Food Laboratory Accreditation Rule Published to Some Concern

An unpublished provision of the Food Safety Modernization Act (FSMA) was addressed in early November with FDA’s publication of the proposed rule, Laboratory Accreditation for Analyses of Foods, which details the use of laboratory oversight for food testing.

“The proposed rule takes important strides to ensure that laboratories demonstrate their competency in testing food,” said Food Laboratory Alliance Director Robin Stombler. “Demonstrating appropriate validation methods, passing proficiency testing, and complying with the international standard ISO 17025:2017 are essential elements with which all food testing laboratories should adapt.”

Laboratories would be required to conduct proficiency testing at least once per year which LGC PT Operations for North America Director Heather Jordan said “will help improve the functioning of the laboratory and ensure the delivery of accurate results.”

There also is some industry concern over the proposed rule’s new Food Testing Order provision (proposed § 1.1108) and how and when it would be applied. The provision provides that FDA “may require an owner or consignee of an article of food to conduct food testing, or to have food testing conducted on their behalf, under this program, to address an identified or suspected food safety problem related to the article of food” and “would thereby constitute notice of an opportunity for a regulatory hearing under 21 CFR part 16.” 

Electronic or written comments on the proposed rule may be submitted through March 3, 2020. For more information, see the rule’s instructions, which follow the Summary, in the Federal Register.