September 27, 2022

Volume XII, Number 270

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September 26, 2022

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FDA Finalizes Guidance for Animal Food Facilities

  • On July 6, 2022, FDA announced it had finalized its Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The guidance aims to help food facilities develop a food safety plan to prevent or significantly minimize hazards in food for animals that could cause illness or injury to people or animals. Additionally, it provides detailed information to help animal food facilities anticipate possible food safety hazards, identify risk-based preventive controls to prevent or minimize those hazards, and create and implement a plan to keep unsafe animal food from entering the marketplace.

  • The document details:

    • How to recognize biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food;

    • Ways to identify and implement preventive controls for hazards that require preventive controls in animal food;

    • Components of preventive control management (e.g., monitoring, corrective actions, and verification (including validation); and

    • Recordkeeping requirements associated with the food safety plan and the implementation of the food safety plan.

  • By way of background, FDA released draft GFI #245, a draft of this guidance in January of 2018. One of the most notable changes in response to stakeholder feedback is the clarification that not all the hazard examples in the guidance are applicable to all animal food or all facilities.

  • Animal food facilities with questions about how this guidance applies to them can contact [email protected] for further assistance. Comments can be submitted here.

Nicholas Prust, Natalie Rainer, and Frederick Stearns also contributed to this article.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 188
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About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office
Associate

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

202-434-4237
Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

202-434-4222
Jill M Mahoney Associate Attorney Keller Heckman
Associate

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

202-434-4184
Richard Mann Partner Keller Heckman DC
Partner

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

202-434-4229
Paula S. Pastuskovas San Francisco Food and Drug Attorney Keller and Heckman
Associate

Paula Pastuskovas counsels domestic and international clients on regulatory and compliance matters in food and drug law. She assists clients in obtaining regulatory clearances for food additives and food-contact materials from the U.S. Food and Drug Administration (FDA), Health Canada, and other comparable international agencies. She advises clients on food labeling, ingredient, and substantiation issues. 

As a resident of the firm’s San Francisco office, Paula also advises companies on compliance with California’s state and local laws. This...

415-948-2830
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