There have been several notable recent developments involving FSMA implementation. Most significantly, FDA proposed to extend the compliance dates for the agricultural water provisions of the Produce Safety rule and announced it will delay the start of Produce Safety rule inspections until spring 2019.  Additionally, FDA has issued another chapter of its Preventive Controls for Human
Foods (PCHF) draft guidance, which addresses the use of heat treatment process preventive controls.

In addition to summarizing these developments, this post also provides a reminder that the next round of FSMA compliance dates for the Preventive Controls rules is September 18, 2017.  Read more.

The U.S. Food and Drug Administration (FDA) has issued a broad request for comment to assist the agency in identifying regulations and related paperwork requirements that it could modify, repeal, or replace to reduce the regulatory burden on the public. The request is specific to products within the jurisdiction of the Center for Food Safety and Applied Nutrition (CFSAN) (i.e., human food, dietary supplements, and cosmetics) and presents a unique opportunity for industry to identify regulations and/or information collection (paperwork) requirements that are outdated, ineffective, or unnecessary; impose costs greater than their associated benefits; or limit job creation.

FDA issued the request as part of its implementation of Executive Orders (EOs) 13771 and 13777. EO 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” states that it is the policy of the executive branch to be prudent and financially responsible in the expenditure of funds from both public and private sources and to manage the costs associated with the government imposition of private expenditures required to comply with federal regulations. EO 13777, entitled “Enforcing the Regulatory Reform Agenda,” directs each agency to establish a Regulatory Reform Task Force to evaluate existing regulations and make recommendations regarding their repeal, replacement, or modification. The information the public submits in response to the request for comment will supplement FDA’s review of its regulations.

This post summarizes FDA’s requests and the specified formatting and instructions for providing comments.  Read more. 

FDA has started conducting inspections to assess compliance with its Foreign Supplier Verification Programs (FSVP) regulation. The initial FSVP compliance date was May 30, 2017, though FSVP importers may have later compliance dates for their various suppliers that are smaller sized businesses. Inspections started earlier this summer. In this post we provide a brief overview of how these inspections are progressing based on the inspections we have learned about.

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There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA) of interest to the food industry. In this post, we summarize the following topics:

  • Delayed start date for inspections for compliance with the preventive controls requirements under the Preventive Controls for Animal Food (PCAF) rule and under the Foreign Supplier Verification Programs (FSVP) rule for animal food importers;
  • Guidance for low-acid canned food (LACF), seafood, and juice manufacturers regarding compliance and exemptions under FSMA;
  • Updated domestic and foreign reinspection fee rates for fiscal year (FY) 2018;
  • Release of new Food Safety Plan Builder software to assist with development of food safety plans; and,
  • Clarification regarding the definition of “retail food establishment” for purposes of the waiver from requirements under the Sanitary Transportation of Human and Animal Food rule.

Click here to read our update.

The U.S. Court of Appeals for the Eighth Circuit has affirmed prison sentences for two senior food company executives as “responsible corporate officers” for the sale of adulterated shell eggs to the public.  The decision reinforces the prevailing view that a “responsible corporate officer” at a food company can face criminal liability even without a specific intent or knowledge to violate the law. The defendants were convicted and sentenced to three months in prison for misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 331(a). On appeal, they argued that their convictions were unconstitutional on the ground that mens rea—an intent to violate the law—is a necessary predicate for conviction under Section 331(a). Invoking the U.S. Supreme Court’s decision in United States v. Park, 421 U.S. 658 (1975), a splintered panel of the Eighth Circuit disagreed, with the majority holding that a corporate officer is held accountable not for others’ acts or omissions, but for his or her “own failure to prevent or remedy the conditions which gave riseto the charges.” In this way, the majority explained, the FFDCA punishes “neglect where the law requires care.”

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FSIS has released a brief Q&A addressing issues related to the new requirement that establishments report to their district offices all instances of adulterated or misbranded products within 24 hours of learning or determining that products have entered commerce. The reporting requirement applies for products received by or originating from an establishment. 9 C.F.R. § 418.2. In FSIS Notice 34-12, the agency reiterated the rule’s basic requirements and indicated establishments were to begin complying on June 7, 2012.  The recently released Q&A document clarifies the agency’s understanding of when a product is “in commerce” and provides some insight into situations the agency considers reportable.

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The Food Safety and Inspection Service (FSIS) will publish in an upcoming issue of the Federal Register a final rule requiring official establishments to notify the agency of adulterated or misbranded food in commerce, creating significant reporting obligations. The final rule also requires establishments to maintain written recall plans and document in writing the results of HACCP plan reassessments. The final rule, which implements portions of the 2008 Farm Bill, carries over most of the elements of the rule proposed in 2010, with a handful of changes

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The Food and Drug Administration has recently revised portions of Section 6 of its Regulatory Procedures Manual, which, among other things, outlines internal agency procedures regarding Park Doctrine prosecutions. After years of dormancy, these procedures reflect the agency’s renewed interest in using the longstanding Park doctrine as part of its enforcement regime. After providing some background information, this memorandum summarizes FDA’s current approach to Park prosecutions.

Click here to read more