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 establishes farming standards to prevent contamination of produce

The FDA has established standards related to produce in an effort to reduce the impact of foodborne illnesses among consumers. These standards to not apply to produce that is usually not consumed raw, grown for personal consumption, or not a raw agricultural product. Additionally, produce that goes through commercial processing techniques that adequately reduce contamination is eligible for exemption. The Final rule will publish in the Federal Register on November 27, 2015. The FDA has also issued a final environmental impact statement that will publish along with the rule.

Standards

These standards, implemented under the Food Safety Modernization Act (FSMA) (P.L. 111-353), are intended to address the situations in which produce can be contaminated with microorganisms of public health significance during growing, harvesting, packing, or holding. The FDA has made changes after considering public comments following the Proposed rule in January 2013 and the supplemental notice of proposed rulemaking issues in September 2014.

Water

The rule establishes criteria for microbial water quality. No detectable generic E. coli are allowed when it is reasonably likely that dangerous microbes would be transferred to the produce. This includes water used: for washing hands, for rinsing food-contact surfaces, in direct contact with produce (including water used to make ice), and for sprout irrigation. If generic E. coli is detected, the water use must be discontinued and corrective actions implemented. For water that is applied directly to growing produce, the FDA has established geometric mean (GM) and statistical threshold values (STV) for the permissible amount of E. coli. The rule also establishes standards for testing untreated water.

Soil amendments

At this time, the FDA considers adherence to the U.S. Department of Agriculture’s (USDA)’s National Organic Program standards for the application of raw manure as a soil amendment to be appropriate in minimizing the likelihood of contamination. The standards call for a 120-day interval between the application of this amendment and harvesting for crops in contact with soil, with a 90-day interval for crops not in contact. The agency is conducting extensive research on the risk of contamination and the number of days needed between application and harvesting.

Sprouts

Sprouts are particularly vulnerable to microbes and have been associated with outbreaks of bacteria. The rule contains standards specific to sprouts, such as preventing the transfer of microbes onto seeds used for sprouting and testing spent irrigation water for pathogens. The time frame for enforcing the standards for sprout operations will be shorter than for the other provisions of the rule.

Other provisions

Workers who are ill or infected must inform their supervisors of any health condition that may result in contamination. Visitors and workers must take measures to prevent contamination of produce and food-contact surfaces. Farm workers must be trained on health and hygiene. The rule includes standards related to sanitation of equipment, tools, and buildings. Farms that rely on grazing or working animals are required to identify and refrain from harvesting produce that is likely to be contaminated by these animals, similar to standards in place for intrusion by wild animals.

Environmental impact

The FDA identified four standards in the rule that could potentially significantly impact the human environment. The FDA considered implementing different GM and STV for water applied to growing produce. It also considered a range of standards for the application intervals for untreated and treated biological soil amendments as well as how farms would respond to domesticated and wild animals and alternatives to the general provision establishing which farms would be covered under the rule.