Webinar: Update and Briefing on Feed Rule November 13, 2008 FDA, Center for Veterinary Medicine Office of Surveillance & Compliance

Transcription

1 2008 BSE Feed Rule Webinar: Update and Briefing on Feed Rule November 13, 2008 FDA, Center for Veterinary Medicine Office of Surveillance & Compliance 1

2 The New 2008 Rule Published in the Federal Register April 25, 2008 Effective date: April 27, 2009 Adds a new section to the regulations - 21 CFR Amends the 1997 BSE Feed Regulation - 21 CFR

3 Need For Enhanced BSE Feed Controls 1997 BSE Feed Rule (Feed Ban) mammalian protein rendering for animal feed rendered mammalian protein rendered mammalian protein feed for poultry, swine, pets feed for ruminants 3

4 Enhancing The Feed Ban brain, spinal cord from cattle > 30 months of age (CMPAF) rendering for animal feed 4

5 Enhancing The Feed Ban brain, spinal cord from cattle > 30 months of age (CMPAF) landfill, incineration, disposal rendering, etc. rendering for animal feed 5

6 Enhancing The Feed Ban brain, spinal cord from cattle > 30 months of age (CMPAF) remaining cattle material landfill, incineration, disposal rendering, etc. rendering for animal feed rendered animal protein feed for poultry, swine, pets 6

7 Requirements of the New Rule 7

8 Cattle Material Prohibited in Animal Feed (CMPAF) Brains and spinal cords from cattle 30 months of age and older slaughter cattle part of procedures for removing SRMs from human food...but creates a new inedible waste stream brains and spinal cords must be segregated from other inedible offal that are to be rendered for animal feed use 8

9 Cattle Material Prohibited in Animal Feed (CMPAF) Dead stock cattle Entire carcass of cattle not inspected & passed for human consumption (dead stock) is CMPAF unless shown to be less than 30 mos. of age OR brains and spinal cords are removed Inspected and passed means inspected and passed ante-mortem inspection by the regulatory authority with jurisdiction including state inspected slaughter facilities 9

10 Cattle Material Prohibited in Animal Feed (CMPAF) BSE-positive cattle No part of cattle tested and found positive for BSE, including tallow, are eligible for use in animal feed 10

11 Cattle Material Prohibited in Animal Feed (CMPAF) Mechanically separated beef Beef derived from mechanical separation of material containing CMPAF may not be used in any animal feed 4-D type pet food operations may continue to use mechanical separation after brain and spinal cord are removed from carcasses of cattle 30 months of age and older 11

12 Tallow Restrictions Tallow is defined as animal fat from cattle this includes fat from independent rendering operations that render mixed species including cattle Tallow containing no more than 0.15% insoluble impurities may be used in ruminant feeds All tallow from non-cmpaf sources may be used in feed for non-ruminants Rule references a specific analytical method for measuring insoluble impurities 12

13 Tallow Rules 21 CFR Tallow for use in animal feed SOURCE OF TALLOW INSOLUBLE IMPURITIES LEVEL FEED USE CAUTION STATEMENT REQUIRED REGULATION any source (non-cmpaf or CMPAF) < or = 0.15% allowed in all animal feeds None 21 CFR and non-cmpaf > 0.15% allowed in all non-ruminant feeds do not feed to cattle or other ruminants CMPAF > 0.15% not allowed in animal feed do not feed to animals

14 Marking for Disposal CMPAF for disposal must be marked by agent visible to the naked eye CMPAF must be disposed of by non-feed method, e.g., landfill, incineration, alkaline digestion, use as boiler fuel, etc. 14

15 Marking CMPAF per 21 CFR (c)(2)(v) Rendering Non-ruminant feed No marking <_0.15% II CMPAF* Tallow >0.15% II ** Ruminant feed No marking Disposal only Marking required MBM Disposal only Marking required *materials that contain CMPAF such as entire carcasses of animals 30 months of age or older, brain and spinal cord or animals 30 months of age or older and other materials that contain or may contain CMPAF, are required to be marked at this point only if not intended for rendering **contains or may contain CMPAF 15

16 Country Designation Allows foreign countries, such as Australia and New Zealand, to petition FDA for exemption from requirements in this rule Consistent with USDA, CFSAN regulations Designated countries would not have to remove CMPAF from feed ingredients exported to the U.S. (but must still comply with 21 CFR ) 16

17 Implementation 17

18 Implementation Plans & Timeline Implementation planning started Rule published Today Rule becomes effective Spring Inspector Training Inspections start December 2007 April 25, 2008 November 13, 2008 April 27,

19 Effective Date The rule becomes effective on April 27, 2009 There is no grace period after that date Product in channels of trade after that date should be in compliance 19

20 Inspections Under the 2008 Rule We estimate that less than 150 rendering facilities in U.S. will be subject to the rule There are a number of states that do not contain any cattle renderers FDA s District offices will work with the States to determine who is best suited to conduct these inspections, based on location, workload, experience, and other factors 20

21 Inspection Checklist We will use the existing inspection checklist The checklist is being expanded to include new questions specific to renderers This will allow data to go into our FACTS database with the rest of the BSE inspection data 21

22 Training of Inspectors We have begun updating the BSE Compliance Program Further training planned for Spring 2009 for inspection personnel likely to conduct these inspections 22

23 Guidance Under Development Aging animals Record-keeping by renderers Brain & spinal cord removal Tallow issues Marking CMPAF Also updating existing small entity compliance guides #

24 Guidance Development Adequacy of aging procedures Possible methods of determining age of cattle include animal ID systems, dairy herd records, dentition, body weight, or feedlot origin Effectiveness of brain and spinal cord removal Inspectors will verify written procedures are in place and being followed 24

25 Laboratory Tools and Analysis 25

26 Tallow Testing New rule specifies analytical method for use in determining insoluble impurities in tallow American Oil Chemists Society (AOCS) Ca 3a-46 (1997) Or another method equivalent in accuracy, precision, sensitivity Sampling very important in making accurate determination of insoluble impurities tallow should be sampled at point where it is ready to go into distribution Working with rendering industry to devise sampling instructions 26

27 Analysis for Brain & Spinal Cord At this time, no practical way of testing for the presence of brain & spinal cord in raw material, rendered product, or finished feed Currently available tests for brain and spinal cord cannot determine the age of the animal it came from 27

28 Regulatory Approach 28

29 Enforcement Challenges FDA has limited authority to conduct inspections at slaughter plants FSIS has limited authority to verify segregation of inedible by-products for animal feed use Therefore, renderers must obtain certification from suppliers that CMPAF has been segregated 29

30 Enforcement Approach Not expected to be significantly different from enforcement of 1997 rule Evaluating aging and brain and spinal cord removal procedures will be similar to evaluating clean-out procedures under 1997 rule Focus is on corrective actions when violations are identified Recalls have been rare in enforcing 1997 rule redundancy in protections make health hazard less likely 30

31 Certification To Renderers Renderers records must include certification or other documentation from each supplier that CMPAF has been excluded from material to be rendered for animal feed Certification acceptable if: It describes supplier s segregation procedures Procedures are in place before supplying any material It is periodically reviewed by renderer Other methods may be acceptable, such as 3 rd party certification 31

32 Third-Party Certification & Affidavits Rule permits (even encourages) use of third-party certification, especially for slaughter facilities supplying to renderers We anticipate wide use of supplier affidavits to satisfy certification requirement 32

33 Renderer Liability Concerns Renderers responsibility to ensure feed ingredients are free of CMPAF is dependent on supplier certification of age, segregation procedures Renderers concerned they will be held responsible if supplier gives them false information FDA will evaluate applicability of criminal provisions against falsifying information to renderers include in guidance documents 33

34 Impacts on Industry 34

35 Economic Impact of 2008 Rule Total compliance cost estimate $64.0 to $80.5 million per year Rule economically significant under Executive Order costs round to $100 million per year Will have a significant impact on substantial number of small entities regulatory flexibility analysis completed in accordance with Regulatory Flexibility Act 35

36 Requirements for Renderers Major burden falls on rendering industry Renderers that handle any cattle material must: maintain records sufficient to demonstrate material rendered for use in animal feed does not contain CMPAF Renderers that intend to render dead cattle for animal feed use must: ensure that deads are under 30 months of age OR ensure that brain and spinal cord are effectively removed use separate equipment for handling CMPAF once removed label materials containing CMPAF with do not feed to animals mark CMPAF with agent that is readily detected visually maintain records sufficient to track CMPAF to ensure it does not enter animal feed Comply with new restrictions on tallow 36

37 Impact on Slaughter Facilities Slaughter facilities may need to develop procedures for segregating CMPAF from other offal Slaughter facilities will be asked by renderers to certify that offal to be rendered for animal feed use is free of CMPAF Slaughter facilities may need to identify other, non-feed means of disposing of CMPAF 37

38 Impact on Cattle Producers Unless cattle producers can provide age verification, renderers may choose not to collect dead stock May need to identify alternative means of disposing of dead stock Potential collateral impact on disposal of other livestock Estimated cost to producers $28-39 million per year, possibly including: lower cattle prices to offset segregation and disposal costs at slaughter loss for cattle no longer rendered increased dead stock collection fees 38

39 Impact on Feed Manufacturers Tallow used in ruminant feed must contain no more than 0.15% insoluble impurities Feed manufacturers will need to be careful with their storage/use of fats & oils 39

40 Carcass Disposal and Environmental Impacts 40

41 Carcass Disposal May be biggest concern of livestock industry FDA does not regulate carcass disposal FDA sensitive to issue, though, and addressed it in Environmental Assessment for this rule 41

42 Expected Impact of 2008 Rule on Disposal CMPAF from slaughter: 28 million pounds initially, disposal most likely to be primarily by landfill Cattle mortalities: Annual beef and dairy cattle losses = 4.2 million head 1.9 million head currently being rendered 2.3 million head are not rendered forecast % decrease in cattle and calves sent to rendering this means 369 million 577 million lbs. to be disposed of by some means other than rendering for animal feed use 42

43 CMPAF as Fertilizer? FDA does not regulate fertilizer Rule does not change any current fertilizer regulation This rule does not prohibit the use of CMPAF materials in or as fertilizer Association of American Plant Food Control Officials (AAPFCO) looking at this issue 43

44 Questions? CVM BSE web page: For further questions contact: Shannon Jordre, Division of Compliance phone OR Burt Pritchett, DVM, Division of Animal Feeds phone