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From: TSS ()
Subject: Second Draft: Framework of the FDA Animal Feed Safety System
Date: December 23, 2006 at 8:49 am PST

----- Original Message -----
From: Terry S. Singeltary Sr.
To: Terry S. Singeltary Sr.
Sent: Wednesday, December 20, 2006 10:11 PM
Subject: Second Draft: Framework of the FDA Animal Feed Safety System

Second 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.) It covers the entire spectrum of Agency activities from pre-approval of food additives and drugs for use in feed, to establishing limits on feed contaminants, providing education and training to and 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 (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 or economic losses for 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.

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 national or international commerce. Issues involving BSE, Chronic Wasting Disease (CWD), dioxins, and microbial contamination are just examples of the most recent issues demonstrating this international economic 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.

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 develop a plan to reduce or eliminate 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 bioterrorism-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 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.

The Federal and State regulatory agencies provide the rules, guidance, and oversight to assist industry in producing 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 facilities, 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.

Risk-based decision-making is used to help determine which feed-related hazards should receive the highest priority by FDA, and the best methods for addressing them.

Feed security measures as they relate to counter-terrorism should become 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: Five (5) 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, distribute, and use feeds result in safe products (component C); regulatory oversight is present at levels commensurate with risk to human and animal health (component D); and training, education, and outreach activities keep our stakeholders well informed and ensure FDA and State feed regulatory personnel are adequately trained (component E). 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 each gap. For purposes of this document, the term gap refers to a process the Agency believes is either totally lacking or is operating under the current feed safety program but needs to be updated to meet current standards. A total of 11 gaps have been identified. The 11 gaps do not reflect all the steps the Agency is taking to improve its feed safety program; however, they do represent most of the more important actions.

As indicated in the operating principles section above, 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 relative risk-ranking method that ranks of all identified feed hazards with 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.” Additional documents will be made available addressing the exposure part of the risk equation (i.e., hazard multiplied by exposure) and the relative risk-ranking scores for the identified contaminants.

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 and D (hazards).

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.

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. 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 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.

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.

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.

FDA is 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. FDA is developing a Memorandum of Understanding with AAFCO explaining the roles of each organization in AAFCO’s process for adding or modifying feed ingredient definitions in the OP. 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. Should this final rule publish, 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 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 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 for contaminants are established, risks from the contaminants can be controlled by either 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.

The Agency’s current procedures for establishing limits for contaminants in animal feed and feed ingredients are located in Appendix III. 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 risk it poses to animal and human health and the risk will be compared to those posed by other feed contaminants (i.e., relative ranking). 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 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). A public meeting was held on September 12, 2006, in Rockville, Maryland, at which presentations were made by AFSS Team members about risk, relative risk-ranking, potential feed contaminants, and health consequence scoring for chemical and microbiological contaminants in animal feed. Details of the meeting are available at One additional meeting is being planned for 2007, during which the exposure component of the relative risk-ranking model will be presented. A subsequent meeting will cover the model, the relative-risk ranking of the contaminants identified, and the way the Agency is likely to use the findings.

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, the there is a need for rapid, inexpensive, and reliable test kits for monitoring of feed ingredients and feed to be developed and validated that could be used by industry and government.

An FDA internal standard operating procedure (SOP) is being developed 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 will focus on steps occurring early in the process of establishing limits for new contaminants or revising existing limits for contaminants. Emphasis will be placed 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, distribution, and/or use of feed ingredients and mixed feed. Feed process control entails measures seeking to detect, prevent, 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, distribution, and use 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, distribution, and use of non-medicated feed ingredients and mixed feed. The reasoning for the establishment 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 Points (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 Codex Code of Practice on Good Animal Feeding (the Code) was also relied on by the AFSS Team 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 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 firms 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 rule at 21 CFR 589.2000. Guidance will be prepared to assist animal feeders ensure their on-farm practices are consistent with the production of safe food.

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. Firms 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.

Component D – Regulatory Oversight

The primary purpose of an inspection is to determine a firm’s or 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 firm’s manufacturing facility. Surveillance inspections are conducted to determine whether a firm is substantially in compliance with the regulations and operating “under control.” Compliance inspections are conducted to evaluate a firm’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 firms, 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 hearings/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 D1. 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. Using a different set of inspection criteria, the Agency sets priorities for inspection of FDA-licensed medicated feed mills for compliance with medicated feed cGMP and other Agency regulations.

CVM is developing a risk-based approach for feed-related inspections as part of its 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 not identified as being of high enough risk to warrant an inspection, to assure the Agency that these establishments were correctly categorized and do not need to be inspected as frequently as higher-risk establishments.

Gap D2. 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 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 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.

Vehicles used to transport feed are also receiving limited inspectional scrutiny. This lack of inspection can result in a significant cross-contamination issue. The terms of the Food Sanitary Transportation Act of 1990, whose authority was transferred recently to FDA and USDA, will be assessed for its role in strengthening the Agency’s ability to regulate the transportation of animal feed.

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% 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.

To accomplish this task, risk associated with the production and distribution of feed ingredients and mixed feed will be ranked to determine those segments of the industry on which the Agency will focus its limited resources. 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 the development, distribution, and implementation of educational materials and guidance.

Gap D3. Feed defense or counterterrorism 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 bioterrorist 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, and other Federal agencies about FDA’s feed defense initiatives and other activities of FDA’s animal feed safety program, and solicit their input.

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. The Office of Regulatory Affairs (ORA) is developing such a document, which would cover all FDA-regulated products, including animal feed. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has posted guidance for industry covering human food on its website.

The Agency (through CFSAN and CVM) is working with industry to conduct vulnerability assessments in the agricultural sector. In December 2005, a vulnerability assessment was conducted of a grain export operation in New Orleans, LA, that will serve as a model and resource for other similarly situated grain establishments. A vulnerability assessment was also done in July 2006 at a cattle feedlot in Nebraska. This feedlot had on site feed manufacturing equipment. A similar assessment is planned at a large commercial feed mill, and a feed firm has volunteered one of its facilities. The information from these assessments will be used to identify those areas of grain handling and feed mill production that are particularly susceptible to deliberate contamination.

Gap D4. FDA-licensed feed mills are required by 21 CFR 510.301 to submit to FDA records and reports concerning clinical and other experience with the types of medicated feeds that required the mill to obtain the license. The Agency began the process to update this regulation a number of years ago when it applied to both dosage form drugs and medicated feed. The process was completed for dosage form drugs but not for medicated feed. A new proposal will be necessary because many years have passed since proposed changes for medicated feed records and reports published. In addition, the proposal may be expanded to require the submission of records and reports to the Agency for all medicated feed, not just medicated feed made from Category II, Type A medicated articles, which require the feed mill to obtain a license.

COMPONENT E – Education and Outreach

Having a program and inspection staff well trained in all facets of the Agency’s animal feed safety system and an industry that knows what it must do to be in 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. Also, it is essential for the Agency to prepare and distribute outreach materials to aid the industry in achieving compliance because increased voluntary compliance by industry means less effort needs to be taken by regulatory agencies. Both training of regulatory personnel and outreach for industry must be timely to be the effective.

Gaps and How Each Gap will be Addressed

Gap E1. If 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 inspecting newly regulated establishments under these programs. 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 that (1) adequate training is provided for timely implementation of the more expansive AFSS, and (2) on an as-needed basis thereafter, the timely education of regulated industry, and (3) an effective outreach initiative to all stakeholders is undertaken.

Gap E2. 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 a firm must either have the labeling on the premises or have access to it via the internet. To facilitate internet access, CVM is developing a web-based database that would house the most recently approved Blue Bird label for feeds containing either category I or II drugs. Making correct label information easier to obtain should increase the probability that feeds will be manufactured and used safely.

Appendix I. Glossary (definitions of words/terms)

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.

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 companion 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 TSE agents, chemical hazards include pesticides, mycotoxins and heavy metals, and physical hazards include glass and metal.

Mixer-feeder: An “entity” that mixes feed, which is fed to its own animals or animals under its control. This type of firm 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 entity if any 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 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.


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 (CFSAN only)

Color Additive Petition; FDA (CFSAN) (21 CFR 71)

AAFCO Ingredient Definition Process (2006 Official Publication; pp 251 - 253)

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) – 2006 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 2006 OP (pp 254 – 358)

Substances Prohibited for Use in Food and Feed (21 CFR 589)

Bioengineered Plants - CFSAN home page ( 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: Limits on contaminants in food and feed have been established by FDA,

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 2006 Official Publication; pg 319; and

Regulatory limit for Salmonella (FDA’s 21 CFR 500.35).

Appendix IV.

Operations/Manufacturing Process Listings:

Medicated Feed cGMPs (21CFR 225)

Type A Medicated Article cGMPs (21 CFR 226)

AAFCO Feed Manufacturing Guidance (2006 OP pp 204 - 218) and Proposed Regulations (in progress)

Low acid canned food regulations (21 CFR 500.23)

Codex Code of Practice for Good Animal Feeding

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 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, 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).

Reduce number of recalls of “mis-manufactured” animal feed, which continue to plague industry and drain Agency resources.

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.

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 they will be adopted by all States. 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 (FD&C Act Subchapter 701)

IOM Subchapter 501; (AAFCO Model Bill)

Enforcement (FD&C Act Subchapter 704-706; IOM Chapter 7)

Federal-State Cooperation (IOM Chapter 3); Regulatory Procedures Manual

Audits conducted by FDA of State inspections

Inspection and Enforcement Listings:

Administrative actions refer to 21 CFR, particularly parts 12, 511, 514, and 571

FDA and AAFCO Enforcement Guidelines (CVM Policy and Procedure Guide 1240.3600)

Federal and State Audits (A guideline is being developed)

First-party inspections (Voluntary Self-Inspection Program – CPG Draft; expected to be published in 2005)

Inspection priorities (BSE Compliance Plan 7371.009)

FDA Compliance Program Guidance Manual, Program 7371.003 Feed Contaminant Program;

FDA Compliance Program Guidance manual, Program 7371.004 Feed Manufacturing Compliance Program;

From: Terry S. Singeltary Sr. []
Sent: Tuesday, July 29, 2003 1:03 PM
Cc:;; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

my name is Terry S. Singeltary Sr., i lost my mother to hvCJD
(Heidenhain Variant Creutzfeldt Jakob Disease).

i would kindly like to comment on the proposed HACCP method of
detecting and or preventing TSEs in the human/animal feed supply.

it seems to me by implementing something that was designed for Astronauts
instead of cattle, something that the GAO has already stated is terribly
flawed (HACCP), i find it very disturbing to continue to insist on refusing
to use rapid TSE TESTING in sufficient numbers to find TSEs, as with
other Countries that they too once thought they were BSE free. for example,
it took Italy 1 MILLION rapid TSE tests since 2001 to find 102 cases of
BSE. THE USA has only tested 48,000 cattle in the 14 years of surveillance.
there is documented proof that indeed the USA cattle have been infected
with a TSE for decades, but the FDA/USDA and other USA Gov. agencies
continue to conveniently ignore these findings. YOU must not ignore
what Richard Marsh found. Plus, you must not ignore Asante/Collinge new
findings that BSE transmission to the 129-methionine genotype can lead
to an alternate phenotype that is indistinguishable from type 2 PrPSc, the
commonest _sporadic_ CJD. The USA has been feeding ruminant by-products back to

cattle, deer, elk and sheep for decades, and TSEs in these species have been
recycled for feed for decades in the USA. The rendering process here in the
USA will not kill this agent. to implement any HACCP over massive rapid
TSE testing is only prolonging the inevitable, and will only allow the
agent to spread further. it is simply a band-aid approach to something that needs a

3. Meat and Poultry: Better USDA Oversight and Enforcement of Safety

Rules Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902, August

FSIS Is Not Ensuring that Plants' HACCP Plans Meet Regulatory


According to FSIS's food safety systems correlation reviews, inspectors
are not consistently identifying and documenting failures of plants'
HACCP plans to meet regulatory requirements. Furthermore, FSIS does
not expect its inspectors to determine whether HACCP plans are based on
sound science--the cornerstone of an effective plan. While in-depth
verification reviews examine the scientific aspects of HACCP plans, they
have been conducted in very few plants, and consumer safety officers
hired to review the scientific soundness of HACCP plans may take several
years to assess the plans at all plants. Moreover, inspectors in 55
percent of the 5,000 plants nationwide did not document any HACCP
violations during fiscal year 2001. When we brought this information to
the attention of FSIS officials, they were surprised that so many plants
had no HACCP violations for an entire year.


2. USDA believes that the title of the report is misleading. We
disagree. We believe the title accurately reflects the concerns detailed
throughout the body of the report.


FDA acknowledges that it has not yet identified and inspected
all firms subject to the ban” pg. 3 ;

The report concludes that “federal actions do not sufficiently ensure
that all BSE-infected animals or products are kept out or that if BSE were found it
would be detected promptly and not spread to other cattle through animal
feed or enter the human food chain” italics added pg. 3 ;

and why does everybody conveniently ignore these findings;

Asante/Collinge et al, that BSE transmission to the 129-methionine genotype
can lead to an alternate phenotype that is indistinguishable from type 2
PrPSc, the commonest _sporadic_ CJD;

To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

•Department of Veterinary Science, University of Wisconsin-Madison, Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville,
Wisconsin 53092

Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in




These findings suggest that TME may result from feeding mink infected
cattle and we have alerted bovine practitioners that there may exist an as yet
unrecognized scrapie-like disease of cattle in the United States (Marsh and
Hartsough, 1986). A new

bovine spongiform encephalopathy has recently been reported in England
(Wells et al., 1987), and investigators are presently studying its transmissibility and
possible relationship to scrapie. Because this new bovine disease in England is
characterized by behavioral changes, hyperexcitability, and agressiveness, it is very
likely it would be confused with rabies in the United Stales and not be diagnosed.
Presently, brains from cattle in the United States which are suspected of rabies infection are
only tested with anti-rabies virus antibody and are not examined histopathologically for
lesions of spongiform encephalopathy.
We are presently pursuing additional studies to further examine the possible
involvement of cattle in the epidemiology of TME. One of these is the
backpassage of our experimental bovine encephalopathy to mink. Because (here are as yet
no agent- specific proteins or nucleic acids identified for these transmissible
neuropathogens, one means of distinguishing them is by animal passage and selection of the
biotype which grows best in a particular host. This procedure has been used to
separate hamster- adapted and mink-udapted TME agents (Marsh and Hanson, 1979). The
intracerebral backpassage of the experimental bovine agent resulted in incubations of
only four months indicating no de-adaptation of the Stetsonville agent for mink after
bovine passage. Mink fed infected bovine brain remain normal after six months. It wili
be essential to demonstrate oral transmission fiom bovine to mink it this proposed
epidemiologic association is to be confirmed.

02N-0273 - Substances Prohibited From ... [PART 1 TSS SUBMISSION]
... compare search on 8/8/01...tss =====ANIMAL PROTEIN ... had
to request to the FOIA >>for the USA madcow feed ban warning letters. ... 03/Jan03/012403/8004be07.html - 68k -

Docket Management Docket: 02N-0273 - Substances Prohibited From ...


The problem is diminishing in most of the 15 EU nations, but in Britain
there were 260 positive tests between January and May, compared with 156 for the same
period last year.

The higher number could be explained partly by the greater number of
tests carried out this year in Britain: 198,143 compared with 122,801.

The European Commission carried out about 4.1 million tests across
member states - about 10% of cattle in the bloc.

It found 591 positive cases of bovine spongiform encephalopathy in the
first five months of the year, down from 603 over the same period last year.



As of April 30, 2003, over 48,000 brains have been examined for BSE or
another form of a TSE in cattle (figure 3
No evidence of either condition has been detected by histopathology or

For the USA to continue to _flounder_ with these TSEs, as they have done
for the past 30 years or so, will only allow the agent to spread. to continue to
ignore what every other Country around the globe has dealt with and is still dealing with, and
to think that the USA is any different, should be taken with great suspicion $

PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle),
it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA
and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III

for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion
as well. NOT to leave out the OIE and it's terribly flawed system of
disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment
on this as a threat to human health. the OIE should also change the mathematical
formula for testing of disease. this (in my opinion and others) is terribly flawed as well.
to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will
find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1
case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof
enough to make drastic changes of this system. the OIE criteria for BSE Country classification
and it's interpretation is very problematic. a text that is suppose to give
guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in relations
with CWD as a human health risk. if we wait for politics and science to
finally make this connection, we very well may die before any decisions
or changes are made. this is not acceptable. we must take the politics and
the industry out of any final decisions of the Scientific community.
this has been the problem from day one with this environmental man made death
sentence. some of you may think i am exaggerating, but you only have to see
it once, you only have to watch a loved one die from this one time, and you
will never forget, OR forgive...yes, i am still very angry...but the
transmission studies DO NOT lie, only the politicians and the industry do...and they are
still lying to this day...


Subject: MAD COW FEED RECALL 220,740 LBS Biofix Holding Inc, Denton, TX
Date: December 22, 2006 at 8:51 am PST
Harina De Carne Y Hueso Porcina 58% Proteina (Pork Meat and Bone Meal 58% Protein), 50 kg bags, Recall # V-005-2007
No lot number. Shipment Purchase Order number: BH-06-1085.
Recalling Firm: Biofix Holding Inc, Denton, TX, by letter on October 16, 2006.
Manufacturer: Allied Premium Protein, Gaffney, SC. Firm initiated recall is ongoing.
Pork Meal with potential to be contaminated with prohibited material distributed without cautionary statement.
220,740 lbs




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