fsma—whatyou&need&to&know& -...

Aurora A. Saulo, Ph.D. Professor and Extension Specialist in Food Technology

University of Hawaii at Manoa [email protected]

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FSMA—What You Need To Know An online informaJonal session

Module II. Current Good Manufacturing PracJce, Hazard

Analysis, and Risk-‐based PrevenJve Controls for Human Food

Important NoJce

•  Because secJons were abbreviated for this presentaJon, the informaJon provided is only an overview and should not be relied upon as a subsJtute for reading the final rule, or obtaining legal advice, or as a summary of all regulatory requirements.

•  Every company must conduct its own detailed review of the final rule.

MODULE II CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-‐BASED PREVENTIVE CONTROLS FOR HUMAN FOOD. IF YOUR ENTITY IS NOT A FARM…

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Final Rule published September 17, 2015

Food Manufacturers or Processors

•  Or faciliJes that manufacture, process, pack or hold human food (21 CFR 117.1) for distribuJon in the U.S. –  DomesJc and imported foods

•  And required to register with FDA under sec. 415 of the FD&C Act, Food Establishment RegistraJon regulaJons (created by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002)

•  Some qualified exempJons and modified requirements apply

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Food Manufacturers or Processors (cont’d)

•  You are under Current Good Manufacturing Prac2ce and Hazard Analysis and Risk-‐based Preven2ve Controls for Human Food (FSMA Final Rule for PrevenJve Controls for Human Food, published September 17, 2015)

hap://www.fda.gov/Food/GuidanceRegulaJon/FSMA/ucm334115.htm

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Full RegulaJon 21 CFR 117 The full regulaJon, 21 CFR 117 – Current Good Manufacturing Prac2ce, Hazard Analysis, and Risk-‐based Preven2ve Controls for Human Food, includes

Subpart A – General Provisions Subpart B – Current Good Manufacturing PracJce (GMP)

èSubpart C – Hazard Analysis and Risk-‐based PrevenJve Controls

Subpart D – Modified Requirements Subpart E – Withdrawal of a Qualified Facility ExempJon Subpart F – Requirements Applying to Records That Must be

Established and Maintained Subpart G – Supply-‐chain Program

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What is a PrevenJve Control (PC)?

•  Risk-‐based reasonably appropriate procedures, pracAces, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards idenJfied under the hazard analysis that are consistent with the current scienJfic understanding of safe food manufacturing, processing, packing, or holding at the Jme of the analysis.

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Key Requirements of FSMA PrevenJve Controls for Human Food

1.  Covered food faciliJes must develop and implement a wriaen food safety plan (21 CFR 117.126(a)(1)) including – Wriaen hazard analysis regardless of outcome (21 CFR 117.130) •  Of known or reasonably foreseeable biological, chemical,

and physical hazards –  Must include evaluaJon of environmental pathogens

when •  RTE food is exposed to the environment prior to packaging

and •  Packaged food is not treated aher packaging

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Key Requirements of FSMA PrevenJve Controls for Human Food (cont’d) – Each hazard will be minimized or prevented by a wriaen risk-‐based PrevenJve Control, appropriate to the nature of the control and its role in that facility’s food safety systemà cornerstone of FSMA.

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PREVENTIVE CONTROLS

ProtecJon against allergen cross-‐contact

Allergen labeling

Process and validaJon of process Cleanliness of food-‐contact surfaces

PrevenJon of cross-‐contaminaJon Supply-‐chain program

Recalls Environmental monitoring

Key Requirements of FSMA PrevenJve Controls for Human Food (cont’d) – Wriaen PrevenJve Controls Management Components (21 CFR 117.140): oversight and management of PC •  Monitoring (21 CFR 117.145): consistent and effecJve •  CorrecJons (for minor errors) and correcJve acJons (21 CFR 117.150): to prevent problem recurrence and ensure PCs are effecJve

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•  VerificaJon (21 CFR 117.155): that PCs are consistently implemented and are effecJve – May include product tesJng and environmental monitoring –  ValidaJon (21 CFR 117.160) »  Required for process controls »  Not required for allergen controls, sanitaJon controls,

supply-‐chain program, and recall plans

•  Recordkeeping •  Record review (21 CFR 117.165(a)(4))

– Food defense plan (for terrorisJc and/or intenJonal contaminaJon, and food fraud)

Key Requirements of FSMA PrevenJve Controls for Human Food (cont’d)

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2.  Wriaen recall plan (21 CFR 117.139) –  Known or reasonably foreseeable biological,

chemical, and physical hazards –  Must include evaluaJon of environmental

pathogens when •  RTE food is exposed to the environment prior to

packaging and •  Packaged food is not treated aher packaging

–  Each idenJfied hazard will require a PC


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3.  Updated cGMP (21 CFR 117 Subpart B) –  Qualified Individuals, including temporary and

seasonal workers, who manufacture, process, pack, or hold food (newàbinding , (21 CFR 117.4(b)(2)-‐(d)): •  Must have the educaJon, training, experience necessary as

appropriate to the individual’s assigned duJes, AND •  Must receive training in the Principles of Food Hygiene and Food Safety, as appropriate to the food, the facility, and the individual’s assigned duJes

•  Records required and kept for food hygiene and food safety training, as appropriate

•  Supervisors must ensure compliance


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–  “Must” replaces “shall” –  Allergen cross-‐contact (rather than “cross-‐

contact”): inadvertent incorporaJon of an allergen into food

–  Facility or faciliJes instead of “plant” or “establishment”: those that are required to register

–  Plant: used to designate the building or structures –  Establishment: used to designate a business enJty


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–  PrevenJng allergen cross-‐contact is mandatory (newàmandatory).

–  Requires cleaning of non-‐food contact surfaces as frequently as necessary to protect against allergen cross-‐contact and contaminaJon of food, food-‐contact surfaces and food packaging (newàmandatory)

–  GMPs for holding and distribuJng human food by-‐products for use as animal food (newàmandatory)


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4.  Risk-‐based supply chain program for idenJfied hazards requiring a supply-‐chain applied control –  21 CFR 117.136 & 117.137. Not needed if •  Facility controls hazards using PC •  Or subsequent enJty will control the hazard (e.g.,

customer or another processor). –  Facility has wriaen assurance from customer regarding

certain acJons customer agrees to take –  Facility discloses that food has not been processed to control

an idenJfied hazard


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–  Receiving facility must have a wriaen risk-‐based supply-‐chain program for raw materials and other ingredients idenJfied as having a hazard requiring a supply-‐chain applied control unless •  Importers meet FSVP requirements or •  Ingredients for research or evaluaJon are used

–  Includes purchasing only from approved suppliers (have hazard controls and demonstrate good supplier performance)


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–  Includes verificaJon by broker or distributor but receiving facility must assess such verificaJon documentaJon as sufficient to control the hazards

–  Includes supplier verificaJon (21 CFR 117.410(b))à now final •  Onsite audits •  Sampling and tesJng •  Review of relevant food safety records


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Food Safety Plan 21 CFR 117.126(a)(1)

•  For human foods, the food safety plan must be prepared by a PrevenAve Controls Qualified Individual

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PrevenJve Controls Qualified Individual 21 CFR 117.126(a)(2)

•  A qualified individual who has successfully completed training in the development and applicaJon of risk-‐based prevenJve 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 system.

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The Only Standard Curriculum Recognized by FDA To Date

•  Food Safety PrevenJve Controls Alliance (FSPCA) curriculum – Lead Instructor: must always be present when the FSPCA PrevenJve Controls for Human Food course is taught

– 3-‐day cerJficate course

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Looks like HACCP, Sounds like HACCP…Is it HACCP?

•  No. This is not HACCP. This is not HARPC. •  This is Hazard Analysis and Risk-‐based PrevenJve Controls for Human Food (aka Preven2ve Controls for Human Food).

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HACCP vs. PrevenJve Controls •  HACCP: Hazard Analysis and CriJcal Control Point System – Global food safety scheme for efficient, comprehensive food safety management system

– Applies to mostly processed foods (low acid, acidified, juice, seafood, meat and poultry)

– Has a kill step •  Hazard Analysis and Risk-‐based Preven?ve Controls – U.S. food safety requirements by FSMA –  Covers all foods of faciliJes required to register with FDA

– Does not necessarily have a kill step 23

•  Animal feed-‐only faciliJes •  Those that sell food directly to consumers and list provisions – Retail food establishments – Farmers markets – Roadside stands – ParJcipants in a community-‐ supported agricultural program

Which Food FaciliJes are Not Covered ?

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Qualified ExempJons and Modified Requirements

21 CFR 117.5 •  Those under regulatory HACCP –  Juice –  Seafood

•  Low acid canned foods (but only microbiological hazards regulated under 21 CFR 113)

•  Those under GMP for Dietary Supplements •  Those subject to Produce Safety Standards •  Raw agricultural commodiJes (except for raw fruits and vegetables under the Produce Safety Standards)

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21 CFR 117.5 •  Qualified FaciliJes (21 CFR 117.5(a)) –  Very small businesses

•  <$1 million total annual sales of human food OR •  Food sales averaging < $500,000/year during the last 3 years AND

•  Sales to qualified end-‐users > sales to others •  Alcoholic beverage producJon and other prepackaged

food sold in conjuncJon with alcoholic beverages (up to 5% pre-‐packed non-‐alcoholic food allowed)

•  Exempt from hazard analysis and risk-‐based prevenJve controls when certain documentaJon is provided

Qualified ExempJons and Modified Requirements (cont’d)

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21 CFR 117.7 •  FaciliJes, such as warehouses, that only store unexposed packaged food – Not exempted: Those unexposed packaged food for which refrigeraJon is required for safety •  Must have temperature controls, monitoring, verificaJon, and records

– GMPs sJll apply


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21 CFR 117.8 •  Certain storage faciliJes, such as grain elevators and warehouses that only store raw agricultural commodiJes other than raw fruits and vegetables under the Produce Safety Standards and intended for further distribuJon or processing are exempt.

•  Not exempted: FaciliJes, such as warehouses that store raw agricultural commodiJes that are fruits and vegetables must have hazard analysis and risk-‐based prevenJve controls.


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•  Qualified exempJon may be withdrawn – When there is an acJve invesJgaJon of an outbreak of foodborne illness linked to the facility

– When FDA determines it is necessary to protect public health and prevent or miJgate an outbreak due to condiJons created by the food covered by the rule


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Complying with FSMA

•  To meet FSMA, you must have an effecJve wriaen food safety system.

•  If you’re following HACCP, you must check if you meet Risk-‐based PrevenJve Controls rule.

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If Your Food Safety Plan is Non-‐compliant…

1.  FDA can criminally charge a company or person for owning, operaJng or acJng as agent in charge of a facility.

2.  FDA can issue a public warning leaer and/or an Import Alert for foreign firms (barred from entering the U.S.).

3.  If food presents a significant food safety risk, FDA can suspend the registraJon (i.e., prevent facility from distribuJng product) unJl correcJve acJon plan is approved.

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Compliance Dates Aher September 17, 2015

Food Facility Descrip?on Compliance Dates

Very small business <$1million average in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale, adjusted for inflaJon

3 years (January 1, 2016)

Small businesses < 500 full-‐Jme equivalent employees 2 years

All other businesses 1 year

Businesses subject to PMO Extended to allow Jme for changes to the PMO safety standards that incorporate requirements of the rule

3 years

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Compliance Dates Aher September 17, 2015 (cont’d)

Food Facility Compliance Dates

Receiving facility: small business and supplier is not subject to Human PC or Produce Safety Rule

2 years

Receiving facility: small business and supplier is subject to Human PC or Produce Safety Rule

2 years or 6 months aher supplier is required to comply, whichever is later

Receiving facility: NOT a small or very small business and supplier is not subject to Human PC or Produce Safety Rule

18 months

Receiving facility: Not a small or very small business and supplier is subject to Human PC or Produce Safety Rule

6 months aher supplier is required to comply

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If You Believe You Are Exempted, Please Ask…

•  What will the consumer think of you and your products when the consumer learns that you do not abide by GAP? Or, that you do not have a food safety plan?

•  Will you be able to sell to your retailers (e.g., Costco, Wal-‐Mart, etc.)?

•  Will en22es buy from you when you don’t have a food safety plan?

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If You Have A QuesJon, Ask:

•  FSPCA Technical Assistance Network hap://www.iit.edu/ifsh/alliance/resources/technical_assistance_network_inquiry_form.shtml •  FDA Technical Assistance Network hap://www.fda.gov/downloads/Food/GuidanceRegulaJon/FSMA/UCM467582.pdf

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END OF MODULE II

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