Animal & Veterinary

Fourth Draft: Framework of the FDA Animal Feed Safety System


Purpose and Scope
Background
Operating Principles of the AFSS
Major Components of the AFSS and Key Definitions
Component A – Ingredients and the Approval Process
Component B – Limits for Feed Hazards
Component C – Process Control for the Production of Feed Ingredients and Mixed Feed
Component D – Reporting of Unsafe Feed
Component E – Regulatory Oversight
Component F – Education and Outreach
Appendix I
Appendix II
Appendix III
Appendix IV
Appendix V
Appendix VI


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 production and distribution of safe feed. (In this document, we define feed as both feed ingredients and mixed animal feed intended for food-producing and non-food-producing animals (e.g. pet animals), 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 hazards, providing education and training, conducting research, performing inspections and taking enforcement for ensuring compliance with Agency regulations. Furthermore, the AFSS includes oversight of feed production, including, manufacture, labeling, storage, distribution and use of all feed at all stages of production, whether at commercial or non-commercial establishments.

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Background

The Federal Food, Drug, and Cosmetic Act (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 safety issues, such as unsafe tissue residues resulting from feeding of 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 identify feed hazards and their potential sources and to enable establishments and FDA prevent or eliminate the occurrence of unacceptable feed risks from those hazards.  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 for example through programs whose purpose is to ensure feed products meet label guarantees for nutritional components.

Animal feed ingredients and mixed feeds produced and used in the US 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 remain hidden.  Recent incidents in which high levels of dioxins were present in mineral supplements used in 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 in 2007 when imported feed ingredients, contaminated with melamine and related compounds, were used in pet food, which sickened dogs and cats.

The production and distribution of feed ingredients and mixed 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. BSE, Chronic Wasting Disease (CWD), dioxins, melamine, 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 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 (FPP), which provided a framework to identify potential food hazards and to counter them before harm occurs. The FPP builds in safety measures across a product’s life cycle, from the time an ingredient of feed or human food is produced to the time complete feed or human food is distributed and consumed.   Recently, President Obama formed a multi-agency Food Safety Working Group (FSWG), which issued its key findings to upgrade the nation's food safety system in a July 2009 report.  The FSWG has recommended a new public-health-focused approach to food safety based on three core principles: prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery. The AFSS, with its strong emphasis on prevention, figures prominently in the Food Protection Plan and also is in alignment with the key principles outlined by the FSWG.

In September 2009, FDA published a draft document on its internet site detailing our strategic vision for building an Integrated National Food Safety System.  FDA is working to fully integrate the nation's food safety system by building an Integrated Food Safety System (IFSS) with its federal, state, local, tribal and territorial regulatory and public health partners. FDA will work with its regulatory partners to develop uniform national standards, including inspection, investigation, and testing protocols; training and certification requirements; establish program audit criteria; and create performance metrics to ensure program objectives are met. A copy of the draft document can be found at: http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/UCM183650.pdf

Title X of the Food and Drug Administration Amendments Act of 2007 (FDAAA 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 U.S. that resulted from the apparent intentional adulteration in China of two feed 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 to ensure that FDA’s animal feed safety program is comprehensive and preventive.

A risk-based, preventive animal feed safety program will require producers and distributors of feed to take into consideration feed hazards (agents in or conditions of feed) which could cause the feed to be unsafe and to develop and implement a plan to prevent hazards from occurring.  Thus, under a “modernized” AFSS, feed producers would improve on their ability 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 feed hazards are also likely to be more capable of detecting and controlling deliberately introduced feed hazards in a terrorism-related event.

FDA would also benefit from a more systematic approach to 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 feed safety program should also result in fewer resource-draining feed emergencies for government agencies.

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Operating Principles of the AFSS

The following operating principles form the basis for the AFSS:

  1. The feed and animal production industries are responsible for the production, distribution, and use of safe feed.
  2. The Federal and State regulatory agencies provide the rules, guidance, and oversight to assist industry in producing and distributing safe feed ingredients and mixed feed.
  3. Rules and guidance provide flexibility in the approaches individual producers of feed can use to meet acceptable safety criteria.
  4. Federal and State regulatory agencies cooperate on all aspects of feed regulation.
  5. Feed regulatory agencies conduct inspections of feed-manufacturing establishments, review product labels, sample and analyze feed for feed hazards and for compliance with label guarantees, and take appropriate actions to address violations.
  6. FDA directs its regulatory resources to those feed hazards that pose the greatest risks to animal and public health.
  7. FDA uses risk-based decision-making to help determine which feed hazards should receive the highest priority by the Agency, and the best methods for addressing them.
  8. Feed defense measures as they relate to preventing and responding to terrorism will become part of the AFSS.
  9. Training is critical for ensuring (1) that industry and regulatory agencies have the most up-to-date knowledge about FDA rules and guidance, and (2) that enforcement by FDA and States is consistent and conducted in an appropriate manner.
  10. Feed intended for food-producing and non-food producing animals, such as pets, are included in the AFSS.
  11. Feed establishments covered in the AFSS include all facilities, equipment and conveyances involved in the production, packaging, storage and distribution of individual feed ingredients and mixed feed and the feeding of animals.
  12. FDA employs an active and aggressive research program to generate data to aid in addressing feed safety questions and gaps.

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Major Components of the AFSS and Key Definitions

Six (6) operating components comprise the AFSS framework. These components cover the processes used by FDA to ensure that: ingredients used in feed are safe (components A and B); the methods used to make, store, and distribute feed 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. Further, while no research gap is identified it is important to recognize the critical role research plays in addressing feed safety issues within FDA.

A feed hazard is defined as a biological, chemical, or physical agent in, or a condition of, feed with the potential to cause illness or injury to animals or humans.  Components B, C, D and E involve feed hazards.  An unacceptable feed risk is defined as a biological, chemical, or physical agent in, or a condition of, feed which is reasonably likely to cause illness or injury to animals or humans.  One challenge in drafting the AFSS framework is defining terms in a way that takes into account the fact that the presence of certain agents in feed or existence of certain conditions of feed does not always pose a significant risk to animal or human health.  It is when controls are not adequate at feed establishments that these same agents or conditions of feed may cause the feed to be a much greater risk to animal or human health.    For example, shipments of corn containing the mycotoxin aflatoxin at levels below 0.1 ppb are not likely to cause an adverse health consequence for animals fed feed made with this corn or for people consuming the food derived from these animals.  However, if environmental and/or other pertinent conditions are not controlled while the corn is in storage at the feed establishment resulting in corn aflatoxin level above 20 ppb and the feed establishment makes feed for lactating dairy cattle, a much greater risk to health now exits for people consuming the milk products from these animals.  The term “unacceptable feed risk” describes situations in which a feed hazard (agent is at a level in feed, or a condition of feed is such as) is reasonably likely to cause illness or injury to animals or humans.

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Component A – Ingredients and the Approval Process

The primary purpose of feed is to provide nutrients.  In addition, ingredients/additives are incorporated into feed for such purposes as to add color, ensure stability for nutrients, provide flavor, and prevent mold growth.  Drugs may also be incorporated into 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 feed.1 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.   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 feed, especially many of those that are considered generally recognized as safe.  The AAFCO OP contains the most complete list of ingredients allowed in 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 feed.  However, as required by the FDAAA 2007, FDA will be establishing feed ingredient standards and definitions through the comment and rulemaking process.  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 was held on May 13, 2008 in Gaithersburg, MD at which the Agency received 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, CVM plans to begin a pilot program and accept Generally Recognized as Safe (GRAS) Notifications for feed ingredients under an interim policy that will be announced in a Federal Register document.  An Ingredient Safety Team has been established in the Division of Animal Feeds to review GRAS Notifications.  CVM is also preparing the Federal Register announcement that will provide firms with information on the interim policy.  This interim policy is being initiated due to the delay in finalizing the Generally Recognized as Safe Notification rule, which was proposed in 1997.  It is anticipated that the interim policy will be in place until this final rule publishes in the Federal Register.

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Component B – Limits for Feed Hazards

Feed contamination can result from exposure of feed ingredients and mixed feed to environmental, agricultural, industrial, or other hazard sources at any stage of the feed production continuum—from pre-harvest activities, through feed manufacturing, storage and transportation, to on-farm feeding practices.  The likelihood of a feed hazard reaching levels that lead to safety concerns (i.e., become an unacceptable feed risk) depends on a multitude of factors.   For example, feed hazards initially present in feed ingredients and mixed feed at levels below the level of concern may be inadvertently increased to toxic or deleterious levels in feed ingredients and mixed feed by certain harvesting and manufacturing practices or storage conditions.  Feed hazards 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 eliminate or control risks from feed hazards in regulated feed products, such as establishing regulatory or guidance limits for feed hazards, prescribing process controls for the regulated feed 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 are unsafe.  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 feed hazards; regulatory limits, which identify levels of feed hazards at which feed ingredients and mixed feed 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 feed hazards by product- or process-based approaches, either initiated by industry or required by a Federal or State regulatory agency regulation.

The Agency has established limits for some of the more obvious feed hazards, but it has no process for systemically assessing the need for limits for other known or newly recognized feed hazards.  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 feed hazards in 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 feed hazards carry the same risk for impairing animal and/or human health.   The Agency needs a systematic process whereby it can distinguish among feed hazards based on the relative risks they pose to animal or human health.

As indicated previously, the Agency is planning to rely heavily on risk assessment 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 AFSS is the systematic application of a risk-ranking method that ranks all identified feed hazards in relation to each other.  The risk-ranking method being developed by the Agency will try to account for the whole feed manufacturing continuum, from feed hazards present in incoming materials or feed ingredients (product-related risks), through the modulation of these feed hazards (increased, decreased or remain at the same level) by manufacturing processes (process-related risks), to how the feed ingredients and mixed feed are handled at various establishments – feed manufacturers, transporters, and on-farm mixers (facility-related risks).  Public meetings were held on September 12, 2006, May 22, 2007 and May 14, 2008 at which AFSS Team members made presentations about risk, risk-ranking, potential feed hazards, and health consequence and exposure scoring for chemical and microbiological feed hazards.  Details of the meetings are available at http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm048038.htm. http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalFeedSafetySystemAFSS/ucm053825.htm

Gap B2. FDA does not currently have a written process triggering development of official regulatory methods for detecting the presence of feed hazards.  When the Agency decides that limits for feed hazards need to be established as action levels, tolerances, regulatory limits, or guidance, there is a need for rapid, inexpensive, and reliable feed ingredient and mixed 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 feed hazard in feed ingredients and or/mixed feed are available for use by FDA and other government agencies and the regulated industry.  This SOP, which is available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/PoliciesProceduresManual/ UCM046777.pdf. places emphasis on ensuring such methods are capable of meeting the Agency’s limits using established criteria.

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Component C – Process Control for the Production of Feed Ingredients and Mixed Feed

Process control is a systematic approach designed to ensure feed safety through 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, eliminate or reduce, to an acceptable level, risks to animals and humans. For example, these process controls can include implementing 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 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 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 feed.  However, to have a comprehensive 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.  At the present, current Good Manufacturing Practice (cGMP) regulations exist for Type A medicated articles and Types B and C medicated feed production and distribution, and for compliance with the BSE feed rules at 21 CFR 589.2000 and 21 CFR 589.2001.

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, l998, 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 citizen 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.

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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 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 and Integrated Food Safety System identify 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 Website.

The FDAAA 2007 also directed the FDA to establish a “Reportable Food Registry” to which instances of reportable human food and animal 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 FFDCA, and by Federal, State and local public health officials.  The Agency is charged with only including in the Reportable Food Registry those human food or animal feed reports where the reportable food has a reasonable probability of causing serious health consequences or death to humans or animals.  In the Federal Register of September 9, 2009, CFSAN, with CVM assistance, announced the availability of a Reportable Food Registry (RFR) guidance document, which provides guidance to the industry in complying with the Reportable Food Registry requirements.  Three public workshops were held on July 25 (College Park, MD), August 5 (Chicago, IL) and August 25 (Oakland, CA) to explain the intent of the guidance in more detail.  The RFR and guidance apply to all FDA-regulated categories of human foods (except dietary supplements and infant formula) and animal feeds.

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 the license.  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 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 65581-65589).  Comments were submitted to the FDA, but no action was taken to complete the process.  Nevertheless the Agency remains committed to strengthening this regulation. However, it will need to begin the process over again by publishing a new proposal because too many years have passed since the 1991 proposal. In addition, the new proposal may be expanded to require the submission of records and reports to the Agency for all medicated feed, not just those medicated feeds, which require the feed mill to obtain a license.

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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 or viewed on the firm’s web site, 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 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.

A new approach the Agency is allowing is the use of third-party certification.  A guidance document, entitled Voluntary Third-Party Certification Programs for Foods and Feeds (http://www.fda.gov/RegulatoryInformation/Guidances/ucm125431.htm ), was released in January 2009 that provides more information on this topic.  While third-party certification programs are not intended to take the place of inspections performed by a regulatory agency, if a firm is participating and compliant in a recognized third-party program that firm is likely at lower risk for problems than a firm not participating in a third-party program.  Further, firms that purchase ingredients and other raw materials from suppliers that participate and are in compliance with a recognized third-party program may have more control over their processes than firms that do not do this.

FDA has a variety of enforcement options available.  Regulatory compliance efforts often rely 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.  Enforcement action would not be taken based on information from third-party certifiers; however, an inspection by a regulatory agency could be used to follow-up and document violations for enforcement action.  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. 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% 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.  The Agency established priorities for inspections under the BSE program starting in FY 09 using a mathematically modeled, risk-based approach. This approach was implemented in FY 2008 for inspection of FDA-licensed medicated feed mills for compliance with medicated feed cGMP and other Agency regulations.

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 always include adequate attention to all segments of the industry responsible for the production, distribution, and use of 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 Food Sanitary Transportation Act of 1990, whose authority was transferred from the Department of Transportation to FDA and USDA on August 10, 2005, will be assessed for its role in strengthening the Agency’s ability to regulate the transportation of feed and feed ingredients.  The CFSAN has the lead on this issue for FDA.  CVM is 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 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 as 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 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 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 FBI, USDA, and industry to conduct vulnerability assessments in the agricultural sector.  In July 2007 a CARVER + Shock vulnerability analysis of a 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.  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 from comparable vulnerability analyses done at a grain exporter, cattle feedlot, and feed company 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.

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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 feed safety program 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 newly regulated establishments.  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 began developing a web-based system that would house the most recently approved Blue Bird label for Type B and C medicated 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 made the system available in June 2009 for a number of approved drugs.  CVM plans to continue to populate the system.

Gap F3.  Assessing and controlling feed hazards must occur along the entire 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 have prepared draft guidance to assist animal feeders in ensuring their on-farm practices are consistent with maintaining, storing and feeding safe feed. This guidance will be available for public comment when completed.  Furthermore, we intend to partner with our stakeholders in the development and dissemination of materials that reduce the guidance to practical terms.

Gap F4. It has been several decades since FDA labeling regulations for 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 (#2007-N-0442) which can be accessed via http://www.regulations.gov/search/Regs/home.html#home using the above number as in the designated search field. A Public Meeting was held on May 13, 2008 to receive verbal comment from interested parties. 

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Appendix I.  Glossary (definitions of words/terms)

Additive: An ingredient or combination of ingredients usually added to 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.

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 agent inadvertently present in feed and feed ingredients.

Feed: This term includes animal feed ingredients and mixed animal 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.

Feed hazard:  A biological, chemical or physical agent in, or condition of feed, which has the potential to cause illness or injury to animals or humans. For example, biological feed hazards include pathogenic bacteria and Transmissible Spongiform Encephalopathy agents, chemical feed hazards include pesticides, mycotoxins and heavy metals, physical feed 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 feed establishment: A 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 system: 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 feed risk: A biological, chemical, or physical agent in, or condition of feed, which is reasonably likely to cause illness or injury to animals or humans.

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Appendix II.

Processes:

  1. Food Additive Petition; FDA (21 CFR 571)
  2. New Animal Drug Application (NADA); FDA (21 CFR 514)
  3. General Recognition of Safety (GRAS) Petitions - FDA (21 CFR 570); GRAS Notification proposed rule 62 FR 18938 (CFSAN is accepting notifications now)
  4. Color Additive Petition; FDA (CFSAN) (21 CFR 71)
  5. AAFCO Ingredient Definition Process (2008 Official Publication; pp 253 - 255)
  6. Common or Usual Name Recognized by the Secretary/Director/ Commissioner of Agriculture; FDA and AAFCO (21 CFR 502 and AAFCO OP)
  7. Bioengineered Plants – CFSAN Guidance document, October 1997 - consultation process with FDA
  8. Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals (FDA Draft Guidance #153)
  9. AAFCO Feed Labeling Model Regulations and Guides (food-producing animals and pet animals) – 2009 Official Publication

Ingredient/Additive Listings:

  1. Food Additives Permitted in Feed and Drinking Water for Animals -21 CFR 573
  2. New Animal Drugs for Use in Animal Feeds - 21 CFR 558
  3. Generally Recognized of Safe (GRAS) substances - 21 CFR 582 & 584
  4. Color Additives - 21 CFR 73 & 74
  5. Feed Ingredient Definitions - AAFCO 2009 OP (pp 338 – 431)
  6. Substances Prohibited for Use in Food and Feed (21 CFR 589)
  7. Bioengineered Plants - CFSAN home page (http://www.fda.gov/Food/default.htm) and 9 CFR 340
  8. Animal Food Labeling - 21 CFR 501, 21 CFR 201
  9. Compliance Policy Guide 7126.08 - Common or Usual Names for Animal Feed Ingredients
  10. Pesticides Approved by EPA for Use in Feed and on Crops - 40 CFR 180
  11. Biologic Products Approved by USDA for Use in Animal Feed - 9 CFR 101-123
  12. 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.

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Appendix III.

Processes: Procedures for establishing limits for contaminants in feed and feed ingredients include the following:

  1. Setting tolerances, action levels and regulatory limits for feed contaminants are described in 21 CFR 509.4 through 509.7.
  2. 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,

  1. Aflatoxin action levels (FDA’s “Compliance Policy Guide” (CPG) 683.100);
  2. Pesticide tolerances (EPA’s Code of Federal Regulations (CFR), Title 40, Part 186 and FDA’s CPG 575.100);
  3. Pesticide action levels (FDA’s CPG 575.100 & Federal Register (FR), Vol. 55, No. 74; April 17, 1990);
  4. Temporary tolerances for PCB’s (FDA’s 21 CFR 509.30);
  5. Guidance levels for Fumonisin (FDA’s Guidance for Industry #112);
  6. Substances prohibited from use in animal food or feed (FDA’s 21 CFR 589);
  7. Tolerances established for drugs in food (FDA’s 21 CFR 556);
  8. Guidance levels for trace mineral contaminants (AAFCO’s 2009 Official Publication; pg 274; and
  9. Regulatory limit for Salmonella (FDA’s 21 CFR 500.35).

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Appendix IV.

Operations/Manufacturing Process Listings:

  1. Medicated Feed cGMPs (21CFR 225)
  2. Type A Medicated Article cGMPs (21 CFR 226)
  3. AAFCO Feed Manufacturing Guidance (2009 OP pp 221 - 230) and Proposed Regulations (to appear beginning with the 2010 OP)
  4. Low acid canned food regulations (21 CFR 500.23)
  5. Codex Code of Practice for Good Animal Feeding http://www.codexalimentarius.net/web/codex/codex27_en.htmExit Disclaimer
  6. HACCP; (seafood 21 CFR 123 and juice 21 CFR 120)
  7. SSOP (21 CFR 120.6 and 123.11)

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Appendix V. 

Process control regulations are needed to:

  1. Broaden coverage by FDA to include all feed ingredients and mixed feed.  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 feed 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.
  2. Prevent feed contamination incidents and thus save animals from pain, suffering, and death, and keep 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 feed 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 cattle deaths in Puerto Rico).  
  3. Reduce number of recalls of improperly manufactured feed, which continue to plague industry and drain Agency resources.
  4. Provide equivalency of regulatory requirements with foreign governments to ensure no or minimal disruption of trade.
  5. 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. 
  6. Provide framework for assisting industry in meeting customer/purchaser assurance.
  7. Provide for more uniform regulatory oversight within the United States.  [Although AAFCO adopted model cGMP regulations for feed manufacturing in 2009, there is no assurance all States will adopt them.  Federal regulations will alleviate this problem.] 
  8. 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.  
  9. Help focus Agency resources on those segments of the industry, which present feed hazards with the greatest risk to animal and/or human health.

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Appendix VI.

Inspection and Enforcement Descriptions: Inspections (FD&C Act Subchapter 701)

  1. Establishment Inspections (Investigation Operations Manual (IOM) Chapter 5): http://www.fda.gov/ICECI/Inspections/IOM/ucm123287.htm; (AAFCO Model Bill, FD&C Act Subchapter 704-706)
  2. Enforcement (Regulatory Procedures Manual (Chapters 4-9), http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm ;  
  3. Recalls (IOM Chapter 7)  http://www.fda.gov/ICECI/Inspections/IOM/ucm123363.htm
  4. Federal-State Cooperation (IOM Chapter 3) http://www.fda.gov/ICECI/Inspections/IOM/ucm123242.htm
  5. Regulatory Procedures Manual http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm  
  6. Audits conducted by FDA of State inspections (Field Management Directive No. 76) http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm056724.htm   

Inspection and Enforcement Listings: 

  1. Administrative actions refer to 21 CFR, particularly parts 12, 511, 514, and 571 http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200321
  2. FDA and AAFCO Enforcement Guidelines (CVM Policy and Procedure Guide 1240.3600)
  3. First-party inspections (Voluntary Self-Inspection Program – CPG being drafted).
  4. Inspection priorities (BSE Compliance Plan 7371.009) http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/UCM113437.pdf
  5. FDA Compliance Program Guidance Manual, Program 7371.003 Feed Contaminant Program; http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/UCM113409.pdf 
  6. FDA Compliance Program Guidance manual, Program 7371.004 Feed Manufacturing Compliance Program; http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm113430.pdf

1Some articles added to feed fall under the purview of other Federal agencies.  Feed-through pesticides are regulated by the Environmental Protection Agency, and vaccines added to feed are the responsibility of the United States Department of Agriculture.

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