Groups call on FDA to issue FSMA laboratory proposed rule

As Food Chemical News reported, the spring 2016 Unified Agenda, which lays out the administration’s regulatory plan for FDA, did not include the FSMA laboratory rule in its list of upcoming regulations. The rule was listed in the fall 2015 update, but FDA told FCN the agency’s priority at this point was to issue FSMA guidance documents.

“While we are working on the FSMA laboratory accreditation rule, our primary focus is on drafting guidances to assist industry in complying with the compliance dates for the seven foundational FSMA regulations,” an FDA spokesman told Food Chemical News. Later, the agency said, “We are actively drafting a proposed rule to implement section 202.”

FSMA required FDA within two years to establish a program for the testing of food by accredited laboratories and to develop the model standards a laboratory must meet to be accredited by a recognized accreditation body.

Pushing back the timing on the laboratory rule is not welcome news.

“Despite the significant, foundational role of laboratories in food safety, there is currently no required accountability for food laboratories. FSMA section 202 helps to remedy this concern,” according to a June 6 letter signed by the Consumer Federation of America, Food Laboratory Alliance, National Association of County and City Health Officials, The Pew Charitable Trusts and Trust for America’s Health. The letter was sent to FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff.

“Both the public and food facilities rely on laboratory test results to detect accurately the presence or absence of harmful pathogens, allergens and spoilage organisms. Laboratories are utilized in the testing of food and finished products, supplier verification, and environmental monitoring. Laboratory test results have a significant impact on the health of the public, the food industry and the economy,” the groups argued.

“As your tenure as Deputy Commissioner for Foods and Veterinary Medicine begins, we ask for the prompt promulgation of the proposed rule for FSMA section 202. We look forward to working with you and learning of the timeline for the issuance of this rule.”