FDA Proposes Rule on Animal Feed and Pet Food Safety; Importer Verification Required by FSVP

FDA said it has focused on a variety of animal food safety issues in recent years, including safety issues related to bovine spongiform encephalopathy (BSE, commonly known as mad cow disease), chronic wasting disease, mycotoxins (especially aflatoxin in animal food intended for lactating dairy cattle), dioxins, melamine, and microbial contamination. Typically, these problems have been discovered after the animal food was already distributed, FDA said, leading to animal illness and death. Ensuring the safety of animal food is also complicated by the fact that many animals consume one food as their sole source of nutrition, it said. For this reason, nutrient deficiencies and excesses in animal foods can also raise safety concerns, said FDA.

FDA announced a series of public meetings to further the proposed animal food rule, in a separate Federal Register notice also set for publication Oct. 29 (here). The first meeting will be held in College Park, Md., on Nov. 21. Additional meetings will be held in Chicago, Ill., on Nov. 25, and Sacramento, Calif., on Dec. 6.

Applies to Pet Food, Animal Feed Facilities Required to Register With FDA

FDA’s proposed rule would apply to animal facilities required to register with FDA under Section 415 of the Food, Drug & Cosmetic Act, unless subject to an exemption. This would include manufacturing processing, packing, and holding of finished products that are intended to be fed to animals, including livestock, pets, and other captive animals, as well as the manufacturing, processing, packing and holding of ingredients that may be used in animal foods, FDA said. While some industry sectors like renderers and grain and oilseed processors have long been considered animal food processors, FDA’s proposed rule would also subject newer sectors involved in the animal food supply chain to food safety requirements. For example, biofuel manufacturers (suppliers of distillers grain for animal food) and other entities that may not have been thought of as animal food manufacturers in the past, such as mineral refiners and manufacturers, would be subject to the proposed rule if they manufacture, process, package or hold animal food, said FDA.

The proposed rule would not apply to farms that manufacture, process, pack or hold food for consumption for their own animals, said FDA, because those facilities are not required to register by the FD&C Act. The requirements would apply to farms operating an animal food manufacturing business in addition to traditional farm activities that require registration, however.

FDA’s proposed animal food rule would require facilities to focus on the hazards most likely to be associated with the ingredients they use that are relevant to the animals that eat the food. So facilities that manufacture, process, pack, or hold an ingredient used for a single animal would only have to focus on hazards related to that animal, but facilities that handle food for various animals would need to consider a broader range of hazards, FDA said.

Exemptions, Modified Requirements for Small Businesses, Farms, Etc.

The animal food proposed rule sets out several exemptions and modified requirements, some of which are similar to proposed exemptions to FDA’s human food safety proposal. Many small businesses would be considered “qualified entities” that wouldn’t have to comply with normal preventative controls requirements. Some facilities subject to other food safety regulations would also be exempted from the proposed animal food rule’s requirements. Exemptions and modified requirements would include:

Modified requirements for small and very small businesses. Small businesses that meet certain requirements, as well as all very small businesses, would be designated as “qualified facilities.” This exemption would be subject to modified requirements (1) small businesses that have average annual sales of less than $500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); and (2) very small businesses. FDA still hasn’t decided on its criteria for very small businesses, and is requesting comments on whether to define very small businesses as those with average annual sales under $2,500,000; $1,000,000; or $500,000.* Rather than be required to comply with full HARPC requirements, “qualified entities” would only have to:

• Notify FDA about its status; and
• Either:
  • Notify FDA that it is addressing hazards through preventive controls and monitoring; or
  • Notify FDA that it complies with applicable local regulations, and notify consumers of the name and complete business address of the facility where the food was manufactured or processed

*FDA’s proposal on hazard analysis and preventative controls for human food proposed to define very small businesses at the lower average sales levels of $1,000,000; $500,000; or $250,000.

On-farm activities for small and very small businesses. “Low risk,” on-farm activities performed by small businesses and very small businesses would be exempt from most HARPC requirements. FDA is proposing to define small businesses as having less than 500 employees for the purposes of the low-risk on-farm activities exemption. FDA said it would define the low-risk activities that qualify for this exemption, which may include re-packing intact fruits and vegetables and grinding, milling, cracking, or crushing grains. It announced the availability of a draft risk assessment on what constitutes low-risk, on-farm activities in a notice released in conjunction with the animal controls rule (here).

Facilities compliant with low-acid canned food regulations. Facilities already compliant with low-acid canned food regulations would be exempt; however, this exemption would only apply to microbiological hazards.

Activities subject to produce safety rule. Activities that are subject to the FDA’s produce safety requirements would not have to comply with HARPC for animal foods requirements. As proposed in January, FDA’s produce safety rule would cover growing, harvesting, packing and holding raw fruits and vegetables on foreign and domestic farms (see 13010805).

Storage of non-fruit and vegetable agricultural commodities. Facilities that only store raw agricultural commodities, other than fruits and vegetables, intended for further distribution or processing would be exempt. This exemption would not apply to storage of fruits and vegetables.

Storage of non-exposed packaged food. Facilities that only store packaged animal food that is not exposed to the environment would be exempt. Modified HARPC requirements would apply to storage of refrigerated packaged animal food.

Animal Food Rule Would Require Food Safety Plan, Monitoring, Corrective Action

FDA’s proposed rule for animal food preventative controls would largely mirror its proposal for human food. The animal food rule would require all covered facilities to develop a plan; identify hazards, identify and implement preventive controls; and then monitor and verify that the controls work.

Written food safety plan. The proposal would require the owner, operator, or agent in charge of a facility to have and implement a written food safety plan that includes: a hazard analysis; preventive controls; monitoring procedures; corrective action procedures; verification procedures; and a recall plan.

Written hazard analysis. The written hazard analysis would have to identify and evaluate “known or reasonably foreseeable hazards” for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are “reasonably likely to occur,” including biological, chemical, physical, and radiological hazards.

Written preventive controls. The proposed rule would require that the owner, operator, or agent in charge of a facility identify and implement preventive controls to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented, and that the animal food will not be adulterated under Section 402 of the FD&C Act. These may include tolerances for the hazard, process controls, sanitation controls, and a recall plan, among other things, FDA said.

Written recall plan. Covered facilities would be required to have a written recall plan for food with hazards that are reasonably likely to occur.

Monitoring. Monitoring of the preventive controls would be required, to provide assurance that they are consistently performed, including requirements to establish and implement written monitoring procedures and establish and maintain records documenting the implementation of the monitoring procedures.

Corrective Action. FDA would require that facilities establish and implement written corrective action procedures that would be used if preventive controls are not properly implemented and take corrective actions in the event of an unanticipated problem.

Verification. The proposal would require that facilities conduct verification of preventative controls, monitoring, corrective action decisions, and effectiveness. It would also require re-analysis of the food safety plan at least once every three years, and more often when circumstances warrant.

Modified Requirements for Non-Exposed Packaged Animal Food

For packaged animal food that is not exposed to the environment, FDA would implement modified requirements. To prevent toxin formation, FDA proposes to require the owner, operator, or agent in charge of facilities solely engaged in the storage of packaged animal food that is not exposed to the environment to conduct activities for any refrigerated packaged animal food that requires time/temperature control, including:

• Establishing and implementing temperature controls
• Monitoring the temperature controls
• Taking appropriate corrective actions when there is a problem with temperature controls
• Verifying that temperature controls are consistently implemented
• Establishing the following records:
  • Documentation of temperature control monitoring
  • Records of corrective actions
  • Documentation of verification activities

Qualified Individual Required

FDA’s proposed rule would establish qualification requirements for a “qualified individual,” who would be required to do or oversee the preparation of the food safety plan, validation of preventive controls, review of records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and re-analysis of a food safety plan. A qualified individual would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided a person with knowledge at least equivalent to that provided through the standardized curriculum, FDA said.

Recordkeeping

FDA would require food facilities maintain records, including their written food safety plan and documentation of monitoring, corrective actions, verification, and training for the qualified individual.

Proposed HACCP Requirements for Animal Food Handlers

FDA is also proposing “general baseline” good manufacturing practices for facilities that manufacture, process, pack and hold animal food. Specific requirements would apply to:

• Personnel in animal food facilities, such as good hygiene practices and protection of food from contamination from personal effects
• The plant and grounds, including proper cleaning maintenance, and elimination of pests
• Sanitary operations, including maintaining clean and sanitary conditions of food contact surfaces, proper use and storage of toxic cleaning compounds, and exclusion of pests
• Sanitary facilities and controls, including the plant’s water supply, plumbing, and toilet and hand-washing facilities
• Equipment and utensils, including the cleaning and maintenance of such items and protecting animal food from contamination
• Processes and controls, including following adequate sanitation principles, proper labeling for ingredients and finished animal food, ensuring the safety of raw materials, and prevention of contamination of animal food during processing
• Warehousing and distribution to protect animal food against contamination and deterioration

Staggered Compliance Date from One to Three Years Based on Business Size

The eventual final rule on CGMP and hazard analysis and preventative controls for animal food would be effective 60 days after the final rule is published, FDA said. FDA will allow one year for businesses other than small and very small businesses to come into compliance. Small businesses will get a two year grace period, and very small businesses will have three years to comply, FDA said.