# Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2013-25126 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** October 29, 2013 - **Citation:** 78 FR 64736 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 225, 500, 507, and 579 [Docket No. FDA-2011-N-0922] RIN 0910-AG10 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system. DATES: Submit either electronic or written comments on the proposed rule by February 26, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 29, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-N-0922 and/or Regulatory Information Number (RIN) 0910-AG10 by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document). Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No 2011-N-0922 and RIN 0910-AG10 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kim Young, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9207, email: kim.young@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose and Coverage of the Proposed Rule Summary of the Major Provisions of the Proposed Rule Costs and Benefits I. Introduction II. Background A. Current Approaches to Animal Food Safety B. The Food and Drug Administration Amendments Act of 2007 C. FDA Food Safety Modernization Act D. Preventive Controls and Hazard Analysis and Critical Control Points (HACCP) Systems E. Animal Food Safety Incidents: Examples and Monitoring F. The Role of Testing as a Verification Measure in a Food Safety System G. The Role of Supplier Approval and Verification Programs in a Food Safety System III. Public Meeting and Preliminary Stakeholder Comments IV. Summary of the Scope of the Proposed Rule V. Highlights of the Proposed Rule A. Overview B. Proposed Subpart A—General Provisions C. Proposed Subpart B—Current Good Manufacturing Practice D. Proposed Subpart C—Hazard Analysis and Risk-Based Preventive Controls E. Proposed Subpart D—Withdrawal of an Exemption Applicable to a Qualified Facility F. Proposed Subpart F—Requirements Applying to Records That Must Be Established and Maintained VI. Compliance Dates VII. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities A. Section 103(c) of FSMA B. Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition C. Results of the Qualitative Risk Assessment D. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Animal Food Combinations Under Section 418 of the FD&C Act E. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Animal Food Combinations Under Section 421 of the FD&C Act VIII. Proposed Subpart A—General Provisions A. Proposed § 507.1—Applicability and Status B. Proposed § 507.3—Definitions C. Proposed § 507.5—Exemptions D. Proposed § 507.7—Requirements That Apply to a Qualified Facility E. Proposed § 507.10—Applicability of Subpart C to a Facility Solely Engaged in the Storage of Packaged Animal Food That is Not Exposed to the Environment IX. Proposed Subpart B—Current Good Manufacturing Practice A. Animal Food and Current Good Manufacturing Practices (CGMPs) B. Proposed Current Good Manufacturing Practices (CGMPs) for Animal Food C. Alternative to Establish Requirements in Place of Guidance in the Proposed Current Good Manufacturing Practices (CGMPs) X. Proposed Subpart C—Hazard Analysis and Risk-Based Preventive Controls A. Proposed § 507. 30—Requirement for a Food Safety Plan B. Proposed § 507.33—Hazard Analysis C. Proposed § 507.36—Preventive Controls for Hazards That are Reasonably Likely to Occur D. Proposed § 507.38—Recall Plan for Animal Food with a Hazard That is Reasonably Likely to Occur E. Proposed § 507.39—Monitoring F. Proposed § 507.42—Corrective Actions G. Proposed § 507.45—Verification H. Proposed § 507.48—Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Packaged Animal Food That is Not Exposed to the Environment I. Proposed § 507.50—Requirements Applicable to a Qualified Individual J. Proposed § 507.55—Records Required for Subpart C K. Request for Comment on Additional Preventive Controls and Verification Procedures Not Being Proposed L. Request for Comment on Other Potential Provisions Not Explicitly Included in Section 418 of the FD&C Act XI. Proposed Subpart D—Withdrawal of an Exemption Applicable to a Qualified Facility A. Requirements of Section 418 of the FD&C Act B. Proposed § 507.60—Circumstances That May Lead FDA to Withdraw an Exemption Applicable to a Qualified Facility C. Proposed § 507.62—Issuance of an Order to Withdraw an Exemption Applicable to a Qualified Facility D. Proposed 507.65—Contents of an Order to Withdraw an Exemption Applicable to a Qualified Facility E. Proposed § 507.67—Compliance With, or Appeal of, an Order to Withdraw an Exemption Applicable to a Qualified Facility F. Proposed § 507.69—Procedure for Submitting an Appeal G. Proposed § 507.71—Procedure for Requesting an Informal Hearing H. Proposed § 507.73—Requirements Applicable to an Informal Hearing I. Proposed § 507.75—Presiding Officer for an Appeal and for an Informal Hearing J. Proposed § 507.77—Timeframe for Issuing a Decision on an Appeal K. Proposed § 507.80—Revocation of an Order to Withdraw an Exemption Applicable to a Qualified Facility L. Proposed § 507.84—Final Agency Action M. Conforming Amendment to 21 CFR Part 16 XII. Proposed Subpart F—Requirements Applying to Records That Must Be Established and Maintained A. Relevant Statutory Provisions B. Proposed § 507.100—Records Subject to the Requirements of this Subpart F C. Proposed § 507.102—General Requirements Applying to Records D. Proposed § 507.106—Additional Requirements Applying to the Food Safety Plan E. Proposed § 507.108—Requirements for Record Retention XIII. FSMA's Rulemaking Provisions XIV. Proposed Conforming Changes XV. Legal Authority A. Current Good Manufacturing Practice Regulations B. Hazard Analysis and Risk-Based Preventive Controls XVI. Preliminary Regulatory Impact Analysis A. Overview B. Regulatory Flexibility Act C. Small Business Regulatory Enforcement Fairness Act of 1996 D. Unfunded Mandates Reform Act of 1995 E. Public Access to the Analyses XVII. Paperwork Reduction Act of 1995 XVIII. Analysis of Environmental Impact XIX. Federalism XX. Comments XXI. References Appendix I. The Role of Testing as a Verification Measure in a Modern Food Safety System A. Verification of Preventive Controls B. Scientifically Valid Sampling and Testing C. Verification Testing of Raw Materials and Ingredients D. Verification of Sanitation Controls to Significantly Minimize or Prevent the Potential for an Environmental Pathogen To Contaminate Food E. Role of Environmental Monitoring in Verifying the Implementation and Effectiveness of Sanitation Controls in Significantly Minimizing or Preventing the Potential for an Environmental Pathogen To Contaminate Food F. The Role of Finished Product Testing in Verifying the Implementation and Effectiveness of Preventive Controls II. The Role of Supplier Approval and Verification Programs in a Food Safety System III. References Executive Summary Purpose and Coverage of the Proposed Rule The proposed rule would establish regulations regarding the manufacturing, processing, packing, or holding 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. Second, it would include new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food. In general, with some exceptions the new preventive control provisions would apply to animal food facilities that are required to register with FDA under FDA's current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions. To put these changes in context, and to provide legal, regulatory, scientific, and technical information relevant to the new provisions, the Agency provides several sections of background. This background discusses the current approaches to animal food safety; summarizes the Food and Drug Administration Amendments Act of 2007 (FDAAA) as it applies to pet food; provides an overview of the provisions of FSMA applicable to this proposed rule; and describes a variety of hazards that have been associated with animal foods and animal food safety problems (including outbreaks of foodborne illness) that have resulted from these hazards. An Appendix also describes the role of testing as a verification measure in a food safety system and the role of supplier approval and verification programs in a food safety system. Summary of the Major Provisions of the Proposed Rule The proposed rule would establish certain CGMP provisions to ensure the safety and suitability of animal food. The implementation of these practices and procedures would protect against the contamination of animal food. The proposed CGMPs would establish procedures in areas such as buildings and facilities, design and layout, cleaning and maintenance, pest control, and personnel hygiene. The proposed rule also would implement the requirements of section 103 of FSMA for animal food facilities that must register under section 415 of the FD&C Act (21 U.S.C. 350d) to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for: • A written food safety plan; • Hazard analysis; • Preventive controls for hazards that are reasonably likely to occur; • Monitoring; • Corrective actions; • Verification; and • Associated records. The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. The Agency does not expect that all possible preventive measures and verification procedures would be applied to all animal foods at all facilities. The proposed rule would also establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls. Facilities that manufacture, process, pack, or hold animal food and that are required to register with FDA under section 415 of the FD&C Act would be required to comply with the proposed regulation unless they are covered by an exemption. The table immediately below summarizes these proposed exemptions in general terms. Importantly, the table in this Executive Summary does not include all the details that a facility must consider to determine whether an exemption applies. The Agency provides those details in the proposed rule (proposed § 507.5) and explains them in section VIII.C. Proposed Exemptions From the New Requirements for Hazard Analysis and Risk-Based Preventive Controls Who or what would be exempt from the requirements for hazard analysis and risk-based preventive controls Notes “Qualified Facility” as defined by FSMA • Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or • Very small business ○ Option 1: Total annual sales of <$500,000 ○ Option 2: Total annual sales of <$1,000,000 ○ Option 3: Total annual sales of <$2,500,000 FDA is proposing three options for defining “very small business” and requests comment on which to adopt in a final rule. Modified requirements would apply—i.e., a qualified facility would be required to: • Notify FDA about its status; and • Either: ○ Notify FDA that it is addressing hazards through preventive controls and monitoring; or ○ Notify FDA that it complies with applicable local regulations, and notify consumers of the name and complete business address of the facility where the animal food was manufactured or processed. • Low risk, on farm activities performed by a small business (<500 employees): or • Low-risk, on-farm activities performed by a very small business ○ Option 1: very small = <$500,000 ○ Option 2: very small = <$1,000,000 ○ Option 3: very small = <$2,500,000 Small and very small on-farm businesses conducting these low risk activities would be exempt from most of the rule's requirements. The Agency would define the low-risk activities that qualify for the exemption, including the specific foods to which they relate (such as re-packing intact fruits and vegetables, or grinding/milling/cracking/crushing grains). Activities that are subject to the “low-acid canned food” requirements of § 500.23 (21 CFR 500.23) and part 113 (21 CFR part 113) • The exemption applies only with respect to microbiological hazards. • The facility must be in compliance with part 113. Activities of a facility that are subject to section 419 of the FD&C Act (21 U.S.C. 350h) (Standards for Produce Safety) Published in the Federal Register January 16, 2013 (78 FR 3504). Facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing A facility that stores raw agricultural commodities that are fruits or vegetables would not be exempt. Facilities solely engaged in the storage of packaged animal food that is not exposed to the environment Modified requirements would apply for the storage of refrigerated packaged animal food. The proposed rule also would establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption. The proposed rule would establish requirements that would apply to all records that would be required by the various proposed provisions. The proposed recordkeeping provisions would implement specific requirements of FSMA regarding records associated with the new provisions for hazard analysis and risk-based preventive controls and would allow facilities to show, and FDA to determine, compliance with the regulatory requirements. The proposed rule would require that a qualified individual prepare the food safety plan, validate preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the required reanalysis of a food safety plan. The proposed rule also would establish minimum requirements for the “qualified individual,” who would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Only a trained individual or individual qualified by job experience is capable of effectively executing these activities. FDA is requesting comment on when and how other elements of a preventive controls system are an appropriate means of implementing the statutory directives, including: A product testing program, an environmental monitoring program, and a supplier approval and verification program, as appropriate. Costs and Benefits The summary of the costs and potential benefits of the proposed rule are presented in the table that follows. Total domestic costs annualized at 7 per cent over 10 years (millions) Proposed Rule with Very Small Business Defined as Less Than or Equal to $500,000 in Annual Revenue $95 Proposed Rule with Very Small Business Defined as Less Than or Equal to $1,000,000 in Annual Revenue 89 Proposed Rule with Very Small Business Defined as Less Than or Equal to $2,500,000 in Annual Revenue 65 I. Introduction On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). This law enables FDA to better protect public health by helping to ensure the safety and security of the human and animal food supply. FSMA enables the Agency to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides the Agency with new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law gives the Agency important new tools to better ensure the safety of imported human and animal foods and directs the Agency to build an integrated national food safety system in partnership with State, local, tribal, and territorial authorities. This new law continues efforts by the human and animal food industries and government to protect and improve the safety of the nation's food supply. At the Federal level, these efforts go back to the Pure Food and Drug Act of 1906, the United States' first national food safety law. FSMA carries forward the basic principle embodied in the 1906 law that food establishments have the primary responsibility and capacity to make food safe and that government's role is to set standards for food safety and provide oversight to help ensure standards are met. Since passage of the 1906 Act, and the most recent revision of its basic food safety provisions in the Federal Food, Drug, and Cosmetic Act of 1938, the combined efforts of the food industry and government have produced a set of standards and practices that make the U.S. food supply among the safest in the world. These efforts include the development and adoption by FDA of CGMP standards for human food that have long provided the regulatory foundation for human food safety. They also include, in more recent years, the adoption for some elements of the animal and human food supply of more targeted, risk-based approaches, such as embodied in the Hazard Analysis and Critical Control Points (HACCP) approach to food safety. HACCP was pioneered by the human food industry and reflects the understanding that food safety is best assured if each producer and processor understands the hazards that are reasonably likely to occur in their particular product and operation and puts in place scientifically sound preventive controls to significantly minimize or eliminate the hazard. FDA has by regulation required seafood and juice processors to implement the HACCP approach to preventive controls. The U.S. Department of Agriculture (USDA) has also mandated HACCP for meat and poultry processors, and many human food companies have implemented such modern preventive control systems for other commodities. While these efforts have contributed to progress on food safety, significant human and animal food safety challenges persist in today's complex, dynamic, and global food system. Today's food supply is highly diverse and increasingly complex, with many new foods in the marketplace that pose new food safety challenges. New pathogens are emerging, and the Agency is seeing commonly known pathogens appear in foods where they have not been traditionally seen. The population of individuals at greater risk for foodborne illness, such as those who are immune-compromised, is increasing. When illness outbreaks occur, they can have devastating impacts on public health and impose substantial economic disruption and cost on the human and animal food industry. The food safety challenge is only compounded by globalization and the increasing amount of imported human and animal food. Congress responded to today's food safety challenges by enacting FSMA. FSMA builds on past experience and the strong foundation provided by the current food safety system, but it also marks an historic turning point for food safety. FSMA directs FDA to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system; meets the food safety challenges of the global food system; and establishes stronger partnerships for food safety across all levels of government and with the private sector to ensure optimal use of public and private resources. FDA has embarked on a comprehensive effort to build the food safety system mandated by Congress, as described on its FSMA implementation Web page at http://www.fda.gov/fsma . A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and FDA's ability to oversee their implementation for both domestic and imported food. These include, among others, regulations establishing preventive control standards for human food and animal food facilities, produce safety standards, standards that define the accountability of importers to verify the safety of food produced overseas, and a new program for accrediting private bodies to provide credible certifications that regulated entities are meeting U.S. safety standards. A proposed rule on foreign supplier verification is closely interconnected to this rule on preventive controls for animal food (and the preventive controls proposed rule for human food), and published in the Federal Register on July 29, 2013 (78 FR 45730). In this document, the Agency proposes standards to implement the requirement in section 103 of FSMA for the adoption of preventive controls in animal food facilities. This preamble provides information on FDA's previous efforts in working to establish CGMPs and process controls for animal food, because these past efforts are the critical starting point and foundation for FSMA implementation. The preamble explains and provides additional background on the rationale for the Agency's proposed regulations implementing FSMA's preventive controls requirement and new CGMPs for the animal food industry. The Agency is seeking comments on all aspects of this proposal. The document for the proposed rule for preventive controls for human food, published in the Federal Register January 16, 2013 (78 FR 3646), contains discussions that are relevant to animal food safety and the development of preventive controls for food for animals. The Agency has identified relevant discussion found in the human food preamble throughout this preamble and references the published document for proposed preventive controls for human food for additional information. II. Background Ensuring the safety of animal food is complex in light of several factors. Animal food is made for a wide variety of species, including animals from which human foods are derived, pet animals, and laboratory animals. Many animals consume one food as their sole source of nutrition. Therefore, the food that they consume must be nutritionally adequate or the food presents a safety hazard to the animals. Nutrient deficiencies or excesses can raise safety concerns. Because different species have different nutritional needs, certain quantities of a nutrient that are needed by one species of animal could pose a health risk to another species of animal. Therefore, safety issues for animal food can be raised not only by biological, chemical, physical, or radiological contaminates of the food that can cause animal or human health concerns, but also by nutrient deficiencies (or excesses) for the animals. Animal foods are also handled in a wide variety of settings. Some foods are handled on farms or in feed mills. Other foods, like pet foods, are handled in homes and often in the kitchen. If the pet food is contaminated with a pathogen of human health concern, this could result in secondary contamination of human food-contact surfaces or human food. Humans could become ill from the pathogen through handling the pet food or through these secondary contaminations. The discussion that follows explains current regulatory tools and other approaches the Agency has explored to address the safety of animal food for animals, the safety of food from food-producing animals consumed by humans, and the safety of humans handling animal food. This proposed rule would implement needed controls for animal food. This proposed rule would also help respond to requests the Agency receives from international standard-setting organizations (e.g., Codex Alimentarius) and individual countries that ask feed-exporting countries to operate animal food safety systems with clear regulatory oversight. A. Current Approaches to Animal Food Safety 1. Animal Feed Safety System Working Group The Agency's efforts to upgrade animal food safety in this country are continually evolving. Historically, FDA's animal food program focused on specific safety issues, such as unsafe tissue residues resulting from feeding of medicated animal food, Bovine Spongiform Encephalopathy (BSE), and Salmonella, but had not addressed animal food safety in a comprehensive manner. In 2003, FDA introduced the concept of an Animal Feed Safety System (AFSS). A working group, the AFSS Working Group, was established 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 need to be addressed. The goal of this working group was, and remains, the development and implementation of a comprehensive, risk-based program that describes how all animal food (individual ingredients and mixtures of ingredients) should be manufactured and distributed to ensure the safety of the food for animal consumption, as well as the safety of human food derived from these animals (e.g., meat, milk, and eggs). The working group's concept for an AFSS covers the entire continuum of Agency activities including: • Pre-approval of additives for use in animal food; • Establishing limits for hazards in animal food; • Providing education and training; • Conducting research; • Performing inspections; • Taking enforcement for ensuring compliance with Agency regulations; and • Establishing partnerships with State regulators with responsibility for animal food safety. The AFSS concept also includes oversight of animal food production, including manufacture, labeling, storage, distribution and use of all animal food at all stages of production and use. A key element of the AFSS concept is a systems approach that includes best management practices during the “manufacturing, labeling, storage, and distribution” of all animal food, coupled with steps to identify hazards and to minimize or eliminate, as appropriate, the occurrence of those hazards. The AFSS Working Group held public meetings on the AFSS concept in September 2003 and April 2005. The meetings were designed primarily to give stakeholders an opportunity to present information to FDA about the direction and scope of the AFSS. Three additional meetings, held in September 2006, May 2007, and May 2008, informed stakeholders of the risk assessment initiatives being undertaken by the AFSS Working Group. Information on these meetings can be found at the Agency's Web site (Ref. 1). The AFSS Working Group used a number of sources in developing its current design of components comprising the AFSS, including comments from the public solicited through public meetings and interactions with State regulatory officials, industry representatives, veterinarians and consumers. In addition, the working group reviewed some of the approaches used by the Agency and by industry to ensure human food safety, such as HACCP systems, Standard Operating Procedures (SOPs), Sanitation Standard Operating Procedures (SSOPs), and CGMPs, to determine their applicability and usefulness to animal food control and regulatory oversight in a risk-based preventive system. The working group also reviewed the Codex Code of Practice on Good Animal Feeding as a comparison to help identify gaps in the Agency's current regulatory approach to animal food safety (Ref. 2). The Codex Code was accepted by the European Union along with other foreign entities and the U.S. delegation, which was comprised of U.S. Federal and State Government officials and industry advisors to the Codex's Task Force on Good Animal Feeding Practices. The AFSS Working Group identified seven operating components to comprise the AFSS. These components cover processes to ensure that: • Ingredients used in animal food are safe; • The methods used to make, store, and distribute animal food result in safe products; • The Agency acquires timely information about unsafe animal food and, when appropriate, makes such information publicly available; • The levels of regulatory oversight are commensurate with risk to human and animal health; • Training, education, and outreach activities keep the Agency's partners and stakeholders well informed and ensure that the Agency and State animal food regulatory personnel are adequately trained; and • An active and aggressive research program is employed to generate data to aid in addressing animal food safety issues. With the assistance of regulated animal food industry, the public, and State regulatory personnel, the working group identified gaps in the regulation of labeling, processing, and distribution of animal food products. The working group describes these gaps and ways to address them in the fourth AFSS Framework Document dated January 2010, which can be found on FDA's Web site (Ref. 3). One critical gap is the lack of Federal regulations to fully address all aspects of producing safe animal food associated with the receiving, manufacturing, processing, packing, holding and distribution of animal food (including pet food, animal feed, and raw materials and ingredients) that does not contain animal drugs (i.e., non-medicated animal food). To fill this gap, the working group began developing a process control standards proposed rule, which aimed to prevent, eliminate, or reduce to acceptable levels the potential risks posed to human and animal health through a systems approach in which adequate control steps would be established throughout the animal food manufacturing process. After the passage of FSMA, the Agency incorporated the work begun on the proposed rule for process control standards into this proposed rule for preventive controls for animal food. In addition, the AFSS Working Group is developing and systematically applying a method that ranks risks associated with all identified hazards. The use of risk concepts is not new for the Agency, as FDA routinely tries to estimate public health impact in deciding where to focus regulatory effort in general. The Agency relies heavily on evaluation of risk posed by hazards that occur in animal food when making decisions about food safety. Information on the AFSS can be found at the Agency's Web site (Ref. 4). 2. Section 402 of the FD&C Act Section 402 of the FD&C Act (21 U.S.C. 342) deems food, including animal food, adulterated in several circumstances, including: a. If it bears or contains any poisonous or deleterious substance which may render it injurious to health (section 402(a)(1)); b. If it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a) of the FD&C Act (21 U.S.C. 346a) (section 402(a)(2)(B)); c. If it bears or contains an unapproved food additive or an unapproved new animal drug (section 402(a)(2)(C)); d. If it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food (section 402(a)(3)); and e. If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health (section 402(a)(4)). While the Agency has issued regulations related to the safety of specific types of animal food and the use of certain food substances in animal food, as will be described further in this preamble, section 402 of the FD&C Act applies to all animal food in interstate commerce. 3. Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Animal foods that are thermally processed low-acid foods packaged in hermetically sealed containers are subject to the regulations in 21 CFR 500.23, which in turn states the provisions of part 113 (21 CFR part 113) applies to animal food. Part 113 establishes the criteria by which FDA determines whether the facilities, methods, practices, and controls used by the commercial processor in the manufacture, processing, or packing of low-acid foods in hermetically sealed containers are operated or administered in a manner adequate to protect the public health. 4. Animal Proteins Prohibited From Use in Animal Feeds The regulation in § 589.2000 (21 CFR 589.2000), prohibiting the use of certain animal proteins in ruminant feed, was published on June 5, 1997 (62 FR 30936). It was designed to prevent the establishment and amplification of BSE, through animal food, by prohibiting the use of certain proteins derived from mammalian tissue in the feeding of ruminant animals. This BSE regulation affects renderers, protein blenders, commercial animal food manufacturers, distributors (including retailers), transporters of animal food and ingredients, on-farm animal food mixers, and ruminant feeders. On December 7, 2000, the USDA/Animal and Plant Health Inspection Service (USDA/APHIS) enacted regulations prohibiting the importation into the United States of all meat and bone meal (MBM), meat meal, bone meal, blood meal, tankage, offal, tallow, or any product containing such, which originated directly from countries identified as having BSE, or from countries having inadequate systems in place to prevent BSE (9 CFR 94.18 and 95.4). The prohibitions include all rendered products of animal origin including poultry meal and fishmeal that are processed in these countries, regardless of species of origin, unless the material is from a non-ruminant species and meets certain conditions assuring no contamination with ruminant material. These prohibitions were deemed necessary by APHIS because of the possibility of cross contamination with the BSE agent. Subsequently, on January 20, 2001, FDA issued Import Alert #99-25, “Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products for Animal Use Consisting or Containing Ingredients of Animal Origin” (Ref. 5). On April 25, 2008, FDA published a final rule in the Federal Register , amending the BSE regulations to prohibit the use of certain cattle origin material in the food or feed of all animals (73 FR 22720). This final rule established new regulations entitled “Cattle Materials Prohibited in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy”. The new regulation, § 589.2001 (21 CFR 589.2001), prohibits the use of certain cattle materials in the feed of all animals and is aimed primarily at rendering operations. This new rule also amended the BSE regulation in 21 CFR 589.2000. FDA assesses compliance of the BSE regulations through the Agency's BSE/Ruminant Feed Ban Inspection Program (7371.009) (Ref. 6). This program is designed to assess an animal food facility's operational practices and procedures in preventing the spread of BSE through inspectional observations and sampling. 5. Medicated Feeds CGMP Section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) provides that a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of the FD&C Act as to safety, and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. In May 1965, the Agency issued Current Good Manufacturing Practice for Medicated Feeds, which implemented section 501(a)(2)(B) of the FD&C Act for medicated animal food (30 FR 6475). The purpose of this medicated feed regulation, part 225 (21 CFR part 225), was to establish specific criteria for CGMPs that would ensure the safety, identity, strength, and the quality and purity characteristics of medicated feed. Medicated feed that is not manufactured, processed, packed, or held in conformity with part 225 is adulterated under section 501(a)(2)(B) of the FD&C Act. The medicated feed CGMPs ensure a pure, safe drug product through requiring specific preventive measures during manufacturing, processing, packing, and holding. In general, the CGMPs in part 225 do not apply to the manufacturing, processing, packing, and holding of non-medicated animal food, even if manufactured in the same facility. However, non-medicated feed would be deemed adulterated under section 402(a)(2)(C)(ii) of the FD&C Act if contaminated with a new animal drug. 6. Animal Food Labeling FDA regulations that establish animal food labeling standards in part 501 (21 CFR part 501) include requirements for a statement of identity, net quantity statement, manufacturer's name and address, and proper listing of ingredients. In addition, the FDAAA required FDA to issue regulations to update the standards for pet food labeling. These implementing regulations are currently being developed by FDA. Further discussion of FDAAA is presented in section II.B. 7. Generally Accepted as Safe (GRAS) Lists and GRAS Notifications GRAS is an acronym for the phrase Generally Recognized as Safe. Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), a substance is not a food additive if it is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. A listing of substances that are considered by the Agency to be generally recognized as safe for specific intended uses in animal food is found in 21 CFR parts 582 and 584. Under section 201(s) of the FD&C Act and 21 CFR 570.30, a substance may be deemed to be GRAS if it is generally recognized as having been adequately shown to be safe under the conditions of its intended use in food through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food. A GRAS substance is not subject to premarket review and approval by FDA. A firm may market a GRAS substance intended for use in animal food based on its own determination that the intended use is GRAS. If the intended use of the substance is not GRAS, the substance and firm marketing it for this use may be subject to enforcement action by FDA. Although not required to do so, firms that have determined that the intended use of a substance in animal food is GRAS may petition FDA to affirm that a substance is GRAS under certain conditions of use under 21 CFR 570.35(c). Alternatively, they may participate in FDA's GRAS notification pilot program. On June 4, 2010, FDA announced that it would begin a voluntary pilot program for GRAS notifications for substances added to animal food (75 FR 31800). This program is based on an April 17, 1997 proposed rule on GRAS notification (62 FR 18938). 8. Approved Food Additives Under section 201(s) of the FD&C Act, a food additive means “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or in the case of a substance used in food prior to January 1, 1958, through scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. . .”. Other substances that are excluded from the definition of a food additive include pesticide chemical residues, pesticide chemicals, color additives, prior sanctioned substances, and new animal drugs. Many substances added to an animal food are food additives, varying by composition and intended use. A food additive generally provides one or more of the following attributes: nutrition, aroma/flavor, stabilization, emulsification, and preservation. A listing of food additives permitted in animal food, including drinking water for animals, is found in 21 CFR part 573. To market a food additive, a sponsor must first petition FDA by submitting information that includes all relevant data bearing on the effect the additive is intended to have in or on food and full reports of investigations made with respect to the safety of the food additive. If FDA approves the petition, FDA publishes a regulation prescribing the conditions of use under which the additive may be safely used. The regulations that apply to food additives used in animal foods and that describe the food additive petition process are published in 21 CFR part 571. 9. Approved Color Additives A color additive, as defined in 201(t)(1) of the FD&C Act, includes a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source that is capable of imparting color when added or applied to food. The listing of approved human and animal food color additives is found in 21 CFR parts 73 and 74. A color additive must be shown to be safe and be listed in the Code of Federal Regulations before it may be used to color foods. An interested person may petition FDA for the listing of a color additive, which includes the submission of data demonstrating the color additive is safe and suitable for the proposed use, as described in 21 CFR part 71. The FDA will, upon written request, advise on the adequacy of studies planned to yield these data (21 CFR 70.42(c)). 10. Animal Food Sampling Program The Agency's Feed Contaminants Program (FCP) is an animal food sampling and inspection program that addresses most animal food contaminants, including pesticides, industrial chemicals, dioxins, heavy metals, mycotoxins, and pathogens. It does not address drug residues and agents that cause BSE and other transmissible spongiform encephalopathies (TSEs), as those contaminants are tested for under other programs. Under the FCP, FDA conducts random surveillance sample collections and inspections as well as followup investigations when an animal food sample is found to contain violative levels of contaminants. The contaminants addressed by the FCP can be hazardous to livestock health and production, pet health, and to human health through residues in animal-derived human food. Many of the more frequently identified contaminants in animal food are toxic, carcinogenic, mutagenic, teratogenic, or otherwise deleterious to animals, humans, or both. Animal food facilities are inspected by FDA and State Agencies. Many of the inspections are performed for FDA by states that have entered into a contract to conduct inspections in accordance with the Agency's procedures. Under State partnership and cooperative agreements, States agree to conduct inspections under their own authorities and to share the results with FDA. Inspections of animal food facilities play an important role in ensuring the safety of the nation's animal food supply. 11. Animal Food Safety Guidance to Industry FDA has issued numerous guidance documents (hereinafter, “guidance” or “guidances”) to assist the animal food industry in implementing food safety regulatory requirements under FDA's jurisdiction. The Agency issues guidances, in accordance with its regulations in § 10.115 (21 CFR 10.115) for “good guidance practices,” to describe its interpretation of or policy on a regulatory issue. Guidances do not establish legally enforceable rights or responsibilities and do not legally bind the public or FDA (§ 10.115(d)(1)). Accordingly, regulated industry is not required to employ the approaches contained in a guidance and instead may choose to use an alternative approach, provided that the alternative approach complies with the relevant statutes and regulations (§ 10.115(d)(2)). Although guidances do not legally bind FDA, they represent the Agency's current thinking on a particular interpretation of or policy regarding a given regulatory issue (§ 10.115(d)(3)). Under § 10.115(c)(1) and (g), FDA publishes a guidance in draft form for public comment before issuing the guidance in final form, except where prior public participation is not feasible or appropriate, if the guidance: (1) Sets forth initial interpretations of statutory or regulatory requirements, (2) sets forth changes in interpretation or policy that are of more than a minor nature; (3) includes complex scientific issues, or (4) covers highly controversial issues. FDA generally issues guidance to industry for the purpose of communicating the Agency's policy decisions and interpretations of its regulatory requirements so that regulated industry better understands how to comply with those requirements. In some cases, the Agency issues guidance specifically targeted to assisting industry in complying with a particular food safety regulation. For example, the Agency has issued several guidances to assist industry in complying with the regulatory requirements for BSE (§§ 589.2000 and 589.2001) (Refs. 7, 8, 9, 10, and 11). In other cases, the Agency issued guidance that is more narrowly focused in scope or is not directly targeted to assisting industry in complying with a particular food safety regulation. For example, the Agency has issued guidance that addresses deoxynivalenol (DON), also known as vomitoxin, in grain and grain by-products used for animal food (Ref. 12) and guidance on measures to address the risk for contamination by Salmonella spp. in raw meat foods for companion and captive non-companion carnivores and omnivores (Ref. 13). 12. Animal Food Safety Compliance Policy Guides FDA issues guidance to its staff in the form of a compliance policy guide (CPG). The primary purpose of a CPG is to explain FDA's policy on regulatory issues related to the statutes and regulations that FDA is responsible for implementing. CPGs advise FDA field inspection and compliance personnel as to FDA's standards and procedures to be applied when determining industry compliance with our regulatory requirements. FDA issues CPGs in accordance with its regulation for good guidance practices in § 10.115 and makes the CPGs available to the public, thereby providing regulated industry with additional insight into how the Agency interprets the statutes and regulations it is responsible for implementing for purposes of assessing compliance with the Agency's regulatory requirements. In general, FDA's animal food safety CPGs are relatively focused in scope. For example, the Agency has issued a CPG regarding Salmonella contamination in all food for animals (Ref. 14), and a CPG that sets forth the criteria that are to be used by FDA personnel to determine whether to take action on animal foods containing aflatoxins (Ref. 15). B. The Food and Drug Administration Amendments Act of 2007 On September 27, 2007, the FDAAA (21 U.S.C. 2102) was signed into law (Pub. L. 110-85). Section 1002(a) of Title X (Food Safety) of the FDAAA requires the Secretary of Health and Human Services (HHS), in consultation with relevant stakeholder groups, including the Association of American Feed Control Officials (AAFCO), veterinary medical associations, animal health organizations, and pet food manufacturers, to issue new regulations establishing, among other things, processing standards for pet foods. A public meeting that included representatives for the previously mentioned stakeholders was held May 13, 2008, after publication of a notice in the Federal Register on April 21, 2008 (73 FR 21357). Neither the FDAAA, nor its legislative history, described what Congress meant by “processing standards” for pet food. In many instances the same ingredients and manufacturing processes are used to produce animal food for both non-food-producing animals, including pets, and food-producing animals. FDA determined that it would not be feasible to implement or enforce processing standards that only applied to one segment of the industry (i.e., pet food.) The proposed rule for process control standards that the Agency was developing (see the discussion in section II.A.1) included all animal food. After FDAAA was signed into law, a discussion of FDAAA and the requirements for processing standards for pet food was added to the preamble of the proposed rule for process controls standards to clarify that the proposed rule would satisfy these requirements for pet food. After FSMA was enacted, the Agency decided to issue one rule that would satisfy the mandate of section 1002(a) of FDAAA and section 103 of FSMA. C. FDA Food Safety Modernization Act 1. Requirements for Food Facilities FSMA was signed into law by the President on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418 (21 U.S.C. 350g) with the same name. Many of the provisions in section 103 of FSMA that are relevant to this rulemaking are codified in section 418 of the FD&C Act. a. General requirements. Section 418 of the FD&C Act contains requirements applicable to food facilities and mandates Agency rulemaking. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food (including animal food) manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose of the preventive controls is to “prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 [of the FD&C Act]. . . .” In addition to those areas specified in section 418(a) of the FD&C Act, sections 418(b) through (i) contain more specific requirements applicable to facilities. These include corrective actions (section 418(e)), verification (section 418(f)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)). Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit “[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act].” Section X discusses proposed requirements (proposed subpart C) that would implement these provisions of section 418 of the FD&C Act. b. Qualified facilities. Section 418(l) of the FD&C Act (Modified Requirements for Qualified Facilities) establishes criteria for a facility to be a qualified facility, establishes an exemption for qualified facilities, establishes modified requirements for qualified facilities, and provides that the Secretary may withdraw the exemption otherwise granted to qualified facilities in specified circumstances. Under section 418(l)(1) of the FD&C Act, a facility is a qualified facility if: (1) It is a very small business as the term would be defined by this rulemaking or (2) it falls within specified limitations on the average annual monetary value of its sales and types of customers. Section 418(l)(2)(A) of the FD&C Act exempts a qualified facility from the requirements for hazard analysis and risk-based preventive controls as set forth in sections 418(a) through (i) of the FD&C Act, as well as the requirements issued under section 418(n) of the FD&C Act. Section 418(l)(2)(B) of the FD&C Act requires a qualified facility to submit documentation to the Secretary of HHS (the Secretary) related to its qualified status and also submit either documentation of the facility's implementation and monitoring of preventive controls or documentation of its compliance with other appropriate non-Federal food safety laws. Section 418(l)(3) of the FD&C Act authorizes the Secretary to withdraw the exemption from a qualified facility in specified circumstances. Section VIII.C discusses a proposed exemption for qualified facilities (proposed § 507.5(d)). Section XI discusses a proposed process for withdrawing an exemption for a qualified facility (proposed subpart D). Section VIII.D discusses proposed requirements that apply to qualified facilities (proposed § 507.7). c. Exemptions and exceptions. In addition to the exemption for qualified facilities in section 418(l)(2)(A) of the FD&C Act, there are several other exemptions and exceptions to the requirements specified in section 418 of the FD&C Act. Section 418(j) of the FD&C Act provides an exemption for facilities that are required to comply and are in compliance with the regulations for seafood HACCP, juice HACCP, or thermally processed low-acid foods packed in hermetically sealed containers. Section 418(k) of the FD&C Act provides an exception for activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety). Section 103(g) of FSMA provides an exemption for certain activities regarding a dietary supplement that is in compliance with section 402(g)(2) of the FD&C Act and section 761 of the FD&C Act (21 U.S.C. 379aa-1). For animal food facilities, only two of those exemptions are relevant: activities that are subject to the requirements for thermally processed low-acid foods packed in hermetically sealed containers (proposed § 507.5(b)), and section 419 of the FD&C Act (proposed § 507.5(c)) as discussed in section VIII.C. 2. Requirements for Agency Rulemaking Section 103 of FSMA contains two separate rulemaking provisions. Section 103(a) of FSMA requires rulemaking related to the hazard analysis and risk-based preventive controls required by section 418 of the FD&C Act. In addition, section 103(c) of FSMA requires rulemaking in two areas: (1) Clarification of certain aspects of the definition of the term “farm” under section 415 of the FD&C Act (Registration of Food Facilities) and (2) possible exemption from or modification of requirements of section 418 and section 421 of the FD&C Act (21 U.S.C. 350j) (Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report) for certain facilities as the Secretary deems appropriate and as further specified in section 103(c)(1)(D) of FSMA. a. General rulemaking requirements. Section 418(n)(1)(A) of the FD&C Act requires that not later than 18 months after the date of FSMA's enactment, the Secretary issue regulations “to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls. . . .” b. Definition of small and very small business. Section 418(l)(5) of the FD&C Act requires the Secretary, in consultation with the Secretary of Agriculture, to conduct a study of the food processing sector regulated by the Secretary and to make determinations in five areas. These areas include, in part: (1) Distribution of food production by type and size of operation, (2) the proportion of food produced by each type and size of operation, (3) the number and types of food facilities co-located on farms, (4) the incidence of foodborne illness originating from each size and type of operation, and (5) the effect on foodborne illness risk associated with certain activities regarding food. Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms “small business” and “very small business,” taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. These terms are significant because section 103 of FSMA contains several provisions specific to such entities. • Small and very small businesses are subject to modifications or exemptions from requirements under section 418 or 421 of the FD&C Act for facilities engaged only in specific types of on-farm activities and involving foods that the Secretary determines to be low risk (section 103(c)(1)(D) of FSMA). • Small and very small businesses are not subject to section 418 of the FD&C Act until 6 months (small businesses) or 18 months (very small businesses) after the effective date of FDA's final rule (section 103(i) of FSMA). • A very small business is deemed a “qualified facility” and would, therefore, qualify for the exemptions as discussed in section VIII.C.1. (section 418(l)(1)(B) of the FD&C Act). Consistent with section 418(l)(5) of the FD&C Act, FDA has consulted with the USDA during its study of the food processing sector. The study is available in the docket established for this proposed rule (Ref. 16). The Agency requests comment on that study. Section VIII.B discusses the proposed definitions for small business and very small business for animal food facilities. FDA will consider comments regarding the study, as well as comments regarding the proposed definitions for small and very small business, in any final rule based on this proposed rule. c. Clarification of the term “facility.” Generally, section 418 of the FD&C Act applies to the owner, operator, or agent in charge of a “facility.” Section 418(o)(2) of the FD&C Act defines “facility” as “a domestic facility or a foreign facility that is required to register under section 415.” Section 415 of the FD&C Act, in turn, requires any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States to register with the Secretary. The requirement in section 415 of the FD&C Act that a facility must register does not apply to farms. FDA's implementing regulations for section 415 (21 CFR part 1, subpart H; later in this document stated as the section 415 registration regulations) define “farm,” in relevant part, as “a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both” (§ 1.227(b)(3)) (21 CFR 1.227(b)(3)). The term “farm” includes a facility that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership (§ 1.227(b)(3)(i)). Under that same definition, the term “farm” also includes a facility that manufactures/processes food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership (§ 1.227(b)(3)(ii)). Section 103(c)(1)(A) of FSMA requires that not later than 9 months after the date of enactment, the Secretary publish a notice of proposed rulemaking in the Federal Register to issue regulations for purposes of section 415 of the FD&C Act with respect to “activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership” and “activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.” The regulation is intended to “enhance the implementation” of section 415 and “clarify the activities that are included within the definition of the term “facility” (section 301(c)(1)(B) of FSMA). In section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646), the Agency discusses the proposal to revise the section 415 registration regulations to enhance the implementation of section 415 and to clarify the definition of the term “facility.” That discussion applies to activities related to animal food and animal food facilities as well. d. Science-based risk analysis and requirements under sections 418 and 421 of the FD&C Act. Section 103(c)(1)(C) of FSMA requires that in issuing the proposed rule the Secretary conduct a science-based risk analysis of: • “Specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and • Specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.” As part of the rulemaking, the Secretary is required to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in sections 418 and 421 of the FD&C Act or modify those requirements, as the Secretary determines appropriate, if such facilities are only engaged in specific types of on-farm manufacturing, processing, packing, or holding activities the Secretary determines to be low risk, and involving specific foods that the Secretary determines to be low risk (section 103(c)(1)(D)(i) of FSMA). Any exemption or modification is limited to small and very small businesses (section 103(c)(1)(D)(ii) of FSMA). Section VII discusses the Agency's approach to the requirement in FSMA section 103(c) for a science-based risk analysis of the types of on-farm manufacturing, processing, packing, or holding operations that can involve animal food that is not consumed on that farm or on another farm under common ownership for purposes of section 415 of the FD&C Act and request comment on that approach. The final approach will consider comments received to this proposed rule. Section VIII.C discusses proposed exemptions for small and very small businesses that are solely engaged in certain types of “low risk” activities involving the on-farm manufacturing, processing, packing, and holding of certain “low risk” animal foods from the requirements of section 418 of the FD&C Act (proposed § 507.5(e) and (f)). The Agency also discusses its tentative conclusion that it should not exempt or modify the frequency requirements under section 421 based solely upon whether a facility only engages in such low-risk activity/food combinations and is a small or very small business. e. Exemption or modification of requirements for certain facilities. Under section 418(m) of the FD&C Act, the Secretary may exempt or modify the requirements for compliance of section 418 of the FD&C Act for hazard analysis and preventive controls for facilities that are solely engaged in the storage of raw agricultural commodities (RACs) (other than fruits and vegetables) intended for further distribution or processing. As discussed in section VIII.C, in accordance with the discretionary language of section 418(m), FDA tentatively concludes that facilities solely engaged in the storage of RACs for animal food, other than fruits and vegetables, intended for further distribution or processing should be exempt from the requirements for hazard analysis and preventive controls that the Agency is proposing in subpart C of part 507. However, as discussed in section VIII.C, the Agency is asking for comment on whether facilities solely engaged in the storage of grains that are RACs for animal food should be included in the final rule. Section 418(m) of the FD&C Act also authorizes the Secretary to exempt or modify the requirements for compliance with section 418 for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment. Section VIII.E describes the proposal for how the requirements of proposed part 507 would apply to such facilities that store animal food (proposed § 507.10). Section X.I discusses the proposed modified requirements for such facilities, directed at the storage of packaged animal foods that are not exposed to the environment and that require time/temperature control to limit the growth of, or toxin formation by, microorganisms of animal and human health significance (proposed § 507.48). FDA proposes to implement section 103 of FSMA in several regulations, rather than a single regulation that covers all food and hazards subject to preventive controls. This proposal is applicable to certain hazards that may be associated with a food facility that manufactures, processes, packs or holds animal food. Section 103 of FSMA applies to “food,” which is not limited to human food. Section 201(f) of the FD&C Act defines “food” to include “articles used for food or drink for man or other animals.” FDA tentatively concludes that the differences between human and animal food are best addressed through separate rulemakings. Section 418(m) of the FD&C Act authorizes the Secretary, by regulation, to modify the requirements for compliance under the section with respect to facilities that are engaged solely in the production of food for animals other than man. The Agency has tentatively concluded that the requirements of section 418 of the FD&C Act are needed to ensure the safety of animal food and in turn the health of animals, the health of humans who are exposed to animal food, and the safety of animal derived products for human consumption. Therefore, the Agency is proposing requirements to implement section 418 of the FD&C Act for animal food with only few modifications (e.g., no allergen controls.) The Agency requests comment on whether the requirements in section 418 of the FD&C Act should be modified further for facilities that are solely engaged in the production of food for animals other than man, based on scientific and public health principles. f. Intentional adulteration. This proposed rulemaking is not intended to address “hazards that may be intentionally introduced, including by acts of terrorism” (section 418(b)(2) of the FD&C Act). FDA plans to address section 103 of FSMA regarding such hazards in a separate rulemaking in the future. FDA tentatively concludes that intentional hazards, which are not addressed in traditional HACCP or other food safety systems, likely will require different kinds of controls and would be best addressed in a separate rulemaking. However, FDA also recognizes that some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in animal foods concerning which there is a widely recognized risk of economically motivated adulteration in certain circumstances. An example of this kind of hazard is the addition of melamine to certain food products apparently to enhance perceived quality and/or protein content. The Agency requests comment on whether to include potential hazards that may be intentionally introduced for economic reasons. The Agency also requests comment on when an economically motivated adulterant can be considered reasonably likely to occur. D. Preventive Controls and Hazard Analysis and Critical Control Points (HACCP) Systems HACCP is a preventive strategy for food safety that involves a systematic approach to the identification and assessment of the risk (likelihood of occurrence and severity) of hazards from a particular food or food production process or practice and the control of those hazards. FDA tentatively concludes for several reasons that HACCP is the appropriate framework to reference in interpreting and implementing section 103 of FSMA. For a full discussion of HACCP and preventive controls systems comparisons, please see section II.C of the document for the proposed rule for the preventive controls for human food (78 FR 3646). E. Animal Food Safety Incidents: Examples and Monitoring 1. Examples of Animal Food Safety Incidents Historically, the Agency has focused on specific animal food safety issues as problems arise, typically after the distribution of the contaminated animal food. Examples include safety issues related to BSE, chronic wasting disease, mycotoxins (especially aflatoxin in animal food intended for lactating dairy cattle), dioxins, melamine, and microbial contamination in pet foods. The massive pet food recall due to adulteration of pet food with melamine and cyanuric acid (chemicals called triazines) in 2007 is a prime example. The actions taken by two protein suppliers in China to intentionally adulterate wheat gluten and rice protein concentrate for economic reasons affected a large number of pet food facilities in the United States and created a nationwide problem by causing illness and death in many dogs and cats. The addition of melamine to wheat gluten and rice protein concentrate resulted in a high nitrogen reading during Kjeldahl testing, a test method used to estimate protein levels in foods. By adding the melamine, a non-protein source of nitrogen, the suppliers created a falsely high estimate of protein in their products. While melamine by itself is relatively non-toxic to mammals, the melamine used to adulterate the wheat gluten and rice protein concentrate in this incident had been combined with cyanuric acid, creating a mixture that became toxic. The presence of cyanuric acid with melamine resulted in a precipitation of crystals (melamine cyanurate) when mixed in a solution (Ref. 17). When the animals ingested the adulterated food, the mix of these two chemicals was absorbed into the blood stream and ultimately created an accumulation of crystals in the tubules of the animals' kidneys, leading to kidney disease and death in many animals. By the time the cause of the illness and deaths was identified, melamine and cyanuric acid contaminated ingredients resulted in the adulteration of millions of individual servings of pet food. Checks to ensure the safety of the imported ingredients had not been conducted by the importer or by the pet food manufacturers that incorporated the ingredients into pet food. During the investigation, FDA determined that leftovers from the production of pet food (commonly called fines) and salvaged, finished pet food products were routinely used in the production of feed for some food-producing animals (e.g., swine and poultry). It was ultimately discovered that some of these fines and salvaged pet food were adulterated with melamine (and other triazine analogs). Urine from swine (that were being raised for human food consumption) that had eaten this contaminated food was tested and found to contain melamine. This discovery resulted in the holding of animals before their marketing for human food in order to provide time for the U.S. government to conduct a risk assessment to ensure the safety of the meat for human consumption. It was ultimately determined there was no risk to human health from eating meat from these animals due to the small amounts of contaminants in the animal feed eaten. The contaminated wheat gluten was also used in the manufacture of fish food used in fish hatcheries for food-producing fish. As a result, there was a recall of the affected fish food. These situations with food-producing animals emphasized the link between adulterated animal food (and ingredients) and the potential for adverse effects on human health. The melamine incident underscored the difficulty in tracing an adulterated ingredient that has been used in a large number of food products. The list of recalled animal foods was constantly updated for multiple weeks after the initial identification of the adulterated ingredients as the distribution of those ingredients was traced. Pet food companies who thought their pet foods were safe because their formulations did not included the use of wheat gluten or rice protein concentrate were surprised to find some of their products were indeed adulterated with the melamine and cyanuric acid. An FDA investigation revealed that a contracted pet food manufacturer was substituting rice protein concentrate for other sources of protein called for in these formulations without contacting the parent company. Additional incidents of animal food contamination not discovered until after the food was distributed include the detection of dioxin in feed. Dioxin has been linked to adverse health effects in humans, such as cancer, immune suppression, and reproductive or developmental effects. Dioxin is a concern in food-producing animals because human dioxin exposure in the United States comes primarily from the consumption of animal products. In 1997, the USDA's Food Safety and Inspection Service, through their dioxin sampling survey, identified dioxins in poultry tissue. Through a multi-agency investigation, the FDA traced this contamination to high levels of dioxins present in an anti-caking agent (ball clay) used in animal food. That same year, FDA issued a statement to users of ball clay products in animal feed requesting those companies to cease the use of ball clay products in animal feeds and feed ingredients (Ref. 18). In 2002, a foreign government identified high dioxin levels in a mineral product intended for animal food imported from the United States (Ref. 19). The source of the dioxin was related to the high temperature used in the mineral manufacturing process. In 2003, another dioxin incident in minerals was identified as a result of an FDA food sampling assignment. In this case, the mineral premix manufacturer purchased a trace mineral that was a by-product of a metal smelting process (Ref. 20). Internationally, in 1999, animal feed contaminated with dioxin and polychlorinated biphenyls in Belgium resulted in animal and human exposure in Europe. The Belgium government estimated the economic impact of the dioxin crisis cost $493 million, of which $106 million was lost in the swine industry alone. The total cost is much greater when factoring in the impact that occurred to the animal and human food industries in European countries that imported contaminated animal food (livestock feed) or human food from Belgium (Ref. 21). In 2009, a dioxin incident occurred in Ireland involving swine feed that resulted in a global recall of Irish pork. This incident resulted in the Irish government providing € 200 million ($266 million) compensation packages for the Irish pork industry due to their economic losses (Ref. 22). These incidents raised public awareness of the problem of dioxin contamination in animal food. Another animal food contaminant that can cause illness and injury to animals and humans is aflatoxin. Aflatoxins are naturally occurring mycotoxins that are produced by many species of the fungus Aspergillus on certain agricultural commodities. Since their discovery in the early 1960's, aflatoxins have been shown to be toxic to animals and humans. Aflatoxins have also been shown to be carcinogenic to laboratory test animals. After consumption, aflatoxins are metabolized by the liver to a reactive intermediate and eliminated as aflatoxin M1 in milk or as aflatoxicol in urine. High level aflatoxin exposure produces acute damage and cirrhosis of the liver as well as cancer of the liver. It appears that no animal species, including humans, is immune to the acute toxic effects of aflatoxins. In 2005, a pet food company in South Carolina recalled dog food that was contaminated with aflatoxin (Ref. 23). The Agency received reports from 4 states of illness in over 40 dogs, including 23 deaths, associated with the consumption of the contaminated pet food. In addition, the company's contaminated pet food was exported to at least 29 foreign countries. The source of this contamination was traced to local corn, which had been contaminated with aflatoxin before entering the pet food facility. Microbial contamination of animal food is also a high concern for the Agency, not only for animals consuming the contaminated food, but also for humans that handle that contaminated animal food. In 2007, FDA identified S. Schwarzengrund, a rare serotype of Salmonella associated with human illness, in a pet food. The Center for Disease Control and Prevention (CDC) traced this rare strain of Salmonella to a pet food manufacturing facility located in Pennsylvania. Analytical tests conducted by FDA confirmed S. Schwarzengrund at the Pennsylvania facility. A recall was issued for two brands of dry dog food and the manufacturing facility ceased operations for 5 months for cleaning and disinfecting. Despite the facility's efforts, additional S. Schwarzengrund illnesses in humans were reported to CDC. After further investigations by FDA, the pet food manufacturing facility issued a nationwide voluntary recall of all dry dog and cat food products produced at the facility over a 5 month period. This recall involved approximately 23,109 tons of dry pet foods, representing 105 brands. While no pets were reported sick, 79 people in 21 states were reported ill due to the handling of pet food contaminated with this Salmonella strain (Ref. 24). In 2010, the CDC notified FDA of an outbreak of salmonellosis ( Salmonella infection) in people in the United Kingdom and the United States. News reports from the United Kingdom indicated over 200 people had become ill, all from the same strain of Salmonella (Ref. 25). UK officials had determined patients in the United Kingdom had been exposed to frozen rodents used as animal food for reptiles and determined these frozen rodents were contaminated with the same strain of Salmonella that was causing the human illness outbreak. U.K. officials traced the origin of these contaminated frozen rodents to a supplier in the United States. UK officials then contacted the CDC. The CDC determined from illness reports that 34 patients in 17 states in the United States were diagnosed with salmonellosis associated with the same strain of Salmonella as the patients in the United Kingdom and of that found in the frozen rodents (Ref. 26). FDA inspected the facility producing the frozen rodents and isolated the same strain of Salmonella from frozen rodent products sampled at the facility. The facility had distributed frozen rodents as animal food worldwide. In June of 2008, following an inspection, FDA initiated a mass seizure of animal food at a pet food distribution center after finding the animal food products were vulnerable to contamination, such as microbial contamination, as a result of infestation of the facility by rodents, birds and other pests. Rodent pellets, rodent urine stains, and bird droppings were found throughout the facility, including on bags and pouches of pet food. Rodents had chewed holes in some of the bags of dry dog and cat food and bird seed. The facility was not taking measures to control pest infestation. Another mass seizure of animal food was executed in August of 2009 at a feed mill because of similar violations. In both cases, the seized products violated section 402(a)(4) of the FD&C Act because the animal food was being held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. In April 2012, epidemiologic and laboratory investigations conducted by officials in local, state, and federal public health, agriculture, and regulatory agencies linked a Salmonella Infantis outbreak to contaminated dry dog food produced by a single production facility located in South Carolina. A total of 49 people (47 individuals in 20 states and 2 individuals in Canada) were reported infected with Salmonella Infantis. Among the 24 human patients with available information, 10 were hospitalized. The results from product testing by multiple agencies along with production codes provided by ill persons, led to multiple recalls by several companies with animal food products manufactured at the implicated production facility. The recalls included 17 brands representing over 30,000 tons of dry dog and cat food produced at the facility. This was the second documented outbreak of human salmonellosis linked to dry pet food in the United States (Ref. 27) (Ref. 28). These examples demonstrate that the safe production and distribution of animal food and ingredients, along with safe meat, milk, and eggs derived from animals that consume this food is an important public health concern, both domestically and globally. The Agency needs to assure the consumer, both here and abroad, that it has a regulatory system designed to ensure production of safe animal food in the United States. Requiring facilities to manufacture, process, pack, or hold animal food under these proposed CGMPs and proposed preventive controls program would help provide that assurance. In addition, the U.S. Government, the animal food industry, animal producers, pet owners and consumers need to have assurance that animal food imported into the United States is safe. 2. Monitoring and Recalls FDA monitors adverse food events through various means, such as FDA's Reportable Food Registry, FDA's Pet Food Early Warning Surveillance System, consumer complaints, tracking industry recalls and FDA and State inspection findings. From fiscal year (October through September) 2006 through 2012, there were 2,277 animal food product recalls. In 2007 alone, 1,054 animal food products were recalled due to contamination with melamine. Reasons for other animal food recalls include contamination with aflatoxins, dioxins, Salmonella, or metal fragments; improper labeling, such as no BSE warning; and subpotent or superpotent nutrient levels, such as elevated levels of vitamin D, copper, zinc, or urea and low levels of potassium, vitamin D, or thiamine. In fiscal year 2012, there were 191 consumer complaints of ill pets reported to FDA related to the dog food contaminated with Salmonella Infantis, discussed previously in this section. For calendar years 2008 through 2012, over 2,500 consumer complaints were called into FDA's district offices regarding animal food for pets and livestock. The complaints ranged from animals refusing to eat their food to animal illness and deaths associated with consumption of an animal food. During the melamine contamination incident in 2007, FDA received over 13,000 consumer complaints about pet food, and over 18,000 calls. Many of these consumer complaints were associated with recalled pet food products contaminated with melamine and cyanuric acid (a contamination that was linked by laboratory testing to illness and deaths in animals as discussed in section II.E.1). In September of 2009, the Agency established the Reportable Food Registry (RFR), where manufacturers, processors, packers, and holders of human or animal food are required to report to the Agency if there is reasonable probability that an article of human or animal food will cause serious adverse health consequences or death to humans or animals. From September 2009 through September 2012 the Agency received 71 primary animal food RFR reports. A primary report is the initial report concerning a reportable food from either industry or public health officials, such as federal, state or local regulators. The hazards identified in the primary animal food reports consisted of 27 microbial hazards, 5 physical hazards, and 39 chemical hazards. The microbial hazards were almost exclusively Salmonella bacteria found in the finished product. The physical hazards included glass, metal or plastic in the finished animal food, some of which reportedly resulted in animal injury or death. The largest number of animal illnesses and deaths reported to FDA through the RFR and attributable to animal food were associated with a subset of chemical hazards, nutrient imbalances. Some examples of nutrient imbalances associated with animal illnesses and deaths include excessive levels of urea in cattle food, excessive levels of copper in sheep food, inadequate levels of thiamine in cat food, inadequate levels of vitamin D in swine food. In addition, toxic levels of medication (new animal drugs) have been found in non-medicated animal food. In May, 2010, the Agency implemented the Safety Reporting Portal, where consumers can submit complaints regarding adverse events in animals associated with the consumption of pet food products. From May 2010 through September 2012 the Agency received over 2,900 consumer complaints for pet food through the Safety Reporting Portal and all were reviewed and evaluated by FDA. F. The Role of Testing as a Verification Measure in a Food Safety System The safety of food is principally ensured by the effective implementation of scientifically valid preventive control measures throughout the food chain (Refs. 29 and 30). Prevention of hazards in animal food is much more effective than trying to differentiate safe from unsafe food using testing. Although testing is rarely considered a control measure, it plays a very important role in ensuring the safety of food. An important purpose of testing is to verify that control measures, including those related to suppliers and those verified through environmental monitoring, are controlling the hazard (Refs. 31 and 32). Testing is used in conjunction with other verification measures in the food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan. As discussed in the Appendix to this document (see sections I.C, I.E, and I.F of the Appendix), microbial testing may include: • Testing raw materials and ingredients to verify that suppliers have significantly minimized or prevented hazards reasonably likely to occur in the raw materials and ingredients; • Testing the environment to verify that sanitation controls have significantly minimized or prevented the potential for environmental pathogens to contaminate animal food; and • Testing finished product to verify that preventive controls have significantly minimized or prevented hazards reasonably likely to occur in the animal food. Each type of testing provides information applicable to managing hazards in animal foods, depending on the animal food and process. The Agency discusses the role of testing as a verification measure in a food safety system in section I of the Appendix to this document. G. The Role of Supplier Approval and Verification Programs in a Food Safety System An animal food can become contaminated through the use of contaminated raw materials or ingredients as evident by the large recall of pet food because of contamination of wheat gluten with melamine (see discussion in section II.E.1). The development of a supplier approval and verification program is part of a preventive approach. Because many facilities acting as suppliers procure their raw materials and ingredients from other suppliers, there is often a chain of suppliers before a raw material or other ingredient reaches the manufacturer/processor. Using a preventive approach, a facility receiving raw materials or ingredients from a supplier can help ensure that the supplier (or a supplier to the supplier) has implemented preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself control the identified hazard. A supplier approval and verification program is a means of ensuring that raw materials and ingredients are procured from those suppliers that can meet facility specifications and have appropriate programs in place, including those related to the safety of the raw materials and ingredients. A supplier approval program can ensure a methodical approach to identifying such suppliers. A supplier verification program is essential to provide initial and ongoing assurance that suppliers are complying with practices to achieve adequate control of hazards in raw materials or ingredients. The Agency discusses supplier approval and verification programs in more detail in section II of the Appendix to this document. III. Public Meeting and Preliminary Stakeholder Comments On April 20, 2011, FDA held a public meeting entitled “FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities” (notice of the meeting published in the Federal Register on April 13, 2011; 76 FR 20588). The purpose of the public meeting was to provide interested persons with an opportunity to discuss implementation of the provisions in section 418 of the FD&C Act. A discussion of this meeting can be found in section IV of the document for the proposed rule for preventive controls for human food (78 FR 3646). IV. Summary of the Scope of the Proposed Rule This proposed rule would apply to animal facilities required to register with FDA under section 415 of the FD&C Act, unless subject to an exemption. This would include manufacturing, processing, packing, and holding of finished products that are intended to be fed to animals, including livestock, pets, and other captive animals, as well as the manufacturing, processing, packing, and holding of ingredients that may be used in animal foods. Some industry sectors, such as renderers and grain and oilseed processors, have long been considered animal food manufacturers and would be subject to the proposed rule. In addition, industry sectors that are newer, such as biofuel manufacturing (suppliers of distillers grain for animal food), or other entities that may not have been thought of as animal food manufacturers in the past, such as mineral refining and manufacturing, would be subject to the proposed rule to the extent that they are engaged in manufacturing, processing, packing, or holding of animal food. This proposed rule would not apply to farms. For example, farms manufacturing, processing, packing, and holding food for consumption by their own animals would not be required to register under section 415 of the FD&C Act and therefore would not be required to comply with the proposed rule. However, if the farm operates an animal food manufacturing business (in addition to its traditional farm activities) that requires registration under section 415 of the FD&C Act, that food manufacturing business would likely need to comply with this proposed rule. In complying with the Hazard Analysis and Risk-Based Preventive Controls section of the proposed rule (subpart C), facilities that manufacture, process, pack, or hold animal food for a single species of animal would focus on hazards most likely to be associated with the ingredients they use, as well as hazards most likely to occur during manufacturing, processing, packing, or holding at the facility, relevant to that species of animal. Facilities that manufacture, process, pack, or hold an ingredient would focus on reducing hazards associated with the ingredient and those species of animal that may consume animal food containing that ingredient. Facilities that manufacture, process, pack, or hold animal food for a range of species or variety of uses would need to consider a more diverse number and type of hazards. In addition to focusing on hazards associated with their incoming ingredients or the types of equipment they use, a feed mill that manufactures food for multiple species would need to be aware of nutritional sensitivities of the animals for which it makes food. For example, a manufacturer that makes food for swine, which can tolerate a relatively large amount of copper in their diet, and food for sheep, which are very sensitive to copper, would need to adopt controls that would ensure that the sheep food it does not contains levels of copper that are unsafe for sheep. Pet foods usually contain ingredients from the same sources used to make food for livestock and pet foods are sometimes manufactured in the same facilities as food for livestock. For these reasons the Agency has not proposed different rules for these different types of facilities. However, the hazards associated with pet food may be significantly different from the risks associated with food for livestock, and the facility manufacturing, processing, packing, or holding would need to identify and address these hazards. Pet foods usually come into the home, so in addition to being safe for pets to eat, they also would need to be safe for the pet owner to handle. For example, pet foods and treats have been known to carry Salmonella (see section II.E). A facility manufacturing pet food would need to address the potential for injury or illness (including death) from the Salmonella hazard in not only animals, but in humans handling that pet food (especially the young, old, or immunocompromised.) V. Highlights of the Proposed Rule A. Overview The proposed rule would establish part 507 and contains regulations regarding the manufacturing, processing, packing, or holding of animal food. The proposed rule would establish new provisions for CGMPs for animal food and ingredients, and it would establish new provisions for risk-based preventive controls. Under the proposed rule, part 507 would be divided into the following subparts: • Subpart A—General Provisions; • Subpart B—Current Good Manufacturing Practice; • Subpart C—Hazard Analysis and Risk-Based Preventive Controls; • Subpart D—Withdrawal of an Exemption Applicable to a Qualified Facility; • Subpart E is Reserved; and • Subpart F—Requirements Applying to Records That Must Be Established and Maintained. B. Proposed Subpart A—General Provisions The proposed rule would establish general provisions under subpart A of part 507. These provisions include the applicability and status, definitions, specified exemptions for certain facilities from the requirements of proposed subpart C (hazard analysis and risk-based preventive controls), and specified exemptions for certain establishments from the requirements from subpart B (current good manufacturing practice). The proposed exemptions from subpart C would be consistent with the requirements established by FSMA or the discretion provided by FSMA. The subjects of the specified exemptions relate to: • Animal food establishments that do not have to register under section 415 of the FD&C Act; • Activities subject to existing Agency regulations governing microbiological hazards for low acid canned animal foods; • Activities subject to the Standards for Produce Safety in section 419 of the FD&C Act; • A “qualified” facility; • Certain low-risk packing or holding activity/animal food combinations conducted on a farm by a small or very small business; • Certain low-risk manufacturing/processing activity/animal food combinations conducted on a farm by a small or very small business; • Facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing; • Facilities that are solely engaged in the holding or transportation of RACs; and • Facilities solely engaged in the storage of packaged animal food that is not exposed to the environment, although the storage of such food that requires time/temperature control to prevent the growth of, or toxin formation by, pathogenic microorganisms would be subject to modified requirements that would be established in proposed subpart C. Proposed subpart A would also implement certain provisions in sections 418(l) and (m) of the FD&C Act for modified requirements with respect to implementing the modified requirements specified in section 418(l) of the FD&C Act for facilities that satisfy the statutory criteria for a “qualified facility.” The Agency proposes to establish requirements that include: • Submission to FDA of documentation that the facility is a qualified facility; and • Submission to FDA of documentation demonstrating that the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective; or • Submission to FDA of documentation that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries. C. Proposed Subpart B—Current Good Manufacturing Practice Proposed subpart B would establish general baseline good manufacturing practices for facilities manufacturing, processing, packing, and holding animal food. These provisions would include specific requirements for: • Personnel in animal food facilities such as following good hygiene practices, and protection of food from contamination from personal effects; • The plant and grounds including proper cleaning, maintenance, and elimination of pests; • Sanitary operations including maintaining clean and sanitary conditions of food contact surfaces, proper use and storage of toxic cleaning compounds, and exclusion of pests; • Sanitary facilities and controls such as the plant's water supply, plumbing, and toilet and hand-washing facilities; • Equipment and utensils including the cleaning and maintenance of such items and protecting animal food from contamination; • Processes and controls including following adequate sanitation principles, proper labeling of ingredients and finished animal food, ensuring the safety of raw materials, and prevention of contamination of animal food during processing; and • Warehousing and distribution to protect animal food against contamination and deterioration. D. Proposed Subpart C—Hazard Analysis and Risk-Based Preventive Controls 1. Written Food Safety Plan The Agency proposes to require that the owner, operator, or agent in charge of a facility have and implement a written food safety plan that includes as applicable: • A hazard analysis; • Preventive controls; • Monitoring procedures; • Corrective Action procedures; • Verification procedures; and • A recall plan. 2. Written Hazard Analysis The Agency proposes to require that the written hazard analysis identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur, including biological, chemical, physical, and radiological hazards. The hazard analysis would include an evaluation of the identified hazards to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur. 3. Written Preventive Controls The Agency proposes to require that the owner, operator, or agent in charge of a facility identify and implement preventive controls (including at critical control points, if any) to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented and that the animal food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act. The preventive controls would include, as appropriate: • Parameters associated with the control of the hazard and the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur; • Process controls; • Sanitation controls; • A recall plan; and • Any other necessary controls. 4. Written Recall Plan The Agency proposes to require that the written recall plan be developed for animal food with hazards that are reasonably likely to occur. 5. Monitoring The Agency proposes to require the monitoring of the preventive controls to provide assurance that they are consistently performed, including requirements to establish and implement written monitoring procedures and establish and maintain records documenting the implementation of the monitoring procedures. 6. Corrective Actions The Agency proposes to require that facilities establish and implement written corrective action procedures that would be used if preventive controls are not properly implemented and take corrective actions in the event of an unanticipated problem. 7. Verification The Agency proposes to require that facilities conduct certain verification activities, including: • Validation of a subset of the preventive controls; • Verification that monitoring is being conducted; • Verification that appropriate decisions about corrective actions are being made; and • Verification that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur. The Agency also proposes to require reanalysis of the food safety plan at least once every 3 years and more often when circumstances warrant. 8. Modified Requirements for a Facility Solely Engaged in the Storage of Packaged Animal Food That is Not Exposed to the Environment Acting on the discretion provided to FDA by section 418(m) of the FD&C Act, the Agency proposes to require that the owner, operator, or agent in charge of a facility solely engaged in the storage of packaged animal food that is not exposed to the environment conduct certain activities for any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance, including: • Establishing and implementing temperature controls; • Monitoring the temperature controls; • Taking appropriate corrective actions when there is a problem with temperature controls; • Verifying that temperature controls are consistently implemented; and • Establishing and maintaining the following records: • Records documenting the monitoring of temperature controls; • Records of corrective actions; and • Records documenting verification activities. The Agency requests comments on these proposed requirements. 9. Qualified Individual The Agency proposes to establish qualification requirements for a “qualified individual,” who would be required to do or oversee the preparation of the food safety plan, validation of preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the reanalysis of a food safety plan. A “qualified individual” would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. 10. List of Required Records The Agency proposes to establish a list of records that would be required under proposed subpart C, including the written food safety plan and records documenting monitoring of preventive controls, corrective actions, verification, and applicable training for the qualified individual. E. Proposed Subpart D—Withdrawal of an Exemption Applicable to a Qualified Facility Proposed subpart D would implement the provisions of section 418(l)(3) of the FD&C Act and establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption. F. Proposed Subpart F—Requirements Applying to Records That Must Be Established and Maintained Proposed subpart F would establish requirements that would apply to all records that would be required by the various proposed provisions of proposed part 507, including: • General requirements related to the content and form of records; • Additional requirements specific to the food safety plan; • Requirements for record retention; • Requirements for official review of records by FDA; and • Public disclosure. VI. Compliance Dates Section 103(i)(1) of FSMA, General Rule, provides that “[t]he amendments made by this section shall take effect 18 months after the date of enactment” (i.e., by July 4, 2012). Section 103(i)(2) of FSMA, Flexibility for Small Businesses, provides that “[n]otwithstanding paragraph (1),” the amendments made by this section “shall apply” to a small business and very small business beginning on the dates that are 6 months and 18 months, respectively, “after the effective date” of FDA's final regulation. FDA is implementing the amendments made by section 103 to the FD&C Act through this rulemaking for animal food (except as they relate to intentional contamination). FDA tentatively concludes that it is appropriate to provide a sufficient time period following publication of the final regulation for facilities to come into compliance. The final regulation will contain provisions that affect which facilities are subject to section 418 and which provisions apply to particular facilities. Without these provisions of the regulation in effect, facilities would be uncertain as to the applicability of certain requirements to them. Further, FDA tentatively concludes that compliance with section 418 will be facilitated greatly by the detail and explanation that will be provided by the final regulation. Most animal food facilities have not been subject to CGMPs and no animal food facility has been subject to preventive controls as put forth in this proposed rule. However, individual animal food facilities, either individually or through feed industry associations have implemented SOPs that are likely to be sufficient to satisfy some of the proposed requirements. The Agency tentatively concludes that the concepts in the proposed CGMPs will not be new to the animal food industry. Still, the Agency expects that the majority of facilities will need to make substantial changes if the proposed regulations are adopted. FDA recognizes that it can take time to implement a food safety system for animal food that would require among other things, CGMPs, performance of a hazard analysis, development of preventive controls, and monitoring of preventive controls. FDA is proposing that the final rule would be effective 60 days after publication in the Federal Register , with staggered compliance dates (see section VI.) However, the Agency recognizes that animal food businesses of all sizes may need more time to comply with the new requirements. FDA believes that it is reasonable to allow for 1 year after the date of publication of the final rule for businesses other than small and very small businesses to come into compliance with the new requirements established under FSMA. FDA also believes that it is reasonable to allow for 2 years after the date of publication of the final rule for small businesses to come into compliance with the new requirements established under FSMA, and 3 years after the date of publication of the final rule for very small businesses to come into compliance with the new requirements. FDA intends to work closely with the animal food industry, extension and education organizations, and state partners to develop the tools and training programs needed to facilitate implementation of the final rule. VII. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities A. Section 103(c) of FSMA 1. Clarification of the Activities That Are Included As Part of the Definition of the Term “Facility” under Section 415 of the FD&C Act Section 103(c)(1)(A) of FSMA requires the Secretary to “publish a notice of proposed rulemaking in the Federal Register to promulgate regulations with respect to—(i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 350d), as amended by [FSMA]; and (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415.” Section 103(c)(1)(B) of FSMA stipulates that such rulemaking “shall enhance the implementation of such section 415 and clarify the activities that are included as part of the definition of the term “facility” under such section.” Section 415 of the FD&C Act, in turn, directs the Secretary to require by regulation that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. The registration requirement in section 415 of the FD&C Act does not apply to farms. FDA regulations that implement section 415 and require food facilities to register with FDA are established in part 1 (21 CFR part 1), subpart H (Registration of Food Facilities) (the section 415 registration regulations). A discussion of the Agency's clarification of the treatment of activities that are included as part of the definition of the term “facility” in section 415 as well as proposed changes to definitions in the section 415 registration regulations can be found in section VIII of the document for the proposed rule for preventive controls for human food (78 FR 3646). 2. Science-Based Risk Analysis Covering Specific Types of On-Farm Packing, Holding, Manufacturing, Processing, Packing and Holding Activities Section 103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover “(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.” Section VII.B describes a draft Qualitative Risk Assessment (the section 103(c)(1)(C) draft RA) (Ref. 33) the Agency performed to satisfy this requirement. 3. Exemptions and Modified Requirements for Certain Facilities Section 103(c)(1)(D)(i) of FSMA requires that, as part of the section 103(c) rulemaking, “the Secretary shall consider the results of the science-based risk analysis . . . and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act (as added by [section 103 of FSMA]) including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act (as added by section 201 [of FSMA]), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.” Section 103(c)(1)(D)(ii) of FSMA provides that the exemptions or modifications described in section 103(c)(1)(D)(i) “shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by [FSMA], if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act.” Section VII.C discusses the results of the section 103(c)(1)(C) draft RA. In section VII.D, the Agency sets forth its tentative conclusions regarding combinations of on-farm manufacturing, processing, packing, and holding activities and animal foods determined to be low risk, considering the results of the section 103(c)(1)(C) draft RA. In section VII.E, the Agency discusses a proposed approach to using the results of the section 103(c)(1)(C) draft RA for the purposes of section 421 of the FD&C Act. Section VIII.C. discusses the Agency's proposal to exempt low-risk combinations of activities and animal foods from the requirements of section 418 of the FD&C Act when performed by farm mixed-type facilities that are small or very small businesses as would be defined in proposed § 507.3. For a complete discussion of FSMA section 103(c) and on-farm activities, please refer to section VIII.B through VIII.D of the document for the proposed rule for preventive controls for human food (78 FR 3646). B. Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition As discussed in section VII.A, section 103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover “(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.” As used in section 103(c)(1) of FSMA, the term “risk analysis” is ambiguous. One interpretation is that the common meaning of the term is intended—a simple evaluation of whether activity/animal food combinations are likely to result in the consumer (animals in relation to food for animals) becoming ill. Another interpretation is that the “risk analysis” should be consistent with the formal definition and related terms used by Codex with respect to food safety (Ref. 34): • Risk is a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food. • Risk analysis is a process consisting of three components: risk assessment, risk management and risk communication. • Risk assessment is a scientifically-based process consisting of hazard identification, hazard characterization, exposure assessment, and risk characterization. • Risk management is the process, distinct from risk assessment, of weighing policy alternatives, in consultation with interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options. • Risk communication is the interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions. Because section 103(c)(1)(C) of FSMA calls for a science-based risk analysis, the Agency is applying the Codex definitions to the extent possible. It is not clear whether the requirement of section 103(c)(1)(C) of FSMA to conduct a science-based risk analysis was intended to encompass all three components of risk analysis. Section 103(c)(1)(D) of FSMA requires the Secretary to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in section 418 of the FD&C Act, including hazard analysis and preventive controls, and the mandatory inspection frequency of section 421, or to modify those requirements for facilities engaged in on-farm manufacturing, processing, packing, or holding activities determined to be low risk involving animal foods determined to be low risk. Thus, section 103(c)(1)(D) of FSMA is focused on ensuring that the Agency's risk management decisions with respect to exempting or modifying requirements applicable to low-risk on-farm activity/animal food combinations under sections 418 and 421 are science-based, as determined by an analysis of the risk of specific types of on-farm activity/animal food combinations required by section 103(c)(1)(C). The Agency therefore tentatively concludes that the analysis required by section 103(c)(1)(C) should be limited to an assessment of the risk of specific types of on-farm activity/animal food combinations for the purposes of making the risk management decisions required by section 103(c)(1)(D). The risk communication component of the risk analysis is accomplished through the discussion of that assessment in this document, the opportunities for public comment (on the risk assessment and on this proposed rule), and the Agency's evaluation of, and response to, comments in a final rule. Consistent with this approach, the Agency conducted a qualitative risk assessment (Ref. 33) (“section 103(C)(1)(C) draft RA”) related to activity/animal food combinations for the purpose of determining which activity/animal food combinations would be considered low risk. The Agency focused on activity/animal food combinations that were identified as being cond [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2013-25126. Public record. Not legal advice.