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  5. FSMA Proposed Rule on Laboratory Accreditation
  1. Food Safety Modernization Act (FSMA)

FSMA Proposed Rule on Laboratory Accreditation

The U.S. Food and Drug Administration (FDA) is proposing to establish a program for the testing of food by accredited laboratories as required by the FDA Food Safety Modernization Act (FSMA). The laboratory accreditation program, once established, will require that the testing of food in certain circumstances be conducted by laboratories that voluntarily become accredited under this program.

Laboratories that become accredited under this program will be required to follow model standards and will be subject to appropriate oversight. Establishing such a program will help FDA ensure the safety of the U.S. food supply and protect U.S. consumers by helping ensure appropriate oversight of certain food testing that is of importance to public health. It will also ensure that the testing is done in accordance with appropriate model standards which will help produce consistently reliable and valid test results. 

Key Features

  1. Overview

    If finalized, the rule would:

    • establish the framework and requirements for accreditation bodies (ABs) seeking recognition by the FDA, as well as requirements for laboratories seeking accreditation;
    • incorporate by reference existing voluntary consensus standards for accreditation bodies and laboratories that industries are familiar with; and
    • require food testing by accredited laboratories in the following specific circumstances, consistent with FDA’s FSMA mandate:
      • to provide evidence to support the admissibility of imported food into U.S. commerce;
      • under an import alert through successful consecutive testing;
      • to address an identified or suspected food safety problem and presented to FDA as part of 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;
      • in response to a food testing order (a new procedure proposed by this rule to address an identified or suspected food safety problem); and
      • to comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests for shell eggs, bottled water, and sprouts)
    • require results of the food testing conducted under this program to be sent directly to the FDA, as FSMA specifies;
    • establish a pathway for an accredited laboratory with a successful track record in the FDA program to streamline their submissions;
    • enable FDA to monitor program activities and to revoke an AB’s recognition or revoke a laboratory’s accreditation under certain circumstances, or place either ABs or laboratories on probation; and
    • establish a publicly available list of recognized ABs and laboratories accredited under this program.
  2. Requirements for Recognized Accreditation Bodies

    The FDA is proposing that:

    • ABs must be signatories of the International Laboratory Accreditation Cooperation Mutual Recognition Agreement (ILAC-MRA), by which they agree to maintain conformity with ISO/IEC 17011:2017 “Conformity Assessment—Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies,” Second edition, November 2017 and ensure that all laboratories they accredit comply with appropriate laboratory standards;
      (ISO/IEC stands for the International Organization for Standardization and the International Electrotechnical Commission, which have issued voluntary international consensus standards.);
    • recognized ABs take certain steps to safeguard against conflicts of interest;
    • ABs follow procedures to accredit laboratories, as well as for withdrawing accreditation or limiting a laboratory’s scope of work;
    • ABs follow certain requirements for submitting reports and notifications to FDA; and
    • ABs follow specific requirements for maintaining records.
  3. Requirements for Accredited Laboratories

    The FDA is proposing that:

    • Accredited laboratories meet model standards. These standards require a laboratory to:
      • demonstrate they are capable of conducting each method of food testing for which each laboratory seeks to be accredited by, among other things, complying with most aspects of ISO/IEC 17025:2017, “General Requirements for the Competence of Testing and Calibration Laboratories,” Third Edition, November 2017;
      • use appropriate analytical procedures and certify its reports of analysis as true and accurate;
      • establish and maintain internal quality systems;
      • establish procedures to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and,
      • assign individuals qualified by training and experience to conduct the analyses.
    • Accredited laboratories submit to FDA analytical reports, either full or abridged, as applicable, for food testing conducted under this program. A full analytical report must include all original compilation of raw data, identify and describe negative and positive quality controls, and include all calculations, among other documentation. An abridged analytical report would include certain more limited information describing the analysis.  
    • To obtain permission to submit abridged analytical reports to FDA on an ongoing basis, accredited laboratories must not be on probation or disqualified from submitting analytical reports, and they must meet the following criteria:
      • They must submit 10 consecutive full analytical reports to FDA under this program.
      • Those submissions must include at least one full analytical report relating to each major food testing discipline in the accredited laboratory’s scope of accreditation for which it seeks to submit abridged analytical reports. (Examples of “major food testing disciplines” include microbiology, chemistry and physical.)
      • None of the consecutive full analytical reports can demonstrate any substantive material shortcoming in the food testing.
      • The consecutive full analytical reports must not contain repeated administrative deficiencies.

    For more information about submitting an abridged analytical report see the Abridged Analytical Reports Flowcharts

    • Examples of the types of laboratories that may be accredited under this program are private laboratories; laboratories run and operated by federal agencies, states, localities; and foreign laboratories.
    • Laboratories accredited under this program will be required to establish, control, and maintain records relating to their food testing activities under this program.
    • FDA may consider invalid any test results, analytical reports and related documents, or associated analyses containing deficiencies or otherwise indicating that any aspect of the food testing is not being done in compliance with the program.
    • Laboratories must respond in writing indicating what corrective actions they have taken or plan to take to address deficiencies that are found.
  4. FDA Oversight of the Program

    The FDA is proposing that:

    • FDA will routinely receive the results of food testing conducted under this program, along with supporting information, indicating accredited laboratories’ compliance with the program.
    • While ABs will have primary oversight of accredited laboratories, FDA will maintain oversight of the program at all times. In addition to monitoring and assessments conducted by the ABs, FDA may conduct its own, onsite assessments and review laboratory records at any time, as FDA deems appropriate, such as to investigate potential problems.

Implementation

The FDA is proposing that the final rule establishing this laboratory accreditation program would be effective 60 days after publication in the Federal Register. Following the effective date, we will announce when we are prepared to accept applications for recognition from ABs. Once we have recognized a sufficient number of ABs, laboratories will be able to apply to the recognized ABs for accreditation.

If finalized, we would publish a notice in the Federal Register communicating when we have attained sufficient laboratory capacity to require future testing to be conducted by an accredited laboratory participating in FDA’s program. Owners and consignees of food that must be tested by a laboratory accredited under this program will not be expected to comply with the requirements sooner than six months after publication of such notice. 

Instructions for Accessing Consensus Standards

We are proposing to incorporate the following consensus standards by reference:

  • ISO/ IEC 17011:2017, “Conformity Assessment--Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies,” Second edition, November 2017, and
  • ISO/IEC 17025:2017, “General Requirements for the Competence of Testing and Calibration Laboratories,” Third edition, November 2017.

These consensus standards are available to the public during the comment period in four different ways:

  • The American National Standards Institute (ANSI), a private non-profit organization that supports the U.S. voluntary standards and conformity assessment system has created a special link where ISO/IEC 17011:2017 and ISO/IEC 17025:2017 are available to view free of charge during the comment period.  
    • Users will need to register to view these documents
    • To return to the documents users may access this ANSI website directly and use the log-in information they developed during registration
  • The standards can be accessed at the National Archives and Records Administration (NARA) or at Dockets Management Staff at FDA.
    • For information on the availability of this material at NARA, call 202-741-6030 or visit at the NARA website
    • The Docket Management Staff at FDA are located at:
      • Dockets Management Staff (HFA-305)
        Food and Drug Administration
        5630 Fishers Lane, rm. 1061
        Rockville, MD 20852
  • Copies of the standards may be purchased from ISO or from IEC
  • Copies of the standards may be purchased from any other source from which the user is assured that the copy to be received is an accurate and current version of the standard.

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