Food Safety Modernization Act:

Implications of New Legislation

David W K Acheson M.D.Leavitt Partners LLC

John W. BodeOFW Law

Increased inspection frequency Expanded records access Import certification authority Mandatory recall authority Fees Port shopping Whistleblower protection

What is new? ◦ FDA must target inspection resources based on risk

Known safety risk of the food Compliance history of a firm Rigor and effectiveness of the facility’s hazard analysis

and risk-based preventive controls

◦ Mandatory inspection frequencies for: Domestic high-risk facilities Domestic low-risk facilities Foreign facilities

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Who is impacted? ◦ All registered facilities (any factory, warehouse, or

establishment that manufactures, processes, packs or holds food)

◦ Some facilities that are small or very small businesses engaged in specific types of on-farm manufacturing, processing, packing or holding that are determined to be low-risk may be exempt from inspection frequency requirements (dependent on regulations to be issued by FDA)

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What will be different?◦ FDA will not be able to meet requirements with

current resources◦ Utilize Federal, State, and Local regulatory partners

(domestic facilities)◦ Utilize third party certification (foreign facilities)◦ Agreements with foreign governments ◦ Deny import of food from firms refusing inspection

What does this mean?◦ Greater regulatory presence◦ Increased oversight of and focus on imported food

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What is new? ◦ If FDA has a reasonable belief an article of food

will cause severe adverse health consequences must provide FDA access to all records -- Relating to that article of food Relating to any other article of food that may

have been impacted in a similar manner

Who is impacted? ◦ Anyone who manufactures, processes, packs,

distributes, receives, holds or imports food ◦ Farms and restaurants are excluded

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What will be different? ◦ Previously, FDA only had access to records

relating to the specific article of food reasonably believed to present a threat of serious health consequences

What does this mean? ◦ “Lower bar” for FDA to access records

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What is new? ◦ Gives FDA authority to require a mandatory recall

of product if responsible party refuses to voluntarily recall

◦ If FDA orders mandatory recall, informal hearing with the responsible party due within 2 days

◦ Failure to comply subject to civil penalties and criminal prosecution

◦ Incident Command Operation for each recall to coordinate government activities

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Who is impacted? ◦ Registered facilities that manufacture, process,

pack, or hold food◦ Farms, restaurants, and retail food establishments

that are exempt from registering under Section 415 of the Food, Drug, and Cosmetic Act will not be directly impacted, but may be involved in recalls

What will be different? Previously, if a firm refused to recall, FDA could issue press and seek court order for injunction and/or seizure of productGives FDA authority to take action without prior court approval

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What does this mean? ◦ Majority of recalls occur voluntarily and quickly

because firms to not want to risk making consumers sick

◦ Mandatory recalls rare◦ Improved government coordination in recalls

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What is new? ◦ FDA may require imported food to be certified by

accredited third-party auditor (which may be a foreign government) to ensure compliance with U.S. laws

◦ Certificates can apply to a specific shipment of food or to a facility

◦ Requirement for certification is based on: Known safety risks associated with the food Know safety risk of the country, territory, or region of

origin Strength of the food safety system in the country,

territory, or region of origin

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Who is impacted? ◦ Foreign manufacturers, processors, packers, holders, and

importers◦ Food safety auditors

What will be different? ◦ Entry of product into the U.S. may be delayed until

certification is obtained

What does this mean? ◦ Gives FDA additional leverage ◦ How FDA defines risk will be important◦ Will likely take time to gain full effect, but may impact

selected foods immediately

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Other Provisions—◦ Fees◦ Port shopping◦ Whistleblower protection

Facility registration Preventive controls Protection against intentional adulteration Performance standards Standards for fresh produce Accreditation of third party auditors Accreditation of laboratories Traceability Foreign supplier verification program Administrative detention of food Prior notice of imported food

Biennial registration of all food facilitiesBetween Oct. and Dec. of even numbered yearsSooner of 180 days or FDA issuance of regulationElectronic submission may be required after 5 years

Suspension of registrationFDA Commissioner finds food presents a reasonable probability of causing serious adverse health consequencesRegistrant entitled to administrative hearingSooner of interim final regulations or 180 days after enactment

Registered Facilities Plans and all related records available to FDA

during inspection Exemption

◦ Comparable plans already required◦ Others

Plans available to FDA at inspection FDA issue regulation within 18 months

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Hazard analysisHazard analysis Preventive controlsPreventive controls ValidationValidation MonitoringMonitoring Verification Verification RecordkeepingRecordkeeping Corrective ActionsCorrective Actions Performance StandardsPerformance Standards

Sanitation proceduresSanitation procedures Recall planRecall plan Food allergen control Food allergen control

programprogram Supplier verification Supplier verification

activitiesactivities Environmental Environmental

samplingsampling TestingTesting

Every 2 years, FDA to review and evaluate relevant health data

Determine most significant foodborne contaminants

Issue contaminant-specific performance standards, which may include action levels

FDA to establish standards for safe production and harvesting For produce FDA has determined such standards minimize the risk of serious adverse health consequencesProposed rule for minimum standards within 1 yearPublish updated Good Agricultural Practices within 1 year

◦ FDA to issue regulations to protect against intentional adulteration

For foods at high risk of intentional adulteration

Regulation issued within 18 months◦ FDA to issue guidance on protection against

intentional adulteration, including model vulnerability assessment and examples of mitigation strategies and

measures Guidance issued within 1 year

FDA to establish a system to recognize accreditation bodies

Accreditation of 3rd party auditors Unannounced audits to certify “foreign

entities” or their food in compliance with FDA requirements

Auditors required to report to FDA serious deficiencies

Auditors’ accreditation subject to summary revocation if food linked to outbreak

Fees to cover cost of program

FDA must establish a program for the testing of food by accredited labs within 2 yearsFood testing for regulatory purposes must be conducted by accredited labs within 30 monthsRequires test results sent directly to FDA within 30 months

Role of epidemiological investigationsFDA to establish a product tracing system to receive information that allows FDA to effectively and rapidly track and trace food for consumption in USFDA conduct pilots of produce and processed food sectors within 180 daysNo specific timeline provided for establishing a product tracing system

Additional recordkeeping requirements for high-risk food

FDA to establish a list of high-risk foods within 1 yearFDA to issue a NRPM on expanded record-keeping requirements for high-risk food

Subject to expanded FDA records accessDuring foodborne disease outbreak or investigation orReasonable belief food presents threat of serious adverse health consequences (or food affected in a similar manner)

Starting 18 months after enactment, FDA may require responsible party to submit “consumer-oriented information”

FDA will then post 1-page summary of information on its website, and “grocery stores” with 15 or more locations will be required to display within 24 hours

FDA to publish list of means of display, which will include giving “target recall information” to the consumer upon purchase of a food

Risk based foreign supplier verification activities required of importers –◦ Preventive controls◦ Produce standards◦ Not adulterated or misbranded regarding allergens

Effective in 2 years Offering food for import without compliant

verification program subject to injunction and criminal prosecution

Voluntary Qualified Importer Program

FDA may detain food when “reason to believe” threat of serious adverse health consequencesPrevious standard was “credible evidence”Lower standard generally aligned with state detention authority FDA to issue an interim final rule within 180 days

Prior Notice requirement expanded to include “any country to which the article of food has been refused entry.”

Effective in 180 days

David Acheson, MD◦ Leavitt Partners◦ david@leavittpartners.com◦ 801-910-5795◦ www.leavittpartners.com

John Bode◦ OFW Law◦ jbode@ofwlaw.com◦ 202-518-6323◦ www.ofwlaw.com