美國動物飼料安全體系A(chǔ)FSS_框架草案第4版

1、Fourth Draft: Framework of the FDA Animal Feed Safety SystemPurpose and Scope: The Animal Feed Safety System (AFSS) is the FDAs 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 ing

2、redients 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 ed

3、ucation 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 producti

4、on, 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

5、.  Historically, FDAs 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 pr

6、ogram 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 fo

7、r many years. State feed regulators have cooperated with FDA in ensuring compliance with Federal regulations, and have complemented FDAs efforts with programs geared toward ensuring that feeds are nutritionally adequate for their intended use and do not cause health problems in animals or human

8、s. 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. 

9、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. 

10、; 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 relate

11、d 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 th

12、ese 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

13、 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 t

14、he 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 products life cycle, from the time a

15、n 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

16、 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

17、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 integrat

18、e 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, investigatio

19、n, 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: /downloads/ForFederalStateandLocalOfficials/UCM183650.pdfTitle X of

20、 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 tw

21、o 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 FDAs animal feed safety program is comprehensive and preventive.  A risk-based, preventive ani

22、mal 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

23、 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 understa

24、nd 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 bene

25、fit 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

26、effective overall feed safety program should also result in fewer resource-draining feed emergencies for government agencies.Operating Principles of the AFSS: The following operating principles form the basis for the AFSS:1. The feed and animal production industries are responsible for the productio

27、n, 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 fe

28、ed 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 complianc

29、e 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

30、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 FD

31、A 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, equi

32、pment 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. Major Compon

33、ents 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

34、(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 o

35、ur 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 wh

36、ich 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 todays standards or expectations.  A total of 14 ga

37、ps 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 addres

38、sing 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

39、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 age

40、nts 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 hea

41、lth.    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

42、 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

43、 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.Component A Ingredients and the Approval ProcessThe prim

44、ary 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 treat

45、ment, 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

46、, 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 als

47、o 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 ente

48、r 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 Associations Official Publication (OP).  FDA evaluates the safety and intended technical effect of the f

49、eed 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 F

50、DA 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. FDAs regulations do not provide a complete listing of ingredients and additives permitted in feed, especially many of those that are considered generally recogn

51、ized 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

52、 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 accepta

53、ble 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 fr

54、om 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 o

55、f Understanding (MOU) with AAFCO explaining the roles of each organization in AAFCOs process for adding or modifying feed ingredient definitions in the OP. The MOU is available at /OHRMS/DOCKETS/98fr/fda225-07-7001-mou0001.pdf.  AAFCO is revising its Guide for New and Modi

56、fied Ingredient Definitions to improve the guides 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 Ing

57、redient 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 finali

58、zing 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.Component B Limits for Feed HazardsFeed contamination can result from exposure of feed ingredi

59、ents and mixed feed to environmental, agricultural, industrial, or other hazard sources at any stage of the feed production continuumfrom pre-harvest activities, through feed manufacturing, storage and transportation, to on-farm feeding practices.  The likelihood of a feed hazard reaching level

60、s 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