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FDA Releases Proposed Regulations for Animal Feed and Pet Food
The Food and Drug Administration (FDA) on Oct. 25 issued its major proposed rule to establish requirements for current good manufacturing practices (CGMPs) and hazard analysis and risk-based preventive controls that would apply to domestic and imported animal feed, pet food, and raw materials and ingredients used in such products.
With the release of the animal feed and pet food regulation, FDA now has issued all five of the so-called “top tier” proposed food safety regulations required by the Food Safety Modernization Act (FSMA). Previously on Jan. 4, FDA issued two proposed rules to address CGMPs and hazard analysis and preventive controls for human food, and standards for produce safety. Later on July 26, FDA released two more proposed rules to cover foreign supplier verification programs and accreditation of third-party auditors.
Other significant rules required by FSMA that FDA has yet to propose will address intentional adulteration of food and the sanitary transportation of food. FDA currently is under a court mandate to propose these rules by Nov. 30 and Jan. 31, respectively.
Overview of FDA’s Proposed Regulations for Animal Feed and Pet Food: FDA’s proposed regulations would apply to domestic and foreign facilities that manufacture, process, pack or hold animal feed and/or pet food. Generally, with some exceptions, that means the new CGMP requirements and hazard analysis and preventive control provisions would apply to facilities that are required to register with FDA under the agency’s current facility registration regulations implemented as part of the Bioterrorism Act. FDA estimates that the proposed regulations would cover 6,287 domestic facilities and 1,843 foreign facilities that are associated with animal feed and pet food.
Significantly, FDA, as it did within its proposed rule for human food, proposes to exempt from the animal feed and pet food regulation grain elevators and other facilities that store only raw agricultural commodities (except fruits and vegetables) intended for further distribution and processing. However, the exemption mirrors the provision included in the proposed human food rule. As such, the rule’s language as currently drafted would negate the exemption for grain elevators that undertake various practices traditionally associated with the safe and effective storage of grain, such as screening, cleaning, conditioning and fumigating. The NGFA has been engaged in on-going discussions with FDA concerning this issue, and will address the proposed exemption within written comments that will be submitted to the agency.
The proposed regulation has two major features: 1) It contains provisions that would establish CGMPs for all types of animal feed and pet food; and 2) it would establish new provisions requiring hazard analysis and risk-based preventive controls.
New CGMPs: The proposed animal feed and pet food CGMPs contain similar safety requirements as those specified in the proposed rule to update the human food CGMP regulations, and would require covered facilities to address issues such as hygienic personnel practices and training; facility operations, maintenance, and sanitation; equipment design, use, and maintenance; processes and controls; and warehousing and distribution. However, the CGMP provisions of the proposed rule are not identical to those proposed for the human food. The proposed animal feed and pet food CGMPs, for example, would not address certain practices that do not pertain to animal feed and pet food, such as avoiding potential cross contact of allergens.
Significantly, the new proposed CGMPs will become an overarching set of requirements for all animal feed and pet food. Therefore, facilities producing medicated animals feeds will be subject to both the new CGMPs and FDA’s existing CGMP regulations for medicated feeds.
Hazard Analysis and Risk-Based Preventive Controls: Under the proposal, covered facilities would be required to identify the hazards that are “reasonably likely to occur” within their operation and to implement preventive controls to effectively minimize or prevent the hazards.
Each covered facility would be required to prepare and implement a written food safety plan that would include the following components:
- A hazard analysis that would identify and evaluate known or reasonably foreseeable hazards for each type of animal feed and/or pet food manufactured, processed, packed, or held at the facility.
- Preventive controls, which would be identified and implemented to provide assurances that hazards that are reasonably likely to occur would be significantly minimized or prevented. These preventive controls would need to be appropriate for the facility and the product being produced, and could address, for example, processing, prevention of cross-contamination, and sanitation affecting product safety. In addition, a recall plan for products for which there are hazards that are reasonably likely to occur would be required. Although not included in the proposed requirements, FDA said it believes a supplier approval and verification program is a risk-based and appropriate control to significantly minimize or prevent hazards from raw materials and ingredients, and is seeking comment on whether to include such a program in its final rule.
- Monitoring procedures that would provide assurance that preventive controls are consistently performed and records to document the monitoring.
- Corrective actions that would be used if preventive controls are not implemented properly. Facilities would be required to correct problems and minimize the likelihood of reoccurrence, evaluate the product for safety, and prevent affected animal feed or pet food from entering commerce. If specific corrective action procedures were not established for the problem, or if a preventive control is found to be ineffective, the facility also would be required to reevaluate the food safety plan to determine if modifications are needed.
- Verification activities to ensure preventive controls are consistently implemented and are effective. FDA said verification activities might include records review of monitoring, correction actions, or instrument calibration. Preventive controls also would be required to be validated to ensure they are effective in controlling the hazard. In addition, the food safety plan would be required to be reassessed at least every three years and otherwise when necessary.
Further, FDA said it recognizes that product and environmental testing programs are science-based verification activities “commonly accepted” in many sectors of the industry, and is seeking comment on these programs. FDA also is seeking comments regarding facility review of customer and other complaints as part of its verification activities.
- Recordkeeping, which would require facilities to keep a written animal food safety plan (including the hazard analysis) and records of preventive controls, monitoring, corrective action, and verification procedures. A qualified individual would be required to prepare the animal food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a reanalysis of the animal food safety plan (or oversee these activities). To be deemed qualified, an individual would be required to successfully complete training in accordance with an FDA-recognized standardized curriculum or be otherwise qualified through job experience to develop and apply an animal food safety system.
Compliance Dates: While proposing that the regulations take effect 60 days after publication of a final rule, FDA proposes that the actual compliance date for facilities be based upon the following business criteria:
- Very Small Businesses – three years after publication of the final rule. FDA is seeking comment on three proposed options to define a “very small business” based on annual sales of animal feed and/or pet food: 1) less than $500,000; 2) less than $1 million; or 3) less than $2.5 million, each adjusted for inflation.
- Small Businesses – two years after publication of the final rule. FDA proposes to define a “small business” as one that employs fewer than 500 persons.
- Other Businesses – one year after publication of the final rule. An “other business” would be a business that is not small or very small.
Estimated Economic Impact: FDA estimates that the proposed rule will have a one-time compliance cost to industry of $100.74 million. Further, FDA said discounting the one-time cost over 10 years at a 7 percent discount rate and adding the annual costs results in a total estimated annualized compliance cost estimate of $128.75 million. FDA also said while many potential benefits of the proposed rule can be identified, the current economic costs of hazards associated with animal feed and pet food could not be sufficiently quantified for comparison.
Submitting Comments: FDA is providing a 120-day comment period closing on Feb. 26, given the proposed rule published in the Oct. 29 edition of the Federal Register.
FDA Announces Public Meetings: FDA will conduct three public meetings on the proposed regulation. The first is Nov. 21, at the FDA Center for Food Safety and Applied Nutrition in College Park, Md. The second meeting will be on Nov. 25 at the Ralph H. Metcalfe Federal Building in Chicago, Ill. The third meeting will be Dec. 6 at the John E. Moss Federal Building in Sacramento, Calif.
Several of NGFA’s committees will analyze and assist in developing the association’s comments on FDA’s proposed rule, including the Biofuels and Co-Products Committee, Country Elevator Committee, Feed Legislative and Regulatory Affairs Committee, and Feed Manufacturing and Technology Committee.
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