PC rule (RM DI food products)Small or very small as defined in 1173
Small lt 500 Full Time Equivalent Employees March 19 2018
Very Small lt $1000000 in salesinventory per year for 3 years
March 18 2019
Other Not small or very small May 30 2017
UNPA copy 2018
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs
In a nutshell
bull US companies required to qualify their foreign suppliers
bull FSVP must be conducted by a ldquoqualified individualrdquo
FSVP works in tandem with PCHF except you must have a unique importer identification
UNPA copy 2018
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs (FSVP)
What
Foreign suppliers meet US safety standards
bull If you are importing a food you are verifying the foreign supplier meets the expectations defined in 21 CFR Part 117-Preventive Controls for Human Food if they have reached their compliance datehellipand most have
bull If you are importing a Dietary Supplement you are verifying 21 CFR Part 111
UNPA copy 2018
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs
Key Requirements
bull Determining known or reasonably foreseeable hazards with each food
bull Evaluating the foreign supplierrsquos performance and compliance history
bull Approve suppliers using written proceduresbull Determine appropriate supplier verification activities and
frequencybull Conducting supplier verification activitiesbull Conducting corrective actions
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplementsbull Found in 1511
bull Based on operation typebull Three ldquosubcategoriesrdquo bull Are you or your customer required to establish and
verify a specification for components and labels [11170(b amp d)] and verification (11173 and 11175)
UNPA copy 2018
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs
Modified Requirements for Dietary Supplements
bull 13 sections in the FSVP rule
FSVP Rule Subcategories based on type of DS operations
FSVP Sections which may apply
1511 (a) MFG 5-7
1511(b) RM distributor selling to MFG 4-6
1511c) DS finished product 8-10
UNPA copy 2018
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
bull ldquohelliprequires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable US safety standardsrdquo
bull Key requirements of FSVP
bull FSVP = process of verifying and approving foreign suppliers
bull Take away verification safety prevention proactive scientific risk-based
Summary FSVP
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
UNPA copy 2018
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
UNPA Education amp Training
UNPA now offers a wide range of public and onsite trainings
bull Current Good Manufacturing Practices (cGMP)
bull PCHF including Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
bull Food Safety Modernization Act (FSMA)
bull lsquoMockrsquo facilities inspections
hellip and a host of other education and training offerings
For more information contact usUNPA copy 2018
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Foreign Supplier Verification Programs
Training
Feb 28 ndash March 1
Sandy Utah
Visit wwwunpacomeventsUNPA copy 2018
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Food Safety Modernization Act (FSMA)
bull Preventive Controls for Human Food (PCHF)
Preventive Controls Qualified Individual (PCQI)
bull Foreign Supplier Verification Programs (FSVP)
Questions
The End
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you
Larisa E PavlickUnited Natural Products Alliance
8017382975larisaunpacom
unpacom
copy 2017 UNPA
Thank you