NSAC's Blog

What to Look For in the FSMA Facility Rule

August 31, 2015

On Monday, August 31 the U.S. Food and Drug Administration (FDA) announced that the final Preventive Controls Rules for Human and Animal Food have been submitted to the Federal Register for publication, which means farmers and processors are one step closer to new food safety standards that will shortly go into effect. It will likely take several more days for the final rules to be available for public viewing, but FDA’s announcement today tacitly acknowledges that FDA is, in effect, meeting its court-ordered deadline to finalize these rules by August 30.

As the final food safety rules are published, NSAC will undertake a thorough analysis of the final rules and provide information and materials to help explain them. For the Preventive Controls Rule for Human Food in particular, we will be looking to the see whether FDA made much-needed adjustments to the final definition of what constitutes a “farm,” in order to draw a clearer line between farms that are covered by the new facility rule and farms that are not.

We will also be paying close attention to an issue that arose during the second comment period on the proposed rule, which would require – in certain circumstances – farms and facilities to have onsite audits. This requirement directly contradicts clear statutory language in the Food Safety Modernization Act (FSMA) that explicitly prohibited FDA from requiring farms or facilities to hire third parties to audit, certify, or implement food safety practices as part of the rules. This critical language – championed by Senator Michael Bennet (D-CO) – was added to FSMA during the legislative debates to protect against excessive costs and administrative burdens on small and very small farms and food enterprises subject to these rules.

Last week, Senator Bennet delivered a letter to FDA, emphasizing this very point. In the letter, the Senator reminded FDA of the clear statutory language and the intent behind it — to avoid placing additional pressures and costs on small farms. NSAC applauds the Senator for this letter, and for speaking out on this issue. We will be looking closely to the final rule once published to determine whether FDA followed the letter and the spirit of the law on this issue, among others.

For a refresher on other key issues to look out for in the Preventive Controls Rule, visit our website.

You can also read our recent blog posts for more on FSMA implementation and appropriations issues.

Categories: Food Safety

One response to “What to Look For in the FSMA Facility Rule”

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