Contents

SUBCHAPTER 330 - STATE OPERATIONAL AUTHORITY

331 - 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 333.

Samples - All state laws provide authority to collect samples of food, drug, and other products within the state.

Embargoes - FDA personnel, except in certain situations involving meat, poultry products, egg products and devices do not have embargo or detention powers (See IOM 311.02, 708, and 750).

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. The cooperating officials must be notified promptly of the final FDA action on the lot so that records may be updated, required releases issued, and inordinately long holding time prevented.

Embargoes should be considered not as a mere convenience to the Food and Drug Administration but as an important and effective cooperation 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 945.01).

331.01 - 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 authority. This is particularly important whenever state embargo powers may be used.

331.02 - 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.

331.03 - FDA Commissioned State Personnel

Qualified state regulatory officials may be commissioned to conduct examinations, inspections, investigations, collect samples and to copy and verify records under the Federal Food, Drug, and Cosmetic Act. For additional information, please see Chapter 3 of the Regulatory Procedures Manual (RPM).

332 - 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. The following is a alphabetical listing of current MOU's for states, the District of Columbia, and the Commonwealth of Puerto Rico. Complete text of the MOU's is in Federal Cooperative Agreements Manual.

332.01 - Alabama (AL)

MOU with AL Department of Public Health Regarding Inspections, Investigations, and Analytical Findings Related to Food Firms. (6/23/92)

332.02 - Arizona (AZ)

MOU with AZ Department of Health Services Concerning Food, Device and Drug Firms. (9/28/94)

332.03 - Arkansas (AR)

MOU with:

1. AR Department of Health and the AR State Plant Board Regarding Monitoring Pesticide Residues and Mycotoxins in Food and Animal Feed. (5/3/96)
2. AR Attorney General and AR Department of Health Regarding the Inspection of Foods, Drugs, Devices, and Cosmetics. (4/17/92)

332.04 - California (CA)

MOU with:

1. CA Department of Food and Agriculture Regarding Monitoring and Enforcement for Pesticide Residues in Raw Agricultural Commodities. (3/31/89)
2. CA Department of Health Services, Food, Drug, and Radiation Safety Division, Food and Drug Branch Concerning the Exchange of Information of Mutual Interest. (1/26/94)
3. CA Department of Health Services concerning the sharing of inventories, planning of work, and exchange of inspection reports and regulatory correspondence relating to blood banks, plasma centers, and the screening, processing, and storage of by-products in the state. (8/17/94)

332.05 - Colorado (CO)

MOU with CO Department of Health and CO Department of Law Regarding Inspections of Food, Drug, Cosmetic, and Medical Device Firms. (4/22/92)

332.06 - Connecticut (CT)

MOU with CT Department of Consumer Protection Regarding the Coordination of Joint Efforts in Monitoring Pesticide and Industrial Chemical Residues In Foods. (5/16/90)

332.07 - Delaware (DE)

MOU with:

1. DE Board of Pharmacy Concerning Regulatory Activities Relating to the Inspection of Drug Manufacturers, Wholesalers, and Distributors. (3/18/88)
2. DE Department of Agriculture, MD Department of Agriculture, PA Department of Agriculture, VA Department of Agriculture and Consumer Services, WV Department of Agriculture, USDA/FSIS - NE & SE Regional Offices Regarding Regulatory Investigations Involving Drug, Pesticide, and Industrial Chemical Residues in Animal Feeds and Meat and Poultry. (9/13/90)
3. DE Division of Public Health Relating to the Food Processing Industry. (8/19/93)

332.08 - District of Columbia (DC)

MOU with DC, Department of Consumer and Regulatory Affairs Concerning Public Health Emergencies, Coordination of Consumer Complaint Investigations, Joint Training Efforts, Analytical Assistance, and Mutual Exchange of Inspectional Information. (3/26/96)

332.09 - Florida (FL)

MOU with:

1. FL Department of Agriculture and Consumer Services Delineates Activities Relating to the Regulation of Milk, Foods, Medicated Feeds, and Pesticides. (10/16/89)
2. FL Department of Health Concerning Cooperation in Consumer Protection Activities Such as Foods, Drugs, Medical Devices, Cosmetics, and Radiation Emitting Electronic Products. (6/25/93)
3. FL Department of Agriculture and Consumer Services, USDA FSIS, Involving Drug, Pesticide and Environmental Chemical Residues in Animal Feed, Meats, and Poultry Tissue. (8/23/91)
4. FL Department of Agriculture and Consumer Services Concerning Milk, Foods, Medicated Feeds and Pesticide Residues. (9/28/94)

332.10 - Georgia (GA)

MOU with GA Department of Agriculture and USDA/FSIS Regarding Regulatory Investigations Involving Drug, Pesticide, and Toxic Chemical Residues in Animal Feeds and in Meat Tissues. (10/11/90)

332.11 - Illinois (IL)

MOU with:

1. IL Attorney General Regarding Development and Implementation of Appropriate Sanctions Concerning Fraud and Deception Involving Foods, Drugs, Devices, and Cosmetic. (12/13/82)
2. IL Department of Public Health Concerning the Monitoring and Investigation of Foodborne Illnesses. (8/18/87)
3. Commercial Feed Regulatory Agencies of the states of Illinois, Indiana, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin Relating to Animal Feed and the Impact of Animal Feed on Food. (5/24/93)

332.12 - Iowa (IA)

MOU with:

1. IA Department of Agriculture & Land Stewardship Relative to Animal Feed Firms. (3/2/93)
2. IA Department of Inspections & Appeals Relative to Wholesale Food Establishments (9/23/93)

332.13 - Indiana (IN)

MOU with Commercial Feed Regulatory Agencies of the states of Illinois, Indiana, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin Relating to Animal Feed and the Impact of Animal Feed on Food (5/24/93)

332.14 - Kansas (KS)

MOU with KS Department of Health and Environment Concerning Inspection, Investigation, and Analytical Findings Related to Food and Drug Firms (revised 5/12/95)

332.15 - Kentucky (KY)

1. MOU with KY State Board of Pharmacy Regarding Investigations of Drug Distributors Involving Violations of the Prescription Drug Marketing Act of 1987 (PDMA) (7/16/90)
2. CAP with KY Department of Health Services Regarding Milk, Food, Cosmetics, Interstate Travel Sanitation, Radiological Health, Drugs, and Pesticides (revised 6/28/90)

332.16 - Louisiana (LA)

MOU with LA Department of Agriculture and Forestry Relating to Food Firms (6/28/94)

332.17 - Maine (ME)

MOU with ME Department of Agriculture, Food and Rural Resources Regarding the Coordination of Joint Efforts in Monitoring Pesticide and Industrial Chemical Residues in Foods (3/22/90)

332.18 - Maryland (MD)

MOU with:

1. MD Department of Health and Mental Hygiene Concerning the Inspection of Food Processing and Storage Industries and emergency public health problems of food origin (revised 1/31/89)
2. DE Department of Agriculture, MD Department of Agriculture, PA Department of Agriculture, VA Department of Agriculture and Consumer Services, WV Department of Agriculture, USDA/FSIS - NE & SE Regional Offices Regarding Regulatory Investigations Involving Drug, Pesticide, and Industrial Chemical Residues in Animal Feeds and Meat and Poultry (revised 9/13/90)

332.19 - Michigan (MI)

MOU with:

1. MI Department of Agriculture Regarding Inspections, Investigations, and Analytical Findings Related to Food Firms (11/20/91)
2. Commercial Feed Regulatory Agencies of the states of Illinois, Indiana, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin Relating to Animal Feed and the Impact of Animal Feed on Food (5/24/93)

332.20 - Minnesota (MN)

MOU with:

1. MN Department of Agriculture Regarding the Inspection of Food and Medicated Feed Firms (7157.50: 7/29/92)
2. Commercial Feed Regulatory Agencies of the states of Illinois, Indiana, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin Relating to Animal Feed and the Impact of Animal Feed on Food (5/24/93)

332.21 - Missouri (MO)

MOU with:

1. MO Department of Health Regarding Food Inspection, Monitoring of Industry Recalls, Disaster Investigations, HIV Related Issues and Exchange of Inspectional and Analytical Information (revised 5/12/95)
2. MO State Board of Pharmacy to Differentiate Between the Practice of Pharmacy and the Manufacture of Finished Pharmaceuticals (1/16/96)

332.22 - Nebraska (NE)

MOU with NE Department of Agriculture Concerning Inspection, Investigations, and Analytical Findings Related to Foods and Animal Feeds Firms (revised 5/23/95)

332.23 - New Jersey (NJ)

MOU with NJ Department of Health Regarding Inspection of Drug Firms, Investigations of Drug Related Health Frauds, Analysis of Drug Samples, and Recalls (2/3/86)

332.24 - New Mexico (NM)

MOU with NM Department of Health and Environment and NM Department of Agriculture Regarding Coordination of Information and Work-Sharing in Monitoring Pesticide Residues and Mycotoxins in Food and Animal Feed Commodities (revised 4/12/94)

332.25 - New York (NY)

Agreement with NY Department of Agriculture and Markets Regarding Coordination of Communications and Work-Sharing to Ensure Prompt and Effective Food- Related Consumer Protection Services (6/20/90)

332.26 - North Carolina (NC)

MOU with NC Department of Agriculture of Food and Drug Firms (10/02/92)

332.27 - North Dakota (ND)

MOU with Commercial Feed Regulatory Agencies of the states of Illinois, Indiana, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin Relating to Animal Feed and the Impact of Animal Feed on Food (5/24/93)

332.28 - Ohio (OH)

MOU with OH Department of Health Regarding Sharing of Information About Levels of Pesticides in Grade A Milk, Milk Products, Grade A Goat Milk, and Goat Milk Products (1/18/90)

332.29 - Oklahoma (OK)

MOU with:

1. OK Department of Health and the OK Department of Agriculture Concerning Joint Efforts for the Coordination of Information in Monitoring Pesticide Residues and Mycotoxins in Food and Animal Feed Commodities (5/9/88)
2. OK Attorney General and OK Department of Health Regarding Fraud and Deception Involving Foods, Drugs, Devices, and Cosmetics (8/17/92)
3. OK Department of Health and the OK Department of Agriculture Concerning Pesticides Residues and Mycotoxins in Food and Animal Feed (1/29/96)

332.30 - Oregon (OR)

MOU with OR Dept. of Agriculture Relating to Food Firms (Being Superceded by Partnership Agreement)

332.31 - Pennsylvania (PA)

MOU with:

1. Allegheny County, PA Health Department Concerning Coordination of Inspection of Food Processing, Storage and Service Facilities, and Interstate Carrier Support Facilities (11/18/78)
2. PA Department of Health Regarding the Inspection of Drug, Device, and Cosmetic Manufacturers, Wholesalers, and Distributors (revised 4/6/88)
3. PA Department of Agriculture Regarding Regulatory Activities Relating to the Inspection of Food Processing and Storage Facilities (revised 11/30/88)
4. DE Department of Agriculture, MD Department of Agriculture, PA Department of Agriculture, VA Department of Agriculture and Consumer Services, WV Department of Agriculture, USDA/FSIS - NE & SE Regional Offices Regarding Regulatory Investigations Involving Drug, Pesticide, and Industrial Chemical Residues in Animal Feeds and Meat and Poultry (revised 9/13/90)

332.32 - Puerto Rico (PR)

MOU with the Commonwealth of Puerto Rico Dept. of Consumer Affairs (DACO) Concerning Cooperative Education Initiatives, Mutual Planning, Sharing Reports of Inspections, Investigations, and Analytical Findings (10/1/93)

332.33 - Rhode Island (RI)

MOU with RI Department of Health Regarding the Coordination of Joint Efforts in Monitoring Pesticide and Industrial Chemical Residues in Foods (9/26/90)

332.34 - South Carolina (SC)

MOU with:

1. SC Department of Agriculture Regarding the Inspection of Food and Drug Firms (7/31/92)
2. SC Department of Agriculture, USDA FSIS, Southeastern Region, Animal & Health Inspection Service, Veterinary Service, and Clemson University Regarding Violative Levels of Drugs, Pesticides and Toxic Chemical Residues in Food Animals (11/08/91)
3. SC Dept. of Health & Environmental Control Concerning Food Firms (11/12/92)

332.35 - South Dakota (SD)

MOU with Commercial Feed Regulatory Agencies of the states of Illinois, Indiana, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin Relating to Animal Feed and the Impact of Animal Feed on Food (5/24/93)

332.36 - Tennessee (TN)

MOU with TN Department of Agriculture Regarding Inspections of Food, Animal Feed, Cosmetic, Medical Device, and Drug Firms (8/25/92)

332.37 - Texas (TX)

MOU with:

1. TX Department of Health Regarding the Regulation of Foods and Drugs Firms (2/11/87)
2. TX Department of Health; TX Department of Agriculture; and TX Agricultural Experiment Station, Office of the TX State Chemist Regarding the Cooperation, Coordination and Sharing of Pesticide Monitoring Data Concerning Residues in Raw and Processed Agricultural Products (revised 6/3/93)
3. TX Department of Health Regarding Methadone Programs, Blood Banks, and Plasmapheresis Operations (5/6/94)

332.38 - Utah (UT)

MOU with UT Department of Agriculture Regarding the Inspection of Food Firms (4/16/92)

332.39 - Virginia (VA)

MOU with:

1. VA Board of Pharmacy for the Inspection of Drug Manufacturers, Wholesalers, and Distributors (revised 3/29/88)
2. VA Department of Agriculture and Consumer Services Concerning Inspection of the Food Processing and Storage Industries (revised 2/28/96)
3. VA Department of Health Concerning the Inspection of the Crabmeat Industry (revised 5/20/88)
4. DE Department of Agriculture, MD Department of Agriculture, PA Department of Agriculture, VA Department of Agriculture and Consumer Services, WV Department of Agriculture, USDA/FSIS - NE & SE Regional Offices Regarding Regulatory Investigations Involving Drug, Pesticide, and Industrial Chemical Residues in Animal Feeds and Meat and Poultry (revised 9/13/90)

332.40 - Washington (WA)

MOU with:

1. WA State Dept. of Agriculture Regarding Inspection and Grading of Grain, Rice, and Pulses (9/10/81)
2. WA State Department of Agriculture Regarding Coordination of Information and Work-Sharing in Monitoring Pesticide Residues in Food and Animal Feed Commodities (4/11/91)
3. WA State Dept. of Agriculture Relating to Food Firms (1/5/93)

332.41 - West Virginia (WV)

MOU with:

1. WV Department of Health Relating to the Inspection of the Food Processing Industry (revised 4/7/88)
2. WV Department of Agriculture Concerning Regulatory Activities Related to Inspections of Food Storage and Medicated Feed Industries (revised 4/19/88)
3. DE Department of Agriculture, MD Department of Agriculture, PA Department of Agriculture, VA Department of Agriculture and Consumer Services, WV Department of Agriculture, USDA/FSIS - NE & SE Regional Offices Regarding Regulatory Investigations Involving Drug, Pesticide, and Industrial Chemical Residues in Animal Feeds and Meat and Poultry (revised 9/13/90)

332.42 - Wisconsin (WI)

MOU with:

1. WI Department of Agriculture, Trade and Consumer Protection Relating to Food and Drug Firms (8/24/92)
2. Commercial Feed Regulatory Agencies of the states of Illinois, Indiana, Michigan, Minnesota, North Dakota, South Dakota, and Wisconsin Relating to Animal Feed and the Impact of Animal Feed on Food (5/24/93)

332.43 - Wyoming (WY)

MOU with WY Department of Agriculture Regarding the Inspection of Food, Drug, and Medical Device Firms (3/20/92)

332.44 - National Association of State

Departments of Agriculture (NSDA)

MOU with NSDA in Order to Provide a Coordinated Structure for the Conduct of Public Education Programs Regarding the Safety and Wholesomeness of the United States Food Supply (3/4/91)