9 Sept 2016
FDA Issues Guidance Documents on Various Requirements for Animal Food
The FDA has issued two draft guidance documents for industry on (1) human food by-products for use as animal food, and (2) current good manufacturing practice requirements for food for animals. While guidance documents generally do not establish legally enforceable responsibilities, they describe the FDA’s current thinking on a topic and should be viewed as recommendations unless specific regulatory or statutory requirements are cited.
Human Food By-Products for Use as Animal Food
This guidance applies to by-products of human food processing for use as animal food, such as wheat middlings generated while processing wheat for flour; grain products (hulls, bran, germ, gluten meal, grits and meals) from other grain processing operations; peels, rinds, pomace, pulp, culls or other similar material generated from processing fruits or vegetables for human consumption; and human food such as potato chips, cookies, bread, pastry products and pasta that is not adulterated and is safe for use as animal food but is not acceptable as human food for quality reasons (such as the wrong size, shape, colour or texture). It does not apply to by-products from other types of processing that are sometimes used for animal food, such as spent grains from fuel ethanol production, glycerine from biodiesel production, lignin sulfonate and kraft lignin from wood pulp production or paper-making, or hemicellulose extracted from wood.
The FDA issued a final rule on 17 September 2015 that applies to establishments that are required to register with the agency as a food facility because they manufacture, process, pack or hold animal food for consumption in the United States. That rule established CGMP regulations and required registered facilities to establish and implement hazard analysis and risk-based preventive controls for animal food. It provides flexibility so that facilities that are producing human and animal food can choose to comply with either the human food requirements in 21 CFR 117 or the animal food requirements in 21 CFR part 507 for the production of the animal food. It also exempts some human food by-products for use as animal food from the requirements of part 507, except for limited holding and distribution CGMPs. These holding and distribution provisions are found in both the animal food CGMPs (21 CFR 507.28) and the human food CGMPs (21 CFR 117.95). The provisions are the same but the agency decided to place them in both regulations for ease of finding.
This guidance explains the requirements that human food facilities must follow when they are providing by-products for use as animal food as well as the requirements facilities performing off-farm packing and holding of raw agricultural commodities subject to the standards for the growing, harvesting, packing and holding of produce for human consumption in 21 CFR part 112 must follow when they are providing by-products for use as animal food. Human food facilities that are distributing a by-product should know whether their by-product can or will be used for animal food and whether it is suitable for use in animal food. Human food facilities that do not intend for their human food by-products to be used as animal food should make that clear during distribution. This can be done, for example, by stating that the by-product is "Not for Animal Food Use" on the invoice, bill of lading or other documentation accompanying the by-product during distribution.
Regardless of whether a human food facility is required to comply with all, some or none of the provisions in part 507, the human food by-products for use as animal food must not be adulterated or misbranded in violation of the Federal Food, Drug and Cosmetic Act. Food, including human food by-products, used for animal food must be safe for the intended use. Human food by-products used for animal food must be generally recognised as safe (GRAS) under the conditions of intended use as animal food or must be the subject of a food additive approval for animal food to prevent the food from being considered adulterated. A substance with a use that is GRAS or approved as a food additive for use in human food may not always be suitable for use in animal food. For example, propylene glycol is considered GRAS as an anti-caking agent for human food when used as specified in the regulations but is prohibited in or on cat food.
Human food by-products for use as animal food may only be subject to limited holding and distribution CGMPs if the human food facility meets two conditions as specified in section 507.12. Specifically, they must be subject to and in compliance with applicable human food safety regulations and the human food facility must not further manufacture or process the human food by-products for use as animal food. The by-products may be from human food production or the off-farm packing and holding of raw agricultural commodities. If the facility meets those two conditions, then once the by-product for use as animal food is separated from the human food it is only subject to the limited requirements found in section 507.28 for its holding and distribution. If the facility does not meet both of these conditions, it must manufacture, process, pack or hold its by-product for use as animal food in compliance with part 507.
Human food that has been rejected for human food safety reasons should be evaluated by establishment management to determine whether it is appropriate to divert to animal food. In addition, a human food by-product for use as animal food that may have an animal food safety concern, for example because it resulted from production of a human food that was rejected for food safety reasons, should be evaluated by establishment management to determine whether it is appropriate to divert to animal food.
If the establishment management decides not to divert the contaminated or adulterated food to acceptable animal food use and chooses to dispose of it, then management should make it clear during disposal that the rejected food is not for use as animal food. If the facility itself is not transporting the food for disposal, it should include the statement "Not for Animal Food Use" on the invoice, bill of lading, container or other documentation accompanying the disposal so that the food is not used for animal food.
CGMP Requirements for Food for Animals
This guidance is intended for domestic and foreign facilities that are required to register as food facilities under the FD&C Act because they manufacture, process, pack or hold animal food for consumption in the United States. It contains information to help these facilities determine whether they need to comply with the CGMP requirements for animal food established in the final rule on this subject published on 17 September 2015. It also provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping.
The CGMPs in 21 CFR part 507, subpart B, provide baseline safety and sanitation standards for the manufacturing, processing, packing and holding of animal food, while the preventive controls requirements in 21 CFR part 507, subpart C, relate to a facility’s identification and evaluation of hazards in their animal food and measures to control hazards requiring preventive controls. CGMPs serve as baseline standards for producing safe animal food, including preventing insanitary conditions in the production of animal food. Animal food that is not manufactured, processed, packed and held according to CGMPs may be considered adulterated in accordance with 21 CFR 507.1(a)(1)(i-ii)).
The FD&C Act prohibits the introduction or the delivery for introduction into interstate commerce of adulterated animal food, as well as carrying out an act (e.g., violating CGMPs) that causes animal food to become adulterated after receipt of that food or its components in interstate commerce while the food is held by a facility for sale. Among other remedies, the U.S. government has authority to file actions in court to remove adulterated animal food from the marketplace (seizure) and/or to prevent a firm from continuing to manufacture and distribute adulterated food (injunction). The guidance document underscores that following the CGMP requirements for animal food is important because it may help prevent a company from producing and distributing adulterated animal food.
Facilities solely engaged in the following activities are not subject to the CGMP requirements in 21 CFR 507, subpart B: (1) holding and/or transportation of one or more raw agricultural commodities; (2) hulling, shelling, drying, packing and/or holding nuts and hulls (without manufacturing/processing, such as grinding shells or roasting nuts); or (3) ginning cotton (without manufacturing/processing, such as extracting oil from cottonseed).
In situations where a facility is required to follow both the human food CGMPs found in 21 CFR part 117 and the animal food CGMPs found in 21 CFR part 507, the FDA will allow the facility the choice between (1) following the CGMPs in part 117 for its human and animal food, or (2) following the CGMPs in part 117 for the human food and the CGMPs in 21 CFR part 507 for the animal food. In deciding which CGMPs to follow, the FDA recommends that facilities consider how they are manufacturing, processing, packing or holding the human and animal food. For example, if a facility has separate employees, production lines and holding areas it might prefer to follow 21 CFR part 117 for the human food and 21 CFR part 507 for the animal food. However, if a facility is using common employees, production lines or holding areas for the human and animal food, it might prefer to follow 21 CFR part 117 for both the human and animal food.