FDA Animal Food Rule Similar to Human Food Regs, With Later Compliance Dates, Higher Small Business Bar

FDA issued its proposed rule on preventive controls requirements for animal food in October 2013 (see 13102519), followed by a revised proposal issued in September 2014 (see 14092901). The agency agreed to issue its final rule by Aug. 30, 2015, settling a lawsuit brought by the Center for Food Safety to force FDA to comply with deadlines set by Congress in FSMA (see 14022124).

Compliance with CGMP provisions is required beginning in September 2016, with later compliance dates for small and very small businesses. Compliance with preventive controls requirements is required beginning in September 2017, again with small businesses getting a grace period.

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

FDA’s final 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 in its proposed rule.

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

FDA’s final rule for animal food preventative controls largely mirrors its final rule on 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 final rule requires a written food safety plan that must be reanalyzed as a whole at least once every three years, said FDA. A facility may “only reanalyze the applicable portion of the food safety plan under certain other circumstances, such as when a facility becomes aware of new information about potential hazards associated with a food,” said FDA.

Written hazard analysis. The written hazard analysis will have to identify and evaluate “known or reasonably foreseeable hazards” to determine whether there are hazards that are “reasonably likely to occur,” including biological, chemical, and physical hazards. The hazard analysis must consider hazards that may be present in the food because they occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain, said FDA in the final rule.

Written preventive controls. The new regulations require that the facility implement preventive controls to ensure that food manufactured, processed, packed, or held by the facility will not be adulterated. FDA said it has made these provisions more flexible by “clearly stating in the final rule that a facility must take into account the nature of the preventive control and the facility’s food safety system when considering which activities are appropriate for that facility.”

Monitoring. Monitoring of the preventive controls is required to ensure that they are consistently performed.

Corrective Actions and Corrections. 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. Less burdensome “corrections” would also be allowed, where the facility can “identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce),” said FDA.

Verification. The proposal would require that facilities conduct verification of preventive controls, monitoring, corrective action decisions, and effectiveness. FDA says the final rule “provides flexibility for which verification activities must occur,” requiring verification activities “as appropriate to the nature of the preventive control and its role in the facility’s food safety system,” said FDA. Validation is not required for all controls, it said.

Supply Chain Program. The final rule does not require a manufacturing/processing facility to implement a preventive control in certain circumstances when the hazard requiring a preventive control will be controlled by another entity in the distribution chain, said FDA. The agency will allow “entities such as distributors, brokers, and aggregators to determine, conduct, and document appropriate supplier verification activities as a service to the receiving facility, provided that the receiving facility reviews and assesses applicable documentation provided by the other entity and documents that review and assessment,” it said. “However, because the approval of suppliers is ultimately the responsibility of the receiving facility, the rule specifies that only a receiving facility can approve suppliers,” said FDA.

Qualified individual. FDA’s final rule would continue to require that preventive controls be “conducted (or overseen) by a preventive controls qualified individual,” said the agency. “A preventive controls qualified individual is a qualified individual who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system,” it said.

Written recall plan. Covered facilities would be required to have a written recall plan for animal food with hazards requiring preventive controls.

Recordkeeping. FDA will require that food facilities maintain records to demonstrate compliance with the new regulations. “To meet these requirements, a facility may use existing records as appropriate,” said FDA.

New CGMP Requirements

FDA’s final rule would also set current good manufacturing practice requirements for animal food facilities. The new regulations include requirements for personnel; plant and grounds; sanitation; water supply and plumbing; equipment and utensils; plant operations; holding and distribution; and holding and distribution of human food by-products for use as animal food. The CGMPs for animal food allow human food facilities in compliance with all applicable FDA human food safety requirements, including human food CGMPs, to only follow the specific CGMPs for the holding and distribution of human food by-products for use as animal food, as long as they do not further process the by-product, said FDA.

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

The new animal food regulations include several exemptions and modified requirements, some of which are similar to exemptions to FDA’s human food preventive controls regulations. Many small businesses will be considered “qualified entities” that wouldn’t have to comply with normal preventive controls requirements. Some facilities subject to other food safety regulations are also exempted from the animal food rule’s requirements. One major difference between the animal and human food exemptions is that the animal food rule sets a higher threshold for very small businesses. 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, may be designated as “qualified facilities.” Facilities with 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) would be eligible. So would “very small businesses,” defined as “a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee).”

Rather than be required to comply with full preventive controls 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

The notification will be in the form of an attestation, and must be submitted every two years at the same time that the facility is required to update its facility registration, said FDA.

The final rule has procedures for withdrawing a qualified facility exemption “in the event an active investigation of a foodborne illness outbreak that is directly linked to the facility, or if FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on relevant conditions or conduct associated with the qualified facility.” An appeal process is available, with the ability for facilities that had their qualified status withdrawn to request an informal hearing and possible reinstatement.

On-farm activities for small and very small businesses. “Low risk,” on-farm activities performed by small businesses (less than 500 full time equivalent employees) and very small businesses (less than $2,500,000 in sales per year) would be exempt from the final rule’s requirements. Low risk activities may include, for example, re-packing roughage products, or cracking grains.

Facilities compliant with low-acid canned food regulations. Facilities already compliant with low-acid canned food regulations are exempt; however, this exemption only applies 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 preventive controls requirements. Though FDA has not yet issued its final produce safety rule, the produce safety rule as currently proposed would cover most fruits and vegetables while they are in their raw or natural (unprocessed) state (see 13010805). It would not apply to raw agricultural commodities that are rarely consumed raw.

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 food that is not exposed to the environment would be exempt. Modified preventive controls requirements would apply to storage of refrigerated packaged food.

Compliance Dates Based on Business Size, Additional Time Provided Since Proposal

In a change from its proposed rule, FDA will allow additional time for compliance with the new animal food safety regulations. Medium and large businesses must comply with the CGMP requirements in this final rule by Sept. 19, 2016, and with the preventive controls requirements by Sept. 18, 2017. Small businesses have until Sept. 18, 2017, for the CGMP requirements, and Sept. 17, 2018, for the preventive controls provisions. Very small businesses have until Sept. 17, 2018 and Sept. 17, 2019, respectively.

“Qualified facilities” will have to comply by Sept. 17, 2019, but must retain records to demonstrate qualified facility status beginning on Jan. 1, 2017, said FDA. Compliance dates for FDA’s new “supply-chain program” requirements is required by Sept. 18, 2017, at the earliest, with later effective dates for small businesses and some facilities that have suppliers that are required to comply with FDA’s preventive controls and produce safety rules, said FDA.