FOOD AND DRUG ADMINISTRATION

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  COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM                    7371.003

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  ---------------------------------------------- ------------------------
  SUBJECT:                                       IMPLEMENTATION DATE:

                                                 

  FEED CONTAMINANTS PROGRAM                      December 13, 2005

                                                 

                                                 COMPLETION DATE:

                                                 

                                                 9/30/2010

                                                 
  ---------------------------------------------- ------------------------

**DATA REPORTING**

+-----------------------------------+-----------------------------------+
| **PRODUCT CODES**                 | **PRODUCT/ASSIGNMENT CODES        |
|                                   | (PACs)**                          |
+-----------------------------------+-----------------------------------+
| **Industry Codes:**               | **71003A - Pesticides/Industrial  |
|                                   | Chemicals**                       |
| **54, 69, 70, 71, 72**            |                                   |
|                                   | **71003B - Elements**             |
|                                   |                                   |
|                                   | **71003C - Mycotoxins**           |
|                                   |                                   |
|                                   | **71003E - Microbes**             |
|                                   |                                   |
|                                   | **71003G - Dioxins**              |
+-----------------------------------+-----------------------------------+

This compliance program is intended to provide guidance and instructions
to Food and Drug Administration (FDA) staff for obtaining information
and taking action to help fulfill the Agency's plans for controlling the
presence of deleterious chemicals and microorganisms in feeds. The
program does not create or confer any rights for any person and does not
operate to bind the FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of applicable statutes
and regulations. It is intended for use by FDA personnel, but is
available electronically to the public.

**A. [MAJOR DELETIONS FROM THE PREVIOUS FEED CONTAMINANTS
PROGRAM]{.underline}**

> 1\. A separate compliance program for all bovine spongiform
> encephalopathy (BSE)-related matters was finalized on October 21,
> 2003. This new BSE-related compliance program is Compliance Program
> 7371.009 - BSE/Ruminant Feed Ban Inspections and it can be viewed from
> the following website:
> <http://www.fda.gov/cvm/Documents/7371-009.doc>. Thus, PAC 71003F (BSE
> Activities) was removed from the Feed Contaminants Program (7371.003).
>
> On September 30, 2005, PACs for the new BSE-related compliance program
> (7371.009) will be:
>
> 71009 BSE/Ruminant Feed Ban Inspections Program
>
> 71R844 BSE Import Activities CVM Products
>
> 71S011 BSE State Contract Inspections
>
> Send all reports involving BSE activities to Dr. Neal Bataller, BSE
> Activities Monitor, Division of Compliance, Compliance Information
> Management Team, HFV-235; (240-276-9202; e-mail:
> <Neal.Bataller@fda.gov>.
>
> 2\. PAC 71003D -- Treated Seed Diversions has been archived. 
> Therefore, this PAC was removed from the Feed Contaminants Program
> (FCP) and all mention of treated seed diversions was deleted.
>
> 3\. FDA/Center for Veterinary Medicine (CVM)/Division of Animal Feed
> (DAF) recently learned that the Contamination Response System (CRS) is
> no longer an active program of the USDA/Food Safety Inspection Service
> (FSIS). Thus, all mention of CRS in the FCP was removed.
>
> \[Note: USDA/FSIS continues to analyze animal-derived products for
> contaminants and to report elevated findings to CVM. CVM may request
> that ORA investigate these elevated findings as part of the FCP, but
> these investigations will not be associated with the CRS.\]

**B. [MAJOR ADDITION TO THE PREVIOUS FEED CONTAMINANTS
PROGRAM]{.underline}**

> Guidance on the analytical priority for mycotoxins in various feed
> ingredients and complete feeds (see Attachment A).

**C. [FIELD REPORTING]{.underline}**

> 1\. Report all collections/analyses of domestic and imported feed
> samples for pesticides, industrial chemicals, elements, mycotoxins,
> microbes and dioxins against this program even though the samples may
> have been collected during inspections conducted under other
> compliance programs.
>
> 2\. Submit the following information and all reports involving
> pesticides, industrial chemicals, elements, mycotoxins, microbes, and
> dioxins to Division of Animal Feed, Medicated Feeds Team, HFV-226;
> Attn: Zoe Gill, Feed Contaminants Program Monitor, 7519 Standish
> Place, MPN4, Rockville, Maryland 20855 (240-453-6867; e-mail:
> Zoe.Gill@fda.gov):

a.  Each district/region should submit an annual feed contaminants
    report by November 30 after the conclusion of each fiscal year. This
    annual report is to be used as a mechanism to provide CVM with
    information that is not readily apparent or retrievable through the
    Field Accomplishments and Compliance Tracking System (FACTS) and
    Operational and Administrative System for Import Support (OASIS)
    databases. Examples include descriptions of federal/state
    cooperation under this compliance program; any local district
    initiatives and the impact of those initiatives; training given and
    other outreach programs; problems encountered; and other noteworthy
    events.

b.  A copy of the collection report **ONLY** when directed by the
    special assignment/survey.

**[Table of Contents]{.underline}**

TOPIC PAGE

**[Part I --
Background]{.underline}**............................................................................................
6

**[Part II --
Implementation]{.underline}**......................................................................................
8

A.
Objectives.....................................................................................................
8

B. Program Management
Instruction.........................................................................
8

1.  District Contact for the Feed Contaminants
    Program.......................................\... 8

2.  Inter-Agency
    Agreements.........................................................................
    9

3.  Program
    Interactions...............................................................................
    9

4.  EPA Regional Office
    Contacts...................................................................
    10

**[Part III --
Inspectional]{.underline}**.........................................................................................
11

A.
Investigations................................................................................................
11

B.
Surveillance..................................................................................................
11

C. Sample
Collections.......................................................................................\...
11

D. District Surveillance and Compliance
Samples......................................................... 12

E. Import
Samples...............................................................................................
13

F. Sample
Size/Handling/Shipment..........................................................................
13

G. Sample
Submission.........................................................................................
13

H. Special Reporting
..........................................................................
14

1.  Pesticide
    Samples...................................................................................
    14

2.  Industrial Chemical
    Samples......................................................................
    14

3.  Microbe
    Samples...................................................................................
    14

**[Part IV --
Analytical]{.underline}**............................................................................................
15

A. Servicing
Labs.............................................................................................\...
15

1.  Pesticide, Industrial Chemical, and Element
    Samples......................................... 15

2.  Dioxin
    Samples.....................................................................................
    15

3.  Mycotoxin
    Samples................................................................................
    15

4.  Microbe
    Samples...................................................................................
    15

B. Procedural
Considerations.................................................................................
16

1.  Pesticides, Industrial Chemicals, and
    Elements.................................................. 16

2.  Mycotoxins..........................................................................................
    17

3.  Microbes.............................................................................................
    17

C.
Methodology.................................................................................................
18

1\. Chemical
Contaminants............................................................................
18

a.  Pesticides and Industrial
    Chemicals..................................................... 18

b.  Elements....................................................................................
    18

c.  Mycotoxins.................................................................................
    19

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2.  Microbes.............................................................................................
    21

D.
Reporting.....................................................................................................
21

1.  Analytical Results and Method Performance
    Data............................................ 21

2.  Sample
    Classification...........................................................................\...
    22

3.  Special
    Reporting..................................................................................
    22

**[Part V --
Regulatory]{.underline}**...........................................................................................
23

A. Regulatory
Action...........................................................................................
23

1\. Domestic
Samples..................................................................................
23

a.  Pesticides and Industrial
    Chemicals.................................................... 23

b.  Elements....................................................................................
    23

c.  Aflatoxins..................................................................................
    24

d.  Vomitoxin..................................................................................
    24

e.  Fumonisins.................................................................................
    24

f.  Ochratoxin A and
    Zearalenone..........................................................
    24

g.  *Salmonella* and *E. coli*
    O157:H7.....................................................\... 24

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2.  Import
    Samples....................................................................................
    25

3.  Additional Regulatory
    Guidance................................................................
    26

**[Part VI -- References, Attachments &
Contacts]{.underline}**.........................................................
27

A.
References...................................................\.................................................
27

B.
Attachments..................................................................................................
28

C.
Contacts.......................................................................................................
28

1.  CVM
    Contacts....................................................................................\...
    28

    a.  Program
        Inquiries..........................................................................
        28

    b.  Regulatory
        Inquiries.......................................................................
        28

    c.  Feed Contaminants Program Manager and Scientific Contact for
        Dioxins,

> Pesticides and Industrial
> Chemicals..................................................... 29

d.  Scientific Contact for
    Mycotoxins...................................................... 29

e.  Scientific Contact for
    Microbes......................................................... 29

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2.  ORA
    Contacts.......................................................................................
    29

    a.  Inspectional
        Inquiries..................................................................\...
        29

    b.  FDA/State Cooperative Sampling
        Plans............................................... 29

    c.  Methodology Inquiries on Pesticides, Industrial Chemicals,
        Dioxins,

> Mycotoxins and
> Elements.............................................................\....
> 30

d.  Methodology Inquiries on
    Microbes.................................................\... 30

e.  Import
    Inquiries...........................................................................
    30

f.  FACTS -- Data Input
    Inquiries..........................................................
    30

g.  FACTS -- National Tables of Field
    Data............................................... 30

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3.  CFSAN
    Contact....................................................................................
    31

**[Part VII -- Center
Responsibilities]{.underline}**..........................................................................
32

Attachment A: Guidance on the Analytical Priority for Mycotoxins in
Various Feed Ingredients

> and Complete
> Feeds............................................................\...\...\...\...\...\...
> 33

Attachment B: Advisory Levels for Vomitoxin (DON or Deoxynivalenol) in
Animal Feeds........ 34

Attachment C: Guidance for Fumonisins in Animal
Feeds.............................................\... 35

**PART I - BACKGROUND**

The FDA has the responsibility to enforce the Federal Food, Drug, and
Cosmetic Act (FFDCA) and to ensure that foods for man and animal are
safe. Within FDA, CVM is responsible for protecting the animal feed
supply and ensuring that it is safe and wholesome, and that the
incidence of harmful residues in human food derived from animals is
minimized. This program is designed to address this responsibility as it
relates to all contaminants, except drug residues and BSE matters.

Animal feeds can be adulterated with pesticides, industrial chemicals,
dioxins, elements, mycotoxins, and microbes. They may present a hazard
to livestock health and production, and to the public health by residues
in animal-derived human food or by their ability to cause disease. Many
of the more frequently identified contaminants in animal feeds are
toxic, carcinogenic, mutagenic, teratogenic, or otherwise deleterious to
animal and human health.

The Feed Contaminants Program (FCP) provides guidance for:

A.  Collection of animal feed samples and analysis for pesticides,
    industrial chemicals, dioxins, elements, mycotoxins and microbes.

B.  Surveillance of the feed industry to identify potential problem
    areas and additional sampling of these problem areas to ensure
    compliance.

C.  Investigation of violative findings.

The scope of the program includes, but is not limited to:

A.  Guidance on submitting an annual feed contaminants report (see Field
    Hardcopy Reporting section above).

B.  Guidance on developing FDA/State cooperative sampling plans.

C.  Guidance on the analytical priority for mycotoxins in feeds and feed
    ingredients.

D.  Coverage of feed and feed ingredients to determine microbial
    contaminants, such as *Salmonella* and *E*. *coli* O157:H7, and
    their antimicrobial susceptibility patterns.

Based on review of contaminant data and other information, CVM may issue
assignments to survey segments of industry or to direct sampling of
specific target products. The Center anticipates that directed
assignments will utilize some of the program\'s resources, especially
for dioxins and microbes. These directed assignments coupled with the
districts' surveillance and compliance activities are expected to
provide contaminants-related data which will supplement that available
from such sources as the United States Department of Agriculture (USDA),
Environmental Protection Agency (EPA), states and industry.

Under this program, the commodities collected and analyses performed may
vary both during the year and from year-to-year. Districts are
encouraged to use some of their resources to maintain adequate coverage
of imported products and to address local or regional contamination
problems.

CVM issued directed assignments in 2000, 2001, 2002, 2003, 2004, and
2005 to help determine background levels of dioxins and dioxin-like
compounds in commonly used animal feeds and feed ingredients. In 1997,
2002 and 2003, CVM was involved in recalls of feeds and feed ingredients
because of elevated dioxin levels. CVM anticipates issuing more directed
surveillance assignments for dioxins in 2006. CVM will continue working
with the FDA Center for Food Safety and Applied Nutrition (CFSAN) to
determine background dioxin levels in food.

**[PART II -- IMPLEMENTATION]{.underline}**

A.  **[OBJECTIVES]{.underline}**

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1.  To collect animal feed samples and analyze them for pesticides,
    industrial chemicals, dioxins, elements, mycotoxins, and microbes.

2.  To generate information on contaminant levels in domestic and
    imported feeds.

3.  To assure the public that the health of animals is not impaired and
    that human health is not compromised by contaminants in animal feed.

4.  To investigate violative feed samples and try to determine the
    source(s) of contamination.

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B.  **[PROGRAM MANAGEMENT INSTRUCTION]{.underline}**

> The field\'s approach to this program is regulatory in nature with
> emphasis on intelligence gathering, selective sampling, and aggressive
> compliance follow-up. Surveillance sampling should be done to cover
> gaps in information. Emphasis should be placed on identifying
> violations of regulatory significance and taking action to control the
> immediate problem and deter future violations. Food and feed sample
> collections and investigations should be planned and conducted to
> prevent unnecessary duplication of efforts.
>
> State officials are valuable sources of information on current and
> potential problems in feed products. Districts should encourage state
> participation in data exchange programs and should coordinate
> equivalent program activities with state officials to prevent
> duplication of efforts in both food and feed sampling and to
> facilitate greater state cooperation. Report time expended on
> intelligence gathering activities, such as meeting with state/local
> officials or gathering data on pesticide usage patterns, as
> investigations. Contact Kevin Smith, Division of Federal-State
> Relations, HFC-150 (301-827-2915; e-mail: Kevin.Smith1@fda.gov) for
> further guidance on developing FDA/State cooperative sampling plans.
>
> Several districts have a Pesticide Coordination Team (PCT) whose
> purpose is to coordinate efforts to ensure implementation of all
> pesticide programs within the district (Field Management Directive
> -134). CVM encourages each district to form a PCT and also encourages
> each district to form teams to coordinate other aspects of this
> program (mycotoxins, elements, dioxins, microbes, etc.).

1.  **[District Contact for the Feed Contaminants Program]{.underline}**

> Each district will annually submit the name, telephone number and
> e-mail address of a District Contact for this program to Zoe Gill, the
> FCP Monitor. In addition, each district will promptly provide any
> change in the District Contact during the year to the FCP Monitor. The
> District Contact will coordinate and communicate with the FDA
> investigator(s), the FDA lab(s), and CVM to try and resolve any
> concerns or questions that may arise from FCP-related activities.

2.  **[Inter-Agency Agreements]{.underline}**

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a.  Per current Memorandum of Understanding (MOU) between FDA, USDA and
    EPA, (described in the Federal Cooperative Agreements manual, August
    1996, Chapter 3 - Residues of Drugs, Pesticides and Environmental
    Contaminants in Foods), FDA has agreed to notify immediately the
    appropriate USDA/FSIS regional offices whenever:

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(1) FDA sample analysis detects pesticide or industrial chemical
    residues in feeds which exceed established tolerances or action
    levels.

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b.  In this MOU, FDA has agreed to notify immediately the appropriate
    EPA regional office whenever:

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(1) An FDA investigation reveals the possible misuse of pesticides, or

(2) FDA sample analysis detects pesticide or industrial chemical
    residues in feeds which exceed established tolerances or action
    levels.

> Note: Field Management Directive (FMD) No. 129 contains specific
> notification criteria.
>
> The field should inform the Feed Contaminants Program Manager, Randall
> Lovell, at (240) 453-6857 (e-mail: **<Randall.Lovell@.fda.gov>)** of
> all violative contamination incidents in feed. The Program Manager or
> designee will provide notification to FSIS and EPA headquarters as
> appropriate. District offices should notify local and state officials
> and regional FSIS and EPA offices of these incidents as appropriate.

3.  **[Program Interactions]{.underline}**

> The Feed Contaminants Program (7371.003) is one of several food safety
> related compliance programs directed by the FDA. CVM wants to list
> some of these other food safety related compliance programs so that
> investigators can consider performing activities from more than one
> program while at a firm (e.g. collect dairy feed samples for mycotoxin
> analysis, collect milk samples for drug and/or aflatoxin M~1~
> analysis, and perform a BSE-related inspection).
>
> 7303.803A\* Domestic Low Acid Canned Foods

7304.004 Pesticides and Industrial Chemicals in Domestic Foods

> 7318.003 Milk Safety Program
>
> 7371.004 Feed Manufacturing Compliance Program
>
> 7371.006 Illegal Drug Residues in Meat & Poultry Program
>
> 7371.009 BSE/Ruminant Feed Ban Inspections
>
> 7303.842 Domestic Fish and Fishery Products Inspection Program
>
> 7303.844 Import Seafood Products
>
> \*Note: The FDA's low acid canned food (LACF) program is administered
> by CFSAN. Thus, the inspections of all LACF manufacturers, even those
> that exclusively produce pet food products, should be reported under a
> CFSAN PAC, 03803A.

4.  **[EPA Regional Office Contacts]{.underline}**

> Regional, state, tribal and/or local contact information for EPA's
> pesticide programs can be found at the following website:
> <http://www.epa.gov/pesticides/contacts/index.htm#office>. Go to the
> By Region column on the right hand side of the screen and find the
> appropriate EPA Region (for example, EPA Region 7 serves Iowa, Kansas,
> Missouri and Nebraska). Click on Pesticide Program (do not click on
> Contact Page). The contact information should be readily apparent on
> the next screen, although you may have to click on the contact you
> want in the upper left corner of this screen. After you click on
> Pesticide Program in Regions 8 and 10, look to the bottom of the
> screen that comes up (but you shouldn't have to scroll down) and click
> on Region 8 Pesticide team or on EPA Region 10 Pesticides Staff. After
> you click on Pesticide Program in Region 6, you should scroll down to
> the bottom of the screen that appears and then click on the
> appropriate contact in the section entitled EPA, State, and Tribal
> Contacts in Region 6.

**[PART III ‑ INSPECTIONAL]{.underline}**

This program does not direct routine inspections. Time is allocated for
follow-up investigations and industry surveillance.

A.  **[INVESTIGATIONS]{.underline}**

> [Investigations Operations Manual]{.underline} (IOM) Subchapter 570
> provides guidance concerning pesticide intelligence gathering
> operations.
>
> Conduct mycotoxin investigations only as follow-ups to previously
> identified problems. For example, when a milk sample is found to
> contain elevated levels of aflatoxin M~1~, dairy feed should be
> sampled to determine the source of the contamination.
>
> The district will conduct investigations into other feed contamination
> incidents, such as dioxins, after an assignment is issued by CVM or by
> CFSAN.

B.  **[SURVEILLANCE]{.underline}**

> FDA Districts will conduct surveillance of local industries to provide
> a clearer picture about the safety of feed ingredients/finished feed
> and to identify potential problem areas. Surveillance may be conducted
> by districts during routine inspectional activities carried out under
> other compliance programs (e.g., 71004 -- Feed Manufacturing and 71006
> -- Illegal Tissue Residues) or by visits from various local, state and
> federal officials. The establishment of a working relationship with
> various local, state and federal authorities is encouraged to alert
> them of FDA\'s interest in feed safety and to facilitate information
> exchange about feed contaminants.

C.  **[SAMPLE COLLECTIONS]{.underline}**

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1.  Collect a wide variety of complete feeds and feed ingredients for
    pesticide/industrial chemical analysis. Emphasis should be placed on
    the most commonly used feeds in the district/region. The commodities
    collected may change annually.

2.  Grains, oilseeds, and complete feeds are the commodities that should
    be emphasized when collecting samples for mycotoxin analysis. In
    **Attachment A**, the most common grains, oilseeds, and complete
    feeds are placed into nine (9) categories and guidance on the
    mycotoxin analytical priority for each category is provided. CVM
    would like to see more feed samples analyzed for vomitoxin,
    zearalenone and ochratoxin A.

3.  Collect a wide variety of complete feeds and feed ingredients,
    including animal and vegetable proteins, for microbe analysis
    (*Salmonella* and *E. coli* O157:H7).

4.  Due to the limited resources for PAC Code 71003B, carefully choose
    samples for element analyses. Pet foods containing fish or fish
    by-products should be considered for mercury analysis. Mineral
    premixes for food-producing animals should be considered for
    selenium analysis.

5.  Collect animal feed and feed ingredients produced, imported, or
    distributed within the district. District discretion and
    inspectional findings should guide sampling. Animal feed for
    food-producing animals, especially lactating dairy cows and laying
    hens, should have priority over feeds for non-food producing
    animals.

6.  When collecting feed/feed ingredients, attempt to determine the
    following:

> a\. the percentage of the ingredients in the finished feed,
>
> b\. the intended use of the finished feed, i.e., starter feed,
> finishing feed, etc,
>
> c\. the animal species or type for which the feed/feed ingredient is
> intended, especially in samples collected for mycotoxin analyses,
>
> d\. whether the feed/feed ingredient will undergo further heat
> processing, especially in samples collected for microbe analyses.

7.  Proper sampling techniques should be used. Whenever possible,
    collect a representative sample of the feed or feed ingredient in
    the original packaging material. If the product is in large units or
    bulk, collect subsamples per [Investigations Operations
    Manual]{.underline} (IOM) Subchapter 420 sampling instructions. For
    bulk material, supply labeling or a list of components. Your
    servicing laboratory can provide guidance regarding contamination
    control procedures.

8.  Collect official samples when possible.  It is not necessary to
    document interstate commerce at the time of collection unless
    violative findings are expected or when following up a violative
    sample.  Investigational (INV) samples may be collected to provide
    surveillance information or to investigate violative findings.

9.  Although CVM may issue them at any time, directed assignments are
    likely only for dioxins and microbes. Collect these samples as
    directed in the assignment. PAC codes 71003H and 71003I, currently
    inactive, have recently been used in directed assignments for
    microbes.

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D.  **[DISTRICT SURVEILLANCE AND COMPLIANCE SAMPLES]{.underline}**

> District surveillance samples should give priority to coverage of
> locally grown or produced animal feed and feed ingredients. Base
> coverage on past violative samples, current analytical findings, and
> on information obtained through intelligence gathering activities. The
> district should emphasize feeds which comprise a significant portion
> of the local industry.
>
> As warranted, coordinate with local, state and federal EPA officials
> to cover pesticides applied under experimental or emergency use
> permits. Guidance may be found in CFSAN's Pesticide and Industrial
> Chemical Compliance Program (7304.004). Districts should not
> ordinarily extend sampling coverage to commodities subject to an
> experimental use permit.
>
> Compliance samples may be collected whenever an inspection or
> investigation reveals that a feed or feed ingredient is contaminated
> or is suspected of being contaminated. Finished feed, intermediate
> products and raw materials should be sampled as appropriate to
> document the probable cause and source of the contaminant.

E.  **[IMPORT SAMPLES]{.underline}**

> District discretion will be used to sample imported animal feeds and
> feed ingredients. Sampling priority should be given to imported feeds
> and feed ingredients from countries and/or companies which export
> significant quantities to the U.S. or which have previously shipped
> violative commodities. The guidelines for sample collections in Part
> III (C) apply to import samples, except for documenting interstate
> commerce. Imported feeds are subject to registration and prior notice.

F.  **[SAMPLE SIZE/HANDLING/SHIPMENT]{.underline}**

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1.  When collecting samples for analysis of pesticides, industrial
    chemicals, and elements, refer to IOM Chapter 4, Sample Schedule 3
    for minimum sample sizes. This sample schedule includes subsection
    4.1 on legume animal feeds, and other forages and fodders and
    subsection 4.2 on straw, hay and other dried products.

2.  For collection of samples for mycotoxin analysis, refer to IOM
    Chapter 4, Sample Schedule 6 for sample sizes.

3.  IOM Chapter 4 contains several other sample schedules that may be
    helpful in some situations. These include Sample Schedule 2 (Sample
    Schedule for Canned and Acidified Food), Sample Schedule 4 (Wheat
    Carload Sampling), Sample Schedule 15 (Veterinary Products, Feeds, &
    By-products for Animal Feeds) and Sample Schedule 16 (Medicated
    Animal Feeds Sampling).

4.  For microbes in feed and feed ingredients, aseptically collect two
    samples. One is an official sample and the other an investigational
    sample. The official sample, which consists of ten subsamples (\~200
    g per subsample), will be for regulatory purposes and should be sent
    to the FDA servicing laboratories. Report time for the collection
    and submission of these 10 subsamples under PAC 71003E.

> The investigational sample (\~300 g) will be for research purposes.
> The investigational sample (\~300 g) should be sent to Dr. David
> Wagner \[MOD II, Room 1503, HFV-530, 8401 Muirkirk Road, Laurel, MD
> 20708; Phone: (301) 210-4255; E-mail address: <David.Wagner@fda.gov>\]
> or his designee and should be labeled "Investigational Sample for
> Research Purposes Only." The investigational sample should be
> identified with the FACTS sample number, the collector's name, the
> date of collection, the State (Oklahoma, New Jersey, etc.) in which
> the sample was collected, and a description of the sample (for
> complete feeds, concentrates or supplements please include the
> production class or species for which the feed is intended).  Report
> time for the collection and preparation of the investigational sample
> under PAC 71R800.

5.  Refer to IOM Subchapter 450 for handling and shipment details.

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G.  **[SAMPLE SUBMISSION]{.underline}**

> Send samples to servicing laboratories as outlined in Part IV, Subpart
> A.

H.  **[SPECIAL REPORTING]{.underline}**

> Report collection information into the FACTS electronic collection
> report (c/r).
>
> **1. [PESTICIDE SAMPLES]{.underline}**
>
> When collecting surveillance samples, districts may use an abbreviated
> c/r format. As per IOM Subchapter 439, select "pesticide sample" from
> list of options in the Flag field of the c/r. Select either
> \"Pesticide Surveillance\" or \"Pesticide Compliance\" in the Flag
> Remarks field of the c/r. Compliance samples are collected on a
> selective basis as the result of an inspection, complaint or other
> evidence there may be a problem with the product.
>
> Report pesticide usage information, when available, into the Remarks
> field of the c/r to assist laboratory and compliance personnel. For
> corn and other raw agricultural products, list the name and address of
> the grower or processor if different from the shipper.
>
> In accordance with Field Management Directive (FMD) No. 129, FDA
> districts are to notify EPA regional offices when FDA investigations
> or sample analyses reveal possible pesticide misuse. For this reason,
> consider the need to collect additional samples or other evidence
> documenting possible pesticide misuse when violative residues are
> suspected. Include information concerning potential pesticide misuse
> and/or drift in the Remarks field of the c/r. When this information
> cannot be obtained, so indicate.
>
> **2. [INDUSTRIAL CHEMICAL SAMPLES]{.underline}**
>
> > For compliance samples collected because of suspected contamination
> > by industrial chemicals, report where the commodity was produced
> > along with the source of the suspected contaminant(s).
>
> > **3. [MICROBE SAMPLES]{.underline}**
>
> > The field should immediately notify Jack Geltman or the FCP Manager,
> > Randall Lovell, about any feed sample collected for regulatory
> > purposes that is found positive for *Salmonella* or *E. coli*
> > O157:H7. Jack Geltman is a Consumer Safety Officer in the Division
> > of Compliance, Enforcement and Regulatory Policy Team, HFV-232, at
> > CVM (240-276-9203; Jack.Geltman@fda.gov).

**[PART IV ‑ ANALYTICAL]{.underline}**

A.  **[SERVICING LABS]{.underline}**

> At the time this document was written, the following information was
> current. If this information differs from that published in the
> current ORA Field Workplan, Part 1, Appendix III, then the Field
> Workplan is the lead document.

1.  **[Pesticide, Industrial Chemical and Element Samples]{.underline}**

**Servicing labs**:

> Northeast Region all to NRL
>
> Southeast Region all to SRL
>
> Central Region BLT & CIN to SRL; NWJ & PHI to NRL; CHI & MIN to KAN;
> DET to ARL
>
> Southwest Region DAL, DEN & KAN to KAN; SWID to ARL
>
> Pacific Region LOS to PRS; SAN to SAN; SEA to PRN

2.  **[Dioxin Samples]{.underline}**

> **Servicing labs:**
>
> All districts will send samples for dioxin analysis to ARL

3.  **[Mycotoxin Samples]{.underline}**

**Servicing labs:**

Send all import samples to PRN

Send domestic samples from:

> Pacific, Northeast & Central Regions to PRN
>
> Southeast Region to SRL
>
> Southwest Region to KAN
>
> \[Note: All mycotoxin servicing labs perform fumonisin analysis so
> shipment of feed samples (primarily corn and corn based feeds) to KAN
> for this analysis is no longer necessary.\]

4.  **[Microbe Samples]{.underline}**

> **Servicing labs**:
>
> Central Region CHI & MIN to DEN; DET to ARL;
>
> BLT, CIN, NWJ & PHI to SRL
>
> Southwest Region DAL, DEN & KAN to DEN;
>
> SWID to ARL
>
> Northeast Region all to NRL
>
> Pacific Region all to SAN
>
> Southeast Region all to SRL
>
> If a positive subsample is identified, pulsed-field gel
> electrophoresis (PFGE) is performed on all isolates (*Salmonella* and
> *E. coli* O157:H7) by the servicing labs.
>
> *Salmonella* serotyping is performed by both ARL and DEN. NRL and SRL
> will send the *Salmonella* isolates to ARL for serotyping. SAN will
> send the *Salmonella* isolates to DEN for serotyping.
>
> Antimicrobial susceptibility testing is performed on all isolates
> (*Salmonella* and *E. coli* O157:H7) by DEN. After serotyping, ARL
> will send the *Salmonella* isolates to DEN for antimicrobial
> susceptibility testing.
>
> If Center assignments are issued, they will designate the analyzing
> laboratories.

B.  **[PROCEDURAL CONSIDERATIONS]{.underline}**

> **1. [Pesticides, Industrial Chemicals and Elements]{.underline}**

a.  In the initial stages of commodity coverage, examine pesticide
    surveillance samples for as many classes of chemicals as feasible.
    Try to examine for the contaminant(s) specified in the Reason for
    Collection field of the c/r and for organohalogen and
    organophosphorus residues. Consider using three or more
    multi-residue methods to provide broader coverage for pesticide
    residues.

b.  A sample considered for regulatory action should be check analyzed
    by a second analyst. A method reagent blank and appropriate recovery
    determinations should be run by the check analyst concurrently with
    his/her analysis.

> Residue identity (and quantity, when possible) should be confirmed by
> at least two independent tests such as: thin layer chromatography
> (TLC), derivatization, element selective gas chromatography (GC)
> detector, mass spectrometry (MS), etc, as deemed necessary by the
> Laboratory Director. Identity of residues which are unusual or of
> particular significance should also be confirmed.

c.  All pesticide analytical packages for actionable samples should meet
    the "Criteria for Analytical Packages to Support Regulatory Action
    on Pesticide Residues". This document is located at
    <http://www.cfsan.fda.gov/~comm/cp04016.html> (see Attachment C) and
    copies also may also be obtained by contacting an ORA Scientific
    Coordinator \[George Salem (301-827-1031; e-mail:
    [George.Salem@fda.gov](mailto:Diane.Obrien@fda.gov)) or Steven Robbs
    (301-827-9555; e-mail: <Steven.Robbs@fda.gov>).

d.  For all element analyses, follow the specifications provided in the
    document "Criteria for Analytical Packages to Support Regulatory
    Action on Toxic Elements in Food and Food-Related Products" (July
    1998). This document has been distributed to the field and copies
    can also be obtained by contacting an ORA Scientific Coordinator
    (George Salem or Steven Robbs). The results of the quality control
    analyses prescribed should meet the established acceptance criteria
    to validate analytical findings on the samples.

> **2.** **[Mycotoxins]{.underline}**
>
> All mycotoxin servicing labs perform fumonisin analysis so shipment of
> feed samples (primarily corn and corn based feeds) to KAN for this
> analysis is no longer necessary.
>
> For all feeds and feed ingredients, CVM would like to see more samples
> analyzed for vomitoxin, zearalenone, and ochratoxin A (see Attachment
> A for guidance).
>
> **3.** **[Microbe Samples]{.underline}**
>
> Ten subsamples (200 g per subsample) of the feed or feed ingredient
> are collected by the FDA investigators for regulatory purposes under
> PAC Code 71003E and sent to the appropriate FDA servicing laboratory.
> Approximately seventy-five (75) grams from each of the 10 subsamples
> should be reserved for the 702(b) portion.
>
> The servicing laboratory should prepare one 375 g composite sample for
> *Salmonella* analysis. Thirty-seven and a half (37.5) grams should be
> collected from each of the 10 subsamples and combined to form a 375 g
> composite sample.
>
> Once a sample is found positive for *Salmonella*, the servicing lab
> will send each isolate to ARL or DEN for serotyping (as indicated in
> Part IV (A)(4)). ARL will send *Salmonella* serotyped isolates to DEN.
> DEN will conduct antimicrobial susceptibility testing on every
> *Salmonella* isolate found in animal feed.
>
> For *E. coli* O157:H7, a 25 g portion from each sub-sample will be
> analyzed individually. Once a sample is found positive for *E. coli*
> O157:H7, the servicing lab will send each isolate to DEN for
> antimicrobial susceptibility testing.
>
> In addition, the servicing lab will determine the pulsed-field gel
> electrophoresis (PFGE) patterns of each *Salmonella* and *E. coli*
> O157:H7 isolate found in animal feed. If feasible, conduct the PFGE
> analysis on animal feed isolates separate from human food isolates.
> The servicing lab will electronically send the image(s) of the PFGE
> patterns from the animal feed isolates to Mr. Jason Abbott, CVM OR
> \[MOD II, Room 1501, HFV-530, 8401 Muirkirk Road, Laurel, MD 20708;
> Phone: (301) 210-4185; E-mail Address: Jason.Abbott@fda.gov\] or his
> designee. Include the FACTS sample number when sending each PFGE image
> to CVM OR. CVM OR will be responsible for sending the PFGE image(s)
> from the animal feed isolates to PulseNet.
>
> Requests to send the *Salmonella* and *E. coli* O157:H7 isolates to
> CVM OR for research purposes will be processed after sample
> disposition according to ORA Laboratory Manual, Volume III, Section
> 2.9.2
> (<http://intranet.ora.fda.gov/dfs/policies/manuals/lm/vol3/section/02.pdf>).
> The *Salmonella* and *E. coli* O157:H7 isolates should be sent to the
> attention of Dr. David Wagner \[CVM Office of Research, MOD II, Room
> 1503, HFV-530, 8401 Muirkirk Road, Laurel, MD  20708\]. 
>
> CVM OR will not analyze the \~300 g investigational samples collected
> under PAC 71R800 for *Salmonella* or *E. coli* O157:H7 as this could
> hinder regulatory action by FDA.

C.  **[METHODOLOGY]{.underline}**

> **1. [Chemical Contaminants]{.underline}**
>
> **a. [Pesticides and Industrial Chemicals]{.underline}**
>
> Use the multi-residue methods described in the most recent edition
> (currently 3^rd^) of the [Pesticide Analytical Manual]{.underline},
> Vol. 1 (PAM I) and the most recent edition (currently 17^th^) of the
> Official Methods of Analysis (OMA) of the Association of Official
> Analytical Chemists International (AOAC) when applicable. When the
> multi-residue methods are inappropriate, use any of the methods cited
> in (1) the current edition of PAM I or of the OMA of AOAC, (2) the FDA
> Laboratory Information Bulletins (LIB), or (3) the peer-reviewed
> literature.
>
> Refer to PAM 1, 3^rd^ edition, Chapter 1, Section 105, guidelines for
> determining the analytical limits of quantitation. Findings below the
> limits of quantitation are to be reported as \"Trace\" (T) with an
> estimated level entered into the "Amount Found" field.
>
> Violative pesticide and industrial chemical residues should be
> confirmed by tests such as element selective gas chromatography (GC)
> detector, gas chromatography-mass spectrometry (GC-MS), etc.
>
> **b. [Elements]{.underline}**
>
> For element analyses use the appropriate Elemental Analysis Manual
> reference or contact an ORA Scientific Coordinator (George Salem or
> Steven Robbs) for guidance and information. The limits of quantitation
> for elements are based on sample weights prescribed in the analysis.

######  (1) Lead (Pb) 0.05 mg/kg

> \(2\) Cadmium (Cd) 0.005 mg/kg

Analyze the sample for Pb and Cd using graphite furnace atomic
absorption spectrometry as described in JAOAC Int. (1993, vol. 76, pages
798-813) or FDA Laboratory Information Bulletin (LIB) \# 3640 using peak
area absorbance mode or using anodic stripping voltammetry as described
in the most recent edition of the OMA of AOAC (currently 17^th^ ed.,
2000). In addition, KAN-DO Total Diet Study SOP Kan-Lab-Met.93 can be
used for the graphite furnace determination of Pb and Cd.

> \(3\) Arsenic (As) 0.05 mg/kg

######## (4) Selenium (Se) 0.05 mg/kg 

A method to support regulatory action for As, Se, Pb and Cd is AOAC
method 986.15 (OMA of AOAC, 17^th^ ed., 2000). The KAN-DO Total Diet
Study SOP Kan-Lab-Met.96 will support regulatory action for As and Se.

\(5\) Mercury (Hg) 0.02 mg/kg

Total mercury is determined using AOAC method 971.21 (OMA of AOAC,
17^th^ ed., 2000) with the option of using a commercially available
mercury vapor generator for the flasks, tubes and recirculation pump
described in the AOAC procedure. A method to support regulatory action
for Hg includes KAN-DO Total Diet Study SOP Kan-Lab-Met.91.

Inductively coupled plasma (ICP) may be used in lieu of the above
methods to simultaneously determine all five of these elements, i.e. Pb,
Cd, As, Se and Hg. A method to support regulatory action would include
KAN-DO Total Diet Study SOP Kan-Lab-Met. 92.

> **c. [Mycotoxins]{.underline}**
>
> Follow the procedures and methods in (1) the most recent edition of
> the OMA of the AOAC (currently 17^th^ ed., 2000), (2) the FDA
> Laboratory Information Bulletins (LIB), or (3) peer reviewed
> literature.
>
> **SAFETY:** **Be aware of the potential hazards in the preparation of
> aflatoxin samples. See Section 49.2.01 (AOAC Method 977.16).**
>
> **General Procedures**
>
> Chapter 49, OMA of AOAC, 17^th^ edition, 2000.
>
> Section 49.2.01 (AOAC Method 977.16) - Sampling and preparation of
> sample and safety precaution.
>
> Section 49.2.02 (AOAC Method 971.22) - Preparation of standards.
>
> **Aflatoxins (B~1~, B~2~, G~1~, and G~2~)**
>
> Section 49.2.03 (AOAC Method 971.22) - Standards for Aflatoxins.
>
> Initial screening: LIB 3555, Aflatest Method (manual or robotic).
>
> **Official Methods**
>
> Section 49.2.04 (AOAC Method 975.35) identification of aflatoxins by
> TLC.
>
> Section 49.2.26 (AOAC Method 975.37) identification of aflatoxins by
> TFA derivative formation on TLC plate.
>
> Section 49.2.08 (AOAC Method 968.22) for peanut products.
>
> Section 49.2.15 (AOAC Method 993.17) for corn and peanuts by TLC.
>
> Section 49.2.17 (AOAC Method 990.33) for corn and peanut butter by LC.
>
> Section 49.2.18 (AOAC Method 991.31) for corn, raw peanuts and peanut
> butter.
>
> Section 49.2.19 (AOAC Method 980.20) for cotton seeds.
>
> Section 49.2.27 (AOAC Method 985.17) identification of aflatoxin B~1~
> by mass spec.
>
> Results of 15 ppb or higher total aflatoxins should be run by the
> official method.
>
> **Zearalenone**
>
> Rapid Test Kits in Grains, Cereals and/or Feed:
> <http://www.aoac.org/testkits/kits-toxins.htm>
>
> Veratox® for Zearalenone:
> <http://www.neogen.com/pdf/FS_CatalogPages/VeratoxZearalenone.pdf>
>
> **Official Methods**
>
> Journal of the Association of Official Analytical Chemists (JAOAC),
> 1986, 69 (5): 894-898, Zearalenone in Feeds.
>
> Section 49.9.02 (AOAC Method 985.18),
>
> -Zearalenol and Zearalenone in Corn.
>
> **Ochratoxin A**
>
> Rapid Test Kits in Grains, Cereals and/or Feed:
> <http://www.aoac.org/testkits/kits-toxins.htm>
>
> Veratox® for Ochratoxin:
> <http://www.neogen.com/pdf/FS_CatalogPages/VeratoxOchratoxin.pdf>
>
> **Official Methods**
>
> Section 49.6.03 (AOAC Method 991.44) for corn and barley.
>
> Modifications -- JAOAC, 1996, 79 (5): 1102-1105.
>
> Section 49.6.04 (AOAC 2000.03) Immunoaffinity column for ochratoxin A
> .
>
> **Fumonisins (B~1~, B~2~ and B~3~)**
>
> LIB 3621 (LC/fluorescence detector) (Fumonisin B~1~ in corn).
>
> Analytical Letters, 1994, 27 (4): 693-715 (NDA Fumonisin B~1~ & B~2~
> in Corn (LC).
>
> JAOAC, 1995, 78 (3): 705-710 (Immunoaffinity Column Coupled with
> Liquid Chromatography for Determination of Fumonisins).
>
> **Official Methods**
>
> Section 49.5.01 (AOAC Method 995.15) OPA Fumonisins B~1~, B~2~, and
> B~3~ in Corn.
>
> Section 49.5.02 (AOAC 2001.04) Immunoaffinity column for fumonisins.
>
> **Vomitoxin (DON)**
>
> Rapid Test Kits in Grains that are performance verified by USDA/GIPSA:
> <http://151.121.3.117/tech-servsup/metheqp/testkit.htm>
>
> LIB 3844.
>
> JAOAC, 1996, 79 (4): 833-887.
>
> **Official Method**
>
> Section 49.4.02 (AOAC Method 986.18) Deoxynivalenol in Wheat.
>
> **2. [Microbes]{.underline}**
>
> Analyze feed/feed ingredient samples for *Salmonella* and *E. coli*
> O157:H7. Use the methods described in the Bacteriological Analytical
> Manual (BAM) Online (see Chapter 5 for *Salmonella* and Chapter 4A for
> *E. coli* O157:H7).
>
> For *Salmonella*, use the 10 subsample composite totaling 375 grams.
>
> For *E. coli* O157:H7, test individual subsamples using 25 grams from
> each subsample.
>
> Note: Instructions will be contained in directed assignments, when
> issued.

D.  **[REPORTING]{.underline}**

> **1. [Analytical Results and Method Performance Data]{.underline}**
>
> Report the pesticide, industrial chemical, element, mycotoxin, dioxin,
> and microbe findings into FACTS.
>
> Report all method performance data (recoveries, control blanks,
> duplicate analyses, etc.) according to instructions in FACTS.
>
> For follow-up regulatory samples, report the sample number and
> analytical findings for the screening samples into FACTS.
>
> **2. [Sample Classification]{.underline}**
>
> When classifying samples, please review Part V --
> Regulatory/Administrative Strategy, A. Regulatory Action and be guided
> by the following examples:
>
> a\. **Sample Class \"l\":** The sample contains no residue or contains
> residues that are within the limits of an established tolerance or
> guideline.
>
> b\. **Sample Class \"2\":** The sample contains a confirmed residue
> for which no tolerance or guideline in the sampled feed has been
> established, but the residue level is of no regulatory significance.
>
> c\. **Sample Class \"3\":** The sample contains a residue which
> exceeds a tolerance or guideline or contains a residue at a
> significant level for which no tolerance or action level in the sample
> feed has been established.
>
> When applying the guidance in FDA/ORA Compliance Policy Guide, Sec.
> 683.100, \"Action Levels For Aflatoxins in Animal Feeds\" to sample
> classification, be guided by the following:
>
> i\. If the intended use of the corn, cotton seed or peanut product is
> known and documented, use the guidance in Sec. 683.100 to determine
> the sample class.
>
> ii\. If the intended use of the corn, cotton or peanut product is
> unknown or the animal species is not listed in Sec. 683.100, then a
> sample with an aflatoxin level exceeding 20 ppb is considered in
> **Sample Class 3.**
>
> **NOTE: For samples coded as Class 3, each violative residue found
> should have the appropriate code entered into the violative residue
> field (i.e., \"X\" for exceeds tolerance, \"N\" for no tolerance, or
> \"A\" for at or above action level). The code should be entered into
> the data records for both the original and check analyses.**
>
> When classifying samples analyzed for microbes, those positive for
> *Salmonella* or *E. coli* O157:H7 should be **Sample Class 3.**
>
> **3. [Special Reporting]{.underline}**
>
> Immediately notify the home district and Randall Lovell, Program
> Manager, at (240) 453-6857 (e-mail:
> [Randall.Lovell@.fda.gov](mailto:randall.lovell@.fda.gov)) of all
> violative sample results.
>
> Notify the Director, Division of Field Investigations, HFC-130, at
> (301) 827-5653, when lots of corn or other grain that are destined for
> export are reported by USDA/GIPSA (Grain Inspection, Packers and
> Stockyards Administration) to contain actionable levels of mycotoxins.

**[PART V ‑ REGULATORY/ADMINISTRATIVE STRATEGY]{.underline}**

Each sample classified as **"3"** should be evaluated for possible
compliance action and may include a meeting with responsible parties, a
warning letter, recall, seizure, and/or other corrective action.

Contact the Division of Compliance, HFV-230, as needed and as directed
by the referenced Compliance Policy Guides. When the firm's initial
corrective actions are not effective, consider recall, seizure or
injunction (e.g., a number of illegal residues from the same firm).
These actions should be initiated only after consultation with the
Division of Compliance. A copy of the findings which may warrant
regulatory action should contain [documentation of the sampling
scheme]{.underline}, [method of collection]{.underline}, [preservation
(including storage conditions)]{.underline}, [analytical
methods]{.underline}, and [data generation signature]{.underline} along
with the [date(s) of these procedures]{.underline}. **Ensure that sample
continuity is fully documented**. The package should be submitted to
HFV-230 (Attn. Jack Geltman) for review along with a recommendation from
the district office.

**A. [REGULATORY ACTION]{.underline}**

> **1. [Domestic Samples]{.underline}**
>
> **a. [Pesticides and Industrial Chemicals]{.underline}**
>
> Tolerances for pesticide residues in raw agricultural commodities are
> established by the EPA. These tolerances can be found in 40 CFR 180
> (Title 40 of the Code of Federal Regulations Part 180) or at the
> following website:
>
> <http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=33c46d4599df4fe5e76ad50625d92fe8&tpl=/ecfrbrowse/Title40/40cfr180_main_02.tpl>
>
> FDA/ORA Compliance Policy Guide (CPG) Sec. 575.100 \"Pesticide
> Residues in Food and Feed - Enforcement Criteria\" also provides
> guidance for regulatory action. This CPG lists FDA action levels for
> unavoidable residues of pesticides whose tolerances have been revoked
> by the EPA. This document can be found at
> <http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg575-100.html>
>
> **Immediately** notify the regional EPA office when investigation
> reveals possible misuse of pesticides (see FMD 129).
>
> The temporary tolerances for polychlorinated biphenyls in animal feed
> can be found in 21 CFR 509.30.
>
> Regulatory action for pesticides and industrial chemicals in feed and
> feed ingredients will be decided on a case-by-case basis.
>
> **b. [Elements]{.underline}**
>
> "Mineral Tolerance of Animals" was published in 2005 by the National
> Academy of Sciences/National Research Council and this book provides
> estimates of the maximum tolerated level for several elements in
> complete feed. Regulatory action for elements in feed and feed
> ingredients will be decided on a case-by-case basis.
>
> **c. [Aflatoxins]{.underline}**
>
> Consult FDA/ORA Compliance Policy Guide Sec. 683.100 for regulatory
> guidance. It can be found at
> <http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg683-100.html>.
> Mass spectrometry confirmation of aflatoxin B~1~ identity should be
> completed prior to taking regulatory action. The home district should
> promptly report analytical results on regulatory samples found to be
> \"out of compliance\" (i.e., judged to be of regulatory significance)
> to the responsible firm and to cooperating state officials. Regulatory
> action for aflatoxins in feed and feed ingredients will be decided on
> a case-by-case basis.
>
> **d. [Vomitoxin]{.underline}**
>
> The advisory levels for vomitoxin in animal feeds were provided in a
> letter dated September 16, 1993, from Ronald G. Chesemore, FDA
> Associate Commissioner for Regulatory Affairs (**see Attachment B for
> details**). Regulatory action for vomitoxin in feed and feed
> ingredients will be decided on a case-by-case basis.
>
> **e. [Fumonisins]{.underline}**
>
> The agency recently published Guidance for Industry on the Fumonisin
> Levels in Human Foods and Animal Feeds
> ([www.cfsan.fda.gov/%7Edms/fumongu2.html](http://www.cfsan.fda.gov/~dms/fumongu2.html);
> Guidance for Industry 112). Corn and corn by-products intended for
> animals and complete animal feeds should not exceed the total
> fumonisin (FB~1~+FB~2~+FB~3~) levels listed in **Attachment C**.
> Regulatory action for fumonisins in feed and feed ingredients will be
> decided on a case-by-case basis.
>
> **f. [Ochratoxin A and Zearalenone]{.underline}**
>
> No tolerances or guidance have been established for these two
> mycotoxins. Regulatory action on positive analytical findings should
> be submitted to the Division of Compliance, HFV-230 (Attn. Jack
> Geltman), for review. Regulatory action for ochratoxin A and
> zearalenone in feed and feed ingredients will be decided on a
> case-by-case basis.
>
> **g. [*Salmonella* and]{.underline}** **[*E. coli*
> O157:H7]{.underline}**
>
> Feed and feed ingredients in which *Salmonella* or *E. coli* O157:H7
> are detected are considered adulterated under Section 402 (a)(1) of
> the FFDCA and 21 CFR 500.35. When *Salmonella* or *E. coli* O157:H7
> are found in a feed sample, the documentation package described in
> Part V above should be submitted to HFV-230 (Attn. Jack Geltman) for
> review by HFV-222.
>
> CVM will evaluate the information provided in a district's
> recommendation for regulatory action and will make a decision, on a
> case-by-case basis, whether such recommendation has met the criteria
> for regulatory action. CVM's decision will be based on inspectional
> findings, technical review findings, type of sample, etc. The decision
> will be provided to the district office for implementation.
> Enforcement action will not be initiated by CVM. Even if no regulatory
> action is recommended, the district will still be responsible for
> contacting the firm about the analytical findings.
>
> **2. [Import Samples]{.underline}**
>
> Imported animal feeds are subject to prior notice under 801(m) of the
> Federal Food, Drug & Cosmetic Act (FFDCA) and to registration
> requirements under 801(l). Failure to provide prior notice or to
> register is prohibited under section 301 of the FFDCA and would make
> the food/feed shipment subject to refusal, and the importer or
> consignee liable to potential enforcement actions such as injunction
> and prosecution.  More specific information on FDA's response to
> registration or prior notice violations is included in the Compliance
> Policy Guide, "Prior Notice of Imported Food Under the Public Health
> Security and Bioterrorism Preparedness and Response Act of 2002."
>
> In addition,  the importer could be subject to permissive debarment as
> described in Section 306(b)(1)(C) of the FFDCA if they are found to be
> importing adulterated food that presents a threat of serious adverse
> health consequences or death to humans or animals or have been
> convicted of a felony for conduct relating to the importation into the
> United States of any food \[Section 306(b)(3) of the FFDCA\].
> Detention without physical examination (DWPE) may be considered for
> imported feeds and feed ingredients which may represent a hazard to
> animal or human health. All recommendations for DWPE should be
> forwarded to the Division of Import Operations and Policy, HFC-170.
>
> The guidance for taking regulatory action on import samples of feed
> can be found in the same locations as that for domestic samples \-- 40
> CFR 180 and Compliance Policy Guide Sec. 575.100 for pesticides; 21
> CFR 509.30 for polychlorinated biphenyls; Mineral Tolerance of Animals
> (National Academy of Sciences/National Research Council, 2005) for
> elements; Compliance Policy Guide (CPG) Sec. 683.100 for aflatoxins;
> Letter dated September 16, 1993, from Ronald G. Chesemore (FDA
> Associate Commissioner for Regulatory Affairs) for vomitoxin; FDA
> Guidance for Industry 112 for fumonisins; and Section 402 (a)(1) of
> the FFDCA and 21 CFR 500.35 for *E. coli* O157:H7 and *Salmonella*.
>
> Refer to Import Alert #72-03 for how to handle
> *Salmonella*-contaminated pig ears (pet treats). Refer to Import Alert
> #71-04 for how to handle *Salmonella*-contaminated feeds other than
> pet treats. These 2 import alerts are found at the following websites:
>
> <http://www.fda.gov/ora/fiars/ora_import_ia7203.html>
>
> <http://www.fda.gov/ora/fiars/ora_import_ia7104.html>
>
> Contact Jack Geltman, Consumer Safety Officer, Enforcement and
> Regulatory Policy Team, HFV-232, at 240-276-9203 or by e-mail at
> <Jack.Geltman@fda.gov> if additional guidance is necessary.
>
> **3. [Additional Regulatory Guidance]{.underline}**
>
> a\. Contact Gloria Dunnavan, Director, Division of Compliance,
> HFV-230, for unusual findings which suggest the need for a health
> hazard evaluation. Gloria can be reached by phone at (240) 276-9201 or
> by e-mail at <Gloria.Dunnavan@fda.gov>
>
> b\. The final disposition of each violative shipment and the action
> taken should be reported into FACTS for all Class **"3"** samples.

**[PART VI - REFERENCES, ATTACHMENTS & CONTACTS]{.underline}**

**A. [REFERENCES\*]{.underline}**

1.  Compliance Program (CP) 7304.004, \"Pesticides and Industrial
    Chemicals in Domestic Foods\" -- website:
    <http://www.cfsan.fda.gov/~comm/cp04004.html>

2.  Memorandum of Understanding (MOU), Federal Cooperative Agreements
    Manual (August, 1996), "MOU with USDA (FSIS and AMS) and EPA
    Regarding Regulatory Activities Concerning Residues of Drugs,
    Pesticides and Environmental Contaminants in Foods.\" (FDA
    225-85-8400)

3.  Field Management Directive (FMD) No. 129, \"Interagency Pesticide
    Referrals Between EPA and FDA\" (February 19, 1982; Revised
    12/16/92) - website:
    <http://www.fda.gov/ora/inspect_ref/fmd/fmd129.htm>

4.  [Investigations Operations Manual]{.underline} (IOM), (2005) -
    website: <http://www.fda.gov/ora/inspect_ref/iom/default.htm>

> Chapter 4, Sampling
>
> Sub Chapter 420 -- Collection Technique
>
> Sub Chapter 430 -- Documentation & CR
>
> Part 439 -- Reporting Sample Collections
>
> Sub Chapter 450 -- Sampling: Preparation, Handling, Shipping
>
> Part 452 -- Sample Handling
>
> Part 454 -- Sample Shipment
>
> Sample Schedule 2, Sample Schedule for Canned and Acidified Foods
>
> Sample Schedule 3, Pesticide Samples
>
> Sample Schedule 4, Wheat Carload Sampling
>
> Sample Schedule 6, Mycotoxin Sample Sizes
>
> Sample Schedule 15, Veterinary Products, Feeds and By-products for
> Animal Feeds
>
> Sample Schedule 16, Medicated Animal Feeds Sampling
>
> Chapter 5, Establishment Inspection
>
> Sub Chapter 570 -- Pesticides

5.  [Official Methods of Analysis of the AOAC]{.underline}, 17th
    edition, 2000, Chapter 49, Vol. II.

6.  [Pesticide Analytical Manual]{.underline}, Vol. 1 (PAM I), 3^rd^
    Edition, Chapter 1, Section 105, "Analytical Limits of
    Quantitation", - website: <http://www.cfsan.fda.gov/~frf/pami3.html>

7.  Elemental Analysis Manual for Food and Related Products, January
    2000 -- website: <http://www.cfsan.fda.gov/~dms/eam-toc.html>

8.  [Bacteriological Analytical Manual (BAM) Online, Chapters 4a and
    5]{.underline} - website:
    <http://www.cfsan.fda.gov/~ebam/bam-toc.html>

9.  FDA Office of Regulatory Affairs, Compliance Policy Guides, Sec.
    683.100, "Action Levels for Aflatoxins in Animal Feeds (CPG
    7126.33)", March 1995, -website:
    <http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg683-100.html>.

10. FDA Office of Regulatory Affairs, Compliance Policy Guides, Sec.
    575.100, \"Pesticide Residues in Food and Feed -- Enforcement
    Criteria (CPG 7141.01)\", March 1995,
    <http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg575-100.html>

> **\*References listed with dates were current at time of
> publication**.

**B. [ATTACHMENTS]{.underline}**

> **ATTACHMENT A** -- Guidance on the Analytical Priority for Mycotoxins
> in Various Feed Ingredients and Complete Feeds

**ATTACHMENT B** -- Advisory Levels for Vomitoxin (DON or
Deoxynivalenol) in Animal Feeds

**ATTACHMENT C** -- Guidance for Fumonisins in Animal Feeds

**C. [CONTACTS]{.underline}**

**1. [CVM Contacts]{.underline}**

> **a. [Program Inquiries]{.underline}**
>
> Zoe Gill, Industry Compliance Analyst
>
> Program Monitor
>
> Medicated Feeds Team, HFV-226
>
> Division of Animal Feeds, CVM
>
> Telephone: (240) 453-6867
>
> E-mail: <Zoe.Gill@fda.gov>
>
> **b. [Regulatory Inquiries]{.underline}**
>
> Jack Geltman, Consumer Safety Officer
>
> Enforcement and Regulatory Policy Team, HFV-232
>
> Division of Compliance, CVM
>
> Telephone: (240) 276-9203
>
> E-mail: <Jack.Geltman@fda.gov>
>
> Gloria Dunnavan, Director
>
> Division of Compliance, HFV-230, CVM
>
> Telephone: (240) 276-9201
>
> E-mail: <Gloria.Dunnavan@fda.gov>
>
> **c. [Feed Contaminants Program Manager and Scientific Contact for
> Dioxins, Pesticides and Industrial Chemicals]{.underline}**
>
> Dr. Randall Lovell, Veterinary Medical Officer
>
> Feed Safety Team, HFV-222
>
> Division of Animal Feeds, CVM
>
> Telephone: (240) 453-6857
>
> E-mail: <Randall.Lovell@fda.gov>
>
> **d. [Scientific Contact for Mycotoxins]{.underline}**
>
> Dr. Michael Henry, Biologist
>
> Feed Safety Team, HFV-222
>
> Division of Animal Feeds, CVM
>
> Telephone: (240) 453-6861
>
> E-mail: <Mike.Henry@fda.gov>
>
> **e. [Scientific Contact for Microbes]{.underline}**
>
> Dr. Henry Ekperigin, Biologist
>
> Feed Safety Team, HFV-222
>
> Division of Animal Feeds, CVM
>
> Telephone: (240) 453-6868
>
> E-mail: <Henry.Ekperigin@fda.gov>
>
> **2.** **[ORA Contacts]{.underline}**

a.  **[Inspectional Inquiries]{.underline}**

> James Dunnie Jr.
>
> ORA/ORO/DFI, HFC-132
>
> Telephone: (301) 827-5652
>
> E-mail: <James.Dunnie@fda.gov>

b.  **[FDA/State Cooperative Sampling Plans]{.underline}**

> Kevin Smith, Supv. Consumer Safety Officer
>
> ORA/ORO/DFSR, HFC-150
>
> Telephone: (301) 827-2915
>
> E-mail: <Kevin.Smith1@fda.gov>

c.  **[Methodology Inquiries on Pesticide/Industrial
    Chemicals/Dioxins/Mycotoxins/Elements]{.underline}**

> George Salem, Chemist
>
> ORA/ORO/DFS, HFC-141
>
> Telephone: 301-827-1031
>
> E-mail: <George.Salem@fda.gov>
>
> Steven Robbs, Chemist
>
> ORA/ORO/DFS, HFC-140
>
> Telephone: 301-827-9555
>
> E-mail: <Steven.Robbs@fda.gov>

d.  **[Methodology Inquiries on Microbes]{.underline}**

> Marsha Hayden, Microbiologist
>
> ORA/ORO/DFS, HFC-141
>
> Telephone: (301) 827-1039
>
> E-mail: <Marsha.Hayden@fda.gov>
>
> Lydia Rosas-Marty, Microbiologist
>
> ORA/ORO/DFS, HFC-141
>
> Telephone: (301) 827-6624
>
> E-mail: [Lydia.Rosas-Marty@fda.gov](mailto:Marsha.Hayden@fda.gov)

e.  **[Import Inquiries]{.underline}**

> Ted Poplawski, Consumer Safety Officer
>
> ORA/ORO/DIOP, HFC-172
>
> Telephone: (301) 594-3849
>
> E-mail: <Ted.Poplawski@fda.gov>

f.  **[FACTS -- Data Input Inquiries]{.underline}**

##### Cheryl Stoddard, IT Specialist

##### OC/OM/OCIO/OIT-ORA, HFR-SW200 (Denver)

> Telephone: (303) 236-3032
>
> E-mail Address: <Cheryl.Stoddard@fda.gov>

g.  **[FACTS -- National Tables of Field Data]{.underline}**

###### John Lechus, Director, DEPM

> ORA/ORM/DPEM, HFC-40
>
> Telephone: (301) 827-1637
>
> E-mail: <John.Lechus@fda.gov>
>
> **3. [CFSAN Contact]{.underline}**
>
> Dr. Paul South, Consumer Safety Officer
>
> OO/OPDF/DPPS/RPBPP, HFS-306
>
> Telephone: (301) 436-1640
>
> E-mail: <Paul.South@fda.gov>

**[PART VII ‑ CENTER RESPONSIBILITIES]{.underline}**

The Division of Animal Feeds, HFV-220, will evaluate the implementation
and effectiveness of this program when requested by the Director, CVM.
The Feed Contaminants Program Manager or designee will prepare an annual
report of the pesticide/industrial chemical, mycotoxin, dioxin, and
microbe findings from this program.

Inter-center coordination is necessary between CVM and CFSAN because
residue findings in feeds and in food derived from animals are often
correlated.

**Attachment A**:

**Guidance on the Analytical Priority for Mycotoxins in Various Feed
Ingredients and Complete Feeds.**

+----------------+-------------+------------+-----------+------------+
| *              | **MYCOTOXIN |            |           |            |
| *COMMODITIES** | ANALYTICAL  |            |           |            |
|                | PRIORITY    |            |           |            |
|                | G           |            |           |            |
|                | UIDANCE\*** |            |           |            |
+----------------+-------------+------------+-----------+------------+
|                | **Priority  | **Priority | *         | **Priority |
|                | 1**         | 2**        | *Priority | 4**        |
|                |             |            | 3**       |            |
+----------------+-------------+------------+-----------+------------+
| **Barley,      | Vomitoxin   | Z          | O         | Ergot      |
| Oats, Wheat    |             | earalenone | chratoxin | Alkaloids  |
| and Rye and    |             |            | A         |            |
| their          |             |            |           |            |
| Products**     |             |            |           |            |
+----------------+-------------+------------+-----------+------------+
| **Corn and     | Aflatoxins  | Z          | Vomitoxin | Ochratoxin |
| Corn           | Fumonisins  | earalenone |           | A          |
| Products**     |             |            |           |            |
+----------------+-------------+------------+-----------+------------+
| **Cottonseed,  | Aflatoxins  | Z          | O         |            |
| Peanuts, and   |             | earalenone | chratoxin |            |
| Sorghum (milo) |             |            | A         |            |
| and their      |             |            |           |            |
| Products**     |             |            |           |            |
+----------------+-------------+------------+-----------+------------+
| **Rice and     | Zearalenone | Fumonisins | O         |            |
| Rice           |             |            | chratoxin |            |
| Products**     |             | Aflatoxins | A         |            |
+----------------+-------------+------------+-----------+------------+
| **Soybean and  | Aflatoxins  | Vomitoxin  | O         |            |
| Soybean        |             |            | chratoxin |            |
| Products**     | Zearalenone |            | A         |            |
+----------------+-------------+------------+-----------+------------+
| **Horse and    | Fumonisins  | Aflatoxins | Ze        | Vomitoxin  |
| Rabbit Feed**  |             |            | aralenone | Ochratoxin |
|                |             |            |           | A          |
+----------------+-------------+------------+-----------+------------+
| **Swine Feed** | Vomitoxin   | Ochratoxin | A         |            |
|                | Zearalenone | A          | flatoxins |            |
|                |             |            | F         |            |
|                |             |            | umonisins |            |
+----------------+-------------+------------+-----------+------------+
| **Cattle and   | Aflatoxins  | Z          | O         | Vomitoxin  |
| Poultry Feed** |             | earalenone | chratoxin | Fumonisins |
|                |             |            | A         |            |
+----------------+-------------+------------+-----------+------------+
| **Dog and Cat  | Vomitoxin   | Z          | O         |            |
| Food**         | Aflatoxins  | earalenone | chratoxin |            |
|                |             |            | A         |            |
|                |             |            | F         |            |
|                |             |            | umonisins |            |
+----------------+-------------+------------+-----------+------------+

\*The mycotoxin(s) mentioned in the Priority 1 column for a particular
commodity should be analyzed for in almost every sample. The
mycotoxin(s) mentioned in the Priority 2 column for a particular
commodity should be analyzed for in most samples. The mycotoxin(s)
mentioned in the Priority 3 column for a particular commodity should be
analyzed for occasionally. The mycotoxin(s) mentioned in the Priority 4
column for a particular commodity should only be analyzed for on rare
occasions.

**Attachment B:**

**Advisory Levels for Vomitoxin (DON or Deoxynivalenol) in Animal
Feeds**.

1.  10 ppm vomitoxin on grains and grain by-products destined for
    ruminating beef and feedlot cattle older than 4 months and for
    chickens with the added recommendation that these ingredients not
    exceed 50% of the diet of cattle or chickens.

2.  5 ppm vomitoxin on grains and grain by-products destined for swine
    with the added recommendation that these ingredients not exceed 20%
    of their diet.

3.  5 ppm vomitoxin on grains and grain by-products destined for all
    other animals with the added recommendation that these ingredients
    not exceed 40% of their diet.

**Attachment C:**

**Guidance for Fumonisins in Animal Feeds.**

  --------------- ------------------------ ------------- -----------------------
  **Animal or     **Recommended Maximum    **Feed        **Recommended Maximum
  Class**         Level of Total           Factor^2^**   Level of Total
                  Fumonisins in Corn and                 Fumonisins in the Total
                  Corn By-Products                       Ration (ppm^1^)**
                  (ppm^1^)**                             

  Horse^3^        5                        0.2           1

  Rabbit          5                        0.2           1

  Catfish         20                       0.5           10

  Swine           20                       0.5           10

  Ruminants^4^    60                       0.5           30

  Mink^5^         60                       0.5           30

  Poultry^6^      100                      0.5           50

  Ruminant,       30                       0.5           15
  Poultry & Mink                                         
  Breeding                                               
  Stock^7^                                               

  All Others^8^   10                       0.5           5
  --------------- ------------------------ ------------- -----------------------

^1^ Total fumonisins = FB~1~ + FB~2~ + FB~3~.\
^2^ Fraction of corn or corn by-product mixed into the total ration.\
^3^ Includes asses, zebras and onagers.\
^4^ Cattle, sheep, goats and other ruminants that are [\>]{.underline} 3
months old and fed for slaughter.\
^5^ Fed for pelt production.\
^6^ Turkeys, chickens, ducklings and other poultry fed for slaughter.\
^7^ Includes laying hens, roosters, lactating dairy cows and bulls.\
^8^ Includes dogs and cats.