Search results for: fsma

  • 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  • FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA).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 In January 2018, FDA published a Draft Guidance to explain the Agency’s current thinking on how to comply with certain HARPC requirements. Then on October 19, 2018, FDA released another draft guidance related to this rule.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.

 

 

  • As previously covered on this blog, the Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP) for expediting the review and import entry of human and animal foods into the United States.  Certification through FDA’s Accredited Third-Party Certification Program is one of the eligibility criteria for participation in the VQIP.  Under the VQIP, 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.  Aside from certifications issued for participation in the VQIP, which is fee-based and completely voluntary, certification may be required by FDA as a condition of entry for imported food products in limited circumstances when specific, risk-based criteria are met.
  • Third-party “certification bodies,” otherwise known as third-party auditors, must be recognized by accreditation bodies before they can issue certifications under the Accredited Third-Party Certification Program.  Accreditation bodies, in turn, must apply for and receive recognition from FDA before they may accredit certification bodies.  FDA announced the recognition of International Accreditation Services, Inc. (IAS) of Brea, California as an accreditation body in an August 23, 2018 constituent update.
  • As can be seen on FDA’s Public Registry of Recognized Accreditation Bodies, IAS is only the fourth accreditation body recognized so far under the Accredited Third-Party Certification Program.  IAS joins ANSI-ASQ National Accreditation Board (ANAB), the American National Standards Institute (ANSI), and the National Bureau of Agricultural Commodity and Food Standards (ACFS) which were recognized – with more limited scopes of authority – earlier this year.  IAS is currently the only recognized accreditation body whose scope of authority includes FDA’s regulations on Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) and Acidified Foods.  IAS and some of the other three FDA-recognized accreditation bodies have the ability to recognize certification bodies for conducting food safety audits under FDA’s Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Human Food (Preventive Controls for Human Food rule), Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Animal Food (Preventive Controls for Animal Food rule), Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety Rule), Hazard Analysis and Critical Control Point (HACCP) Systems (Juice HACCP), and Fish and Fishery Products (Seafood HACCP).

 

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about the VQIP.

 

  • FDA issued a final rule more than two years ago, on July 14, 2016, to amend and update the Agency’s food facility registration requirements and implement revisions that were mandated by the Food Safety Modernization Act (FSMA).  FDA’s compliance guidance for the updated food facility registration requirements was issued in draft on November 7, 2016 and was updated – again in draft – on December 27, 2016.  (See previous blog coverage here.)
  • On August 17, 2018, FDA informally announced the availability of the finalized guidance document titled Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.  (See also 83 Fed. Reg. 42024, August 20, 2018.)  FDA concurrently announced the release of a new draft document titled Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration addressing registration requirements when multiple entities are involved in the use of shared physical space, such as where one entity owns a building and lessees manufacture/process, pack or hold food in the building.  (See 83 Fed. Reg. 42062, August 20, 2018.)  All comments on the new supplement that are received by October 19, 2018 will be considered when FDA incorporates it into a future edition of the Q&A Guidance on Food Facility Registration.
  • FDA states that the August 2018 Q&A Guidance on Food Facility Registration has been modified in response to numerous comments received on the draft guidance document.  Changes to the document, however, are not highlighted for easy comparison to the draft guidance.  We are reviewing the August 2018 Q&A Guidance to identify all differences as compared to the draft guidance and determine whether FDA has changed its views on any food facility registration requirements as opposed to merely clarified the Agency’s position.

 

 

  • As previously covered on this blog, on August 24, 2016, FDA published a final rule that extended and clarified the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  The implicated rules are (1) Preventive Controls for Human Food Rule, (2) Preventive Controls for Food for Animals Rule, (3) Produce Safety Rule, and (4) Foreign Supplier Verification Programs (FSVP) Rule.  FDA’s January 2018 “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry” announced FDA’s intent to exercise enforcement discretion with regard to the facilities and requirements that are addressed in the August 24, 2016 rule.
  • Section 212 of the Small Business Regulatory Enforcement Fairness Act (SBREFA) requires FDA to publish a small entity compliance guide (SECG) to assist small entities in complying with actions like the August 24, 2016 final rule on the four FSMA provisions and to explain and clarify the actions that a small entity must take to comply with the rule. The notification of availability of the guidance document “Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide” (May 2018 SECG) was published in 83 Fed. Reg. 22193 (May 14, 2018).
  • The May 2018 SECG does not include any new substantive information and simply confirms FDA’s previous advice by directing the reader to the January 2018 guidance.  The “new” document appears to satisfy the Agency’s SBREFA obligations to provide guidance to small entities regarding the August 2016 final rule.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about the FSMA compliance dates.

 

  • As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered by these rules.
  • On March 19, 2018, FDA released a draft guidance to assist businesses in determining their size under the Preventive Controls regulations. A “small business” is defined in the rules as a business (including any subsidiaries or affiliates) employing fewer than 500 full-time equivalent employees. The draft guidance explains terms such as “subsidiary,” “affiliate” and “full-time equivalent employee.” It also provides a method for calculating full-time equivalent employees, and gives examples of the types of situations businesses might encounter when trying to determine their number of employees.
  • More information concerning about FDA’s final rule for Preventive Control for Human Food and for Preventive Controls for Animal Food can be found here and here.
  • As previously reported on this blog (see here, here and here), the U.S. Food and Drug Administration (FDA) has issued guidance documents, fact sheets, and a Q&A document on how to comply with the foreign supplier verification program (FSVP) final rule, under the Food Safety Modernization Act (FSMA). The FSVP regulation establishes requirements relating to: the use of qualified individuals to conduct FSVP activities, hazard analysis, food and supplier evaluation, foreign supplier verification, corrective actions, recordkeeping, and importer identification. On January 25, 2018, FDA released three additional guidance documents related to the FSVP.
  • The guidance document, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide, explains who is eligible to use FDA’s modified procedures for very small importers or importers of food from certain small foreign suppliers. It also discusses the actions that a small entity must take to comply with the rule.
  • The guidance document, Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities, explains FDA’s intent to exercise enforcement discretion for importers of grain raw agricultural commodities (RACs) that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import.
  • The draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, includes information on how importers can meet the modified FSVP requirements for importers of dietary supplements, very small importers, importers of food from certain small foreign suppliers, and importers of food from countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to that of the United States. This draft guidance also provides a different interpretation on two issues addressed in the preamble to the FSVP final rule.
    • First, the preamble to the FSVP final rule states that waxing and cooling raw agricultural commodities, when done by a packing operation for purposes of storage or transport, may be considered a packing activity; while the draft guidance states that such activities may be packing activities and/or holding activities, depending on the circumstances.
    • Second, FDA states in the preamble to the FSVP final rule importers may need to address hazards that may be intentionally introduced by acts of terrorism. The draft guidance clarifies that importers are not required under the FSVP regulation to consider in their hazard analysis hazards that are intentionally introduced to cause wide scale public health harm but should consider warning letters or other enforcement action taken by FDA against foreign suppliers for violation of FDA’s regulation on intentional adulteration as part of their evaluation of potential suppliers.
  • FDA will be accepting comments on the draft FSVP guidance until May 25, 2018 (instructions on how to submit comments can be found in the Federal Register notice announcing the availability of the draft guidance (83 FR 3445). We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities.
  • Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects of the Food Safety Modernization Act (FSMA). 83 FR 598. In short, this guidance document outlines the Agency’s intent to not enforce certain FSMA requirements as they currently apply to certain entities and/or activities. This enforcement discretion specifically relates to certain provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety) and how they apply to:
    • facilities that would be farms except for certain factors and activities
    • written assurances provisions in all four rules related to the customer’s control of identified hazards that are a potential risk to public health
    • the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food, and
    • FSVP requirements for importers of food contact substances.
  • As our readership is well aware, FDA had previously extended the compliance dates for many of the provisions covered by this guidance (see August 2016 compliance date extension). The enforcement discretion policies enumerated in the guidance will remain in place until and unless FDA decides to take further action on any of these issues.
  • Our detailed summary of the enforcement discretion policies and their potential impact on industry will be posted to our Firm’s website shortly. In the meantime, please feel free to contact us with any questions at fooddrug@khlaw.com.