On October 29, 2013, the United States Food and Drug Administration (FDA) published in the Federal Register a long-awaited proposed rule aimed at strengthening the safety of food for animals, including pet food and animal feed. According to FDA, the proposed rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, will help ensure the safety of food for animals as well as help prevent foodborne illness in humans and animals. The rule is part of the Food Safety Modernization Act (FSMA) mandated by Congress in December 2011 to modernize the food safety system and focus on preventing food safety problems, rather than relying primarily on responding to problems after they occur. The proposed rule works in concert with standards proposed in July 2013 for imported foods and the accreditation of third party auditors for foreign food facilities.
FDA’s proposed rule on current good manufacturing practices (CGMPs) and preventive controls for food for animals focuses on preventing problems in order to improve the safety of these products. The preventive controls provisions of the proposed rule, which are required by FSMA, would apply to domestic and imported animal food, including pet food, animal feed, and raw materials and ingredients. Facilities producing animal food would be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results, and specify what actions would be taken to correct problems that arise.
The proposed rule would establish for the first time CGMPs that specifically address the manufacturing, processing, packing, and holding of animal food. FDA thought it important to establish CGMPs for animal food as prerequisite requirements to ensure that these products are manufactured under conditions and practices that protect against contamination. The proposed rule also would establish hazard analysis and risk-based preventive controls for food for animals to implement the provisions in Section 103 of FSMA.
New Practices and Controls
The proposed animal food CGMPs address similar safety requirements as those contained in the proposed rule to update the human food CGMP regulations. These areas include hygienic personnel practices and training; facility operations, maintenance, and sanitation; equipment and utensil design, use, and maintenance; processes and controls; and warehousing and distribution.
Under the proposal, each owner, operator, or agent in charge of a facility (those required to register with FDA under Section 415 of the Food Drug and Cosmetic Act), with certain exceptions, would be required to comply with the hazard analysis and risk-based preventive controls. The preventive controls are science‐ and risk‐based in that they would require controls that are necessary to protect human and animal health and exempt certain facilities from requirements or modify requirements for certain low-risk activities.
Second, they are flexible in that firms can develop preventive controls that fit their products and operations, as long as they are adequate to significantly minimize or prevent all food safety hazards that are reasonably likely to occur. Each facility would be required to prepare and implement a written food safety plan, which would include a hazard analysis, preventive controls, monitoring, corrective actions, verification, and recordkeeping.
Rulemaking Process and How to Submit Comments
The proposed rule was published in the October 29, 2013,_ Federal Register_ for review and comment no later than 120 days after publication date. FDA will review responses received during the comment period and possibly revise the rule before making it final. The proposed rule and supporting documents are available in FDA’s official docket at www.regulations.gov and at www.fda.gov/fsma.
FDA has conducted extensive outreach to industry, the consumer community, other government agencies, and the international community to gain input and perspective on how best to implement this and other proposed rules required by FSMA. That input and perspective shaped the proposed rule in a way that will help to ensure they are practical, flexible, and effective. FDA held three public meetings and will participate in several additional meetings during the comment period.
FDA is proposing that the requirements be effective 60 days after the final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, FDA is proposing tiered compliance dates based on facility size.
The National Renderers Association (NRA) and multiple other feed organizations are developing extensive comments that are due February 26, 2014. A collaborative plea is being made to FDA seeking an extension of the comment period to March 31, 2014, due to the extensive nature of the proposed rule. NRA has established a new committee on feed regulation that will study the proposed rule in-depth along with staff.
Even though the concepts in the proposed rule are very familiar to renderers participating in the NRA-sponsored Rendering Industry Code of Practice, the regulatory approach could be overzealous, records requirements could be ominous, submitting detailed food safety plans could expose proprietary information, and the tremendous pressure on FDA to inspect thousands of feed mills never before inspected could lead to an inexperienced, poorly trained, and over-stretched inspection force. However, NRA is optimistic that renderers participating in the code of practice will be well-positioned to comply with the proposed rule, and the code of practice will be updated to include new requirements as soon as they are made clear.
December 2013 RENDER | back