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FDA Proposes Regulations to Ensure Safety of Animal Food

Monday, October 28, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is proposing new regulations designed to improve the safety of animal food. Comments on this proposed rule are due no later than 120 days after Oct. 28 (i.e., approximately Feb. 26, 2014). In addition, the FDA will hold the following public meetings to discuss and receive input on this rule: Nov. 21 in College Park, Md.; Nov. 25 in Chicago, Ill.; and Dec. 6 in Sacramento, Calif.

The proposed rule would establish provisions on current good manufacturing practices with respect to the manufacturing, processing, packing and holding of animal food for domestic and foreign facilities required to register under the Federal Food, Drug and Cosmetic Act. The proposed CGMPs would establish procedures in areas such as buildings and facilities, design and layout, cleaning and maintenance, pest control and personnel hygiene.

The FDA also is proposing to require that certain animal food facilities (generally, those required to register with the FDA under its current food facility registration regulations) establish and implement hazard analysis and risk-based preventive controls for animal food. These controls would include requirements for covered facilities to maintain a written food safety plan, perform a hazard analysis and institute preventive controls for the mitigation of hazards that are reasonably likely to occur. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions and maintain records documenting these actions. The FDA notes that it does not expect that all possible preventive measures and verification procedures would be applied to all animal foods at all facilities.

The FDA is requesting comment on when and how other elements of a preventive controls system are an appropriate means of implementing the statutory directives, including a product

testing program, an environmental monitoring program and a supplier approval and verification

program, as appropriate.

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