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  • Those who manufacture, process, pack, or hold foods that are on FDA’s Food Traceability List (FTL), including certain cheeses, shell eggs, nut butters, various fresh fruits and vegetables, finfish, crustaceans, mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing non-transformed FTL foods, are subject to further recordkeeping requirements in addition to the traceability requirements that are generally applicable to other foods.  On November 21, 2022, FDA published the FDA Food Safety Modernization Act (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule), discussed here, which requires these entities to maintain records containing information known as key data elements (KDEs) that are associated with critical tracking events (CTEs) in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods.  When requested, these records must be provided to FDA within 24 hours or some reasonable time to which FDA has agreed. 
  • On May 18, 2023, FDA published a Small Entity Compliance Guide (SECG) to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in 21 CFR part 1, subpart S.  The SECG defines key terms of the Food Traceability Rule and, in addition to providing detailed guidance on how to comply with each part of the rule, offers guidance for determining whether an entity may be exempt from the rule and instructions on petitioning for a modification, waiver, or exemption from various requirements of the rule.  The SECG also notes that violation of any recordkeeping requirement under FSMA section 204, including any Food Traceability Rule violation, is prohibited under the Federal Food, Drug, and Cosmetic Act, except when such violation is committed by a farm, and that articles that appear not to comply with the requirements of the Food Traceability Rule are subject to refusal of admission to the U.S. 
  • The compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule is Tuesday, January 20, 2026. 
  • As we reported, FDA released a list on January 31, 2022 of important guidance topics that are a priority for completion this year.  The list includes enforcement policy guidance concerning five of the seven foundational rules implementing the FDA Food Safety Modernization Act (FSMA).
  • On March 14, 2022, FDA published notification of availability of Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions Guidance for Industry.  The March 2022 guidance describes new or extended FSMA enforcement discretion policies as follows:
    • FDA extended the policy, announced in March 2019 Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds, not to enforce part 112 for entities engaged in the relevant activities while FDA considers rulemaking to address the unique circumstances of these commodities.
    • FDA extended the enforcement policies announced in January 2018 Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs as follows:
      • Until rulemaking involving certain farm-related activities is finalized, FDA will not enforce for listed entities (1) the part 117 (human food) and/or part 507 (animal food) preventive controls requirements; (2) the part 507 current good manufacturing practice (CGMP) requirements for the listed entities that are subject to the part 507 CGMPs; or (3) the part 117 CGMP requirements with regard to non-produce raw agricultural commodities (RACs).
      • Until the completion of new rulemaking that considers complex supply chain relationships and resource requirements, FDA will not enforce certain requirements for written assurances in part 117, part 507, the FSVP regulation, and Part 112 (the Produce Safety regulation).
      • While FDA considers the issue, it will not enforce the part 507 preventive controls requirements related to human food by-products if after separation from the human food, the entities are performing one of a limited number of identified manufacturing/processing activities.
    • FDA clarified that the enforcement discretion policies under the January 2018 guidance extend to any requirement (under FSVP or the preventive controls supply-chain program requirements) for an importer or receiving facility to verify a supplier’s compliance with a FSMA requirement which itself is associated with an enforcement discretion policy, although FSVP requirements which are not associated with an enforcement discretion policy remain subject to FDA’s usual enforcement policies.
    • FDA announced it does not intend to enforce the requirements of Part 121 (Intentional Adulteration) for those facilities that are under the farm-activity related enforcement policy described in the January 2018 guidance until the completion of rulemaking, which will clarify food facility registration requirements for those entities (e.g., facilities that would be farms except for ownership of the facility; facilities that would be farms if they did not color RACs).
    • FDA announced it does not intend to enforce the requirement for reanalysis of the Food Defense Plan (FDP) in 21 CFR 121.157(b)(3) when improper implementation of a mitigation strategy or combination of mitigation strategies is addressed through implementation of corrective actions procedures that correct the problem and reduce the likelihood of recurrence.
    • FDA extended the policy, announced in November 2017 Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food, which was extended in a November 6, 2019 update, as discussed here, not to enforce requirements for a supply-chain program for certain raw materials and other ingredients while FDA works to better understand additional practical challenges related to compliance with supplier verification and approval challenges related to co-manufacturing.
  • This guidance is immediately effective per FDA’s determination that prior public participation is not feasible or appropriate with respect to these new and extended enforcement policies because the guidance presents a less burdensome policy that remains consistent with FDA’s public health mission.  FDA will, however, review any comments that are received and revise the guidance when appropriate, as required under 21 CFR 10.115(g)(3)(ii).

On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued its “Temporary Policy Regarding Preventive Controls and FSVP [Foreign Supplier Verification Food Program] Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry.” As previously reported in this blog, FDA had recently announced it would postpone most foreign inspections until April 2020, cancel all foreign travel by agency officials, and limit domestic travel to “mission critical only” through April. Also as reported in this blog, FDA announced it would scale back domestic inspections in response to COVID-19.

Pursuant to the Guidance, the Agency further announces its intention to exercise enforcement discretion regarding requirements in three food regulations to conduct onsite audits of food suppliers, if other supplier verification methods are used instead: (1) Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 C.F.R. part 117); (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 C.F.R. part 507); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 C.F.R. part 1 subpart L). The Guidance provides information regarding the specific circumstances under which FDA intends to refrain from enforcing the requirements for an onsite audit.

The Guidance notes that receiving facilities and FSVP importers should resume onsite audits within a reasonable period of time after it becomes practicable to do so, and should update their food safety plans and foreign supplier verification programs accordingly. The Agency states it will provide timely notice about the withdrawal of this temporary policy. We will continue to monitor the situation for any developments.

 

  • We reported on the Food and Drug Administration’s (FDA) November 2017 guidance giving certain co-manufacturers two more years to comply with requirements for a supply-chain program for certain raw materials and other ingredients under the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs.  FDA determined that more time was needed for brand owners to establish new contracts with the firms the brand owners select to supply their co-manufacturers.  To comply with the supply-chain program requirements, co-manufacturers often need detailed information about suppliers that only the brand owner has, and that cannot be shared because of confidentiality clauses in the contracts between brand owners and the co-manufacturers’ suppliers.
  • On November 6, 2019, the date that FDA’s enforcement policy applicable to certain co-manufacturers would have expired, FDA announced that a forthcoming notice will be published soon in the Federal Register extending the enforcement discretion policy while FDA works to better understand additional challenges industry is facing in trying to meet the FSMA supply-chain requirements.  The non-enforcement policy extension was granted after requests from the American Frozen Food Institute (AFFI) and Food and Beverage Issues Alliance (FBIA) indicated their members have yet to overcome the many contractual and logistical barriers to compliance with the supplier verification requirements as they relate to brand owners and co-manufacturers and further consultation between FDA and industry is needed to resolve these compliance challenges.
  • FDA’s November 6, 2019 announcement does not identify a new compliance deadline for co-manufacturers benefitting from the new extension of FDA’s enforcement policy for the relevant FSMA supply-chain program requirements.  Co-manufacturers are still responsible for other applicable requirements under the Federal Food, Drug, and Cosmetic Act.

 

  • The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories.  Under this program, FDA must recognize accreditation organizations that accredit food testing laboratories and adopt model accreditation standards that such laboratories must meet.
  • On November 1, 2019, FDA released a proposed rule under which FDA will recognize accreditation bodies, which will, in turn, accredit laboratories to conduct food testing.  FDA’s proposed laboratory accreditation program partially incorporates two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for accreditation bodies and laboratories, respectively.  Once the laboratory accreditation program is established, testing of human and animal food in certain circumstances must be conducted by an accredited laboratory and the results must be sent directly to FDA.  A full test report is required unless the testing laboratory meets FDA’s proposed provisions for submitting an abridged report.  Circumstances where testing by an accredited laboratory would be required include:

 – To comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests of shell eggs, bottled water, and sprouts);

 – To provide evidence on the admissibility of imported food (e.g., for a food that has been detained due to an appearance of adulteration);

 – To support the removal of a food from an import alert through successful consecutive testing;

 – To address an identified or suspected food safety problem and provide evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order;

 – To respond to a “food testing order,” which is a new procedure proposed by this rule to address an identified or suspected food safety problem.

  • Laboratories run and operated by federal agencies, states, localities, and foreign government entities, as well as private laboratories, including in-house laboratories, will be eligible for accreditation under FDA’s proposed program.  Laboratories could be accredited in one or more major disciplines (e.g., microbiology, chemistry, and physical testing).  FDA will establish a publicly available list of recognized accreditation bodies and laboratories accredited.  Both accrediting bodies and accredited laboratories will be subject to FDA oversight, although accrediting bodies will have primary oversight of accredited laboratories.
  • Comments on FDA’s proposed rule are due by March 3, 2020.  The laboratory accreditation program would become effective 60 days after a final rule is published; however, FDA will allow itself an unspecified time period after that to get ready to accept applications for recognition from accrediting bodies.  Then it will take more time for FDA to recognize a sufficient number of accrediting bodies so that laboratories may then apply for accreditation.  In this regard, the compliance date for testing to be conducted by an accredited laboratory participating in FDA’s program would be no sooner than six months after FDA publishes notice of sufficient laboratory capacity.  Thus, mandatory testing by an accredited laboratory appears to be a couple of years away at the earliest.
  • On September 30, 2019, FDA announced the establishment of the Food Safety Dashboard, which is designed to measure the progress of the seven foundational rules of the Food Safety Modernization Act (FSMA), to track their impact, and to help FDA to refine its implementation of the rules. As FDA embarks on a New Era of Smarter Food Safety, continuing the successful implementation of FSMA will support the Agency’s goal of reducing illness and death due to preventable contamination of FDA-regulated human and animal food products, explained the Agency in a press release. (For more information on FDA’s New Era of Smarter Food Safety, see our September 28 blog.)
  • The initial metrics on the Food Safety Dashboard will begin to track outcomes for three FSMA rules in the areas of inspections and recalls. These are:
    • “Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls” rules for both human food and food for animals (preventive controls rules).
    • Imported food safety, including data relevant to the “Foreign Supplier Verification Program” (FSVP) rule.
  • “We plan to update the data for these three FSMA rules quarterly, with our goal being to ultimately publish metrics for all seven rules,” stated Acting FDA Commissioner Ned Sharpless and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in a statement about the Dashboard. They added, “Many factors will influence these data over time, especially in the early phases of implementation.” FDA expects that it will take several years to establish meaningful trends from the data on the Dashboard.
  • The Food Safety Dashboard is available as part of the FDA-TRACK program, the FDA’s agency-wide performance management system.
  • On August 19, two consumer groups, Center for Food Safety (CFS) and Center for Environmental Health (CEH), filed suit against the FDA in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA). At issue in the lawsuit is Section 422 of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by FSMA.  Section 422 (21 U.S.C. 350k) required that by January 4, 2013, FDA establish a program to detect and address foodborne illness outbreaks with more accredited laboratories and provide a database of accredited labs.  Among other requirements, FDA was to establish a program for the testing of food by accredited laboratories; establish a publicly available registry of accreditation; and develop model standards that a laboratory must meet in order to be accredited by a recognized accreditation body. 21 U.S.C. §350k(a).
  • In the complaint, CFS and CEH allege that missing the 2013 deadline and failing to propose final regulations by six years violated FSMA and the Administrative Procedures Act (APA), and “is putting millions of lives at continued risk from contracting foodborne illness, contrary to Congress’s commands.” According to CFS staff attorney, Ryan Talbott, “[a]ccurate laboratory testing is essential to reduce the foodborne illness threat. […] FDA was required to establish a comprehensive food testing program years ago, but has yet to do so. We will hold FDA accountable and protect the public health, as we always have.”
  • The lawsuit comes after 2018 saw several foodborne illness outbreaks, most notably the multistate outbreak of E. coli linked to romaine lettuce. In 2018, the Centers for Disease Control and Prevention (CDC) investigated 24 foodborne illness outbreaks as compared to 7 outbreaks in 2017.  This year, the CDC has already investigated 12 outbreaks.
  • CFS and CEH have sued FDA over missed FSMA deadlines twice before. Our readers may recall the 2012 suit against FDA after the agency missed seven statutory Congressional deadlines for promulgating FSMA’s food safety regulations. See Str. For Food Safety v. Hamburg, 954 F.Supp.2d 965 (N.D. Cal. 2013). The 2012 Court held that “FDA’s failure to promulgate the mandated regulations by their statutory deadlines constituted a failure to act under the Administrative Procedure Act (APA) and unlawful withholding of the regulations in violation of FSMA and the APA.” The Court granted injunctive relief and established a timeline for FDA to promulgate the final regulations. In October of 2018, CFS and CEH sued the agency for failure to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods by the statutory deadlines. On June 7, 2019, via Consent Decree, FDA agreed to a schedule of deadlines to establish reporting requirements for “high-risk” foods.
  • FDA has yet to respond to the current CFS and CEH complaint. Keller and Heckman will continue to monitor the developments of this case.
  • The FDA Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees from (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs.  See Sections 743(a)(1)(A), (B), and (D), respectively, of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Every year since Fiscal Year (FY) 2012, FDA has published the established rates for assessing fees for food facility reinspections, recall orders, and importer reinspections.  These FSMA authorized fees have not been collected, however, because guidelines mandated under Section 743(b)(2)(B)(iii) of the FD&C Act, for considering the burden of such fees on small businesses, are not yet available, and FDA is also still considering various issues associated with the assessment and collection of importer reinspection fees.  Additionally, guidance is also pending regarding the circumstances under which FDA would consider non-compliance to be materially related to a food safety requirement of the FD&C Act.  It is food safety related noncompliance issues that trigger a reinspection (subject to a fee assessment) to evaluate corrective actions.
  • In the July 25, 2019 Federal Register, FDA announced its FY 2020 rate of $240/hour, exclusive of travel, that will be assessed for FDA staff working on certain food facility reinspections, recall orders, and importer reinspections.  FDA’s rates where domestic travel or foreign travel are required are $258/hour and $301/hour, respectively, and are both increased as compared to the rates of $253/hour and $282/hour, respectively, for FY 2019, which ends September 30, 2019.  It does not appear as though any of these FSMA authorized fees will be collected for FY 2020 because FDA simultaneously announced (as it has in the past) that it does not intend to issue invoices for reinspection or recall order fees until FDA publishes a guidance document outlining the process through which firms may request a reduction in fees and that importer reinspection fee issues are still under consideration.