FDA Issues Final Rule For Lab Accreditation For Analyses of Foods

By David Fairfield, NGFA Senior Vice President, Feed

The U.S. Food and Drug Administration (FDA) on Dec. 1 announced its final rule that establishes a program for the testing of food by accredited laboratories as required by the Food Safety Modernization Act (FSMA).

The rule is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced FDA oversight of participating laboratories.

The final regulations require owners and consignees of human and animal food to use an FDA-accredited laboratory for food testing under the following circumstances:

• To support removal of a food from an import alert through successful consecutive testing requirements;
• To support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
• As required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
• As required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow FDA to require use of an FDA-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
• When conducted in connection with certain administrative processes, such as testing submitted in connection with a mandatory food recall order or an appeal of an administrative detention order.

Regarding a directed food laboratory order, FDA under the rule may require the owner or consignee to conduct food testing, or to have food testing conducted on their behalf, to address an identified or suspected food safety problem, as FDA deems appropriate.

FDA states repeatedly in the preamble of the rule that a directed food laboratory order will generally be limited to the rare situation when the agency has reason to question the accuracy or reliability of past or present test results and where an identified or suspected food safety problem exits.

When issued, the directed food laboratory order will specify the food product or environment to be tested; whether the food testing may be conducted using an FDA-accredited laboratory that is owned, operated, or controlled by the owner or consignee; the timeframe in which the food testing must be conducted; and the manner of the food testing, such as the methods that must be used.

Significantly, the final rule does not apply to all food testing that a facility may perform. Food testing, including environmental testing, is only required to be conducted by an FDA-accredited laboratory under the certain circumstances specified in the rule.

In addition, for facilities covered by the FSMA-related human or animal food preventive controls rules, the rule does not require testing done as a routine prerequisite program and/or verification activity to be performed by an accredited laboratory

FDA within the rule specifies eligibility requirements that accreditation bodies and laboratories wishing to voluntarily participate in the program will need to satisfy, as well as procedures for how the agency will manage and oversee the program. FDA intends to announce in early 2022 that accreditation bodies may apply for recognition.

Once FDA has recognized a sufficient number of accreditation bodies, the agency will announce that laboratories may apply to the recognized accreditation bodies for FDA-accreditation.

When there is sufficient FDA-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 an FDA-accredited laboratory for such food testing.

FDA states it also will maintain an online public registry listing of recognized accredited bodies and accredited laboratories when the rule is fully implemented.

- From the Dec. 10 NGFA Newsletter