Attachment_3.pdf

FORM FDA 3719 (10/09) Page 1

Department of Health and Human Services Food and Drug Administration

REPORT OF INSPECTION FOR COMPLIANCE WITH 21 CFR §589.2000 and §589.2001

PSC Graphics (301) 443-1090 EF

FEI NUMBER:

Firm (Legal) Name Date Current Inspection Ended

Lead Investigator

FDA District Office

Name and title of most responsible person at this site

GPS Coordinates of Inspected Site

Lead Affiliation (Check one)

Firm State

Name and title of person(s) interviewed

Operational Status (Check only one) (See Instructions) [If firm is OOB, Skip ALL Sections!]

ZIP Code Telephone Number

Firm (Physical) Address

Firm City Federal State Agency (Enter name below)

Operational Seasonal Inactive Out of Business Information above includes changes to firm's name and/or address

Section 1 — Complete for ALL firms 1.

3.

a) b) d) a) c)

Type of firm inspected? (Check ALL that apply)

Does the firm receive feeds or feed ingredients that contain or may contain prohibited material (PM)? (Check only one)

Does the firm handle (manufacture, process, blend, distribute, transport or use) feed or feed ingredients that are intended for the feeding of ruminant animals?

Is the firm aware of the BSE rule, 21 CFR §589.2000?

If Question 3 is "YES, but PM is only in Retail Pet/Lab Feed" or "NO," check all of the following that describe voluntary safeguards the firm has in place to assure they do not receive prohibited material.

Does the firm handle (manufacture, process, blend, distribute, transport or use) feed or feed ingredients that are intended for the feeding of non-ruminant animals?

Renderer Feed Mill (FDA Licensed)

On-farm Feed Mixer Protein Blender

Feed Mill (not FDA Licensed)

Feeder of Ruminants

Transporter (Hauler)

Pet Food Manufacturer Human Food Processor

Distributor/Retailer Animal Feed/Pet Food Salvager

Yes Yes

Yes

No No

No

YesYES, but PM is Only in Retail Pet/Lab Feed

Written assurance from suppliers that they no longer manu-facture/distribute any products containing prohibited materials

Written procedures for the label review of incoming materials

Written assurance from transporters that they do not transport products containing prohibited materials

Uses only vegetable source proteins and uses no animal proteins

Written assurance from transporters that they utilize dedicated transport equipment OR utilize clean-out measures that adequately prevent commingling or cross-contamination

Testing of incoming materials (Please describe)

Uses animal proteins only from exempted sources (Check all that apply)

No

Blood "Plate waste" Equine Fish Milk Porcine Poultry Gelatin

Other (Specify):

2.

a)

If the firm is manufacturing feed, does it use tallow (animal fat from cattle) in animal feed formulations?

If yes, does tallow used in ruminant feed contain not more than 0.15% insoluble impurities? NoYes

YesFirm does not manufacture feed. No

Cynthia.Martin Typewritten Text Attachment 3

Cynthia.Martin Typewritten Text

FORM FDA 3719 (10/09) Page 2

b) If Question 3 is either "YES, but PM is ONLY in Retail Pet/Lab Feed" or "YES", is imported prohibited material (not originating in the United States) used? Yes No Unknown

Please list the country/ies of origin for the imported prohibited material.

4.

6.

7.

8.

5.Is the received product containing prohibited material intended ONLY for further distribution?

Are the received feeds or feed ingredients containing prohibited materials (referred to in #3 above) labeled with the caution statement, "Do not feed to cattle or other ruminants"? (Check only one)

Are the outgoing feeds or feed ingredients containing prohibited materials labeled with the caution statement, "Do not feed to cattle or other ruminants"? (Check only one)

Describe records the firm maintains in tracking prohibited materials throughout their receipt, processing and distribution.

Does the firm manufacture or process products containing prohibited materials?

Yes No Are ONLY retail feed sales of pet food involved?

h)

Yes

Yes Yes Yes Yes Yes

PM is Only for Rendering

No Outgoing Feeds/Ingredients containing PM

PM is Only in Retail Pet/Lab Feed

PM is Only in Retail Pet/Lab Feed

Yes

Yes

Yes

Yes

Yes

Yes

No

No No No No No

Yes No

No

No

No

No

No

No

Section 2 — Complete for ALL firms EXCEPT: Firms that are ONLY Q1a) Firm Type = "Other" OR Firms that are ONLY Q1a) Firm Type = "Feeder of Ruminants"

Date of receipt or purchase or sale or delivery

Sequencing of feeds

Name and address of the seller

Flushing the system (Please describe)

Name and address of the purchaser

Written sequencing and flushing procedures

Identification of the product

Documentation maintained of sequencing and flushing

Quantity

Flushed materials discarded or labeled with the caution statement

Copies are available for inspection and copying

Physical clean-out (e.g. vacuuming, cleaning) Dedicated equipment used for prohibited materials Product containing prohibited material is always in packaged form when in the firm's possession Other (Please describe)

9.

10.

11.

a) a) b) b)

Does the firm manufacture, process, blend, repackage, or transport BOTH products containing prohibited materials AND products containing only non-prohibited materials?

If the answer to Q9a) is "NO," then SKIP to Question 11.

Please describe any additional safeguards the firm has in place to assure that outgoing feeds or feed ingredients containing prohibited material are not shipped to ruminant feeders (if none, please enter "None").

Does the firm manufacture, process, blend, repackage, or transport BOTH products containing prohibited materials AND feeds or feed ingredients that may be used for ruminants?

If the answer to Q9a) is "YES," check ALL of the following that describe the measures the firm has in place to avoid commingling or cross-contamination.

If the answer to Q9a) is "YES", does the firm have a system in place to avoid commingling and cross-contamination?

a) b) c) d) e) f)

Are ONLY retail feed sales involved? ........................................... Yes No g)

Other (Please describe)

If Question 3 is "No" or if Question 1.a) is only "Feeder of Ruminants", skip to Section 4.

Section 3 — COMPLETE this section ONLY if the firm is marked as:

Describe the firm type. (Check one, or more if applicable)12.

Does the firm process cattle and/or cattle offal, with or without other livestock species?13.

Q1a) Firm Type = "Renderer"

Yes No

Yes No

Does the firm collect, receive or process material (including dead stock cattle 30 months of age or older) that contains “cattle material prohibited in animal feed” (CMPAF)?

Does the firm differentiate cattle less than 30 months old from those that are 30 months of age or older?

14.

Yes No

Independent Renderer (rendering facility not affiliated with a slaughter facility)

Other (Please describe) 4-D Processor (non-cooking facility) Transfer Station, Transporter Livestock Slaughter Facility with On-Site Rendering

Dentition (examination of teeth)

Other (Please describe) Livestock producer herd records Affidavit from supplier

Page 3FORM FDA 3719 (10/09) a)

If yes, check all of the following methods that the firm uses to differentiate cattle by age.a)

Does the firm produce tallow for use in animal feed?..........................................................................15. Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

c) If 15(b) is “NO”, is outgoing tallow containing more than 0.15% insoluble impurities labeled with the caution statement “Do Not Feed To Cattle Or Other Ruminants”?

b) If yes, does the tallow contain not more than than 0.15% insoluble impurities?

b) Does the firm have written procedures explaining the process(es) used above?

c) Does the firm maintain records for at least one year documenting the methods noted above?

16.

If Question 13 is "No", then skip to Section 4.

Does the firm separate CMPAF from material that may be used in animal feed?

Remove striated muscle and offal from the carcass

Other (Please describe) Remove only the brain and spinal cord Remove the vertebral column and head from the rest of the carcass

If yes, check all of the following methods that the firm uses to separate CMPAF from material that may be used in feed.a)

Yes No

Yes No

b) Does the firm have written procedures explaining the process(es) used above?

c) Does the firm maintain written records for at least one year documenting the methods noted above?

Yes Nof) Is the CMPAF marked with an agent that can be seen by visual inspection?

Yes Noe) Is the CMPAF labeled “do not feed to animals”?

Yes Nod) Does the firm have separate equipment for handling CMPAF once removed from the whole carcass?

17.

Yes No

Does the firm generate CMPAF?

Landfill

Other (Please describe) Rendering Alkaline or thermal digestion Incineration

If yes, what method does the firm use to dispose of the CMPAF? (Check all that apply)a)

Yes No

Yes No

b) Does the firm have records that document disposition of CMPAF?

c) Do the records demonstrate that CMPAF is not going into animal feed?

18.

FORM FDA 3719 (10/09) Page 4

Section 4 — SKIP this section when the firm is ONLY marked as:

Section 5 — Complete this section ONLY if the firm is marked as:

Section 6 — Complete for ALL Firm Types

19.

21.

20.

22.

23.

a) a) a) b) b) a) d) b) e) f) c) c) d) e)

Are any incoming feeds or feed ingredients transported in bulk form?

Are ruminant feeders doing the following?

Are any outgoing feeds or feed ingredients transported in bulk form?

Check all deviations that were noted at the time of inspection.

If any deviations were noted above, describe the deviations, and the actions and commitments made to correct each deviation.

Are any outgoing feeds or feed ingredients transported in bagged/packaged form?

Observing the caution statement on feeds containing prohibited material (PM)

Feeding non-ruminant species (Not including cats and dogs)

Maintaining copies of labeling for feeds containing animal protein (AP)

Feeding non-ruminant species (Not including cats and dogs) feeds containing prohibited material

Feeding cats and/or dogs

Maintaining copies of purchase invoices for feeds containing animal protein

(Not including retail pet food for cats and dogs)

(Not including retail pet food for cats and dogs)

Does the firm utilize its own transportation vehicles for the delivery of any outgoing bulk feeds or feed ingredients?

Does the firm utilize other firms' transportation vehicles for the delivery of any outgoing bulk feeds or feed ingredients?

If 20(d) is "YES," do ALL outbound transporters provide written assurance that they utilize dedicated transport equipment OR utilize clean-out measures that adequately prevent commingling or cross-contamination with prohibited material?

Q1a) Firm Type = "Other" OR

Q1a) Firm Type = "Feeder of Ruminants"

Q1a) Firm Type = "Transporter (Hauler)"

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No Outgoing Feeds/Ingredients

Commingling Recordkeeping

Labeling Feeding Ruminants Prohibited Material

No Deviations Noted

No Outgoing Feeds/Ingredients

No PM-feeds on premises

No AP-feeds on premises

No PM-feeds on premises

No AP-feeds on premises

No Outgoing Feeds/Ingredients

No Outgoing Feeds/Ingredients

No

No

No

No

No

No

No

No

No

No

No

No

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No b) a) c) d) e)

Are any incoming feeds or feed ingredients transported in packaged form?

Are you attaching any descriptions, exhibits, records, labeling, reports or supplemental information?

Does the firm utilize its own transportation vehicles for the delivery of any bulk incoming feeds or feed ingredients?

Does the firm utilize other firms' transportation vehicles for the delivery of any bulk incoming feeds or feed ingredients?

If 19(d) is "YES," do ALL inbound transporters provide written assurance that they utilize dedicated transport equipment OR utilize measures that adequately prevent commingling or cross-contamination with prohibited material?

FORM FDA 3719 (10/09) Page 5

INSTRUCTIONS — For the Lead Investigator District BSE Coordinator. The FDA District BSE Coordinator is responsible for communicating and receiving information related to the BSE Checklist/Report. Questions, comments and concerns should be directed to this individual. Completed BSE Reports of Inspection generated by State agencies should be mailed to the District BSE Coordinator, not to CVM. The Districts are responsible for checking the forms for completeness and accuracy, and for entering the information into FACTS.

BSE Checklist/Report Version. Please make sure you are using the most current BSE Checklist/Report version. The version date is located at the bottom of the form. Check with your BSE District Coordinator or the FDA/CVM website (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/ Forms/UCM052412.pdf) to make sure you are using the most recent version. Other versions may not be compatible with the BSE Checklist/Report Database and may invalidate the information collected.

BSE Checklist/Report Alterations. Some agencies may choose to alter the BSE Checklist/Report to better fit their own operations. While CVM does not necessarily object to such alterations, changes must be added to the end of the form. No additions, deletions or revisions should be made to the main body of the CVM-version of the BSE Checklist/Report.

Legibility. Illegible writing results in inaccurate data, which compromises the BSE Compliance Program. If you are submitting a handwritten checklist, please print your responses to the questions.

Completing Sections. Sections should be fully completed for each of the firm types indicated in the header of each Section.

Sections inappropriately skipped (based on the firm type) may cause the BSE Checklist/Report to be considered incomplete.

Incomplete BSE Reports of Inspection may require follow-up with the investigator and may require a follow-up inspection at the firm.

Completing Questions. The BSE Checklist/Report instructions and flow of questions must be followed. Blank or unanswered required questions may cause the BSE Checklist/Report to be considered incomplete. Incomplete BSE Reports of Inspection will require a follow-up with the investigator and may require a follow-up inspection of the firm.

Descriptive Fields. For those questions that ask for an explanation or description, please be brief and capture the essential elements with as few words as possible. If you feel certain answers require a more lengthy description, consider recording the information on a separate page, which should be attached to the BSE Checklist/Report and so noted in the question at the end of the checklist which asks if additional documents are attached.

Additional Narrative. For those state BSE/Ruminant Feed inspections not being done under federal contract or those state contract BSE/Ruminant Feed inspections that do not include an FDA-481, it is recommended that a brief narrative report accompany the BSE Checklist/Report summarizing the inspection. A brief summary should cover the entire inspection and should include other details not captured in the Checklist/ Report.

CHECKLIST QUESTIONS

Firm information - Complete for ALL firms, regardless of the firm type.

FEI Number. The FEI number is absolutely required. It is the District's responsibility to provide this information, and you may need to contact your District BSE Coordinator for this information. The District may need to assign an FEI number after the inspection is completed. For example, if the firm has not been inspected before, the District will assign an FEI number when it receives the report.

Firm Name. Use the firm's accurate legal name. Do not use "Doing Business As" (DBA) firm names if at all possible.

Firm Address. The address should reflect the physical location of the firm's activities. Post Office Box numbers are unacceptable. If the firm's mailing address is different than their physical address, please make a note of this information.

Date Current Inspection Ended. If the inspection went more than one day, enter the date of the last day of the inspection.

Lead Investigator. Enter the name of the lead investigator.

Lead Affiliation. If the inspection was done by FDA, check this box. If the inspection was done by a State, check the box and write in the name of the State.

FDA District Office. Enter the name of the FDA District in which the inspected firm is located.

GPS Coordinates. This information is not required by FDA at this time.

Name and Title of the Person(s) Interviewed. Record the name and title of the person(s) interviewed during the inspection.

Name and Title of Most Responsible Person at the Site.

Record the name and title of the most responsible person at the facility, for example the firm's President or Manager. This may or may not be the person interviewed during the inspection.

Operational Status. Mark the firm's operational status.

Inspection reports should be completed for Seasonal and Inactive firms since they might begin production at any time.

Out of Business firms require no more information gathering.

Changes to Firm Name and Address. If the facility/site has a new name and/or address, please check the box indicating this and make sure the address recorded on the inspection report is correct. Please record the firm's former name and/or address somewhere in your inspection report.

FORM FDA 3719 (10/09) Page 6

Section 1 - Complete for ALL firms, regardless of the firm type (with the exception of firms which are Out of Business).

Question 1a) Firm Type. Please understand the firm type categories provided and use these categories whenever applicable. More detail is provided in Compliance Program 7371.009.

Considerations

Question 1 - b) Further defines "handling" for better clari-fication. c) Asks whether the firm makes feed for non-ruminant animals. d) Asks whether the firm is aware of the BSE rule or not.

Question 2 - This question is new. Does the firm receive and use “tallow” (animal fat from cattle) in feeds they manufacture?

If the firm does not manufacture feed mark the box that says “firm does not manufacture feed”. If the firm does not use tallow, mark “NO” and skip 2a). If the firm does use tallow and you marked yes on Q2) then you need to answer Q2a). If the firm manufactures ruminant feed and if they use tallow as an ingredient in ruminant feed, check the label of the tallow to make sure it contains no more than 0.15% insoluble impurities.

Mark “YES” if it does, or “NO” if it does not. If the firm is a renderer that processes cattle, mark "YES" to Q2) and answer Q2a). If the firm is a renderer that does not process cattle, mark

Q2) "NO".

Question 3 - If you answer "NO" or "YES, but PM is only in Retail Pet/Lab feed" then go through the list of boxes in 3a) to describe the safeguards the firm is taking to make sure they do not receive prohibited material for use in their manufacturing operation. If the answer to Q3) is "no", or if the firm is only a "feeder of ruminants" , then do not complete question 3b) and skip to Section 4, Question 19, of the inspection report form. 3b) If imported prohibited material is used, please record the country of origin of that product.

Question 4 - Is the received product that contains prohibited material being held only for further distribution? Mark "Yes" or "No".

Question 5 - Is the firm manufacturing, or otherwise processing, products that contain prohibited material? Mark "Yes" or "No".

Note - The answers to questions Q4) and Q5) can both be "No", but they cannot both be "Yes".

Question 6 - Are feeds containing prohibited material properly labeled with the caution statement? Raw animal products destined for a renderer are not required to be labeled. If you are inspecting someone supplying/transporting raw animal products to a renderer, mark "PM is only for rendering". Retail pet foods are exempted from the requirement to have the caution statement on the label, unless the product is salvaged or distressed.

Section 2 - If the firm "handles" (manufacture, process, blend, distribute, transport or use) prohibited materials or feeds which may contain prohibited material, complete section 2.

Question 7 - Asks if outgoing feeds that contain (or may contain) prohibited material are properly labeled with the caution statement. The first option, "No Outgoing Feeds/ Ingredients containing PM", for example, may be used when inspecting a farm that mixes its own feed. The second box, "PM is ONLY in Retail Pet/Lab Feeds" is to be used in those cases where the only prohibited material on the premises is found in pet or lab animal feed.

Question 8 - The purpose of the question is for the Investigator/ Inspector to simply note the types of recordkeeping being utilized and not to indicate their adequacy with respect to the BSE/ Ruminant Feed Regulation (21 CFR §589.2000).

Recordkeeping inadequacies should be indicated and described in Section 6. Retail sales are sales made to the ultimate consumer — people purchasing feed for their animals. g) Mark "yes" if the firm sells feed (any kind of feed, including pet food)

A single firm can be categorized as one or more firm types, so mark all firm types that are appropriate.

The BSE Checklist/Report may not fully describe the activities of certain multiple firm type combinations. Please contact your BSE District Coordinator if additional guidance is needed.

Warehouse operations should be marked as Distributor/ Retailer.

Feed mills should be described on the basis of FDA licensure and NOT on whether the firm produces medicated feeds. A single firm cannot be marked as both a licensed feed mill and an unlicensed feed mill.

Ingredient manufacturers are considered unlicensed feed mills.

Ruminant feeders (e.g. dairy farms, feedlots) might also be On-farm Mixers, but On-farm Mixers might not be ruminant feeders (e.g. swine farms). The "Feeder of Ruminants and Other Species" category has been deleted in this version of the inspection report form. If doing an inspection at a farm that does NOT feed ruminants, but does feed other species of livestock, check the "Other" box and write-in "non-ruminant feeder".

On-farm Mixing applies to mixing that is not performed for the purpose of commercial distribution. Generally the use of on-farm mixed feeds occurs on the same farm premises where the feed is made. However, in some cases feeds mixed on-farm are utilized off-premises and/or outside the direct supervision of the farm manager (e.g., a farm where mixed feeds are delivered for feeding at physically different farm locations, perhaps under a contract arrangement).

On-farm Mixers are subject to the requirements of the BSE/ Ruminant Feed regulation (21 CFR §589.2000) just like commercial feed mills.

If the firm manufactures human food, mark the Human Food Processor box.

The "Other" category should be used only for firm operations that are not described by the other categories listed. Improper use of the "Other" category may cause inaccurate and/or inadequate information to be collected in the remaining Sections.

Feed or Feed Ingredients. These are products intended to be fed to animals or used to manufacture animal feeds.

Substances intended solely for other purposes (e.g.

fertilizers) are not included in this category.

Page 7FORM FDA 3719 (10/09) but does not manufacture feed at the site. h) If you marked "yes" on g) and the only type of feed sold at the firm is pet food, mark "yes" on h) as well.

Question 9 - Commingling and cross-contamination can occur when products are processed or handled, such as with manufacturing, blending, repackaging or transporting a product.

a) Asks if the firm makes a feed product containing prohibited material AND a feed product which does not contain any prohibited material. b) Asks if the firm makes a feed product containing prohibited material AND a feed product for ruminants.

Question 10 - If the answer to 9a) is “NO”, skip to Question 11.

If 9a) is “YES”, then answer 10a) by indicating whether or not the firm has a system in place to avoid commingling and cross-contamination. Mark the boxes in 10b) that best describe the measures the firm has adopted to avoid commingling and cross-contamination. Use the narrative fields if necessary.

Question 11 - Briefly describe in writing any additional safeguards the firm may have in place to prevent outgoing feed products that contain prohibited material from being shipped to ruminant feeders.

Section 3 - This section is new and is used only for inspections at rendering establishments. If the firm is not a renderer, skip this section.

Question 12 - Mark the box that best describes the type of rendering firm being inspected. If the first four choices do not seem to describe the firm's principal activity, then mark “other” and very briefly describe the type of firm being inspected. We prefer that you mark only one box, but the question will allow you to mark more than one box if necessary.

Question 13 - If the firm processes cattle, cattle offal, or beef scraps (regardless of whatever else they do) mark “YES” and continue with section 3. If the firm does not process cattle or any cattle origin material mark “NO” and skip to Section 4.

Question 14 - Does the firm collect, receive or process cattle material prohibited in animal feed (CMPAF)? CMPAF is the brain and spinal cord of cattle 30 months of age and older, or material which may contain the brain and spinal cord of cattle 30 months of age and older. Mark “YES” or “NO”.

Question 15 - Q15a) Does the firm produce tallow (animal fat from cattle) and market it for use in animal feed? If so, mark “YES”. If Q15a) is “YES”, go to Q15b) and answer whether the tallow contains 0.15% insoluble impurities or less (meaning it may be used in ruminant feeds) or not. If Q15b) is “NO” then continue to Q15c) and answer the question about whether the caution statement “do not feed to cattle or other ruminants” is being used on the label of the tallow product.

Question 16 - This question asks if the firm differentiates cattle by age, and then if they do, what methods do they use to differentiate cattle 30 months and over from cattle under 30 months of age. If the firm does not differentiate cattle by age, mark “NO” and skip to Q17). Q16a) lists three common options, and provides a space to describe any “other” method. Mark the boxes next to those methods the firm uses. You may mark multiple boxes. If you mark “other”, please briefly describe the firm's method. Q16b) asks if the firm has written procedures explaining the process(es) used above, and Q16c) asks if they have records documenting these activities for the last year.

Mark “YES” or “NO”.

Question 17 - This question asks about the methods the firm uses to separate CMPAF from material that may be used in feed, how the firm handles it once it is separated, and whether they have written procedures and records in place. If the firm does not separate CMPAF from material that may be used in feed, mark “NO” and skip to Q18). Q17a) lists three common options, and provides a space to describe any “other” method.

Mark the boxes next to those methods the firm uses. You may mark multiple boxes. If you mark “other”, please briefly describe the firm's method. Q17b) asks whether the firm has written procedures describing their processes, and Q17c) asks whether the firm has records documenting what they have done. Mark “YES” or “NO”. Q17d) asks whether the firm has separate equipment for handling CMPAF once it has been removed, Q17e) asks whether the CMPAF is marked with the “do not feed to animals” caution statement, and Q17f) asks if the CMPAF has been dyed or stained with an agent that can be seen by visually inspecting the product. Mark “YES” or “NO” to all of these questions.

Question 18 - This question asks about the methods the firm uses to dispose of any CMPAF they may be generating. If the firm does not generate CMPAF mark “NO” and skip to Section

4. Q18a) lists four common options, and provides a space to describe any “other” method. Mark the boxes next to those methods the firm uses. You may mark multiple boxes. If you mark “other”, please briefly describe the firm's method. Q18b) asks whether the firm has records that document how the CMPAF is being disposed of, and Q18c) asks if these records demonstrate that CMPAF is not going to someone who is going to make feed with that material. Mark “YES” or “NO” to these two questions

Section 4 - This section of the checklist deals with the transportation of feeds and feed ingredients in and out of manufacturing facilities and feeding operations, including feed mills, ingredient manufacturers, and ruminant feeders. This section is not intended to be used during the inspection of firms engaged only in transportation. Transportation equipment is treated like mixing equipment, for example, and when inspecting a transportation firm you would ask the same questions about recordkeeping and cleanout asked of feed mills, renderers and other facilities that may handle prohibited material.

Question 19 - Deals with the transport of feeds and ingredients into the firm. On 19 e) only answer “yes” if EVERY inbound transporter provides written assurance that they use dedicated equipment or have adequate cleanout procedures, otherwise the answer is “no”.

Question 20 - Deals with the transport of feeds and ingredients from the firm. On 20 e) only answer “yes” if EVERY outbound transporter provides written assurance that they use dedicated equipment OR have adequate cleanout procedures, otherwise the answer is “no”.

Section 5 - This section is to be used only when the firm feeds ruminant animals.

Question 21 - Contains six questions to be answered when inspecting a ruminant feeder. a) Mark "No PM-feeds on premises" only if you found NO feed on the premises containing prohibited material, not including retail pet food intended for cats

FORM FDA 3719 (10/09) Page 8 and dogs. b) Mark "No AP-feeds on premises" only if you found NO feed on the premises containing animal protein, not including retail pet food intended for cats and dogs. c) Mark "No AP-feeds on premises" only if you found NO feed on the premises containing animal protein, not including retail pet food intended for cats and dogs. d) Are they feeding animals other than ruminants and dogs/cats? "Yes" or "No". e) Mark "No PM-feeds on premises" if the feed for the non-ruminant species does not contain prohibited material, not including retail pet food intended for cats and dogs. f) Does the firm have pet cats and/or dogs? Please answer.

Section 6 - This section should be completed for all firms, unless the firm was found to be Out of Business (OOB).

Question 22 - a) Mark the boxes for any deviations of 21 CFR §589.2000 and §589.2001 identified during the inspection. b) Is to be used to further describe any deviations identified, and to record action taken, or commitments made, by the firm in response. Issues related to 21 CFR §589.2000 and §589.2001 may be noted for firms that are not handling prohibited material.

An example would be the use of the caution statement when the firm is not handling prohibited material.

Question 23 - Are you attaching any descriptions, exhibits, records, labels or supplemental information? If so, check the box and do not forget to attach the other documents.

INSTRUCTIONS — For the District BSE Coordinator The District BSE Coordinator has a key role and overall responsibility for ensuring that BSE Reports of Inspection are completed fully and accurately, which is vital to the success of BSE compliance efforts. The District BSE Coordinator should pay particular attention to ensuring the following:

Familiarity with the Instructions for the Lead Investigator.

The most recent version of the BSE Checklist/Report and accompanying instructions are distributed and utilized.

The BSE Checklist/Report has not been unacceptably altered.

All required sections are completed. All questions within a required section are completed.

Handwritten forms are legible.

The FEI number is provided.

The FDA District Office identity is provided.

Response inconsistencies are resolved.

All completed BSE Reports of Inspection generated by State agencies should be sent to the District BSE Coordinator, not to CVM. The Districts are responsible for checking the forms for completeness and accuracy, and for entering the information into FACTS.

Any questions, concerns or comments regarding the BSE Checklist/Report or the BSE/Ruminant Feed Inspection Compliance Program should be directed to the BSE Coordinator in the appropriate District. The following individuals are additional BSE/Ruminant Feed Inspection Compliance Program contacts:

CVM: Shannon Jordre shannon.jordre@fda.hhs.gov 240-276-9229

ORA: Jim Dunnie james.dunnie@fda.hhs.gov 301-827-5652

FDA-3719.indd wwragg

FORM FDA 3719 (10/09)

Department of Health and Human Services Food and Drug Administration REPORT OF INSPECTION FOR COMPLIANCE WITH 21 CFR §589.2000 and §589.2001 PSC Graphics (301) 443-1090 EF PSC Graphics (3 0 1) 4 4 3 - 1 0 9 0 E F

FEI NUMBER:

Firm (Legal) Name Date Current Inspection Ended Lead Investigator FDA District Office Name and title of most responsible person at this site GPS Coordinates of Inspected Site Lead Affiliation (Check one) Firm State Name and title of person(s) interviewed Name and title of person or persons interviewed Operational Status (Check only one) (See Instructions) [If firm is OOB, Skip ALL Sections!] ZIP Code Telephone Number Firm (Physical) Address Firm City Federal State Agency (Enter name below) Operational Seasonal Inactive Out of Business Information above includes changes to firm's name and/or address Section 1 — Complete for ALL firms 1.

3.

a) b) d) a) A) c) Type of firm inspected? (Check ALL that apply) Does the firm receive feeds or feed ingredients that contain or may contain prohibited material (PM)? (Check only one) Does the firm handle (manufacture, process, blend, distribute, transport or use) feed or feed ingredients that are intended for the feeding of ruminant animals?

Is the firm aware of the BSE rule, 21 CFR §589.2000?

If Question 3 is "YES, but PM is only in Retail Pet/Lab Feed" or "NO," check all of the following that describe voluntary safeguards the firm has in place to assure they do not receive prohibited material.

Does the firm handle (manufacture, process, blend, distribute, transport or use) feed or feed ingredients that are intended for the feeding of non-ruminant animals?

Renderer Feed Mill (FDA Licensed) On-farm Feed Mixer Protein Blender Feed Mill (not FDA Licensed) Feeder of Ruminants Transporter (Hauler) Pet Food Manufacturer Human Food Processor Distributor/Retailer Animal Feed/Pet Food Salvager Yes Yes Yes No No No Yes YES, but PM is Only in Retail Pet/Lab Feed Written assurance from suppliers that they no longer manu- facture/distribute any products containing prohibited materials Written assurance from suppliers that they no longer manufacture/distribute any products containing prohibited materials Written procedures for the label review of incoming materials Written assurance from transporters that they do not transport products containing prohibited materials Uses only vegetable source proteins and uses no animal proteins Written assurance from transporters that they utilize dedicated transport equipment OR utilize clean-out measures that adequately prevent commingling or cross-contamination Testing of incoming materials (Please describe) Uses animal proteins only from exempted sources (Check all that apply) No Blood "Plate waste" Equine Fish Milk Porcine Poultry Gelatin Other (Specify):

2.

a) A) If the firm is manufacturing feed, does it use tallow (animal fat from cattle) in animal feed formulations?

If yes, does tallow used in ruminant feed contain not more than 0.15% insoluble impurities?

No Yes Yes Firm does not manufacture feed.

No

FORM FDA 3719 (10/09)

b) If Question 3 is either "YES, but PM is ONLY in Retail Pet/Lab Feed" or "YES", is imported prohibited material (not originating in the United States) used?

Yes No Unknown Please list the country/ies of origin for the imported prohibited material.

4.

6.

7.

8.

5.

Is the received product containing prohibited material intended ONLY for further distribution?

Are the received feeds or feed ingredients containing prohibited materials (referred to in #3 above) labeled with the caution statement, "Do not feed to cattle or other ruminants"? (Check only one) Are the outgoing feeds or feed ingredients containing prohibited materials labeled with the caution statement, "Do not feed to cattle or other ruminants"? (Check only one) Describe records the firm maintains in tracking prohibited materials throughout their receipt, processing and distribution.

Does the firm manufacture or process products containing prohibited materials?

Yes No Are ONLY retail feed sales of pet food involved?

h) Yes Yes Yes Yes Yes Yes PM is Only for Rendering No Outgoing Feeds/Ingredients containing PM PM is Only in Retail Pet/Lab Feed PM is Only in Retail Pet/Lab Feed Yes Yes Yes Yes Yes Yes No No No No No No Yes No No No No No No No Section 2 — Complete for ALL firms EXCEPT:

Firms that are ONLY Q1a) Firm Type = "Other" OR Firms that are ONLY Q1a) Firm Type = "Feeder of Ruminants" Date of receipt or purchase or sale or delivery Sequencing of feeds Name and address of the seller Flushing the system (Please describe) Name and address of the purchaser Written sequencing and flushing procedures Identification of the product Documentation maintained of sequencing and flushing Quantity Flushed materials discarded or labeled with the caution statement Copies are available for inspection and copying Physical clean-out (e.g. vacuuming, cleaning) Dedicated equipment used for prohibited materials Product containing prohibited material is always in packaged form when in the firm's possession Other (Please describe) 9.

10.

11.

a) a) b) b) Does the firm manufacture, process, blend, repackage, or transport BOTH products containing prohibited materials AND products containing only non-prohibited materials?

If the answer to Q9a) is "NO," then SKIP to Question 11.

Please describe any additional safeguards the firm has in place to assure that outgoing feeds or feed ingredients containing prohibited material are not shipped to ruminant feeders (if none, please enter "None").

Does the firm manufacture, process, blend, repackage, or transport BOTH products containing prohibited materials AND feeds or feed ingredients that may be used for ruminants?

If the answer to Q9a) is "YES," check ALL of the following that describe the measures the firm has in place to avoid commingling or cross-contamination.

If the answer to Q9a) is "YES", does the firm have a system in place to avoid commingling and cross-contamination?

a) b) c) d) e) f) Are ONLY retail feed sales involved?

Yes No g) Other (Please describe) If Question 3 is "No" or if Question 1.a) is only "Feeder of Ruminants", skip to Section 4.

Section 3 — COMPLETE this section ONLY if the firm is marked as:

Describe the firm type. (Check one, or more if applicable) 12.

Does the firm process cattle and/or cattle offal, with or without other livestock species?

13.

Q1a) Firm Type = "Renderer" Yes No Yes No Does the firm collect, receive or process material (including dead stock cattle 30 months of age or older) that contains “cattle material prohibited in animal feed” (CMPAF)?

Does the firm differentiate cattle less than 30 months old from those that are 30 months of age or older?

14.

Yes No Independent Renderer (rendering facility not affiliated with a slaughter facility) Other (Please describe) 4-D Processor (non-cooking facility) Transfer Station, Transporter Livestock Slaughter Facility with On-Site Rendering Dentition (examination of teeth) Other (Please describe) Livestock producer herd records Affidavit from supplier

FORM FDA 3719 (10/09)

a) If yes, check all of the following methods that the firm uses to differentiate cattle by age.

a) Does the firm produce tallow for use in animal feed?

15.

Yes No Yes No Yes No Yes No Yes No Yes No c) If 15(b) is “NO”, is outgoing tallow containing more than 0.15% insoluble impurities labeled with the caution statement “Do Not Feed To Cattle Or Other Ruminants”?

b) If yes, does the tallow contain not more than than 0.15% insoluble impurities?

b) Does the firm have written procedures explaining the process(es) used above?

c) Does the firm maintain records for at least one year documenting the methods noted above?

16.

If Question 13 is "No", then skip to Section 4.

Does the firm separate CMPAF from material that may be used in animal feed?

Remove striated muscle and offal from the carcass Other (Please describe) Remove only the brain and spinal cord Remove the vertebral column and head from the rest of the carcass If yes, check all of the following methods that the firm uses to separate CMPAF from material that may be used in feed.

a) Yes No Yes No b) Does the firm have written procedures explaining the process(es) used above?

c) Does the firm maintain written records for at least one year documenting the methods noted above?

Yes No f) Is the CMPAF marked with an agent that can be seen by visual inspection?

Yes No e) Is the CMPAF labeled “do not feed to animals”?

Yes No d) Does the firm have separate equipment for handling CMPAF once removed from the whole carcass?

17.

Yes No Does the firm generate CMPAF?

Landfill Other (Please describe) Rendering Alkaline or thermal digestion Incineration If yes, what method does the firm use to dispose of the CMPAF? (Check all that apply) a) Yes No Yes No b) Does the firm have records that document disposition of CMPAF?

c) Do the records demonstrate that CMPAF is not going into animal feed?

18.

FORM FDA 3719 (10/09)

Section 4 — SKIP this section when the firm is ONLY marked as:

Section 5 — Complete this section ONLY if the firm is marked as:

Section 6 — Complete for ALL Firm Types 19.

21.

20.

22.

23.

a) a) a) b) b) a) d) b) e) f) c) c) d) e) Are any incoming feeds or feed ingredients transported in bulk form?

Are ruminant feeders doing the following?

Are any outgoing feeds or feed ingredients transported in bulk form?

Check all deviations that were noted at the time of inspection.

If any deviations were noted above, describe the deviations, and the actions and commitments made to correct each deviation.

Are any outgoing feeds or feed ingredients transported in bagged/packaged form?

Observing the caution statement on feeds containing prohibited material (PM) Feeding non-ruminant species (Not including cats and dogs) Maintaining copies of labeling for feeds containing animal protein (AP) Feeding non-ruminant species (Not including cats and dogs) feeds containing prohibited material Feeding cats and/or dogs Maintaining copies of purchase invoices for feeds containing animal protein (Not including retail pet food for cats and dogs) (Not including retail pet food for cats and dogs) Does the firm utilize its own transportation vehicles for the delivery of any outgoing bulk feeds or feed ingredients?

Does the firm utilize other firms' transportation vehicles for the delivery of any outgoing bulk feeds or feed ingredients?

If 20(d) is "YES," do ALL outbound transporters provide written assurance that they utilize dedicated transport equipment OR utilize clean-out measures that adequately prevent commingling or cross-contamination with prohibited material?

Q1a) Firm Type = "Other"

OR

Q1a) Firm Type = "Feeder of Ruminants" Q1a) Firm Type = "Transporter (Hauler)" Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Outgoing Feeds/Ingredients Commingling Recordkeeping Labeling Feeding Ruminants Prohibited Material No Deviations Noted No Outgoing Feeds/Ingredients No PM-feeds on premises No AP-feeds on premises No PM-feeds on premises No AP-feeds on premises No Outgoing Feeds/Ingredients No Outgoing Feeds/Ingredients No No No No No No No No No No No No Yes Yes Yes Yes Yes No No No No No b) a) c) d) e) Are any incoming feeds or feed ingredients transported in packaged form?

Are you attaching any descriptions, exhibits, records, labeling, reports or supplemental information?

Does the firm utilize its own transportation vehicles for the delivery of any bulk incoming feeds or feed ingredients?

Does the firm utilize other firms' transportation vehicles for the delivery of any bulk incoming feeds or feed ingredients?

If 19(d) is "YES," do ALL inbound transporters provide written assurance that they utilize dedicated transport equipment OR utilize measures that adequately prevent commingling or cross-contamination with prohibited material?

FORM FDA 3719 (10/09)

INSTRUCTIONS — For the Lead Investigator District BSE Coordinator. The FDA District BSE Coordinator is responsible for communicating and receiving information related to the BSE Checklist/Report. Questions, comments and concerns should be directed to this individual. Completed BSE Reports of Inspection generated by State agencies should be mailed to the District BSE Coordinator, not to CVM. The Districts are responsible for checking the forms for completeness and accuracy, and for entering the information into FACTS.BSE Checklist/Report Version. Please make sure you are using the most current BSE Checklist/Report version. The version date is located at the bottom of the form. Check with your BSE District Coordinator or the FDA/CVM website (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052412.pdf) to make sure you are using the most recent version. Other versions may not be compatible with the BSE Checklist/Report Database and may invalidate the information collected.BSE Checklist/Report Alterations. Some agencies may choose to alter the BSE Checklist/Report to better fit their own operations. While CVM does not necessarily object to such alterations, changes must be added to the end of the form. No additions, deletions or revisions should be made to the main body of the CVM-version of the BSE Checklist/Report.Legibility. Illegible writing results in inaccurate data, which compromises the BSE Compliance Program. If you are submitting a handwritten checklist, please print your responses to the questions.Completing Sections. Sections should be fully completed for each of the firm types indicated in the header of each Section.

Sections inappropriately skipped (based on the firm type) may cause the BSE Checklist/Report to be considered incomplete. Incomplete BSE Reports of Inspection may require follow-up with the investigator and may require a follow-up inspection at the firm.Completing Questions. The BSE Checklist/Report instructions and flow of questions must be followed. Blank or unanswered required questions may cause the BSE Checklist/Report to be considered incomplete. Incomplete BSE Reports of Inspection will require a follow-up with the investigator and may require a follow-up inspection of the firm. Descriptive Fields. For those questions that ask for an explanation or description, please be brief and capture the essential elements with as few words as possible. If you feel certain answers require a more lengthy description, consider recording the information on a separate page, which should be attached to the BSE Checklist/Report and so noted in the question at the end of the checklist which asks if additional documents are attached.Additional Narrative. For those state BSE/Ruminant Feed inspections not being done under federal contract or those state contract BSE/Ruminant Feed inspections that do not include an FDA-481, it is recommended that a brief narrative report accompany the BSE Checklist/Report summarizing the inspection. A brief summary should cover the entire inspection and should include other details not captured in the Checklist/ Report.

CHECKLIST QUESTIONS

Firm information - Complete for ALL firms, regardless of the firm type.FEI Number. The FEI number is absolutely required. It is the District's responsibility to provide this information, and you may need to contact your District BSE Coordinator for this information. The District may need to assign an FEI number after the inspection is completed. For example, if the firm has not been inspected before, the District will assign an FEI number when it receives the report.Firm Name. Use the firm's accurate legal name. Do not use "Doing Business As" (DBA) firm names if at all possible.Firm Address. The address should reflect the physical location of the firm's activities. Post Office Box numbers are unacceptable. If the firm's mailing address is different than their physical address, please make a note of this information.Date Current Inspection Ended. If the inspection went more than one day, enter the date of the last day of the inspection.Lead Investigator. Enter the name of the lead investigator.Lead Affiliation. If the inspection was done by FDA, check this box. If the inspection was done by a State, check the box and write in the name of the State.

FDA District Office. Enter the name of the FDA District in which the inspected firm is located.GPS Coordinates. This information is not required by FDA at this time.Name and Title of the Person(s) Interviewed. Record the name and title of the person(s) interviewed during the inspection.Name and Title of Most Responsible Person at the Site. Record the name and title of the most responsible person at the facility, for example the firm's President or Manager. This may or may not be the person interviewed during the inspection.Operational Status. Mark the firm's operational status. Inspection reports should be completed for Seasonal and Inactive firms since they might begin production at any time. Out of Business firms require no more information gathering. Changes to Firm Name and Address. If the facility/site has a new name and/or address, please check the box indicating this and make sure the address recorded on the inspection report is correct. Please record the firm's former name and/or address somewhere in your inspection report.

FORM FDA 3719 (10/09)

Section 1 - Complete for ALL firms, regardless of the firm type (with the exception of firms which are Out of Business). Question 1a) Firm Type. Please understand the firm type categories provided and use these categories whenever applicable. More detail is provided in Compliance Program 7371.009.

Considerations List Item 1.

Question 1 - b) Further defines "handling" for better clari- fication. c) Asks whether the firm makes feed for non-ruminant animals.