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.
  • On July 23, 2019, FDA published a notice in the Federal Register announcing the fiscal year 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized by the Third-Party Certification Program, as authorized by the 2011 Food Safety Modernization Act (FSMA).
  • Under FSMA, FDA established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals and that meet applicable FDA food safety requirements. As previously covered on this blog, the accreditation process includes a web-based application and user fee.
  • In fiscal year 2020, FDA will collect an initial application fee for accreditation bodies seeking recognition of $41,328, an annual fee for recognized accreditation bodies of $1,945, an annual fee for certification bodies accredited by a recognized accreditation body of $2,432, and an initial application fee for a certification body seeking direct accreditation from FDA of $41,328. The fee rates are effective October 1, 2019, and will remain in effect through September 30, 2020.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about FSMA or the Accredited Third-Party Certification Program.

  • FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA).
  • The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 FR 55907). In January 2018, FDA published a Draft Guidance to explain the Agency’s current thinking on how to comply with certain HARPC requirements. Then on October 19, 2018, FDA released another draft guidance related to this rule. The “Guide to Minimize Food Safety Hazards of Fresh-cut Produce” is specifically for fresh-cut produce processors and explains how they can comply with the CGMP and HARPC requirements imposed by the Preventive Controls Rule. The draft guidance defines “fresh-cut produce” as “any fruits or vegetables or combination thereof that has been physically altered (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking).” When finalized, this draft guidance will replace the 2008 guidance, “Guide to Minimize Microbial Food Hazards of Fresh-cut Fruits and Vegetables.”
  • The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353). The second draft guidance document published by FDA on October 19, 2018, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” relates to this rule. The draft guidance reflects the flexibility that was built into the Produce Safety Rule to accommodate practices that vary by region and commodity, explained FDA Commissioner Scott Gottlieb, M.D. in a Statement on the new draft guidance documents. (FDA may issue additional draft guidance on the Produce Safety Rule to address agricultural water in the future. As we previously reported on this blog, FDA published a proposed rule in September 2017 seeking to extend the compliance dates for the agricultural water standards set forth in the Produce Safety Rule.)
  • Comments on these draft guidance documents need to be submitted by April 22, 2019, to be considered by FDA before it begins work on the final versions of these guidance documents. We will continue to monitor and report on developments related to these rules and other FSMA developments.
  • The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed suit against the FDA on October 15 for failure to implement provisions of the Food Safety Modernization Act (FSMA).  CFS and CEH assert FDA has failed to meet several important FSMA action deadlines related to FDA’s mandate to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods. These requirements are codified at 21 U.S.C. §§ 2223(d)(1)-(2), which states that such designations should be made no later than 1 year after January 4, 2011.
  • As background, the overarching purpose of FSMA is to “rapidly and effectively” identify recipients of a food to prevent or mitigate a foodborne illness outbreak. Thus, under Section 204 of FSMA, Congress included numerous provisions that focused specifically on the goal of “rapidly and effectively” preventing or mitigating foodborne illness. CFS and CEH allege that FDA failed to complete the following Section 204 mandated actions:
    • (1) In order to enhance the tracking and tracing of food, Congress required FDA to conduct pilot projects on potential food-tracing systems and report their findings. The findings were to be reported by October 1, 2011.
    • (2) FDA was to designate a classification of “high-risk” foods, meaning foods that were at the highest risk of being carriers of foodborne illness. FDA was to base a “high-risk” classification on a set of criterion, including known safety risks of the food, the history and severity of foodborne illness, outbreaks attributed to such foods, and the steps taken during the manufacturing process to reduce possible contamination. The “high-risk” classification was to be designated by January 4, 2012.
    • (3) Congress required FDA to promulgate a proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack or hold foods that are designated high-risk. The proposed rulemaking was to be promulgated no later than January 4, 2013.
    • (4) Congress required that FDA publish the list of designated “high-risk” foods on its website at the same time the agency promulgated the final rule food additional recordkeeping requirements.
  • According to CFS and CEH, FDA failed to meet the above-listed deadlines, and in some instances, did not adhere to Congressionally-required actions. While CFS and CEH acknowledge FDA belatedly conducted the pilot program and submitted its report to Congress in November 2016, they note that FDA has still not designated a “high-risk” foods classification, nearly five years after the Congressionally-mandated deadline. CFS and CEH state that FDA’s failure to implement these regulations by their statutory deadlines is “an abdication of the agency’s fundamental responsibilities.” And therefore, the organizations brought the lawsuit to require FDA to complete implementation of these actions by Court-established deadlines.
  • This pending litigation is, in essence, phase II of an action brought by CFS in 2012 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), referred to in the current complaint as FSMA I. 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. FDA met each Court-established deadline for FSMA I and promulgated the required rules. However, the “high-risk” classification was outside the scope of FSMA I, and hence is at the center of the current lawsuit.
  • FDA has yet to respond to the CFS and CEH complaint. Keller and Heckman will continue to monitor the developments of this case.
  • On May 16, 2016 (81 FR 30219), FDA issued a draft guidance document intended to assist “qualified facilities” comply with modified requirements under the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA).  A qualified facility is defined as: (1) a very small business (defined with respect to annual market value of food sold or held); or (2) a facility with average annual sales of <$500,000 over the prior 3-year period and with at least 50% of sales directly to consumers or to local retailers or restaurants (within the same state or within 275 miles of facility).  21 CFR 117.3 (human food); 21 CFR 507.3 (animal food).  Under the modified requirements, a business must submit a form to FDA, attesting to its status as a qualified facility.  (See previous blog coverage here.)
  • On September 14, 2018, FDA announced the availability of the finalized guidance document titled Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food And Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.  (See also 83 Fed. Reg. 46878, September 17, 2018.)  FDA concurrently announced the release of the required attestation forms, Form FDA 3942a for facilities subject to the PC Human Food rule, and Form FDA 3942b for facilities subject to the PC Animal Food Rule, along with instructions on how to fill them out and how they should be submitted.
  • Changes to the guidance were minor and include: (1) clarification regarding recordkeeping and FDA review of records, (2) clarification regarding how a facility can meet the definition of a “very small business,” (3) addition of new examples of calculations, and (4) explanation of a simpler method for determining whether a facility’s 3-year average of food sales and food market value is below the inflation adjusted threshold for a “very small business.”
  • The dates for submitting an attestation to FDA have not changed.  Facilities subject to the PC Human Food rule must submit their first attestation to FDA by December 17, 2018, if they began manufacturing, processing, packing, or holding food before September 17, 2018.  Facilities subject to the PC Animal Food rule must submit their first attestation by December 16, 2019, if they began manufacturing, processing, packing, or holding animal food before September 17, 2019.  Beginning in 2020, attestation forms will need to be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.