Inspections, Compliance, Enforcement, and Criminal Investigations
Port of Cascade Locks 12/31/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
December 31, 2012
RETURN RECEIPT REQUESTED
In reply, please refer to Warning Letter SEA 13-09
Jess Groves, President
Port of Cascade Locks
355 WaNaPa Street
Cascade Locks, OR 97014-0307
Dear Mr. Groves:
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has changed the classification of your watering point from “Approved” to “Provisional” for interstate carrier use. Your interstate conveyance customers will be notified of this change in classification.
On October 2-3, 2012, FDA conducted an inspection of your watering point at 355 WaNaPa Street, Cascade Locks, Oregon. This comprehensive inspection was conducted under the authority of the Public Health Service Act (PHS Act) to determine your compliance with the applicable sections of the Interstate Conveyance Sanitation regulations under Title 21, Code of Federal Regulations, Part 1250 (21 CFR Part 1250), in accordance with 21 CFR Part 1240. 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 violations of 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 FDA 483) to your firm (copy attached). To comply with 21 CFR 1250.67(a), all servicing area piping systems, hydrants, taps, faucets, hoses, buckets, and other appurtenances necessary for delivery of drinking and culinary water to a conveyance shall be designed, constructed, maintained, and operated in such a manner as to prevent contamination of the water. As documented on the Form FDA 483, the following are significant violations of 21 CFR 1250.67(a) on which we base the “Provisional” classification:
1. The potable water system for Port of Cascade Locks, which includes a boat launch that serves as a watering point utilized by interstate conveyances, is not protected from contamination from potential backflow. Specifically, there is not adequate backflow prevention at the 36 slip private vessel marina, the river cruise dock, and approximately 30 hose bib connections throughout the port. To comply with federal regulations, you must have an adequate backflow prevention device installed at each connection, including the 30 hose bib connections.
2. You do not perform annual testing for the Double Check Valve Assembly (DCVA) manufactured by (b)(4) with a model number (b)(4) that is intended to protect the port’s water system from potential contamination to ensure that this device is operating properly. Backflow prevention devices should be tested annually by someone who is certified to do so.
With regard to violation 1, during the inspection, the investigator was told that your firm would immediately begin the process of developing a current map of the port’s water system, hiring a professional plumber to review the port’s water system, and reviewing all water outlets to determine the type of backflow protection that is required on each water outlet. With regard to violation 2, the investigator was told that the DCVA would be tested in the near future. We have not, however, received documentation of any corrective actions and therefore cannot evaluate these promised corrections. We will verify the adequacy of your corrective actions at the next inspection of your facility.
The inspectional observations, identified above, are not intended to be an all-inclusive list of the violations observed at your watering point. It is your responsibility to ensure adherence with all requirements of FDA regulations at your watering points, and any other conveyances or facilities involving interstate travel and sanitation under your control.
Based on these inspectional findings, a “Provisional” classification has been assigned to your watering point for a 30-day period, after which time a reinspection will be conducted. A “Provisional” classification means that the watering point may continue to operate; however, significant correction of violations must be made. If significant corrections are not made by the time of the next inspection, FDA will reclassify the watering point as “Non-Approved” for use by conveyances. We note that land and air conveyances engaged in interstate travel must obtain potable water for drinking and culinary purposes from watering points approved by FDA (21 CFR 1240.80).
Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for delay and when you will complete the corrections.
Your response should be addressed to Compliance Officer Heidi Marks at the above address. If you have any questions with regard to this letter, you may direct them to Ms. Marks at the above address, firstname.lastname@example.org, or 425-302-0418.
Charles M. Breen
Officer in Charge
USCGC Bluebell (WLI 313)
6767 N. Basin Avenue
Portland, OR 97217-3992