u.s. food safety modernization act: a primer
DESCRIPTION
The first overhaul of the U.S. food manufacturing process in more than 80 years, the federal Food Safety Modernization Act (FSMA) law updates the role of the government in verifying the safety and availability of our food supply. FSMA, as it rolls out, has implications for both domestic manufacturers and those that distribute goods made abroad, in foreign facilities. The Food Institute analyzed the intersection of daily food production and regulatory compliance in this first in a series of 3 presentations on FSMA.TRANSCRIPT
THE FDA FOOD SAFETY MODERNIZATION ACT
A Primer
The more things change…
The more they stay the same
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RECALLS…RECALLS….RECALLS
Enacted January 4, 2011
Most expansive changes since 1938 Act
Sweeping new enforcement authorities
Exacting new food import requirements
Major new program activities for FDA
Ambitious schedule for increased inspections
* Food Safety Modernization Act PL 111-353, 124 Stat. 3885
Increased inspection frequency
Expanded records access
Import certification authority
Mandatory recall authority
Fees
Whistleblower protection
*Effective Immediately
Must re-register every even-numbered year (Oct. 1 – Dec. 31)
New registration information
Introducing food into commerce without complying is a “prohibited act”
*Biennial Registration
Elements:Hazard analysis
Preventive controlsMonitoring of preventive controls
Corrective actionsVerification
Performance Standards (if any)Records
* Hazard Analysis and Preventive Controls
FDA is required to conduct vulnerability assessment of food system and determine mitigation strategies to protect against intentional adulteration
Implementation: FDA regulations within 18 months
FDA guidance documents within 1 year
*Food Defense
Hazard analysis and preventive controls plan
Registered food facilities must keep hazard analysis and preventive
controls plan and related records for 2 years
*New Recordkeeping Requirements
Domestic high-risk facilities: every 3 years
Other domestic facilities: every 5 years
When: effective immediately, but subject to appropriations
*Increased Inspection Frequency
If foreign facility, or government of a foreign
country, refuses to permit entry of U.S. inspectors or designees within 24 hours
of official request, food from that facility will be
refused admission
*Inspection of Foreign 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
*New Fees for Registered Facilities
*OTHER NEW REQUIREMENTS
FDA has discretionary authority to require consumer notification of “reportable foods”
If report made to the Reportable Food Registry, FDA may require responsible party to submit “consumer-oriented information” to FDA
FDA then will post 1-page summary on its website
* Consumer Notification of Reportable Foods
Any grocery store that sold reportable food and is part of chain with 15 or more locations must provide notification to consumers within 24 hours and maintain for 14 days
Manner and location of notification to be determined by FDA within 1 year (e.g., notice where food is sold in store, targeted information given to consumer at cash register)
Question: What is a grocery store?
* Consumer Notification of Reportable Foods
All testing of food for a regulatory purpose must be done by an accredited lab and results sent directly to FDARegulatory 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
*Lab Testing
*NEW FDA POWERS
FDA must first give company opportunity to voluntarily recall product
If no voluntary recall, FDA may order company to cease distribution
After opportunity for informal hearing (within 2 days), FDA may order recall.
Failure to comply a is “prohibited act” and subject to civil fine ($50,000 for individuals, $250,000 for companies)
*Mandatory recall authority
FDA may detain food if “reason to believe” article of food is adulterated or misbranded
Previously, FDA needed “credible evidence” food posed “threat of serious adverse health consequences or death”
When: within 180 days
* Expanded Administrative Detention Authority
If reasonable probability food from a facility will cause serious adverse health consequences or death to humans or animals, FDA may suspend registration of:
Facility responsible for causing hazard; and
Any facility that packed, received, or held the food if it knew, or had reason to
know, of hazard
When: within 180 days
Implementation: FDA to issue regulations
* Authority to Suspend Facility Registration
The FSMA greatly expands FDA records access authority
Hazard analysis and preventive controls plan and certain related records (e.g., monitoring records, verification records, nonconformance and corrective action records)
* Expanded Records Access Authority
Reports of regulatory audits by accredited third-party auditors and documents used to prepare such reports
* Expanded Records Access Authority
Lab accreditation system
Third-party auditor accreditation system
Product tracing system for food
*FDA’s New Responsibilities
*A BIT OF RELIEF
Registration feesCivil fines (except for failure to
comply with recall order)Country of origin labelingFull pedigree traceabilityReportable Food Registry reporting
requirement extended to all employees
*FSMA Does Not Include
FDA has 6 Working Groups in charge of implementation:
Preventive StandardsInspection and Compliance
ImportsFederal-State Integration
FeesReports and Studies
*FDA Implementation
“We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves.” John Taylor, Acting Principal Deputy Commissioner, FDA (quoted in Bloomberg Businessweek)
*FDA Implementation
Improve documentation/recordkeepingHazard analysis and preventive controls plan
USDA National Agricultural Library, Food Safety Information Center:
http://fsrio.nal.usda.gov/nal_display/index.php?info_center=1&tax_level=1&tax_subject=614
The Food Institute’s resource on HACCPhttps://
foodinstitute.com/catalog/product/haacp-us-food-safety-2nd-ed
Foreign Supplier Verification ProgramDomestic facilities should also review
supply chain management
* Companies Should Prepare
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*Resources
*FDA’s webpage on the FSMA: http://www.fda.gov/Food/FoodSafety/FSMA/default.htm
*The Food Institute’s webinar series on FSMA implementation for companies: https://foodinstitute.com/catalog/product/Food-Safety-Modernization-Act-series
*Washington Section of www.FoodInstitute.Com & Weekly Report