Last week, tThe FDA announced it was proposing a rule to establish a system to accredit laboratories to test feed and food as was required by the FDA’s Food Safety Modernization Act (FSMA). When the system is finalized, it will mean testing of feed or food in specific cases must happen at facilities accredited through the program.
Laboratories taking part in the accreditation program will have a set of model standards to follow and an oversight system will be in place, the FDA said.
The US agency currently requires that feed and food be tested at certain times to establish safety, the agency said. That analysis is predominately done at private facilities adhering to multiple standards and with varying levels of oversight.
“Under the new proposed program, only laboratories accredited by an Accreditation Body (AB) recognized by the FDA will be able to conduct food testing in certain circumstances, which are outlined in the proposed rule,” the agency said. “Further, the results will be required to be sent directly to the FDA by the accredited laboratories.”
The goal of the proposed regulation is to boost the accuracy and reliability of feed and food testing by ensuring consistent standards and improving the oversight of laboratories involved, the agency said.
The final rule is set to be effective 60 days following its publication in the Federal Register and public comments are being collected through March 3. Once in place, facilities interested in becoming accreditation bodies can apply and laboratories will have the opportunity to take part in the certification process.
The proposed rule is not set to disrupt the routine preventive measures used by the animal feed industry to do product testing or environmental monitoring, an FDA spokesperson told us. However, it does modify existing practice for some feed testing:
“When there is an identified or suspected food safety problem, there are circumstances where animal food will be required to be analyzed by an accredited laboratory under this program,” the spokesperson said.
“The circumstances most relevant to animal food are: testing to provide evidence to support the admissibility of imported food into US commerce under an import alert through successful consecutive testing [and] testing to address an identified or suspected food safety problem that is presented to FDA,” the spokesperson said.
Testing to address a safety problem is needed to provide “evidence for an informal hearing before a mandatory recall order,” or “evidence submitted for an appeal of an administrative detention order,” and to develop “a corrective action plan submitted after an order suspending the registration of a food facility,” the spokesperson said.
Feed testing at an accredited facility would be necessary in response to a food testing order, the spokesperson said. That process is a new procedure included in the rule to “address an identified or suspected food safety problem.”
Proposed regulation details
The proposed rule seeks to establish the “framework and requirements for accreditation bodies” along with the steps necessary for those facilities seeking to become accredited laboratories, the FDA said. And it would develop a process for accredited facilities with positive track records to streamline submissions.
The rule specifies the circumstances when feed and food products would need to use accredited sites for testing, the agency said.
The potential regulation helps FDA review program activities and manage or reprimand both accrediting bodies and laboratories as necessary. And it establishes a public list of accreditation bodies and accredited facilities.