Third Edition: Draft Framework of the FDA Animal Feed Safety System
Purpose and Scope: The Animal Feed Safety System (AFSS) is the FDA’s program for animal feed aimed at protecting human and animal health by ensuring safe feeds. (In this document, we define feed as mixed feed as well as feed ingredients, as stated in Appendix I.) The AFSS covers the entire continuum of Agency activities from pre-approval of additives for use in feed, to establishing limits on feed contaminants, providing education and training, conducting inspections and taking enforcement for ensuring compliance with Agency regulations. The AFSS includes oversight of labeling, production, distribution, and administration of all feed ingredients and mixed feeds at all stages of manufacture, distribution, and use, whether at commercial or non-commercial establishments.
Background: The Federal Food, Drug, and Cosmetic Act (FFDCA or the Act) is the basic Federal statute under which the FDA regulates food and drugs. In the Act, the term “food” is defined as food for man or other animals, and includes animal feed. Historically, FDA’s feed program has focused on specific feed safety issues, such as medicated feeds, Bovine Spongiform Encephalopathy (BSE), and Salmonella, but has not addressed feed safety in a comprehensive manner. A comprehensive feed safety program is intended to help prevent the occurrence of future feed safety problems and enable FDA to identify and control such problems when they occur. Although the title Animal Feed Safety System may be new, FDA has actively regulated animal feed for many years. State feed regulators have cooperated with FDA in ensuring compliance with Federal regulations, and have complemented FDA’s efforts with programs geared toward ensuring that feeds are nutritionally adequate for their intended use and do not cause health problems in animals or humans. States have also worked to minimize economic losses by feed purchasers.
Animal feed ingredients and mixed feeds produced and used in this country have a good safety record. However, because oversight of this industry is limited and focused on a few known safety issues, potential human and animal health problems may remain hidden. Recent incidents in which high levels of dioxins were present in mineral supplements used in animal feed reflect these types of hidden risks. Sampling and analysis of domestic catfish as human food and of imported feed ingredients by a foreign government elevated the problem of dioxins into public awareness. Likewise, the public became alarmed last year when imported feed ingredients, contaminated with melamine and related compounds, were used in pet food, which resulted in sick dogs and cats.
The production and distribution of feed ingredients and animal feed, and the meat, milk, and eggs derived from animals that consume these feed materials, have become a global business. World markets, and the customers served by these markets, often react negatively when questions arise about the safety of a feed commodity introduced into domestic or international commerce. Issues involving BSE, Chronic Wasting Disease (CWD), dioxins, and microbial contamination are examples of the most recent issues demonstrating this international impact. Implementation of a preventive, risk-based system comprised of both regulatory and voluntary components designed to ensure the continued production of safe feed commodities should provide the U.S.-based animal feed industry with a more competitive market position through increases in confidence about the safety of U.S. feed and animal-derived food supplies.
In November 2007 FDA released its Food Protection Plan, which provides a framework to identify potential food hazards and to counter them before harm occurs. The Plan builds in safety measures across a product’s life cycle, from the time a food or feed is produced to the time it is distributed and consumed. FDA’s integrated approach encompasses three core elements: prevention, intervention and response. The AFSS, with its strong emphasis on prevention, figures prominently in the Food Protection Plan. Also, in November 2007, the Import Strategy Action Plan, which was developed by an interdepartmental group lead by the DHHS Secretary, was released. Feed safety is addressed in this document too.
Title X of the Food and Drug Administration Amendments Act of 2007 imposes several requirements on the FDA in the food safety domain, several of which were a direct reaction to the dog and cat illnesses and deaths in the United States that resulted from the apparent intentional adulteration in China of two ingredients with melamine, cyanuric acid and related compounds. Those mandates that include animal feed have been added to the developmental work identified in this document for ensuring FDA’s animal feed safety system is comprehensive and preventative.
A risk-based, preventive animal feed safety program will require producers and distributors of animal feeds to take into consideration hazards, whose presence in or introduction into their feeds pose an unacceptable risk to animal or human health and to develop a plan to prevent or eliminate, or reduce to an acceptable level, those hazards. Thus, under a “modernized” AFSS, feed producers’ knowledge would improve on how to identify and minimize or eliminate hazards associated with animal feed before those hazards result in decreased production, adverse health consequences to the animal and potential risks to human health. Further, producers of animal feed who understand their own business and technical processes well enough to establish effective control points for naturally occurring and/or accidental hazards are also likely to be more capable of detecting and controlling deliberately introduced hazards in a terrorism-related event.
FDA would also benefit from a more systematic approach to animal feed safety. Limited Agency and state resources can be more effectively utilized by focusing research, inspections, and feed sampling and analysis programs on those situations representing the greatest risks to public and animal health. We believe a more effective overall animal feed safety program should also result in fewer resource draining feed emergencies for government agencies.
Operating Principles of the AFSS: The following operating principles form the basis for the AFSS:
The animal feed and animal production industries are responsible for the production, distribution, and use of safe animal feed.
Federal and State regulatory agencies provide the rules, guidance, and oversight to assist industry in producing and distributing safe animal feed and feed ingredients.
Rules and guidance provide flexibility in the approaches individual producers of animal feed can use to meet acceptable safety criteria.
Federal and State regulatory agencies cooperate on all aspects of feed regulation.
Feed regulatory agencies conduct inspections of feed-producing establishments, review product labels, sample and analyze feeds for hazards and for compliance with label guarantees, and take appropriate actions to address violations.
FDA directs its regulatory resources to those feed-related hazards that pose the greatest risks to animal and public health.
FDA uses risk-based decision-making to help determine which feed-related hazards should receive the highest priority by the Agency, and the best methods for addressing them.
Feed defense measures as they relate to preventing and responding to terrorism are part of the AFSS.
Training is critical for ensuring that industry and regulatory agencies have the most up-to-date knowledge about FDA rules and guidance, and for ensuring enforcement by FDA and States is consistent and conducted in an appropriate manner.
Feeds intended for food-producing and other types of animals, such as pets, are included in the AFSS.
Feed establishments covered in the AFSS include all facilities, equipment and conveyances involved in the production, storage, packaging and distribution of individual feed ingredients and mixed feed and the feeding of animals.
Major Components of the AFSS: Six (6) operating components comprise the AFSS. These components cover the processes used by FDA to ensure that: ingredients used in animal feeds are safe (components A and B); the methods used to make, store, and distribute feeds result in safe products (component C); the Agency acquires timely information about unsafe feed and makes such information publicly available (component D); regulatory oversight is present at levels commensurate with risk to human and animal health (component E); and training, education, and outreach activities keep our stakeholders well informed and ensure FDA and State feed regulatory personnel are adequately trained (component F). More information on each component follows, including, among other things, the identification of the gaps the Agency believes exist within each component, and the manner in which the Agency intends to address, or has already addressed each gap. For purposes of this document, the term gap refers to a process the Agency believes is either totally lacking or is operating currently but needs to be updated to meet today’s standards or expectations. A total of 14 gaps have been identified. The 14 gaps do not reflect all the steps the Agency is taking to improve its feed safety program; however, they do represent the more important actions.
As indicated in the operating principles section above, the Agency is planning to rely heavily on risk assessment approaches when making decisions about feed safety. The use of risk concepts is not new for the Agency, as we routinely estimate public health impact in deciding where to focus regulatory effort. However, what will be new under the “modernized” AFSS is the systematic application of a risk-ranking method that ranks all identified feed hazards in relation to each other. In preparation for a public meeting held September 12, 2006, two documents were made available for public review and comment. They are (1) the “List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients,” and (2) the “Determining Health Consequence Scoring for Feed Contaminants.” For the public meeting held on May 22, 2007, one additional risk document was made publicly available. This document was “Exposure Scoring for Feed Contaminants – A Swine Feed Example.” At the May 14, 2008 public meeting, the Agency will describe the model it has developed to rank the risks of the more common hazards in swine feed. “Risk Ranking of Feed Hazards: Swine Feed Example” will be made publicly available prior to the meeting. As data become available additional documents will be made available covering risk-ranking scores for other hazards and for other animal species.
A feed hazard is defined as a biological, chemical, or physical agent in, or a condition of, feed with the potential to cause an adverse health effect in humans or animals. Contaminants are defined as all potentially toxic or deleterious biological, chemical, or physical hazards inadvertently present in animal feeds and feed ingredients.1 Thus, feed contaminants are feed hazards, but not all feed hazards are feed contaminants. This distinction is important in understanding the scope of Component B (contaminants only) and Components C, D and E (hazards).
Component A – Ingredients and the Approval Process
The primary purpose of animal feed is to provide nutrients. In addition, ingredients/additives are incorporated into animal feed for such purposes as to add color, ensure stability for nutrients, provide flavor, and prevent mold growth. Drugs may also be incorporated into animal feed for disease prevention and treatment, as well as for improved animal productivity. The Act provides the authority for FDA to regulate ingredients and additives used in animal feed.2 Depending on its intended purpose, an ingredient/additive could be classified as a food additive, a generally recognized as safe substance, a new animal drug, or a color additive. Regulations that mandate and specify data requirements and the application/petition format required to be submitted for Agency review and approval for each of these categories are contained in Title 21 of the Code of Federal Regulations (CFR). These regulations also provide timeframes for Agency decisions on these applications/petitions.
FDA also controls some ingredients and additives using procedures not covered by regulations. For example, a voluntary consultation process is used to review data on plants modified through biotechnology before they enter the marketplace. Another example is FDA participation in the Association of American Feed Control Officials’ (AAFCO) process for adding or modifying feed ingredient definitions to the Association’s Official Publication (OP). FDA evaluates the safety and intended technical effect of the feed ingredient that is the subject of the definition for AAFCO when such an evaluation is deemed necessary by AAFCO. A third example is the recognition by FDA of the names of feed ingredients defined in the AAFCO OP as the common or usual name of the ingredients (see CPG 7126.08).
A complete listing of the formal and informal processes used by FDA and the location where ingredient/additive listing can be found is provided in Appendix II.
Gap and How the Gap will be Addressed:
Gap A1. FDA’s regulations do not provide a complete listing of ingredients and additives permitted in animal feed, especially many of those that are considered generally recognized as safe. The AAFCO contains the most complete list of ingredients allowed in animal feed found in a single publication. The AAFCO OP, which is updated annually, has a section devoted to the definition of feed ingredients/additives. While FDA relies heavily on this publication, the OP is a non-Federal document, and does not have the force and effect of law.
Previously, FDA had begun developing a Compliance Policy Guide (CPG) to explain the relationship between FDA and AAFCO and to establish a policy whereby FDA would recognize the ingredients defined in the OP as acceptable for use in animal feed. However, as required by the FDAAA 2007, FDA will be establishing feed ingredient standards and definitions through the comment and rulemaking process. We will decide whether a CPG is necessary once the regulations are in place. FDA established a docket (FDA-2007-N-0442) in a Federal Register notice on January 7, 2008 for receiving comments from its stakeholders on section 1002(a) of the FDAAA 2007. Further, a public meeting is planned for May 13, 2008 in Gaithersburg, MD for the Agency to receive verbal and written comments on the mandate from Congress to write regulations to ensure pet food safety.
FDA has developed a Memorandum of Understanding (MOU) with AAFCO explaining the roles of each organization in AAFCO’s process for adding or modifying feed ingredient definitions in the OP. The MOU is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/fda225-07-7001-mou0001.pdf. AAFCO is revising its Guide for New and Modified Ingredient Definitions to improve the guide’s clarity and usefulness.
In addition, FDA plans to finalize the Generally Recognized as Safe (GRAS) Notification rule, which was proposed in 1997. When this final rule publishes in the Federal Register, CVM will begin accepting GRAS notification submissions after the rule’s effective date.
Component B – Limits for Animal Feed Contaminants
Feed contaminants can result from contact of feeds and feed ingredients with environmental, agricultural, industrial, or other sources of hazards at any stage of the feed continuum—from pre-harvest activities, through feed manufacturing, storage and transportation, to on-farm feeding practices. The likelihood of a feed contaminant reaching levels that lead to safety concerns depends on a multitude of factors. For example, contaminants initially present in feeds and feed ingredients at levels low enough to be below the level of concern may be inadvertently increased to toxic or deleterious levels in animal feeds and feed ingredients by certain harvesting and manufacturing practices or storage conditions. Contaminants could also be added to feed as deliberate acts of terrorism to cause serious adverse animal and human health and economic problems.
Several approaches are used by the Agency to help prevent or control risks from contaminants in regulated products, such as establishing regulatory or guidance limits for the contaminants, prescribing process controls for the regulated products, establishing tolerances through the food additive petition process, or relying on a case-by-case review by experts to determine whether specific contamination incidents have resulted in unsafe feed. Limits can take the form of tolerances, which are regulations having the force of law; action levels, which are informal judgments about the levels at which consumers may be safely exposed to contaminants; regulatory limits, which identify levels of contaminants at which animal feeds and feed ingredients are considered to be adulterated; and guidance levels, which represent the Agency’s current policy to industry. Once limits are created and understood, it becomes easier to control the risks from the contaminants by product- or process-based approaches, either initiated by industry or required by a Federal or State regulatory agency.
The Agency has established limits for some of the more obvious contaminants, but it has no process for systemically assessing the need for limits for other known or newly recognized contaminants. This AFSS component includes the processes by which FDA assesses the need to establish regulatory or guidance limits, and prioritizes the needs based on the level of risk posed to animal or human health.
Appendix III contains the Agency’s current procedures for establishing limits for contaminants in animal feed and feed ingredients. The same appendix also contains references for the limits established by FDA, the U.S. Environmental Protection Agency, AAFCO, Codex Alimentarius Commission, the Food and Agricultural Organization, and the World Health Organization.
Gaps and How Each Gap will be Addressed:
Gap B1. Not all contaminants in animal feed carry the same risk for impairing animal and/or human health. The Agency needs a systematic process whereby it can distinguish among feed contaminants based on the risks they pose to animal or human health.
A method is being developed whereby each feed contaminant will be evaluated to determine the relative risk it poses to animal and human health compared to those posed by other feed contaminants. The risk-ranking exercise will be conducted for contaminants present in incoming materials or feed ingredients (product-related risks) and as the contaminants are modulated (increased, decreased or remain at the same level) by manufacturing processes (process-related risks), and by how the feeds and feed ingredients are handled at various establishments – feed manufacturers, transporters, and on-farm mixers (facility-related risks). Public meetings were held on September 12, 2006, and May 22, 2007 at which AFSS Team members made presentations about risk, risk-ranking, potential feed contaminants, and health consequence and exposure scoring for chemical and microbiological contaminants in animal feed. Details of the meetings are available at http://www.fda.gov/cvm/CVM_Updates/AFSS906.htm and http://www.fda.gov/cvm/CVM_Updates/AFSSPM2007Update.htm. One additional meeting is planned for May 14, 2008, during which the ranking model will be discussed using swine feed as an example. Future documents will be made available as additional data are entered into the model.
Gap B2. FDA does not currently have a written process triggering development of official regulatory methods for detecting the presence of contaminants in feeds. When the Agency decides that limits for feed contaminants need to be established as action levels, tolerances, regulatory limits, or guidance, there is a need for rapid, inexpensive, and reliable feed ingredient and feed monitoring test kits to be developed and validated that could be used by industry and government.
FDA developed an internal standard operating procedure (SOP) for ensuring that methods of detecting a contaminant in feed ingredients and or/feeds are available for use by FDA and other government agencies and the regulated industry. This SOP, which is available at http://www.fda.gov/cvm/Policy_Procedures/3415.pdf , places emphasis on ensuring such methods are capable of meeting the Agency’s limits using established criteria.
Component C – Process Control for the Production of Feed Ingredients and Mixed Feed
Process control is a systematic approach designed to ensure feed safety though the identification and use of appropriate controls during the manufacturing, packaging, storage, and distribution of feed ingredients and mixed feed. Feed process control entails measures seeking to prevent, or eliminate or reduce, to an acceptable level, risks to animals and humans. For example, these process controls can include following written procedures to ensure aflatoxins are not present at unsafe levels by testing incoming loads of feed ingredients known to be susceptible to the molds that produce this mycotoxin. Established verification procedures in a feed process control system are used to confirm products are safe and comply with regulatory requirements. The Act provides the statutory authority to regulate the manufacture, packaging, storage, and use of animal drugs, including Type A medicated articles and medicated animal feed, to ensure conformity with current good manufacturing practices (cGMPs). Regulations that mandate and specify medicated feed and Type A medicated article cGMPs are located in Title 21 of the Code of Federal Regulations (21 CFR 225 and 226, respectively). Complete citations of the regulations are listed in Appendix IV
Gaps and How Each Gap will be Addressed
Gap C1. FDA’s current animal feed safety program does not fully address all aspects of feed safety associated with the manufacture, packaging, storage and distribution of all feed ingredients and mixed feed. Currently, FDA has regulations governing the controls used in the manufacturing, packaging, storage, and use of Type A medicated articles and Type B and C medicated animal feed. However, to have a comprehensive animal feed safety program, a broader regulatory approach is required so that it addresses feed safety issues associated with the manufacture, packaging, storage, and distribution of non-medicated feed ingredients and mixed feed. The reasoning for the development of process control regulations is in Appendix V.
FDA has used the following approaches to establish process controls in other product areas: Hazard Analysis and Critical Control Point (HACCP), Standard Operating Procedures (SOPs) Sanitation Standard Operating Procedures (SSOPs) and other approaches pertaining to production, manufacturing, packaging, storage, distribution or use of various commodities. The AFSS Team reviewed these approaches to determine their applicability to feed ingredients and mixed feed regulatory oversight, with emphasis on their usefulness in a risk-based preventive system. The Team also relied on the Codex Code of Practice on Good Animal Feeding (the Code) in identifying gaps and in recommending corrective measures. The Code was accepted by the U.S. delegation, which was comprised of government officials and industry advisors, to the Codex’s Task Force on Good Feeding Practices. The Code encourages the implementation of good manufacturing practices and, where applicable, HACCP-based approaches.
Process control regulations, which seek to prevent, eliminate, or reduce to acceptable levels the potential risks posed to human and animal health will be developed through a systems approach in which adequate control steps are established throughout the feed ingredient and mixed feed manufacturing continuum. Where necessary, guidance will help explain the process control regulations as well as provide assistance to regulators and establishments in risk-based decision-making.
Gap C2. Even though cGMP regulations exist for medicated feeds, modernization of these regulations is needed to reflect changes in technology, to add clarity and specificity to some of the requirements, and to honor commitments made in response to a citizen petition in 1998.
There have been several additions to the Act, and regulations have been published to implement these additions. The cGMPs, however, have not been substantially changed since the publication of what was termed “Second Generation of Medicated Feeds” in 1986. With Second Generation, a two-tiered set of cGMPs was established; one set (21 CFR 225.1- 225.115) for those who manufactured medicated feed requiring an approved Medicated Feed Application (MFA) and a less stringent set (21 CFR 225.120 to 225.202) for those who did not. The next significant change was not until the passage of the Animal Drug Availability Act of 1996. With this amendment to the Act, the MFA system was abandoned and a system for facility licensing was begun. Establishments that formerly held approved MFAs to use certain approved animal drugs in manufacturing medicated feed had to be licensed to use them after this amendment.
On July 21, 1998, AAFCO, the American Feed Industry Association and the National Grain and Feed Association, with the endorsement of the American Veterinary Medical Association and the National Pork Producers Council filed a Citizen Petition requesting the Agency to change the cGMPs into a single set of cGMPs that would apply to all medicated feed manufacturers. The proposal was purported to streamline and clarify regulations, and to update portions of the cGMPs that were no longer appropriate. The petition also proposed exemptions for certain segments of the industry, even though seeking equity was part of the original goals. For there to be equity among all segments of the medicated feed manufacturing industry, cGMP regulations need to be designed to equally promote the manufacture of safe and effective medicated feed by all segments of the industry.
The Agency informed the petitioners in a letter dated December 10, 1998, that their petition had considerable merit and that the Agency was partially granting their request by publishing proposed changes to the medicated feed cGMP regulations. The Agency made some modifications in addition to those specified in the petition. The rewrite was put on hold pending consideration of proposing these regulations as part of the AFSS initiative. A key challenge facing the Agency is presenting public health protection outcomes from such new regulations.
Component D – Reporting of Unsafe Feed
The surveillance programs conducted by the FDA and state feed control offices generate analytical data about unsafe feed. Surveillance by the feed industry, animal producers, practicing veterinarians and the public can be an important source of additional information should any of these groups learn about animal feed becoming adulterated. The reporting to FDA of such incidents is not required by regulation, with the exception of certain feed establishments and then only for certain medicated feeds. Nevertheless, the Agency often receives adverse event information when the parties involved believe a significant health issue might be the result. The Agency investigates such a report to determine its veracity, how the event occurred, the populations at greatest risk, the steps for controlling the situation, and because the FDA is a regulatory agency, the appropriate enforcement action to help prevent future occurrences.
Gaps and How Each Gap will be Addressed
Gap D1. The FDA’s Food Protection Plan identifies the need for the Agency to be more responsive to unsafe food and feed incidents. The Agency needs to know of such incidents before they cause widespread injury and/or death. Further, the public needs to be advised about those incidents to ensure the protection of themselves and their pet animals.
The FDAAA 2007 requires FDA, within a year, to establish an early warning and surveillance system to identify any adulteration incidents affecting the pet food supply and also to alert the public about any outbreaks of illness associated with pet food. Congress instructed consideration of existing surveillance and monitoring tools already operating to monitor human or animal health, such as FoodNet, PulseNet, and FDA’s Food Emergency Response Network. The Agency has taken several steps to improve communication about a pet food recall, including posting information about a recall in a single location on FDA’s Web site.
The FDAAA 2007 also directed the FDA to establish a “Reportable Food Registry” to which instances of reportable food and feed would be added by the Agency via an electronic portal. The source of this information would come from reports made by food and feed establishments that have registered with FDA as required by Section 415(a) of the Act, and Federal, State and local public health officials. The Agency is charged with only placing those food or feed reports where the reportable food has a reasonable probability of causing serious health consequences or death to humans or animals. The Center for Food Safety and Nutrition (CFSAN), with CVM assistance, is building the “Reportable Food Registry,” which Congress gave the Agency until September 2008 to have publicly available.
Gap D2. FDA-licensed feed mills are required by 21 CFR 510.301 to submit to FDA records and reports concerning clinical and other experience only with the types of medicated feeds that required the mill to obtain an approved medicated feed license. This means that FDA-licensed feed mills are not required to submit records and reports concerning clinical and other experience with the types of medicated feeds not requiring the license. Furthermore, non-FDA-licensed feed mills are not required to submit to FDA records and reports concerning experience with medicated feeds. Hence, this regulation does not require submission by feed establishments and animal drug manufacturers of the type of information the Agency could use to make more informed decisions about the safety of marketed animal feed.
The Agency began the comment and rulemaking process to update 21 CFR 510.301 by publishing proposed changes in a Federal Register notice on December 17, 1991 (56 FR 65581). Comments were submitted to the FDA, but no action was taken to complete the process for medicated feeds. Nevertheless, the Agency remains committed to strengthening this regulation. However, it is very likely that FDA will need to begin the process over again because the Agency may expand the intent of the regulation to require the submission of records and reports to the Agency for all medicated feed, not just those medicated feeds that require the feed mill to obtain a license, and because a long time (17 years) has passed since the original proposal. .
Component E – Regulatory Oversight
The primary purpose of an inspection is to determine an establishment’s or a product’s degree of compliance with applicable regulations. The term inspection should be considered in its broadest view. Thus, an inspection could cover, for example, the review of labeling done at the regulator’s site of business and an on-site assessment of the establishment’s manufacturing facility. Surveillance inspections are conducted to determine whether an establishment is in compliance with the regulations and operating “under control.” Compliance inspections are conducted to evaluate an establishment’s compliance with the provisions of the regulations and document inspectional observations supporting possible enforcement action. Because the majority of inspections of feed manufacturing and distribution establishments, which fall under the jurisdiction of FDA, are done by State agencies using Federal or State authority, a strong working relationship with State counterparts will continue to be a significant component of the FDA’s Animal Feed Safety System. A scientific- and risk-based approach will be utilized to improve the Agency’s ability to prioritize and allocate inspection resources by targeting establishments, facilities, products, and processes posing the greatest risks to animal or human health.
FDA has a variety of enforcement options available. Regulatory compliance efforts often focus on voluntary compliance with the law and regulations. When voluntary compliance and education are unsuccessful, the Agency has other options, such as, Untitled Letters, Warning Letters, informal meetings, mediation, civil penalties, administrative hearings, injunctions, seizures, and criminal prosecutions. See Appendix VI for cites for locating more information on regulatory oversight.
Gaps and How Each Gap will be Addressed:
Gap E1. The U.S. animal feed industry is large, diverse and dynamic. Although inspection and enforcement are essential elements of an effective regulatory program, the number of feed and feed ingredient producers, distributors and animal feeders is too large to inspect regularly and enforcement is labor intensive. It is unlikely that resources, now or in the future, will be able to provide enough inspections and enforcement actions to provide 100 percent assurance of feed safety. Therefore, the AFSS will take a risk-based approach to determining which feed products, processes and/or establishments present the greatest risk to animal and human health.
Inspection obligations and inspections of establishments of regulatory concern cannot always be met with the greatest dispatch and efficiency because of limited Agency resources and competing priorities. Currently, the Agency has established priorities for inspections under the BSE inspection program based on a combination of risk factors, but we are in the process of implementing a mathematically-modeled, risk-based assignment of inspections in preparation for planning work in FY 2009. The Agency implemented this approach for inspection of FDA-licensed medicated feed mills for compliance with medicated feed cGMP and other Agency regulations in FY 2008.
CVM is currently in the process of implementing a risk-based approach for feed-related inspections on a program-by-program basis; however, we are already looking beyond that and trying to develop a mechanism for comparing risk across programs as part of a more general risk-based approach for all inspections. This approach will allow the Center to prioritize inspections for a given fiscal year or other time frame, and will permit the Center to identify specific establishments or types of establishments to be inspected. Statistically-based audits will be conducted of establishments, or establishment types, not of high enough risk to warrant a full inspection to assure the Agency that they were correctly categorized and to monitor for changes in industry practices.
Gap E2. FDA’s current feed safety program does not include adequate attention to all segments of the industry responsible for the production, distribution, and use of animal feed. Regulatory oversight has focused principally on the commercial medicated feed industry and large integrated operations even though there has been a major shift in the industry to more non-commercial production of all types of feed. Some of these non-commercial operations are making more feed than most commercial feed companies. CVM is considering how to improve oversight of the non-commercial feed producers and other segments of the feed industry, such as transportation vehicles, importers, and warehouse/storage facilities. Risk associated with these segments will be assessed to determine where the Agency will focus its limited resources.
Vehicles used to transport feed are also receiving limited inspectional scrutiny. This lack of inspection can result in a significant cross-contamination issue. The Sanitary Food Transportation Act of 1990, whose authority was transferred from the Department of Transportation to FDA and the United States Department of Agriculture (USDA) on August 10, 2005, will be assessed for its role in strengthening the Agency’s ability to regulate the transportation of animal feed and feed ingredients. CFSAN has the lead on this issue for FDA. CVM will be assisting.
Feed imports have increased dramatically without a significant shift in the way the Agency conducts its oversight until recently. All imported products are required to meet the same standards as domestic goods. However, without regulations to establish the feed and feed ingredient good manufacturing standards, neither foreign firms nor U.S. importers have guidelines to follow to ensure that the feed products that are imported into the United States are safe.
On September 10, 2007, the President’s Interagency Working Group on Import Safety reported the burdens facing border officials caused by the growth of imports and an increased focus on security. The report noted that these officials must manage larger volumes of imports from countries that often have less-developed regulatory systems. In addition, border officials must consider more complex risk scenarios, use more sophisticated screenings and examinations, and employ new technologies to ensure product safety. The report made clear that a new Strategic Framework would be needed to assure the safety of imported products that are consumed and used by Americans. The Agency is working on such strategic frameworks now. The AFSS is intended to play a vital role in providing a program for foreign feed and feed ingredient processors, and domestic importers to follow to ensure the safety of feed and feed ingredients.
Gap E3. Feed defense measures have, for the most part, been developed and implemented outside the Agency’s animal feed safety program. The current program has traditionally focused on controlling feed hazards, which occur naturally in feeds or were inadvertently added. However, the feed hazards identified by the AFSS Team include some that could be deliberately added to feed and feed ingredients in terrorist acts. The purpose of such deliberate contamination could be to inflict critical harm to food-animal production, and/or to negatively impact human health. The FDA’s feed safety program is vital to maintain the capability to prevent or minimize the chances of feed from being used as a vehicle for the transmission or spread of agents of terror, and to rapidly identify and eliminate or control such agents or feed contamination events whenever they occur in feeds or feed ingredients. FDA should establish and implement feed defense measures in coordination with other Federal and State agencies that also have responsibilities for ensuring animal or human health.
The CVM’s Counterterrorism Coordinator will work to inform appropriate officials and offices at the USDA, Department of Homeland Security (DHS), and other Federal agencies about FDA’s feed defense initiatives and other activities of FDA’s animal feed safety program, and solicit their input.
CVM developed a set of criteria for use by the FDA’s Prior Notice Center (PNC) for targeting imported animal feed and/or feed ingredients that may be at risk for deliberate contamination, thereby, threatening human or animal health. The PNC, which was created in response to the Public Health Security and Bioterrorism and Response Act of 2002 and gave high priority to improved information management to help protect the food supply, works closely with DHS, USDA, and other agencies responsible or imported food products. The PNC is now applying CVM’s criteria into FDA’s High Risk Prior Notice Targeting strategies in conjunction with those priorities recommended by CFSAN.
Suggested security measures in the form of Guidance for Industry would benefit the regulated industry in understanding what it could do to prevent and control deliberate contamination of feed. CVM is developing such a document, which would cover mixed feed and feed ingredients. We find that emphasis on the “A” portion of the FDA’s Center for Food Safety and Applied Nutrition’s ALERT message in the post-melamine environment is warranted to protect public and animal health and the establishments that provide food and feed. The “A” stands for “How do you Assure yourself that the supplies and ingredients you use are from safe and secure sources.
The Agency (through CFSAN and CVM) is working with the Federal Bureau of Investigation (FBI), USDA, and industry to conduct vulnerability assessments in the agricultural sector. In July 2007 a CARVER + Shock vulnerability analysis (http://www.cfsan.fda.gov/~dms/vltcarv.html) of an animal feed manufacturing establishment in a major feed-producing state in the central United States was conducted as part of the Strategic Partnership Program Agroterrorism (SPPA) initiative (http://www.cfsan.fda.gov/~dms/agroterr.html). SPPA is an on-going initiative in cooperation with the DHS, FBI, USDA, the States and industry to protect important sub-sectors from a terrorist attack. The information from this assessment, as well as that gleaned in 2005 and 2006 from comparable vulnerability analyses done at a grain exporter and cattle feedlot, respectively, will be used by industry to harden potential soft targets that may be used by a terrorist trying to cause harm to the United States or a particular industry segment.
COMPONENT F – Education and Outreach
In conjunction with inspection and enforcement activities, AFSS will also place emphasis on developing and implementing education and outreach programs. For a comprehensive regulatory approach to be successful cooperation between FDA and State regulatory programs will be essential. In addition, the timely development and distribution of educational materials and guidance documents as portions of the AFSS are implemented will be necessary.
Having program and inspection staff well trained in all facets of the Agency’s animal feed safety system and an industry that knows what is required for compliance with FDA rules in order to prepare, distribute and use feeds in a safe manner are critically important. However, such education and outreach initiatives need to be timely, informative, understandable, and available to those needing the information.
The introduction of a new regulatory feed program or modification of an existing regulatory feed program requires training be given to ensure FDA and State personnel understand the new or modified program and are capable of carrying out its mandate. Furthermore, it is essential for the Agency to prepare and distribute outreach materials to aid the industry in achieving compliance because voluntary compliance by industry means less compliance effort by regulatory agencies. The key to these outreach and education efforts is timing.
Gaps and How Each Gap will be Addressed
Gap F1. When new regulations or revisions in the inspection programs occur as a result of the comprehensive, risk-based AFSS, FDA and State field inspectors will need to become proficient in understanding and implementing the changes, which could for example include inspecting establishments not previously part of either FDA’s or a State’s inventory. Likewise, the regulated industry will need to understand the changes so it can comply with any new requirements.
A plan will be developed to ensure the timely and effective implementation of the more expansive AFSS. This plan should ensure: (1) outreach to all stakeholders; (2) thorough instruction on implementation; and, (3) timely implementation, with additional follow-up training, if necessary.
Gap F2. When a feed mill submits a medicated feed mill license application, it commits to having current approved Type B and/or Type C medicated feed labeling in its possession prior to receiving Type A medicated articles (21 CFR 515.10). Such medicated feed labeling is located in the approved new animal drug applications and is known as “Blue Bird” labeling. The Agency has defined “in its possession” to mean that an establishment must either have the labeling on the premises or have access to it via the Internet. It is the Agency’s position that access to the Internet provides the medicated feed industry with the best opportunity to ensure accurate labeling is developed and used.
To facilitate Internet access, CVM is developing a web-based system that would house the most recently approved Blue Bird label for feeds containing either Category I or II drugs. Making correct medicated feed label information easier to obtain should increase the probability that medicated feeds will be manufactured properly and labeled correctly, procedures that are important for safe and effective use of medicated feed. CVM intends to make the system available in test format by the end of June 2008.
Gap F3. Assessing and controlling feed hazards must occur along the entire animal feed continuum, including the use (feeding) of feedstuffs on-farm. The Agency’s feed safety program activities have dealt mainly with commercial feed establishments. However, on-farm establishments, which represent the last location of feed before it is fed to food animals, have received limited FDA and State oversight.
While no regulations are being considered at this time to address the safe feeding of food-producing animals, we plan to prepare guidance to assist animal feeders in ensuring their on-farm practices are consistent with maintaining, storing and feeding safe feed.
Gap F4. It has been several decades since FDA labeling regulations for animal feed, including pet food, have been updated. On the other hand, the AAFCO model pet food regulations have been amended nearly each year since they were adopted by the AAFCO membership in 1967. Because the AAFCO regulations aimed to keep pace with industry desires and public interests, they became the de facto accepted standard, even though they have not been adopted by every state. The public, pet food industry, government agencies and AAFCO agree that current federal pet food labeling can be improved to provide more meaningful information to pet owners about the nutrition and safe use of the food they purchase for their pets.
Updated labeling standards for pet food are mandated by the FDAAA 2007. Congress is requiring a regulation that includes standards for nutritional and ingredient information on the label. The Agency established a docket (FDA-2007-N-0442), which can be accessed via http://www.regulations.gov/search/index.jsp for accepting public comment, and is holding a Public Meeting on May 13, 2008 to receive verbal comment from interested parties. The FDA has until September 2009 to publish the final regulation.
Appendix I. Glossary (definitions of words/terms)
Additive: An ingredient or combination of ingredients usually added to animal feed in micro quantities to address a specific need. Examples include FDA-approved food and color additives and some items considered generally recognized as safe for technical purposes in feed.
Animal feed establishment: A “person” who manufactures, stores, packages, distributes, or feeds a feed product; the term “person” is as defined in the FFDCA and includes individual, partnership, corporation, and association. “Person” does not include a person who feeds non-food-producing animal in or around his or her home.
Commercial establishment: A person who sells, barters, trades, gives, donates, or debits a feed product.
Comprehensive: A feed safety program, which includes the manufacture, storage, packaging, labeling, distribution, and transportation of feed ingredients and mixed feeds, and the feeding of animals.
Contaminant: Potentially toxic or deleterious biological, chemical, or physical hazard inadvertently present in animal feed and feed ingredients.
Feed: This term includes feed ingredients and mixed feed intended for food-producing and non-food-producing animals.
Feed: This term includes feed ingredients and mixed feed intended for food-producing and non-food-producing animals.
Gap: A FDA feed safety activity that is either completely non-existent or is operational but requires updating to meet current standards.
Hazard: A biological, chemical, or physical agent in, or condition of, feed with the potential to cause an adverse health effect in humans or animals. For example, biological hazards include pathogenic bacteria and Transmissible Spongiform Encephalopathy agents, chemical hazards include pesticides, mycotoxins and heavy metals, physical hazards include glass and metal, and conditions of feed include baby pig feed that is too finely ground and improperly heat-treated soybean meal.
Ingredient: A defined component, or constituent part of a feed added to provide nutrition or for other technical purposes.
Mixer-feeder: An “entity” that mixes and feeds feed to its own animals or animals under its control. This type of establishment is generally a feedlot or an individual farm.
Non-commercial animal feed establishment: An animal feed establishment that does not sell or debit feed products (i.e., has no customers). Generally, a “farm” is a commercial feed establishment if any feed product produced on/by the farm is not used on the farm.
Risk-based approach: Consideration of both the likelihood of animal or human exposure to feed hazards and the health consequences of such exposure when making regulatory decisions.
Unacceptable risk: When the potential harm either to animal or humans from a feed product attains a level not acceptable to decision-makers. The level may vary depending on the type of harm.
Appendix II.
Processes:
Food Additive Petition; FDA (21 CFR 571)
New Animal Drug Application (NADA); FDA (21 CFR 514)
General Recognition of Safety (GRAS) Petitions - FDA (21 CFR 570); GRAS Notification proposed rule 62 FR 18938 (CFSAN is accepting notifications now)
Color Additive Petition; FDA (CFSAN) (21 CFR 71)
AAFCO Ingredient Definition Process (2008 Official Publication; pp 253 - 255)
Common or Usual Name Recognized by the Secretary/Director/ Commissioner of Agriculture; FDA and AAFCO (21 CFR 502 and AAFCO OP)
Bioengineered Plants – CFSAN Guidance document, October 1997 - consultation process with FDA
Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals (FDA Draft Guidance #153)
AAFCO Feed Labeling Model Regulations and Guides (food-producing animals and pet animals) – 2008 Official Publication
Ingredient/Additive Listings:
Food Additives Permitted in Feed and Drinking Water for Animals -21 CFR 573
New Animal Drugs for Use in Animal Feeds - 21 CFR 558
Generally Recognized of Safe (GRAS) substances - 21 CFR 582 & 584
Color Additives - 21 CFR 73 & 74
Feed Ingredient Definitions - AAFCO 2008 OP (pp 256 – 361)
Substances Prohibited for Use in Food and Feed (21 CFR 589)
Bioengineered Plants - CFSAN home page (http://www.cfsan.fda.gov/) and 9 CFR 340
Animal Food Labeling - 21 CFR 501, 21 CFR 201
Compliance Policy Guide 7126.08 - Common or Usual Names for Animal Feed Ingredients
Pesticides Approved by EPA for Use in Feed and on Crops - 40 CFR 180
Biologic Products Approved by USDA for Use in Animal Feed - 9 CFR 101-123
Indirect Food Additives Resulting from Packaging Materials for Animal and Pet Food – 21 CFR 181 and 174 through 179 as cited by 21 CFR 570.13 and 570.14.
Appendix III.
Processes: Procedures for establishing limits for contaminants in feed and feed ingredients include the following:
Setting tolerances, action levels and regulatory limits for feed contaminants are described in 21 CFR 509.4 through 509.7.
Setting guidance levels are described in FDA’s Good Guidance Practices Regulations, 21 CFR 10.115.
Contaminant Limits: FDA has established limits on contaminants in food and feed
Aflatoxin action levels (FDA’s “Compliance Policy Guide” (CPG) 683.100)
Pesticide tolerances (EPA’s Code of Federal Regulations (CFR), Title 40, Part 186 and FDA’s CPG 575.100)
Pesticide action levels (FDA’s CPG 575.100 & Federal Register (FR), Vol. 55, No. 74; April 17, 1990)
Temporary tolerances for PCB’s (FDA’s 21 CFR 509.30)
Guidance levels for Fumonisin (FDA’s Guidance for Industry #112)
Substances prohibited from use in animal food or feed (FDA’s 21 CFR 589)
Tolerances established for drugs in food (FDA’s 21 CFR 556)
Guidance levels for trace mineral contaminants (AAFCO’s 2008 Official Publication; pg 321
Regulatory limit for Salmonella (FDA’s 21 CFR 500.35)
Appendix IV.
Operations/Manufacturing Process Listings:
Medicated Feed cGMPs (21 CFR 225)
Type A Medicated Article cGMPs (21 CFR 226)
AAFCO Feed Manufacturing Guidance (2008 OP pp 206 - 220) and Proposed Regulations (in progress)
Low acid canned food regulations (21 CFR 500.23)
Codex Code of Practice for Good Animal Feeding http://www.codexalimentarius.net/web/codex/codex27_en.htm
HACCP; (seafood 21 CFR 123 and juice 21 CFR 120)
SSOP (21 CFR 120.6 and 123.11)
Appendix V.
Process control regulations are needed to:
Broaden coverage by FDA to include all feeds and feed ingredients. Current FDA feed “manufacturing” regulations for preventing feed/food safety problems address drugs, BSE, and biological contamination of canned pet food. Comparable “manufacturing” regulations do not exist for other potential hazards and feed types, some of which have created serious problems for the industry and FDA and have brought into question the ability of the Agency to protect animal and human health.
Prevent animal feed contamination incidents and thus save animals from pain, suffering, and death, and keep unsafe food derived from animals from compromising public health. Recent incidents CVM knows about in which animal morbidity and/or mortality has occurred cover a broad range of hazards, such as, dioxins, melamine and related compounds, aflatoxin, fumonisin, selenium, vitamin D, monensin (animal drug), salt, and in some situations, unknown agents (e.g., Hawaii dairy cattle deaths and in Puerto Rico).
Provide equivalency of regulatory requirements with foreign governments to ensure no or minimal disruption of trade.
Maintain public confidence in the safety of food of animal origin and in the ability of FDA to meet its mandate of protecting animal and human health.
Provide framework for assisting industry in meeting customer/purchaser assurance.
Reduce the number of recalls of improperly manufactured animal feed, which continue to plague industry and drain Agency resources.
Provide for more uniform regulatory oversight within the United States. [AAFCO is developing model cGMP regulations comparable in coverage to those FDA have begun writing. If and when AAFCO’s regulations are accepted by AAFCO (the Board and the members) there is no assurance all States will adopt them. Federal regulations will alleviate this potential problem.]
Allow for greater industry knowledge of the minimum steps it needs to do on a regular basis to ensure its products are safe, which will reduce liability and could result in more industry oversight.
Help focus Agency resources on those segments of the industry, which present hazards with the greatest risk to animal and/or human health.
Appendix VI.
Inspection and Enforcement Descriptions: Inspections (FFDCA Subchapter 701)
IOM Subchapter 501 http://www.fda.gov/ora/inspect_ref/iom/contents/ch5_toc.html; (AAFCO Model Bill)
Enforcement (FFDCA Subchapter 704-706; IOM Chapter 7) http://www.fda.gov/ora/inspect_ref/iom/contents/ch7_toc.html
Federal-State Cooperation (IOM Chapter 3) http://www.fda.gov/ora/inspect_ref/iom/contents/ch3_toc.html
Regulatory Procedures Manual http://www.fda.gov/ora/compliance_ref/rpm/default.htm
Audits conducted by FDA of State inspections http://www.fda.gov/ora/inspect_ref/fmd/fmd76-Appendix.htm
Inspection and Enforcement Listings:
Administrative actions refer to 21 CFR, particularly parts 12, 511, 514, and 571 http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200321
FDA and AAFCO Enforcement Guidelines (CVM Policy and Procedure Guide 1240.3600)
Federal and State Audits (FDA Field Management Directive #76)
First-party inspections (Voluntary Self-Inspection Program – CPG being drafted.
Inspection priorities (BSE Compliance Plan 7371.009) http://www.fda.gov/cvm/Documents/7371-009.pdf
FDA Compliance Program Guidance Manual, Program 7371.003 Feed Contaminant Program; http://www.fda.gov/cvm/Documents/7371-003.pdf
FDA Compliance Program Guidance Manual, Program 7371.004 Feed Manufacturing Compliance Program; http://www.fda.gov/cvm/Documents/7371-004.pdf
April 2008
Edited for typographical errors in the 2nd and 3rd paragraphs under "Major Components of the AFSS", May 7, 2008
Edited for typographical errors in Appendix V, May 12, 2008
1Does not include unapproved or prohibited feed ingredients; these ingredients are intentionally added to animal feeds to achieve a technical or nutritional effect, but are either not approved by any of the mechanisms identified under Component A or are actually prohibited by FDA for use in all or some animal feeds; also, does not include inherent, naturally occurring constituents of animal feeds or feed ingredients or contaminants that may arise directly from the manufacturing process (e.g., residual starting materials), because these hazards are identified and controlled during the feed ingredient approval processes under Component A.
2Some articles added to animal feed fall under the purview of other Federal agencies. Feed-through pesticides are regulated by the Environmental Protection Agency, and vaccines added to animal feed are the responsibility of the United States Department of Agriculture.
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