The Food and Drug Administration (FDA) has issued its proposed rule on Current Good Manufacturing Practice (CGMPs) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals under the Food Safety Modernization Act (FSMA).
“Because the dairy industry is a significant source of inputs into animal feed production, many IDFA members will be required to comply with these additional regulations and should carefully consider how they will affect their operations,” said John Allan, IDFA’s vice president of regulatory affairs and international standards.
The proposed rule would apply broadly to any facility that manufactures, processes, packs, or holds animal food. “Animal food” is defined to include pet food, animal feed, and raw materials and ingredients that will be used in food for animals. The proposed rule specifically addresses “waste” diverted from human food facilities for use in animal food. Facilities in compliance with FDA’s preventive controls for human food regulation (proposed 21 CFR Part 117) are deemed in compliance with the animal food proposed rule, so long as their hazard analysis also addresses hazards reasonably likely to occur in the animal food.
Facilities owned by food companies that only have small annual sales of waste for animal food may be subject to a partial exemption from compliance with the animal food proposed rule as a “qualified facility.”
FDA proposes that covered facilities would be required to come into compliance with the proposed rule one year after publication of the final rule in the Federal Register. Small businesses, defined as those with fewer than 500 employees, would be required to comply with the requirements two years after the publication date. Very small businesses would be given two extra years (3 years total) to come into compliance after the date of publication of the final rule.
Members may login below to read a detailed summary of the proposed rule prepared by IDFA’s legal counsel, Hogan Lovells US LLP.
FDA Extends Comment Period for Two Proposed FSMA Rules
The U.S. Food and Drug Administration (FDA) is extending the comment period on two proposed rules: “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” and “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” that appeared in the July 29, 2013 Federal Register.
Comments on these two proposed rules as well as comments on the information collection provisions associated with these rules may be submitted until January 27, 2014. Comments were originally due by November 26, 2013.
IDFA is planning to comment on behalf of the industry. Members should send any concerns or comments to Clay Detlefsen, IDFA vice president of regulatory affairs and general counsel at firstname.lastname@example.org.
FDA is taking this action in response to requests for an extension to allow interested persons an opportunity to consider the interrelationship between these two proposed rules and the proposed rule announced in October 2013, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.”
For more information, contact Allan at email@example.com.
Please login to view this member's only content