+----------------+--------------------------+--------------------------+
| **SUBJECT:**   |                          | **IMPLEMENTATION DATE:** |
|                |                          |                          |
| ###### BSE/R   |                          | **10/21/2003**           |
| uminant Feed B |                          |                          |
| an Inspections |                          |                          |
+----------------+--------------------------+--------------------------+
|                |                          | **COMPLETION DATE:**     |
|                |                          |                          |
|                |                          | ######                   |
+----------------+--------------------------+--------------------------+
| ######         |                          |                          |
| DATA REPORTING |                          |                          |
+----------------+--------------------------+--------------------------+
| **PRODUCT      | **PRODUCT/ASSIGNMENT     |                          |
| CODES**        | CODES**                  |                          |
+----------------+--------------------------+--------------------------+
| **INDUSTRY     | > **71009** BSE/Ruminant |                          |
| CODES:**       | > Feed Ban Inspections   |                          |
|                | > Program                |                          |
| 67, 68, 69,    | >                        |                          |
| 70, 71, 72     | > **71R844** BSE         |                          |
|                | > [Import]{.underline}   |                          |
|                | > 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]{.underline}**

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a.  **[Hardcopy Reports]{.underline}**

> 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]{.underline}**

> 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]{.underline} sample collections/analyses under PAC
> 71009, and [import]{.underline} sample collections/analyses under PAC
> 71R844.

[Number range CHAPTERTable of Contents]{.underline}

(Mouse-click, as instructed, on [underlined]{.underline}, 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](#PIBackground)](#PIBackground)

[**Part II - Implementation [7](#PIIImplentation)**](#PIIImplentation)

1.  [Objectives. [7](#_Ref16485156)](#_Ref16485156)

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2.  [Program Management Instructions. [7](#_Ref16485179)](#_Ref16485179)

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a.  [Inspection Priorities. [7](#_Ref16485196)](#_Ref16485196)

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b.  [Planning Instructions.](#_Ref16485217) [8](#_Ref16485240)

c.  [Program Interactions. [8](#_Ref16485240)](#_Ref16485240)

    [**Part III -- Inspectional
    [10](#PIIIInspectional)**](#PIIIInspectional)

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1.  [Operations](#_Ref16484351). [10](#_Ref16484351)

# [**Definitions**](#definitions.). [10](#definitions.)

a.  [Domestic Inspection Approach. [14](#_Ref16485687)](#_Ref16485687)

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(1) [**Does the firm receive and/or process prohibited material?**
    [15](#PM)](#PM)

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(a) [Does the firm handle prohibited material? -- NO or DON'T KNOW
    [15](#_Ref16485720)](#_Ref16485720)

(b) [Does the firm handle prohibited material? -- YES
    [16](#PMYes)](#PMYes)

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v.  [Label Caution Statement -- [17](#Label)](#Label)

vi. [Recordkeeping](#_Ref16485748) -- [18](#_Ref16485748)

vii. [Avoiding Commingling -- [20](#_Ref16485764)](#_Ref16485764)

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(2) [Ruminant Feeders [23](#_Ref16485795)](#_Ref16485795)

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(a) [Prohibited Material. [23](#_Ref16485808)](#_Ref16485808)

(b) [Feed Storage.](#RFFS) [24](#RFFS)

(c) [On--Farm Mixing.](#_Ref16485835) [24](#_Ref16485835)

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(3) [Investigative notes. [25](#_Ref16485923)](#_Ref16485923)

(4) [Reporting. [26](#_Ref16485942)](#_Ref16485942)

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(a) [Checklist - Report of Inspection For Compliance With 21 CFR
    §589.2000.](#_Ref16485953) [26](#_Ref16485953)

(b) [Other Reporting Requirements. [27](#_Ref16485969)](#_Ref16485969)

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b.  [Import Approach. [28](#_Ref16486022)](#_Ref16486022)

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(1) [BSE at-risk countries](#_Ref16486035) [28](#_Ref16486035)

(2) [Non-BSE at-risk countries [29](#ImportNonBSE)](#ImportNonBSE)

## [*Part IV -- Analytical* [30](#PIVAnalytical)](#PIVAnalytical) {#part-iv-analytical-30 .unnumbered}

1.  [Analysis to be Conducted. [30](#_Ref16486077)](#_Ref16486077)

2.  [Sample Size.](#_Ref16486335) [30](#_Ref16486335)

3.  [Sample Preparation and Submission.
    [31](#_Ref16486686)](#_Ref16486686)

## [*Part V - Regulatory/Administrative Strategy* [32](#PVRegAdm)](#PVRegAdm) {#part-v---regulatoryadministrative-strategy-32 .unnumbered}

1.  [Enforcement](#_Ref16486760). [32](#_Ref16486760)

2.  [Charges and Enforcement Approach.
    [33](#_Ref16486824)](#_Ref16486824)

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a.  [Adulteration](#_Ref16486835) [33](#_Ref16486835)

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a.  [Misbranding [33](#_Ref16486846)](#_Ref16486846)

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c.  [Prioritized Inspectional Violative Situations:](#_Ref16486917)
    [34](#_Ref16486917)

d.  [Provisions for Enforcement Action:
    [36](#_Ref16486943)](#_Ref16486943)

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(1) [When Ruminant Feed is Involved [38](#EnfActRF)](#EnfActRF)

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(a) [402(a)(2)(C) Case:](#_Ref16486961) [38](#_Ref16486961)

(b) [402(a)(4) Case: [39](#RFa4)](#RFa4)

(c) [403(a)(1) Case:](#_Ref16486973) [41](#_Ref16486973)

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(2) [When Non-Ruminant Feed is Involved [42](#EnfActNRF)](#EnfActNRF)

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(a) [403(a)(1) Case:](#_Ref16487523) [42](#_Ref16487523)

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3.  [Recalls](#_Ref16487537). [43](#_Ref16487537)

4.  [Refusals](#Refusals). [46](#Refusals)

###### [Part VI - References, Attachments, and Program Contacts [47](#part-vi---references-attachments-and-program-contacts)](#part-vi---references-attachments-and-program-contacts) {#part-vi---references-attachments-and-program-contacts-47 .unnumbered}

1.  [Program Contacts [47](#_Ref16487576)](#_Ref16487576)

2.  [Attachments](#Attachments) [49](#Attachments)

3.  [Applicable References or Aids [49](#_Ref16487666)](#_Ref16487666)

[Attachment A: Ruminant Feed Ban Regulation
[51](#AttachReg)](#AttachReg)

[Attachment B: Checklist -- Report of Inspection for Compliance with 21
CFR §589.2000](#AttachChecklist) [56](#AttachChecklist)

[Attachment C: Modified AOAC Official Method 964.07, Microscopy of
Animal Feed, Basic Microscopic Examination
[57](#AttachBasic)](#AttachBasic)

[Attachment D: Modified AOAC Official Method 970.09, Microscopy of
Animal Feed, Identification of Mammalian Tissues and Mineral
Constituents](#AttachMammalian) [60](#AttachMammalian)

###### [**Attachment E: Safety Guidance for Imported Feeds Assignment -- Collection and Analysis** [62](#attachment-e)](#attachment-e)

[Attachment F: Import Alert #99-25 [64](#AttachAlert)](#AttachAlert)

[Attachment G: 9 CFR §94.18, USDA Restrictions on the Importation of
Meat and Edible Products from Ruminants
[68](#AttachUSDA1)](#AttachUSDA1)

[Attachment H: 9 CFR §95.4, USDA Restrictions on the Importation of
Processed Animal Protein and Other Animal Products](#AttachUSDA2)
[71](#AttachUSDA2)

[Attachment I: 21 CFR §7.40, Recall Policy](#AttachRecallReg)
[75](#AttachRecallReg)

[]{#PIBackground .anchor}**[Part I - Background]{.underline}**

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](#AttachReg), 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 (See [9 CFR §94.18](#AttachUSDA1) and [9 CFR
§95.4](#AttachUSDA2)). 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](#AttachAlert), "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](#AttachReg). 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](#AttachReg) and animal feed
labeling requirements.

[]{#PIIImplentation .anchor}**[Part II - Implementation]{.underline}**

1.  []{#_Ref16485156 .anchor}**[Objectives]{.underline}.**

> 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](#AttachReg). 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.  []{#_Ref16485179 .anchor}**[Program Management
    Instructions]{.underline}.**

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a.  []{#_Ref16485196 .anchor}**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](#AttachReg) 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 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

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-   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.  []{#_Ref16485217 .anchor}**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.fda.gov/cvm/default.html>).

c.  []{#_Ref16485240 .anchor}**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 opportunity
    presents itself and resources allow through inspections that are
    conducted under the following programs:

#####  Compliance Program  {#compliance-program .unnumbered}

#### 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

7371.008 National Drug Residue Milk Monitoring 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).

[]{#PIIIInspectional .anchor}**[Part III -- Inspectional]{.underline}**

1.  []{#_Ref16484351 .anchor}**[Operations.]{.underline}**

# 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](#AttachReg):

-   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](#_Ref16487576).

(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 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.

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-   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)](#AttachRega2), 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)](#AttachRegd) 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
    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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a.  []{#_Ref16485687 .anchor}**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](#AttachReg). 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](#AttachChecklist)), 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](#_Ref16487576) 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.

###### [Conducting a Domestic Inspection]{.underline}:  {#conducting-a-domestic-inspection .unnumbered}

(1) []{#PM .anchor}[Does the firm receive and/or process prohibited
    material]{.underline}?

    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)](#_Ref16485720).

    If the answer to question (1) is **YES**, proceed to [Section
    (1)(b)](#PMYes).

    **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](http://www.fda.gov/cvm/index/bse/bse_guidance.htm), which
    are located on the CVM website.

(a) []{#_Ref16485720 .anchor}**[Does the firm handle prohibited
    material]{.underline}? -- 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:

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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]{.underline}? 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)](#PMYes).

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]{.underline}? If YES, copy the records,
     begin documenting for possible enforcement action, and proceed to
     [Section (1)(b)](#PMYes).

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]{.underline}?

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]{.underline} sources
    (examples: porcine, equine, poultry, fish, gelatin)

-   Analyzes incoming product

(b) []{#PMYes .anchor}**[Does the firm handle prohibited
    material]{.underline}? -- YES**

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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

v.  []{#Label .anchor}[**Label Caution Statement**]{.underline} -

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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"](#_Ref16487537)).

    **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](#AttachReg), 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]{.underline}. 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, proceed
    with evidence collection to support legal action and as directed
    under the BSE recall strategy (See [Part V -- Section 3,
    "Recalls"](#_Ref16487537)).

    [Is the caution statement displayed in a conspicuous or prominent
    manner?]{.underline} 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]{.underline}. 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]{.underline}** - 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.

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vi. []{#_Ref16485748 .anchor}**[Recordkeeping]{.underline}** -

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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,
    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

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-   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)](#AttachRegc1ii), and also
    required by [21 CFR §589.2000(d)(1)](#AttachRegd1) and [21 CFR
    §589.2000(e)(1)(i)](#AttachRege1i). The required records must be
    kept for a minimum of one year per [21 CFR
    §589.2000(h)(1)](#AttachRegh1). 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)](#AttachRegc1ii), as required by [21 CFR
    §589.2000(d)(1)](#AttachRegd1) and [21 CFR
    §589.2000(e)(1)(i)](#AttachRege1i).

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](http://www.fda.gov/ora/compliance_ref/rpm_new2/ch6.html#pur)[)]{.underline})
> 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. []{#_Ref16485764 .anchor}**[Avoiding Commingling]{.underline}** -

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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 \[[21 CFR
    589.2000(e)(1)(iii)(A)](#AttachRege1iiiA)\]; **or**

-   the use of the same equipment with adequate clean-out procedures
    that prevent carry-over of prohibited material into the ruminant
    feed \[[21 CFR §589.2000(e)(1)(iii)(B)](#AttachRege1iiiB)\]

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,
    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)](#AttachRege1ii).

D)  **Firms Avoiding Commingling with [Separate Equipment]{.underline}**
    -- 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]{.underline} - 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]{.underline} rationale, analysis,
    or tests by the firm of the adequacy of the clean-out process. Try
    to obtain documentation of sequencing practices.

    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)](#AttachRege1iv) 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) []{#_Ref16485795 .anchor}**Ruminant Feeders.**

    The regulation, [21 CFR §589.2000(f)](#AttachRegf), 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](#AttachReg) 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.  []{#_Ref16485808 .anchor}**Prohibited Material.**

> The investigator should determine whether any feed containing
> prohibited material is present on the farm premises. [21 CFR
> §589.2000(f)](#AttachRegf) 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.

b.  []{#RFFS .anchor}**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](#AttachReg) 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](#AttachReg) 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)](#_Ref16485835)).

c.  []{#_Ref16485835 .anchor}**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)](#PMYes) of this guidance subpart.

(3) []{#_Ref16485923 .anchor}**Investigative notes.**

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(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](http://www.fda.gov/ora/compliance_ref/rpm_new2/ch6.html#pur)
    Chapter 6, Regulatory Procedures Manual (RPM[)]{.underline}) for
    instructions on recommending inspection warrants).

(b) Any violation of the requirements of [21 CFR §589.2000](#AttachReg)
    should be listed on the FDA-483 and fully documented. Collect
    documentary (DOC) samples to support possible regulatory action.
    (See [IOM, Chapter
    4](http://www.fda.gov/ora/inspect_ref/iom/ChapterText/400.html#SUB400)
    for instructions on collecting DOC samples.)

(c) All violations of [21 CFR §589.2000](#AttachReg) 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](#_Ref16486917)). 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](#PIVAnalytical)).

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(4) []{#_Ref16485942 .anchor}**Reporting.**

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(a) []{#_Ref16485953 .anchor}**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](#AttachChecklist))," 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/cvm/RuminantFeedInspections.htm>).
    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
    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) []{#_Ref16485969 .anchor}**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"](#_Ref16487576)).

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b.  []{#_Ref16486022 .anchor}**Import Approach.**

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(1) []{#_Ref16486035 .anchor}**[BSE affected and BSE-at-risk
    countries]{.underline}**

> [Import Alert #99-25](#AttachAlert) ("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 the importation of animal feed products that present a
> risk of BSE. (See [9 CFR §94.18](#AttachUSDA1) and [9 CFR
> §95.4](#AttachUSDA2)). The import alert covers all meat and bone meal
> (MBM), meat meal, bonemeal, blood meal, tankage, offal, or any product
> containing such from countries in which BSE exists or from designated
> BSE-at risk countries or that was rendered/processed in BSE at-risk
> countries' plants processing animal materials, regardless of species
> of origin, including poultry and fish meal. In implementing the Import
> Alert, import entry reviewers should consider the following:

-   The Import Alert addresses all sources of animal protein, including
    non-ruminant, fish, poultry, and all non-mammalian sources without
    regard to the prohibited material exemptions provided in [21 CFR
    §589.200(a)(1)](#AttachRega1). The USDA/APHIS Import Permit process
    is the primary means of assuring that animal byproduct meals
    imported from BSE-at-risk countries into the U.S. are free of
    ruminant protein sources.

-   Unprocessed non-ruminant products that are in a form that can be
    plainly ascertained through direct observation to be free of
    ruminant material (e.g., frozen whole fish, dried pig ears) should
    not be considered "Detained Without Physical Examination" (DWPE), as
    directed by the Import Alert. Import entry reviewers, however,
    should be vigilant to attempts to intentionally smuggle
    ruminant-source products into shipments of unprocessed non-ruminant
    material.

-   All product codes addressed by the Import Alert should be reviewed,
    including pet foods, amino acids, and the various dietary
    supplements. Ingredient listing should be examined, whenever
    available.

-   All incidents involving the entry of products addressed by the
    Import Alert should be considered as serious and warranting
    assessment under the BSE Recall Strategy (See [Part V -- Section 3,
    "Recalls"](#_Ref16487537)).

(2) []{#ImportNonBSE .anchor}**[Non-BSE at-risk countries]{.underline}**

> Countries, other than those listed in [Import Alert
> #99-25](#AttachAlert), are not subject to the import prohibition.
> Nonetheless, import entry reviewers should ensure that all animal feed
> and feed ingredients that contain or may contain prohibited material
> are in compliance with the label caution statement requirements of the
> [21 CFR §589.2000](#AttachReg) (See [Part III -- Section 1b(1)(b)v,
> "Label Caution Statement](#Label)"). Regardless, feed and feed
> ingredient labeling should be in compliance with FDA labeling
> requirements. Import entry reviewers should especially ensure that
> ingredient listings meet U.S. requirements and sufficiently allow
> reviewers to ascertain whether the product contains or may contain
> prohibited material. Reviewers especially need to be vigilant for
> transshipments of products that may have originated in the BSE-at-risk
> countries and countries with BSE listed in the Import Alert.

[]{#PIVAnalytical .anchor}**[Part IV -- Analytical]{.underline}**

1.  []{#_Ref16486077 .anchor}**[Analysis to be Conducted.]{.underline}**

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a.  Samples should be analyzed for the presence of animal tissue using
    the feed microscopy procedure outlined in "Modified AOAC Official
    Method 964.07, Microscopy of Animal Feed, Basic Microscopic
    Examination" ([Attachment C](#AttachBasic)), and "Modified AOAC
    Official Method 970.09, Microscopy of Animal Feed, Identification of
    Mammalian Tissues and Mineral Constituents" ([Attachment
    D](#AttachMammalian)), with the following modifications:

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1)  It is not necessary to determine the weight of animal tissue
    fragments found

2)  Filters may be wet with glycerin/alcohol to prevent loss of dry
    material in airflow

3)  No action should be taken based on normal filth items such as rodent
    hair or excreta. Identification of ruminant hair would warrant Lab
    Classification 2, so hair identification is desirable. The presence
    of hair or excreta from rodents, cats, dogs, humans, and other
    species would not be considered for classification of the sample.

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4)  Analysis should be based on a composite of the subs in each sample.
    **Note:** Samples collected according to the sampling instructions
    above should already be composited when received by the lab.

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5)  Violative or potentially violative findings should be confirmed by a
    second analyst. Check analysis (i.e., analysis of a new portion of
    composite) is not required.

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2.  []{#_Ref16486335 .anchor}**[Sample Size]{.underline}**

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a.  If the product is in bulk, collect sixteen (16) one-ounce subs from
    various locations in the shipment. The sample subs should be
    combined in one whirl-pak bag.

b.  If the product is in discrete retail packages (i.e., may be as large
    as 50 lb. bags), collect one (1) one-ounce sub from each of
    sixteen (16) retail packages. Combine the subs in one whirl-pak bag.

**CAUTION:** This material may be dusty and consist of fine particles,
especially if the product is in bulk. Exercise appropriate precautions
when collecting samples of dusty, loose material**.** Refer to \"Safety
Information for Imported Feeds Assignment - Collection and Analysis\"
([Attachment E](#attachment-e)).

3.  []{#_Ref16486686 .anchor}**[Sample Preparation and
    Submission]{.underline}**

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a.  These samples should not require any special temperature conditions
    or shipping containers. Room temperature and packing in regular
    cardboard containers should be sufficient.

b.  Samples collected in the following Districts should be submitted to
    the indicated labs for analysis:

> **SERVICING LABORATORIES**:
>
>  
>
> **Northeast Regional Laboratory (NRL)**
>
> New England District (NWE), New York District (NYK), New Jersey
> District (NWJ) and Philadelphia District (PHI)
>
>  
>
> **Southeast Regional Laboratory (SRL)**
>
> Atlanta District (ATL), Baltimore District (BLT), Cincinnati District
> (CIN), Florida District (FLA), New Orleans District (NOL), and San
> Juan District (SJN)
>
>  
>
> **Arkansas Regional Laboratory (ARL)**
>
> Chicago District (CHI), Detroit District (DET), Minneapolis District
> (MIN), and Southwest Import District (SWID)
>
>  
>
> **Denver District Laboratory (DEN-LB)**
>
> Dallas District (DAL), Denver District (DEN), and Kansas City District
> (KAN)
>
>  
>
> **Pacific Regional Laboratory -- Southwest (PRL-SW)**
>
> Los Angeles District (LOS), and San Francisco District (SAN)
>
>  
>
> **Pacific Regional Laboratory -- Northwest (PRL-NW)**
>
> Seattle District (SEA)
>
>  

[]{#PVRegAdm .anchor}**[Part V - Regulatory/Administrative
Strategy]{.underline}**

1.  []{#_Ref16486760 .anchor}**Enforcement -**

    Although much of the industry has complied with the regulations as a
    result of education and voluntary compliance, inspections still
    occasionally reveal that some firms are not in compliance with [21
    CFR §589.2000](#AttachReg). Districts should prioritize their
    resources for dealing with these non-compliant firms before
    initiating routine inspections. Since analytical methods currently
    available do not quantify the level of prohibited material in animal
    feed, inspectional observations, admissions, photographs, and record
    review are the primary tools for documenting violations. Whenever
    potentially violative conditions are found, evidence should be
    collected to support enforcement action.

    There may be situations in which a firm or individual is new to the
    industry and does not know of the dangers/hazards of BSE or of FDA's
    expectations for compliance with the regulation. In these
    situations, the agency believes the individual or firm should have
    known the dangers or hazards and our expectations, or they should
    not be in the business of handling or manufacturing animal feed or
    feed ingredients. If such a situation is encountered, or if a
    previously compliant firm is subsequently found to be out of
    compliance, Districts might consider issuing a Warning Letter or
    initiating other enforcement actions (See [Section 2d, "Provisions
    for Enforcement Action"](#_Ref16486943)). All Warning Letters
    proposals will be reviewed by the centers. Firms that receive
    Warning Letters should be re-inspected within 90 days to verify that
    corrections have been fully implemented. District offices should
    review current instructions regarding the review and processing of
    warning letters prior to issuance.

> Follow FDA's regulations and procedures prior to sharing non-public
> information with the public, or federal, state, local, and foreign
> government officials. 
>
>  

**NOTE**: Warning Letters should be considered for situations that
involve violations that are classified as "Official Action Indicated,"
or OAI. See [Section 2c, "Prioritized Inspectional Violative
Situations"](#_Ref16486917) for determining the appropriateness of a
Warning Letter. See [Section 2d, "Provisions for Enforcement
Action"](#_Ref16486943) for the level of documentation that would be
required for other types of enforcement actions.

2.  []{#_Ref16486824 .anchor}**Charges and Enforcement Approach-**

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a.  []{#_Ref16486835 .anchor}**Adulteration** - Sections 402(a)(2)(C)
    and 402(a)(4)

> It is easier to bring an adulteration case under the legal standard of
> Section 402(a)(2)(C) of the Act than under Section 402(a)(4) of the
> Act because in the food additive context the ingredient is legally
> presumed to be unsafe. Consequently, the investigator\'s priority
> should be on establishing a violation of Section 402(a)(2)(C).

(1) Animal proteins prohibited from use in ruminant feeds are unapproved
    food additives as defined in section
    [201(s)](http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm) of the
    Act. Therefore, the presence of such material(s) in ruminant feed
    causes the feed to be adulterated under Section
    [402(a)(2)(C)](http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm) of
    the Act. This charge may be supported by evidence showing that
    prohibited material is being used frequently or regularly as an
    ingredient in ruminant feed or feed supplements, or that clean out
    and sequencing procedures are so inadequate that it is highly likely
    that the feeds will contain prohibited material. In order to support
    this charge, documentary evidence should be available to establish
    that the suspect ruminant feed or ingredient contains or likely
    contains prohibited material.

(2) Animal feeds and feed ingredients containing prohibited material are
    considered potentially injurious to ruminant and public health.
    Therefore the use of such material(s) in ruminant feed causes the
    feed to be adulterated under section
    [402(a)(4)](http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm) of
    the Federal Food, Drug and Cosmetic Act (Act). In order to support
    this charge, documentary evidence should be available to establish
    that the suspect ruminant feed or ingredient contains or may contain
    prohibited material. Investigators should collect supporting records
    documenting the labeling of the prohibited material(s) and finished
    product, receipt and use of the prohibited material in the
    production of the sampled product, and affidavits from responsible
    individual(s).

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b.  []{#_Ref16486846 .anchor}**Misbranding** -

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(1) Animal feeds and feed ingredients that contain prohibited material
    but fail to bear the required caution statement are misbranded under
    section
    [403(a)(1)](http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm) of
    the Act, in that the label is false and misleading because it failed
    to disclose a material fact, (See
    [201(n)](http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm)).

(2) Animal feeds and feed ingredients that contain prohibited material
    but fail to bear the required caution statement in a conspicuous or
    prominent manner are misbranded under section
    [403(f)](http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm) of the
    Act.

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c.  []{#_Ref16486917 .anchor}**Prioritized Inspectional Violative
    Situations:**

-   OAI - Evidence that **prohibited material** is being used as an
    ingredient in **ruminant** feed or feed supplements. \[**NOTE**:
    Addition of the caution statement at the time of inspection will not
    rectify this violation. The violation should be noted, regardless of
    any immediate corrective actions.\]

-   OAI - Failure to have any or having only **grossly** **inadequate**
    systems/measures in place to **prevent** **commingling** and
    cross-contamination when firm handles prohibited material and
    produces **both ruminant and** **non-ruminant** feed.

-   OAI - Firm has but **fails to follow its written** systems/measures
    to **prevent commingling** and cross-contamination when firm handles
    prohibited material and produces **both ruminant and non-ruminant**
    feed.

-   OAI - **Failure** to perform any **clean-out**, flush, and/or follow
    a sequencing plan to prevent commingling and cross-contamination
    when firm handles prohibited material and produces **both ruminant
    and non-ruminant** feed.

-   OAI - The **clean-out**, flushing, and/or sequencing plan firm uses
    to prevent commingling and cross-contamination is **not adequate**;
    firm handles prohibited material and produces **both ruminant and
    non-ruminant** feed.

-   OAI - The **clean-out**, flushing, and/or sequencing plan firm uses
    to prevent commingling and cross-contamination is **not performed on
    an appropriate, routine basis**; firm handles prohibited material
    and produces **both ruminant and non-ruminant feed**.

-   OAI -- **Renderer intentionally separates** mammalian and
    nonmammalian materials and **fails** to obtain and use non-mammalian
    \[e.g., fish or poultry\], or pure pork, or pure equine material
    from a single species slaughter facility.

-   OAI - Evidence that **prohibited material** is being used frequently
    or regularly as a component of a feed ingredient or as an ingredient
    in **non-ruminant** feed with **no caution statement.**

-   VAI - Firm has systems/measures in place to **prevent commingling**
    and cross-contamination **but does not have those measures in
    writing**, when firm handles prohibited material and produces **both
    ruminant and non-ruminant** feed \[i.e., firm has plan but it is not
    in writing\].

-   VAI - **Failure to maintain records** to track prohibited material
    throughout its receipt, processing, and distribution.

-   VAI - **Incomplete** **records** to track prohibited material
    throughout its receipt, processing, and distribution.

-   VAI - **Distribution records lack name and address of for each
    purchaser** of product containing prohibited material \[especially
    noted with cash sales\].

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-   VAI --Animal feed ingredients or non-ruminant feeds contain
    prohibited material but **fail** to bear the required **caution
    statement** in a **conspicuous or prominent manner.**

d.  []{#_Ref16486943 .anchor}**Provisions for Enforcement Action:**

> When conducting an inspection to determine compliance with [21 CFR
> §589.2000](#AttachReg), be prepared to document significant violations
> for possible enforcement action. The basis of the regulation is that
> certain mammalian proteins, specifically prohibited materials, are
> unsafe food additives in ruminant feed. Inspectional efforts and
> documentation should be focused on demonstrating the actual or likely
> inclusion of those unsafe food additives in ruminant feed and/or the
> failure to properly label feeds containing this material.
>
> If the violative feeds are still available, discuss the firm's
> intentions to rectify the situation. If the firm does not plan on
> destruction and/or a recall, consider the possibility of a seizure,
> injunction and State actions, such as embargo or stop sale. Seizures
> should be limited to situations where there is clear documentation
> that ruminant feed has likely been contaminated with prohibited
> material. Injunction should be considered in situations where there is
> evidence that the firm has not corrected its violative practices, or
> there is reason to believe that it will not correct its violative
> practices.
>
> The following information will be important in supporting and
> demonstrating the conclusion that prohibited material is or is likely
> to be present in products manufactured, processed, or distributed by
> the firm or individual being inspected. Make every attempt to obtain
> or determine the following:

-   Volume of product produced

-   Frequency of production

-   Describe the records kept to show product/ingredient use

-   Number of employees involved with the mixing operation

-   Describe the records that show how the product was mixed

-   Describe the type and level of supervision of the employees during
    mixing

-   Describe the handling of prohibited material \[how it is identified,
    how it is stored\]

-   Is the firm aware of the rule?

-   Does the firm understand the rule?

-   Describe the training employees receive at the firm

-   Describe the equipment, especially the complexity of operating
    and/or cleaning, including equipment design flaws

-   If the firm uses flushing for clean-out, describe the flush
    material, the volume, how the firm validates the amount and type of
    flush material, and how and when do they check the completion and
    adequacy of the flush

-   Describe how flush material is subsequently utilized or disposed of

> Violations of 21 CFR § 589.2000 may result in adulteration charges
> under Sections 402(a)(2)(C) and 402(a)(4) of the Act and misbranding
> charges under Section 403(a)(1) of the Act. For adulteration charges,
> it is easier to bring a case under the legal standard of Section
> 402(a)(2)(C) of the Act than under the standard of Section 402(a)(4)
> of the Act because in the food additive context the ingredient is
> legally presumed to be unsafe. Therefore, the investigator\'s priority
> should be on establishing a violation of Section 402(a)(2)(C) alone or
> in combination with a violation of Section 403(a)(1).

(1) []{#EnfActRF .anchor}**When Ruminant Feed is Involved**

> The investigator may establish the following violations alone or in
> combination:

(a) []{#_Ref16486961 .anchor}**[Adulteration under
    402(a)(2)(C)]{.underline}**:

> **The highest priority** for an enforcement action would be those
> firms/individuals that are producing feed for ruminant animals
> containing prohibited material either in a facility producing only
> ruminant feed, or in a facility producing ruminant and non-ruminant
> feed with inadequate controls in place.
>
> The presence of the prohibited material in the ruminant feed needs to
> be demonstrated and supported through direct observation by the
> investigator, admissions by firm's employees and managers, and/or
> records of receipt and use of the material and inadequate handling at
> the production facility. The following inspectional observations could
> be used to support this enforcement action:

I.  Evidence that prohibited material is being used frequently or
    regularly as an ingredient in ruminant feed or feed supplements.
    Note how often this occurs. This evidence can be developed through
    **(a)** observations of the investigator; **(b)** admissions by
    firm's management/employees; and/or **(c)** records of ingredient
    receipt and use in feed. Records can include documents such as
    invoices, receiving tickets, weight tickets, purchase orders, batch
    production records, and mixing records.

> In addition, analytical reports from feed microscopy demonstrating the
> presence of mammalian tissue can be added information for support of
> the presence of prohibited material. \[**CAUTION**: Since the
> analytical reports are supportive, the analytical reports should be
> accompanied by other supporting information that demonstrate the
> presence of prohibited material in order to support a 402(a)(2)(C)
> violation.\]

(b) []{#RFa4 .anchor}**[Adulteration under 402(a)(4)]{.underline}**:

> If the facility is producing both ruminant and non-ruminant feed, the
> following inspectional observations could be used to support this
> enforcement action

I.  Failure to have any or having only grossly inadequate
    systems/measures in place to prevent commingling and
    cross-contamination when firm handles prohibited material and
    produces both ruminant and non-ruminant feed. This evidence can be
    developed through the same techniques noted in
    [**402(a)(2)(C)**](#_Ref16486961).

> **OR**

I.  Firm has but fails to follow its written systems/measures to prevent
    commingling and cross-contamination when firm handles prohibited
    material and produces both ruminant and non-ruminant feed. This
    evidence can be developed through the same techniques noted in
    [**402(a)(2)(C)**](#_Ref16486961).

> **OR**

I.  Failure to perform any clean-out, flush, and/or follow a sequencing
    plan to prevent commingling and cross-contamination when firm
    handles prohibited material and produces both ruminant and
    non-ruminant feed. This evidence can be developed through the same
    techniques noted in [**402(a)(2)(C)**](#_Ref16486961).

> **OR**

I.  The clean-out, flushing, and/or sequencing plan firm uses to prevent
    commingling and cross-contamination is not adequate and the firm
    handles prohibited material and produces both ruminant and
    non-ruminant feed. This evidence can be developed through the same
    techniques noted in [**402(a)(2)(C)**](#_Ref16486961).

> **OR**

I.  The clean-out, flushing, and/or sequencing firm uses to prevent
    commingling and cross-contamination is not performed on an
    appropriate, routine basis and the firm handles prohibited material
    and produces both ruminant and non-ruminant feed. This evidence can
    be developed through the same techniques noted in
    [**402(a)(2)(C)**](#_Ref16486961).

> **SUPPORTING**
>
> In addition, the following observations may be used to supplement the
> 402(a)(4) observations described in any of the observations above:

II. Failure to maintain records to track prohibited material throughout
    its receipt, processing, and distribution.

> **OR**

II. Firm has systems/measures in place to prevent commingling and
    cross-contamination but does not have those measures in writing,
    when firm handles prohibited material and produces both ruminant and
    non-ruminant feed \[i.e., firm has plan but it is not in writing\].

> **OR**

II. Incomplete records to track prohibited material throughout its
    receipt, processing, and distribution.

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(c) []{#_Ref16486973 .anchor}**[Misbranding Under
    403(a)(1)]{.underline}**:

> **Another high priority** for consideration for an enforcement action
> are those firms/individuals producing **feed ingredients** containing
> prohibited material that are likely to be incorporated into ruminant
> feed and the label fails to bear the required caution statement "Do
> Not Feed to Cattle or Other Ruminants."
>
> The presence of the prohibited material in the feed ingredient needs
> to be demonstrated and supported through direct observation by the
> investigator, admissions by firm's employees and managers, and/or
> records of receipt and use of the material and inadequate handling at
> the production facility. **Additionally, you will need to establish
> the likelihood that the feed ingredient will be used in ruminant
> feed.** That could be established through label claims or reviewing
> the firm's customer base. The following inspectional observations
> could be used to support this enforcement action:

I.  Labeling lacks the required caution statement "Do Not Feed To Cattle
    or Other Ruminants."

> **AND**

II. Evidence that prohibited material is being used frequently or
    regularly as a component of the feed ingredient. This evidence can
    be developed through **(a)** observations of the investigator;
    **(b)** admissions by firm's management/employees; and/or **(c)**
    records of ingredient receipt and use in feed. Records can include
    documents such as invoices, receiving tickets, weight tickets,
    purchase orders, batch production records, and mixing records.

> In addition, analytical reports from feed microscopy demonstrating the
> presence of mammalian tissue can be added information for support of
> the presence of prohibited material. \[**CAUTION**: Since the
> analytical reports are supportive, the analytical reports should be
> accompanied by other supporting information that demonstrates the
> presence of prohibited material in order to support a 402(a)(2)(C)
> violation.\]

(2) []{#EnfActNRF .anchor}**When Non-Ruminant Feed is Involved**

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(a) []{#_Ref16487523 .anchor}**[403(a)(1) Case:]{.underline}**

> Non-ruminant feed and feed ingredients may legally contain "prohibited
> material," but the products must bear the caution statement "Do Not
> Feed to Cattle or Other Ruminants."
>
> The presence of the prohibited material in the non-ruminant feed or
> feed ingredient needs to be demonstrated and supported through direct
> observation by the investigator, admissions by firm's employees and
> managers, and/or records of receipt and use of the material and
> inadequate handling at the production facility. You are likely to find
> this kind of misbranding violation at a facility that is producing
> both ruminant and non-ruminant feed. Additionally assess whether the
> ruminant feed or feed ingredients are violative. See [Section (1),
> When Ruminant Feed is Involved](#EnfActRF) for inspectional
> observations that could be used to support the non-ruminant feed and
> feed ingredient misbranding enforcement action.

3.  []{#_Ref16487537 .anchor}**Recalls -**

-   When violations are encountered investigators should determine the
    firm's intentions concerning the recall of any and all adulterated
    and/or misbranded products that have entered commercial
    distribution.

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-   Give the firm an opportunity to voluntarily recall all violative
    feeds and feed ingredients, and dispose of the products
    appropriately.

-   If the firm voluntarily recalls, follow the standard procedures in
    [**Chapter 7, Regulatory Procedures
    Manual**](http://www.fda.gov/ora/compliance_ref/rpm_new2/ch7.html).

-   If the firm refuses to voluntarily recall, or the recall is
    ineffective, request State assistance with State actions such as
    embargo or stop sales and initiate an FDA-requested recall, with FDA
    press release.

-   Coordinate any recall activity with State counterparts, including
    the possible sharing of recall audit check responsibilities.

-   Make sure all States and Districts that are affected, or are
    potentially affected, are notified of the recall.

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-   The following information is intended to be used to accommodate
    three "generic" scenarios which to date have represented the
    majority of situations that FDA has confronted when dealing with the
    use, distribution and labeling of animal feed products containing
    prohibited materials. The purpose of this information is to provide
    guidance to assure similar recall situations will be handled in a
    consistent manner, and to reduce the burden on FDA of having to
    re-evaluate situations that present the same variables. This
    document is not intended to cover all situations -- and any new or
    novel scenarios will require review and evaluation by CVM.

> **Note**: Due to the potential seriousness of these scenarios, they
> should be managed as Class I recalls requiring adequate press to alert
> consumers of the risks associated with these products.

**[Scenario \# 1.]{.underline} Product contains Prohibited Material from
a domestic or imported source.**

> U.S. manufacturer of animal feed received prohibited material from
> either a domestic or imported source, which is then used as an
> ingredient in the manufacture of non-ruminant feed (i.e., equine,
> fish, swine, poultry, etc.). The non-ruminant feed is not properly
> labeled with the required warning statement, "Do not feed to cattle or
> other ruminants".

(1) [**Classification**:]{.underline} Class II

(2) [**Reason**:]{.underline} The products are misbranded in that they
    contain prohibited materials and are not properly labeled in
    accordance with 21 CFR **§**589.2000 (See [Attachment
    A](#AttachReg)).

(3) [**Action**:]{.underline}

-   **Production/Distribution**: Request immediate labeling of all "in
    stock" product awaiting shipment with the warning label, "Do not
    feed to cattle or other ruminants"

-   **Publicity**: Press should be issued immediately by the responsible
    firm and/or FDA in accordance with established policy for Class I
    recalls. Publication in the FDA Enforcement Report once the recall
    action has been classified.

-   **Recall:** pursue voluntary recall by the responsible firm to the
    retail level. Field correction by placement of adequately sized,
    prominently printed sticker that includes the required warning
    statement may be acceptable; however, return of product to the
    responsible firm for such relabeling activities would be preferable.

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-   [Depth]{.underline}: Retail level

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-   [Notification]{.underline}: 100%

-   [Effectiveness Checks]{.underline}: Level A, 100% verification of
    consignee notification and appropriate response

-   [Audit Checks]{.underline}: Level B modified (25%) to
    wholesale/distributor level. Level B (25%) at retail level

-   [Inspection]{.underline}: Initiate establishment inspection to
    identify products being produced, their intended uses, and assure
    that product is appropriately labeled.

-   [State involvement]{.underline}: Advise State counterparts of the
    situation and enlist their assistance in monitoring.

-   [Animal Control]{.underline}: N/A. No animals involved.

-   [Disposition of recalled/held product]{.underline}: Witness any
    reconditioning of product on hand.

**[Scenario #2.]{.underline} Prohibited material from domestic or from
an imported source is used as an ingredient in feed, or as feed to
ruminants.**

> U.S. manufacturer of non-ruminant animal feeds uses prohibited
> material from a domestic source, or from an imported source, and that
> feed is fed to ruminants either as a supplement (i.e., dairy cow
> supplement), by mistake, or unknowingly due to inadequate
> flushing/cleaning of equipment.

(1) [**Classification**:]{.underline} Class II

(2) **[Reason]{.underline}**: The ruminant feed or feed ingredient
    contains prohibited material, with or without a caution statement.

(3) [**Action**:]{.underline}

-   **Production/Distribution**: Pending results of the investigation.

-   **Publicity**: Press should be issued immediately by the responsible
    firm and/or FDA in accordance with established policy for Class I
    recalls. Publication in the FDA Enforcement Report once the recall
    action has been classified.

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-   **Recall**: Pursue voluntary recall to the retail level by the
    responsible firm, or seek FDA requested recall.

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-   [Depth]{.underline}: Retail level

-   [Notification]{.underline}: 100%

-   [Effectiveness Checks]{.underline}: Level A, 100% verification of
    notification and appropriate response

-   [Audit Checks]{.underline}: Level B (25%) to direct consignees
    (distributors/retailers). Level B (25%) to retail accounts of
    audited distributors

-   [Inspection]{.underline}: GMP inspection is indicated to review
    production controls, scope of possible adulteration, extent of time
    such practices have been ongoing, and to obtain necessary recall
    information

-   [State Involvement]{.underline}: Advise State counterparts of the
    situation and enlist their assistance in monitoring.

-   [Animal Control]{.underline}: Assess control over the disposition of
    ruminant animals fed the prohibited protein so as to prevent their
    slaughter for human food or other animal feed. Coordination with
    States and USDA/FSIS should be considered. Consult with CVM
    regarding coordination and regulatory approach of animal
    disposition.

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-   [Disposition of recalled /held product]{.underline}: Oversee
    appropriate disposition of feed and status of animals that have been
    fed the feed. Determine if relabeling feed with the warning label is
    an option

4.  []{#Refusals .anchor}**Refusals -**

> 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 under 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](http://www.fda.gov/ora/compliance_ref/rpm_new2/ch6.html#pur)
> Chapter 6, Regulatory Procedures Manual (RPM[)]{.underline}) for
> instructions on recommending inspection warrants).

###### [Part VI - References, Attachments, and Program Contacts]{.underline} {#part-vi---references-attachments-and-program-contacts .unnumbered}

1.  []{#_Ref16487576 .anchor}**Program Contacts**

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a.  **Center for Veterinary Medicine (CVM)**

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(1) **Program Inquiries**

> Neal Bataller <nbatalle@cvm.fda.gov> 301-827-0163

Program Monitor

Office of Surveillance and Compliance, Division of Compliance, HFV-230

a.  **Office of Regulatory Affairs (ORA)**

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(1) **Inspectional Inquiries**

> Jim Dunnie <jdunnie@ora.fda.gov> 301-827-5652
>
> Office of Regional Operations, Division of Field Investigations,
> HFC-130

(1) **Analytical Inquiries**

> Larry D Hoostelaere <ldhooste@ora.fda.gov> 301-827-1032

Office of Regional Operations, Division of Field Sciences, HFC-140

(2) **Federal/State Relations Inquiries**

> Paul Bachman <Paul.Bachman@ora.fda.gov> 301-827-2904

Office of Regional Operations, Division of Federal-State Relations,
HFC-150

(3) **Import Inquiries**

> Linda Wisniowski <lwisniow@ora.fda.gov> 301-443-6553

Office of Regional Operations, Division of Import Operations, HFC-170

(4) **Enforcement Inquiries**

> Pam Schweikert <pschweik@ora.fda.gov> 301-827-0403

Office of Enforcement, Division of Compliance Management and Operations,
HFC-210

b.  **BSE District Coordinators**

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(1) **ATL-DO** (GA, NC, SC)

Blake Bevill <bbevill@ora.fda.gov> 404-253-2218

(1) **BLT-DO** (MD, VA, WV)

> Karen Anthony <kanthony@ora.fda.gov> 804-379-1627 x11
>
> Diane Milazzo <dmilazzo@ora.fda.gov> 804-379-1627

(2) **CHI-DO** (IL)

Mark Peterson [mpeterso@ora.fda.gov](mailto:mpeterson@ora.fda.gov)
217-492-4095

(3) **CIN-DO** (KY, OH)

Guy Cartwright <gcartwri@ora.fda.gov> 614-487-1273

(4) **DAL-DO** (AR. OK, TX)

Edward D. Edmiston <eedmisto@ora.fda.gov> 240-541-9580 x109

(5) **DEN-DO** (CO, NM, UT, WY)

> Teresa C. Thompson
> [tthompso@ora.fda.gov](mailto:tthompso@ora.f.da.gov) 801-524-3190 x22

(6) **DET-DO** (IN, MI)

Dennis Downer <ddowner@ora.fda.gov> 317-226-6500 x11

(7) **FLA-DO** (FL)

Leon Law <llaw@ora.fda.gov> 813-228-2671 x20

(8) **KAN-DO** (KS, MO, NE)

Robert Wilson <bwilson@ora.fda.gov> 913-752-2426

(9) **LOS-DO** (AZ, Southern CA)

Barbara Rincon <brincon@ora.fda.gov> 949-608-4439

(10) **MIN-DO** (MN, ND, SD, WI)

Howard Burmester <hburmest@ora.fda.gov> 605-330-4383

(11) **NOL-DO** (AL, LA, MS, TN)

> James Blakely <jblakely@ora.fda.gov> 601-965-4581

Anthony Abel <maabel@ora.fda.gov> 615-781-5374 x111

(12) **NWE-DO** (CT, MA, ME, NH, VT)

Janice Gordon <jgordon@ora.fda.gov> 802-951-6240

(13) **NWJ-DO** (NJ)

Shirley Isbill <sisbill@ora.fda.gov> 732-940-8946 x13

> Wayne Meyer <wmeyer@ora.fda.gov> 732-940-8946

(14) **NYK-DO** (NY)

Joseph Erdmann <jerdmann@ora.fda.gov> 315-448-7601 x13

(15) **PHI-DO** (DE, PA)

Michael O\'Meara <mommeara@ora.fda.gov> 302 573-6447 x11

(16) **SAN-DO** (HI, Northern CA)

> Thomas Gordon <tgordon@ora.fda.gov> 559-447-3376
>
> James Henry <jhenry@ora.fda.gov> 559-447-3376 x19
>
> Karen Robles <krobles@ora.fda.gov> 916-930-3674

(17) **SEA-DO** (AK, ID, MT, OR, WA)

Carol Gripp <cgripp@ora.fda.gov> 425-483-4905

William Hughes <whughes@ora.fda.gov> 503-671-9711 x13

(18) **SJN-DO** (PR)

Eliezar Ramos <eramos@ora.fda.gov> 787-831-3337/38 x13

(19) **SWI-DO**, Southwest Import District (AZ, CA, NM, TX)

> L.B. Booty <lbooty@ora.fda.gov> 713-802-7541

1.  []{#Attachments .anchor}**Attachments**

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a.  **Attachment A:** [21 CFR §589.2000, Animal proteins prohibited in
    ruminant feed](#AttachReg)

b.  **Attachment B:** [Checklist -- Report of Inspection for Compliance
    with 21 CFR §589.2000](#AttachChecklist)

c.  **Attachment C:** [Modified AOAC Official Method 964.07, Microscopy
    of Animal Feed, Basic Microscopic Examination](#AttachBasic)

d.  **Attachment D:** [Modified AOAC Official Method 970.09, Microscopy
    of Animal Feed, Identification of Mammalian Tissues and Mineral
    Constituents](#AttachMammalian)

###### Attachment E: [**Safety Guidance for Imported Feeds Assignment -- Collection and Analysis**](#attachment-e)

e.  [**Attachment F:**](#attachment-e) [Import Alert
    #99-25](#AttachAlert)

f.  **Attachment G**: [9 CFR §94.18, USDA Restrictions on the
    Importation of Meat and Edible Products from
    Ruminants](#AttachUSDA1)

g.  **Attachment H:** [9 CFR §95.4, USDA Restrictions on the Importation
    of Processed Animal Protein and Other Animal Products](#AttachUSDA2)

h.  **Attachment I:** [21 CFR §7.40, Recall Policy](#AttachRecallReg)

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2.  []{#_Ref16487666 .anchor}**Applicable References or Aids**

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1.  [Inspection Operations Manual
    (IOM)](http://www.fda.gov/ora/inspect_ref/iom/iomtc.html),:

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a.  [Chapter 3 - Federal and State
    Cooperation](http://www.fda.gov/ora/inspect_ref/iom/Contents/ch3_toc.html)

b.  [Chapter 4 -
    Sampling](http://www.fda.gov/ora/inspect_ref/iom/contents/ch4_toc.html)

c.  [Chapter 5 - Establishment
    Inspection](http://www.fda.gov/ora/inspect_ref/iom/contents/ch5_toc.html)

d.  [Chapter 6 -
    Imports](http://www.fda.gov/ora/inspect_ref/iom/contents/ch6_toc.html)

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2.  [FDA/ORA Regulatory Procedures
    Manual](http://www.fda.gov/ora/compliance_ref/rpm/)

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a.  [Chapter 6 -- Judicial
    Actions](http://www.fda.gov/ora/compliance_ref/rpm_new2/ch6.html)

b.  [Chapter 7 -- Recall and Emergency
    Procedures](http://www.fda.gov/ora/compliance_ref/rpm_new2/ch7.html)

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3.  [21 CFR §589.2000 - Animal proteins prohibited in ruminant
    feed](#AttachReg)

# [**AOAC Official Methods of Analysis**](http://www.aoac.org/pubs/oma_revised.htm)

5.  [Compliance Programs]{.underline}

#### 7318.003 Milk Safety Program

a.  7371.003 Feed Contaminants Program

b.  7371.004 Feed Manufacturing Compliance Program

c.  7371.006 Illegal Drug Residues in Meat & Poultry Program

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e.  7371.008 National Drug Residue Milk Monitoring Program

# [**Small Entities Guidance Documents**](http://www.fda.gov/cvm/index/bse/bse_guidance.htm)

a.  [Guidance for Industry 67: Small Entities Compliance Guide for
    Renderers](http://www.fda.gov/cvm/guidance/guidance67.pdf)

b.  [Guidance for Industry 68: Small Entities Compliance Guide for
    Protein Blenders, Feed Manufacturers, and
    Distributors](http://www.fda.gov/cvm/guidance/guidance68.pdf)

c.  [Guidance for Industry 69: Small Entities Compliance Guide for
    Feeders of Ruminant Animals with On-Farm Feed Mixing
    Operations](http://www.fda.gov/cvm/guidance/guidance69.pdf)

d.  [Guidance for Industry 70: Small Entities Compliance Guide for
    Feeders of Ruminant Animals without On-Farm Feed Mixing
    Operations](http://www.fda.gov/cvm/guidance/guidance70.pdf)

e.  [Guidance for Industry 76: Questions and Answers BSE Feed
    Regulation](http://www.fda.gov/cvm/guidance/guida76.htm)

[]{#AttachReg .anchor}**Attachment A**

**21 CFR §589.2000**

**Animal proteins prohibited in ruminant feed**

\[Code of Federal Regulations\]

\[Title 21, Volume 6\]

\[Revised as of April 1, 2001\]

From the U.S. Government Printing Office via GPO Access

\[CITE**:** 21CFR589**.**2000\]

**TITLE 21**\--FOOD AND DRUGS

**CHAPTER I**\--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES\--(Continued)

**PART 589**\--SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR
FEED\--Table of Contents

**SUBPART B**---LISTING OF SPECIFIC SUBSTANCES PROHIBITED FROM USE IN
ANIMAL FOOD OR FEED

**Sec. 589.2000 Animal proteins prohibited in ruminant feed.**

(a) Definitions---

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(1) []{#AttachRega1 .anchor}Protein derived from mammalian tissues means
    any protein-containing portion of mammalian animals, excluding:
    Blood and blood products; gelatin; inspected meat products which
    have been cooked and offered for human food and further heat
    processed for feed (such as plate waste and used cellulosic food
    casings); milk products (milk and milk proteins); and any product
    whose only mammalian protein consists entirely of porcine or equine
    protein.

(2) []{#AttachRega2 .anchor}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 to minimal processing, or distribute them to firms
    other than renderers (as defined here) whose intended use for the
    products may include animal feed. The term includes renderers that
    also blend animal protein products.

(3) Blender means any firm or individual which obtains processed animal
    protein from more than one source or from more than one species, and
    subsequently mixes (blends) or redistributes an animal protein
    product.

(4) 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.

(5) Nonmammalian protein includes proteins from nonmammalian animals.

(6) Distributor includes persons who distribute or transport feeds or
    feed ingredients intended for animals.

(7) Ruminant includes any member of the order of animals which has a
    stomach with four chambers (rumen, reticulum, omasum, and abomasum)
    through which feed passes in digestion. The order includes, but is
    not limited to, cattle, buffalo, sheep, goats, deer, elk, and
    antelopes.

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(b) Food additive status. The Food and Drug Administration has
    determined that protein derived from mammalian tissues for use in
    ruminant feed is a food additive subject to section 409 of the
    Federal Food, Drug, and Cosmetic Act (the act). The use or intended
    use in ruminant feed of any material that contains protein derived
    from mammalian tissues causes the feed to be adulterated and in
    violation of the act, unless it is the subject of an effective
    notice of claimed investigational exemption for a food additive
    under Sec. 570.17 of this chapter.

(c) Requirements for renderers that are not included in paragraph (e) of
    this section.

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(1) Renderers that manufacture products that contain or may contain
    protein derived from mammalian tissues and that are intended for use
    in animal feed shall take the following measures to ensure that
    materials identified in paragraph (b) of this section are not used
    in the feed of ruminants:

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(i) Label the materials as follows: "Do not feed to cattle or other
    ruminants"; and

(ii) []{#AttachRegc1ii .anchor}Maintain records sufficient to track the
     materials throughout their receipt, processing, and distribution,
     and make the copies available for inspection and copying by the
     Food and Drug Administration.

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(2) Renderers described in paragraph (c)(1) of this section will be
    exempted from the requirements of paragraphs (c)(1)(i) and
    (c)(1)(ii) of this section if they:

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(i) Use exclusively a manufacturing method that has been validated by
    the Food and Drug Administration to deactivate the agent that causes
    transmissible spongiform encephalopathy (TSE) and whose design has
    been made available to the public;

(ii) Use routinely a test method that has been validated by the Food and
     Drug Administration to detect the presence of the agent that causes
     TSE\'s and whose design has been made available to the public.
     Renderers whose products test positive for agents that cause TSE\'s
     must comply with paragraphs (c)(1)(i) and (c)(1)(ii) of this
     section. Records of the test results shall be made available for
     inspection by the Food and Drug Administration; or

(iii) Use exclusively a method for controlling the manufacturing process
      that minimizes the risk of the TSE agent entering the product and
      whose design has been made available to the public and validated
      by the Food and Drug Administration.

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(3) Renderers described in paragraph (c)(1) of this section will be
    exempted from the requirements of paragraph (c)(1)(ii) of this
    section if they use a permanent method, approved by FDA, to make a
    mark indicating that the product contains or may contain protein
    derived from mammalian tissue. If the marking is by the use of an
    agent that cannot be detected on visual inspection, the renderer
    must use an agent whose presence can be detected by a method that
    has been validated by the Food and Drug Administration and whose
    design has been made available to the public.

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(d) []{#AttachRegd .anchor}Requirements for protein blenders, feed
    manufacturers, and distributors that are not included in
    paragraph (e) of this section.

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(1) []{#AttachRegd1 .anchor}Protein blenders, feed manufacturers, and
    distributors that manufacture, blend, process, and distribute
    products that contain or may contain protein derived from mammalian
    tissues shall comply with paragraph (c)(1) of this section.

(2) Protein blenders, feed manufacturers, and distributors, shall be
    exempt from paragraphs (d)(1) of this section if they:

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(i) Purchase animal products from renderers that certified compliance
    with paragraph (c)(2) of this section or purchase such materials
    from parties that certify that the materials were purchased from
    renderers that certified compliance with paragraph (c)(2) of this
    section; or

(ii) Comply with the requirements of paragraph (c)(2) of this section
     where appropriate.

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(3) Protein blenders, feed manufacturers, and distributors, shall be
    exempt from paragraph (c)(1)(ii) of this section if they:

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A.  Purchase animal protein products that are marked in accordance with
    paragraph (c)(3) of this section or purchase such materials from
    renderers that certified compliance with paragraph (c)(3) of this
    section, or purchase such materials from parties that certify that
    the materials were purchased from renderers that certified
    compliance with paragraph (c)(3) of this section; or

B.  Comply with the requirements of paragraph (c)(3) of this section
    where appropriate.

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(4) Pet food products that are sold or are intended for sale at retail
    and feeds for nonruminant laboratory animals are exempt from the
    labeling requirements in paragraphs (c) and (d) of this section.
    However, if the pet food products or feeds for nonruminant
    laboratory animals are sold or are intended for sale as distressed
    or salvage items, then such products shall be labeled in accordance
    with paragraph (c) or (d) of this section, as appropriate.

(5) Copies of certifications as described in paragraphs (d)(2) and
    (d)(3) of this section, shall be made available for inspection and
    copying by the Food and Drug Administration.

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(e) Requirements for persons that intend to separate mammalian and
    nonmammalian materials.

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(1) Renderers, protein blenders, feed manufacturers, distributors, and
    others that manufacture, process, blend and distribute both products
    that contain or may contain protein derived from mammalian tissues
    or feeds containing such products, and protein products from other
    animal tissues or feeds containing such products, and that intend to
    keep those products separate shall:

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(i) []{#AttachRege1i .anchor}Comply with paragraphs (c)(1) or (d)(1) of
    this section as appropriate except that the labeling requirement
    shall apply only to products that contain or may contain protein
    derived from mammalian tissues or feeds containing such products;

(ii) []{#AttachRege1ii .anchor}In the case of a renderer, obtain
     nonmammalian or pure porcine or pure equine materials only from
     single-species slaughter facilities;

(iii) Provide for measures to avoid commingling or cross-contamination;

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(A) []{#AttachRege1iiiA .anchor}Maintain separate equipment or
    facilities for the manufacture, processing, or blending of such
    materials; or

(B) []{#AttachRege1iiiB .anchor}Use clean-out procedures or other means
    adequate to prevent carry-over of products that contain or may
    contain protein derived from mammalian tissues into animal protein
    or feeds that may be used for ruminants; and

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(iv) []{#AttachRege1iv .anchor}Maintain written procedures specifying
     the clean-out procedures or other means, and specifying the
     procedures for separating products that contain or may contain
     protein derived from mammalian tissue from all other protein
     products from the time of receipt until the time of shipment.

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(2) Renderers, blenders, feed manufacturers, and distributors will be
    exempted from applicable requirements of paragraph (e)(1) of this
    section, if they meet the criteria for exemption under paragraphs
    (c)(2) or (c)(3) of this section, and (d)(2) or (d)(3) of this
    section.

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(f) []{#AttachRegf .anchor}Requirements for establishments and
    individuals that are responsible for feeding ruminant animals.
    Establishments and individuals that are responsible for feeding
    ruminant animals shall maintain copies of purchase invoices and
    labeling for all feeds containing animal protein products received,
    and make the copies available for inspection and copying by the Food
    and Drug Administration.

(g) Adulteration and misbranding.

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(1) Animal protein products, and feeds containing such products, that
    are not in compliance with paragraphs (c) through (f) of this
    section, excluding labeling requirements, will be deemed adulterated
    under section 402(a)(2)(C) or 402(a)(4) of the act.

(2) Animal protein products, and feeds containing such products, that
    are not in compliance with the labeling requirements of
    paragraphs (c) through (f) of this section will be deemed misbranded
    under section 403(a)(1) or 403(f) of the act.

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(h) Inspection; records retention.

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(1) []{#AttachRegh1 .anchor}Records that are to be made available for
    inspection and copying, as required by this section, shall be kept
    for a minimum of 1 year.

(2) Written procedures required by this section shall be made available
    for inspection and copying by the Food and Drug Administration.

The collection of information requirements are approved under OMB Number
0910-0339.

[]{#AttachChecklist .anchor}**Attachment B**

**Checklist -- Report of Inspection for Compliance with 21 CFR
§589.2000**

**(**[[http://www.fda.gov/cvm/index/bse/RuminantFeedInspections.htm]{.underline}](http://www.fda.gov/cvm/index/bse/RuminantFeedInspections.htm)**)**

![](media/image1.wmf)

**Checklist - Version 4.2**

[]{#AttachBasic .anchor}**Attachment C**

**Modified AOAC Official Method 964.07**

**Microscopy of Animal Feed**

**Basic Microscopic Examination**

1.  **Apparatus**

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a.  Magnifier and illuminator with desk base, 3X, or reading glass

b.  Microscopes and illuminator.

> [Illuminators]{.underline}: Illuminator for this purpose should be
> compact with a flexible arm. Halogen lighting preferred. Cool white
> circular fluorescent acceptable. Minimum 3X magnification.
>
> [Compound microscope]{.underline}: The minimum specifications for this
> microscope should be a binocular body with adjustable focus flat
> widefield eyepieces (10X); parfocalized plan-acromatic objective
> lenses of 2.5, 10, 40 and 100X magnifications; adjustable condenser
> with numerical aperture to match the 100X objective lens and with an
> optional daylight correction filter carrier (neutral density filters
> should also be in the lighting assembly); mechanical stage with
> coaxial controls; built-in halogen light source of at least 20 watts;
> and options for polarization and interference contrast or phase
> contrast lighting.
>
> [Stereomicroscope]{.underline}: The minimum specifications for this
> microscope should be a binocular body with adjustable focus flat
> widefield eyepieces (10X); zoom focusing from 7X to 30X (45X
> preferred); lighted base with incident, transmitted and mixed halogen
> illumination with rheostat for adjusting light intensity;
> (alternative: halogen dual light pipe, objective lens mounted circle
> light or individual halogen lights for high intensity incident
> illumination) and interchangeable and removable base plates and clips.

c.  Stainless Steel Sieves. A small 16 mesh sieve. (Optional) A set of 3
    inch diameter or smaller sieves with cover, pan, 10, 20, 30, 40, 60
    and 80 mesh.

d.  Mortar and pestle. Porcelain, approximately 4 inches in diameter.

e.  Spot plates. Clear glass (to be painted black on the bottom) and
    white porcelain. Alternative: disposable plastic spot plates.

f.  Hand tools:

> Dissecting kit including, but not necessarily limited to:

-   Forceps, heavy blunt pair for large objects

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-   Forceps, fine needle tips for fine particles

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-   Microspatula, stainless steel

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-   Knife or scalpel; small size

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-   Glass rods drawn to a fine tip or plastic utensils with fine tip

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-   Dissecting needles, straight and bent

g.  Plasticware:

-   Dropping bottles, polyethylene and polypropylene

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-   1 ounce polypropylene cup

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-   1/4 teaspoon rectangular measuring spoon (any rectangular shaped
    stainless steel 1/4 teaspoon)

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-   plastic funnel

h.  Glassware:

-   Beakers, 150 and 250 ml

i.  Miscellaneous

-   coffee filters (or any hard surface, thin, rapid filter paper) set
    into a collection bottle

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-   Petri dishes (100 mm) for drying floated fractions

j.  Laboratory balance.

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2.  **Reagents**

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(i) Chloroform. Technical; recover by filtration and distillation.

(ii) Acetone. Technical.

(iii) Dilute hydrochloric acid. 1N (approx. 2.5 ml conc. HCl diluted to
      30 ml).

(iv) Iodine solution. Use AOAC 964.01 section (B.)(f.) but without
     standardization.

(v) Mounting media of sufficiently different refractive index from
    material observed; e.g. Glycerol-phenol mountant. Dissolve 20 g of
    crystalline phenol in 4 ml of glycerol in a 100 ml beaker (requires
    time to absorb some moisture from the air or add a few drops of
    water to stabilize).

(vi) Silver nitrate solution. Dissolve 3 g silver nitrate in 30 ml
     distilled water.

(vii) Sulfuric acid, 30 N. (Alternative: Sakaguchi reagent: 1 g. boric
      acid in 100ml 80% sulfuric acid)

(viii) Blood peroxidase : see AAFM Manual (reference 1) p.135.

(ix) Dilute acetic acid. Dilute glacial acetic acid 1:1 with distilled
     water.

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3.  **Standards**

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a.  Feed ingredients. Collect representative samples of ingredients to
    be used as authentics, conforming to the definitions of the
    Association of American Feed Control Officials for comparison with
    samples. Store each ingredient in an airtight screw capped
    polystyrene, polypropylene or glass bottle. Control insects in the
    collection by placing the bottle in a zipper plastic bag and storing
    at 0 F for 7-10 days. Use no preservatives that will change the
    aroma, chemical or physical characteristics of ingredients.

[]{#AttachMammalian .anchor}**Attachment D**

**Modified AOAC Official Method 970.09**

**Microscopy of Animal Feed**

**Identification of Mammalian Tissues and Mineral Constituents**

1.  **Principle**

> Feeds containing animal tissues and mineral when suspended in CHCl3
> (chloroform) readily separate into 2 fractions. The organic fraction
> floats and contains blood, muscle fibers, connective tissues, organ
> tissues, feathers, hoof and horn particles, fines thereof, all
> vegetative tissues from plants, and microbial residues. The minerals
> and mineralized materials sink. These include bones, teeth,
> exoskeleton, fish scales, and glass, sand and other mineral materials.

2.  **Preparation of Sample**

> Place approximately 4 g of ground (mortar and pestle) sample that
> passes a 16-mesh sieve into a 1 ounce polypropylene medicine cup.
> Place approximately 1-2 g in a 100mm Petri dish labeled "untreated"
> and examine stereoscopically for animal tissues, as per sections C and
> D, below.
>
> If no animal tissues are detected in the untreated portion, continue
> on the remaining approximately 2 g sieved sample as follows, in a fume
> hood. Pour sufficient clean chloroform (about 15 ml) over the sample
> to form a distinct separation line between the floating material and
> the heavy mineral particles at the bottom. Stir for about 20 seconds.
> Squeeze the cup to conform to the shape of the 1/4 teaspoon
> rectangular measuring spoon (any rectangular shaped stainless steel
> 1/4 teaspoon). Immediately lift (or assist to decant) the floating
> organic fraction into a plastic funnel with a folded and trimmed
> coffee filter (or any hard surface, thin, rapid filter paper) set into
> a collection bottle. Gently pour the excess chloroform from the sample
> cup leaving the minerals at the lowest point of the bottom. Rinse the
> mineral fraction with two small washes of CHCl3. Drain excess solvent
> from the mineral fraction and set in the hood to dry. Remove the
> filter paper with the organic fraction and place in a 100 mm glass
> Petri dish or other container not affected by chloroform. Drying can
> be accelerated on a hot plate set on the lowest heat setting.
>
> When the organic fraction is dry, scrape the filter paper gently to
> remove all the sample but do not remove fibers from the paper.
> Transfer the organic fraction to a tared 100 mm plastic Petri dish for
> analysis (alternatively transfer the sample to a weighing paper, weigh
> and then transfer the sample to a Petri dish for analysis). When the
> mineral fraction is dry, transfer it to a weighing paper, weigh the
> fraction and transfer it to a 100 mm plastic Petri dish. Record the
> weights of the fraction and calculate the percentages of each fraction
> from the total sample weight.

3.  **Identification of Animal Tissues in the floating phase**

> Examine the dried organic fraction stereoscopically for the range of
> particles present. Isolate and confirm the presence of the following
> ingredients: hair, blood particles, and horn or hoof particles.
> Confirm by microchemical tests as appropriate and as described in the
> manual (1) and/or AOAC (2).

4.  **Identification of Bone and Mineral Particles in the mineral
    phase**

> Examine bones stereoscopically for the range of particles present.
> Take a small aliquot, prepare a slide in mounting media and examine at
> 100X with a compound microscope. Use the lacunae and internal
> structures to confirm the identity of the bone, i.e., mammalian,
> avian, or marine. Confirm by microchemical tests as appropriate and as
> described in the Manual (1) and/or AOAC (2).

**References**:

1)  Manual of Microscopic Analysis of Feedstuffs, 3rd ed., Bates et al,
    American Association of Feed Microscopists (AAFM)

2)  AOAC Official Methods of Analysis, 17th ed., Vol. 1., Chapter 4,
    sec. 4.9

###### Attachment E

###### Safety Guidance for Imported Feeds Assignment -- Collection and Analysis

# 

# Safety Information -- Sample Collection

The main objective of these recommendations is to minimize all exposure
to feeds and feed dust at the time of sample collection and to minimize
future exposure through feed dust on your clothing or equipment.

1.  **Personal protective equipment (PPE) recommended for personnel
    collecting feed samples**:

-   Respiratory protection : [minimum half-mask air-purifying respirator
    (face-sealing) with P100 filters (HEPA)]{.underline}

-   Ocular (eye) mucous membrane protection: [goggles]{.underline}

-   Percutaneous (through skin openings such as cuts, abrasions-
    unbroken skin poses no known hazard) -- [waterproof gloves on hands;
    cover skin lesions, cuts, abrasions with waterproof
    dressing]{.underline}

-   Clothing contamination -- [disposable coveralls]{.underline}

2.  **Collection and bagging procedures:**

    Minimize dust as much as possible when collecting 16 -- 1 oz subs
    and combining them into one sample. Wipe the outside of whirl-pak
    bag with a water-dampened paper towel in a clean area, and place
    this bag into another whirl-pak bag (double bag the sample).

3.  **Cleanup and PPE removal:**

> When in a dust-free area, remove the disposable coveralls by turning
> inside-out, rolling up and placing in a plastic bag for disposal. Wipe
> shoes with water dampened paper towel. Remove goggles and respirator;
> wipe outside of goggles and respirator with water-dampened paper
> towel. Place goggles and respirator in clean carrying bag. Place all
> wipes in the disposal bag with the disposable coveralls. Place the bag
> in a trash receptacle.

# Safety Information -- Laboratory Sample Processing and Analysis 

1.  [Sample custodian]{.underline}

> Should ensure that the paper sample bag is puncture-free indicating
> that the whirl pak sample bags remain sealed. If the bag is not intact
> contact the feed analysts for decontamination procedures.

2.  [Sample Preparation and Analysis (see next section for
    decontamination)]{.underline}

-   Personal protective equipment: laboratory safety glasses, water
    impervious gloves such as latex when not working with organic
    solvents, viton gloves when working with chloroform, lab coats.

-   Review the MSDS for chloroform, which is a suspect carcinogen and
    teratogen. Use chloroform only in the fume hood and wear viton
    gloves when working with this solvent.

-   Place signage on the door to indicate biohazard work is being
    performed in your area.

-   Discourage other lab occupants from walking near your area when you
    are working at the fume hood or at your stereoscope or microscope.

-   Use disposable equipment whenever possible to avoid decontamination
    issues.

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-   Sample bags should be opened in a fume hood on a waterproof
    disposable liner. Wipe the outside of the whirl pak sample bag with
    5.25% hypochlorite solution (undiluted bleach).

-   Perform all sample preparation in the fume hood.

-   When grinding samples with the mortar and pestle, cover the mortar
    with plastic wrap loosely to prevent any feed particles from leaving
    the mortar. Gently grind the sample. Place the plastic wrap in a
    temporary disposal bag until the sample is analyzed.

-   The water layer in the separation step should be saved until the
    sample analysis is performed. If the sample is found to be
    violative, use paper towels to absorb the liquid, and place in the
    red biohazard bag for incineration.

-   Perform a microscopic analysis in a HEPA-filtered cabinet or at a
    location approved by an ORA/FDA Industrial Hygienist. Other suitable
    location: slot hood exhaust away from analysts breathing zone.

3.  [Decontamination (Violative Samples)]{.underline}

-   The disposable equipment and materials (implements, paper, petrie
    dishes, slides, etc.) used during the procedure should be placed in
    a red biohazard bag for incineration. This bag should be sealed when
    not being filled. Once filled, it should be placed in a secure
    location for collection by a biohazard/medical waste disposal
    company (for example: Stericyle : 800-355-8773) which will send it
    for incineration. Paperwork showing collection and disposal
    information should be kept on file.

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-   All non-disposable equipment and surfaces (unprotected lab bench
    tops, mortar and pestle, metal sieves, test tubes, metal spatulas)
    which have come into contact with a violative feed sample must be
    decontaminated by one of the following methods:

1)  Soak equipment for 30 minutes with 5.25% hypochlorite (full strength
    commercial bleach) for 30 minutes. Rinse well with water. The bleach
    solution is sink disposable. This method is preferred since it does
    not generate a hazardous waste.

2)  Soak equipment for 30 minutes with 1.0 N NaOH. Dispose of solution
    in chemical hazardous waste container, which is specifically labeled
    to receive NaOH. Rinse equipment well with water. Place rinse in
    hazardous waste container or check rinse pH as required by your
    hazardous waste program to determine if neutralization and/or sink
    disposal is acceptable. Do not dilute to lower the pH for sink
    disposal.

[]{#AttachAlert .anchor}**Attachment F**

**Import Alert #99-25**

**(**<http://www.fda.gov/ora/fiars/ora_import_ia9925.html>**)**

**Detention Without Physical Examination**

**of Animal Feed, Animal Feed Ingredients and Other Products for Animal
Use**

**Consisting or Containing Ingredients of Animal Origin**

**and Not the Subject of a Valid USDA Import Permit**

**Type of Alert:** Detention Without Physical Examination

(Note: This Import Alert contains the agency\'s current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(s) at
issue. It does not create or confer any rights for, or on any person,
and does not operate to bind FDA or the public.)

**PRODUCT:** ALL ANIMAL FEED (INCLUDING PET FOOD), ANIMAL FEED
INGREDIENTS,AND OTHER PRODUCTS FOR ANIMAL USE CONSISTING OF OR
CONTAINING INGREDIENTS OF ANIMAL ORIGIN (SEE ATTACHMENT A)

**PRODUCT CODES:** SEE ATTACHMENT A

**PROBLEM:** POSSIBLE CONTAMINATION WITH THE INFECTIOUS AGENT FOR BOVINE
SPONGIFORM ENCEPHALOPATHY (BSE)

**PAC:** 71R844

**PAF:** MIC

**COUNTRIES:** ALBANIA (AL), ANDORRA (AD), AUSTRIA (AT), BELGIUM (BE),
BOSNIA-HERZEGOVINA (BA), BULGARIA (BG), CANADA (CA), CROATIA (HR), the
CZECH REPUBLIC (CS), DENMARK (DK), the FEDERAL REPUBLIC OF YUGOSLAVIA
(YU), FINLAND (FI), FRANCE (FR), GERMANY (DE), GREECE (GR), HUNGARY
(HU), IRELAND, REPUBLIC of (IE), ISRAEL (IL), ITALY (IT), JAPAN (JP),
LEICHSTENSTEIN (LI), LUXEMBOURG (LU), the former YUGOSLAV REPUBLIC OF
MACEDONIA (MK), MONACO (MC), NETHERLANDS (NL), NORWAY (NO), OMAN (OM),
POLAND (PL), PORTUGAL (PT), ROMANIA (RO), SAN MARINO (SM), the SLOVAK
REPUBLIC (SLOVAKIA) (SK), SLOVENIA (SI), SPAIN (ES), SWEDEN (SE),
SWITZERLAND (CH) UNITED KINGDOM (Great Britain & Northern Ireland, and
Falkland Islands) (GB)

**CHARGE:** \"The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that it appears that such article has been
manufactured, processed, or packed under insanitary conditions.\" (OASIS
Charge Code: MFR INSAN)

**RECOMMENDING OFFICE:** CVM, Division of Compliance (HFV-230)

**REASON FOR ALERT:** On December 7, 2000, USDA/APHIS enacted an
immediate prohibition on the importation into the United States of all
meat and bone meal (MBM), meat meal, bone meal, blood meal, tankage,
offal, or any product containing such, which originated directly from
Europe or was rendered/processed in European plants processing animal
materials, regardless of species of origin, including poultry and fish
meal. This prohibition was deemed necessary by APHIS because of the
possibility of cross contamination with the BSE agent.

BSE is the bovine form of a group of uniformly fatal neurological
diseases known as TSEs (Transmissible Spongiform Encephalopathies). BSE
appears to be spread in part through feeding of infected material to
cattle. At this time, the causative agent is unknown and there is no
test for the presence of the agent in animal derived products. There
appears to be a link between the bovine TSE, BSE, and a human form of
TSE known as vCJD (new variant Creutzfeldt-Jakob Disease).

The United States Department of Agriculture (USDA), Animal and Plant
Health Inspection Service (APHIS), Veterinary Services (VS) regulates
the importation of animals and animal-derived materials to ensure that
exotic animal diseases, such as BSE, are not introduced into United
States animal populations. More specifically, under 9 CFR 95.4, the USDA
does not allow the importation of animal feeds or feed ingredients that
contain or consist of processed animal protein (e.g. meat and bone meal)
and other animal waste and by product materials that have been derived
from animals that have been in specified BSE-affected and BSE-at-risk
countries. The USDA may, however, allow for the importation of specific
non-ruminant animal-derived products, provided the product is the
subject of a valid USDA import permit (VS Form 16-6).

**GUIDANCE:** Districts may detain without physical examination
shipments of animal feeds (including pet food), animal feed ingredients,
and other products for animal use consisting of, or containing,
ingredients of animal origin as listed in Attachment A from the
designated countries if the product is not the subject of a valid USDA
import permit (VS Form 16-6).

OASIS Screening Criteria have been loaded to ensure that entries of
products that contain or may contain animal protein or by-products will
be selected for review by the entry reviewer. As part of the review
process, the entry reviewer should contact the filer/importer, request
paper entry documents \*\*\*(USDA import permit, VS Form 16-6)),\*\*\*
and remind the filer/importer of their requirement to hold the shipment
intact pending FDA release. Additionally, the entry reviewer should
determine the intended use of the product, the ingredients, and the name
and address of the ultimate consignee.

If the filer/importer does not agree to hold the product intact pending
FDA release, contact the local office of US Customs and ask that they
detain the product. Products which (from labeling or other
documentation) appear to contain animal protein or by-products \*\*\*
and which are not the subject of a valid USDA import permit (VS Form
16-6)\*\*\*should either be detained by FDA or recommended to USDA/APHIS
for appropriate action. (The location of the APHIS/Plant Protection and
Quarantine office can be determined by calling USDA\'s Veterinary
Medical Office at (301) 734-7633).

Products detained and refused under the above reference charge may not
be reconditioned or converted to non-FDA regulated use. They must be
either destroyed or exported.

Please note that APHIS has received information that shipments of
animal-derived products may be offered for entry under descriptions that
may be misleading or appear to not be subject to their prohibition, such
as fertilizer, adhesive, supplement, nutritional supplement, additive,
feed/food additive.

**PRIORITIZATION GUIDANCE:** I

**FOI:** No purging is required

**PREPARED BY:** Gloria J. Dunnavan, CVM, Division of Compliance,
HFV-230 (301-827-1168) and Dr. Neal Bataller (301-827-0163) and Linda
Wisniowski, DIOP, (301-443-6553)

**KEYWORDS:** MBM, Feed, Meal, Animal, European Union, EU, BSE, TSE

**DATE LOADED INTO FIARS:** October 1, 2003

**ATTACHMENT A**

Products Subject to Detention Without Physical Examination

(NOTE: This list is subject to revision as additional information is
received.)

69 - Medicated Animal Feeds

69 \[ \]\[ \]\[ \]\[ \]\[ \] All products

70 - Non-Medicated Animal Feeds

70 \[ \]\[ \]\[ \]\[ \]\[ \] All products

71 - By-products for Animal Food

71 \[ \]\[ \]\[ \]\[ \]\[ \] All products EXCEPT:

71F \[ \] \[ \] \[ \] - Brewery and Distillery

71G \[ \] \[ \] \[ \] - Corn Products

71H \[ \] \[ \] \[ \] - Flour Mill

71I \[ \] \[ \] \[ \] - Rice Mill

71J \[ \] \[ \] \[ \] - Fruit

71K \[ \] \[ \] \[ \] - Vegetable

71L \[ \] \[ \] \[ \] - Oilseed

72 - Pet and Laboratory Animal Food

72 \[ \] \[ \] \[ \] \[ \] \[ \] All products

[]{#AttachUSDA1 .anchor}**Attachment G**

###### 9 CFR §94.18 {#cfr-94.18 .unnumbered}

**USDA Restrictions on the Importation**

**of Meat and Edible Products from Ruminants**

\[Code of Federal Regulations\]

\[Title 9, Volume 1\]

\[Revised as of January 1, 2003\]

From the U.S. Government Printing Office via GPO Access

\[CITE: 9CFR94.18\]

**TITLE 9**\--ANIMALS AND ANIMAL PRODUCTS

**CHAPTER I**\--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT
OF AGRICULTURE

**PART 94**\--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG CHOLERA, AND
BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED
IMPORTATIONS\--Table of Contents

**Sec. 94.18** Restrictions on importation of meat and edible products
from ruminants due to bovine spongiform encephalopathy.

(a) \(1\) Bovine spongiform encephalopathy exists in the following
    regions: Austria, Belgium, the Czech Republic, Denmark, Finland,
    France, Germany, Greece, the Republic of Ireland, Israel, Italy,
    Japan, Liechtenstein, Luxembourg, Oman, The Netherlands, Poland,
    Portugal, Slovakia, Slovenia, Spain, Switzerland, and the United
    Kingdom.

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(3) The following regions, because of import requirements less
    restrictive than those that would be acceptable for import into the
    United States and/or because of inadequate surveillance, present an
    undue risk of introducing bovine spongiform encephalopathy into the
    United States: Albania, Andorra, Bosnia-Herzegovina, Bulgaria,
    Croatia, the Federal Republic of Yugoslavia, Hungary, the Former
    Yugoslav Republic of Macedonia, Monaco, Norway, Romania, San Marino,
    and Sweden.

(4) A region may request at any time that the Administrator consider its
    removal from a list set forth in paragraphs (a)(1) or (a)(2) of this
    section by following the procedures set forth in Secs. 92.2(b) (1)
    through (4), 92.2(b) (5) through (11), and 92.2(c) of this chapter.

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(b) Except as provided in paragraph (d) of this section, the importation
    of fresh (chilled or frozen) meat, meat products, and edible
    products other than meat (excluding gelatin, milk, and milk
    products), from ruminants that have been in any of the countries
    listed in paragraph (a) of this section is prohibited.

(c) Gelatin. The importation of gelatin derived from ruminants that have
    been in any region listed in paragraph (a) of this section is
    prohibited unless the following conditions have been met:

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(1) The gelatin must be imported for use in human food, human
    pharmaceutical products, photography, or some other use that will
    not result in the gelatin coming in contact with ruminants in the
    United States.

(2) The person importing the gelatin must obtain a United States
    Veterinary Permit for Importation and Transportation of Controlled
    Materials and Organisms and Vectors by filing a permit application
    on VS form 16-3.\\17\\

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\17\\ VS form 16-3 may be obtained from the Animal and Plant Health

Inspection Service, Veterinary Services, National Center for Import-

Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

(3) The permit application must state the intended use of the gelatin
    and the name and address of the consignee in the United States.

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(d) Transit shipment of articles. Fresh (chilled or frozen) meat, and
    edible products other than meat, that are prohibited importation
    into the United States in accordance with this section may transit
    the United States for immediate export if the following conditions
    are met:

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(1) The person moving the articles must obtain a United States
    Veterinary Permit for Importation and Transportation of Controlled
    Materials and Organisms and Vectors by filing a permit application
    on VS form 16-3.\\18\\

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\\18\\ VS form 16-3 may be obtained from the Animal and Plant Health

Inspection Service, Veterinary Services, National Center for Import-

Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

(2) The articles must be sealed in leakproof containers bearing serial
    numbers during transit. Each container must remain sealed during the
    entire time that it is in the United States.

(3) The person moving the articles shall notify, in writing, the Plant
    Protection and Quarantine Officer at both the place in the United
    States where the articles will arrive and the port of export prior
    to such transit. The notification must include the:

    i.  United States Veterinary Permit for Importation and
        Transportation of Controlled Materials and Organisms and Vectors
        permit number;

    ii. Times and dates of arrival in the United States;

    iii. Times and dates of exportation from the United States;

    iv. Mode of transportation; and

    v.  Serial numbers of the sealed containers.

(4) The articles must transit the United States in Customs bond.

(Approved by the Office of Management and Budget under control number
0579-0015)

\[56 FR 63868, Dec. 6, 1991, as amended at 58 FR 65104, Dec. 13, 1993;
59 FR 24638, May 12, 1994; 59 FR 67616, Dec. 30, 1994; 62 FR 18264, Apr.
15, 1997; 62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 62 FR
61434, Nov. 18, 1997; 62 FR 66000, Dec. 17, 1997; 63 FR 408, Jan. 6,
1998; 63 FR 4347, Jan. 28, 1998; 63 FR 71210, Dec. 24, 1998; 64 FR
38550, July 19, 1999; 65 FR 51519, Aug. 24, 2000; 66 FR 22426, May 4,
2001; 66 FR 29900, June 4, 2001; 66 FR 42600, Aug. 14, 2001; 66 FR
52484, Oct. 16, 2001; 66 FR 54643, Oct. 30, 2001; 66 FR 62914, Dec. 4,
2001; 67 FR 4878, Feb. 1, 2002; 67 FR 12832, 12834, Mar. 20, 2002; 67 FR
44018, July 1, 2002; 67 FR 47244, July 18, 2002\]

[]{#AttachUSDA2 .anchor}**Attachment H**

###### 9 CFR §95.4 {#cfr-95.4 .unnumbered}

**USDA Restrictions on the Importation**

**of Processed Animal Protein and Other Animal Products**

\[Code of Federal Regulations\]

\[Title 9, Volume 1\]

\[Revised as of January 1, 2003\]

From the U.S. Government Printing Office via GPO Access

\[CITE: 9CFR95.4\]

**TITLE 9**\--ANIMALS AND ANIMAL PRODUCTS

**CHAPTER I**\--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT
OF AGRICULTURE

**PART 95**\--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS),
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES \-- Table of
Contents

**Sec. 95.4** Restrictions on the importation of processed animal
protein, offal, tankage, fat, glands, certain tallow other than tallow
derivatives, and serum due to bovine spongiform encephalopathy.

a.  Except as provided in paragraphs (c) through (f) of this section,
    the importation of the following is prohibited:

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(1) Any of the materials listed in paragraphs (a)(1)(i) through
    (a)(1)(iv) of this section that have been derived from animals that
    have been in any region listed in Sec. 94.18(a) of this chapter:

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(i) Processed animal protein, tankage, offal, and tallow other than
    tallow derivatives, unless, in the opinion of the Administrator, the
    tallow cannot be used in feed, regardless of the animal species from
    which the material was derived;

    ii. Glands and unprocessed fat tissue derived from ruminants;

    iii. Processed fats and oils, and derivatives of processed animal
         protein, tankage, and offal, regardless of the animal species
         from which the material was derived; and

    iv. Derivatives of glands from ruminants.

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(2) Any of the materials listed in paragraphs (a)(2)(i) through
    (a)(2)(iv) of this section that have been stored, rendered, or
    otherwise processed in a region listed in Sec. 94.18(a) of this
    chapter, or that have otherwise been associated with a facility in a
    region listed in Sec. 94.18(a) of this chapter or with any material
    listed in paragraph (a)(1) through (a)(3) of this section:

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(i) Processed animal protein, tankage, offal, and tallow other than
    tallow derivatives, unless, in the opinion of the Administrator, the
    tallow cannot be used in feed, regardless of the animal species from
    which the material was derived;

(ii) Glands and unprocessed fat tissue derived from ruminants;

(iii) Processed fats and oils, and derivatives of processed animal
      protein, tankage, and offal, regardless of the animal species from
      which the material was derived; and

(iv) Derivatives of glands from ruminants.

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(3) Products containing any of the items listed in paragraphs (a)(1) and
    (a)(2) of this section.

    a.  Except as provided in paragraphs (d) and (f) of this section,
        the importation of serum from ruminants that have been in any
        region listed in Sec. 94.18(a) of this chapter is prohibited,
        except that serum from ruminants may be imported for scientific,
        educational, or research purposes if the Administrator
        determines that the importation can be made under conditions
        that will prevent the introduction of bovine spongiform
        encephalopathy into the United States. Serum from ruminants
        imported in accordance with this paragraph must be accompanied
        by a permit issued by APHIS in accordance with Sec. 104.4 of
        this chapter, and must be moved and handled as specified on the
        permit.

    b.  Materials that are otherwise prohibited importation into the
        United States under paragraph (a) of this section may be
        imported into the United States if the following conditions are
        met prior to importation:

        1.  The material is derived from a nonruminant species, or from
            a ruminant species if the ruminants have never been in any
            region listed in Sec. 94.18(a) of this chapter.

        2.  All steps of processing and storing the material are carried
            out in a foreign facility that has not been used for the
            processing and storage of materials derived from ruminants
            that have been in any region listed in Sec. 94.18(a) of this
            chapter.

        3.  The facility demonstrates to APHIS that the materials
            intended for exportation to the United States were
            transported to and from the facility in a manner that would
            prevent cross-contamination by or commingling with
            prohibited materials.

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(4) If the facility processes or handles any material derived from
    mammals, the facility has entered into a cooperative service
    agreement executed by the operator of the facility and APHIS. In
    accordance with the cooperative service agreement, the facility must
    be current in paying all costs for a veterinarian of APHIS to
    inspect the facility (it is anticipated that such inspections will
    occur approximately once per year), including travel, salary,
    subsistence, administrative overhead, and other incidental expenses
    (including excess baggage provisions up to 150 pounds). In addition,
    the facility must have on deposit with APHIS an unobligated amount
    equal to the cost for APHIS personnel to conduct one inspection. As
    funds from that amount are obligated, a bill for costs incurred
    based on official accounting records will be issued to restore the
    deposit to the original level, revised as necessary to allow for
    inflation or other changes in estimated costs. To be current, bills
    must be paid within 14 days of receipt.

(5) The facility allows periodic APHIS inspection of its facilities,
    records, and operations.

(6) Each shipment to the United States is accompanied by an original
    certificate signed by a full-time, salaried veterinarian of the
    government agency responsible for animal health in the region of
    export certifying that the conditions of paragraphs (c)(1) through
    (c)(3) of this section have been met.

(7) The person importing the shipment has applied for and obtained from
    APHIS a United States Veterinary Permit for Importation and
    Transportation of Controlled Materials and Organisms and Vectors by
    filing a permit application on VS form 16-3. (VS Form 16-3 may be
    obtained from APHIS, Veterinary Services, National Center for
    Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
    electronically at <http://www.aphis.usda.gov/ncie>.)

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(d) The importation of serum albumin, serocolostrum, amniotic liquids or
    extracts, and placental liquids derived from ruminants that have
    been in any region listed in Sec. 94.18(a) of this chapter, and of
    collagen and collagen products that meet any of the conditions
    listed in paragraphs (a)(1) through (a)(3) of this section, is
    prohibited unless the following conditions have been met:

    1.  The article is imported for use as an ingredient in cosmetics;

    2.  The person importing the article has obtained a United States
        Veterinary Permit for Importation and Transportation of
        Controlled Materials and Organisms and Vectors by filing a
        permit application on VS form 16-3 (VS Form 16-3 may be obtained
        from APHIS, Veterinary Services, National Center for
        Import-Export, 4700 River Road Unit 38, Riverdale, MD
        20737-1231, or electronically at
        <http://www.aphis.usda.gov/ncie>.); and

    3.  The permit application states the intended use of the article
        and the name and address of the consignee in the United
        States. (e) Insulin otherwise prohibited from importation into
        the United States under paragraph (a) of this section is not
        prohibited from importation under that paragraph if the insulin
        is for the personal medical use of the person importing it and
        if the person importing the shipment has applied for and
        obtained from APHIS a United States Veterinary Permit for
        Importation and Transportation of Controlled Materials and
        Organisms and Vectors by filing a permit application on VS form
        16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary
        Services, National Center for Import-Export, 4700 River Road
        Unit 38, Riverdale, MD 20737-1231, or electronically at
        <http://www.aphis.usda.gov/ncie>. Note: Insulin that is not
        prohibited from importation under this paragraph may be
        prohibited from importation under other Federal laws, including
        the Federal Food, Drug, and Cosmetic Act, 21 U.S.C, 321 et seq.)

        e.  Articles that are prohibited importation into the United
            States in accordance with this section may transit the
            United States for immediate export if the following
            conditions are met:

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(1) The person moving the articles has obtained from APHIS a United
    States Veterinary Permit for Importation and Transportation of
    Controlled Materials and Organisms and Vectors by filing a permit
    application on VS form 16-3. (VS Form 16-3 may be obtained from
    APHIS, Veterinary Services, National Center for Import-Export, 4700
    River Road Unit 38, Riverdale, MD 20737-1231, or electronically at
    http://www.aphis.usda.gov/ncie.)

(2) The articles are sealed in leakproof containers bearing serial
    numbers during transit. Each container remains sealed during the
    entire time that it is in the United States.

(3) The person moving the articles notifies, in writing, the Plant
    Protection and Quarantine Officer at both the place in the United
    States where the articles will arrive and the port of export prior
    to such transit. The notification includes the:

    i.  United States Veterinary Permit for Importation and
        Transportation of Controlled Materials and Organisms and Vectors
        permit number;

    ii. Times and dates of arrival in the United States;

    iii. Times and dates of exportation from the United States;

    iv. Mode of transportation; and

    v.  Serial numbers of the sealed containers.

(4) The articles transit the United States in Customs bond.

(Approved by the Office of Management and Budget under control numbers
0579-0015 and 0579-0183)

\[66 FR 42600, Aug. 14, 2001\]

[]{#AttachRecallReg .anchor}**Attachment I**

**21 CFR §7.40**

**Recall Policy**

\[Code of Federal Regulations\]

\[Title 21, Volume 1\]

\[Revised as of April 1, 2001\]

From the U.S. Government Printing Office via GPO Access

\[CITE**:** 21CFR7**.**40\]

**TITLE 21**\--FOOD AND DRUGS

**CHAPTER I**\--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES

**PART 7**\--ENFORCEMENT POLICY\--Table of Contents

**Subpart C**\--Recalls (Including Product Corrections)\--Guidance on
Policy, Procedures, and Industry Responsibilities

**Sec. 7.40 Recall policy.**

Source: 43 FR 26218, June 16, 1978, unless otherwise noted.

(a) Recall is an effective method of removing or correcting consumer
    products that are in violation of laws administered by the Food and
    Drug Administration. Recall is a voluntary action that takes place
    because manufacturers and distributors carry out their
    responsibility to protect the public health and well-being from
    products that present a risk of injury or gross deception or are
    otherwise defective. This section and Secs. 7.41 through 7.59
    recognize the voluntary nature of recall by providing guidance so
    that responsible firms may effectively discharge their recall
    responsibilities. These sections also recognize that recall is an
    alternative to a Food and Drug Administration-initiated court action
    for removing or correcting violative, distributed products by
    setting forth specific recall procedures for the Food and Drug
    Administration to monitor recalls and assess the adequacy of a
    firm\'s efforts in recall.

(b) Recall may be undertaken voluntarily and at any time by
    manufacturers and distributors, or at the request of the Food and
    Drug Administration. A request by the Food and Drug Administration
    that a firm recall a product is reserved for urgent situations and
    is to be directed to the firm that has primary responsibility for
    the manufacture and marketing of the product that is to be recalled.

(c) Recall is generally more appropriate and affords better protection
    for consumers than seizure, when many lots of product have been
    widely distributed. Seizure, multiple seizure, or other court action
    is indicated when a firm refuses to undertake a recall requested by
    the Food and Drug Administration, or where the agency has reason to
    believe that a recall would not be effective, determines that a
    recall is ineffective, or discovers that a violation is continuing.

\[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19,
2000\]