Memorandum of Understanding
The United States Customs Service
The Food and Drug Administration
The U.S. Customs Service of the Department of the Treasury and the Food and Drug Administration, hereby jointly agree to the following memorandum of understanding.
A. PURPOSE OF AGREEMENT
1. To establish a working relationship between the U.S. Customs Service (Customs) and the Food and Drug Administration (FDA) for the cooperative enforcement of Section 801 of the Food, Drug and Cosmetic Act (FD&C Act).
2. To establish uniformity in the exercise of the import sampling and refusal authority in the enforcement of Section 801 of FD&C Act.
3. To delegate authority to certain FDA officers to collect samples, issue Notices of Sampling and Notices of Refusal of Admission on behalf of the District Director of Customs.
The important provisions of the FD&C Act are the joint responsibility of the United States Customs Service and the Food and Drug Administration (FDA), to whom authority has been delegated by the Secretaries of the Treasury (TD 53654) and Health, Education, and Welfare (21 CFR 5.1), respectively. Since the statute vests in the Secretary of the Treasury authority to deliver samples of imported products to FDA for analysis, the statute has always been construed as identifying the Secretary of the Treasury as having the authority to collect the samples and issue the corresponding "Notice of Sampling". Similarly, since the statute vests in the Secretary of the Treasury the authority to destroy any article which has been refused admission, based upon the results of the FDA analysis, this language has also been construed as identifying the Secretary of the Treasury as having authority to refuse admission and issue the corresponding "Notice of Refusal of Admission".
In actual practice, FDA personnel at most ports, collect the samples, issue the appropriate notice of sampling, and, where applicable, having determined that an article is in violation of the Act and may not be brought into compliance, issue a refusal notice. Actions by an FDA employee have been under written delegated authority received from the local District Director of Customs. This system of individual agreements at the local level has been inefficient for both agencies. Thus, to promote efficiency and uniformity, both agencies believe that a comprehensive delegation of authority for the enforcement of Section 801 should be accomplished.
1. It is mutually agreed by Customs and FDA that the authority to collect samples, issue notices of sampling, and issue notices of refusal of admission, pursuant to Section 801 of the FD&C Act, is delegated to FDA at all ports except those ports presently without FDA offices or physically serviced by FDA personnel.
2. The delegation of authority shall be pursuant to Section 401(i), Tariff Act of 1930, as amended, (19 U.S.C. 1401(i)), and Treasury Delegation Order 165, Revised (T.D. 53654, 19 Fed. Reg. 7241) as amended.
3. The Commissioner of Customs authorizes the designation of certain FDA Officers as Customs Officer (excepted) without additional compensation.
4. The Commissioner of the Food and Drug Administration shall identify pursuant to 21 CFR 5.45 those FDA Officers to be designated as Customs Officers (excepted).
5. Each designated FDA Officer, after appropriate orientation by Customs will be provided a copy of Customs Form 55 (1/11/74) "Designation, Customs Officer (Excepted)" which identifies the officer, authority duties, and duty station.
6. The duty station of the designated FDA Officers shall be limited to the specific Customs district, port or as otherwise specified on Customs Form 55.
7. The responsibilities of the designated FDA Officer as a Customs Officer (excepted) shall be limited to: (a) the collection of required samples for FDA purposes, (b) issuing notices of sampling and (c) issuing notices of refusal of admission under the authority of the District Direct of Customs.
8. The designated officer shall immediately advise Customs of any identified or suspected irregularities or violations concerning Customs matters.
9. Responsible Customs and FDA offices shall maintain a current file of the designated officers. Such designation may be revoked at any time by either responsible office upon notification of the other agency. FDA shall notify Customs immediately of any designated officer who has resigned, has been suspended or terminated from FDA employment or who has been transferred or detailed to another area.
10. At those locations where Customs Officers will be performing sampling for FDA purposes, FDA will provide necessary orientation and training on FDA requirements. Any training shall be scheduled to alleviate as much interference as possible with operational commitments.
11. This agreement does not alter working relationships and continued cooperation between local offices of each agency and should result in improved protection of the American consumer from products which violate the FD&C Act.
D. TERM OF AGREEMENT
This agreement will be effective from the date of signature. It may be terminated by either agency upon 90 days advance written notice to the other.
Revisions to this agreement may be made upon the approval of both agencies and shall become effective upon the date of agreement.
Section 801 of the Federal Food, Drug and Cosmetic Act and the Recovery Act of 1932 (31 U.S.C. 686), Section 401(i), Tariff Act of 1930, as amended (19 U.S.C. 1401(i)) and Treasury Delegation Order 165, Revised (T.D. 53654, 19 Fed. Reg. 7241) as amended.
G. LIAISON OFFICERS
1. Harrison C. Feese (202) 566-8651
Import Compliance & Interagency Liaison Program Manager
Duty Assessment Division
U.S. Customs Service
Washington, D.C. 20229
2. Richard R. Klug (301) 443-6360
Assistant for Import Operations (HFO-410)
Associate Director for Field Support, DFRG, FCB
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Approved and Accepted
Signed by: Commissioner
Date: July 20, 1979
Approved and Accepted
Signed by: Commissioner
Date: August 14, 1979