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.”

FDA considers simplifying agricultural water standards under the FSMA produce safety rule

In response to industry feedback, the FDA is considering the simplification of the microbial quality and testing requirements for agricultural water established by the Food Safety Modernization Act’s (FSMA’s) (P.L. 111-353) produce safety rule while still protecting public health.

The FSMA’s produce safety rule (80 FR 74353) establishes two sets of criteria for microbial water quality of agricultural water, both of which are based on the presence of generic E. coli, which can indicate the presence of fecal contamination:

  • No detectable generic E. coli are allowed for certain uses of agricultural water in which it is reasonably likely that potentially dangerous microbes, if present, would be transferred to produce through direct or indirect contact. Examples include water used for washing hands during and after harvest, water used on food-contact surfaces, water used to directly contact produce (including to make ice) during or after harvest, and water used for sprout irrigation. The rule establishes that such water use must be immediately discontinued and corrective actions taken before re-use for any of these purposes if generic E. coli is detected. The rule prohibits use of untreated surface water for any of these purposes.
  • The second set of numerical criteria is for agricultural water that is directly applied to growing produce (other than sprouts). The criteria are based on two values, the geometric mean (GM) and the statistical threshold (STV). The GM of samples is 126 or less colony forming unit (CFU) of generic E.coli per 100 mL of water and the STV of samples is 410 CFU or less of generic E.coli in 100 mL of water.

If the water does not meet these criteria, corrective actions are required as soon as is practicable, but no later than the following year. Farmers with agricultural water that does not initially meet the microbial criteria have additional flexibility by which they can meet the criteria and then be able to use the water on their crops. These options include, for example:

  • Allowing time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
  • Allowing time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
  • Treating the water.

The produce safety rule bases testing frequency on the type of water source (i.e. surface or ground water).

Testing Untreated Surface Water

In testing untreated surface water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of 20 samples, collected as close as is practicable to harvest over the course of two to four years. The initial survey findings are used to calculate the GM and STV (these two figures are referred to as the “microbial water quality profile”) and determine if the water meets the required microbial quality criteria.

Testing untreated ground water

For untreated ground water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of four samples, collected as close as is practicable to harvest, during the growing season or over a period of one year. The initial survey findings are used to calculate the GM and STV and determine if the water meets the required microbial quality criteria.

For untreated ground water that is used for the purposes for which no detectable generic E. coli is allowed, the FDA requires farms to initially test the untreated ground water at least four times during the growing season or over a period of one year. Farms must determine whether the water can be used for that purpose based on these results.

Testing public water supplies

There is no requirement to test agricultural water that is received from public water systems or supplies that meet requirements established in the rule (provided that the farm has public water system results or certificates of compliance demonstrating that the water meets relevant requirements), or if the water is treated in compliance with the rule’s treatment requirements.

Industry feedback

The feedback that the FDA has received in response to the produce safety rule is that some of these standards, which include numerical criteria for pre-harvest microbial water quality, may be too complex to understand, translate, and implement. These factors can be important to achieving high rates of compliance.

FDA response

In response to these industry concerns, the FDA is considering how it might simplify the water standards. The FDA indicates it intends to work with stakeholders as these efforts related to the water standards proceed.

 

FDA considers establishing a new ‘Office of Patient Affairs’

The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more transparent, accessible, and robust experience for patient communities, the FDA is considering establishing a new Office of Patient Affairs.

On November 4, 2014, the FDA established a docket (FDA-2014-N-1698) for the public to submit information related to the FDA’s implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144), Patient Participation in Medical Product Discussions under FDASIA section 1137.

Based on the comments received, the FDA identified objectives for its patient engagement activities. First, to develop a nuanced understanding of the patient experience of disease by: (1) gathering patient perspective on what is clinically meaningful; (2) assessing attitudes towards benefit-risk and tolerance of uncertainty; and (3) enhancing the science of eliciting and integrating patient input.

Second, to support patients and their advocates in understanding regulatory processes and navigating the FDA by: (1) communicating relevant FDA positions, procedures, and activities; (2) connecting patients and their advocates with the appropriate resources; and (3) resolving discrete challenges and needs.

To achieve these objectives, the FDA is considering establishing a central “Office of Patient Affairs.” The responsibilities of this central office would include:

  • offering a single, central entry point to the FDA for the patient community;
  • providing triage and navigation services for inbound inquiries from patient stakeholders;
  • hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with the FDA by patient stakeholders and the FDA’s relationships with patient communities; and
  • developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

The Office of Patient Affairs would be directly accountable to the medical product Centers. A regular evaluation of this central office and of FDA’s overall patient engagement efforts are also proposed.