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.

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The Trump Administration recently released its Fiscal Year (FY) 2018 budget request. The FY 2018 budget request is notable because it proposes dramatic cuts to both the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), among other agencies. Presidential budget proposals are at most a starting point – with Congress ultimately responsible for deciding what funds to appropriate – but often provide valuable insight into an administration’s priorities.

The FY 2018 budget request earmarks a total of $5.1 billion for FDA as a whole – an increase of $456 million or 10 percent above the funding provided by Congress in the FY 2017 Continuing Resolution. This increase, however, would consist of reducing FDA’s total budget authority by $854 million, while proposing an increase in user fees of $1.3 billion in non-food programs (which are unlikely to pass, as explained below).

The FY 2018 budget request proposes $137 billion to USDA, a decrease of $12 billion or 8 percent from an estimated $149 billion in FY 2017, and outlines plans to lower spending on USDA programs by roughly $230 billion over a decade. This memorandum discusses FDA and USDA’s plans for reducing expenditures as they relate to food safety.

As described in more detail below, the proposed FY 2018 budget calls for a sizeable reduction ($82.8 million) in FDA’s food safety program and a modest increase ($25 million) in the Food Safety and Inspection Services (FSIS) food safety program at USDA. Notably, no new user fees are proposed for either FDA or FSIS food safety budgets, although the USDA budget alludes to a desire for legislation authorizing user fees, as have past budgets.

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The Food Safety and Inspection Service (FSIS) recently issued a notice instructing inspectors in establishments to collect data on the use of certain raising and other claims as a prelude to developing a field compliance testing program to verify that various approved claims are accurate based on product testing. The survey covers establishments that produce raw ground beef products, raw chicken parts, and ready-to-eat (RTE) products. Inspectors will complete a “Labeling Claims Questionnaire” to collect information on three types of labeling claims: 1) claims on raw ground beef products that hormones were not administered to the cattle; 2) claims for raw chicken parts that antibiotics were not used in the chicken production; and 3) soy-free claims on RTE products.  Claims of limited use of antibiotics for raw chicken parts are not included in the survey.

FSIS intends to use the information collected to conduct an exploratory sampling program to verify that such claims are accurate based on actual product testing. This notice also provides some insight on the types of claims FSIS has reviewed and approved for each of the categories of claims itis evaluating under this notice, as discussed further below.

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Following the release of the Food and Drug Administration’s (FDA’s) nutrition labeling revisions in May 2016, the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS) is proposing to amend the nutrition labeling requirements for meat and poultry products. The proposed revisions parallel almost exactly FDA’s final nutrition labeling revisions.  Comments are due 60 days from the date the proposed rule is officially published in the Federal Register.
This rule proposes several significant changes for many meat and poultry product labels. As with the FDA final rule, the FSIS proposed rule would (1) require the declaration of “Added Sugars,” vitamin D, and potassium and remove the requirement to declare “Calories from Fat”; (2) revise the definition of dietary fiber; (3) revise the format of the Nutrition Facts Panel (NFP); (4) require dual-column labeling for certain containers; (5) update the reference amounts customarily consumed (RACCs) for several product categories; (6) consolidate some RACCs across meat and poultry products; and (7) create several new RACCs. The new and updated RACCs include those for appetizers and candies with meat or poultry. Additionally, the proposed rule would consolidate the nutrition labeling regulations (which are currently separate for meat and poultry products) into a single part at 9 CFR part 413. FSIS proposes a two-year compliance period for large companies and a three-year period for small companies.

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Consumers will have greater access to Omega fatty acid content on meat, poultry, and egg product labels based on new guidance issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). Under these guidelines, FSIS will permit on labels factual statements identifying the amount of Omega fatty acids per serving, although qualifiers are required if the Omega fatty acids are not inherent in the animal protein tissue.

The compliance guideline provides clarity around Omega-3 claims and reflects a degree of flexibility in FSIS’s approach not formally recognized in the past. Although compliance guidelines technically are nonbinding guidance documents, they reflect current FSIS policy and FSIS typically treats the guidelines as mandatory. FSIS is accepting comments on the compliance guideline for 60 days, although the document is effective immediately.

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The Food and Drug Administration (FDA) recently published a final rule extending several compliance deadlines for specific provisions in four of the seven major FDA Food Safety Modernization Act (FSMA) final rules.  The extensions affect provisions of the Preventive Controls for Human Food, Preventive Controls for Animal Food, Foreign Supplier Verification Program (FSVP), and Produce Safety rules. The extensions each address specific issues that were brought to the agency’s attention by industry. Importantly, these are limited extensions for particular issues, rather than blanket extensions of the compliance date for the entire regulations.

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The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced the beginning of its “Generically Approved Label Record Assessment Pilot Project.”  This project is the pilot phase of FSIS’s inspectional program to assess the effectiveness of the expanded generic approval program in ensuring meat and poultry labels comply with FSIS regulations. The pilot program will take place through the end of September and will begin with five establishments. Although the pilot project affects only a few establishments, it signals that FSIS plans to begin reviewing generically approved labels more closely in the relatively new future and shows how the Agency plans to do so. Companies operating under FSIS inspection might use this opportunity to review their generic approval compliance programs and prepare for closer Agency scrutiny.

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The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) released its final pathogen reduction performance standards for Salmonella and Campylobacter in raw chicken parts and not-ready-to-eat (NRTE) comminuted chicken and turkey products, entitled New Performance Standards for Salmonella and Campylobacter in Not-Ready-to-Eat Comminuted Chicken and Turkey Products and Raw Chicken Parts and Changes to Related Agency Verification Procedures: Response to Comments and Announcement of Implementation Schedule (the Notice).

The new standards set a high bar for Salmonella and Campylobacter reduction, and FSIS speculates that a significant percentage of the poultry industry initially will not meet the standards.

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The Food Safety and Inspection Service (FSIS) will soon publish in the Federal Register its long anticipated final rule modernizing the poultry slaughter inspection system. The final rule generally tracks the Agency’s January 2012 proposal with some modifications, most notably a lower line speed than proposed for chicken establishments. The new system, dubbed the New Poultry Inspection System (NPIS), is modeled after the Agency’s long-running HACCP Based Inspection Models Project (HIMP) pilot program and is designed to give establishments more control over their slaughter and processing operations.

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Yesterday, the Food Safety and Inspection Service (FSIS) released a compliance guideline addressing steps meat and poultry establishments can take to control and prevent the introduction of undeclared allergens into food products. The guidance, Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and Declaration through Labeling (the Guidelines), identifies key steps FSIS recommends establishments take to identify potential sources of foodborne allergens, prevent and control the introduction of allergens into foods, and ensure all allergens are declared on food labels. Guidelines are technically nonbinding recommendations, but FSIS considers food adulterated and misbranded if its label fails to declare any of the “Big Eight” allergens present in the food.  FSIS “recommends that establishments consider incorporating the practices set out in [the Guidelines] in their HACCP plan or Sanitation SOPs or other prerequisite programs.”

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