Contents

SUBCHAPTER 310 - 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 MOU's 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.

311 - U.S. DEPARTMENT OF AGRICULTURE (USDA)

See IOM 303 for procedures to be followed when making inspections of firms under USDA inspection or subject to inspection by USDA.

311.01 - 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 district will then determine the need for samples or additional action.

311.02 - USDA Complaints

Whenever a complaint is received involving any meat-containing 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, and (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 & 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 314.03 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.

311.03 - USDA Acts

This is a listing of various USDA Acts under which FDA has been delegated detention authorities for products subject to USDA inspection. See IOM 750 for additional information. See IOM Exhibit 311 for a chart depicting jurisdictional lines for products regulated by FDA and USDA.

Federal Meat Inspection Act (MIA) - Sections 402 and 409(b) of the Federal Meat Inspection Act (MIA) provide FDA representatives may detain meat products subject to the MIA found outside an inspected plant, if they have reason to believe the products are adulterated or misbranded under the FD&C Act. Detention may not exceed twenty (20) days and the items detained shall not be moved by any person from the place of detention until released by the FDA representative.

Poultry Products Inspection Act PPIA - Sections 19 & 24(b) of the Poultry Products Inspection Act (PPIA) provide that FDA representatives may detain poultry products subject to the PPIA found outside an inspected plant, if they have reason to believe the products are adulterated or misbranded under the FD&C Act. Detention may not exceed twenty (20) days and the items detained shall not be moved from the place of detention until released by the FDA representative.

Egg Products Inspection Act (EPIA) - Sections 19 & 23(d) of the Egg Products Inspection Act (EPIA) provide FDA representatives may detain egg products subject to the EPIA found outside an inspected plant, if they have reason to believe the products are in violation of the EPI Act. Detention may not exceed twenty (20) days and the items detained shall not be moved from the place of detention until released by the FDA representative.

311.04 - FDA-USDA Agreements & MOUs

MOU's and Agreements with USDA and its various units will be listed and in some cases described below. This first subsection covers MOU's with the USDA, USDA/other agency, and FDA. The following subsections provide information about MOU's 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.
2. USDA, NIH Regarding Importation of Biological Specimens Under US/USSR Scientific Exchange Agreement.
3. USDA Concerning Public Education in the Basics of Food Safety, Nutrition, and Veterinary Medicine.
4. USDA Concerning Sampling & Aflatoxin Testing of Imported Pistachios or Peanuts.
   Importers of pistachio nuts voluntarily offer to USDA inspectors 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.
   The FDA Liaison Officer is the Director, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-600 (301-436-2359).
   The USDA Liaison Officer is the Chief of Technologies Services Branch, Science Division, AMS (202-690-4025).
5. USDA and DHHS Regarding General War Food Inspection.
   Staff units and officials of USDA and FDA shall confer on matters of joint concern. In an immediate post-attack period USDA food inspectors or designated FDA Inspectors may act to inspect and approve foods meeting emergency standards for safety. DHHS/FDA will provide appropriate guidelines for use by USDA personnel in assuring compliance for food inspection in the emergency period. The emergency liaison officers appointed by each agency may be assigned to the other agency's headquarters emergency relocation sites for the purpose of coordinating food inspection services.
   The FDA Liaison Officer is the Director, Emergency Operations Center, HFC-160, (301-827-5655).
   The USDA Liaison Officer is the Director, Emergency Response Division, Food Safety and Inspection Service (202-501-7515)
6. USDA Regarding the Reduction of Salmonella enteritidis (S.E.) Infection of Humans.

311.05 - Agricultural Marketing Service (AMS)/USDA (MOU's)

MOU with:

1. AMS Concerning the Inspection and Grading of Food Products.
   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 (301-436-2359)
   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.
   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, Emergency Operations Center, HFC-160, (301-827-5653).
   The FDA Liaison Officer for imported shell eggs is the Branch Chief, Import Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-606 (301-436-2413).
   The USDA Liaison Officer is the Deputy Administrator, Poultry Program, Agricultural Marketing Service (202-720-4476).
3. AMS Concerning Imported Dates and Date Material.
   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 (301-436-2401).
   The USDA Liaison Officer is the Chief, Processed Products Branch, Fruit & Vegetable Division, Agricultural Marketing Service (202-720-4693).
4. AMS Concerning Cooperative Efforts for Inspection, Sampling, and Examination of Imported Raisins.
   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 (301-436-2401) .
   The USDA Liaison Officer is the Chief, Processed Products Branch, Fruit & Vegetable Division, Agricultural Marketing Service (202-720-4693).
5. AMS Regarding Aflatoxin Testing Program for In-Shell Brazil Nuts.
   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 (301-436-2359).
   The USDA Liaison Officer is the Chief of Technologies Services Branch, Science Division, AMS (202-690-4025).
6. AMS Concerning Aflatoxin in Peanuts.
   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 (301-436-2359).
   The USDA Liaison Officer is the Chief of Technologies Services Branch, Science Division, AMS (202-690-4025).
7. AMS & FSIS and EPA re: Regulatory Activities Concerning Residues of Drugs, Pesticides, and Environmental Contaminants in Foods. 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 (301-436-2401).
   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.
   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 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, Emergency Operations Center, HFC-160, (301-827-5655).
   The USDA Liaison Office is the Chief, Grading Branch, Dairy Division, Agricultural Marketing Service, (202-720-3171) or Chief, Standardization Branch, (202-720-7473).

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

MOU with:

1. APHIS Concerning Mutual Responsibilities for Regulating Biological Products.
   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, (301-827-6647).
   The USDA Liaison Office is the Director, Center for Veterinary Biologics, Animal and Plant Health Inspection Service, (301-734-8245).
2. APHIS and NIH Regarding the Care and Welfare of Laboratory Animals.

311.07 - Federal Grain Inspection Service/USDA (FGIS)

MOU with FGIS Concerning Inspection of Grain, Rice, Pulses, and Food Products.

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, (301-436-1700) or Director, Division of Programs and Enforcement Policy, Center for Food Safety and Applied Nutrition, HFS-305, (301-436-1400).

The USDA Liaison Office is the Director, Field Management Division, Federal Grain Inspection Service, Grain Inspection, Packers and Stockyards Administration (202-720-0228).

311.08 - 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;
   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 Deputy Director, Emergency Operations Center, HFC-160, (301-827-5660).
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 on-site 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.
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, Emergency Operations Center, HFC-160, (301-827-5653)
The USDA Liaison Office is the Deputy Administrator, Field Operations, Food Safety and Inspection Service (202-720-8803).

3. FSIS & AMS and EPA re: Regulatory Activities Concerning Residues of Drugs, Pesticides, and Environmental Contaminants in Foods.
4. FSIS (NE & 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.
5. FSIS and GA Department of Agriculture Regarding Regulatory Investigations Involving Drug, Pesticide, and Toxic Chemical Residues in Animal Feeds and in Meat Tissues.

311.09 - Science and Education Administration/USDA (SEA)

MOU with SEA Concerning Educational Programs in the Use of Animal Drugs.

312 - U.S. DEPARTMENT OF COMMERCE (DOC)

312.01 - Commerce (DOC)

MOU's with DOC and USDA Concerning Inspection of Industrial Fishery Products Intended for Animal Feed Use.

312.02 - National Oceanic and Atmospheric Administration (NOAA) - National Marine Fisheries Service (NMFS)

MOU with:

1. NOAA/NMFS Regarding Inspection Programs for Fishery Products - The National Marine Fisheries Service (NMFS) of the National Oceanic & Atmospheric Administration (NOAA), Department of Commerce, operating under the authority of the Agriculture Marketing Act and the Fish & 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 303 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 (301-436-1415)
   The NMFS Liaison Office is the Seafood Inspection Program, Department of Commerce, NOAA (301-713-2355).
2. NOAA/NMFS Concerning Enforcement of Laws -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 (301-436-1415)
   The NMFS Liaison Office is the Seafood Inspection Program, Department of Commerce, NOAA (301-713-2355).

312.03 - U.S. Patent and Trademark Office (USP&TO;)(DOC)

MOU's with:

1. USP&TO/DOC Concerning Orphan Drugs.
2. USP&TO/DOC to Establish a Product's Eligibility for Patent Term Restoration.

313 - DEPARTMENT OF DEFENSE (DOD)

FDA has a number of MOU's with DOD and its various elements.

313.01 - DOD MOU's

1. DOD Concerning Licensure of Military Blood Banks.
2. DOD Concerning Investigational Use of Drugs, Antibiotics, Biologics, and Medical Devices by DOD.

FDA also has a number of Interagency Agreements (IAG) with DOD to include IAG with:

1. DOD Concerning FDA Responsibility for Quality Assurance of DOD Procured Drugs and Biologics.
2. DOD Regarding Testing of Tea Purchased by DOD.
3. DOD Regarding FDA Quality Assurance Responsibility for DOD Contracts for Medical Devices.

313.02 - US Army Corps of Engineers (DOD)

MOU with US Army/Corps of Engineers Concerning Consumer Protection During Natural Disasters.

313.03 - US 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.

313.04 - Defense Personnel Support Center (DPSC)

1. MOU with DPSC Concerning Exchange of Information Regarding Food & Cosmetic Recalls and Hazardous Food Situations.
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 313.01 above.

   FDA under the Government-Wide Quality Assurance Program (GWQAP) makes certain inspections and furnishes information as to the capabilities of firms bidding or desiring to bid on government contracts. In areas involving GWQAP activities follow the procedures set forth in that activity. Each district has procedures to be followed in these areas, so when this type operation is involved, you will be given specific sampling or investigational assignments by your district.

   Samples shall be collected only from those depots and hospitals selected in advance by the district. DOD Depot and hospital locations must notify their headquarters prior to releasing their stock. Prior to visiting a U.S. Government installation to collect samples of foods, drugs, or medical devices, districts may contact the Division of Compliance Information & Quality Assurance (DCIQA) (HFC-240) so that the visit can be expedited.

   See IOM 407 for information regarding GWQAP samples and IOM 512.04 for information regarding GWQAP FDA 483.

313.05 - Department of Navy/Bureau of Medicine and Surgery

MOU with Dept. the Navy/Bureau of Medicine and Surgery Regarding the Microwave Oven Survey.

314 - DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

This Agency has a number of MOU's with the Department and other HHS units.

314.01 - HHS MOU's

MOU with USDA and HHS Regarding General War Food Inspection.

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

A MOU with ACYF to Assure the Feeding Programs in Head Start Centers Conform with Federal Food Safety and Sanitation Responsibilities.

314.03 - Centers for Disease Control and Prevention (CDC)

MOU with:

1. CDC Concerning In-Vitro Diagnostics.
2. CDC Regarding Radiation Emergencies.
3. CDC Regarding Exchange of Information and Coordination of Actions.

Additional information is being provided here because of the close working agreement to assure the prompt 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. See IOM 910 and FMD #64 for procedures on Epidemiological Investigations Alert Reporting Procedures.

1. 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 Emergency Operations (E.O.) Center, ORO, HFC-160, (301-443-1240). The E.O. contact will immediately phone the consignee district to advise them of the shipment.
2. 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 EMOPS (301) 443-1240. This situation falls under the jurisdiction of the Foreign Quarantine Section of the Centers for Disease Control and Prevention (CDC) Atlanta, Ga.
3. 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:
   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 Emergency Operations Center, ORO, HFC-160, (301) 443-1240 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.
   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 Emergency Operations Center, HFC-160, (301) 443-1240 or (301) 827-5660.
   "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.
   1. 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 a.1. above, determine whether it is appropriate to share the requested information with the requesting agency.
      3. The requesting agency agrees that:
         1. 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;
         2. 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;
         3. if the requesting agency receives a Freedom of Information Act (FOIA) request for the shared information, it will refer the request to the information-sharing agency; and,
         4. it shall promptly notify the appropriate office of the information-sharing agency 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.
   2. 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 above in section a1 and a2. However, once the requesting agency has obtained the information it seeks, it shall comply with those procedures set forth in section a3 above.
   3. Liaison Officers
      1. For FDA:
         Associate Commissioner for Regulatory Affairs
         Contact: Ellen Morrison, Director EmergencyOperations Center
         Food and Drug Administration
         5600 Fishers Lane, HFC-160
         Rockville, MD 20857
         (301) 443-1240 or (301) 827-5660
      2. For CDC:
         Associate Director for Science
         Dixie E. Snyder, MD
         Centers for Disease Control
         Public Health Service
         Department of Health and Human Services
         Atlanta, GA 30333 (404) 639-7240

314.04 - Health Care Financing Administration (HCFA)

MOU with HCFA Concerning Blood Banking and Transfusion Programs.

314.05 - Health Services Administration (HSA)

MOU with HSA Concerning Quality Assurance for Drugs, Biologics, Chemicals and Reagents Procured by HSA.

314.06 - National Center for Health Statistics (NCHS)

A MOU with NCHS Regarding Exchange of Information.

314.07 - National Institute of Drug Abuse (NIDA)

MOU's with:

1. NIDA Regarding Mutual Responsibilities in Implementing the Jointly Published Narcotic Addict Treatment Regulations.
2. NIDA Concerning Cooperative Interaction in Expediting Domestic Scheduling of Drugs of Abuse.

314.08 - National Institutes of Health (NIH)

MOU with:

1. NIH Regarding Anticancer Drugs.
2. NIH and USDA Regarding Importation of Biological Specimens under US/USSR Scientific Exchange Agreement.
3. NIH and APHIS Regarding the Care and Welfare of Laboratory Animals.

315 - DEPARTMENT OF JUSTICE

315.01 - 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".

315.02 - 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.

315.03 - 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 tamperings with products regulated by USDA.

For complete information regarding FBI/FDA actions under FATA, see IOM 970.

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