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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Town of Bucksport 07-Oct-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New England District Office
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
Fax (781) 596-7896


WARNING LETTER

NWE-01-09W

VIA CERTIFIED MAIL

October 7, 2008

Roger Raymond, Town Manager
Town of Bucksport
50 Main Street
Bucksport, Maine 04416-4112

Dear Mr. Raymond:

This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has classified your watering point, located at 94 Main Street, Bucksport, Maine as "Provisional."

On June 11, and July 28, 2008, an FDA investigator conducted an inspection of your facility in Bucksport, Maine, consisting of a vessel watering point for American Cruise Lines. This inspection was conducted under the authority of the Public Health Service Act (PHS Act) to determine your compliance with applicable sections of the Interstate Conveyance Sanitation regulations (21 CFR Part 1250). These regulations were promulgated pursuant to Section 361 of the PHS Act (42 U.S.C. § 264). Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases. This inspection revealed significant deviations from 21 CFR Part 1250, under the PHS Act. Based on these findings, your watering point is classified as "Provisional."

At the conclusion of the inspection, the FDA investigator issued a list of inspectional observations (Form 483) to David L. Milan, Economic Development Director for Bucksport, Maine. As documented on this form (copy enclosed), the following are the significant violations at your watering point, on which we based the "Provisional" classification:

1. Your facility failed to ensure that pipes and fittings conveying potable water to any fixture, apparatus, or equipment shall be installed in such a way that back flow will be prevented as required by 21 CFR 1250.82(e). Specifically, none of the facility's potable watering points are equipped with backflow prevention devices.

2. Your facility failed to ensure that all servicing area piping systems, hydrants, taps, hoses, buckets, and other appurtenances necessary for delivery of drinking and culinary water to a conveyance are designed, constructed, maintained and operated in such a manner as to prevent contamination of the water as required by 21 CFR 1250.67(a). Specifically, the investigator observed a garden hose being used as a delivery method for potable water. This garden hose used for vessels was lying on the pier and not protected.

The inspectional observations, identified above, are not intended to be an all-inclusive list of the conditions at your facility. It is your responsibility to ensure adherence with all requirements of the regulations at this facility and all other vessel watering points under your control.

A "Provisional" classification means that land and air conveyances engaged in interstate traffic may continue to obtain potable water for drinking and culinary purposes from your facility; however, significant correction of violations must be made. FDA will re-inspect this facility to determine its classification. If significant corrections are not made by the time of the next inspection, FDA will classify the facility as "Non-Approved" for vessel use. We note that land and air conveyances engaged in interstate traffic must obtain potable water for drinking and culinary purposes from watering points approved by the FDA (21 CFR 1240.80).

Please advise this office in writing within fifteen (15) days of receipt of this letter regarding the measures you have implemented to correct the violations. If you cannot complete all corrections before you respond, your response should explain the reason for the delay, and the date by which corrections will be expected. Please direct your response to Bruce R. Ota, Compliance Officer, at the address listed above.

Sincerely,

/S/

CDR Domeric J. Veneziano
Acting District Director
New England District

Enclosure (FDA483)