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January 2011

Food Safety Modernization Act: Overview and Impact

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Food Safety Modernization Act

• Signed into law on January 4, 2011

• Most sweeping overhaul of the food safety system since 1938

• Several provisions are already in effect

• Increased inspection frequency

• Expanded records access

• Import certification authority

• Mandatory recall authority

• Fees

• Port shopping

• Whistleblower protection

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Mandatory Inspection Frequencies

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

Who is impacted?

◦ All registered facilities (any factory, warehouse, or establishment that manufactures, processes, packs or holds food)

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Mandatory Inspection Frequencies

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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Expanded Records Access

What is new?

◦ If FDA has a reasonable belief an article of food will cause severe adverse health consequences, a facility 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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Expanded Records Access

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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Mandatory Recall Authority

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

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

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Mandatory Recall Authority

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

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

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Mandatory Recall Authority

What will be different

◦ Previously, if a firm refused to recall, FDA could issue press and pursue a court order, in each applicable jurisdiction, to seize the product

◦ Gives FDA authority to take action without prior court approval

What does this mean?

◦ Majority of recalls occur voluntary and quickly because firms to not want to risk making consumers sick

◦ Fills a gap in FDA authority◦ Probably will not be used on a routine basis

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Certification of Imported Food

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

Who is impacted?

◦ Foreign manufacturers, processors, packers, holders, and importers◦ Food safety auditors

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Certification of Imported Food

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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Immediate Impact Other provisions:

Fees Re-inspection of a facility (including importers) Cover all FDA recall related costs Participate in Voluntary Qualified Importer Program

Port Shopping Requires notification by FDA to the Secretary of Homeland

Security when food is refused admission to prevent importers from port shopping

Whistleblower protections No entity engaged in manufacturing, processing, packing,

transporting, distributing, receiving, holding or importing food may discharge or discriminate against a whistleblower

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Other Key Requirements

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 Prior notice of imported food

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Impact on Registered Facilities

Biennial Facility Registration ◦ Sooner of 180 days or FDA issuing regulation◦ FDA can suspend registration if food presents a reasonable probability

of causing serious adverse health consequences

Preventive Controls Requirement◦ Identify hazards◦ Implement preventive controls◦ Monitor, correct, and verify◦ Document

Foreign supplier verification◦ Food was produced in compliance with preventive controls and

produce standards◦ Food is not adulterated or misbranded

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Tracking and tracing ◦ FDA to pilot product tracing in processed food and produce sectors◦ Implement a product tracing system◦ Additional record-keeping requirements for high-risk foods

Protection against intentional contamination ◦ FDA to issue guidance on mitigation strategies◦ FDA to issue regulations on who is required to implement mitigation

strategies

New dietary ingredients◦ FDA guidance on definition of new dietary ingredient◦ Evidence needed to document the safety of new dietary ingredients◦ Appropriate methods for establishing the identify of a new dietary

ingredient

Impact on Registered Facilities

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Impact on Importers

Foreign supplier verification program◦ Importers must verify that imported food is produced in compliance

with U.S. laws and regulations

Voluntary qualified importer program◦ Expedited review of food offered by importers participating in the

program

Authority to require certification for imported food◦ Allows FDA to require certificates of compliance with U.S. laws and

regulations based on known risks associated with the food or country, region or territory of origin

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Impact on Importers

Changes to prior notice requirements◦ Must notify FDA of any country that refused the product

Accreditation of third party auditors ◦ Conduct audits of foreign facilities and issue certifications to ensure

product is in compliance with U.S. laws and regulations◦ Determine if a facility is eligible to offer food for import under the

voluntary qualified importer program

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Impact on Laboratories

Accreditation of Laboratories◦ FDA to develop program within 2 years ◦ Accreditation will be required for regulatory testing within 30 months

Testing methods, use of new methods, method validation◦ Model standards for accreditation◦ Required plan for building capacity with foreign governments should

include provisions for the multilateral acceptance of laboratory methods and testing and detection techniques

Performance Standards◦ FDA will review foodborne contaminants and issue regulations or

guidance and action levels as necessary to reduce risks

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Next Steps

Monitor implementation of legislation ◦ Impact of much of the legislation is dependent on how regulations are

drafted◦ Implementation is dependent of FDA resources

Provide input on rule-making process

Stay in front of changes ◦ Understand and respond to dynamics ◦ Review current business and identify vulnerabilities and opportunities

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Thank You