Memorandum of Understanding
Between The Environmental Protection Agency
and The Food and Drug Administration
FOOD AND DRUG ADMINISTRATION
COMPLIANCE POLICY GUIDES
CHAPTER 55b-MOU's and IAG's-FEDERAL
SUBJECT: MOU with the EPA regarding potable water on interstate conveyances. (FDA 225-78-4006)
To provide a mechanism whereby the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) will coordinate their agency regulatory activities with respect to the suitability of potable water intended for drinking and culinary purposes onboard Interstate Carrier Conveyances.
For purposes of this agreement "EPA" shall mean the U.S. Environmental Protection Agency acting directly or through the States which have assumed the primary enforcement responsibility under the Safe Drinking Water Act.
There are three elements comprising the composite system which delivers water to the tap on-board the Interstate Carrier Conveyance. They are:
(1) The public water system from which the Interstate Carrier Conveyance receives its water supply,
(2) the watering point where drinking water and culinary water is actually transferred to the ICC, and
(3) the ICC water system itself.
Under the Provisions in the Safe Drinking Water Act (SDWA) and its associated regulation, Interstate Carrier Conveyances (ICC) serving drinking water to 25 or more persons at least 60 days per year are public water systems and as such are subject to the National Interim Primary Drinking Water Regulations (NIPDWR) promulgated by EPA. EPA has jurisdiction under the SDWA over the public water systems furnishing drinking water to ICC's. EPA has certain regulatory authority over watering points and the water system due to the consecutive nature of the systems in assuring suitable drinking water at the tap on-board the ICC.
Under the provisions of the Food, Drug, and Cosmetic Act, the Public Health Service Act and their associated regulations, the FDA has authority to regulate water to ensure that food is not adulterated and to take actions necessary to prevent the transmission of communicable disease. FDA also has regulatory authority over ICC on-board culinary systems.
On many of the conveyances, the on-board culinary water and drinking water are within one system. Therefore, the responsibilities of both the EPA and FDA with respect to ICC's are complementary. Thus, a coordinated approach by these agencies will assure the provision of suitable potable water to the traveling public and crews on ICC's.
To facilitate the purpose of this agreement, it is specifically agreed that:
A. The EPA will administer a regulatory program with respect to public water systems from which ICC's receive their water supply. The public water system that serves the ICC's will sample drinking water and report to the EPA. In case of violation, EPA will take action against the public water system and will notify FDA.
FDA will in turn notify the ICC headquarters whose conveyances utilize watering points served by the public water system of the EPA determination and any regulatory action FDA considers appropriate.
B. The EPA will administer a regulatory program with respect to watering point and on-board carrier drinking water suitability. The ICC's and watering points will sample for the suitability of the drinking water and report to EPA. In the event of a watering point or on-board system violation, EPA will notify FDA. FDA will in turn notify the ICC headquarters whose conveyances utilize watering points of the EPA determination and regulatory action FDA considers appropriate. FDA may, if it deems appropriate, including conveyances in violation in their inspection/monitoring schedule.
C. EPA will administer a regulatory program for ICC's using on-board treatment. The ICC's will sample for the suitability of the drinking water and will report to EPA. In the event of a violation, EPA will notify FDA.
D. The FDA will continue to administer an on going regulatory program with respect to the watering point and on-board carrier culinary water systems. The FDA will notify EPA of violations. This continuing program of construction and operation inspections is complementary to an EPA program.
E. Both agencies will:
1. Maintain close working relations with each other in headquarters and in the field.
2. Exchange procedures and techniques in determining and administering compliance within the appropriate regulatory constraints promulgated by each agency.
3. Coordinate enforcement efforts, thereby avoiding duplication of efforts, to assure the full safety and health protection of the public.
IV. DURATION OF AGEEMENT:
A. This agreement, when accepted by both parties, covers an indefinite period of time and may modified by mutual consent in writing both parties, or terminated by either party upon thirty (30) days advance written notice.
B. This agreement will be reviewed annually by both agencies to ensure that it is still appropriate and the terms and provisions are current.
C. Nothing in the agreement is intended to diminish or otherwise affect the authority of either agency to carry out its respective statutory functions.
EPA will provide FDA an annual report on compliance status of public water systems used in conjunction with carriers and compliance status of drinking water suitability of ICC's and watering points.
FDA will provide EPA an annual report on location and compliance of watering points and compliance status of carrier culinary water systems.
VI. LIAISON OFFICERS:
A. A liaison officer has been designated for each agency to serve as a contact point. These liaison officers will be responsible for maintaining communication as to procedures and internal activities of their respective agencies in the area of common interest. These liaison Officers are as follows:
1. For EPA:
Drinking Water Branch
ODW ( WH-550)
U.S. Evironmental Protection Agency
401 M. St. S.W.
Washington, DC 20460
Telephone No: 202-426-3983.
2. For FDA:
Interstate Travel Sanitation Branch ( HFF-324)
Food and Drug Administration
Bureau of Foods
200 C St. S.W.
Washington, DC 20204
Telephone No: 202-245-1505.
B. The respective liaison officer accompanied by appropriate staff will hold meetings from time to time, but not less than annually, to discuss matters of concern to each agency.
The Public Health Service Act ( P.L. 78-410), the Food, Drug, and Cosmetic Act (P21 USC 321), the Safe Drinking Water Act ( P.L. 93-523).
Approved and Accepted
for the United States Environmental Protection Agency
Signed by: Thomas C. Jorling
Office of Water and Hazardous Materials
Date: July 14, 1978
Approved and Accepted
for the Food and Drug Administration
Signed by: Joseph P. Hile
Associate Commissioner for Regulatory Affairs
Date: September 14, 1978