A few months after the Food and Drug Administration completed the last of seven final rules implementing the Food Safety Modernization Act (FSMA), the agency has now released draft guidance documents designed to help companies comply with the sweeping 2011 law.
The guidance documents instruct companies operating processing, packing and storage facilities for human and animal foods on how to meet the requirements of the law’s preventative controls rules, finalized last September. Businesses can expect more guidance documents to come in the future, FDA officials said.
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 requirements by Sept. 19, while animal food facilities must meet only CGMP standards by the same date. Smaller facilities have additional time to comply.
Draft Guidance for Industry No. 235 gives information to companies making animal food on how to comply with safety rules in areas such as personnel, sanitation, plant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.
Draft Guidance for Industry No. 239 covers facilities that take human food byproducts such as wheat middlings or vegetable pulp and use them in animal food.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The final draft guidance covers the classification of activities such as harvesting, packing, holding or manufacturing for farms and facilities, describing which rules apply to a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 public comment period for the drafts began August 25. FDA is planning to host a webinar in September to discuss the draft guidance documents in more detail, the agency said in a statement.