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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Department of Transportation 10-Nov-03

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

Public Health Service
Food and Drug Administration

 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707


FEI [redacted]

 

04-BLT-04

November 10, 2003

NOTIFICATION OF USE-PROHIBITED CLASSIFICATION

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Alfred H. Foxx, Jr., Director
Department of Transportation
417 E. Fayette Street, 5th Floor
Baltimore, Maryland 21202

Dear Mr. Foxx:

This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has now classified eight. Baltimore City Inner Harbor vessel watering points as "Use-Prohibited."

Three inspections of the Inner Harbor vessel watering points revealed that the facilities for delivery of water to conveyances and the sanitary conditions surrounding such delivery at the eight specified watering-points are not sufficient to prevent the introduction, transmission, or spread of communicable diseases as required for FDA approval under 21 CFR 1240.83(a). Although the inspection conducted on August 14-21, 2003, revealed that you made progress toward improving the sanitation of your watering points, the conditions under which the Inner Harbor vessel watering points are maintained remain insanitary.

FDA inspected nineteen (19) of the twenty (20) vessel watering points located at the Baltimore City Inner Harbor on May 8, 9, and 14-16, 2003. At the conclusion of the inspection, FDA issued a list of Inspectional Observations (Form FDA 483) to Mr. Anthony Wallnofer, Chief of the Transportation Maintenance Division. Examples of critical deficiencies noted during the inspection included a watering point with a raw sewages pill and two (2) with open sewers; (9) watering points with no suitable backflow prevention device; twelve (12) watering points with inadequate drainage; fifteen (15) hydrants not identified for their intended use; and ten (10) watering points littered with trash and debris.

FDA sent a Warning Letter (03-BLT-17), dated June 10, 2003, to the City of Baltimore, Transportation Maintenance Division, as a result of the inspection. The Warning Letter directed the division to advise FDA, in writing, within 15 working days of receipt of the letter, of the actions it had taken to correct the deficiencies and to assure that such deficiencies do not recur. Mr. Wallnofer assured FDA that your Transportation Maintenance Division would submit a response to the Warning Letter. However, to date no response has been received.

On July 14-15, 2003, FDA conducted a re-inspection of the Baltimore City Inner Harbor vessel watering points. The City of Baltimore, Department of Transportation, was given prior notice of the re-inspection in the June 10 Warning Letter. The re-inspection included all 20 watering points. Although some critical deficiencies had been corrected, many remained. Critical deficiencies that remained included open sewers at watering points, watering points with inadequate or non-existing backflow prevention devices, and watering points with sand added to cover trash and debris. FDA granted the Transportation Maintenance Division's verbal request for an additional thirty (30) days to correct the deficiencies and scheduled a new re-inspection.

On August 14, 15, 20, and 21, 2003, FDA conducted a second re-inspection of the 20 Baltimore City Inner Harbor vessel watering points. The inspection revealed that some deficiencies noted during the two previous inspection shad been corrected. However, critical deficiencies remained. The deficiencies noted include:

1. No backflow prevention device at point of use for potable water outlets at four (4) of the 20
watering points.
2. Four(4) of the 20 watering points with backflow prevention devices are located in benches
containing wells that are subject to flooding and inadequate drainage.
3. Three (3) of the 20 watering points have leaking backflow prevention devices.
4. When asked by FDA, Baltimore City, Department of Transportation, did not provide any record
of inspection and maintenance of the watering points, and testing of the installed backflow
prevention devices present on the eight watering points selected for "Use-Prohibited"
classification.

As the manager of the Inner Harbor vessel watering points, it is your responsibility to ensure that the facilities for delivery of water to conveyances and the sanitary conditions surrounding such delivery are sufficient to prevent the introduction, transmission, or spread of communicable diseases. The sanitation deficiencies outlined in this letter are not intended to be an all-inclusive list of the deficiencies that exist at the Baltimore City Inner Harbor vessel watering points.

Vessel watering points with non-existing backflow prevention devices or inadequate backflow prevention devices may compromise the safety of the potable water supply on board vessels and of the Baltimore City's municipal system. Contaminated drinking water is a conduit for the spread of communicable diseases.

Due to the public health safety concerns associated with sanitation deficiencies, FDA has classified the following Baltimore City Inner Harbor vessel watering points as "Use-Prohibited":

  • Pier Six (6), west side Watering point "A"- Missing backflow prevention device, no cutoff distribution line to hydrant, outlet is not directed downward or horizontally

  • Pier Five (5), west side watering point "A"-Inadequate drainage in backflow prevention device housing ( i.e., either underwater or subject to flooding)

  • Pier Five (5), west side watering point "B"-Missing backflow prevention device, no cutoff distribution line to hydrant, outlet is not directed downward or horizontally

  • Pier One(1), west side watering point "A"-Water seeping/leaking from backflow prevention device

  • Inner Harbor Marina watering point at [redacted] Inadequate backflow prevention device (location not at point of use, constituting a dead leg)

  • West wall watering point "A" -Water seeping/leaking from backflow prevention device

  • Westwall watering point "D"-Inadequate drainage in backflow prevention device housing (i.e., either underwater or subject to flooding)

  • West wall watering point "E" -Water seeping/leaking from backflow prevention device

The vessel "watering points listed above will retain a "Use-Prohibited" classification until FDA conducts a re-inspection and the vessel watering points achieve adequate sanitation. FDA will conduct a re-inspection after you have submitted an acceptable Corrective Action Plan (CAP). The CAP should outline the corrective actions that your agency has taken or plans to take to correct the deficiencies and to assure that such deficiencies do not recur. The CAP should also include timeframes necessary to complete all corrective actions."

We note that interstate conveyances must obtain potable water for drinking and culinary purposes from watering points approved by the FDA (21 CFR 1240.80). Therefore, interstate conveyances may no longer use the eight water points now classified as "Use-Prohibited."

You should notify this office within 5 business days as to whether you intend to close the Inner Harbor vessel watering points classified as "Use-Prohibited."

Please send your response and the CAP to the attention of Vinetta Howard-King, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215.

Sincerely,

/S/

Lee Bowers
District Director
Baltimore District

Cc:
Mr. Anthony Wallnofer, Chief
Department of Transportation
Transportation Maintenance Division
520 Fallsway,
Baltimore, MD 21202