Search results for: accreditation

  • On July 12, 2022, FDA announced its recognition of six accreditation bodies under the Laboratory Accreditation for Analyses of Foods (LAAF) program. Accredited bodies under LAAF may, in turn, accredit laboratories to the standards established under the Food Safety Modernization Act of 2011 (FSMA).
  • By way of background, FSMA directs FDA to establish a program for the setting of food by accredited laboratories.  FDA’s final rule on LAAF became effective on December 1, 2021, and provides eligibility requirements and procedures on how FDA will oversee the LAAF program.  The LAAF program aims to improve the reliability of certain food testing through enhanced FDA oversight of participating laboratories and accreditation bodies. To be eligible for LAAF recognition, an accreditation body must be a full member of the International Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC Mutual Recognition Arrangement with demonstrated competence to ISO/IEC 17011:2017(E) and a scope of “Testing: ISO/IEC 17025.”
  • As previously reported, on February 11, 2022, FDA announced the launch of the LAAF application portal where interested accreditation bodies may apply for recognition under the LAAF program. A list of the recognized accreditation bodies will be listed in the public registry. Additional information and commonly asked questions on FSMA and the LAAF program may be found here.
  •  The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, also referred to as the Third-Party Program (TPP).  The voluntary TPP allows accreditation bodies (ABs) to apply for recognition by FDA. Recognized ABs have the authority to accredit certification bodies (CBs), otherwise known as third-party auditors. In turn, the CBs (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals. FDA can require certification as a condition of entry for imported food products in limited circumstances when specific, risk-based criteria are met. Importers can use a certification to establish eligibility to participate in the Voluntary Qualified Importer Program (VQIP).
  • In a June 24, 2022 Constituent Update, FDA announced that it has recognized Jamaica National Agency for Accreditation (JANAAC), as an AB under the Accredited Third-Party Certification Program for a period of five years.  JANAAC joins three other ABs that are currently recognized in various scopes of accreditation, i.e., ANSI National Accreditation Board (ANAB), Thailand’s National Bureau of Agricultural Commodity and Food Standards (ACFS), and International Accreditation Services (IAS).  FDA has recognized JANAAC as having the authority to accredit CBs with the ability to conduct food safety audits under ten of the eleven possible scopes of accreditation:
    • Acidified Foods (AF)
    • Dietary Supplements
    • Juice Hazard Analysis and Critical Control Points (Juice HACCP)
    • Low-Acid Canned Foods (LACF)
    • Medicated Feed Current Good Manufacturing Practices (Medicated Feed CGMPs)
    • Preventive Controls for Animal Food (PCAF)
    • Preventive Controls for Human Food (PCHF)
    • Produce Safety
    • Seafood Hazard Analysis and Critical Control Points (Seafood HACCP)
    • Shell Eggs
  • JANACC is the only recognized AB whose scope of authority includes Medicated Feed CGMPs and Shell Eggs.  No AB is yet recognized with the authority to accredit CBs with the ability to conduct safety audits for Infant Formula.
  •  The Food Safety Modernization Act of 2011 (FSMA) directs FDA to establish a program for the testing of food by accredited laboratories.  We reported on FDA’s Final Rule which became effective on December 1, 2021 and provides eligibility requirements and procedures on how FDA will oversee a new Laboratory Accreditation for Analyses of Foods (LAAF) program.  Under the LAAF program, FDA will recognize accreditation bodies that will, in turn, accredit laboratories, which will test food and provide results directly to FDA.  Testing by a LAAF-accredited lab will be required to support removal of a food from an import alert or admission of an imported food detained at the border; to address an identified or suspected food safety problem with shell eggs, sprouts, and bottled drinking water; to address an identified or suspected food safety problem in certain, rare circumstances; and in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention.
  • On February 11, 2022, FDA announced the launch of the LAAF application portal (with User Guide) where interested accreditation bodies may apply for recognition under the LAAF program.  Once the FDA has recognized a sufficient number of accreditation bodies, the agency will announce that laboratories may apply to the recognized accreditation bodies for LAAF-accreditation.  When there is sufficient LAAF-accredited laboratory capacity for the food testing covered by the final rule, the agency will publish a document in the Federal Register giving owners and consignees 6 months’ notice that they will be required to use a LAAF-accredited laboratory for such food testing.
  • There is no way of predicting when the first LAAF-accredited laboratories will be available for food testing.  FDA anticipates that LAAF-accredited laboratory capacity may become available at different times for various types of food testing described in the final rule, e.g., testing for biological, chemical, physical, radiological hazards, or, most commonly, microbiological hazards.
  • In 2019, we reported on FDA’s proposed rule to Implement a Laboratory Accreditation Program for Food Testing.  On December 1, 2021, FDA published a final rule pursuant to the Food Safety Modernization Act (FSMA) on Laboratory Accreditation for Analyses of Foods (LAAF). LAAF will establish a laboratory accreditation program for testing of food in certain circumstances. Under the program, FDA will recognize accreditation bodies that will, in turn, accredit laboratories. The final rule provides eligibility requirements and procedures on how FDA will oversee the program.
  • The LAAF program is intended to improve the accuracy and reliability of certain food testing through uniform standards and enhanced FDA oversight. After the LAAF final rule is fully implemented, owners and consignees will be required to use LAAF-accredited laboratories for food testing under specific circumstances, such as to support removal of a food from an import alert or to support admission of an imported food detained at the border.
  • FDA plans to announce that accreditation bodies may apply for recognition in early 2022.  Eligibility requirements for accreditation bodies include complying with ISO/IEC 17011:2017(E), being a member of the International Laboratory Accreditation Cooperative (ILAC), and signing the ILAC Mutual Recognition Arrangement (MRA); the regulations also include conflict of interest provisions. Laboratories may apply for LAAF-accreditation after a sufficient amount of accreditation bodies have been recognized. Once enough laboratories are accredited, the agency will give owners and consignees 6 months’ notice that LAAF-accredited laboratories will be required for such food testing.

 

  • As previously discussed on this blog, the U.S. Food and Drug Administration (FDA) released a proposed rule on November 4, 2019 for recognizing accreditation bodies, which will, in turn, accredit laboratories to conduct food testing.  An FDA accreditation program for food testing laboratories is mandated by the FDA Food Safety Modernization Act (FSMA).  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.
  • FDA has thus far received comments from the American National Standards Institute (ANSI) National Accreditation Board (NAB) and two large food industry groups.  The Food and Beverage Issue Alliance and the American Frozen Food Institute have merely asked FDA to extend the comment period beyond the original March 3, 2020 due date.  The ANSI-NAB submitted substantive comments: asking FDA to clarify proposed nomenclature (e.g., “probationary,” probationary status,” and “accredited”), to use terms consistently, and to clearly document supplemental requirements for recognized accreditation bodies and qualified accredited laboratories beyond ISO/IEC 17011 and ISO/IEC 17025, respectively.
  • FDA recently announced a 30-day extension – until April 6, 2020 – for submitting comments on the proposed rule and associated information collection provisions for the proposed regulations on the laboratory accreditation program.
  • 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.

 

  • 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.

  • As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.
  • On January 31, 2018, the FDA announced that ANSI-ASQ National Accreditation Board (ANAB) – an organization jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ) – became the first accreditation body to receive FDA recognition under the voluntary Accredited Third-Party Certification Program, created by the Food Safety Modernization Act (FSMA). FDA explained that it recognized ANAB for a five-year term because it met the applicable FDA requirements, which were validated through application review and on-site assessment.  Additional information on this development is available in our client alert available here.
  • Keller and Heckman will continue to monitor and provide updates regarding FDA’s implementation of the Accredited Third-Party Certification Program and other FSMA-related issues.
  • As previously covered on this blog, in November 2015, the FDA announced the implementing final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” that establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.  Click here for our summary of the final third-party certification rule.
  • On December 7, 2016, FDA issued final guidance for industry containing recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The Agency previously issued a draft version of this guidance in July 2015.
  • Keller and Heckman attorneys regularly advise on FSMA-related compliance, including the third-party certification final rule, and stand ready to assist interested parties.

FDA issues a proposed rule and draft guidance to implement its third-party accreditation program under FSMA.

  • The FDA Food Safety Modernization Act (FSMA) directs FDA to establish a program for accrediting third parties to conduct food safety audits and issue certifications for facilities and food.  The Agency may use certifications:  (1) as a condition of entry for certain imported foods that FDA has determined to pose a food safety risk; and (2) to facilitate participation in the Voluntary Qualified Importer Program (VQIP), previously covered on this blog.  Participation in the accredited third-party audit/certification program is voluntary.  FDA issued a proposed rule to implement the program on July 29, 2013.  A final rule is anticipated in Fall 2015.  FSMA directs FDA to establish user fees to implement the third-party accreditation program and to develop Model Accreditation Standards that recognized accreditation bodies must use to qualify third-party auditors/certification bodies.
  • On July 23, 2015, FDA released a proposed rule to establish user fees to fund the Agency’s work in implementing the new third-party accreditation program.  The proposal indicates that four parties would be subject to user fees:
    1. Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program;
    2. Recognized accreditation bodies participating in the third-party accreditation program;
    3. Auditors/certification bodies submitting applications or renewal applications for direct accreditation; and
    4. Accredited auditors/certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party accreditation program.
  • The proposal would establish both application fees and annual fees to cover FDA’s costs in implementing the program.  FDA proposes to notify the public of the fee schedule annually prior to the beginning of the fiscal year for which the fees apply, and each fee schedule would be adjusted to account for inflation and improved estimates of the cost to FDA of performing relevant work for the upcoming year.  User fees would be non-refundable and no exemption or reduced fee exists for small businesses.  Non-payment of application fees would result in FDA deeming the applications to be incomplete.  Non-payment of annual fees would result in the suspension, and ultimately, revocation, of recognition/accreditation of previously recognized/accredited bodies.
  • Also on July 23, 2015, FDA released a draft guidance document intended to serve as the Model Accreditation Standards for the third-party accreditation program.  FDA considered various voluntary consensus standards and ultimately drew guidance from International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) ISO/IEC 17021:  Conformity Assessment — Requirements for bodies providing audit and certification management systems (2011) (ISO/IEC 17021:2011).  The draft guidance addresses topics such as capacity and competence; conflicts of interest; quality assurance; records procedures; and regulatory audit reports, and provides the Agency’s recommendations in each area.
  • Both the proposed rule and the notice of availability of the draft guidance are scheduled for publication in the Federal Register on July 24, 2015.  FDA will accept comments for 75 days after publication, i.e., until October 7, 2015.   Stakeholder comments will influence FDA’s implementation of the third-party accreditation program, which, in turn, will affect implementation of the VQIP and the Agency’s efforts to ensure the safety of the imported food supply.