Interstate Travel Sanitation

PURPOSE

To provide FDA district offices guidance on handling EPA reports of violations of National Interim Primary Drinking Water Regulations applicable to interstate carrier conveyances.

BACKGROUND

EPA under authority of the Safe Drinking Water Act (SDWA) administers a regulatory program over water systems, and for water quality with respect to carrier watering points and on-board carrier drinking water suitability. FDA under authority of the PHS and FD&C Acts administers a regulatory program with respect to the adequacy of sanitary practices of water systems at watering points and on-board carriers.

FDA has executed a Memorandum of Understanding (MOU) (Compliance Policy Guide 7155b.08) with EPA to set forth cooperative working arrangements, in regulating the suitability of water intended for drinking and culinary purposes on interstate carrier conveyances. The MOU, in part, describes a system of reporting violative results to carrier companies and watering points.

FDA Districts are being notified by EPA when public water systems, inter-state carrier conveyance watering points, or on-board water does not meet EPA drinking water requirements. Districts have asked for guidance as to what to do with the results received from EPA.

POLICY

The nature of EPA Reports of Violations of National Interim Primary Drinking Water Regulations and the necessary subsequent FDA actions (see Field Management Directive No. 67 for notification procedures) are as follows:

1. Notification of a Violative Public Water System

   EPA will notify FDA of "acute" violations, i.e., bacteriological, turbidity, or nitrate, and the FDA District Office will notify the carrier companies that the watering points connected to that water system are "Not-Approved." Watering Points management must also be notified of this action by FDA.

2. Notification of Violative Watering Point

   EPA will notify FDA of water quality related violations, and the FDA District Office will notify the carrier companies that the watering points is "Not-Approved." Watering point management must also be notified of the action by FDA.

3. Notification of Violative Water on a Conveyance

   EPA will notify the FDA of violations of applicable drinking water requirements and the FDA District Offices will notify the carrier company of the report if the water is used for culinary food processing. FDA will not notify the carrier company of the report if the water is not used for culinary food processing purposes, since this is EPA's responsibility. Should there be a reason to believe that a water supply has become contaminated, FDA will immediately notify EPA with the water supply name (if known) and watering point location.

4. CFSAN Contact

   Assistant Director for Interstate Travel Sanitation Program
   Retail Protection Branch, HFS-627
   Telephone (202) 205-8280
   FAX (202) 205-5560