Title II, Section 202 of the Food Safety Modernization Act (FSMA), signed into law in January 2011, instructed the Food and Drug Administration (FDA) to establish a program for the testing of food by accredited laboratories. FSMA stipulated that accredited labs must possess “a demonstrated capability to conduct one or more sampling and analytical testing methodologies for food,” as verified by the accreditation process.
On November 4, 2019, the FDA posted a proposed rule to address this component of FSMA.
According to an FDA announcement, “(e)stablishing 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. “
Step one – Authorize Accrediting Bodies
The rule includes guidance on certification of accrediting bodies (AB) tasked with evaluating laboratories seeking accreditation. The process of certifying ABs would rely heavily on ISO/IEC 17011:2017 standards. Approved ABs will be authorized by the FDA to: accredit labs, refuse or withdraw a lab’s accreditation, and determine or limit a lab’s scope of work.
Laboratories would need accreditation to perform food analysis under the following circumstances:
- providing evidence to support the admissibility of imported food into U.S. commerce;
- under an import alert through successful consecutive testing;
- addressing an identified or suspected food safety problem and presented to FDA as part of the 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;
- responding to a Food Testing Order * (a new procedure proposed by this rule to address an identified or suspected food safety problem);
- complying with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests for shell eggs, bottled water, and) require results of the food testing conducted under this program to be sent directly to the FDA;
* A Food Testing Order is a directive issued by the FDA requiring a food manufacturer to submit product and/or environmental samples for analysis. The testing would need to be completed by an accredited laboratory, with the results reported directly to the FDA.
ISO 17025 Will Provide Baseline Benchmark
To attain accreditation, Laboratories must:
- 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;
- assign individuals qualified by training and experience to conduct the analyses.
The FDA announcement states, “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.”
FDA Will Catalog Accrediting Bodies and Approved Labs
Once the FDA has instituted the program, they will maintain and make publicly available a list of approved Accrediting Bodies and Accredited Laboratories.
The FDA will accept comments on the proposed rule until March 3, 2020, at the https://www.regulations.gov electronic filing system.