Global Life Sciences: US-FDA Update
On October 29, 2013, the U.S. Food and Drug Administration (“FDA” or the “Agency”) proposed a new rule to ensure the safety of food fed to animals. Along with creating new current good manufacturing practice regulations (“CGMP”) specifically tailored to the manufacturing, processing, packing and holding of animal food, the proposed rule would apply the preventive control provisions outlined in the FDA Food Safety Modernization Act (“FSMA”) to animal food. FSMA directs FDA to establish preventative methods to protect the food supply so that problems do not occur, rather than rely only on its reactionary powers after a food safety issue is identified.
Comments on the proposed rule are due 120 days after publication, by February 26, 2014. The rule can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2013-10-29/pdf/2013-25126.pdf.
Historically, FDA’s animal food program focused on specific safety issues, such as unsafe tissue residues resulting from feeding animals medicated food, Bovine Spongiform Encephalopathy (BSE), and Salmonella, but had not addressed animal food safety in a comprehensive manner. To address obvious deficiencies, a working group, the Animal Feed Safety System (AFSS) Working Group, was established in 2003, and “charged with reviewing the many separate regulations and supporting programs related to regulation of animal food by FDA and the States, and identifying gaps in the regulation of animal food that needed to be addressed. The goal of the working group was to develop and implement a comprehensive, risk-based program that described how all animal food (individual ingredients and mixtures of ingredients) should be manufactured and distributed” to ensure the safety of the food for both animals and humans.
With the passage of FSMA, FDA has now begun the process of adopting through regulations some of the food safety mechanisms identified by the AFSS. The proposed rule addresses the safety of animal food in two ways.
First, it would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. The proposed CGMPs would establish mandatory manufacturing procedures in areas such as buildings and facilities, design and layout, cleaning and maintenance, pest control, and personnel hygiene. Under the proposed rule, manufacturers must adhere to CGMP provisions to protect against the possibility of a foodborne illness outbreak through contaminated animal food. While farms do not need to comply with these provisions, these proposed rules would establish for all other animal food manufacturers, distributors and warehouses, procedures for sanitary operations, sanitary facilities and controls, cleaning and maintenance, pest control, process controls, warehousing and distribution controls, and personnel hygiene. FDA does not expect that most of these CGMPs will be new to the food industry.
Second, the rule would include new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food. As with human foods, FDA’s new preventive control requirements for animal food producers are “HACCP-like” – Hazard Analysis Critical Control Points” – measures that apply to most foreign and domestic establishments registered with FDA as animal food facilities. All facilities involved in manufacturing, processing, packing, and holding of finished products intended as food or ingredients for food for animals, including livestock, pets, and captive animals, are subject to this proposed rule. These facilities are required to establish and implement a food safety system that includes:
- A written food safety plan;
- Hazard analysis;
- Preventive controls for hazards that are reasonably likely to occur;
- Corrective actions;
- Verification; and
Preventive controls are only necessary where facilities determine that hazards are reasonably likely to occur, as FDA recognizes that the hazards and risks for each facility may differ significantly depending on the type of product manufactured. The agency proposes to require a written hazard analysis for each known or reasonably foreseeable hazard for every type of animal food manufactured, processed, packed, or held at the facility, including an evaluation of its likeliness to occur and its potential consequences. Food safety plans should include a hazard analysis, preventive controls, monitoring procedures to observe the effectiveness of the preventive controls, corrective action procedures, verification procedures to validate the preventive controls identified and implemented, and a recall plan that addresses each hazard that is likely to occur. The food safety plan should be, at a minimum, reanalyzed every three years or when needed. Hazard considerations should also apply to the packaging and labeling segments of manufacturing. FDA has not yet determined whether preventive control plans should include potential hazards that may be intentionally introduced for economic reasons, but is entertaining comments on the issue.
The proposed rule also requires “qualified individuals” to prepare the food safety plan, validate preventive controls, review records for effectiveness and appropriateness of preventive controls and corrective actions, and perform a required reanalysis of a food safety plan to respond to new hazards and developments in scientific understanding every three years. FDA defines a qualified individual as one with appropriate training or job experience in the development and application of risk-based preventive controls. FDA requests comments on whether regulations should provide more detail on the acceptable training for qualified individuals.
FDA proposes to require facilities to submit documentation that they are exempt from food safety regulations as a “qualified facility” under section 418(l) of the Food, Drug, and Cosmetic Act, that the owner or agent in charge of facilities has identified potential hazards, and that they are in compliance with local laws and regulations. FDA contemplates that this system would provide for “self-certification” that the facility is a qualified facility and has identified the potential hazards associated with the food produced and is implementing and monitoring controls to address the hazards or is complying with local food safety regulations. Extensive recordkeeping requirements are mandated throughout the proposed rules.
Exemptions or modifications are being considered for: very small businesses, low risk on-farm activities performed by a small or very small business, activities subject to the low-acid canned food requirements (canned pet food), facilities that are subject to Standards for Produce Safety under 21 USC § 350h, facilities engaged in storage of raw agriculture commodities, and facilities engaged in storage of packaged animal foods without exposure to the environment. FDA has requested comments on definitions and applicability of these exemptions. Exempt businesses are considered “qualified facilities.”
While not an element of the proposed rule, FDA is also soliciting comments on whether other elements of a preventive control system may be appropriate, including a final product testing program, an environmental monitoring program, and a supplier approval and verification program.
FDA intends to implement the final rule 60 days after publication in the Federal Register, with staggered compliance dates. For businesses other than small or very small business, FDA is proposing to require implementation within a year of publication; for small businesses, two years; and for very small businesses, three years. If you have any questions regarding this update, please contact Diane McEnroe (+1.212.839.5621, email@example.com), William McConagha (+1.202.736.8322, firstname.lastname@example.org), or the Sidley lawyer with whom you usually work.
For further information on the FDA Practice, please contact:
Raymond A. Bonner
email@example.com Coleen Klasmeier
For further information on the Global Life Sciences Practice, please contact:
firstname.lastname@example.orgMichael W. Davis
email@example.com Paul E. Kalb, M.D.
firstname.lastname@example.org James C. Stansel
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