FDA inspected American Cruise Line's American Star and American Heritage vessels from in April 2022, through June 2022, and from June 2022, through August 2022. The investigation and inspections were initiated by FDA after three passengers who traveled in April 2021, September 2021, and September-October 2021 aboard these vessels were diagnosed with Legionnaires’ disease. FDA investigators collected biofilm swabs and potable water samples from these vessels and identified Legionella pneumophilia serogroup 1 and Legionella spp. in the potable water system of the vessels thus determine that the water is adulterated as defined by regulation..
FDA had issues with the response by the company in terms of response to the issue. There were issues with the test methodology the company was using..The company did "not monitor potable water parameters, such as free or total chlorine residual, temperature, and pH on the vessel when docked and not in operation or while in operation."
FDA had issues with the response by the company in terms of response to the issue. There were issues with the test methodology the company was using..The company did "not monitor potable water parameters, such as free or total chlorine residual, temperature, and pH on the vessel when docked and not in operation or while in operation."
As an example from one of the boat inspections, "Free chlorine and total chlorine residual were measured at 1.5ppm and 2ppm, respectively, in the potable water holding tanks where water is initially stored in the vessel. After the potable water traveled from the potable water holding tanks where initially stored to distal piping onboard the vessel such as showerheads, seven of 10 biofilm swabs and 10 of 14 bulk potable water samples had no free or total chlorine residual. The dissipation in chlorine residual from the potable water holding tanks to distal piping indicates that conditions, such as the presence of biofilm or planktonic microorganisms, led to the immediate use of the residual chlorine in the potable water system on the vessel."
"Eight of 10 biofilm swabs from showerhead pipes and a wait station hand sink faucet aerator and 11 of 14 bulk potable water samples had temperature ranges from 83.1°F - 112.6°F, which is ideal for Legionella growth."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-cruise-lines-641736-01242023
WARNING LETTER
American Cruise Lines
MARCS-CMS 641736 — JANUARY 24, 2023
Recipient:
Paul E. Taiclet
Executive Vice President
American Cruise Lines
741 Boston Post Road, Suite 200
Guilford, CT 06437
United States
Taiclet@americancruiselines.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
January 24, 2023
Warning Letter 641736
Dear Mr. Taiclet:
The United States Food and Drug Administration (FDA) inspected your American Star and American Heritage vessels from April 30, 2022, through June 17, 2022, and from June 15, 2022, through August 15, 2022, respectively. FDA also conducted an investigation of the American Star and American Heritage vessels in December 2021. The investigation and inspections were initiated by FDA after three of your passengers who traveled in April 2021, September 2021, and September-October 2021 aboard these vessels were diagnosed with Legionnaires’ disease. American Cruise Lines and FDA were notified by the Centers for Disease Control and Prevention (CDC) of the first confirmed case of Legionnaires’ disease at the end of April 2021 (American Heritage), the second at the beginning of November 2021 (American Star), and the third at the end of November 2021 (American Heritage).1
During our inspections, FDA investigators collected biofilm swabs and potable water samples from your American Star and American Heritage vessels. Laboratory Analysis of those samples identified Legionella pneumophilia serogroup 1 and Legionella spp. (hereinafter collectively called Legionella) in the potable water system of the vessels. FDA investigators also observed insanitary conditions related to the potable water systems onboard the vessels. At the conclusion of the inspections, the FDA investigators issued a Form FDA 483, Inspectional Observations, to both vessels.
Based on FDA’s inspectional findings, we have determined that the potable water onboard the American Star and American Heritage vessels is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that it has been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health.
Additionally, the presence of Legionella in the potable water on the American Star and American Heritage vessels, as evidenced by the laboratory analysis of FDA’s water samples, causes your vessels’ potable water to be adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that it bears or contains a poisonous or deleterious substance which may render it injurious to health.
We received your responses to the biofilm swabs and potable water positive results for Legionella and to the Form FDA 483 in regard to the American Star on the following dates: June 2, 2022, June 4, 2022, June 13, 2022, June 28, 2022, July 5, 2022, July 6, 2022, July 8, 2022, July 11, 2022, July 12, 2022, July 14, 2022, July 20, 2022, August 2, 2022, and August 16, 2022. We received your responses in regard to the American Heritage on July 19, 2022, August 1, 2022, August 16, 2022, and August 28, 2022.
After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continued concerns and to provide detailed information describing our findings.
American Star
Presence of Legionella Onboard the Vessel
On April 30, 2022, FDA investigators collected ten (10) biofilm swabs and fourteen (14) bulk one-liter potable water samples from various locations on your vessel. The Maryland Department of Health laboratory recovered Legionella from:
Biofilm Swabs (60% of samples positive):
• 5 Showerhead pipes in passenger cabins
• Wait station hand sink faucet aerator in the galley
Potable Water (93% of samples positive):
• 7 Showerhead pipes in passenger cabins
• 2 Showerhead pipes in crew rooms
• Wait station hand sink faucet aerator in the galley
• Galley prep sink faucet aerator
• Potable water holding tank
• Post pump (b)(4) hot water return spigot
Post-Notification Actions
You did not change your procedures regarding potable water after CDC notified you on November 5, 2021, that one of your passengers was diagnosed with Legionnaires’ disease. For example, you did not change your procedures for flushing or disinfection and did not perform environmental sampling. Subsequently, after FDA notified you of its detection of Legionella onboard your vessel (June 2, 2022), you disinfected the vessel’s potable water system on (b)(4). On June 4, 2022, you provided a letter to each passenger notifying them of the presence of Legionella in the potable water system onboard your vessel and mitigation steps you had taken. Also, you provided a letter notifying passengers who were onboard the vessel previously from May 3, 2022 to June 4, 2022.
During the week of (b)(4), you conducted water sampling using a field test kit. On June 24, 2022, FDA expressed concerns to you regarding the use of this field test kit and ending passenger notifications based on this testing because your testing was limited to Legionella pneumophilia serogroup 1 and did not include species identified as present on the vessel by FDA’s testing. In addition, FDA expressed concerns with the sensitivity, detection limit, and size of the water samples collected for the field test kit you used. On June 28, 2022, you shared additional sample collection results with FDA, separate from the field test kit, that were analyzed in a laboratory.
FDA expressed concerns with these laboratory results not being representative nor sufficient to determine whether Legionella is still present and your use of these and the field test kit results to justify ending notification of passengers. Specifically, FDA collected 14 bulk water and 10 biofilm swab samples; you collected (b)(4) bulk water and (b)(4) biofilm swab samples for the laboratory tests. Thirteen of fourteen (92.86%) of FDA’s bulk water samples and 6 of 10 (60%) of FDA’s biofilm swab samples were positive for Legionella. You did not evaluate most of the bulk water and biofilm swab locations that were positive from FDA’s sampling. In addition, one of the biofilm swabs you took was from a (b)(4) that was negative from FDA’s sampling.
You restarted passenger notifications and provided them from July 9, 2022 to July 30, 2022. On (b)(4), you collected additional samples and notified FDA of negative results on August 16, 2022. On September 20, 2022, FDA submitted additional follow-up questions regarding the vessel’s sampling process, laboratory results, and future disinfection process. To date, we have not received a response.
Further, in FDA’s emails to American Cruise Lines on July 11, 2022 and August 5, 2022, we reminded you that a voluntary corrective action plan to FDA would include not only testing for Legionella, but other documents, such as detailed procedures put in place onboard the vessel to address Legionella, documentation of those procedures being accomplished, and verification that those procedures are effective.
Vessel Inspection
During the inspection, the following insanitary conditions and practices were observed: Failure to Monitor Potable Water Parameters
You did not monitor potable water parameters, such as free or total chlorine residual, temperature, and pH on the vessel when docked and not in operation or while in operation. Sample collection of biofilm swabs and potable water samples by FDA investigators on April 30, 2022, documented the following:
Free chlorine and total chlorine residual were measured at 1.5ppm and 2ppm, respectively, in the potable water holding tanks where water is initially stored in the vessel. After the potable water traveled from the potable water holding tanks where initially stored to distal piping onboard the vessel such as showerheads, seven of 10 biofilm swabs and 10 of 14 bulk potable water samples had no free or total chlorine residual. The dissipation in chlorine residual from the potable water holding tanks to distal piping indicates that conditions, such as the presence of biofilm or planktonic microorganisms, led to the immediate use of the residual chlorine in the potable water system on the vessel.
Eight of 10 biofilm swabs from showerhead pipes and a wait station hand sink faucet aerator and 11 of 14 bulk potable water samples had temperature ranges from 83.1°F - 112.6°F, which is ideal for Legionella growth.
pH was measured between 5-7 for biofilm swabs and bulk potable water samples. pH level is important to consider as it impacts the effectiveness of the chlorine residual. pH can also cause potential corrosion of potable water pipes when not carefully monitored. Unlike temperature, it is not possible to set a single target value for pH since there are several factors that a water operator would use to determine the target. The efficacy of chlorination is affected by many factors, one of which is pH. The efficacy of chlorine declines as pH increases >7, with significant loss of efficacy at pH >8. While the optimum pH range for systems treated with monochloramine is 7.5 to 9.0, it is important to know how your source water is treated to determine the appropriate pH range for each of your systems.
By monitoring these parameters, you can ensure that the vessel’s potable water system is operating in a way to minimize hazardous conditions that could encourage Legionella and other waterborne pathogens to grow. If you find that one or more of these parameters is not being met, the next step would be to take corrective actions to get conditions back within an acceptable range for the vessel’s potable water system.
While the vessel (b)(4), the potable water system was flushed and filled (b)(4). Stagnant or standing water in a potable water system can increase the risk for growth and spread of Legionella and other biofilm-associated bacteria. When water is stagnant, hot water temperatures can decrease to the Legionella growth range. Stagnant water can also lead to low or undetectable levels of disinfectant, such as chlorine. Therefore, it is also essential for you to monitor parameters such as free or total chlorine residual, temperatures, and pH during water stagnation to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella (and other waterborne pathogens) to grow.
Failure to Monitor Disinfection Effectiveness
According to the Port Engineer, cabin outlets were allowed to run for approximately (b)(4) during (b)(4) disinfection when the vessel (b)(4). No specific sequence was given to crew in the galley, crew quarters, and various other cabins for turning on the faucets, taps, showerheads, and other locations to run the disinfectant.
During the disinfection, you did not measure the disinfectant level, pH, and temperature to verify that an adequate amount of the disinfectant at an appropriate pH and temperature reached the proximal, medial, and distal faucets and showerheads and other areas that are part of the potable water system. Without verifying the disinfectant level, pH, and temperature during disinfection in a complex potable water system such as a vessel you cannot know whether the disinfection was effective in various areas of the potable water system. In addition, you did not perform environmental sampling of the potable water system, i.e., testing biofilm swabs and bulk potable water for microorganisms such as Legionella, to validate the effectiveness of the disinfection and your frequency of disinfection ((b)(4)).
American Cruise Lines’ Response
We received your new Water Log on July 12, 2022, which provides for recording water samples from (b)(4) for temperature, free chlorine, and pH. You changed the Water Log on August 17, 2022, to specify hot or cold water for each location. In addition, you created an additional Water Log, received by FDA on August 17, 2022, to record water samples for temperature, free chlorine, and pH (b)(4) on (b)(4) from (b)(4) on the vessel.
You have not provided detailed documentation of your new procedures related to water monitoring, documentation of these procedures being accomplished (i.e., completed Water Logs), and verification that these procedures are effective. In addition, we have the following concerns regarding your Water Logs:
Neither Water Log indicates your acceptable ranges for temperature and pH.
Both Water Logs specify that free chlorine must be maintained at (b)(4)ppm. It is unclear how you established this level and whether it is the target level in cold only or both hot and cold water. Free chlorine that drops below an appropriately determined target level at a specific location could be indicative that additional corrective actions need to be considered, such as disinfection of the potable water system. Neither Water Log has a section for any corrective action(s) that may have occurred when free chlorine was detected below (b)(4) ppm. Therefore, it is not clear what you plan to do if this occurs.
Both Water Logs specify (b)(4) for water collection; a vessel can be an extremely complex water system, and it is essential to consider (b)(4) for potable water parameters occurs. Also, water collection should focus on the hot water system because Legionella grows best in warm water; nearly all of FDA’s samples were taken from your hot water system.
Also, timing is also essential to consider when monitoring potable water; potable water parameters taken after water has been stored on the vessel for a few days before refilling and/or flushing will provide different information compared to potable water parameters taken immediately after refilling and/or flushing. For example, a potable water holding tank that has just been flushed, refilled, and immediately sampled for potable water parameters would likely indicate the current parameters of the potable water taken onboard. A potable water tank that has not been flushed and/or refilled for a period of time such as a few days would be informative as to what occurs to the potable water after filling onboard and whether acceptable ranges of potable water parameters continue to be met. Your Water Logs do not specify when potable water parameters are to be taken.
We note that both Water Logs refer only to free chlorine and not total chlorine. Vessels collect water from various locations; it is essential for the vessel to know what disinfectant such as chloramine or chlorine is being used by the potable water source being onloaded to the vessel. For example, if you take on water that is disinfected with chloramine, you would need to monitor both free chlorine and total chlorine.
You have not provided additional information regarding how you will address the risk from stagnant water during docking. Further, it is not clear whether your (b)(4) and (b)(4) Water Logs are for use only during vessel operation or will also be used during docking. As explained previously, it is essential to monitor parameters such as free or total chlorine, temperatures, and pH when water is stagnant to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella to grow.
American Heritage
Presence of Legionella Onboard the Vessel
On June 15, 2022, FDA investigators collected twenty-four (24) biofilm swabs and twenty-nine (29) bulk one-liter potable water samples from various locations on your vessel. The Maryland Department of Health laboratory recovered Legionella from:
Biofilm Swabs (8% of samples positive):
• 1 Showerhead pipe in a passenger cabin
• 1 Bathroom faucet aerator in a passenger cabin
Potable Water (7% of samples positive)
• 1 Showerhead pipe in a passenger cabin
• 1 Bathroom faucet aerator in a passenger cabin
Post-Notification Actions
On April 30, 2021 and November 30, 2021 , you were notified by CDC of confirmed cases of Legionnaires’ disease. After being notified of two confirmed cases of Legionnaires’ disease with travel onboard the American Heritage, you did not change your procedures for flushing or disinfection and did not perform potable water or environmental sampling. On (b)(4), you disinfected the vessel’s potable water system. Subsequently, on June 15, 2022, FDA collected water and biofilm samples from the vessel. On July 14, 2022, FDA notified you of the positive findings regarding Legionella onboard the vessel. Subsequently, you provided notifications to each passenger on the voyage departing July 16, 2022, of the presence of Legionella in the potable water system. You also provided notifications to passengers onboard the vessel previously that departed on June 18, 2022, June 25, 2022, July 2, 2022, and July 9, 2022.
FDA’s positive samples were collected after your (b)(4) disinfection and thus show that your disinfection was not fully effective. The passenger cabin where FDA detected Legionella in the showerhead pipe and bathroom faucet aerator is very distal to the potable water holding tanks and water heaters; distal locations are where routine chlorine levels would be lowest and hyperchlorination would be least effective. You subsequently disinfected the showerhead pipe and sink faucet aerator in the positive passenger cabin and installed a (b)(4) on the showerhead in that cabin to decrease the risk of exposure to Legionella. However, you have not performed any additional disinfection of the potable water system since (b)(4), which is prior to FDA’s collection of positive samples.
We continue to have concerns with the potential exposure of passengers and crew members to Legionella onboard the American Heritage. We note that you have chosen not to do remediation and disinfect the potable water system after notification that the showerhead pipe and sink faucet aerator in a passenger cabin had biofilm swabs and potable water samples that tested positive for Legionella. FDA’s sampling results demonstrate that the disinfection performed on (b)(4), prior to the initial representative sampling by FDA, was not sufficient to address Legionella onboard the American Heritage. The device on the showerhead in the passenger cabin that assists in limiting exposure from showering does not address the overall concern that Legionella may be present in the vessel’s potable water system. Also, although you indicated that you disinfected the sink faucet aerator, you have not addressed the Legionella found in the biofilms from the pipe and in the sink faucet aerator of the passenger cabin. When Legionella is associated with a protozoa, including amoebae (as can be the case with a biofilm present), it can be more resistant to disinfection such as the use of chlorine. You need to ensure that the disinfection procedures you use are effective for the removal of biofilms associated with Legionella.
As we have informed you previously, a voluntary corrective action plan would include documentation of detailed procedures put in place onboard the vessel for control of Legionella, documentation of those procedures being accomplished, and verification that those procedures are effective. On July 21, 2022, FDA expressed concern that you had not provided a detailed disinfection process to be used in the future for the potable water system. On August 28, 2022, you provided a response which stated that you will do a “(b)(4)” of the vessel with no less than (b)(4)ppm of (b)(4) for a minimum of (b)(4) when (b)(4). To date, you have not provided any procedures for how you will accomplish this and to show that it is adequate to address the increased risk of Legionella when water is stagnant.
Vessel Inspection
During the inspection, the following insanitary conditions and practices were observed:
Failure to Monitor Potable Water Parameters
You did not monitor parameters of the potable water, such as free or total chlorine residual, temperatures, and pH on the vessel when docked and not in operation or while in operation.
Sample collection of biofilm swabs and potable water samples by FDA investigators on June 15, 2022, documented the following:
Nineteen of 24 biofilm swabs and 24 of 29 bulk potable water samples had no free or total chlorine residual. Lack of free and/or total chlorine indicates that conditions, such as the presence of biofilm or planktonic microorganisms may have led to the immediate use of this residual chlorine in the potable water system onboard the vessel.
Twenty-two of 24 biofilm swabs and 26 of 29 bulk potable water samples had temperature ranges from 81.3°F - 113°F, which is ideal for potential Legionella growth.
pH was measured between 6-7 for biofilm swabs and bulk potable water samples. pH level is important to consider as it impacts the effectiveness of the chlorine residual. pH can also cause potential corrosion of potable water pipes when not carefully monitored. Unlike temperature, it is not possible to set a single target value for pH since there are several factors that a water operator would use to determine the target. The efficacy of chlorination is affected by many factors, one of which is pH. The efficacy of chlorine declines as pH increases >7, with significant loss of efficacy at pH >8. While the optimum pH range for systems treated with monochloramine is 7.5 to 9.0, it is important to know how your source water is treated to determine the appropriate pH range for each of your systems.
By monitoring these parameters, you can ensure that the vessel’s potable water system is operating in a way to minimize hazardous conditions that could encourage Legionella and other waterborne pathogens to grow. If you find that one or more of these parameters (e.g., pH, free or total chlorine, temperature) is not being met, the next step would be to take corrective actions to get conditions back to within an acceptable range for the vessel’s potable water system.
While the vessel was (b)(4), the potable water system was flushed and filled (b)(4). Stagnant or standing water in a potable water system can increase the risk for growth and spread of Legionella and other biofilm-associated bacteria. When water is stagnant, hot water temperatures can decrease to the Legionella growth range. Stagnant water can also lead to low or undetectable levels of disinfectant, such as chlorine. Therefore, it is essential for you to monitor parameters such as free or total chlorine residual, temperatures, and pH during water stagnation to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella (and other waterborne pathogens) to grow.
Failure to Monitor Disinfection Effectiveness
The Engineering Manager stated that disinfection was performed once from March 2021 to March 2022 and (b)(4) during (b)(4) from (b)(4). During disinfection, cabin outlets were allowed to run for approximately (b)(4). No specific sequence was given to crew in the galley, crew quarters, and various other cabins for turning on the faucets, taps, showerheads, and other locations to run the disinfectant.
The disinfection consisted of forcing the potable water tanks to a (b)(4) concentration of (b)(4)ppm for (b)(4) and then flushing (b)(4) shower heads and sinks on the vessel. Afterwards, the (b)(4) was adjusted down to (b)(4)ppm to make the water potable again. During the disinfection, you did not measure the disinfectant level, pH, and temperature to verify that an adequate amount of the disinfectant at an appropriate pH and temperature reached the proximal, medial, and distal faucets and showerheads and other areas that are part of the potable water system.
Further, the disinfection you performed on (b)(4), was not sufficient as demonstrated by FDA’s sampling results from June 15, 2022 that showed the presence of Legionella in a passenger cabin. Lack of verification of the disinfectant, pH, and temperature during disinfection in a complex potable water system such as a vessel prevents you from knowing whether the disinfection was effective in various areas of the potable water system. In addition, you did not sample the potable water system for microorganisms such as Legionella to verify the effectiveness of the disinfection.
American Cruise Lines’ Response
On July 19, 2022, we received your new (b)(4) and (b)(4) Water Log, which provides for recording water samples for temperature, free chlorine, and pH. You stated that the updated (b)(4) Water Log would reflect water samples from (b)(4), and the updated (b)(4) Water Log would reflect water samples from the 22 same locations for the next 30 days inclusive of the showerhead pipes and sink faucet aerators that were positive for Legionella. On August 1, 2022, FDA received a new (b)(4) Water Log and a (b)(4) Water Log to replace the (b)(4) Water Log and to be completed (b)(4) from (b)(4).
Aside from the Water Logs, we have not received documentation regarding your procedures for water monitoring, documentation of these procedures being accomplished (i.e., completed Water Logs), and verification that these procedures are effective. We have similar concerns with regards to these Water Logs as we express earlier in this letter for the Water Logs for the American Star.
Regarding disinfection during (b)(4), your August 28 response stated that you will do a “(b)(4)” of the vessel with no less than (b)(4)ppm of (b)(4) for a minimum of (b)(4) when the (b)(4). However, you have not provided any procedures for how you will accomplish this and to show that it is adequate to address the increased risk of Legionella when water is stagnant. Also, it is not clear whether the (b)(4) and (b)(4) Water Logs you provided are for use only when the vessel is in operation or also will be used when the vessel is docked. As explained earlier, it is essential for you to monitor parameters such as pH, free or total chlorine residual, and temperatures during water stagnation to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella (and other waterborne pathogens) to grow. Water that stagnates for extended periods of time may allow for the growth of these biofilms, which can decrease the effectiveness of the disinfectant used. As a reminder, when Legionella is associated with a protozoa, including amoebae (as can be the case with a biofilm present), it can be more resistant to disinfection such as the use of chlorine.
Note that “Only potable water shall be provided for drinking and culinary purposes by any operator of a conveyance engaged in interstate traffic” (see 21 CFR 1240.80). Potable water is defined as “[w]ater which meets the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations as set forth in 40 CFR part 141 and the [FDA’s] sanitation requirements as set forth in [21 CFR Parts 1240 and 1250]” (see 21 CFR 1240.3).
Finally, we note that you have other vessels in your fleet. Although we are not aware of a case of Legionnaires’ disease being associated with any of those vessels, based on your practices on the American Star and American Heritage, we have concerns about the potable water on your other vessels. Specifically, if adequate practices are not followed regarding potable water on those vessels, there is a potential for waterborne illnesses to occur. It would not be appropriate to wait until there is a confirmed case of Legionnaires’ disease to address the water practices onboard those other vessels. As a reminder, people at increased risk of Legionnaire’s disease include those 50 years of age or older and we understand that the majority of your passengers onboard the American Star and American Heritage exceed this age.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your vessels. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to Stephen Rabe, Compliance Officer, via email at: ORAHAFEAST5FirmResponses@fda.hhs.gov or to U.S. Food and Drug Administration, 550 Main Street, Suite 4-930, Cincinnati, OH 45202. If you have any questions about the content of this letter, you may contact Mr. Rabe at 513-322-0660.
Please also send a copy of the reply to Beira Montalvo, Compliance Officer, via email at: Beira.Montalvo@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Division Director
Office of Human and Animal Food Operations
East 5
"Eight of 10 biofilm swabs from showerhead pipes and a wait station hand sink faucet aerator and 11 of 14 bulk potable water samples had temperature ranges from 83.1°F - 112.6°F, which is ideal for Legionella growth."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-cruise-lines-641736-01242023
WARNING LETTER
American Cruise Lines
MARCS-CMS 641736 — JANUARY 24, 2023
Recipient:
Paul E. Taiclet
Executive Vice President
American Cruise Lines
741 Boston Post Road, Suite 200
Guilford, CT 06437
United States
Taiclet@americancruiselines.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
January 24, 2023
Warning Letter 641736
Dear Mr. Taiclet:
The United States Food and Drug Administration (FDA) inspected your American Star and American Heritage vessels from April 30, 2022, through June 17, 2022, and from June 15, 2022, through August 15, 2022, respectively. FDA also conducted an investigation of the American Star and American Heritage vessels in December 2021. The investigation and inspections were initiated by FDA after three of your passengers who traveled in April 2021, September 2021, and September-October 2021 aboard these vessels were diagnosed with Legionnaires’ disease. American Cruise Lines and FDA were notified by the Centers for Disease Control and Prevention (CDC) of the first confirmed case of Legionnaires’ disease at the end of April 2021 (American Heritage), the second at the beginning of November 2021 (American Star), and the third at the end of November 2021 (American Heritage).1
During our inspections, FDA investigators collected biofilm swabs and potable water samples from your American Star and American Heritage vessels. Laboratory Analysis of those samples identified Legionella pneumophilia serogroup 1 and Legionella spp. (hereinafter collectively called Legionella) in the potable water system of the vessels. FDA investigators also observed insanitary conditions related to the potable water systems onboard the vessels. At the conclusion of the inspections, the FDA investigators issued a Form FDA 483, Inspectional Observations, to both vessels.
Based on FDA’s inspectional findings, we have determined that the potable water onboard the American Star and American Heritage vessels is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that it has been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health.
Additionally, the presence of Legionella in the potable water on the American Star and American Heritage vessels, as evidenced by the laboratory analysis of FDA’s water samples, causes your vessels’ potable water to be adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that it bears or contains a poisonous or deleterious substance which may render it injurious to health.
We received your responses to the biofilm swabs and potable water positive results for Legionella and to the Form FDA 483 in regard to the American Star on the following dates: June 2, 2022, June 4, 2022, June 13, 2022, June 28, 2022, July 5, 2022, July 6, 2022, July 8, 2022, July 11, 2022, July 12, 2022, July 14, 2022, July 20, 2022, August 2, 2022, and August 16, 2022. We received your responses in regard to the American Heritage on July 19, 2022, August 1, 2022, August 16, 2022, and August 28, 2022.
After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continued concerns and to provide detailed information describing our findings.
American Star
Presence of Legionella Onboard the Vessel
On April 30, 2022, FDA investigators collected ten (10) biofilm swabs and fourteen (14) bulk one-liter potable water samples from various locations on your vessel. The Maryland Department of Health laboratory recovered Legionella from:
Biofilm Swabs (60% of samples positive):
• 5 Showerhead pipes in passenger cabins
• Wait station hand sink faucet aerator in the galley
Potable Water (93% of samples positive):
• 7 Showerhead pipes in passenger cabins
• 2 Showerhead pipes in crew rooms
• Wait station hand sink faucet aerator in the galley
• Galley prep sink faucet aerator
• Potable water holding tank
• Post pump (b)(4) hot water return spigot
Post-Notification Actions
You did not change your procedures regarding potable water after CDC notified you on November 5, 2021, that one of your passengers was diagnosed with Legionnaires’ disease. For example, you did not change your procedures for flushing or disinfection and did not perform environmental sampling. Subsequently, after FDA notified you of its detection of Legionella onboard your vessel (June 2, 2022), you disinfected the vessel’s potable water system on (b)(4). On June 4, 2022, you provided a letter to each passenger notifying them of the presence of Legionella in the potable water system onboard your vessel and mitigation steps you had taken. Also, you provided a letter notifying passengers who were onboard the vessel previously from May 3, 2022 to June 4, 2022.
During the week of (b)(4), you conducted water sampling using a field test kit. On June 24, 2022, FDA expressed concerns to you regarding the use of this field test kit and ending passenger notifications based on this testing because your testing was limited to Legionella pneumophilia serogroup 1 and did not include species identified as present on the vessel by FDA’s testing. In addition, FDA expressed concerns with the sensitivity, detection limit, and size of the water samples collected for the field test kit you used. On June 28, 2022, you shared additional sample collection results with FDA, separate from the field test kit, that were analyzed in a laboratory.
FDA expressed concerns with these laboratory results not being representative nor sufficient to determine whether Legionella is still present and your use of these and the field test kit results to justify ending notification of passengers. Specifically, FDA collected 14 bulk water and 10 biofilm swab samples; you collected (b)(4) bulk water and (b)(4) biofilm swab samples for the laboratory tests. Thirteen of fourteen (92.86%) of FDA’s bulk water samples and 6 of 10 (60%) of FDA’s biofilm swab samples were positive for Legionella. You did not evaluate most of the bulk water and biofilm swab locations that were positive from FDA’s sampling. In addition, one of the biofilm swabs you took was from a (b)(4) that was negative from FDA’s sampling.
You restarted passenger notifications and provided them from July 9, 2022 to July 30, 2022. On (b)(4), you collected additional samples and notified FDA of negative results on August 16, 2022. On September 20, 2022, FDA submitted additional follow-up questions regarding the vessel’s sampling process, laboratory results, and future disinfection process. To date, we have not received a response.
Further, in FDA’s emails to American Cruise Lines on July 11, 2022 and August 5, 2022, we reminded you that a voluntary corrective action plan to FDA would include not only testing for Legionella, but other documents, such as detailed procedures put in place onboard the vessel to address Legionella, documentation of those procedures being accomplished, and verification that those procedures are effective.
Vessel Inspection
During the inspection, the following insanitary conditions and practices were observed: Failure to Monitor Potable Water Parameters
You did not monitor potable water parameters, such as free or total chlorine residual, temperature, and pH on the vessel when docked and not in operation or while in operation. Sample collection of biofilm swabs and potable water samples by FDA investigators on April 30, 2022, documented the following:
Free chlorine and total chlorine residual were measured at 1.5ppm and 2ppm, respectively, in the potable water holding tanks where water is initially stored in the vessel. After the potable water traveled from the potable water holding tanks where initially stored to distal piping onboard the vessel such as showerheads, seven of 10 biofilm swabs and 10 of 14 bulk potable water samples had no free or total chlorine residual. The dissipation in chlorine residual from the potable water holding tanks to distal piping indicates that conditions, such as the presence of biofilm or planktonic microorganisms, led to the immediate use of the residual chlorine in the potable water system on the vessel.
Eight of 10 biofilm swabs from showerhead pipes and a wait station hand sink faucet aerator and 11 of 14 bulk potable water samples had temperature ranges from 83.1°F - 112.6°F, which is ideal for Legionella growth.
pH was measured between 5-7 for biofilm swabs and bulk potable water samples. pH level is important to consider as it impacts the effectiveness of the chlorine residual. pH can also cause potential corrosion of potable water pipes when not carefully monitored. Unlike temperature, it is not possible to set a single target value for pH since there are several factors that a water operator would use to determine the target. The efficacy of chlorination is affected by many factors, one of which is pH. The efficacy of chlorine declines as pH increases >7, with significant loss of efficacy at pH >8. While the optimum pH range for systems treated with monochloramine is 7.5 to 9.0, it is important to know how your source water is treated to determine the appropriate pH range for each of your systems.
By monitoring these parameters, you can ensure that the vessel’s potable water system is operating in a way to minimize hazardous conditions that could encourage Legionella and other waterborne pathogens to grow. If you find that one or more of these parameters is not being met, the next step would be to take corrective actions to get conditions back within an acceptable range for the vessel’s potable water system.
While the vessel (b)(4), the potable water system was flushed and filled (b)(4). Stagnant or standing water in a potable water system can increase the risk for growth and spread of Legionella and other biofilm-associated bacteria. When water is stagnant, hot water temperatures can decrease to the Legionella growth range. Stagnant water can also lead to low or undetectable levels of disinfectant, such as chlorine. Therefore, it is also essential for you to monitor parameters such as free or total chlorine residual, temperatures, and pH during water stagnation to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella (and other waterborne pathogens) to grow.
Failure to Monitor Disinfection Effectiveness
According to the Port Engineer, cabin outlets were allowed to run for approximately (b)(4) during (b)(4) disinfection when the vessel (b)(4). No specific sequence was given to crew in the galley, crew quarters, and various other cabins for turning on the faucets, taps, showerheads, and other locations to run the disinfectant.
During the disinfection, you did not measure the disinfectant level, pH, and temperature to verify that an adequate amount of the disinfectant at an appropriate pH and temperature reached the proximal, medial, and distal faucets and showerheads and other areas that are part of the potable water system. Without verifying the disinfectant level, pH, and temperature during disinfection in a complex potable water system such as a vessel you cannot know whether the disinfection was effective in various areas of the potable water system. In addition, you did not perform environmental sampling of the potable water system, i.e., testing biofilm swabs and bulk potable water for microorganisms such as Legionella, to validate the effectiveness of the disinfection and your frequency of disinfection ((b)(4)).
American Cruise Lines’ Response
We received your new Water Log on July 12, 2022, which provides for recording water samples from (b)(4) for temperature, free chlorine, and pH. You changed the Water Log on August 17, 2022, to specify hot or cold water for each location. In addition, you created an additional Water Log, received by FDA on August 17, 2022, to record water samples for temperature, free chlorine, and pH (b)(4) on (b)(4) from (b)(4) on the vessel.
You have not provided detailed documentation of your new procedures related to water monitoring, documentation of these procedures being accomplished (i.e., completed Water Logs), and verification that these procedures are effective. In addition, we have the following concerns regarding your Water Logs:
Neither Water Log indicates your acceptable ranges for temperature and pH.
Both Water Logs specify that free chlorine must be maintained at (b)(4)ppm. It is unclear how you established this level and whether it is the target level in cold only or both hot and cold water. Free chlorine that drops below an appropriately determined target level at a specific location could be indicative that additional corrective actions need to be considered, such as disinfection of the potable water system. Neither Water Log has a section for any corrective action(s) that may have occurred when free chlorine was detected below (b)(4) ppm. Therefore, it is not clear what you plan to do if this occurs.
Both Water Logs specify (b)(4) for water collection; a vessel can be an extremely complex water system, and it is essential to consider (b)(4) for potable water parameters occurs. Also, water collection should focus on the hot water system because Legionella grows best in warm water; nearly all of FDA’s samples were taken from your hot water system.
Also, timing is also essential to consider when monitoring potable water; potable water parameters taken after water has been stored on the vessel for a few days before refilling and/or flushing will provide different information compared to potable water parameters taken immediately after refilling and/or flushing. For example, a potable water holding tank that has just been flushed, refilled, and immediately sampled for potable water parameters would likely indicate the current parameters of the potable water taken onboard. A potable water tank that has not been flushed and/or refilled for a period of time such as a few days would be informative as to what occurs to the potable water after filling onboard and whether acceptable ranges of potable water parameters continue to be met. Your Water Logs do not specify when potable water parameters are to be taken.
We note that both Water Logs refer only to free chlorine and not total chlorine. Vessels collect water from various locations; it is essential for the vessel to know what disinfectant such as chloramine or chlorine is being used by the potable water source being onloaded to the vessel. For example, if you take on water that is disinfected with chloramine, you would need to monitor both free chlorine and total chlorine.
You have not provided additional information regarding how you will address the risk from stagnant water during docking. Further, it is not clear whether your (b)(4) and (b)(4) Water Logs are for use only during vessel operation or will also be used during docking. As explained previously, it is essential to monitor parameters such as free or total chlorine, temperatures, and pH when water is stagnant to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella to grow.
American Heritage
Presence of Legionella Onboard the Vessel
On June 15, 2022, FDA investigators collected twenty-four (24) biofilm swabs and twenty-nine (29) bulk one-liter potable water samples from various locations on your vessel. The Maryland Department of Health laboratory recovered Legionella from:
Biofilm Swabs (8% of samples positive):
• 1 Showerhead pipe in a passenger cabin
• 1 Bathroom faucet aerator in a passenger cabin
Potable Water (7% of samples positive)
• 1 Showerhead pipe in a passenger cabin
• 1 Bathroom faucet aerator in a passenger cabin
Post-Notification Actions
On April 30, 2021 and November 30, 2021 , you were notified by CDC of confirmed cases of Legionnaires’ disease. After being notified of two confirmed cases of Legionnaires’ disease with travel onboard the American Heritage, you did not change your procedures for flushing or disinfection and did not perform potable water or environmental sampling. On (b)(4), you disinfected the vessel’s potable water system. Subsequently, on June 15, 2022, FDA collected water and biofilm samples from the vessel. On July 14, 2022, FDA notified you of the positive findings regarding Legionella onboard the vessel. Subsequently, you provided notifications to each passenger on the voyage departing July 16, 2022, of the presence of Legionella in the potable water system. You also provided notifications to passengers onboard the vessel previously that departed on June 18, 2022, June 25, 2022, July 2, 2022, and July 9, 2022.
FDA’s positive samples were collected after your (b)(4) disinfection and thus show that your disinfection was not fully effective. The passenger cabin where FDA detected Legionella in the showerhead pipe and bathroom faucet aerator is very distal to the potable water holding tanks and water heaters; distal locations are where routine chlorine levels would be lowest and hyperchlorination would be least effective. You subsequently disinfected the showerhead pipe and sink faucet aerator in the positive passenger cabin and installed a (b)(4) on the showerhead in that cabin to decrease the risk of exposure to Legionella. However, you have not performed any additional disinfection of the potable water system since (b)(4), which is prior to FDA’s collection of positive samples.
We continue to have concerns with the potential exposure of passengers and crew members to Legionella onboard the American Heritage. We note that you have chosen not to do remediation and disinfect the potable water system after notification that the showerhead pipe and sink faucet aerator in a passenger cabin had biofilm swabs and potable water samples that tested positive for Legionella. FDA’s sampling results demonstrate that the disinfection performed on (b)(4), prior to the initial representative sampling by FDA, was not sufficient to address Legionella onboard the American Heritage. The device on the showerhead in the passenger cabin that assists in limiting exposure from showering does not address the overall concern that Legionella may be present in the vessel’s potable water system. Also, although you indicated that you disinfected the sink faucet aerator, you have not addressed the Legionella found in the biofilms from the pipe and in the sink faucet aerator of the passenger cabin. When Legionella is associated with a protozoa, including amoebae (as can be the case with a biofilm present), it can be more resistant to disinfection such as the use of chlorine. You need to ensure that the disinfection procedures you use are effective for the removal of biofilms associated with Legionella.
As we have informed you previously, a voluntary corrective action plan would include documentation of detailed procedures put in place onboard the vessel for control of Legionella, documentation of those procedures being accomplished, and verification that those procedures are effective. On July 21, 2022, FDA expressed concern that you had not provided a detailed disinfection process to be used in the future for the potable water system. On August 28, 2022, you provided a response which stated that you will do a “(b)(4)” of the vessel with no less than (b)(4)ppm of (b)(4) for a minimum of (b)(4) when (b)(4). To date, you have not provided any procedures for how you will accomplish this and to show that it is adequate to address the increased risk of Legionella when water is stagnant.
Vessel Inspection
During the inspection, the following insanitary conditions and practices were observed:
Failure to Monitor Potable Water Parameters
You did not monitor parameters of the potable water, such as free or total chlorine residual, temperatures, and pH on the vessel when docked and not in operation or while in operation.
Sample collection of biofilm swabs and potable water samples by FDA investigators on June 15, 2022, documented the following:
Nineteen of 24 biofilm swabs and 24 of 29 bulk potable water samples had no free or total chlorine residual. Lack of free and/or total chlorine indicates that conditions, such as the presence of biofilm or planktonic microorganisms may have led to the immediate use of this residual chlorine in the potable water system onboard the vessel.
Twenty-two of 24 biofilm swabs and 26 of 29 bulk potable water samples had temperature ranges from 81.3°F - 113°F, which is ideal for potential Legionella growth.
pH was measured between 6-7 for biofilm swabs and bulk potable water samples. pH level is important to consider as it impacts the effectiveness of the chlorine residual. pH can also cause potential corrosion of potable water pipes when not carefully monitored. Unlike temperature, it is not possible to set a single target value for pH since there are several factors that a water operator would use to determine the target. The efficacy of chlorination is affected by many factors, one of which is pH. The efficacy of chlorine declines as pH increases >7, with significant loss of efficacy at pH >8. While the optimum pH range for systems treated with monochloramine is 7.5 to 9.0, it is important to know how your source water is treated to determine the appropriate pH range for each of your systems.
By monitoring these parameters, you can ensure that the vessel’s potable water system is operating in a way to minimize hazardous conditions that could encourage Legionella and other waterborne pathogens to grow. If you find that one or more of these parameters (e.g., pH, free or total chlorine, temperature) is not being met, the next step would be to take corrective actions to get conditions back to within an acceptable range for the vessel’s potable water system.
While the vessel was (b)(4), the potable water system was flushed and filled (b)(4). Stagnant or standing water in a potable water system can increase the risk for growth and spread of Legionella and other biofilm-associated bacteria. When water is stagnant, hot water temperatures can decrease to the Legionella growth range. Stagnant water can also lead to low or undetectable levels of disinfectant, such as chlorine. Therefore, it is essential for you to monitor parameters such as free or total chlorine residual, temperatures, and pH during water stagnation to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella (and other waterborne pathogens) to grow.
Failure to Monitor Disinfection Effectiveness
The Engineering Manager stated that disinfection was performed once from March 2021 to March 2022 and (b)(4) during (b)(4) from (b)(4). During disinfection, cabin outlets were allowed to run for approximately (b)(4). No specific sequence was given to crew in the galley, crew quarters, and various other cabins for turning on the faucets, taps, showerheads, and other locations to run the disinfectant.
The disinfection consisted of forcing the potable water tanks to a (b)(4) concentration of (b)(4)ppm for (b)(4) and then flushing (b)(4) shower heads and sinks on the vessel. Afterwards, the (b)(4) was adjusted down to (b)(4)ppm to make the water potable again. During the disinfection, you did not measure the disinfectant level, pH, and temperature to verify that an adequate amount of the disinfectant at an appropriate pH and temperature reached the proximal, medial, and distal faucets and showerheads and other areas that are part of the potable water system.
Further, the disinfection you performed on (b)(4), was not sufficient as demonstrated by FDA’s sampling results from June 15, 2022 that showed the presence of Legionella in a passenger cabin. Lack of verification of the disinfectant, pH, and temperature during disinfection in a complex potable water system such as a vessel prevents you from knowing whether the disinfection was effective in various areas of the potable water system. In addition, you did not sample the potable water system for microorganisms such as Legionella to verify the effectiveness of the disinfection.
American Cruise Lines’ Response
On July 19, 2022, we received your new (b)(4) and (b)(4) Water Log, which provides for recording water samples for temperature, free chlorine, and pH. You stated that the updated (b)(4) Water Log would reflect water samples from (b)(4), and the updated (b)(4) Water Log would reflect water samples from the 22 same locations for the next 30 days inclusive of the showerhead pipes and sink faucet aerators that were positive for Legionella. On August 1, 2022, FDA received a new (b)(4) Water Log and a (b)(4) Water Log to replace the (b)(4) Water Log and to be completed (b)(4) from (b)(4).
Aside from the Water Logs, we have not received documentation regarding your procedures for water monitoring, documentation of these procedures being accomplished (i.e., completed Water Logs), and verification that these procedures are effective. We have similar concerns with regards to these Water Logs as we express earlier in this letter for the Water Logs for the American Star.
Regarding disinfection during (b)(4), your August 28 response stated that you will do a “(b)(4)” of the vessel with no less than (b)(4)ppm of (b)(4) for a minimum of (b)(4) when the (b)(4). However, you have not provided any procedures for how you will accomplish this and to show that it is adequate to address the increased risk of Legionella when water is stagnant. Also, it is not clear whether the (b)(4) and (b)(4) Water Logs you provided are for use only when the vessel is in operation or also will be used when the vessel is docked. As explained earlier, it is essential for you to monitor parameters such as pH, free or total chlorine residual, and temperatures during water stagnation to determine whether your frequency of flushing and filling is adequate to minimize hazardous conditions that could encourage biofilm development and Legionella (and other waterborne pathogens) to grow. Water that stagnates for extended periods of time may allow for the growth of these biofilms, which can decrease the effectiveness of the disinfectant used. As a reminder, when Legionella is associated with a protozoa, including amoebae (as can be the case with a biofilm present), it can be more resistant to disinfection such as the use of chlorine.
Note that “Only potable water shall be provided for drinking and culinary purposes by any operator of a conveyance engaged in interstate traffic” (see 21 CFR 1240.80). Potable water is defined as “[w]ater which meets the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations as set forth in 40 CFR part 141 and the [FDA’s] sanitation requirements as set forth in [21 CFR Parts 1240 and 1250]” (see 21 CFR 1240.3).
Finally, we note that you have other vessels in your fleet. Although we are not aware of a case of Legionnaires’ disease being associated with any of those vessels, based on your practices on the American Star and American Heritage, we have concerns about the potable water on your other vessels. Specifically, if adequate practices are not followed regarding potable water on those vessels, there is a potential for waterborne illnesses to occur. It would not be appropriate to wait until there is a confirmed case of Legionnaires’ disease to address the water practices onboard those other vessels. As a reminder, people at increased risk of Legionnaire’s disease include those 50 years of age or older and we understand that the majority of your passengers onboard the American Star and American Heritage exceed this age.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your vessels. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to Stephen Rabe, Compliance Officer, via email at: ORAHAFEAST5FirmResponses@fda.hhs.gov or to U.S. Food and Drug Administration, 550 Main Street, Suite 4-930, Cincinnati, OH 45202. If you have any questions about the content of this letter, you may contact Mr. Rabe at 513-322-0660.
Please also send a copy of the reply to Beira Montalvo, Compliance Officer, via email at: Beira.Montalvo@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Division Director
Office of Human and Animal Food Operations
East 5
No comments:
Post a Comment