Partnering with the Regulators: The Role of Third-Party Accreditation in Food Safety

Living in a world of ever-increasing interdependence and an era of limited government financial and human resources, it is imperative that those charged with protecting health and safety leverage private sector institutions and existing frameworks. That this moment arrives now at a point where the government is being tasked with undertaking the most significant change in the regulation of the food supply makes this partnership both inevitable and absolutely necessary.

Accreditation is an internationally accepted, conformity-assessment tool for ensuring laboratory competence and confidence in the accuracy and reliability of test data. The accreditation infrastructure is well established through accreditation bodies (ABs) and the mutual recognition arrangements of the International Laboratory Accreditation Cooperation (ILAC) supported by regional cooperation arrangements, including the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the multi-lateral agreement with the Inter-American Accreditation Cooperation (IAAC).

ILAC functions as a forum for harmonization of laboratory-accreditation procedures and policies, thus reducing technical barriers to trade and promoting laboratory accreditation as a mechanism to enhance confidence in testing facilities. ILAC member ABs are recognized as competent to accredit testing organizations through a rigorous peer evaluation process: ABs must meet the requirements of ISO/IEC 17011 and use ISO/IEC 17025 as the basis for accreditation of laboratories. In turn, under the ILAC, MRA, and regional co-operations, competent laboratories are recognized globally, thus acting to facilitate acceptance of the testing results that accompany goods across national borders.

The U.S. government also has been an active participant in accreditation activities. According to The Administrative Conference of the United States in its Agency Use of Third-Party Programs to Assess Regulatory Compliance, “…federal agencies in diverse areas of regulation have developed third-party programs to assess whether regulated entities are in compliance with regulatory standards and other requirements. Through these programs, third parties are charged with assessing the safety of imported food… Third parties also ensure that products labeled as organic and energy-efficient meet applicable federal standards. In these regulatory third-party programs, regulated entities generally contract with third parties to carry out product testing and other regulatory compliance assessment activities in the place of regulatory agencies. Regulatory agencies take on new roles in coordinating and overseeing these third-party actors.”

Traditionally, ABs have worked with regulators to establish specific technical requirements applied to the ISO 17025 accreditation framework: The AB is responsible for executing the assessment and accreditation process, but the regulator retains responsibility for the ultimate decisions on the acceptance of that organization’s accreditation. Because of the sources of the food supply, governmental recognition of accreditation bodies operating in accordance with international standards is much more practical than agencies themselves accrediting the individual conformity assessment bodies (CABs) or ABs. Thus the public/private partnership paradigm: To assess regulatory compliance, a regulatory agency approves ABs that accredit CABs that assess whether regulated entities or regulated products are in conformity with a regulatory standard. (Source: Administrative Conference of the United States-Recommendations)

Following are some relevant public-private partnerships serving as useful examples for rule-making associated with the sweeping changes in approaches called for in the FDA Food Safety Modernization Act (FSMA). For example, Section 202 directs the secretary to: “recognize bodies that accredit laboratories…for testing of food and to work with recognized accreditation bodies to increase the number of accredited labs.”

• U.S. Department of Defense (DoD) Environmental Laboratory Accreditation Program (DoD ELAP). DoD ELAP recognized ILAC-recognized U.S.-based accreditation bodies provide accreditation services for implementing the ELAP laboratory accreditations of environmental testing laboratories performing testing in support of the DoD Environmental Restoration programs at DoD operations. The accreditation requirements comprise ISO 17025, 2003 NELAC Requirements plus additional specific DoD “Gray Box” criteria.
   
• U.S. Consumer Product Safety Commission (CPSC) accreditation requirements for third-party testing laboratories. In conformance with CPSIA, all products falling under these regulations must be tested against the commission’s children’s product safety rules by a laboratory accredited to ISO 17025 by an accreditation body who is a signatory to the ILAC Mutual Recognition Arrangement (ILAC MRA) and the accreditation must be registered with, and accepted by, the commission.
   
• U.S. Environmental Protection Agency (EPA) recognition of testing laboratories for Energy Star. EPA recognizes laboratories performing product testing in support of the Energy Star and its specific product family test methods and requirements. Laboratory recognition criteria require that accreditation bodies operate in accordance with the ISO 17011 provision of objective evidence of compliance to ISO 17025 and additional “Gray Box” requirements.

In each of these examples, all the organizations are treated equally by the regulatory agency, using the same recognition criteria for ABs and the same accreditation requirements in the assessments of the CABs. This is especially important on an international basis. Otherwise, if different standards were used it would be considered a trade barrier.
 

As previously alluded, FSMA is probably the most significant attempt at reforming the U.S. food safety laws since the Federal Food, Drug, and Cosmetic (FDC) Act of 1938 was passed by Congress. Its aim, when FSMA was signed into law by President Obama on January 4, 2011, was to ensure a safe U.S. food supply, and this was to be accomplished by a significant paradigm shift away from responding and containing contamination to taking concrete action to prevent it from occurring in the first place.

However, while the law was signed nearly three years ago, this approach is still not yet in effect. To date, the FDA has released four proposed rules: 1) Rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; 2) Rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; 3) Rule on Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications; and 4) Rules to Help Ensure the Safety of Imported Food Preventive Controls for Human Food. However, each of these has generated significant comment from the many stakeholders involved which threatens to further delay implementation.

In addition, none of these proposed rules have yet to address the role of the accredited laboratory. In fact, as noted previously, although FSMA section 202 creates a new section 422 in the FD&C Act addressing laboratory accreditation for the analyses of foods, including use of accredited laboratories in certain circumstances, at present, in its words, the “FDA supports laboratories’ interests in pursuing accreditation, but FDA has not yet fully developed its thinking or rulemaking with regard to FSMA implementation so any interpretations of requirements are premature at this time.”

We shall thus wait and see…

Roger Brauninger is biosafety program manager for A2LA and a member of QA’s Advisory Board.