CHAPTER 3 INVESTIGATIONS OPERATIONS MANUAL 2023

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CHAPTER 3 - FEDERAL AND STATE COOPERATION

SUBCHAPTER 3.1 - COOPERATIVE EFFORTS....................3-2

3.1.1 - POLICY.........................................................................3-2

3.1.2 - LAWS, CODES, AGENCIES ........................................3-2

3.1.2.1 - Agreements and Memoranda of Understanding (MOU)

.................................................................................................3-2

3.1.3 - OTHER GOVERNMENT INSPECTION........................3-3

3.1.3.1 - Federal.......................................................................3-3

3.1.3.2 - Discussion with Federal Inspector .............................3-3

3.1.3.3 - State and Local..........................................................3-3

SUBCHAPTER 3.2 - FEDERAL AGENCY INTERACTION .....3-3

3.2.1 - U. S. DEPARTMENT OF AGRICULTURE (USDA) ......3-3

3.2.1.1 - Foods Rejected by USDA..........................................3-3

3.2.1.2 - USDA Complaints......................................................3-4

3.2.1.3 - USDA Acts.................................................................3-4

3.2.1.4 - FDA-USDA Agreements & MOUs..............................3-4

3.2.1.5 -....................................................................................3-4

3.2.1.6 - Animal Plant Health Inspection Service/USDA (APHIS)

.................................................................................................3-6

3.2.1.7 - Federal Grain Inspection Service/ USDA (FGIS).......3-6

3.2.1.8 - Food Safety and Inspection Service/USDA (FSIS)....3-6

3.2.1.9 - Science and Education Administration/USDA (SEA).3-7

3.2.2 - U.S. DEPARTMENT OF COMMERCE (DOC)..............3-7

3.2.2.1 - Commerce (DOC)......................................................3-7

3.2.2.2 - National Oceanic and Atmospheric Administration 

(NOAA) - National Marine Fisheries Service (NMFS) ..............3-7

3.2.2.3 - U.S. Patent and Trademark Office (USP&TO) (DOC)3-7

3.2.3 - DEPARTMENT OF DEFENSE (DOD)..........................3-7

3.2.3.1 - DOD MOUs................................................................3-7

3.2.3.2 – U.S. Army Corps of Engineers (DOD).......................3-8

3.2.3.3 – U.S. Army Medical Research and Development 

Command (DOD).....................................................................3-8

3.2.3.4 - Defense Personnel Support Center (DPSC)..............3-8

3.2.3.5 - Department of Navy/Bureau of Medicine and Surgery.3-

8

3.2.3.6 - Defense Health Agency (DHA), Public Health Division, 

Veterinary Services Branch (DHA VS) (DoD) ..........................3-8

3.2.3.6.1 – DoD/FDA Liaisons..................................................3-8

3.2.4 - DEPARTMENT OF HEALTH AND HUMAN SERVICES 

(HHS).......................................................................................3-8

3.2.4.1 - HHS MOUs ................................................................3-8

3.2.4.2 - Administration for Children, Youth and Families (ACYF)

.................................................................................................3-8

3.2.4.3 - Centers for Disease Control and Prevention (CDC)...3-8

3.2.4.3.1 - INTERVIEWS..........................................................3-9

3.2.4.3.2 - INFORMATION EXCHANGE AND COORDINATION

.................................................................................................3-9

3.2.4.3.3 - ROUTINE REQUESTS FOR INFORMATION ........3-9

3.2.4.3.4 - EMERGENCY REQUESTS FOR CONFIDENTIAL 

INFORMATION......................................................................3-10

3.2.4.3.5 - LIAISON OFFICERS.............................................3-10

3.2.4.4 - Centers for Medicare and Medicaid Services (CMS)3-10

3.2.4.5 - Health Services Administration (HSA) .....................3-10

3.2.4.6 - National Center for Health Statistics (NCHS)...........3-10

3.2.4.7 - National Institute of Drug Abuse (NIDA) ..................3-10

3.2.4.8 - National Institutes of Health (NIH)............................3-10

3.2.5 - DEPARTMENT OF HOMELAND SECURITY.............3-10

3.2.5.1 - U.S. Customs and Border Protection.......................3-10

3.2.5.2 - Secret Service .........................................................3-11

3.2.5.2.1 - LIAISON................................................................3-11

3.2.5.2.2 - DEFINITIONS.......................................................3-11

3.2.5.2.3 - PURPOSE ............................................................3-12

3.2.5.2.4 - CRITERIA FOR REQUESTING FDA ASSISTANCE 3-

12

3.2.5.2.5 - SCOPE OF INVESTIGATION...............................3-12

3.2.5.2.6 - INTERAGENCY COOPERATION.........................3-12

3.2.5.2.7 - DISTRICT CONTACT...........................................3-12

3.2.5.2.8 - LEAD INVESTIGATOR QUALIFICATIONS..........3-12

3.2.5.2.9 - STEPS FOR CONDUCTING A SPECIAL SECRET 

SERVICE INVESTIGATION.................................................. 3-12

3.2.5.2.10 - SAMPLING......................................................... 3-13

3.2.5.2.11 - REPORTING...................................................... 3-13

3.2.6 - DEPARTMENT OF JUSTICE..................................... 3-14

3.2.6.1 - U.S. Attorney........................................................... 3-14

3.2.6.2 - Drug Enforcement Administration (DEA) (Formerly: 

Bureau of Narcotics).............................................................. 3-14

3.2.6.3 - Federal Bureau of Investigation (FBI)...................... 3-14

3.2.6.4 - U.S. Marshals Service............................................. 3-14

3.2.7 - DEPARTMENT OF LABOR: OCCUPATIONAL SAFETY 

AND HEALTH ADMINISTRATION (OSHA)........................... 3-14

3.2.8 - TREASURY DEPARTMENT...................................... 3-14

3.2.8.1 - Alcohol and Tobacco Tax and Trade Bureau (TTB) 3-14

3.2.8.2 - Internal Revenue Service (IRS)............................... 3-15

3.2.9 - DEPARTMENT OF VETERANS AFFAIRS VETERANS 

ADMINISTRATION (VA)........................................................ 3-15

3.2.10 - CONSUMER PRODUCT SAFETY COMMISSION 

(CPSC).................................................................................. 3-15

3.2.11 - ENVIRONMENTAL PROTECTION AGENCY (EPA) 3-15

3.2.11.1 - EPA MOUs............................................................ 3-15

3.2.12 - AGENCY FOR TOXIC SUBSTANCES AND DISEASE 

REGISTRY (ATSDR)............................................................. 3-16

3.2.13 - FEDERAL TRADE COMMISSION (FTC)................. 3-16

3.2.14 - U.S. NUCLEAR REGULATORY COMMISSION (NRC)3-

17

3.2.15 - U.S. POSTAL SERVICE (USPS) ............................. 3-17

3.2.15.1 - Change of Address Information............................. 3-17

3.2.15.2 - Postal Box Information .......................................... 3-17

3.2.15.3 - Authority ................................................................ 3-17

3.2.16 - FIRM LOCATIONS................................................... 3-17

3.2.17 - FEDERAL FOOD SAFETY COALITION .................. 3-18

SUBCHAPTER 3.3 - STATE OPERATIONAL AUTHORITY . 3-18

3.3.1 - STATE OPERATIONAL AUTHORITY........................ 3-18

3.3.1.1 - FDA Personnel with State Authority ........................ 3-18

3.3.1.2 - Joint Inspections...................................................... 3-19

3.3.1.3 - FDA Commissioned State Personnel...................... 3-19

3.3.1.4 – State Contract Inspections ..................................... 3-19

3.3.2 - STATE MEMORANDA OF UNDERSTANDING......... 3-19

3.3.3 - STATE AUTHORITIES AND PHONE CONTACT 

NUMBERS ............................................................................ 3-19

3.3.3.1 - Alabama (AL) .......................................................... 3-19

3.3.3.2 - Alaska (AK) ............................................................. 3-19

3.3.3.3 - Arizona (AZ)............................................................ 3-19

3.3.3.4 - Arkansas (AR)......................................................... 3-20

3.3.3.5 - California (CA)......................................................... 3-20

3.3.3.6 - Colorado (CO)......................................................... 3-20

3.3.3.7 - Connecticut (CT)..................................................... 3-20

3.3.3.8 - Delaware (DE)......................................................... 3-20

3.3.3.9 - Florida (FL).............................................................. 3-20

3.3.3.10 - Georgia (GA)......................................................... 3-20

3.3.3.11 - Hawaii (HI) ............................................................ 3-20

3.3.3.12 - Idaho (ID) .............................................................. 3-20

3.3.3.13 - Illinois (IL).............................................................. 3-20

3.3.3.14 - Indiana (IN) ........................................................... 3-20

3.3.3.15 - Iowa (IA)................................................................ 3-20

3.3.3.16 - Kansas (KS).......................................................... 3-20

3.3.3.17 - Kentucky (KY) ....................................................... 3-20

3.3.3.18 - Louisiana (LA)....................................................... 3-20

3.3.3.19 - Maine (ME)............................................................ 3-21

3.3.3.20 - Maryland (MD)....................................................... 3-21

3.3.3.21 - Massachusetts (MA).............................................. 3-21

3.3.3.22 - Michigan (MI)......................................................... 3-21

3.3.3.23 - Minnesota (MN)..................................................... 3-21

3.3.3.24 - Mississippi (MS).................................................... 3-21

3.3.3.25 - Missouri (MO)........................................................ 3-21

3.3.3.26 - Montana (MT)........................................................ 3-21

3.3.3.27 - Nebraska (NE)....................................................... 3-21
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3.3.3.28 - Nevada (NV)..........................................................3-21

3.3.3.29 - New Hampshire (NH).............................................3-21

3.3.3.30 - New Jersey (NJ) ....................................................3-21

3.3.3.31 - New Mexico (NM) ..................................................3-21

3.3.3.32 - New York (NY).......................................................3-22

3.3.3.33 - North Carolina (NC) ...............................................3-22

3.3.3.34 - North Dakota (ND) .................................................3-22

3.3.3.35 - Ohio (OH) ..............................................................3-22

3.3.3.36 - Oklahoma (OK)......................................................3-22

3.3.3.37 - Oregon (OR)..........................................................3-22

3.3.3.38 - Pennsylvania (PA) .................................................3-22

3.3.3.39 - Rhode Island (RI)...................................................3-22

3.3.3.40 - South Carolina (SC)...............................................3-22

3.3.3.41 - South Dakota (SD).................................................3-22

3.3.3.42 - Tennessee (TN).....................................................3-22

3.3.3.43 - Texas (TX).............................................................3-22

3.3.3.44 - Utah (UT)...............................................................3-22

3.3.3.45 - Vermont (VT) .........................................................3-22

3.3.3.46 - Virginia (VA)...........................................................3-23

3.3.3.47 - Washington (WA)...................................................3-23

3.3.3.48 - West Virginia (WV).................................................3-23

3.3.3.49 - Wisconsin (WI).......................................................3-23

3.3.3.50 - Wyoming................................................................3-23

SUBCHAPTER 3.4 - INTERNATIONAL ARRANGEMENTS..3-23

3.4.1 - INTERNATIONAL ARRANGEMENTS........................3-23

3.4.2 - MUTUAL RECOGNITION AGREEMENTS.................3-23

3.4.2.1 - European Community ..............................................3-23

3.4.2.2 - Food Products .........................................................3-23

SUBCHAPTER 3.5 - NON-GOVERNMENT AGREEMENTS. 3-23

3-1 FDA/USDA JURISDICTION.............................................3-24

USDA JURISDICTION...........................................................3-24

HISTORY OF MENU ITEMS..................................................3-26

HISTORY OF MENU ITEMS..................................................3-27

ADDRESS INFORMATION REQUEST ................................. 3-28

SUBCHAPTER 3.1 - COOPERATIVE 

EFFORTS

3.1.1 - POLICY

The scope of consumer protection is extended by 

cooperative efforts of federal, state, local, territorial, and 

tribal agencies and international cooperation. Procedures 

to appropriately share responsibilities and cooperate with 

our consumer protection partners are essential.

Procedures to appropriately share responsibilities to 

cooperate with our consumer protection partners are 

essential . 

Federal, state, local, territorial, and tribal cooperation shall 

be fostered whenever possible. The Agency issues the IOM 

as well as other FDA manuals to international regulators 

and conformity assessment bodies, and state, local, 

territorial and tribal inspectors. FDA fosters cooperation 

through correspondence, FDA testimony, press releases, 

reprints from the Federal Register, and distribution of all 

pertinent policy and regulations issued by FDA which have 

significance in other regulatory jurisdictions. The Agency 

may share FDA’s non-public information as long as the 

sharing complies with the Agency’s confidentiality laws and 

procedures.

Districts, headquarters' offices, and resident post personnel 

in particular, should maintain liaison with federal, state, 

local territorial, and tribal officials.

Follow District policy regarding contacts with appropriate 

federal, state, local, territorial, and tribal officials to 

exchange information, coordinate operations, and arrange 

joint inspections. If an assignment calls for joint work with 

state, local, territorial or tribal inspectors, make every effort 

to accomplish this work. See IOM 3.3.1. When you travel 

internationally, follow policy established in the "GUIDE TO 

INTERNATIONAL INSPECTIONS AND TRAVEL."

3.1.2 - LAWS, CODES, AGENCIES

Many states have enacted the basic Uniform Food, Drug, 

and Cosmetic Bill, and others have adopted at least a part 

of the Uniform Bill. The provisions of these laws are very 

similar to the 1938 provisions of the Federal Food, Drug, 

and Cosmetic Act. A few states have enacted the Pesticide 

Food and Color Additives or Kefauver-Harris type 

amendments. See IOM 3.3.3.

Most states without the Uniform FD&C Act, have laws 

based on the 1906 Food and Drug Act. Most larger cities 

have their own ordinances and regulations. A portion of the 

food supply of the United States is consumed within the 

state in which it is produced, and is therefore, not directly 

under the jurisdiction of the Federal Food, Drug and 

Cosmetic Act as amended. Thus, the various state and 

local agencies are solely responsible for policing this 

supply.

The departments of the executive branch of the federal 

government operate under the laws and regulations which 

they are specifically responsible for enforcing. Since 

responsibilities may overlap and be duplicated, operating 

agreements and liaison between agencies is essential for 

smooth and efficient governmental operation. Section 

702(c) of the FD&C Act [21 U.S.C. 372(c)] recognizes this 

by providing that the records of any department in the 

executive branch shall be open to inspection by authorized 

DHHS personnel.

District management is responsible for maintaining official 

liaison between FDA and other federal agencies. However, 

for day by day operations, personal contact between 

various operating federal investigators, inspectors, and 

agents is desirable and encouraged.

3.1.2.1 - Agreements and Memoranda of 

Understanding (MOU)

It is FDA’s policy to enter into MOUs with other entities in 

situations in which there are a need to define lines of 

authority or responsibility, or to clarify cooperative 

procedures (see SMG 2820.1). FDA and various agencies 

often enter into formal or informal agreements, and/or 

understandings to improve consumer protection through 

more effective use of collective resources and to eliminate 
CHAPTER 3 INVESTIGATIONS OPERATIONS MANUAL 2023 

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duplication of activities. These agreements and 

understands specify areas of primary responsibility.

Prior to disclosing FDA’s information, ensure that the 

Agreement and MOU contain confidentiality provisions that 

comply with FDA’s information disclosure laws and 

procedures (e.g., sharing with the public (FOI), federal 

government officials 21 CFR 20.85, state/local 21 CFR 

20.88, foreign 21 CFR 20.89). Contact ORA Office of 

Partnerships at OP.Feedback@fda.hhs.gov when 

encountering an MOU for the first time, drafting an MOU, or 

for clarification of disclosure 

A complete listing (domestic, academia and nonprofit) is publicly available on the FDA MOUs page

3.1.3 - OTHER GOVERNMENT INSPECTION

General procedures regarding cooperation with other 

federal, state, and local officials are furnished below.

During establishment inspections determine the specific 

type of inspection service and inspecting units, such as the 

name of the federal, state, county, or city health agency or 

department. Obtain the name and title of the inspectional 

official, and general method of operation. IOM 5.4.9.3 

discusses coverage of grade A Dairy Plants.

3.1.3.1 - Federal

Compulsory Continuous Inspection - Do not inspect firms, 

or that portion of a plant, under compulsory, continuous 

inspection under United States Department of Agriculture's 

(USDA) Meat Inspection Act, Poultry Products Inspection 

Act, or Egg Products Inspection Act, except on specific 

instructions from your supervisor or assignment document.

Ingredients or manufacturing processes common to both 

USDA and FDA regulated products should be inspected by 

FDA. See IOM 3.2.1.3 for FDA/USDA Agreements in 

specific areas.

Provide routine FDA coverage of such firms as breweries 

and wineries, which may be intermittently inspected on a 

compulsory basis by the U.S. Treasury Department, U.S. 

Public Health Service, or other agencies.

Voluntary - All products inspected under the voluntary 

inspection service of the Agriculture Marketing Service 

(AMS), USDA, and the National Marine Fisheries Service 

(NMFS), US Department of Commerce, are subject to FDA 

jurisdiction and are usually given routine coverage; 

however, formal written Agreements or a MOU between 

FDA and other agencies are often executed and may 

govern the agreeing agencies' operations on these types of 

inspected plants. 

3.1.3.2 - Discussion with Federal Inspector

If you are assigned to cover a federally inspected plant 

which is under either compulsory or voluntary inspection, 

check to see if an Agreement or a MOU exists between 

FDA and the agency involved to determine the obligations 

of both agencies. When you arrive at the firm:

1. Identify yourself to the inspector(s) and invite him/her to 

accompany you on the inspection but do not insist on 

their participation.

2. At the conclusion of the inspection, offer to discuss your 

observations and provide the in-plant inspector with a 

copy of your Inspectional Observations (FDA 483).

3.1.3.3 - State and Local

State and local officials usually have extensive regulatory 

authority over firms in their area regardless of the interstate 

movement or origin of the food products involved. Joint 

FDA-State or local inspections are occasionally conducted. 

These are usually arranged by district administrative or 

supervisory personnel. See IOM 3.3.1.

SUBCHAPTER 3.2 - FEDERAL AGENCY 

INTERACTION

This subchapter deals with the interaction of the FDA with 

other federal agencies. This interaction will be discussed 

below. Each agency with which FDA has agreements or an 

MOU is listed separately. Information regarding MOUs and 

other interactions are discussed as appropriate. 

Information about the complete MOU or agreement can be 

found in the appropriate Cooperative Agreements Manual. 

Listings of all Liaison Officers are included below.

3.2.1 - U. S. DEPARTMENT OF 

AGRICULTURE (USDA)

See IOM 3.1.3 for procedures to be followed when making 

inspections of firms under USDA inspection or subject to 

inspection by USDA.

3.2.1.1 - Foods Rejected by USDA

All procurement and processing contracts administered by 

USDA for edible food products require compliance with 

FDA regulations. The USDA routinely reports to the FDA its 

findings on lots of flour, cereal, or other products which 

have been rejected for acceptance into USDA-sponsored 

programs, based on FDA guidelines. This notification of 

rejection is routinely furnished to the involved District office. 

When a District office receives such notification, it will 

determine appropriate follow-up by evaluating the reason 

for rejection, current priority assignments, and workload.

Samples should not be routinely collected from the USDA 

rejected material. If a follow-up inspection is made the 
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District will then determine the need for samples or 

additional action.

3.2.1.2 - USDA Complaints

Whenever a complaint is received involving any meatcontaining product, including such items as soups, 

combination infant foods, frozen dinners, etc., evaluate the 

need to contact USDA. Most products containing red meat 

or poultry are regulated by USDA. The exceptions include:

1. Products containing meat from game animals, such as 

venison, rabbits, etc.

2. Meat-flavored instant noodles

3. The product "pork and beans" which contain only a 

small amount of pork fat and for historic reasons is 

regulated by FDA.

Determine from the consumer whether there is a round 

"shield" on the label with the USDA establishment number. 

Alternatively, the establishment number may be identified 

in the lot number. Red meat products under USDA 

jurisdiction will often contain the abbreviation "EST" 

followed by a one to four-digit number; poultry products 

under USDA jurisdiction will contain the letter "P" followed 

by a number.

FDA reports suspected outbreaks to USDA and CDC. In 

addition, FDA and CDC have an agreement that FDA will 

be immediately advised whenever CDC ships botulism 

antitoxin anywhere in the United States or its possessions. 

See IOM 3.2.4.3 regarding interaction with CDC.

USDA and FDA have an agreement whereby FDA informs 

a designated USDA Compliance and Evaluation Area 

Office about any foodborne disease where a meat or 

poultry product is suspected. Conversely, USDA will alert 

the FDA District office on suspected products subject to 

FDA jurisdiction. In order for your District to alert USDA 

promptly, check with your supervisor immediately if meat or 

poultry products are involved in an outbreak you are 

investigating, or which comes to your attention.

3.2.1.3 - USDA Acts

The following USDA Acts under which FDA has been 

delegated detention authorities for products subject to 

USDA inspection are:

1. Federal Meat Inspection Act (FMIA) see IOM 2.7.1.2.2

2. Poultry Products Inspection Act PPIA see IOM 2.7.1.2.3

 

3. Egg Products Inspection Act (EPIA) see IOM 2.7.1.2.4

See IOM 2.7.1 for additional information. See IOM Exhibit 

3-1 for a chart depicting jurisdictional lines for products 

regulated by FDA and USDA.

3.2.1.4 - FDA-USDA Agreements & MOUs

MOUs and Agreements with USDA and its various units will 

be listed and, in some cases, described below. This first 

subsection covers MOUs with the USDA, USDA/other 

agency, and FDA. The following subsections provide 

information about MOUs with other USDA units.

MOU with:

1. US Department of Commerce and USDA Concerning 

Inspection of Industrial Fishery Products Intended for 

Animal 315 Feed Use (225-75-7001).

2. USDA, NIH Regarding Importation of Biological 

Specimens under US/USSR Scientific Exchange 

Agreement (225-74-1010). 

3. USDA and DHHS Regarding General War Food 

Inspection (225-75-8004).

4. USDA Concerning the trade facilitation of milk and milk 

products exported from the United States (225-20-017). 

3.2.1.5 - Agricultural Marketing Service (AMS)/

USDA (MOUs)

MOU with:

1. AMS Concerning the Inspection and Grading of Food 

Products (225-72-2009).

This MOU has extensive separation of duties between 

AMS and FDA.

Both agencies agree to maintain a close working 

relationship, in the field as well as headquarters. Both 

agencies will work with industry toward greater 

efficiency connected with improvement of coding 

methods. Each agency will designate a central contact 

point to which communications dealing with this 

agreement or other issues may be referred to for 

attention.

The FDA Liaison Officer is the Director, Office of 

Compliance, Center for Food Safety and Applied 

Nutrition, HFS-600 (240-402-1364). 

The USDA Liaison Officer is the Chief of Technologies 

Services Branch, Science Division, AMS (202-690-

4025).

2. AMS Regarding the Egg Products Inspection Act. FDA 

has exclusive jurisdiction over restaurants, institutions, 

food manufacturing plants, and other similar 

establishments, that break and serve eggs or use them 

in their products (225-75-4003).

AMS shall notify FDA whenever it has reason to believe 

that shell eggs or egg products have been shipped in 

commerce in violation of the act to a receiver for which 

FDA has exclusive jurisdiction, and notify FDA when 

applications are made to import shell eggs into the U.S.

FDA will notify AMS so that they can check on the seller 

of any restricted eggs when it is determined that more 

restricted eggs than are allowed in U.S. Consumer 

Grade B. are encountered. FDA will also notify AMS of 

any unwholesome egg products it encounters, including 

imported shell eggs which contain restricted eggs not in 

accordance with USDA regulations and labeling 

requirements.

The FDA Liaison Officer is the Director, Office of 

Emergency Operations, HFA-615, (866-300-4374).

The FDA Liaison Officer for imported shell eggs is the 

Branch Chief, Import Product Adulteration Branch, 
CHAPTER 3 INVESTIGATIONS OPERATIONS MANUAL 2023

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Division of Enforcement, Office of Compliance, Center 

for Food Safety and Applied Nutrition, HFS-606 (1-888-

723-3366).

The USDA Liaison Officer is the Deputy Administrator, 

Poultry Program, Agricultural Marketing Service (202-

720-4476).

3. AMS Concerning Imported Dates and Date Material 

(225-72-2001).

FDA inspects samples and examines imported dates 

and date products intended for processing to determine 

whether they are in compliance with the statute.

AMS, upon request, will provide FDA with a copy of 

each examination report which will contain information 

such as that in the FDA Technical Bulletin Number 5, 

Microanalytical Procedures Manual.

The FDA Liaison Officer is the Director, Division of 

Natural Products, Microanalytical Branch, Center for 

Food Safety and Applied Nutrition, HFS-315 (240-402-

1990).

The USDA Liaison Officer is the Chief, Processed 

Products Branch, Fruit and Vegetable Division, 

Agricultural Marketing Service (202-720-4693).

4. AMS Concerning Cooperative Efforts for Inspection, 

Sampling, and Examination of Imported Raisins (225-

73-2007).

AMS evaluates raisins for grade condition requirements 

and at the time and place of entry all lots of imported 

raisins. Upon completion of the examination, AMS 

promptly notifies the appropriate FDA District Office of 

any lots found not to meet minimum acceptance criteria 

because of insect infestation, filth, etc., and any 

questionable cases regarding the laboratory 

examination results. At the end of the season, the AMS 

provides FDA with a copy of each examination report.

FDA accepts, unless it notifies USDA to the contrary, 

AMS findings on any lot of raisins sampled and 

inspected by them. FDA will detain any lots of raisins 

rejected by USDA because they contain insect 

infestation, etc. See the cooperative agreement manual 

for details of responsibilities.

The FDA Liaison Officer is the Director, Division of 

Natural Products, Microanalytical Branch, Center for 

Food Safety and Applied Nutrition, HFS-315 (240-402-

1990).

The USDA Liaison Officer is the Chief, Processed 

Products Branch, Fruit and Vegetable Division, 

Agricultural Marketing Service (202-720-4693).

5. AMS Regarding Aflatoxin Testing Program for In-Shell 

Brazil Nuts (225-96-2002).

Importers of Brazil Nuts voluntarily offer for USDA 

inspections before introducing them into U.S. 

commerce. USDA is responsible for sampling and 

testing each lot for aflatoxin in accordance with 

procedures prescribed by FDA and for issuing an 

analysis certificate for each lot. The Agricultural 

Marketing Service (AMS) will forward a copy of each 

certificate to the appropriate FDA District office. FDA 

accepts the certificate and then allows entry of the lots 

into U.S. commerce provided the aflatoxin level does not 

exceed the current action level prescribed by FDA.

The FDA Liaison Officer is the Director, Office of 

Compliance, Center for Food Safety and Applied 

Nutrition, HFS-600 (240-402-1364).

The USDA Liaison Officer is the Chief of Technologies 

Services Branch, Science Division, AMS (202-690-

4025).

6. AMS Concerning Aflatoxin in Peanuts (225-96-2001).

AMS will use FDA administrative guidelines on objective 

samples to certify peanuts, recognizing that GMPs 

remove significant quantities of unfit peanuts and that

levels of aflatoxin are reduced by heating. USDA will 

provide FDA with a copy of the analytical certificate and 

identification of the applicant on each lot found to 

exceed 25 ppb of aflatoxin and the analysis certificate 

on any lot on request. FDA will routinely confirm 

chemical assays in finished product at 20 ppb by 

bioassay procedures.

FDA will not formally object to the offering of lots of 

peanuts to processors where certificates show levels of 

aflatoxin above 25 ppb but will examine finished 

products from such lots. Such lots of raw peanuts may 

be subject to appropriate action in cases where there is 

lack of assurance that the finished product will comply 

with current standards.

The FDA Liaison Officer is the Director, Office of 

Compliance, Center for Food Safety and Applied 

Nutrition, HFS-600 (240-402-1364).

The USDA Liaison Officer is the Chief of Technologies 

Services Branch, Science Division, AMS (202-690-

4025).

7. AMS and FSIS and EPA re: Regulatory Activities 

Concerning Residues of Drugs, Pesticides, and 

Environmental Contaminants in Foods (225-85-8910). 

Parts of this MOU are discussed below. Information 

about the complete MOU can be found in the 

appropriate Cooperative Agreements Manual. The 

contact offices are as follows:

The FDA Liaison Office is the Director, Division of 

Natural Products, Microanalytical Branch, Center for 

Food Safety and Applied Nutrition, HFS-315 (240-402-

1990).

The USDA Liaison Office is the Administrator, Food 

Safety and Inspection Service (202-720-7025).

The EPA Liaison Office is the Office of Pesticide 

Programs, (703-305-7090), or Health Effects Division, 

(703-305-7351).

8. AMS Concerning Salmonella Inspection and Sampling 

Coverage of Dry Milk Plants (225-75-4002).

Parts of this MOU are discussed below. Information 

about the complete MOU can be found in the 

appropriate Cooperative Agreements Manual.

USDA has two types of voluntary inspection programs: 

Plant Inspection Program for USDA Approved for 

Grading Services, and their Resident Inspection and 

Grading Program.

Plant Inspection Program (PIP). Under the PIP, dry milk 

plants are surveyed for approval every three months. 

This includes a salmonella surveillance testing of the 

plant's product and environmental material. Product 

inspection and grading is provided on request and dry 

milk products produced under this program are eligible 

to bear the USDA shield.

FDA will accept the AMS Salmonella Surveillance 

Program results on such plants and the finished dry milk 

products after shipment from those plants will not be 

sampled by FDA for Salmonella examinations. This 
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does not preclude FDA sampling dry milk at 

manufacturing plants using dry milk as an ingredient as 

a follow-up to consumer complaints, or where the dry 

milk may have become contaminated or adulterated 

after leaving the dry milk manufacturer's control. Neither 

will it preclude FDA inspections of any plant for 

problems other than Salmonella whether or not such 

plant produces dry milk products under USDA 

inspection, or the sampling of their products, including 

dry milk products, for problems other than Salmonella.

The FDA Liaison Office is the Director, Office of 

Emergency Operations, HFA-615, (866-300-4374).

The USDA Liaison Office is the Chief, Grading Branch, 

Dairy Division, Agricultural Marketing Service, (202-

720-3171) or Chief, Standardization Branch, (202-720-

7473).

3.2.1.6 - Animal Plant Health Inspection 

Service/USDA (APHIS)

MOU with APHIS Concerning Mutual Responsibilities for 

Regulating Biological Products (225-82-7000).

Referral and exchange information for purposes of 

investigation and appropriate legal action. To coordinate 

investigations and enforcement actions and to avoid 

duplication of effort, FDA and USDA agree to provide each 

other with any information which may be germane to either 

agency's enforcement functions. Information regarding 

pending investigations and enforcement actions shall be 

provided to the liaison officers noted below on a regular 

basis.

The FDA Liaison Office is the Director, Office of 

Surveillance and Compliance, Center for Veterinary 

Medicine, HFV-200, (240-453-6830).

The USDA Liaison Office is the Director, Center for 

Veterinary Biologics, Animal and Plant Health Inspection 

Service, (301-734-8245).

APHIS and NIH Regarding the Care and Welfare of 

Laboratory Animals.

3.2.1.7 - Federal Grain Inspection Service/

USDA (FGIS)

MOU with FGIS Concerning Inspection of Grain, Rice, 

Pulses, and Food Products (225-80-2000).

During an FDA inspection of any facility that processes, 

packs, or holds agricultural products, the investigator and 

or inspector will request that the FGIS inspector or licensee 

stationed at a facility accompany him/her during the 

inspection.

The inspector/investigator will request from FGIS any 

information concerning quality determinations of specific 

lots of products against which FDA has taken or may take 

action.

FDA will notify FGIS of any details concerning serious 

objectionable conditions found by FDA to exist in 

processing plants, packing plants, grain elevators, or any 

other facility where FGIS provides official services.

General matters involving this agreement may be referred 

to the agencies' liaison officers.

The FDA Liaison Office is the Director, Office of Plant and 

Dairy Foods and Beverages, Center for Food Safety and 

Applied Nutrition, HFS-300, (240-402-1488) or Director, 

Division of Programs and Enforcement Policy, Center for 

Food Safety and Applied Nutrition, HFS-305, (240-402-

1988).

The USDA Liaison Office is the Director, Field Management 

Division, Federal Grain Inspection Service, Grain 

Inspection, Packers and Stockyards Administration (202-

720-0228).

3.2.1.8 - Food Safety and Inspection 

Service/USDA (FSIS)

1. FSIS Pertaining to Class I and Class II Recalls of Food 

Products that Contain Poultry and/or Meat Products that 

have been Manufactured in a FSIS Inspected 

Establishment (225-75-4072);

FDA and FSIS agree that they will keep the customary 

records and make those related to the operation of this 

agreement available to the other agency. Both agencies 

will furnish reports of the progress of the work and such 

other reports as may be mutually agreed upon from time 

to time between cooperating parties.

The FDA Liaison Officer is the Director, Office of 

Emergency Operations, HFA-615, (866-300-3474). The 

USDA Liaison Officer is the Director, Emergency 

Planning Office, Food Safety and Inspection Service 

(301-504-2121)

2. FSIS Concerning Inspection of Food Manufacturing 

Firms FDA investigators will attempt to contact any onsite FSIS inspectors when they arrive at a plant, invite 

them to participate in the inspection and discuss with or 

report any adverse findings involving meat and poultry 

products to that inspector prior to leaving the premises 

(225-99-2001).

When report findings are classified "indicated" FDA will 

provide FSIS with a copy when the plant is also 

inspected by FSIS.

If the FDA investigator has found unsanitary conditions 

or otherwise adulterated products, the appropriate FSIS 

office should be informed by telephone unless the FDA 

investigator has already reported his findings to the 

FSIS inspector at the plant.

To any extent possible, consider information provided 

by FSIS to minimize duplication of effort.

The FDA Liaison Office is the Director, Office of 

Emergency Operations, HFA-615, (866-300-4374). 

The USDA Liaison Office is the Deputy Administrator, 

Field Operations, Food Safety and Inspection Service 

(202-720-8803).
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3. FSIS and AMS and EPA re: Regulatory Activities 

Concerning Residues of Drugs, Pesticides, and 

Environmental Contaminants in Foods (225-85-8400).

4. FSIS (NE and SE Regional Offices), DE Department of 

Agriculture, MD Department of Agriculture, PA 

Department of Agriculture, VA Department of 

Agriculture and Consumer Services, WV Department of 

Agriculture Regarding Regulatory Investigations 

Involving Drug, Pesticide, and Industrial Chemical 

Residues in Animal Feeds and Meat and Poultry (225-

76-4002).

5. FSIS and GA Department of Agriculture Regarding 

Regulatory Investigations Involving Drug, Pesticide, and 

Toxic Chemical Residues in Animal Feeds and in Meat 

Tissues (225-20-019).

6. FSIS Regarding Primary Regulatory Authority over 

Siluriformes Fish and Fish Products (225-20-019). 

https://www.fda.gov/about-fda/domestic-mous/mou225-20-019

3.2.1.9 - Science and Education 

Administration/USDA (SEA)

MOU with SEA Concerning Educational Programs in the 

Use of Animal Drugs (225-78-1002).

3.2.2 - U.S. DEPARTMENT OF COMMERCE 

(DOC)

3.2.2.1 - Commerce (DOC)

MOUs with DOC and USDA Concerning Inspection of 

Industrial Fishery Products Intended for Animal Feed Use.

3.2.2.2 - National Oceanic and Atmospheric 

Administration (NOAA) - National Marine 

Fisheries Service (NMFS)

MOU with:

1. NOAA/NMFS Regarding Inspection Programs for 

Fishery Products (225-76-2001) - The National Marine 

Fisheries Service (NMFS) of the National Oceanic and 

Atmospheric Administration (NOAA), Department of 

Commerce, operating under the authority of the 

Agriculture Marketing Act and the Fish and Wildlife Act 

is responsible for the development and advancement of 

commercial grade standards for fishery products and 

better health and sanitation standards in the industry 

and for furnishing inspection, analytical, and grading 

services to interested parties. The major purpose is to 

encourage and assist industry in improving the quality 

and safety of its products. This MOU outlines joint 

responsibilities between NOAA and FDA. See IOM 3.1.3 

for guidance on joint inspections when inspecting firms 

under the voluntary NMFS program.

The FDA Liaison Office is the Policy Guidance Branch, 

Division of Programs and Enforcement Policy, Office of 

Seafood, Center for Food Safety and Applied Nutrition, 

HFS-416 (240-402-2545). 

The NMFS Liaison Office is the Seafood Inspection 

Program, Department of Commerce, NOAA (301-713-

2355).

2. NOAA/NMFS Concerning Enforcement of Laws (225-

86-2000) - Against Illegal Commerce in Molluscan 

Shellfish.

FDA will support NMFS Lacey Act investigations to the 

extent that regulatory authority and resources allow. 

This may include conducting food sanitation inspections 

of suspect shellfish shippers, reviewing interstate 

shipping records and obtaining affidavits to the extent 

possible, collecting and analyzing shellfish samples to 

be used as evidence of violations, and removing 

adulterated shellfish from the marketplace. Refer to the 

appropriate Cooperative Agreements manual for further 

discussion of this MOU.

The FDA Liaison Office is the Policy Guidance Branch, 

Division of Programs and Enforcement Policy, Office of 

Seafood, Center for Food Safety and Applied Nutrition, 

HFS-416 (240-402-2545). 

The NMFS Liaison Office is the Seafood Inspection 

Program, Department of Commerce, NOAA (301-713-

2355).

3.2.2.3 - U.S. Patent and Trademark Office 

(USP&TO) (DOC)

MOUs with:

1. USP and TO/DOC Concerning Orphan Drugs (225-84-

8000).

2. USP and TO/DOC to Establish a Product's Eligibility for 

Patent Term Restoration (225-86-8251).

3. DOD Concerning Food Protection (Food Safety and 

Food Defense) (225-16-020) 

3.2.3 - DEPARTMENT OF DEFENSE (DOD)

FDA has a number of MOUs with DOD and its various 

elements.

3.2.3.1 - DOD MOUs 

1. DOD Concerning Licensure of Military Blood Banks 

(225-74-1017).

2. DOD Concerning FDA Responsibility for Quality 

Assurance of DOD Procured Drugs and Biologics (225-

97-4000).

3. DOD Concerning Food Protection (Food Safety and 

Food Defense (225-16-020).

FDA also has a number of Interagency Agreements (IAG) 

with DOD to include IAG with:

1. DOD Concerning Investigational Use of Drugs, 

Antibiotics, Biologics, and Medical Devices by DOD 

(224-75-3003).

2. DOD Regarding FDA Quality Assurance Responsibility 

for DOD Contracts for Medical Devices (224-82-4001).
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3.2.3.2 – U.S. Army Corps of Engineers 

(DOD)

MOU with US Army/Corps of Engineers Concerning 

Consumer Protection During Natural Disasters.

3.2.3.3 – U.S. Army Medical Research and 

Development Command (DOD)

MOU with U.S. Army Medical Research and Development 

Command Regarding Quality Assurance Support for 

Medical Material Having Military Application (225-99-4000).

3.2.3.4 - Defense Personnel Support Center 

(DPSC)

1. MOU with DPSC Concerning Exchange of Information 

Regarding Food and Cosmetic Recalls and Hazardous 

Food Situations (225-82-4003).

2. The Defense Personnel Support Center purchases vast 

quantities of foods and drugs for use by the Armed 

Forces. The products are purchased on contract and 

must meet standards and contract specifications to be 

accepted. Any products failing to meet these 

specifications are rejected. These are mentioned in IOM 

3.2.3.1 above.

FDA, under the Government-Wide Quality Assurance 

Program (GWQAP), furnishes information to the military 

regarding the capabilities of firms bidding or desiring to bid 

on government contracts. Occasionally Districts may be 

requested by the OO/OEIO/DCS/Enforcement Systems 

Branch to make inspections or collect samples in support 

of the GWQAP. When this is necessary, 

OO/OEIO/DCS/Enforcement Systems Branch will provide 

the District with specific procedures and instructions. DoD 

depots and hospitals must notify their command centers 

prior to release of their stocks. For this reason, prior to 

visiting a U.S. Government installation to collect samples of 

food, drugs or medical devices, Districts should contact 

OO/OEIO/DCS/Enforcement Systems Branch (see 

Directory, ORA Headquarters Directory, Office of 

Enforcement and Import Operations, Division of 

Compliance Systems).

3.2.3.5 - Department of Navy/Bureau of 

Medicine and Surgery

MOU with Dept. of the Navy/Bureau of Medicine and 

Surgery Regarding the Microwave Oven Survey (225-77-

1001).

3.2.3.6 - Defense Health Agency (DHA), 

Public Health Division, Veterinary Services 

Branch (DHA VS) (DoD)

MOU with DoD Concerning Food Protection (225-16-020) 

establishes a mutually acceptable understanding between 

DoD and FDA that aims to strengthen global food protection 

programs and supports the medical readiness of the US 

Armed Forces. Both agencies have agreed to develop 

information-sharing networks and processes to share 

information on facility audits; recalls and/or advisories, 

import alerts, adverse food and supplement events, 

laboratory findings or methods and other food protection 

procedures. Both agencies have further agreed to share 

laboratory data and research related to food protection 

including Food Emergency Response Network (FERN) and 

electronic Laboratory Exchange Network. DoD and FDA 

are collaborating in the development of food protection 

capabilities that include: joint inspections; training 

exercises; meetings and conferences; risk 

communications; and assessment of risk. All activities are 

coordinated by the agency Liaisons as per IOM section 

3.2.3.6.1 – DoD/FDA Liaisons

FDA’s MOU with DoD Concerning Food Protection (225-

16-020) requires both agencies to identify and provide 

points of contact (POCs)/liaisons between DoD and FDA 

for both routine and emergency situations and exercises.

1. DoD designates the Chief, Inter-Agency 

Coordination (Food Protection) Officer 

2. The FDA Liaison to DoD is Kathryn A. Nagy, 404-

253-1225.

3.2.4 - DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS)

This Agency has a number of MOUs with the Department 

and other HHS units.

3.2.4.1 - HHS MOUs

MOU with USDA and HHS Regarding General War Food 

Inspection (225-75-8004).

3.2.4.2 - Administration for Children, Youth 

and Families (ACYF)

A MOU with ACYF to Assure the Feeding Programs in 

Head Start Centers Conform to Federal Food Safety and 

Sanitation Responsibilities (225-89-2000).

3.2.4.3 - Centers for Disease Control and 

Prevention (CDC)

MOU with:

1. CDC Concerning In-Vitro Diagnostics (225-75-5012).

2. CDC Regarding Radiation Emergencies (225-81-

6000).

3. CDC Regarding Exchange of Information and 

Coordination of Actions (225-82-8000).

Additional information is being provided here because of 

the close working agreement to assure the prompt 
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exchange of information on suspected foodborne 

outbreaks.

Since it is essential that any suspected outbreaks be 

reported promptly to CDC, communicate any information 

you may learn in connection with foodborne outbreaks to 

your supervisor as soon as possible. Botulism Antitoxin 

Shipments - CDC is responsible for maintaining and 

shipping necessary supplies of botulinum antitoxin. When 

CDC makes a shipment of botulinum antitoxin, CDC will 

immediately, regardless of the day or time, phone the Office 

of Emergency Operations (OEO), HFA-615, (866-300-

4374). The OEO contact will immediately phone the 

consignee District to advise them of the shipment. 

1. Outbreaks on Foreign Flag Vessels - If an outbreak 

involving a foreign flag vessel or a US Flag vessel with 

an international itinerary comes to your attention, report 

it to your supervisor immediately who will then report it 

to OEO 866-300-4374. This situation falls under the 

jurisdiction of the Vessel Sanitation Program of the 

Centers for Disease Control and Prevention (CDC) 

Atlanta, Ga.

2. Outbreaks Involving Interstate Conveyances - Reports 

of illness attributed to travel on an interstate conveyance 

(plane, bus, train, or vessel) are the responsibility of 

FDA.

When a report of illness is received, you are encouraged to 

share it with state and local public health officials in case 

they received additional illness reports. Additionally, the 

procedures outlined in this Subchapter are to be followed 

including the following 5 items:

3.2.4.3.1 - INTERVIEWS

Interviews with the ill passenger, family members and/or 

physician (as applicable), should be in-depth enough to 

hypothesize whether the carrier may be related to the 

illness. Factors such as time of onset of symptoms, history 

of eating suspect foods, and other potential exposures 

should be considered. The carrier should also be contacted 

to determine whether other reports of illness have been 

received. The information developed should be evaluated 

to determine whether further follow-up is necessary (i.e., 

the carrier suspect). On those carriers where a reservation 

system is used, the names and phone numbers of 

passengers should be obtained to determine if other 

individuals became ill. It may be necessary to contact other 

passengers to determine if they consumed any food or 

water on the trip, and if they became ill in the time period 

associated with the original complaint. When a report of 

additional related or similar illnesses is received, 

immediately contact the Office of Emergency Operations, 

ORO, HFA-615, 866-300-4374 and relay the information. 

Also contact the state epidemiologist of the affected state 

to report the details of the illness. It may be advantageous 

to request assistance from them in the epidemiological 

investigation, particularly if patient specimens are needed 

to determine the cause.

3.2.4.3.2 - INFORMATION EXCHANGE AND 

COORDINATION

Recently FDA revised the MOU between FDA and CDC 

regarding exchange of information and coordination of 

actions. This MOU provides a framework for coordination 

and collaborative efforts between the two agencies. It also 

provides the principles and procedures by which 

information exchanges between FDA and CDC will take 

place. The new memorandum supersedes the MOU 

between CDC and FDA dated 4/1/82. When receiving a 

request for information from the CDC immediately notify the 

Director of the Office of Emergency Operations, HFA-615, 

866-300-4374.

"FDA and CDC agree that the following principles and 

procedures will govern the exchange of nonpublic 

information between the two agencies. Although there is no 

legal requirement the FDA and CDC exchange information 

in all cases, FDA and CDC agree that there should be a 

presumption in favor of full and free sharing of information 

between FDA and CDC. Both agencies recognize and 

acknowledge however that it is essential that any 

confidential information that is shared between FDA and 

CDC must be protected from unauthorized public 

disclosure. See e.g., 21 USC sec. 331(j); 18 USC sec. 

1905; 21 CFR Parts 20 and 21; 42 CFR Parts 5 and 5b; 

and, 42 USC sec. 301(d). Safeguards are important to 

protect the interests of, among others, owners and 

submitters of trade secrets and confidential commercial 

information; patient identities and other personal privacy 

information; privileged and/or pre-decisional agency 

records; and information protected for national security 

reasons. Any unauthorized disclosure of shared 

confidential information by the agency receiving the 

information shall be the responsibility of that agency.

3.2.4.3.3 - ROUTINE REQUESTS FOR 

INFORMATION

Routine Requests for Information:

1. The requesting agency must demonstrate, in writing, 

why it is necessary for it to obtain the requested 

information.

2. The agency receiving the request for information shall, 

based upon the sufficiency of the need-to-know 

demonstration described in section 1 above, determine 

whether it is appropriate to share the requested 

information with the requesting agency.

3. The requesting agency agrees that:

a. It shall limit the dissemination of shared information 

it receives to internal agency offices and/or 

individuals that have been identified in its written 

request and/or have a need-to-know;

b. Agree in writing not to publicly disclose any shared 

information in any manner including publications and 

public meetings without written permission of the 

agency that has shared the information;

c. If the requesting agency receives a Freedom of 

Information Act (FOIA) request for the shared 
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information, it will refer the request to the 

information-sharing agency; and,

d. It shall promptly notify ORA’s DIDP at ORA OSPOP 

Testimony – Info Sharing Team 

ORAOSPOPTestimonyInfoSharingTeam@fda.hhs.gov when there is any 

attempt to obtain shared information by compulsory 

process, including but not limited to a FOIA request, 

subpoena, discovery request, or litigation complaint 

or motion.

4. The agency that shares information with the requesting 

agency shall include a transmittal letter, along with any 

agency records exchanged, indicating the type of 

information.

3.2.4.3.4 - EMERGENCY REQUESTS FOR 

CONFIDENTIAL INFORMATION

In cases in which the requesting agency has a need to 

obtain certain information as soon as possible due to 

emergency circumstances, such as a foodborne illness 

outbreak, FDA and CDC may utilize the following 

procedures:

1. The requesting agency shall indicate orally or in writing 

to the agency in possession of the relevant information 

that it has the need to obtain certain identifiable 

information as soon as possible due to the existence of 

emergency circumstances and describe what the 

emergency circumstances are.

2. The requesting agency shall verbally agree to protect 

from unauthorized public disclosure any and all 

information that is shared, according to all applicable 

laws and regulations.

3. The existence of an actual emergency situation shall 

warrant, as determined by the agency in possession of 

the requested records, the waiver of the need-to-know 

demonstration and determination described in sections 

1 and 2 (Routine Requests for Information) above. 

However, once the requesting agency has obtained the 

information it seeks, it shall comply with those 

procedures set forth in section 3 (Routine Requests for 

Information) above.

3.2.4.3.5 - LIAISON OFFICERS

Liaison Officers

1. For FDA:

Office of Commissioner

Contact: Mark Russo, Acting Director, Office of Crisis 

Management 

Food and Drug Administration

12903 New Hampshire Ave.

White Oak, Bldg., 32, Room 1352, HFA-600

Silver Spring, MD 20993

866-300-4374

2. For CDC:

Associate Director for Science

Harold W. Jaffee, MD, MA

Centers for Disease Control

Public Health Service

Department of Health and Human Services

Atlanta, GA 30333 404-639-7240

3.2.4.4 - Centers for Medicare and Medicaid 

Services (CMS)

MOU with Centers for Medicare and Medicaid Services 

(CMS) Concerning Blood Banking and Transfusion 

Programs (225-80-4000).

3.2.4.5 - Health Services Administration 

(HSA)

MOU with HSA Concerning Quality Assurance for Drugs, 

Biologics, Chemicals and Reagents Procured by HSA (225-

75-8002).

3.2.4.6 - National Center for Health Statistics 

(NCHS)

A MOU with NCHS Regarding Exchange of Information 

(225-83-6000).

3.2.4.7 - National Institute of Drug Abuse 

(NIDA)

MOUs with:

1. NIDA Regarding Methadone Mutual Responsibilities in 

Implementing the Jointly Published Narcotic Addict 

Treatment Regulations (225-81-3000).

2. NIDA Concerning Cooperative Interaction in Expediting 

Domestic Scheduling of Drugs of Abuse (225-85-

8251).

3.2.4.8 - National Institutes of Health (NIH)

MOU with:

1. NIH Regarding Anticancer Drugs (225-75-3001).

2. NIH and USDA Regarding Importation of Biological 

Specimens under US/USSR Scientific Exchange 

Agreement (225-74-1010).

3. NIH and APHIS Regarding the Care and Welfare of 

Laboratory Animals (225-83-8400).

3.2.5 - DEPARTMENT OF HOMELAND 

SECURITY

3.2.5.1 - U.S. Customs and Border Protection

MOU with:

1. Customs Service and the FDA Regarding Identifying 

Roles and Authority Concerning Electronic Products

(225-74-6004).

2. Customs Service to Establish a Working Relationship 

for Cooperative Enforcement (225-79-4003).

3. Customs Services Regarding the Needs of the Trading 

Public in Expediting the Collection, Processing and the 

Use of Import Information (225-91-4003).
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3.2.5.2 - Secret Service

The Secret Service operates under the Department of 

Homeland Security and is charged with the responsibility of 

protecting the President of the United States and certain 

other prominent persons. They also enforce the laws and 

regulations relating to currency, coins, and obligations and 

securities of the U.S. and foreign governments.

Authority for Secret Service to request FDA assistance, and 

for FDA to respond, is derived from the "Presidential 

Protection Assistance Act of 1976", P.L. 94-524 (90 Stat. 

2475-7), Sections 1-10. Section six states in part:

"Executive Departments and Executive Agencies shall 

assist the Secret Service in the performance of its duties by 

providing services, equipment, and facilities on a temporary 

and reimbursable basis when requested by the Director and 

on a permanent and reimbursable basis upon advance 

written request of the Director; except that the DOD and the 

Coast Guard shall provide such assistance on a temporary 

basis without reimbursement when assisting the Secret 

Service in its duties directly related to the protection of the 

President or the Vice President or other officer immediately 

next in order of succession to the office of the President."

Note: At the present time the Agency is not claiming 

reimbursement from Secret Service until a study of total 

costs of our support function is completed.

FDA's authority for entry and inspection is derived from 

Secret Service authority and its request for FDA assistance. 

When called upon by the Secret Service to assist with a 

food service function, FDA's response is that of an advisor. 

Authority for decisions regarding food and beverages to be 

consumed by protectees is retained by the Secret Service.

Note: Do Not issue a Notice of Inspection - FDA 482 unless 

the investigation evolves into the collection of a sample for 

the enforcement of the FD&C Act. You are in the firm under 

the Secret Service authority.

FDA may initiate action against products encountered 

which are suspected of being in violation of the FD&C Act 

or the FPLA.

3.2.5.2.1 - LIAISON

The Secret Service and FDA have an arrangement 

whereby the Secret Services alerts the Assistant 

Commissioner for Human and Animal Food Operations 

(ACHAFO) when the President, Vice President or other 

protectees are visiting certain geographical areas and are 

to consume prepared meals. Secret Service may request 

that food service facilities used to prepare meals for 

protectees be monitored for food safety purposes. Within 

OHAFO, the Office of State Cooperative Programs (OSCP) 

Division of Retail Food Protection (DRFP) is responsible for 

fulfilling this request. In addition to protectee visits, the 

Secret Service may request that FDA provide food safety 

and food defense monitoring for high profile events such as 

National Special Security Events (NSSEs). The ACHAFO 

has designated OSCP and the Senior Emergency 

Response Coordinators as the FDA lead personnel to work 

collaboratively with the state or local entity with retail food 

safety jurisdiction to address food safety and food defense 

issues before and during NSSEs. More specific information 

regarding procedures, roles and responsibilities is provided 

in the Special Event Planning Guidance (SEPG).

If you are alerted by Secret Service Agents that the 

President, Vice President or other protectees will visit the 

area, immediately contact your supervisor who in turn will 

contact the OSCP Director. This communication should 

occur as soon as possible to ensure that proper 

arrangements can be made for working with the state or 

local jurisdiction to provide food safety and defense 

monitoring during the visit.

3.2.5.2.2 - DEFINITIONS

Definitions:

1. Advanced Prepared Food means food that was 

prepared on location at the food service establishment 

prior to arrival of the Lead Investigator.

2. Food Service Function means a public event where food 

will be provided to a protectee.

3. Lead Advance Agent means the Secret Service Agent 

in charge of all security arrangements. This person is 

responsible for all sites to be visited by the protectee,

and is a representative of the Office of Protective 

Operations (Secret Service Headquarters).

4. Lead Investigator means the FDA person designated by 

the FDA District/region to coordinate the investigational 

activities at the site of a food service function.

5. Person-in-Charge means the available person in the 

food service establishment authorized to make 

necessary changes/decisions such as the general 

manager, executive chef, banquet manager, caterer's 

representative or other management person.

6. Pre-prepared Food means potentially hazardous food 

that was received at the food service establishment in a 

prepared form. Examples would include chicken salad, 

liver pate, gefilte fish, hors d'oeuvres, etc. which were 

prepared at another location, and then transported to 

the food service establishment providing food for the 

event.

7. Protectee means any person eligible to receive the 

protection authorized by law.

8. Protective Detail means a team of Secret Service 

agents responsible for security surrounding public 

events to be attended by a protectee during a trip. 

Protective details are assigned and coordinated by 

Secret Service Headquarters but may include Secret 

Service field representatives.

9. District Contact means the Director, Investigations 

Branch. 

10.Site Advance Agent means the Secret Service person 

responsible for security arrangements at a specific site 

to be visited by the protectee. This person is part of the 

protective detail headed by the Lead Advance Agent. 

Note: the term Site Advance Agent will include any 
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agent designated by the Site Advance Agent to be the 

contact with the FDA Lead Investigator.

11.Support Personnel means FDA persons deemed 

necessary by FDA in order to properly inspect a food 

service function.

3.2.5.2.3 - PURPOSE

FDA's primary purpose in support of Secret Service is to 

minimize the possibility of the protectee becoming ill from a 

food intoxication or foodborne infection resulting from 

inadequate knowledge of food safety requirements by food 

service personnel, inadequate facilities, improper operating 

procedures, or carelessness. FDA is further concerned that 

food have no visible signs of filth, and that it is prepared in 

a clean environment.

FDA personnel are not trained to detect deliberate attempts 

to harm persons by the addition of poisonous or toxic 

substances to food. The Secret Service retains 

responsibility for matters involving criminal intent. However, 

FDA personnel should immediately report to the Site 

Advance Agent peculiar behavior or suspicious conditions 

observed during their investigation.

3.2.5.2.4 - CRITERIA FOR REQUESTING FDA 

ASSISTANCE

The decision to request FDA assistance is made by Secret 

Service Office of Protective Operations (Headquarters). 

FDA has provided certain criteria to aid Secret Service in 

determining how they might derive maximum benefit from 

FDA. Regardless what criteria are used, FDA should 

always respond to Secret Service requests for assistance. 

Secret Service considers factors other than the FDA 

supplied criteria in making its judgment regarding requests 

for assistance.

3.2.5.2.5 - SCOPE OF INVESTIGATION

The focus of the FDA investigation should be on the menu 

items that the protectee will be served, or from which the 

protectee will make a selection. Food, facilities, personnel, 

procedures, etc. are only considered by FDA as they relate 

to the specific food and beverage items which may be 

consumed by the protectee. Do not conduct a traditional 

regulatory type food service inspection. The Food Service 

EIR (FDA 2420) will not normally be part of the report 

prepared following this special investigation. State/local 

regulatory authorities have jurisdiction over food 

establishments and have a primary responsibility for public 

health protection of the general public or participating 

members or guests of the organization sponsoring the 

event.

3.2.5.2.6 - INTERAGENCY COOPERATION

Upon contact by Secret Service and after contacting your 

supervisor to apprise district management of the Secret 

Service request, the appropriate state/local regulatory 

authority should be contacted and encouraged to 

participate prior to and during the food service function. 

These officials may offer invaluable assistance because of 

their familiarity with the establishment and because of their 

regulation over the establishment on a long-term basis.

3.2.5.2.7 - DISTRICT CONTACT

The district contact should receive Secret Service requests 

for assistance and initiate the FDA response. If a resident 

post is contacted directly for assistance, immediately 

contact your supervisor who will notify the director 

investigations branch. The director investigations branch 

will designate the lead investigator and arrange for 

assignment of support personnel and equipment as 

required. The lead investigator could be on district or region 

staff according to district/region policy.

3.2.5.2.8 - LEAD INVESTIGATOR 

QUALIFICATIONS

The best suited investigator (criteria optional) assigned to 

coordinate investigation of these food service functions 

should be one who:

1. Possesses OPM "Critical Sensitive" security clearance.

2. Is standardized in the use of the FDA Food Code.

3. Is experienced in Secret Service food service functions, 

if possible. New personnel should accompany 

experienced personnel before being assigned as Lead 

Investigator, if at all possible.

4. Is able and authorized to quickly mobilize an 

investigational team (FDA/State/Local).

5. Is able and authorized to make quick decisions on 

important food protection/sanitation questions.

6. Has a background in food microbiology.

3.2.5.2.9 - STEPS FOR CONDUCTING A 

SPECIAL SECRET SERVICE INVESTIGATION

Steps for Conducting a Special Secret Service Investigation 

(District Contact/Lead Investigator).

Verify the call with the Secret Service and obtain from them:

1. Information about the site advance agent with whom 

FDA is to coordinate its activities. This should include 

the name(s) of agent(s) assigned, location(s) and 

telephone number(s).

2. Information about the firm(s) providing food for the food 

service function, to include:

a. Names of persons-in-charge of food service 

establishment and caterers.

b. Telephone numbers.

c. Addresses of firm(s).

d. Location where food service function will be held (if 

different).

e. Date of function.

f. Time of food events during function.

Obtain through means prearranged and agreed upon by 

FDA district/region management:
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1. FDA support personnel needed.

2. Equipment required to conduct special investigation.

Contact the person-in-charge at the facility to:

1. Introduce the lead investigator.

2. Advise of purpose and scope of special investigation.

3. Arrange for personal interview to discuss menu, food 

preparation schedule and history (times/specific 

locations in establishment), and any intended use of 

pre- prepared foods.

4. Obtain telephone number(s) at the site(s) where FDA 

lead investigator may be reached while on location.

Contact state and local regulatory agencies responsible for 

retail food protection and sanitation. Request participation 

by inspectional personnel of the local office which provides 

routine inspectional coverage of the facility where the food 

service function is being held.

Meet with person-in-charge on location, in order to:

1. Be introduced to other key employees who have 

responsibility for the target meal or kitchen facilities, i.e. 

banquet manager, executive chef, maintenance 

supervisor, etc.

2. Inform person-in-charge of the names of other FDA, 

state, or local regulatory personnel to be involved.

3. Obtain the use of an area within the establishment that 

will become an FDA base of operations. The location 

should have convenient access to a telephone but may 

not be necessary for small functions.

Coordinate with Secret Service command post on location, 

in order to:

1. Inform site advance agent of the names of other FDA, 

state or local regulatory personnel to be involved.

2. Determine method for final selection of specific meal(s) 

to be served to protectee(s).

Carry out investigation by:

1. Basing judgments on the provisions of the FDA Food 

Code. In consideration of food sources, food protection, 

personnel, food equipment/utensils, water, waste 

disposal, vermin control, storage and use of toxic 

materials, and other code items as they relate to the 

food items to be served to the protectee.

2. Taking the history of each item on the menu to be served 

the protectee. The history for each potentially hazardous 

food (including advance prepared and pre-prepared 

Food) must be detailed. Include timetables for 

preparation and storage, and the names of specific 

employees involved in its preparation. This will 

immediately establish parameters needed for FDA to 

complete a comprehensive, but well focused 

investigation (See IOM 3.2.5.2.3 above. Though every 

effort should be made by the lead investigator to help 

the person-in-charge and the Secret Service in their 

efforts to assure that preparation and arrangements for 

the food service function flow smoothly and efficiently, 

FDA personnel must be aware that their responsibility is 

for assuring that all prudent steps have been taken to 

minimize the risk of foodborne illness to the protectee.

3.2.5.2.10 - SAMPLING

Samples shall be collected at the discretion of the lead 

investigator. Two types of samples should be considered.

1. Typical Meal - In the unlikely event that a protectee (or 

others) becomes acutely or seriously ill during the hours 

following a food service function, it could be very helpful 

to have samples of meals served for analysis. Should 

this happen, FDA's response should be coordinated 

with the FDA Office of Emergency Operations at 866-

300-4374.

FDA under Secret Service authority should request that 

two complete meals, including beverages, be randomly 

selected from the meals being served to the head table. 

This selection should be made by the same person and 

at the same time head table meals are selected.

If a reception is a planned part of the event, an example 

of each type of hors d'oeuvres should also be retained.

These meals should be kept intact, covered, and 

retained under refrigeration by the person-in-charge for 

72 hours following the event. Cost of the meals may, at 

the establishment's option, be invoiced to the 

organization sponsoring the food service function.

Note: Examples of food items selected in this manner 

cannot be considered a representative sample of food 

offered at the function. However, such food examples 

could be an aid to the FBI and food regulatory 

personnel, should a suspected food related illness 

occur.

2. Food Samples - Occasionally, the lead investigator may 

elect to collect official samples of a food product 

because of a selected violation of the FD&C Act or for 

some other reason. When this is done, issue an FDA 

482, Notice of Inspection. In these cases, samples 

should be collected in accordance with procedures 

outline in IOM Chapter 4.

3.2.5.2.11 - REPORTING

Verbal Report - The lead investigator shall report to the site 

advance agent in person or by telephone.

1. Significant adverse findings should be immediately 

reported to the site advance agent during the 

investigation, if resolution of the finding has the potential 

for disrupting the smooth flow of the food service 

function.

2. At the conclusion of the investigation, and prior to 

leaving the location, notify the site advance agent of 

FDA conclusions and recommendations. One of the 

following responses would be normal:

a. No restrictions recommended. Protectee should be 

permitted to consume any food or beverage being 

offered.

b. A recommendation that the protectee be advised that 

one or more specifically named items available 

should not be selected or consumed.

c. In unusual cases, it may be necessary to 

recommend that the protectee not eat food prepared 

for the event, or not drink the water provided.

Narrative Report - Following each special investigation 

conducted for the Secret Service, write a Memo of 
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Investigation for your supervisor’s endorsement. The report 

is for FDA's internal use and should be a chronological 

accounting beginning with how and when the Secret 

Service request was received and concluding with 

recommendations tendered to the Secret Service, and any 

F/U actions recommended to or planned by participating 

State/local food protection agencies. The narrative report 

should include time frames, contact persons, a copy of the 

menu, a description of the investigational process used, 

adverse findings, corrective steps taken, the selection and 

retention of typical meals, and how and why official samples 

(if any) were collected and submitted, and a discussion of 

other matters of significance in your opinion.

Each narrative report must contain:

1. Total time on location.

2. Total time of inspection including, time on location and 

time necessary for making arrangements in advance, 

and preparation and submission of required reports. It 

does not include travel time.

3. Total travel time and mileage.

3.2.6 - DEPARTMENT OF JUSTICE

3.2.6.1 - U.S. Attorney

You may be contacted by the U.S. Attorney's office to 

discuss possible or pending cases or other matters 

pertinent to FDA. Notify your supervisor of these contacts. 

You may be accompanied by your supervisor or a 

compliance officer. If you are contacted by the U.S. 

Attorney's Office regarding any criminal issues, this is to be 

referred immediately to the appropriate OCI Office.

During any discussion with the U.S. Attorney, inform him 

that you are qualified to report the facts of whatever case 

or item being discussed, but inform him that you are a fact 

witness only and not qualified as an "expert".

3.2.6.2 - Drug Enforcement Administration 

(DEA) (Formerly: Bureau of Narcotics)

You should follow the procedures outlined in the 

Information Disclosure manual if you receive a request to 

share information with another Federal agency.

3.2.6.3 - Federal Bureau of Investigation (FBI)

The FBI, USDA and FDA are authorized to investigate 

reported tampering of FDA regulated consumer products 

under the Federal Anti-Tampering Act (FATA), Title 18, 

USC, Section 1365. In most cases, FDA's authority for such 

investigations is also found in the FD&C Act.

USDA and the FBI share enforcement of the FATA with 

FDA as described below:

1. FBI Responsibility - FDA understands that the FBI's 

primary response in FATA matters will be to investigate 

particularly those cases that involve a serious threat to 

human life or if a death has occurred. The FBI will also 

investigate FATA matters involving threatened 

tamperings, and actual or threatened tamperings 

coupled with an extortion demand.

The FBI will rely on FDA to determine if tampering with 

FDA products has occurred.

2. USDA Responsibility - The USDA will investigate and 

interact with the FBI on tampering with products 

regulated by USDA.

For complete information regarding FBI/FDA actions under 

FATA, see IOM 8.1.5.9.3.

3.2.6.4 - U.S. Marshals Service 

The U.S. Marshals Service (USMS) is the enforcement 

arm of the federal court. The USMS is primarily 

responsible for the service of civil process. In other 

words, when FDA takes an action, such as seizure the 

U.S. Marshal actually serves the complaint for forfeiture 

and "arrests" the goods. FDA employees typically 

accompany the U.S. Marshal to assist in identifying the 

goods which are to be seized. The USMS is 

also responsible for ensuring the safe conduct of judicial 

proceedings and protecting federal judges, jurors and 

other members of the federal judiciary. District Offices 

may find it useful to contact the local U.S. Marshals when 

preparing a situation plan to deal with issues of personal 

safety while conducting inspections or other 

operations. See IOM 5.2.1.2.2. and

http://www.usmarshals.gov/

3.2.7 - DEPARTMENT OF LABOR: 

OCCUPATIONAL SAFETY AND HEALTH 

ADMINISTRATION (OSHA)

The MOU with OSHA Concerns Standards for Electronic 

Product Radiation (225-74-6008).

3.2.8 - TREASURY DEPARTMENT

Many different agencies operate under the direction of this 

department. These include the Internal Revenue Service, 

and the Alcohol and Tobacco Tax and Trade Bureau. 

Agreements and MOUs with the Treasury Department will 

be discussed below.

3.2.8.1 - Alcohol and Tobacco Tax and Trade 

Bureau (TTB)

FDA and TTB share jurisdiction over alcoholic 

beverages. The MOU between FDA and TTB (formerly 

the Bureau of Alcohol, Tobacco and Firearms (ATF)) 

delineates the enforcement responsibilities of each 

agency with respect to alcoholic beverages (MOU 225-88-

2000). This MOU, among other things, confirms that TTB 

will be responsible for testing alcoholic beverages to 

determine the extent of an adulteration problem and that 

when FDA learns or is advised that an alcoholic beverage 

is or may be adulterated, FDA will inform TTB. FDA will 

also provide laboratory assistance and health hazard 
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evaluations at TTB request. TTB generally has 

responsibility for alcoholic beverage labeling; however, 

FDA also has jurisdiction over the labeling of wine with 

less than 7% alcohol by volume (such as alcoholic ciders 

and most wine coolers), and beer described in the TTB’s 

Ruling 2008-3 

(https://www.ttb.gov/images/pdfs/rulings/2008-3.pdf) as 

not being a “malt beverage” (also see FDA Guidance for 

Industry: Labeling of Certain Beers Subject to the Labeling 

Jurisdiction of the Food and Drug Administration, 

(https://www.fda.gov/Food/GuidanceRegulation/Guidance

DocumentsRegulatoryInformation/ucm166239.htm).

Labeling questions for these alcoholic beverages that are 

under FDA’s jurisdiction should be directed to Office of 

Nutrition and Food Labeling, Center for Food Safety and 

Applied Nutrition, 240-402-2373. 

Based on this MOU (225-88-2000), FDA should refer all 

complaints involving alcoholic beverages (distilled spirits, 

wines, and malt beverage products except for labeling 

issues related to wine with less than 7% alcohol by volume 

and beer described in the TTB’s Ruling 2008-3 as not being 

a “malt beverage”) to TTB using the procedure outlined 

below. When a complaint is received from a consumer, it 

should be entered into FACTS with the disposition “referred 

to other Federal agency”. If the complaint is reporting a 

suspected tampering, it should be referred to the home 

district and OCI for follow up. In all cases, a copy of the 

FACTS consumer complaint report should be forwarded 

directly to the TTB Market Compliance Office with a copy to 

the FDA liaison officer to facilitate appropriate follow up 

between the two agencies at the headquarters level. 

TTB Market Compliance Office can be reached at 202-

453-2251 (Email: Market.Compliance@ttb.gov; Fax: 202-

453-2873). The FDA Liaison Officer (Office of Food 

Safety, Center for Food Safety and Applied Nutrition) can 

be reached at 240-402-1700 (Email: FDA-TTB-LiaisonOfficer@fda.hhs.gov; Fax: 301-436-2632).

3.2.8.2 - Internal Revenue Service (IRS)

MOU with IRS Concerning Legal Actions Taken by FDA 

Against Alcoholic Beverage Firms for Under filling of 

Containers (225-71-2006).

The FDA Liaison Office is the Division of Enforcement, 

Office of Compliance, Center for Food Safety and Applied 

Nutrition, HFS-605 (240-402-2094).

The ATF Liaison Office is the Chief, Industry Compliance 

Division (202-927-8100).

3.2.9 - DEPARTMENT OF VETERANS 

AFFAIRS VETERANS ADMINISTRATION (VA)

MOU with the VA are:

1. Concerning Exchange of Medical Device Experience 

Data (225-75-5011).

2. Concerning Communications and Cooperation Regarding Clinical Research with Investigational New Drugs 

and Devices, Including Biologicals (225-82-8400).

3. To promote cooperation and coordination between the 

Food and Drug Administration and the Veterans Health 

Administration for the purpose of enhancing food safety 

and sanitation in food operations serving health care 

facilities of the Department of Veterans Affairs (225-93-

2000).

IAGs with the VA are:

1. VA Concerning FDA Responsibility for Quality 

Assurance for Drugs, Biologicals, Chemicals and 

Reagents Procured by VA (224-76-8049).

2. VA Regarding FDA Quality Assurance Responsibility for 

VA Contracts for Medical Devices (224-82-4002).

3. To provide mammography inspections, pursuant to 

Public Law 102-539 and Public Law 104-262, to 

Veterans Health Administration facilities.

3.2.10 - CONSUMER PRODUCT SAFETY 

COMMISSION (CPSC)

MOUs with CPSC are:

1. CPSC Concerning CPSC Use of FDA Documents (225-

74-8001).

2. CPSC Regarding Jurisdiction with Respect to Food, 

Food Containers, and Food Related Articles and 

Equipment (225-76-2003).

3.2.11 - ENVIRONMENTAL PROTECTION 

AGENCY (EPA)

The EPA administers many Acts one of them is the National 

Environmental Protection Act (NEPA). FDA must be guided 

by this Act when assisting in voluntary destructions, 

disposal of laboratory wastes, etc.

Do not condone the wanton pollution of waterways, 

uncontrolled burning, the creation of a public nuisance or 

other questionable disposal practices. Note that certain 

products should not be disposed of in a conventional 

manner (e.g., sanitary landfill, flushing down the drain, etc.). 

In particular, certain products that have been banned in the 

past (chloroform, methapyrilene, hexachlorophene, PCB, 

etc.), are classified by EPA as hazardous and toxic 

substances and may require a special method of disposal 

by a licensed hazardous disposal facility. Any possible 

hazardous or toxic substance (carcinogen, mutagen, etc.) 

should not be disposed of without prior consultation by the 

firm with the U.S. Environmental Protection Agency and/or 

the regulating state authority. Refer to 21 CFR 25 and the 

National Environmental Protection Act for guidance 

regarding the environmental impact of voluntary 

destructions.

3.2.11.1 - EPA MOUs 

MOUs with:
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1. EPA Regarding Matters of Mutual Responsibility Under 

Federal FD&C Act and Federal Insecticide, Fungicide 

and Rodenticide Act (225-73-8010).

2. EPA Regarding Potable Water on Interstate 

Conveyances (225-78-4006).

The EPA administers a regulatory program in this area, 

but FDA has the responsibility of notifying the ICC 

headquarters when problems are found. FDA will, if 

deemed appropriate include conveyances in their 

inspection/monitoring schedule. Both agencies will 

coordinate enforcement efforts, thereby avoiding 

duplication of efforts.

3. EPA Concerning Control of Drinking Water (225-79-

2001).

FDA has responsibility for water, and substances in 

water, used in food and for food processing and bottled 

drinking water.

FDA will take appropriate regulatory action to control 

bottled drinking water and water and substances in 

water, used in food and for food processing.

The FDA Liaison Office is the Division of Programs and 

Enforcement Policy, Office of Plant and Dairy Foods and 

Beverages, Center for Food Safety and Applied 

Nutrition, HFS-305 (240-402-1488).

The EPA Liaison Office is the Drinking Water 

Technologies Branch, Drinking Water Standards 

Division (202-260-3022).

4. EPA and USDA (FSIS and AMS) re: Regulatory 

Activities Concerning Residues of Drugs, Pesticides, 

and Environmental Contaminants in Foods (225-85-

8400).

3.2.12 - AGENCY FOR TOXIC SUBSTANCES 

AND DISEASE REGISTRY (ATSDR)

The ATSDR (formerly CDC Superfund) staff has been 

designated as the lead agency for the DHHS response to 

chemical emergencies. The CDC ATSDR Public Health 

Advisors are located at the EPA Regional Offices. These 

advisors would not only alert your office of chemical 

emergencies but would be invaluable in answering 

questions concerning the severity of the problem and 

discussing protective measures. Under no circumstances, 

are FDA employees to enter areas designated as 

hazardous. 

If it is necessary to contact ATSDR employees, their 

addresses and phone numbers are listed below:

AGENCY FOR TOXIC SUBSTANCES AND DISEASE 

REGISTRY (FORMERLY KNOWN AS SUPERFUND)

Louise A. House

EPA Region I

ATSDR 

EPA Bldg

60 Westview St.

Lexington, MA 02173

617-860-4314

George Pettigrew

EPA Region VI (6HE)

1445 Ross Ave.

Dallas, TX 75202

214-655-8361

Arthur Black Denise Jordan-Izaguirre

EPA Region II

Rm 3137C

26 Federal Plaza

New York, NY 10278

212-264-7662

EPA Region VII

Waste Management Branch

726 Minnesota Ave

Kansas City KS 66101

913-551-7692

Charles J. Walters

EPA Region III

841 Chestnut Bldg

Philadelphia, PA

19106

215-597-7291

303-294-1063

Glenn J. Tucker

ATSDR Region VIII (8HWMFF)

Waste Management Div.

Suite 500

999 18th St.

Denver, CO 80202

Robert E. Safay

Air & Waste Mgmt Div.

Region IV

345 Courtland St.

Atlanta, GA 30365

404-347-1847

William Q. Nelson

ATSDR Region IX

75 Hawthorne St

Rm 09261

San Francisco, CA 94105

415-744-2194

Louise A. Fabinski

Emerg. & Remedial Br.

EPA Region V (M-SHS-6)

77 W. Jackson Blvd

Chicago, IL 60604

312-886-0840

George Thomas

EPA Region X (MSHW113)

1200 6th Ave.

Seattle, WA 98101

206-553-2113

Some situations where ATSDR guidance is indicated are 

mentioned below.

In wrecks the physical impact usually causes most damage. 

Toxic items in the same load, this is illegal, may rupture and 

add to the contamination. In train wrecks, other railcars 

loaded with chemicals, oils or other contaminating materials 

may rupture and contaminate food and drug products in 

otherwise undamaged cars. Removal of the wreckage may 

cause further physical damage or chemical contamination. 

Exposure to weather may also adversely affect the 

products.

Do not overlook the possibility that runoff of toxic chemicals 

from wrecked and ruptured cars may contaminate adjacent 

or nearby streams supplying water to downstream firms 

under FDA jurisdiction.

Chemical spills occurring on land or water can pose a 

serious threat to the environment and contaminate FDA 

regulated products both directly and indirectly.

Hazardous waste sites also pose a hazard to the immediate 

environment, as well as offsite, if runoff contaminates 

nearby surface waters or if leachate contaminates ground 

water supplies.

3.2.13 - FEDERAL TRADE COMMISSION 

(FTC)

The MOU with FTC Concerns Exchange of Information 

(225-71-8003).
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3.2.14 - U.S. NUCLEAR REGULATORY 

COMMISSION (NRC)

The U.S. Nuclear Regulatory Commission and the U.S. 

Department of Health and Human Services, Food and Drug 

Administration signed a MOU (225-03-4001) on August 26, 

1993 (FR Vol. 58, No. 172, 09/08/93, 47300-47303). The 

purpose of the MOU is to coordinate existing NRC and FDA 

regulatory programs for medical devices (including 

utilization facilities used for medical therapy), drugs, and 

biological products utilizing byproduct, source, or special 

nuclear material regulated under the Atomic Energy Act of 

1954, as amended. These regulatory programs include 

activities for evaluating and authorizing the manufacture, 

sale, distribution, licensing, and labeled intended use of 

such products.

Medical devices affected by this MOU include but are not 

limited to: in vitro diagnostic kits (radioimmunoassay); 

utilization facilities licensed to perform medical therapy; and 

teletherapy and brachytherapy sources, systems, and 

accessory devices. Biologicals include, but are not limited 

to, licensed in vitro diagnostic kits (radioimmunoassay), and 

certain radiolabeled biologics for in-vivo use. Drugs include 

all those that contain byproduct, source, or special nuclear 

material.

The organizations in FDA that are responsible for regulating 

these products are CDRH, CDER, and CBER.

The FDA Liaison Offices are the Center for Devices and 

Radiological Health, Director, Office of Regulatory 

Programs(301-796-5895), Center for Drug Evaluation and 

Research, Director, Office of Compliance, HFD-300 (301-

796-3100), and the Center for Biologic Evaluation and 

Research, Director, Office of Compliance and Biologics 

Quality, HFM-600 (301-827-6190).

The NRC Liaison Office is the Director, Office of Nuclear 

Material Safety and Safeguards (301-504-3352).

3.2.15 - U.S. POSTAL SERVICE (USPS)

FDA cooperates with postal authorities in areas of mutual 

concern. If contacted by postal authorities, extend 

courtesy and cooperation. In any doubtful situation or 

incidents involving excessive expenditure of time and/or 

resources, check with your supervisor

3.2.15.1 - Change of Address Information 

At times during an investigation or inspection it may 

become necessary to visit local post offices to obtain new 

or forwarding addresses of individuals involved.

Procedure:

1. Introduce yourself and display your credentials to the 

local P.O. clerk or official.

2. State the information desired.

3. Present the clerk or official on duty the statement in 

writing on FDA letterhead using the wording from IOM 

Exhibit 3-3 which may be reproduced or typed on district 

letterhead.

4. If you are still refused information or delayed in any 

manner, contact the nearest U.S. Postal Inspector to 

handle the matter.

5. At this time there is no charge for providing this 

information to a Federal Agency. The regulation 

promulgating a fee has been stayed.

3.2.15.2 - Postal Box Information

At times during an investigation or inspection it will 

become necessary to obtain the name and address of the 

holder of a postal box (PO Box).

Procedure:

1. Introduce yourself and display credentials to the local 

P.O. clerk or official.

2. State the information you desire.

3. Present the clerk or official the statement in writing on 

FDA letterhead using the wording from IOM Exhibit 3-3 

which may be reproduced or typed on district letterhead.

4. At this time there is no charge for providing this 

information to a Federal Agency. The regulation 

promulgating a fee has been stayed.

5. If you are still refused the information or are delayed in 

any manner, contact the nearest U.S. Postal Inspector 

to handle the matter.

3.2.15.3 - Authority 

The authority for providing forwarding address information 

to government agencies is defined in 39 CFR 265.6(d)(5)(i)

which states as follows:

(5) Exceptions. Except as otherwise provided in these 

regulations, names or addresses of postal customers will 

be furnished only as follows:

(i)To a federal, state, or local government agency upon 

prior written certification that the information is required for 

the performance of its duties.

Additionally, 39 CFR 265.6(d)(7) may apply: Address 

verification. The address of a postal customer will be 

verified at the request of a federal, state, or local 

government agency.

3.2.16 - FIRM LOCATIONS

Many firms FDA is required to inspect are difficult to locate, 

including growers, farms, and other types of operations in 

rural areas. Directions to these firms can be obtained from 

many sources, including:

1. Visits to Post Offices.

2. If the envelope has a postal meter number and no return 

address, check with the USPS to determine the name of 

the firm or holder of that "PB Meter" number.

3. Visits to local health departments.

4. Visits to county extension services.
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5. Visits to USDA - Agricultural Stabilization and 

Conservation Offices of Soil Conservation Service 

Offices.

Many of these offices have maps of the counties, 

municipalities, etc. which can be purchased or copied and 

used with their guidance to find the firms.

After the directions are obtained or the maps copied, copies 

of the maps with directions can be included in the factory 

jacket.

3.2.17 - FEDERAL FOOD SAFETY COALITION

In August 1999, FDA began an interagency Federal Food 

Safety Coalition with other federal agencies in an effort to 

focus on food protection of high-risk populations. The 

group's objective is to promote the development of effective 

public health protection systems for food safety within 

federal programs using the FDA Model Food Code, 

emphasizing foodborne illness interventions, to reduce the 

occurrence of the five leading illness risk factors. A formal 

MOU or partnership has not yet been developed. The 

agency members are as follows:

1. Dept. of Veterans Affairs, Veterans Health Admin.

2. United States Department of Agriculture, Food and 

Nutrition Service Child Nutrition Division 

3. Dept. of Justice, Bureau of Prisons

4. Dept. of Health and Human Services:

a. Head Start Program

b. Administration on Aging

c. Indian Health Services

d. Centers for Medicare and Medicaid Services

e. Food and Drug Administration, Center for Food 

Safety and Applied Nutrition 

5. CDC – Vessel Sanitation Program

6. Department of Defense: 

a. US Air Force

b. US Army 

c. US Coast Guard 

d. US Navy 

7. Department of Interior, National Park Service

8. US Congress, Office of the Attending Physician

SUBCHAPTER 3.3 - STATE OPERATIONAL 

AUTHORITY

3.3.1 - STATE OPERATIONAL AUTHORITY

Establishment Inspections - All state and local officials have 

some type of jurisdiction over the food and drug 

establishments located within their state or local 

boundaries, regardless of the interstate movement or origin 

of the products involved. Some states divide the 

responsibility for food, drugs, etc., among the various 

agencies within the state. See IOM 3.3.31. 

Samples - All state laws provide authority to collect samples 

of food, drug, and other products within the state.

Embargoes - FDA does not have embargo authority. Some 

states have embargo and detention authorities, these 

authorities are specific within each state. FDA does have 

administrative detention authority for medical devices and 

food. Administrative detention for medical devices and food 

can be used when the Agency has reason to believe that 

the article is adulterated, misbranded, or presents a threat 

of serious adverse health consequences to humans or 

animals. See FD&C Act section 304(g) and (h), IOM 

3.2.1.3, 2.2.10, and 2.7.1 for administrative detention 

information. 

Some state laws empower their inspectors to place an 

immediate embargo on products that are, or are suspected 

of being, adulterated or misbranded or otherwise in 

violation of their laws. As a cooperative measure most state 

agencies will have their inspectors place an embargo at the 

request of an FDA representative. Do not routinely request 

such embargo. District assignments may include 

instructions relative to cooperative embargoes.

In all instances, exercise care in requesting embargoes. In 

accordance with Field Management Directive 50 (FMD 50), 

the appropriate state agency should be notified of pending 

or recommended compliance/enforcement actions within 

five working days. When a state institutes an embargo at 

FDA’s request, the District must assure that cooperating 

officials are kept informed of the status of the resulting 

administrative or legal action. The District must promptly 

notify state officials when the resulting action is final so that 

the state can update records and issue required releases 

for the lot. This helps prevent inordinately long holding 

times by the state.

Embargoes should not be considered as a mere 

convenience to the Food and Drug Administration but as an 

important and effective cooperative measure to be applied 

only when circumstances indicate such action.

Disaster Operations - Following major disasters, FDA 

regional directors and District directors will arrange for 

close cooperation with local and state food and drug 

officials, Health Departments, the Public Health Service 

and other agencies engaged in comparable work. When 

requested to do so, FDA District personnel will assist local 

and state officials during such emergencies. At such times 

FDA personnel may be temporarily commissioned by local 

or state authorities and provided the authority to place 

embargoes (See IOM 8.1.5.8.6).

3.3.1.1 - FDA Personnel with State Authority

Certain states have designated selected FDA employees 

as special representatives or agents of the particular state 

agency. In these cases, they have furnished the FDA 

individuals with official state credentials. The FDA 

representatives given this authority will receive instructions 

and training, by their District, in the proper exercise of the 

powers conferred on them and must operate within the 

guidelines established by their District to monitor this 
CHAPTER 3 INVESTIGATIONS OPERATIONS MANUAL 2023 

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authority. This is particularly important whenever state 

embargo powers may be used.

3.3.1.2 - Joint Inspections

Joint inspections with state or local inspectors are arranged 

by the District supervisory personnel. Joint inspections are 

conducted in the same manner as inspections by FDA 

alone and findings are discussed with the accompanying 

inspector. The cooperating inspector may wish to take 

action against the merchandise or the firm under pertinent 

local or state laws.

3.3.1.3 - FDA Commissioned State Personnel

Qualified state regulatory officials may be commissioned

under section 702(a)(1)(A) of the FD&C Act.to conduct 

examinations and investigations, which can include 

conducting inspections, collecting samples, copying and 

verifying records and carrying out an administrative 

detention order (following approval by the FDA District

Director) under the FD&C Act.

3.3.1.4 – State Contract Inspections

FDA contracts with state regulatory partners to provide 

enhanced regulatory oversight of its regulated firms. 

Contract programs include Human Food, Animal Food, Shell 

Eggs, Medical Device, and Mammography Quality Standards 

Act (MQSA). The state regulatory partner must have 

equivalent regulations or be a commissioned official. 

Field Management Directive 76 (FMD-76) governs the 

oversight of the state contract audit program for all contract 

programs except MQSA. 

All certified MQSA Inspectors are required to receive a 

satisfactory audit from a certified MQSA auditor during each 

Federal Fiscal Year. https://www.fda.gov/federal-statelocal-tribal-and-territorial-officials/contracts/mqsainspection-contract-program

3.3.2 - STATE MEMORANDA OF 

UNDERSTANDING

The FDA has entered into agreements with various state 

and local agencies covering a variety of issues and work 

sharing agreements. At the present time not all the states 

have entered into agreements with FDA. A listing of current 

MOUs for states, the District of Columbia, and the 

Commonwealth of Puerto Rico are on FDA’s MOU page.

3.3.3 - STATE AUTHORITIES AND PHONE 

CONTACT NUMBERS

This section contains information regarding various state 

enforcement authorities. Some states operate under state 

laws patterned after the FD&C Act of 1906 or the current 

FD&C Act. However, most of the states operate under a 

"Uniform FD&C Act" which was developed by the 

Association of Food and Drug Officials (AFDO).

States that have adopted the Uniform FD&C Act as their 

legal guideline have in most cases adopted the entire act. 

The food authority in most cases includes among other 

things the adoption of the food and color additive 

provisions, pesticide residue amendments, enrichment 

guidance, etc. The Uniform FD&C Act also includes a 

provision for automatic adoption of changes in the FD&C 

Act. Some state legislatures have also included this 

provision in their laws. Some other provisions of the 

Uniform Act adopted by state include the new drug 

provisions, medical device laws, and cosmetic 

requirements.

Some states have also adopted the Association of 

American Feed Control Officials (AAFCO) model bill as 

their legal guideline for feed inspections.

In most cases the contact for "Consumer Protection Issues" 

would be located in the Office of the State Attorney General 

and would usually cover consumer fraud and other 

consumer protection issues. The State Attorney General's 

staff usually has mechanisms to deal with health fraud 

issues not efficiently dealt with by traditional FDA 

approaches. Contact your District Health Fraud Monitor for 

guidance in cooperative efforts with the State Attorney 

General's staff.

A complete listing of the personnel and programs at the 

state and local level may be found in the FDA Internet 

Directory of State and Local Officials which was prepared

by the Office of Partnerships (HFC-150) at 

https://www.fda.gov/ForFederalStateandLocalOfficials/def

ault.htm or http://www.afdo.org/ 

3.3.3.1 - Alabama (AL)

Alabama has adopted the FD&C Act of 1906 and the 1970 

AAFCO as their legal guideline. The control agencies are 

Agriculture and Health. They have not adopted the new 

drug provisions, the medical device law, nor the automatic 

adoption provisions.

3.3.3.2 - Alaska (AK)

Alaska has adopted the Uniform FD&C Act without the 

automatic adoption provision and have not adopted either 

AAFCO feed bill. The controlling agencies are Health, 

Social Services, and Environmental Conservation. Alaska 

has adopted the various provisions of the Uniform bill.

3.3.3.3 - Arizona (AZ)

Arizona operates under the Uniform FD&C Act and the 

1970 AAFCO Feed Bill. The controlling agencies are 

Health, Pharmacy and the State Chemist. They have not 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 3

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adopted the medical device law, cosmetics law, nor the 

automatic adoption provisions of the Uniform FD&C Act.

3.3.3.4 - Arkansas (AR)

Arkansas operates under the Uniform FD&C Act and the 

1970 AAFCO Feed Bill. The agencies in control are Health 

and the Plant Board. They have not adopted the new drug 

provisions or the automatic adoption provision.

3.3.3.5 - California (CA)

California has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health.

3.3.3.6 - Colorado (CO)

Colorado has adopted the Uniform FD&C Act and the 

automatic adoption provisions of the Uniform FD&C Act. 

The controlling agencies are Agriculture and Health. They 

have not adopted either version of the AAFCO Feed Bill.

3.3.3.7 - Connecticut (CT)

Connecticut has adopted the FD&C Act, the Uniform FD&C 

Act and the 1958 AAFCO Feed Bill along with the automatic 

adoption provisions of the Uniform FD&C Act. The 

controlling agencies are Agriculture and Consumer 

Protection.

3.3.3.8 - Delaware (DE)

Delaware has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture, Health, and Pharmacy. They 

have not adopted the food and color additive amendments, 

the pesticide residue amendment, enrichment amendment, 

new drug provisions, medical device law, and the cosmetics 

law.

3.3.3.9 - Florida (FL)

Florida has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health.

3.3.3.10 - Georgia (GA)

Georgia has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture and Pharmacy. They have not adopted the food 

additive, color additive or pesticide residue amendments.

3.3.3.11 - Hawaii (HI)

Hawaii has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture, Health and the Attorney General.

3.3.3.12 - Idaho (ID)

Idaho has adopted the Uniform FD&C Act and the 1958 

AAFCO Feed Bill and has not adopted the automatic 

adoption provisions of the Uniform FD&C Act. The 

controlling agencies are Agriculture, Health and Pharmacy. 

They have not adopted the food additive, color additive or 

pesticide residue amendments of the Act.

3.3.3.13 - Illinois (IL)

Illinois has adopted the Uniform FD&C Act and the 1958 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the enrichment provisions of the Act.

3.3.3.14 - Indiana (IN)

Indiana has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Health and the State Chemist.

3.3.3.15 - Iowa (IA)

Iowa has adopted the 1906 FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the FD&C Act. The controlling agencies are 

Agriculture, Health and Appeals, and Pharmacy.

3.3.3.16 - Kansas (KS)

Kansas has adopted the Uniform FD&C Act and the 1958 

AAFCO Feed Bill and has not adopted the automatic 

adoption provisions of the Uniform FD&C Act. The 

controlling agencies are Agriculture and Health.

3.3.3.17 - Kentucky (KY)

Kentucky has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Human Resources, Pharmacy, and the 

University of Kentucky Registration Services.

3.3.3.18 - Louisiana (LA)

Louisiana has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 
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agencies are Agriculture and Health. They have not 

adopted the provisions of the medical device law.

3.3.3.19 - Maine (ME)

Maine has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture and Pharmacy. They have not adopted the food 

and color additive amendments nor the new drug provisions 

or the medical device law.

3.3.3.20 - Maryland (MD)

Maryland has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the enrichment provisions of the Act.

3.3.3.21 - Massachusetts (MA)

Massachusetts has adopted the Uniform FD&C Act and the 

1970 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the new drug provisions of the Act.

3.3.3.22 - Michigan (MI)

Michigan has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture, Commerce, Licensing and Registration. They 

have not adopted the enrichment provisions or the 

cosmetics law.

3.3.3.23 - Minnesota (MN)

Minnesota has adopted the Uniform FD&C Act and the 

1970 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Pharmacy. They have not 

adopted the enrichment provisions, the new drug 

provisions, the medical device law, nor the cosmetic law.

3.3.3.24 - Mississippi (MS)

Mississippi has adopted the 1906 FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture, Commerce and the State Chemistry Lab. They 

have not adopted the food additive, color additive, and 

pesticide residue amendments, nor the new drug provisions 

or cosmetic law.

3.3.3.25 - Missouri (MO)

Missouri has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture and Health. They have not adopted the 

enrichment provisions of the Act.

3.3.3.26 - Montana (MT)

Montana has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health.

3.3.3.27 - Nebraska (NE)

Nebraska has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture and Health. They have not adopted the new 

drug provisions nor the medical device and cosmetic laws.

3.3.3.28 - Nevada (NV)

Nevada has adopted the Uniform FD&C Act but not the 

automatic adoption provisions of the Uniform FD&C Act. 

They have not adopted either version of the AAFCO Feed 

Bill. The controlling agencies are Agriculture and Health. 

They have not adopted the enrichment provisions of the 

Act.

3.3.3.29 - New Hampshire (NH)

New Hampshire has adopted the Uniform FD&C Act and 

the 1970 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health.

3.3.3.30 - New Jersey (NJ)

New Jersey has adopted the Uniform FD&C Act and the 

1970 AAFCO Feed Bill but not automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the pesticide residue amendment.

3.3.3.31 - New Mexico (NM)

New Mexico has adopted the Uniform FD&C Act and the 

1958 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture, Environment, Health and 

Pharmacy. They have not adopted the food additive or color 

additive amendments.
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 3

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3.3.3.32 - New York (NY)

New York has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Markets, Health, and 

Pharmacy. They have not adopted the cosmetics law.

3.3.3.33 - North Carolina (NC)

North Carolina has adopted the Uniform FD&C Act and 

both versions of the AAFCO Feed Bills along with the 

automatic adoption provisions of the Uniform FD&C Act. 

The controlling agency is Agriculture. They have not 

adopted the enrichment provisions of the Act.

3.3.3.34 - North Dakota (ND)

North Dakota has adopted the Uniform FD&C Act and 

neither version of the AAFCO Feed Bill but not the 

automatic adoption provisions of the Uniform FD&C Act. 

The controlling agencies are Consolidated Laboratories, 

Health and Pharmacy.

3.3.3.35 - Ohio (OH)

Ohio has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture and Pharmacy.

3.3.3.36 - Oklahoma (OK)

Oklahoma has adopted the Uniform FD&C Act but neither 

version of the AAFCO Feed Bills nor the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the food additive or color additive amendments, 

the enrichment provisions nor the new drug provisions.

3.3.3.37 - Oregon (OR)

Oregon has adopted the Uniform FD&C Act and the 1958 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Pharmacy. They have not 

adopted the cosmetics law.

3.3.3.38 - Pennsylvania (PA)

Pennsylvania has adopted the 1906 FD&C Act and the 

1958 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the food additive, color additive, and pesticide 

residue amendments nor the enrichment provisions.

3.3.3.39 - Rhode Island (RI)

Rhode Island has adopted the Uniform FD&C Act and the 

1970 AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Environmental Management and Health.

3.3.3.40 - South Carolina (SC)

South Carolina has adopted the Uniform FD&C Act and the 

1958 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health.

3.3.3.41 - South Dakota (SD)

South Dakota has adopted the Uniform FD&C Act and the 

1970 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture, Commerce and Regulations. 

They have not adopted the new drug provisions, medical 

device law, nor the cosmetics law.

3.3.3.42 - Tennessee (TN)

Tennessee has adopted the Uniform FD&C Act and the 

1970 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling agency 

is Agriculture.

3.3.3.43 - Texas (TX)

Texas has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Health and the State Chemist.

3.3.3.44 - Utah (UT)

Utah has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the new drug provisions.

3.3.3.45 - Vermont (VT)

Vermont has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Health. They have not 

adopted the enrichment provisions.
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3.3.3.46 - Virginia (VA)

Virginia has adopted the Uniform FD&C Act and the 1958 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agencies are 

Agriculture and Pharmacy.

3.3.3.47 - Washington (WA)

Washington has adopted the Uniform FD&C Act and the 

1958 AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Pharmacy.

3.3.3.48 - West Virginia (WV)

West Virginia has adopted the 1906 FD&C Act and the 

1970 AAFCO Feed Bill but not the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture, Health and Pharmacy. They have 

not adopted the food additives or color additive 

amendments, the new drug provisions, the medical device 

law and the cosmetics law.

3.3.3.49 - Wisconsin (WI)

Wisconsin has adopted the Uniform FD&C Act and the 

1958 AAFCO Feed Bill along with the automatic adoption 

provisions of the Uniform FD&C Act. The controlling 

agencies are Agriculture and Pharmacy. They have not 

adopted the enrichment provisions, the new drug 

provisions, the medical device law, and the cosmetics law.

3.3.3.50 - Wyoming

Wyoming has adopted the Uniform FD&C Act and the 1970 

AAFCO Feed Bill but not the automatic adoption provisions 

of the Uniform FD&C Act. The controlling agency is 

Agriculture.

SUBCHAPTER 3.4 - INTERNATIONAL 

ARRANGEMENTS

3.4.1 - INTERNATIONAL ARRANGEMENTS

The Agency has over the years entered into agreements 

with foreign governments regarding the quality of foods, 

drugs, and other products exported to the United States. 

Refer to FDA's website at 

https://www.fda.gov/international-programs/internationalarrangements/cooperative-arrangements for additional 

information. 

3.4.2 - MUTUAL RECOGNITION 

AGREEMENTS

3.4.2.1 - European Community

Changes in FDAMA have required that FDA begin the 

process of acceptance of mutual recognition agreements 

relating to the regulation of FDA regulated commodities, 

facilitate commerce between the US and foreign countries 

and other activities to reduce the burden of regulation and 

to harmonize regulatory requirements. See Section 410 of 

FDAMA. Additional specific information is available at 

https://www.fda.gov/international-programs/internationalarrangements/mutual-recognition-agreement-mra. 

3.4.2.2 - Food Products

In July 1999, the United States and the EC signed the 

"AGREEMENT BETWEEN THE UNITES STATES OF 

AMERICA AND THE EUROPEAN COMMUNITY ON 

SANITARY MEASURES TO PROTECT PUBLIC AND 

ANIMAL HEALTH IN TRADE IN LIVE ANIMALS AND 

ANIMAL PRODUCTS". This agreement is very much like a 

mutual recognition agreement and is based on the 

equivalence process. It covers a very wide range of human 

food products, all of animal origin, such as milk and dairy 

products, seafood, honey, wild game, snails, frog legs and 

canned pet food. For purposes of this agreement, the EC is 

considered one "party" and not 15 Member States. 

Activities to begin assessing equivalence are underway.

SUBCHAPTER 3.5 - NON-GOVERNMENT

AGREEMENTS

The Agency has entered agreements with various nongovernmental groups to formulate various programs and 

guidance See FDA’s Cooperative Agreements page.
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 3-1 

3-24

3-1 FDA/USDA JURISDICTION

This table summarizes information concerning jurisdiction overlap for human food products regulated by 

either or both FDA and USDA. It does not cover products made for on-site consumption such as pizza parlors, 

delicatessens, fast food sites, etc. 

This table does not apply to meat and meat products intended for use in animal food. 

FDA JURISDICTION USDA JURISDICTION

21 USC 392(b) Meats and meat food 

products capable of use as human 

food shall be exempt from the 

provisions of this Act to the extent of 

the application or the extension 

thereto of the Meat Inspection Act. 

FDA responsible for all non-specified 

red meats (bison, rabbits, game 

animals, zoo animals and all 

members of the deer family including 

elk (wapiti) and moose)). FDA 

responsible for all non-specified birds 

including wild turkeys, wild ducks, 

and wild geese.

For products not intended to use for 

human food this exemption does not 

apply. Any ingredient, including 

meat and meat food products, used 

in animal food is regulated by FDA. 

The Federal Meat Inspection 

Act regulates the inspection of 

the following amenable 

species capable of use as 

human food: cattle, sheep, 

swine, goats, horses, mules or 

other equines, including their 

carcasses and parts. It also 

covers any additional species 

of livestock that the Secretary 

of Agriculture considers 

appropriate.

Mandatory Inspection of 

Ratites and Squab (including 

emu) announced by 

USDA/FSIS April 2001

The Poultry Products 

Inspection Act (PPIA) 

defines the term poultry as 

any domesticated bird. 

USDA has interpreted this to 

include domestic chickens, 

turkeys, ducks, geese and 

guineas. The Poultry 

Products Inspection Act 

states poultry and poultry 

products shall be exempt 

from the provisions of the 

FD&C Act to the extent they 

are covered by the PPIA. 

Mandatory Inspection of 

Ratites and Squab 

announced by USDA/FSIS 

April 2001

The Egg Products Inspection Act 

defines egg to mean the shell egg of 

domesticated chicken, turkey, duck, 

goose or guinea. Voluntary grading 

of shell eggs is done under USDA 

supervision. (FDA enforces 

labels/labeling of shell eggs.)

Products with 3% or less raw meat; 

less than 2% cooked meat or other 

portions of the carcass; or less than 

30% fat, tallow or meat extract, alone 

or in combination. 

Products containing less than 2% 

cooked poultry meat; less than 10% 

cooked poultry skins, giblets, fat and 

poultry meat (limited to less than 2%) 

in any combination. * 

Closed-face sandwiches. 

Any meat or meat food product used 

in or for animal food is regulated by 

FDA, regardless of %

Products containing greater 

than 3% raw meat; 2% or 

more cooked meat or other 

portions of the carcass; or 

30% or more fat, tallow or 

meat extract, alone or in 

combination. * 

Open-face sandwiches.

Products containing 2% or 

more cooked poultry; more 

than 10% cooked poultry 

skins, giblets, fat and poultry 

meat in any combination. * 

Egg products processing plants (egg 

breaking and pasteurizing 

operations) are under USDA 

jurisdiction.

FDA is responsible for shell eggs 

and egg containing products that do 

not meet USDA’s definition of “egg 

product.” FDA also has jurisdiction in 

establishments not covered by 

USDA; e.g. restaurants, bakeries, 

cake mix plants, etc.

Egg processing plants (egg washing, 

sorting, packing) are under FDA 

jurisdiction.

Products that meet USDA’s definition 

of “egg product” are under USDA 

jurisdiction. The definition includes 

dried, frozen, or liquid eggs, with or 

without added ingredients, but 

mentions many exceptions. The 

following products, among others, 

are exempted as not being egg 

products: freeze-dried products, 

imitation egg products, egg 

substitutes, dietary foods, dried nobake custard mixes, eggnog mixes, 

acidic dressings, noodles, milk and 

egg dip, cake mixes, French toast, 

sandwiches containing eggs or egg 

products, and balut and other similar 

ethnic delicacies. Products that do 

not fall under the definition, such as 

egg substitutes and cooked 

products, are under FDA jurisdiction.

Cheese pizza, onion and mushroom 

pizza, meat flavored spaghetti sauce 

(less than 3% red meat), meat 

flavored spaghetti sauce with 

Pepperoni pizza, meat-lovers 

stuffed crust pizza, meat 

sauces (3% red meat or 

more), spaghetti sauce with 

Chicken sandwich (open 

face), chicken noodle soup Homogeneous cheese and meat 

products, e.g., cheese balls with 

pepperoni, must contain more than 
EXHIBIT 3-1 INVESTIGATIONS OPERATIONS MANUAL 2023

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mushrooms, (2% meat), pork and 

beans, sliced egg sandwich (closedface), frozen fish dinner, rabbit stew, 

shrimp-flavored instant noodles, 

venison jerky, buffalo burgers, 

alligator nuggets, noodle soup 

chicken flavor

meat balls, open-faced roast 

beef sandwich, hot dogs, corn 

dogs, beef/vegetable pot pie

50 percent meat to be amenable to 

USDA inspection. Cheese products 

that contain 50 percent or less meat 

are considered products of the dairy 

food industry and, thus, are exempt 

from USDA inspection. When 

cheese and meat are separate 

components in a package, the 

packaged product is amenable, 

provided, it contains 2 percent 

cooked meat.

Jurisdiction for products produced under the School Lunch Program, for military use, etc. is determined via the same algorithm although 

the purchases are made under strict specifications so that the burden of compliance falls on the contractor. Compliance Policy Guide 

565.100, 567.200 and 567.300 provide additional examples of jurisdiction. IOM 3.2.1 and 2.7.1 provide more information on our 

interactions with USDA and Detention Authority.

* These percentages are based on the amount of meat or poultry product used in the product at formulation. 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 3-2 

3-26

HISTORY OF MENU ITEMS

DATE PLACE4/25/03 Hyatt Hotel

St. Louis, MO

EMPLOYEE(S) 

INVOLVED

R. BrownB. BlackC. WhiteK. Green" "" " B. Black& K. GreenR. Brown& A. SmithChef WelshC. WhiteChef Welsh

TIMES

1600-17301700 - 17301350 - 1450?-1600

1600-16301630-1700

0730

0845-09450945-17300900-10301030-12001700-17301500-18001800-18301930-1900

TEMP OF

5o-230oF

5o-300oF

40oF

5o-40oF

40oF40oF55oF75oF

75o-40oF

75oF

75o-225oF

200oF

36o-140oF

135oF

130oF

STEPS IN 

PROCESS

bake

deep fry

slice

thaw

slice

plate

wash

plate

cool

slice

bake

plateroast

slice

plate

LOCATION

freezerfreezer

cooler

freezer

cooler

" " 

ADVANCE 

PREPARED

yes 4/10Chef Welsh

PRE-PARED

yes

yes

yes

DATE 

REC’ D

4/20

4/21

4/24

4/10

4/24

" 

4/24

SUPPLIER

IndependentFoodsSt. Louis, MOITAL-AMERFoodsSt. Louis, MOFox DairySt. Louis, MOJoe’ s Butcher ShopE. St. Louis, IL

(liver)

Lombardi’ sSt. Louis, MO

" 

Joe’ s Butcher ShopE. St. Louis, ILSonoma Valley CA

" 

MENU

ITEM

Egg Rolls(Appetizer)Ravioli(Appetizer)Cheeses(Appetizer)Pate(Appetizer)Produce(Salad)CrownPotatoesPrime RibWineChateau St. Juan 20012000 Marion Cabernet
EXHIBIT 3-2 INVESTIGATIONS OPERATIONS MANUAL 2023 

3-27

HISTORY OF MENU ITEMS

DATE PLACE

EMPLOYEE(S) 

INVOLVED TIMES TEMP OF STEPS IN PROCESS LOCATION ADVANCE PREPARED PRE-PARED DATE REC’ D SUPPLIER MENU ITEM
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 3-3 

3-28

To: Postmaster

Agency Control Number: 

Date: 

ADDRESS INFORMATION REQUEST

Please furnish this agency with the new address, if available, for the following individual or verify 

whether or not the address given below is one at which mail for this individual is currently being 

delivered. If the following address is a post office box, please furnish the street address as 

recorded on the boxholder's application form.

Name:

Last Known Address:

I certify that the address information for this individual is required for the performance of this 

agency's official duties. 

(Signature of Agency Official)

(Title)

 . 

FOR POST OFFICE USE ONLY

[ ] MAIL IS DELIVERED TO ADDRESS GIVEN NEW ADDRESS

[ ] NOT KNOWN AT ADDRESS GIVEN .

[ ] MOVED, LEFT NO FORWARDING ADDRESS .

[ ] NO SUCH ADDRESS

[ ] OTHER (SPECIFY): BOXHOLDER'S STREET ADDRESS

 . .

 . .

 Agency return address Postmark/Date Stamp

Under the authority of 39 CFR 265.6(d)(5)(i) and (d)(7)

265.6 Availability of records.

(d) Disclosure of names and addresses of customers. Upon request, the names and addresses of specifically identified Postal Service customers will be made available only as follows:(5) Exceptions. Except 

as otherwise provided in these regulations, names or addresses of Postal Service customers will be furnished only as follows: (i) To a federal, state or local government agency upon prior written 

certification that the information is required for the performance of its duties. The Postal Service requires government agencies to use the format appearing at the end of this section when requesting the 

verification of a customer's current address or a customer's new mailing address. If the request lacks any of the required information or a proper signature, the postmaster will return the request to the 

agency, specifying the deficiency in the space marked ‘OTHER’. A copy of PS Form 1093 may be provided. 

(7) Address verification. The address of a postal customer will be verified at the request of a Federal, State, or local government agency upon written certification that the information is required for the 

performance of the agency's duties. “Verification” means advising such an agency whether or not its address for a postal customer is one at which mail for that customer is currently being delivered. 

“Verification” neither means nor implies knowledge on the part of the Postal Service as to the actual residence of the customer or as to the actual receipt by the customer of mail delivered to that 

address. The Postal Service requires government agencies to use the format appearing at the end of this section when requesting the verification of a customer's current address or a customer's new 

mailing address. If the request lacks any of the required information or a proper signature, the postmaster will return the request to the agency, specifying the deficiency in the space marked “OTHER”.

U.S. Food and Drug Administration

www.fda.gov
EXHIBIT 3-3 INVESTIGATIONS OPERATIONS MANUAL 2023

3-29

INSTRUCTIONS FOR COMPLETING IOM EXHIBIT 3-3

If you have already attempted to locate the individual or firm by sending mail marked 

on the outside of the envelope "DO NOT FORWARD. ADDRESS CORRECTION 

REQUESTED", without results, then proceed with this form according to the 

instructions below.

INSTRUCTIONS

1. Address the request to the Postmaster at the post office of the last known address.

2. Insert FEI # if known; or assignment or sample number for Agency Control number.

3. On the lines provided, give the name and last known address, including zip code, of the 

individual or firm. Do not include any other identifying information such as race, date of 

birth, social security number, etc. 

4. The Postal Service provides the service of address verification to Government agencies 

only. For this reason, the Postal Service requires the signature and title of an agency 

official to certify that the address information requested is required in the performance of 

the agency's official duties. The agency official should be if possible, the chief of the office 

requesting the information. In the interests of efficiency, the signature may be preprinted 

or rubber-stamped. 

5. Type or stamp the agency's return mailing address in the space provided at the bottom of 

the request. Include your full name and title or the appropriate person’s full name and title 

to whom the form should be returned to. Mail or deliver the request to the Postmaster at 

the post office of the last known address. 

You are not required to submit this request in duplicate or to furnish a return envelope.