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FDA Released its Proposed Animal Food Rule: What’s in it?

FDA published its proposed animal food rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, in the Federal Register yesterday. The proposed rule, which FDA promulgated pursuant to section 103 of the Food Safety Modernization Act (FSMA), will require entities in the livestock feed and pet food industry to adopt food safety practices similar to those in the human food industry. The provisions included in the proposed rule will bring about sweeping changes to how food safety issues are addressed. However, FDA has hinted that the final version of the animal food rule may contain even more obligations for animal food entities.

As the rather wordy title of the rule suggests, the proposed rule requires animal food facilities to undertake a two-pronged approach to food safety. First, the proposed rule establishes Current Good Manufacturing Practices (CGMPs) for animal food operations. The CGMPs outline food safety practices that must be followed to prevent contamination or adulteration of animal food. Second, the rule also requires most animal food facilities to engage in Hazard Analysis and Risk-Based Preventive Controls (HARBPC). The HARBPC are the “teeth” of the proposed rule and are designed to require facilities to hold themselves accountable for food safety issues.

In case you haven’t had a chance to read all 103 pages of the Federal Register that pertain to the proposed animal food rule, here is a brief summary.

Applicability

FDA proposes that the animal food rule will apply to all animal food entities that are required to register as a food facility under section 415 of the Food, Drugs, and Cosmetics Act. Farms are exempt from the new rule; however, if a farm processes ingredients onsite that were not grown on the farm, then they must register.

The proposed rule also contains modified (lower) requirements for (1) entities that FDA deems “small businesses” and “very small businesses”; (2) grain elevators; (3) low-risk livestock feed processing and packing activities undertaken by small and very small businesses; (4) canned pet food manufacturers; and (5) facilities solely engaged in the storage of packaged animal food.

Current Good Manufacturing Practice

The proposed rule used the new human food CGMPs as a starting point for animal food; however the two proposed CGMPs are not identical. One notable exception is that animal food processors will not have to address allergens. The areas that the new CGMPs cover include: hygienic personnel practices and training; facility operations, maintenance, and sanitation; equipment and utensil design, use, and maintenance; processes and controls; and warehousing and distribution.

Hazard Analysis and Risk-Based Preventive Controls

The HARBPC portion of the rule would require animal food facilities to adopt a science and risk-based approach to implement animal food controls that are necessary to protect animal and human health. The approach is inspired by HACCP systems, but it could be viewed by some as going even further by requiring preventive controls in areas that are not critical control points.

HARBPC revolves around the preparation of and compliance with a written food safety plan. The written food safety plan must include:

  1. A Hazard Analysis, which identifies animal and product-specific hazards which may occur and determines which are reasonably likely to occur;
  2. Preventive Controls, which are designed to minimize or prevent the hazards that are reasonably likely to occur;
  3. A Recall Plan, which assigns responsibilities for the various scenarios that could occur during a recall;
  4. Monitoring procedures to verify the preventive controls are consistently performed;
  5. Corrective Actions that will be performed if it is discovered preventive controls are not performed or are ineffective; and
  6. Verification to ensure the preventive controls are effective, including records review, calibration of instruments, and ensuring corrective actions are effective.

Many of the activities conducted pursuant to the HARBPC requirements must be conducted by someone FDA deems a “qualified” individual. The HARBPC portion of the proposed rule is also accompanied by substantial recordkeeping requirements.

Items That May Make Their Way into the Final Rule

FDA has requested comment on a few items that it did not include in the proposed rule. We take this as a hint that these items may make their way into the final version of the rule. These include:

  1. Supplier Verification: FDA is interested in receiving comments on whether the final rule should include requirements for supplier verification for some or all forms of animal food. This could include supplier approval and verification schemes and on-site audits.
  2. Finished Product and Environmental Testing: The proposed rule does not require facilities to engage in finished product testing, but FDA is requesting comments to determine if, when, and how product testing should be incorporated into the final rule. Additionally, FDA is interested in receiving comments on whether facilities should be required to engage in environmental testing for pathogens such as Salmonella spp. or Listeria spp.
  3. Responses to Customer Complaints: FDA is requesting comments on whether the HARBPC food safety plan should include a procedure to address customer complaints.

Deadline for Comments

The deadline for submission of public comments to the docket is February 26, 2014. FDA will also hold three public meetings to discuss the proposed rule with the public. The meetings will be held on: November 21, 2013 in College Park, Maryland; November 25, 2013 in Chicago, Illinois; and December 6, 2013 in Sacramento, California.

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