FDA delays routine regulatory inspections for large animal food facilities

The FDA has announced that routine regulatory inspections for large animal food facilities to ensure compliance with regulations under the FDA’s Preventive Controls for Animal Food rule (80 FR 56170) will not begin until the fall of 2018. Effective September 18, 2017, large animal food facilities must comply with preventive controls requirements mandated by the Food Safety Modernization Act (FSMA) (P.L. 111-353).

Education and flexibility

Large animal food facilities, those with 500 or more full-time equivalent employees, also had to comply with the current Good Manufacturing Practice (cGMP) requirements by September 2016. Based on feedback from animal food producers, the FDA has decided that although the new preventive control regulations will take effect as announced in the final rule as of September 18, 2017, the FDA will first focus on education before regulation. The agency noted that the industry needs additional time and technical assistance to fully understand the requirements of the new regulations for preventive controls. Jenny Murphy, a consumer safety officer with the FDA’s Center for Veterinary Medicine, said in a recent interview that the FDA will allow larger facilities some flexibility to further develop their plans and ensure that their system is operating correctly as guidance from FDA and other resources are put in place.

Increased inspections

While the FDA announced a delay in the routine regulatory inspections for the prevent controls requirements, the FDA will increase oversight of cGMPs with more routine inspections. Effective September 18, 2017, both large and small animal food facilities must meet the cGMP requirements. The cGMPs establish a foundation before establishing preventive controls. “CGMPs establish a base to make sure you don’t contaminate the animal food and the preventive controls take it a step further by making you really concentrate on things that, if they’re found in animal food, could be a public health concern,” said Murphy. “Once you have CGMPs in place, you can see where you need extra layers of protection.”

The FDA adopted the Final rule in an effort to improve public health, and established for the first time cGMPs for food for animals, which are akin to the cGMPs that have long applied to human food. Along with the cGMPs, facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule also mandates that animal food facilities establish a supply chain program.

FDA opens toolbox for imported food oversight

The FDA is relying on “a range of tools” to ensure the safety of imported foods, in keeping with directives under the FDA Food Safety Modernization Act (FSMA). Because 15 percent of the Food supply is imported, the FDA has developed “a multi-faceted toolkit” to help ensure the safety of imported food. To meet food safety oversight demands, the FDA is allocating resources based upon risk, leveraging the work of other responsible entities in the food supply chain, and combining FSMA tools with existing methods (inspections, physical examinations, sampling/testing).

Food supply

According to the FDA, about 15 percent of the U.S. food supply is imported. However, some aspects of the food supply are predominantly supplied through imports. For example, nearly 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood are derived from imports. Food supply imports come from more than 200 countries and around 125,000 firms.

Oversight

Dr. Donald Prater, Acting Assistant Commissioner for Food Safety Integration in the Office of Foods and Veterinary Medicine (FVM), noted that under changing oversight protocols, while the level of oversight will be comparable across the food supply chain, “the deployment of the tools may be different.” For example, he noted the requirement that importers verify their suppliers produce food consistent with U.S. food safety standards. He indicated that the goal of imported food safety oversight was not to establish the same system of oversight for domestic and imported foods, but, instead, “to ensure that foods imported from abroad are as safe as those produced domestically.”

Fish advice issued for women and parents of young children

Fish and shellfish provide protein, are low in saturated fat, are rich in many micronutrients, and provide certain omega-3 fatty acids. However, as a result of natural processes and human activity, fish also contain mercury in the form of methylmercury. Methylmercury can adversely affect the central nervous system, particularly the developing brain of the fetus. As a result, women who are pregnant or may become pregnant, as well as breastfeeding mothers and parents of young children, need information to make informed choices when it comes to fish that are healthy and safe to eat.

In June 2014, the FDA and the U.S. Environmental Protection Agency (EPA) jointly released a draft update to a March 2004 document entitled “What You Need to Know About Mercury in Fish and Shellfish.” The agencies have now announced revised fish advice that contains advice and supplemental questions and answers for those who want to understand the advice in greater detail. The fish advice contains a reference chart that sorts 62 types of fish into three categories:

  • Best Choices (36 types of fish)
  • Good Choices (19 types of fish)
  • Choices to avoid (7 types of fish: King mackerel, Marlin, Orange roughy, Shark, Swordfish, Tilefish (Gulf of Mexico), and Tuna (bigeye))

The reference chart suggests that women of childbearing age (16-49 years old), especially pregnant and breastfeeding women, and parents and caregivers of young children should observe the following guidelines:

  • Eat two to three servings of fish a week from the Best Choices list or one serving from the Good Choices list.
  • Eat a variety of fish.
  • Serve one to two servings of fish a week to children, starting at age two.
  • If you eat fish caught by family or friends, check for fish advisories. If there is no advisory, eat only one serving and no other fish that week.

The recommended serving size for an adult is four ounces. For children age four to seven, the recommended serving size is two ounces.

How were fish categorized?

The agencies note that they took a cautious and highly protective approach in determining which fish belonged in each category. They calculated how many servings the average pregnant woman could eat in a week using information on mercury content of each fish type from FDA’s database for commercial fish and other sources. If she could eat that fish at least three times a week, then they listed it in the “Best Choices” category. If she could eat that fish only once a week, or twice but not three times a week, then they listed it in the “Good Choices” category. If she could not eat a serving of that fish once a week, then they listed the fish in the “Choices to Avoid” category.

Why are some fish in more than one category?

The agencies explain why tuna and tilefish appear in multiple categories on the chart. Tuna comes in different types (or species), such as albacore, bigeye, and yellowfin. And because some types of tuna that are bigger or live longer tend to have higher mercury levels, they are in different categories. For example, canned light tuna is in the Best Choices category. Albacore (or white) tuna and yellowfin tuna are in the Good Choices category, and bigeye tuna is in the Choices to Avoid. In addition, fish of the same species that are caught in different geographic locations can vary in mercury content. For example, tilefish are in two categories because tilefish in the Gulf of Mexico have higher mercury levels than those in the Atlantic Ocean. As such, Gulf of Mexico tilefish is in the Choices to Avoid and Atlantic Ocean tilefish is in the Good Choices.

If some species of fish are not on the reference chart, such as mussels, that means the agencies did not have enough reliable mercury data to include it.

 

FDA wants to know how you define “healthy”

The FDA wants to know how consumers view and use the Nutrition Facts label while purchasing foods; so much so that it is taking steps seeking public input on how the claim “healthy” is used on food packages. Noting that there are various terms on food packages such as “healthy,” “low in fat,”or “good source,” the FDA recognized that many consumers do not have the time to consider the details of nutrition information on every package purchased. In fact, most purchase decisions are made quickly, within three to five seconds.

The agency’s interest extends to questions such as: (1) what current dietary recommendations should be reflected in the definition of “healthy;” (2) what are the public health benefits of defining the term “healthy;” (3) what do consumers expect of foods that carry a “healthy” claim; and (4) what factors and criteria should be used for the new definition of “healthy.” Future public forums will explore these topics. The FDA will also begin the process of evaluating other label claims in order to modernize food labels in a manner that consumers find useful.

The public input is in part due to concerns that food manufacturers were not complying with requirements permitting content claims. In 2015, the FDA issued a warning letter to Kind, saying the food manufacturer could not claim its fruit and nut bars were healthy because they contained too much saturated fat and because it described the antioxidant content as healthy despite no medical definition to back up the claim. Following receipt of the closeout letter, Kind requested confirmation that it could use the phrase “healthy and tasty” only in text referencing its corporate policy. The FDA did not object, as long as Kind did not use those terms on the same display panel as nutrient content claims or nutrition information.

While the FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition as the agency does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in a newly published guidance document are met.