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FDA Releases FSMA Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Animal Food

The U.S. Food and Drug Administration issued the first five chapters of a draft guidance to help animal food facilities subject to the Preventive Controls for Animal Food rule develop a food safety plan to significantly minimize or prevent hazards that could cause illness or injury to people or animals.

The draft guidance, entitled “Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,” includes five chapters and provides an overview of:

  • food safety plan requirements;
  • recommendations for conducting a hazard analysis;
  • hazards associated with the manufacturing, processing, packing, and holding of animal food;
  • examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and
  • preventive control management components.

The FDA intends to publish additional guidance on the animal food preventive controls provisions and will continue to announce additional guidance as it becomes available. A future guidance document will provide in-depth guidance on the supply-chain program preventive control.

Businesses that are not small or very small businesses under the rule were required to comply with the animal food preventive control provisions on Sept. 18, 2017. Small businesses need to comply by no later than Sept. 17, 2018, and very small businesses need to comply with limited provisions by Sept. 17, 2019. Last year, the FDA announced that it intends to delay routine preventive controls inspections for large businesses until fall 2018 to allow the animal food industry more time to focus on development of their food safety plans and to consider information in the draft guidance.

The FDA is seeking public comment on this this draft guidance for 180 days, from Jan. 23, 2018 to July 23, 2018.

To submit comments to the docket electronically, visit http://www.regulations.gov and type FDA-2016-D-2343 in the search box.

To submit comments to the docket by mail, use the following address. Please be sure to include docket number FDA-2016-D-2343 on each page of your written comments.

Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852