fsma hazard analysis steps
DESCRIPTION
Food Regulations, Food Safety Modernization Act, business information, compliance, food production, manufacturingTRANSCRIPT
THE FOOD SAFETY MODERNIZATION ACT
Highlighting Hazard Analysis
Brian ToddPresident
The Food Institute
RECALLS…RECALLS….RECALLS
Major Food RecallsE. coli, packaged spinach – August 2006
Salmonella, peanut butter – February 2007Listeria, chicken – February 2007E. coli, ground beef – June 2007
Clostridium botulinum, canned meat – July 20072 E. coli, ground beef – October 2007
Salmonella, frozen pot pies – October 2007E. coli, frozen pizza – November 2007
Animal handling, beef processing – February 2008Salmonella, tomatoes(?), peppers – June/July 2008
Salmonella, processed peanuts – January 2009Salmonella, eggs – August 2010
Salmonella, peanut butter – August 2014
Current Recalls are covered in Today in Food daily,
Washington section of The Food Institute Report, weekly.
Food Safety Modernization Act PL 111-353, 124 Stat. 3885
Enacted January 4, 2011Most expansive changes since 1938
ActSweeping new enforcement
authoritiesExacting new food import
requirementsMajor new program activities for FDA
Ambitious schedule for increased inspections
NEW REQUIREMENTS FOR REGISTERED FOOD FACILITIES
Biennial RegistrationMust re-register every
even-numbered year (Oct. 1 – Dec. 31)
New registration information
Introducing food into commerce without
complying is a “prohibited act”
Hazard Analysis and Preventive Controls
Each registered facility must conduct a hazard analysis and implement a written preventive
controls plan When: 18 months after date of enactment, but later for small businesses and very
small businessesImplementation: FDA
regulations within 18 months
Hazard Analysis and Preventive ControlsHazard analysis:
Identify and evaluate all reasonably foreseeable hazards
that may be associated with your facility
Includes all hazards (e.g., biological, chemical, physical, radiological; allergens; drug
residues; intentional contamination)
Hazard Analysis and Preventive Controls
Preventive Controls:
Controls to ensure (a) hazards controlled; (b) food not
adulterated under FD&C 402 or 403 (allergen labeling)
May include GMPs, sanitation, environmental sampling, food
allergen control, supplier verification activities, recall
plan
Hazard Analysis and Preventive ControlsRecordkeeping:
Must retain copy of written plan as well as monitoring records, corrective action
records, corrective actions, and verification of the efficacy
of preventive controlsAvailable to FDA upon request
Food DefenseFDA is required to conduct
vulnerability assessment of food system and determine mitigation
strategies to protect against intentional adulteration
Implementation: FDA regulations within 18 monthsFDA guidance documents within 1
year
Food DefenseRegulations:
Will apply only to foods at high risk of intentional
adulterationWill specify “mitigation strategies or measures”Guidance documents:
Model vulnerability assessment
Examples of mitigation measures
New Recordkeeping Requirements
FDA is required to issue regulations with additional recordkeeping requirements for
high-risk foodsWhen: FDA to designate high-risk foods
within 1 year, publish proposed rule within 2 years
Question: What additional recordkeeping requirements?
Limitations (e.g., may not require full pedigree, use of specific technologies)
New Recordkeeping Requirements
Hazard analysis and preventive controls plan
Registered food facilities must keep hazard analysis and
preventive controls plan and related records for 2 years
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Mandatory Inspection Frequency
High-risk facility designation based on:Safety risks of the food -- e.g., pathogens,
allergens, foreign objects?Facility’s compliance history -- e.g., Class I recall,
Form 483?Rigor of hazard analysis and preventive controls
Whether certified by accredited third party auditor
Any other factors FDA considers appropriate
New Fees for Registered Facilities
No registration feeFee for each facility subject to re-
inspectionFee for failure to comply with a
recall orderFee for accredited third-party
auditorsFee for export certificates
Fresh Produce StandardsFDA is required to establish standards for safe production and harvesting of fresh fruits and vegetables for which determines such standards needed to reduce hazardsStandards: soil amendments, water, animals, hygiene, temperature control When: within 1 yearImplementation: FDA regulations
Fresh Produce StandardsExemptions:
Farms with <$500,000 in annual sales that sell more to “qualified end-users” than to all other customers.Facilities subject to hazard analysis and preventive control plans.FDA may exempt small and very small businesses that produce fresh produce FDA determines is low risk.FDA may grant variances to States, foreign countries.
Sanitary Transportation of Food
FDA required to issue regulations on sanitary transportation of food
When: within 18 months
Performance StandardsFDA is required to review relevant public health data (epidemiologic and toxicological) every 2 years, and determine most significant
foodborne contaminants
FDA is required to issue, by regulation or guidance,
contaminant-specific performance standards
Lab Testing
All testing of food for a regulatory purpose must be
done by an accredited lab and results sent directly to FDA
Regulatory testing: for admission of imported food,
removal from Import Alert, to comply with a specific testing
requirement, or otherwise required by FDA
When: within 30 months
NEW FDA POWERS
Authority to suspend facilities registrationExpanded Records AccessMandatory recall authority
Expanded Administrative Detention Authority
NEW FDA POWERS
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TraceabilityEpidemiological investigations
FDA to establish a product tracing system to receive
information that allows FDA to effectively track and trace food
for consumption in US.FDA conduct pilots of produce
and processed food sectors within 270 days, report to
Congress 18 months
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Traceability Recordkeeping
Additional recordkeeping for high-risk foodFDA to establish a list of high-risk foods
FDA to issue NOTICE OF PROPOSED RULEMAKING on expanded recordkeeping
requirements for high-risk food
FSMA does not include Registration fees
Civil fines (except for failure to comply with recall order)
Country of origin labeling Full pedigree traceability
Reportable Food Registry reporting requirement extended to all employees
FDA implementationFDA has 6 Working Groups in charge of implementation:
Preventive StandardsInspection and ComplianceImportsFederal-State IntegrationFeesReports and Studies
Companies: Prepare now
Improve documentation/recordkeepingHazard analysis and preventive controls plan
USDA National Agricultural Library, Food Safety Information Center: fsrio.nal.usda.gov/nal_display/
index.php?info_center=1&tax_level=1&tax_subject=614 Universities with HACCP knowledge:
www.fsis.usda.gov/Science/HACCP_Validation_Resources/index.asp
Food Institute HACCP Guidebook
www.foodinstitute.com/catalog/product/haacp-us-food-safety-2nd-ed
“HAZARDING” SOME PREDICTIONS
The FSMA provides for accredited third-party auditors to certify foreign facilities and imported foods. What about domestic facilities and foods?
May FDA make regulatory decisions in reliance on third-party certification of domestically produced foods?
Third-party certification
Introducing food into commerce in violation of facility registration-21 U.S.C. 331(d)
Operating a facility without a hazard analysis and preventive controls plan-21 U.S.C. 331(uu)
Failure to comply with FDA standards for fresh produce-21 U.S.C. (vv)
New “Prohibited Acts”
Failure to comply with FDA food defense regulations for foods at high risk of intentional adulteration-21 U.S.C. 331(ww)
Any violation of a recordkeeping requirement under §204 of FSMA, except if committed by a farm-21 U.S.C. 331(e)
Failure to comply with a recall order-21 U.S.C. 331(xx)
New “Prohibited Acts”
A grocery store’s knowing and willful failure to comply with consumer notification requirement-21 U.S.C. 331(yy)
Importing food if the importer does not have in place a Foreign Supplier Verification Program-21 U.S.C. 331(zz)
New “Prohibited Acts”
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