FDA Releases Food Safety Guidance

By Casey Wooten

Aug. 24 — Just a few months after the Food and Drug Administration completed the last of seven final rules implementing the Food Safety Modernization Act, the agency has released draft guidance documents designed to help companies comply with the sweeping 2011 law.

Released Aug. 24, the three documents instruct companies operating processing, packing and storage facilities for human and animal foods on meeting the requirements of FSMA's preventative controls rules, finalized in September 2015 (See previous story, 09/01/15).

In May, the FDA rolled out the last final rule implementing FSMA, that one dealing with food facility security, though the agency said more information was to come (See previous story, 05/27/16).

In an Aug. 24 online post, Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, and Tracey Forga, acting director of the FDA's Center for Veterinary Medicine, said the guidance documents were part of an effort to educate businesses about the new standards.

“Meeting the FSMA mandate involves cooperation between the FDA and the food industry,” the FDA officials said. “From the smallest food operation to the largest company, we want to be sure that we’re all on the same page and these draft guidances will help get us there.”

The public comment period for the drafts will begin Aug. 25.

Businesses can expect more guidance documents to come in the future, the FDA officials said.

Safety Compliance

FSMA requires food makers to draft and implement a safety plan, and sets deadlines for companies to meet preventative controls requirements. Large human food facilities must meet preventative controls and Current Good Manufacturing Practice (CGMP) requirements by Sept. 19, while animal food facilities must meet only CGMP standards by the same date.

Smaller facilities have additional time to comply.

One of the draft guidance documents, Draft Guidance for Industry No. 235, gives information to companies making animal food on how to comply with safety rules in areas such as personnel, sanitation, plant operation and water supply, among others.

Another document, Draft Guidance for Industry No. 239, covers facilities that take human food byproducts such as wheat middlings or vegetable pulp and use them in animal food. That guidance provides information on what parts of FSMA's Preventative Controls for Animal Food rule apply to the byproduct from human food.

The final draft guidance covers the classification of activities such as harvesting, packing, holding or manufacturing for farms and facilities, describing which rules apply to a specific business. The guidance states that, in general, businesses that only perform activities within the “farm” definition are not subject to the FSMA Preventative Controls for Human Food rule. However, when activities involved covered produce, farms may be subject to the FSMA Produce Safety Rule.

The FDA is planning to host a webinar in September to discuss the draft guidance documents in more detail, the agency said in a statement.

To contact the reporter on this story: Casey Wooten in Washington at cwooten@bna.com

To contact the editor responsible for this story: Heather Rothman at hrothman@bna.com

For More Information

The FDA statement and guidance documents are available at http://src.bna.com/h1b.

The FDA officials' online post is available at http://src.bna.com/h1j.

Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.