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

Brian ToddThe Food Institute

201-791-5570Brian.Todd@FoodInstitute.c

om

*THANK YOU

www.foodinstitute.com/joinfi