Attachment_6_-_BSE_Control_Compliance_Program_(CPGM_7371.009).pdf

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM

DATE OF ISSUANCE: 10/21/2003 Page 1

FORM FDA 2438

7371.009

SUBJECT: IMPLEMENTATION DATE:

10/21/2003 BSE/Ruminant Feed Ban Inspections

COMPLETION DATE:

Continuous

DATA REPORTING

PRODUCT CODES PRODUCT/ASSIGNMENT CODES

INDUSTRY CODES:

71009 BSE/Ruminant Feed Ban Inspections Program

67, 68, 69, 70, 71, 72 71R844 BSE Import Activities CVM Products

71S007 BSE Medicated Feed State Contract Inspections (Licensed) 71S008 BSE Medicated Feed State Contract Inspections (Unlicensed) 71S009 BSE Illegal Tissue Residue State Contract Inspections

1. Field Reporting

a. Hardcopy Reports

Copies of all Warning Letters should be submitted to CVM, Division of Compliance (HFV-230) and ORA, Office of Enforcement (HFC-210)

Hardcopies of other investigational reports, including checklists and State reports should be submitted to the appropriate FDA District Office. Copies should not be submitted to

CVM (HFV-230).

b. FACTS Reporting

All BSE inspections reported in FACTS should also have a BSE checklist reported.

Similarly, no checklist can be entered in FACTS without an accompanying BSE inspection.

Report domestic sample collections/analyses under PAC 71009, and import sample collections/analyses under PAC 71R844.

DATE OF ISSUANCE: 10/21/2003 Page 2

Table of Contents

(Mouse-click, as instructed, on underlined, colored topic to move to that section.)

(Use upper left navigation arrows, if available, to return to previous section.)

TOPIC PAGE

Part I - Background 5

Part II - Implementation 7

1. Objectives. 7

2. Program Management Instructions. 7

a. Inspection Priorities. 7

b. Planning Instructions. 8

c. Program Interactions. 8

Part III – Inspectional 10

1. Operations. 10

a. Definitions. 10

b. Domestic Inspection Approach. 13

(1) Does the firm receive and/or process prohibited material? 14

(a) Does the firm handle prohibited material? – NO or DON’T KNOW 14

(b) Does the firm handle prohibited material? – YES 15

v. Label Caution Statement – 16

vi. Recordkeeping – 17

vii. Avoiding Commingling – 19

(2) Ruminant Feeders 22

(a) Prohibited Material. 22

(b) Feed Storage. 23

(c) On–Farm Mixing. 23

(3) Investigative notes. 24

(4) Reporting. 25

DATE OF ISSUANCE: 10/21/2003 Page 3

FORM FDA 2438

7371.009

(a) Checklist - Report of Inspection For Compliance With 21 CFR §589.2000. 25

(b) Other Reporting Requirements. 26

c. Import Approach. 27

(1) BSE at-risk countries 27

(2) Non-BSE at-risk countries 28

Part IV – Analytical 29

1. Analysis to be Conducted. 29

2. Sample Size. 29

3. Sample Preparation and Submission. 30

Part V - Regulatory/Administrative Strategy 31

1. Enforcement. 31

2. Charges and Enforcement Approach. 32

a. Adulteration 32

b. Misbranding 32

c. Prioritized Inspectional Violative Situations: 33

d. Provisions for Enforcement Action: 35

(1) When Ruminant Feed is Involved 37

(a) 402(a)(2)(C) Case: 37

(b) 402(a)(4) Case: 38

(c) 403(a)(1) Case: 40

(2) When Non-Ruminant Feed is Involved 41

(a) 403(a)(1) Case: 41

3. Recalls. 42

4. Refusals. 45

Part VI - References, Attachments, and Program Contacts 46

1. Program Contacts 46

DATE OF ISSUANCE: 10/21/2003 Page 4

FORM FDA 2438

7371.009

2. Attachments 49

3. Applicable References or Aids 49

Attachment A: Ruminant Feed Ban Regulation 51 Attachment B: Checklist – Report of Inspection for Compliance with 21 CFR §589.2000 56 Attachment C: Modified AOAC Official Method 964.07, Microscopy of Animal Feed, Basic

Microscopic Examination 57 Attachment D: Modified AOAC Official Method 970.09, Microscopy of Animal Feed, Identification of Mammalian Tissues and Mineral Constituents 60 Attachment E: Safety Guidance for Imported Feeds Assignment – Collection and Analysis 62 Attachment F: Import Alert #99-25 64 Attachment G: 9 CFR §94.18, USDA Restrictions on the Importation of Meat and Edible

Products from Ruminants 68 Attachment H: 9 CFR §95.4, USDA Restrictions on the Importation of Processed Animal

Protein and Other Animal Products 71 Attachment I: 21 CFR §7.40, Recall Policy 75

DATE OF ISSUANCE: 10/21/2003 Page 5

FORM FDA 2438

Part I - Background

Bovine Spongiform Encephalopathy (BSE) is the bovine form of a group of uniformly fatal neurological diseases known as Transmissible Spongiform Encephalopathies (TSEs). BSE appears to be spread through the feeding of infected material to cattle. BSE is a public health issue for the U.S. This disease has been linked to the human TSE known as variant Creutzfeldt- Jakob Disease (vCJD), presumably through people consuming ruminant tissues infected with the BSE agent. In addition, BSE has had a devastating economic effect on the livestock industry in countries where it has been identified or suspected.

On August 4, 1997, the “Animal Proteins Prohibited From Use In Animal Feeds” regulation, 21 CFR §589.2000, became effective. This regulation is designed to prevent the establishment and amplification of BSE through animal feed, by prohibiting the use of certain proteins derived from mammalian tissue in the feeding of ruminant animals. This regulation affects renderers, protein blenders, commercial animal feed manufacturers, distributors (including retailers), transporters of animal feed and feed ingredients, on-farm animal feed mixers, and ruminant feeders. Based on the acute need to control the entry and spread of this disease, the Agency has set a goal of full compliance with the regulation.

At the present time, the causative agent for BSE is not fully understood, although prions are the suspected mode of transmission of this disease. Currently, there is no direct test for the presence of the BSE prion agent in animal feed, feed ingredients, and other animal feed products. In lieu of an FDA-validated test method for detecting the presence of the agent that causes BSE, efforts are focused on prohibiting the inclusion of certain mammalian proteins in ruminant feed. Tests are presently available for identifying mammalian proteins in animal feeds. Feed microscopy is one such test method for mammalian proteins. Feed microscopy analysis is a useful tool to help ensure that product potentially contaminated with prohibited materials does not enter the U.S., and to help assure that domestic and imported products also are not adulterated with prohibited materials. Additional analytical methods are in development.

In January 1998, the FDA undertook an initiative to prevent the establishment and amplification of BSE and other TSE’s through animal feed. The Agency’s approach strongly emphasized education and incorporated training seminars, guidance documents, and the distribution of various written and printed materials. The initiative combined these educational efforts with an inspectional approach to all renderers, feed mills, protein blenders and other firms subject to this regulation.

On December 7, 2000, the USDA/APHIS enacted regulations prohibiting on the importation into the United States of all meat and bone meal (MBM), meat meal, bone meal, blood meal, tankage, offal, tallow, or any product containing such, which originated directly from countries identified as having BSE, or from countries having inadequate systems in place to prevent BSE

DATE OF ISSUANCE: 10/21/2003 Page 6

FORM FDA 2438

7371.009

(See 9 CFR §94.18 and 9 CFR §95.4). The prohibitions included all products of animal origin that were rendered or processed in these countries, regardless of species of origin, and including poultry and fishmeal unless the material is from a non-ruminant species and meets certain conditions assuring no contamination with ruminant material. These prohibitions were deemed necessary by APHIS because of the possibility of cross contamination with the BSE agent.

Subsequently, on January 20, 2001, the FDA issued Import Alert #99-25, “Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products for Animal Use Consisting or Containing Ingredients of Animal Origin.”

This compliance program guidance should be used by federal and state investigators to conduct inspections or investigations of renderers, protein blenders, licensed and unlicensed feed manufacturers, distributors, retailers, on-farm feed mixers, and ruminant feeders. The purpose of these inspections is to assess compliance with 21 CFR §589.2000. The program provides guidance for collecting evidence to support regulatory action when non-compliance is found.

In addition, this compliance program guidance should be used by import personnel in determining the appropriateness of animal feeds and feed ingredients coming into the United States. Import personnel should ensure that prohibited material does not enter the U.S from BSE-at-risk countries, unless accompanied by all relevant federally required certificates and documentation. Import personnel should also ensure that labeling for products coming in from non-BSE-at-risk countries is in full compliance with 21 CFR §589.2000 and animal feed labeling requirements.

DATE OF ISSUANCE: 10/21/2003 Page 7

FORM FDA 2438

Part II - Implementation

1. Objectives.

The primary goal of this compliance program is to enhance the FDA’s uniformity in inspection and compliance of firms subject to the regulation prohibiting the utilization of specified animal proteins in ruminant feeds, 21 CFR §589.2000. The purpose of these regulations is to prevent the establishment and/or amplification of BSE within the United States. Additional features of the compliance program are as follows:

To provide guidance to federal, state, and local officials for conducting on-site inspections of a variety of firm types, as described by the regulation.

To provide guidance for determining the need and type of enforcement action based on inspection findings.

To provide guidance on sampling and analytical methods for supporting inspection findings.

To emphasize the need for using this compliance program as a part of other inspections and compliance programs that are conducted by federal, state and local officials.

Since the threat of the introduction of BSE within the United States is an ever-present and continuing concern, this compliance program will be used on a continuing basis and incorporated into standard inspectional protocols.

2. Program Management Instructions.

a. Inspection Priorities.

The first inspectional priority under this program is to inspect those firms that have a violative history that has been classified by the FDA as “Official Action Indicated” or OAI. These inspections should be conducted with the intent that regulatory action will be pursued should the firm be unwilling or unable to take immediate actions to correct the violations.

21 CFR §589.2000 pertains to a variety of firms and animal production operations that involve the manufacture, distribution, transportation, and feeding of animal feeds.

Although the intent of the rule is to ensure that specified animal proteins are not fed to ruminant animals, the regulation is written broadly in such a way as to include some operations that do not necessarily involve ruminant feeds or the feeding of ruminant animals. Inspectional resources for surveillance are to be spent covering those firms or industries potentially having the most adverse affect on BSE prevention efforts should

DATE OF ISSUANCE: 10/21/2003 Page 8

FORM FDA 2438

7371.009 non-compliance with the regulations be encountered. In planning and prioritizing inspections, the following firm/industry types should be considered, in order of descending priority:

Follow-up to ‘OAI’ inspections Firms that have a violative history Firms handling prohibited materials (Renderers, Protein Blenders, and Feed Mills) Rendering operations Protein blenders Commercial feed mills (licensed and unlicensed) Animal feed distributors/retailers (ruminant feeds involved) Pet food/animal feed salvage operations On-farm feed mixers (ruminant and non-ruminant animals on farm premises) Haulers/transporters of animal feeds (ruminant feeds involved) Ruminant feeders (dairy cattle) Ruminant feeders (ruminants other than dairy cattle) Animal feed distributors/retailers (no ruminant feeds involved) Haulers/transporters of animal feeds (no ruminant feeds involved) On-farm feed mixers (only ruminant or no ruminant animals on farm premises)

b. Planning Instructions.

Inspection planning should generally be based on the priority of firms as listed above.

Information should be collected on whether a firm has been documented as receiving, processing or distributing prohibited material. This information can be obtained directly through the FACTS database, and through the BSE District Coordinator. A listing of these firms can also be found through the CVM Website (http://www.accessdata.fda.gov/BSEInspect/).

c. Program Interactions.

The success of this program to support the prevention of the introduction and amplification of BSE in the United States is dependent on the ability of investigators to identify violative firms and operations. While initial efforts by Federal and State investigators have identified and inspected most renderers and commercial feed mills, continued efforts are needed to identify and continue to inspect all firms subject to the regulation. Mobile feed mills, animal feed salvagers, feed distributors, feed transporters, and ruminant farms are areas that should receive additional attention. When appropriate, add-on BSE inspections should be conducted under this present program whenever the http://www.accessdata.fda.gov/BSEInspect/

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FORM FDA 2438

7371.009 opportunity presents itself and resources allow through inspections that are conducted under the following programs:

Compliance Programs

7318.003 Milk Safety Program

7371.003 Feed Contaminants Program

7371.004 Feed Manufacturing Compliance Program

7371.006 Illegal Drug Residues in Meat & Poultry Program

Guidance on inspections addressing FDA BSE efforts involving human dietary supplements can be found in the CFSAN-administered, “Dietary Supplements – Import and Domestic” compliance program (Compliance Program 7321.008).

http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm112583.htm http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/UCM170274.pdf http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm113409.pdf http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm113430.pdf http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm113433.pdf

DATE OF ISSUANCE: 10/21/2003 Page 10

FORM FDA 2438

Part III – Inspectional

1. Operations.

a. Definitions.

(1) Prohibited Material – Any protein derived from mammalian animals (Examples:

meat and bone meal; organs; offal; hair; collagen), with the following exclusions:

Blood and blood products Gelatin Inspected meat product which has been cooked and offered for human food, AND which has been further heat processed for animal feed (Examples: restaurant plate waste; cellulosic food casing; surplus from manufacturers or distributors of human food products that are prepared or offered for sale.)

Milk products (Examples: milk; milk-derived products) Any product whose ONLY mammalian protein consists entirely of porcine (pig) or equine (horse) protein.

(2) Non-Prohibited Material – For purposes of clarification, the following materials are not prohibited for use in ruminant feed under 21 CFR §589.2000:

Non-protein ingredients (Examples: fat; amino acids, bone ash; bone phosphate;

bone charcoal) Non-mammalian sources of protein (Examples: fish, poultry, vegetable) Products of mammalian origin that are not intended for use in animal feeds or feed ingredients (Example: bone meal labeled for use as a fertilizer)

These examples are not all inclusive. Any questions concerning whether certain ingredients should be considered as prohibited material should be directed to CVM, Division of Compliance.

(3) Pet Food – For the purposes of this guidance, pet food is any feed that is commercially prepared and distributed for consumption by pets. A pet is any domesticated animal normally maintained in or near the household(s) of the owner(s) thereof. Examples include dogs, cats, rats, mice, hamsters, gerbils, rabbits, ferrets, nonhuman primates, canaries, psittacine birds, mynahs, finches, tropical fish, goldfish, snakes, and turtles. Horses or other equids are not considered to be pets within this guidance because they are routinely slaughtered for human food.

(4) Ruminant - Ruminant includes any member of the order of animals that has a stomach with four chambers (rumen, reticulum, omasum, and abomasum) through

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FORM FDA 2438

7371.009 which feed passes in digestion. The order includes, but is not limited to, cattle, buffalo, sheep, goats, deer, elk, and antelopes.

(5) Renderer - Renderer means any firm or individual that processes slaughter byproducts, animals unfit for human consumption or meat scraps. The term includes persons who:

Collect such materials and subject them only to minimal processing. With respect to rendering practices, “minimal processing” should be considered as the process of applying heat to raw materials for the purpose of removing the moisture and fat from the solid protein portion of animal tissues.

Collect such materials and distribute them to firms other than renderers (as defined here) whose intended use for the products may include animal feed. This definition should be interpreted to include any firm or individual that provides ingredients or raw materials to a pet food manufacturer, regardless of whether the material has been minimally processed.

Are renderers that also blend animal protein products.

Collectors are generally not subject to the regulation since (1) they do not minimally process their collected animal waste materials; and (2) they distribute their collected animal waste materials only to renderers. However, any collector who additionally distributes collected material directly to a non-rendering firm (e.g., a pet food manufacturer) should also be considered a renderer under 21 CFR §589.2000(a)(2), and, therefore, subject to the full provisions of the regulation.

While pet food manufacturing may involve the application of heat to raw materials, pet food manufacturing operations are not generally considered as rendering, unless the purpose of the process is to produce product that contains a stable protein ingredient. Cooking is not necessarily synonymous with rendering. As such, collectors or firms distributing animal waste materials directly to pet food manufacturers should not seek to avoid the requirements of 21 CFR §589.2000(d) by claiming that the pet food manufacture destination solely consists of rendering operations.

Slaughter facilities do not collect animal waste materials, but rather generate these materials as byproducts of their operations. In contrast, dead stock processing operations (e.g., 4-D plants) are subject to the regulation, since they process animal waste materials or byproducts (e.g. dead animals, animal carcasses), but do not produce them themselves. The rule regulates firms beginning at the level of the renderer. Outgoing materials from inspected slaughter facilities, therefore, do not require the caution statement under the regulation, regardless of their destination.

However, we recognize that in some instances, both slaughter and rendering

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FORM FDA 2438

7371.009 operations may take place on the same premises. In these instances, the regulation will apply to all operations that occur within the recognized rendering facilities.

In general, a slaughterhouse, collector, dealer, hauler or anyone else who supplies a renderer with material to be rendered is not subject to the specific requirements of this regulation. However, the renderer has a responsibility to seek assurance from the supplier of non-prohibited material that the nonmammalian, pure porcine or pure equine materials come from single-species slaughter facilities. Assurance might include a certificate from the supplier, or specification of source in a business contract.

Note: Collectors are generally not subject to the regulation since (1) they do not minimally process their collected animal waste materials; and (2) they distribute their collected animal waste materials only to renderers. Collecting activities might include processes such as skinning, salting, cutting, or trimming. Nevertheless, while collectors may not be subject to the regulation, the responsibility is placed on renderers to ensure that all carcasses and waste products obtained from collectors indeed do not contain any prohibited material. This could include a certification from the supplier, or specification of source in a business contract.

(6) Feed Manufacturer - Feed manufacturer includes manufacturers of complete and intermediate feeds intended for animals, and includes on-farm, in addition to off-farm, feed manufacturing and mixing operations. The term includes manufacturers of pet food and laboratory animal feed.

(7) Distributor - Distributors include persons who distribute or transport feeds or feed ingredients intended for animals. The term includes retailers of feeds and feed products; the distribution activities of blenders and feed manufacturers; and transporters of animal feed and feed ingredients.

(8) Transporter – Transportation may occur by roads, rails, water or air. While the regulation covers all transportation activities, inspectional efforts should be preferentially directed to activities in which loose or bulk animal feeds or feed ingredients are handled, since these activities may result in commingling or cross-contamination of feeds not containing prohibited materials with feeds containing prohibited material.

(9) Ruminant Feeder – A ruminant feeder is any establishment or individual that is responsible for feeding ruminant animals. Examples include, but are not limited to:

dairies, cattle feedlots, calf and lamb raising operations, and the general feeding of ruminants, such as cattle, buffalo, sheep, goats, deer, elk, and antelopes.

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FORM FDA 2438

b. Domestic Inspection Approach.

Investigators are encouraged to use their knowledge, training, and experience in assessing compliance with the BSE regulations, as the requirements pertain to a wide variety of firm types. Although inspections will focus on key operational areas such as raw materials, processing methods and equipment, record keeping and labeling, investigators are cautioned to be alert and pursue any information that might indicate a potential violation of 21 CFR §589.2000. Investigators are expected to assess current systems of the firm (operational practices and procedures), to ensure they are effective and being followed. The results of inspections conducted under this program should be recorded on the checklist (See Attachment B), and violative observations noted in the FDA form 483, AND fully described in the EIR.

Federal-State Interactions - Districts are strongly encouraged to work with their State counterparts in trying to address any violative situation through a joint State enforcement approach. If a District encounters a violative operation that does not engage in interstate commerce and the State is unable to take action, contact CVM, Division of Compliance for further instructions. Examples of when State involvement should be considered include:

Obtaining embargoes or stop-sale orders in advance of a seizure;

Seeking state intervention if their laws or regulations can lead to removal of product from distribution channels in a more expedient manner;

Obtaining suspension or withdrawal of a State feed manufacturing license;

When interstate commerce cannot be established.

DATE OF ISSUANCE: 10/21/2003 Page 14

Conducting a Domestic Inspection:

(1) Does the firm receive and/or process prohibited material?

In obtaining an answer to this question, also ask

What kind of protein do they receive?

If they receive mammalian protein, what kind of mammalian protein?

If the answer to question (1) is NO or DON’T KNOW, proceed to Section (1)(a).

If the answer to question (1) is YES, proceed to Section (1)(b).

Note: If this is an initial inspection, be sure to discuss the requirements of the BSE regulation and leave a copy of the regulation and appropriate Small Entities Compliance Guides, which are located on the CVM website.

(a) Does the firm handle prohibited material? – NO or DON’T KNOW

If the answer to (1) Is NO, they do not receive and/or process prohibited material, OR they do not know, verify the firm’s status by means of the following:

i. Inspect the facility, carefully observing the materials in the receiving and storage areas. Pay particular attention to the raw material coming in and any material waiting to be processed.

ii. Do you see any prohibited material? If YES, copy the records showing receipt of this material, including, if available, documentation of inter-state commerce, document for possible enforcement action, and proceed to Section (1)(b).

iii. Review a representative number of the firm’s receiving records and/or invoices for the incoming material, going back up to one year or to the last inspection date. Do these records show receipt of prohibited material? If YES, copy the records, begin documenting for possible enforcement action, and proceed to Section (1)(b).

iv. If the firm is a renderer, protein blender, or feed mill, list and document all animal species for which feeds are manufactured by the firm. Does the firm manufacture and/or distribute feed or feed ingredients intended for ruminant animals?

http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm

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7371.009

v. Determine what procedures or safeguards, if any, the firm has in place to ensure it does not receive prohibited material. Describe the safeguards or procedures in your report. Examples of safeguards and procedures are as follows:

Written assurance from supplier that they no longer manufacture any products containing prohibited materials Labeling review of incoming materials Uses only vegetable source proteins Uses pure animal proteins only from exempted sources (examples:

porcine, equine, poultry, fish, gelatin) Analyzes incoming product

(b) Does the firm handle prohibited material? – YES

i. Obtain information about the source of the prohibited material.

Is it from a domestic, single source? Is it from a domestic, mixed source? Is it from a foreign source and if so, from what country or countries?

Note: The firm bears the burden of ensuring the safety of its products.

This includes the ability to identify the source of the prohibited material.

ii. Inspect the facility, carefully observing the materials in the receiving and storage areas. Pay particular attention to the raw material coming in and any material waiting to be processed.

iii. List and document all the species for which animals feeds are manufactured by the firm.

iv. The remaining inspection should focus on the three primary aspects of the regulation:

Label caution statement requirement Recordkeeping requirements Requirements for avoiding commingling

DATE OF ISSUANCE: 10/21/2003 Page 16

v. Label Caution Statement -

A. Review a representative copy of the label for each INCOMING product (raw materials and finished products) that contains prohibited material. Note whether each label bears the required caution statement, “Do not feed to cattle or other ruminants.'' In the case of raw or bulk ingredients, labeling may consist of a placard or other labels attached to the invoice or delivery ticket, or manufacturer's invoice that identifies the animal feed or feed ingredient. If the required caution statement is not present, collect copies of all violative labels, document for possible enforcement action, and perform a trace back/trace forward as indicated by the findings. If, through tracing, it is determined that prohibited material was used in the production of ruminant feeds or was fed to ruminants, proceed to document for legal action and as directed under the BSE recall strategy (See Part V – Section 3, “Recalls”).

Note: Since collectors who do not minimally process their collected animal waste materials AND who distribute their collected animal waste materials only to renderers are not subject to 21 CFR §589.2000, prohibited materials received by renderers from collectors are not expected to bear the caution statement.

Note: All products received at pet food/animal feed salvagers that contain or may contain prohibited material must bear the required caution statement. Only pet food that is intended for retail sale and nonrumimant laboratory animal feed are exempt from this requirement. Pet foods sold as distressed or salvaged items are not considered intended for retail sale as pet foods, and therefore must be labeled with the required caution statement.

B. Review a representative copy of the label for each OUTGOING product that contains prohibited material. Note whether each label bears the required caution statement, “Do not feed to cattle or other ruminants.'' In the case of raw or bulk ingredients, labeling may consist of a placard or other labels attached to the invoice or delivery ticket, or manufacturer's invoice that identifies the animal feed or feed ingredient. If the required caution statement is not present, document for possible enforcement action, and perform a trace back/trace forward as indicated by the findings. If through tracing, it is determined that prohibited material was used in the production of ruminant feeds or was fed to ruminant animals, DATE OF ISSUANCE: 10/21/2003 Page 17

7371.009 proceed with evidence collection to support legal action and as directed under the BSE recall strategy (See Part V – Section 3, “Recalls”).

Is the caution statement displayed in a conspicuous or prominent manner? If the answer is NO, collect evidence for evaluation.

Discuss with the firm as to their rationale or intent in displaying the statement in this manner.

Note: Only pet food that is intended for retail sale and nonrumimant laboratory animal feed are exempt from the caution statement requirement. Pet foods sold as distressed or salvaged items are no longer intended for retail sale as pet foods, and therefore must be labeled with the required caution statement.

Manufacturers, distributors and retailers of pet food should be evaluated for existing procedures/controls to ensure that the required caution statement is placed on pet foods that are salvaged or distressed.

Product for Export - Prohibited material products destined for export must be labeled that they are intended for export, such as with the statement, “For Export Only.” This marking should be clear and conspicuous. The label should be placed on the shipping packages or, if the exported product does not have a shipping package or container, on shipping invoices or other documents accompanying the exported product, as allowed under 21 CFR 1.101(b)(3). Other legal requirements for exported products should also be met. The caution statement is not required on products for export.

Any prohibited material product that was destined for export but is diverted back into domestic commerce for any reason (e.g. salvage, quality), will be subject to all the requirements of the regulation.

vi. Recordkeeping -

A. Review a representative number of receipt, processing, and distribution records for incoming prohibited material AND outgoing processed product containing the prohibited material.

Records may include invoices, receiving tickets, receiving logs, DATE OF ISSUANCE: 10/21/2003 Page 18

7371.009 disbursement records, weight tickets, purchase orders, and other business records or documents.

An invoice or other similar document reflecting receipt of purchase, and sale or delivery of the products usually satisfies this requirement by the firm. The documents should be available for inspection and copying. Specifically, you should note whether the documents include:

Date of receipt or purchase or sale or delivery of the product Name and address of the seller Name and address of the consignee Identification of the product Quantity of the product

Note additionally whether ONLY retail sales of prohibited material are involved. You should take into consideration whether recording the name and address of the consignee may not be feasible or practical for firms that are only involved with retail sales.

B. The firm must maintain records sufficient to track the prohibited material through the receipt, processing and distribution of the feed material, and make these records available for inspection and copying per 21 CFR §589.2000(c)(1)(ii), and also required by 21 CFR §589.2000(d)(1) and 21 CFR §589.2000(e)(1)(i). The required records must be kept for a minimum of one year per 21 CFR §589.2000(h)(1). More specifically, all records related to the receipt, processing, and distribution of a single outgoing product should be retained on the premises for not less than one year after the date of the shipment of the product. The records should be legible and kept in a clean and orderly manner.

Note: Pet food that is intended for retail sale and non-ruminant laboratory animal feed is exempt ONLY from the caution statement requirement. All firms manufacturing and/or distributing pet food and non-ruminant laboratory animal feed are subject to ALL recordkeeping requirements described above per 21 CFR §589.2000(c)(1)(ii), as required by 21 CFR §589.2000(d)(1) and 21 CFR §589.2000(e)(1)(i).

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7371.009

C. If the firm fails to meet some or all of the above requirements, document for possible enforcement action.

D. Records of the interstate movement of food and the holding thereof during and after such movement must be made available for inspection and copying under Section 704 of the Act. Should the firm refuse access to or copying of such records, Districts should contact the FDA/Office of Enforcement (OE) to determine whether it would be appropriate to obtain an inspection warrant under Section 704. The investigator should first make a verbal request for the records. If this request is refused, recommend to OE/DCMO that an administrative inspection warrant be obtained to gain access to the required records (See Chapter 6, Regulatory Procedures Manual (RPM)) for instructions on recommending inspection warrants).

E. These records are used to determine current compliance with the rule. If there are NO RECORDS, document for possible enforcement action

vii. Avoiding Commingling -

A) Determine whether the firm manufactures, processes, blends and distributes BOTH products containing prohibited material AND products containing only non-prohibited materials. If the answer is YES, consider the following:

The firm can only avoid commingling or cross-contamination of ruminant feed with prohibited material by one of two methods, either:

the use of separate equipment [21 CFR 589.2000(e)(1)(iii)(A)];

or the use of the same equipment with adequate clean-out procedures that prevent carry-over of prohibited material into the ruminant feed [21 CFR §589.2000(e)(1)(iii)(B)]

B) Inspect incoming material receipt and storage areas, product processing and finished product storage areas. Describe the separation system and procedures to avoid commingling and cross contamination (dust control, separate equipment and/or buildings, http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176735.htm

DATE OF ISSUANCE: 10/21/2003 Page 20

7371.009 and other controls on incoming and finished product identification and storage).

C) For Renderers, determine whether the firm receives non-prohibited material that consists ONLY of non-mammalian protein, pure pork, or pure-equine materials from single-species slaughter facilities, as is required by 21 CFR §589.2000(e)(1)(ii).

D) Firms Avoiding Commingling with Separate Equipment –

Firms might use separate equipment or facilities for the intended manufacture, processing, and blending (including storage) of products containing prohibited material AND products containing only non-prohibited materials. Separation can consist of entirely separate buildings, rooms or other locations; or separate storage containers for incoming material and finished product, and separate manufacturing lines.

Separate equipment should be clearly identified to ensure that prohibited material is not accidentally added to non-prohibited material production runs.

E) Firms Avoiding Commingling with Adequate Clean-out

Procedures - If the same equipment is shared for BOTH products containing prohibited material AND products containing only non-prohibited material, describe the clean-out procedures. Clean-out can consist of physical cleaning (e.g. vacuuming, sweeping, washing), flushing, sequencing, or other means, either alone or in combination with separation measures, that are adequate to prevent carryover of prohibited material into runs that are intended to be free of prohibited material. Clean-out procedures should be used on all equipment and conveyances (e.g. trucks, rail cars) that handle both prohibited material and non-prohibited material.

Flushing with a complete change of operating volume will generally be considered as adequate clean-out. However, other practices used by the firm may also be considered as adequate clean-out. These firms should consider the unique characteristics of their operational equipment in determining alternative clean-out procedures. Any practice ultimately used for cleaning out the system should be based on a documented rationale, analysis, or tests by the firm of the adequacy of the clean-out process. Try to obtain documentation of sequencing practices.

DATE OF ISSUANCE: 10/21/2003 Page 21

Flushing procedures, in particular, should take into account the type of flush material used, and the time and volume requirements of the flush as is appropriate for the operational equipment. Firms should also have documented procedures describing how the flush materials are subsequently processed, including storage and labeling of the materials, utilization in other feeds, and/or appropriate disposal (e.g., incineration, landfill).

Determine whether the firm maintains written procedures or SOPs specifying all aspects of clean-out and other practices for separating prohibited material from non-prohibited material from the time of receipt until the time of shipment as required in 21 CFR §589.2000(e)(1)(iv) and, if so, try to collect a copy of the SOPs.

SOPs or documentation for clean-out should include:

how the clean-out is implemented;

who is responsible;

how the clean-out is monitored, recorded, and verified;

a description of how flush material is subsequently handled;

the rationale, analysis or test for determining the adequacy of the clean-out process.

F) If the inspection finds no controls or inadequate controls in place to prevent commingling or cross-contamination between product containing prohibited material and product containing non-prohibited material, document the violation(s) for regulatory action.

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(2) Ruminant Feeders.

The regulation, 21 CFR §589.2000(f), requires that ruminant feeders:

Maintain copies of purchase invoices of all feeds containing animal proteins received;

Maintain labeling for all feeds containing animal protein products received;

Make all copies available for inspection and copying;

Maintain these records for a minimum of one year.

The primary intent of 21 CFR §589.2000 is to prevent prohibited material products being fed or recycled back to ruminant animals. However, the above regulatory requirements for ruminant feeders primarily address recordkeeping, and do not directly address some of the feeding and storage practices that occur in ruminant operations. The investigator should be aware of the actual requirements under this regulation. Nevertheless, the investigator should take the opportunity to observe whether on-farm practices are sufficient for ensuring that prohibited material is not fed, intentionally or unintentionally, to ruminant animals. While the regulation may not necessarily address all aspects of the following observational areas, the investigator should nevertheless consider discussing the importance of these areas with the ruminant feeder.

a. Prohibited Material.

The investigator should determine whether any feed containing prohibited material is present on the farm premises. 21 CFR §589.2000(f) states that establishments and individuals are responsible for maintaining copies of purchase invoices and labeling for all feeds containing animal protein products received.

Investigators encountering situations where prohibited material has been fed to ruminants should consult with CVM. CVM will consult with the USDA, Food Safety and Inspection Service (FSIS) for determining the most appropriate course of regulatory action.

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b. Feed Storage.

Feed storage, particularly in operations where both ruminant and non-ruminant species are being fed, should be examined. If ruminant feeds and non-ruminant feeds are stored in the same location, the investigator should note the procedures used for ensuring that ruminant animals are not fed non-ruminant feeds and should take photographs or draw diagrams of feed bins and equipment. In particular, investigators should note whether:

Feed bins are labeled to identify ruminant and non-ruminant feed. (This is not required by 21 CFR §589.2000 but will help the investigator determine whether ruminants have been fed non-ruminant feed.)

Bulk feeds for ruminants are separated from non-ruminant feeds for preventing mix-up, commingling and/or cross-contamination (This is not required by 21 CFR §589.2000 but will help the investigator determine whether ruminants have been fed non-ruminant feed.)

Transportation and feed equipment handling both ruminant and non-ruminant feeds is either separate or adequately cleaned (See Section (2)(c)).

c. On–Farm Mixing.

Special attention should be placed on farm operations that are mixing rations for both ruminant and non-ruminant animals particularly if prohibited materials are contained in any of the feeds or feed ingredients. On-farm mixing operations should be examined in a manner and to an extent similar to that for commercial feed mills. If prohibited materials are involved in on-farm mixing operations, the farm is subject to the manufacturing requirements of commercial feed mills. If prohibited materials are involved, refer to Section (1)(b) of this guidance subpart.

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(3) Investigative notes.

(a) Records of the interstate movement of food and the holding thereof during and after such movement must be made available for inspection and copying under Sections 703 and/or 704 of the Act. Should the firm refuse access to or copying of such records, Districts should contact the FDA/Office of Enforcement (OE) to determine whether it would be appropriate to obtain an inspection warrant under Section 704. If, however, FDA relies on Section 703 to inspect the records, the agency may not use the records or any evidence derived from the records in a criminal prosecution of the person from whom the records were obtained. The investigator should first make a verbal request for the records. If this request is refused, recommend to OE that an administrative inspection warrant be obtained to gain access to the required records (See Chapter 6, Regulatory Procedures Manual (RPM)) for instructions on recommending inspection warrants).

(b) Any violation of the requirements of 21 CFR §589.2000 should be listed on the

FDA-483 and fully documented. Collect documentary (DOC) samples to support possible regulatory action. (See IOM, Chapter 4 for instructions on collecting DOC samples.)

(c) All violations of 21 CFR §589.2000 should be considered as potentially serious.

However, in consideration of the wide variety of violative situations possible, the investigator should use the attached prioritized listing of possible situations (See Part V, Section 2c – Prioritized Inspectional Violative Situations). The investigator should note the observations and collect documentary samples required for each situation.

(d) Certain violative situations may later require feed analysis to determine whether the suspect feed or feed ingredient may contain prohibited material. In anticipation of case development, the investigator should consider obtaining feed samples for analysis (See Part IV – Analytical).

http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176735.htm http://www.fda.gov/ICECI/Inspections/IOM/ucm122526.htm

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(4) Reporting.

(a) Checklist - Report of Inspection For Compliance With 21 CFR §589.2000.

The checklist entitled, “Report of Inspection For Compliance With 21 CFR §589.2000 (See Attachment B),” should be completed for all inspections or investigations conducted under this Compliance Program.

The most recent version of the checklist is available at the CVM Website (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM0 52412.pdf). Periodically reference this Website to ensure that you are using the most current version. The checklist is accompanied by instructions. The difficulties in using a simple checklist to adequately describe the operations of a large variety of firm types necessitate that the instructions be understood. All investigators should be provided with a copy of the checklist that includes these instructions.

The primary purpose of the checklist is to provide general guidance to investigators to assess firm operations and to facilitate quality assurance in the administration of this Compliance Program. While all deviations from the Ruminant Feed Ban regulation should be clearly noted on the checklist, investigators should not depend solely on the checklist to determine compliance status. Ascertaining the initial classification of compliance status will depend primarily on the experience of the investigator and familiarity with this Compliance Program, with subsequent supervisory and compliance review.

Districts are responsible for archiving all inspectional documents and for entering information into FACTS. No materials should be sent to CVM, unless otherwise requested. All completed checklists, along with endorsed EIRs or memos of investigation, and FDA-483 forms should be sent by States to the FDA District BSE Monitor and not to CVM. The BSE District Monitors, or their designees, will be responsible for checking the State checklists and inspectional information for completeness and accuracy. Timeliness of entry into FACTS should take into consideration the type of violations that were noted during the inspections. In general, inspections and checklists for violative firms should be entered into FACTS within ten (10) days after receipt.

Checklists for FDA-conducted inspections should be entered into FACTS by the lead investigator. Checklists for State-conducted inspections should be entered into FACTS by District personnel having the appropriate FACTS BSE entry role.

The anticipated development of the new e-SAF system (electronic State access to http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052412.pdf http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052412.pdf

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7371.009

FACTS) should provide States with the capability of direct checklist input into the FACTS system.

The full and accurate completion of the checklist is essential to successfully maintain this compliance program. Entry of the checklist information allows for further analysis of inspectional findings on a nationwide basis. In addition to identifying firms requiring additional enforcement action, the database allows for trend analysis of certain segments of the industry and of compliance with certain aspects of the Ruminant Feed Rule. No inspections or investigations conducted under this program can have an administrative status of ‘completed’ unless an accompanying checklist has been entered into the FACTS system. Similarly, based on database design requirements, incomplete checklists cannot be entered into the FACTS module.

The checklists and other information submitted under this program are used solely within the confines of this Compliance Program. Information that pertains to other Compliance Programs or FDA activities generally will not be forwarded to those respective programs. Information should not be submitted that is intended for review under other compliance programs. Copies should be made of all necessary documents for simultaneous submission to those other programs, as required.

(b) Other Reporting Requirements.

Be sure to report time spent on the inspection under the PAC Code for BSE inspections. Note that the FACTS BSE module will not be available unless a BSE PAC code has been identified on the FACTS inspectional coversheet. If the inspection covers multiple programs, report time spent on this part of the inspection separately. Individual FDA District Offices and States may have additional reporting requirements. Any questions or problems that arise concerning inspections, reporting, or enforcement issues should be directed to the contacts listed in this program (See Part VI – Section 1, “Program Contacts”).

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c. Import Approach.

(1) BSE affected and BSE-at-risk countries

Import Alert #99-25 (“Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products for Animal Use Consisting or Containing Ingredients of Animal Origin”) describes FDA's import enforcement efforts to detain products that appear to violate 21 CFR § 589.2000 and to support the USDA/APHIS prohibition of…