Sacramento, CA – On April 6 the period of comment on the Laboratory Accreditation for Analyses of Foods Proposed Rule ends. Although this specific rule sounds like it does not apply to the food industry, it has the potential to impact food manufacturers, importers, and laboratories significantly. Safe Food Alliance highly suggests that anyone who manufactures food in the United States take the time to review the proposed rule and submit necessary comments carefully. This period is the last opportunity to impact the rule before the Food and Drug Administration (FDA) begins the final draft.
In preparation for the comment period, the FDA created a list of questions that they would like to receive comment on. That list can be found here. In addition to the FDA created questions, comments can be submitted addressing any aspect of the proposed rule. Potential questions are:
- Does the FDA have the legal authority to establish food testing orders?
- Should the FDA provide more clarity regarding “suspected food safety problems”?
- Are there concerns that the expectations for testing covered by the rule could extend to routine testing through inspections or otherwise?
- Is 24 hours enough time to challenge a food testing order?
The FDA is moving forward with creating the rule due to a lawsuit with the Center for Food Safety (CFS). The suit was brought forward because the FDA missed the January 2013 deadline dictated by FSMA to create the program. The lawsuit began in August 2019 and reached a settlement in January 2020 with an agreement to finalize the Laboratory Accreditation Rule by February 2022.
Background
Congress enacted the Food Safety Modernization Act (FSMA) in 2011 and has been rolling out the rules since it’s passing. On November 4, 2019, the FDA issued the Laboratory Accreditation for Analyses of Foods Proposed Rule, which came about as a result of section 202 of FSMA. In FSMA, the regulation directed the FDA to “establish a program for the testing of food by accredited laboratories; establish a publicly available registry of accreditation bodies recognized by the FDA and laboratories accredited by accreditation bodies; increase the number of qualified laboratories, and develop model laboratory standards.” This led to the proposed rule being created with guidelines for FDA accredited labs to conduct specific food testing.
If the proposed rule passes as it stands, food testing will be required when the FDA issues a “food testing order,” serious agency enforcement action is needed, and involving imports (keep in mind that these import rules are separate from FSVP). When the government issues a food testing order to a company, it is in response to an identified or suspected food safety problem, not based on routine testing and typically high-risk foods. Instead, these orders are meant for scenarios that could negatively impact public health.
Beyond new instances when the FDA plans to require testing, new sampling requirements have been created that all accredited labs must follow. Now, before analyzing a sample, the lab must collect written documentation of the sampler’s qualifications, a sampling plan, a written sample collection report with sampling procedures and techniques, and chain of custody documentation. At this time, the FDA has chosen not to require accreditation for samplers, but it is “strongly encouraged.” Safe Food Alliance foresees this as an area that may change after the comment period is over, as the FDA specifically requested comment on this topic.
To submit a comment, you can do so here before April 6, 2020.
