New York State Bottled and Bulk Water Program 2012 Annual Report
The Bottled and Bulk Water Program 2012 Annual Report is a summary of certification program activities conducted by the New York State Department of Health (Department) under the purview of Title 2, Section 225 of the Public Health Law of the Laws of New York, during the 2012 calendar year. The standards for bottled and bulk water facilities are contained in 10 NYCRR Subpart 5-6, Bottled and Bulk Water Standards, of the State Sanitary Code (Subpart 5-6). Subpart 5-6 requires that all bottled or bulk water sold, offered for sale or delivered for human consumption, food preparation, or culinary purposes be certified by the Department.
Initial certification of bottled and bulk water requires the submission of the following items:
- an engineering drawing for the source site and bottling facility;
- a detailed engineering report outlining sanitization, maintenance and operational procedures;
- samples of product labels;
- water quality data;
- product samples; and
- an inspection report.
To be eligible for recertification, bottled and bulk water facilities must submit the following on an annual basis:
- current water quality analyses for each source and finished product;
- a current inspection report;
- labels used for distribution in New York State;
- a completed questionnaire; and
- disinfection waiver documentation (if applicable) annually to be eligible for renewal (see Bottled or Bulk FAQs).
In 2012, 7 bottled water facilities and 2 bulk water facilities received initial certification to sell, offer for sale or deliver for human consumption, food preparation, or culinary purposes their products in New York State. By the end of 2012, the total number of bottled and bulk water facilities certified by the Department reached 228. Of these 228 certified bottled/bulk water facilities, 73 are located in New York State, 119 are located out-of-state but within the United States and 36 are located in foreign countries.
|Bottled and Bulk Water Facility Location||Number of Certified Facilities|
|Out of State (within USA)||119|
|Out of Country||36|
Uncertified Bottled and Bulk Water in New York State
As required under Subpart 5-6.2, "No person shall sell, offer for sale or deliver bottled or bulk water for human consumption, food preparation, or culinary purposes unless certified by the Commissioner in accordance with the requirements of this Subpart". Therefore, after the Department is notified that facilities are illegally selling and/or distributing bottled and/or bulk water in New York State, the Department requires the facility to cease their activities of selling and/or distributing their product in New York State until they have obtained the necessary certification. Accordingly, the Department sends a letter to each uncertified bottled or bulk water facility stating that they must cease and desist from selling, offering for sale and delivering their bottled and/or bulk water in New York State as well as instruct their offices, branches and distributors to remove all the bottled water products from the New York State market.
In 2012, no bottled water companies/distributors were notified by the Department that they were not certified to sell, distribute, and/or offer for sale bottled water products in New York State, 2 bulk water haulers were notified by the Department that they were not certified to sell or distribute potable water in New York State and that all bulk hauling for human consumption, food preparation or culinary purposes within New York State must cease.
In response to Super Storm Sandy disaster relief efforts, New York Governor Andrew Cuomo signed, on October 26, 2012, Executive Order 58 suspending the Public Health Law and State Sanitary Code regulations related to bottled and bulk water. The Executive Order allowed the donation of non-certified bottled and bulk water for disaster relief if the Commissioner of Health finds that the water is fit for human consumption. In response, one out of state water production facility was given approval to distribute bottled water in New York.
Failure to Maintain Certification
In 2012, the Department notified 30 bottled and bulk water facilities they were no longer certified for failure to meet the renewal requirements outlined in Subpart 5-6, Subdivision 5-6.16(d) and were instructed to withhold from selling, offering for sale or delivering bottled or bulk water in New York State, for human consumption, food preparation or culinary purposes. Of these 30 bottled and bulk water facilities, 23 certifications were reinstated.
The Department's required public notice of those certified bottled and bulk water facilities that are no longer certified includes monthly updates pursuant to Section 225(u)(vi) of the Public Health Law of the Laws of New York. The facility will appear on the top of each notice the month it becomes no longer certified and will be repeated on 11 successive monthly notices unless the facility becomes recertified within 12 months. After 12 months, the notice requirement has been met and the facility is dropped from all listings until such time as the facility applies for certification
136 certified bottled water facilities reported, that of the approximately 5,385,558,825 total gallons they produced during 2011, approximately 544,545,483 gallons were distributed to New York State. This distribution is an aggregate of several product types including but not limited to: well, spring, mineral, carbonated, distilled, deionized, drinking, and sparkling waters. 64 certified bulk water haulers reported that approximately 99,026,064 gallons of potable drinking water was distributed in New York State in 2011.
NOTE: 2012 production numbers will be reported in 2013.
An annual inspection must be made of each bottled and bulk water facility. The inspection may be conducted by the Department, local county health department or district office, or by a third party approved by the Department. Out-of-state bottling facilities must provide certification from the appropriate regulatory agency of the state or country having jurisdiction over the bottling operation, indicating that the facility has been inspected and approved to bottle or package water for human consumption. Annual inspection of facilities consists of sampling and an evaluation of the source, bottling and treatment processes, sanitation and maintenance procedures as well as compliance with good manufacturing practices.
- Annual Requirements
New York State certified bottled and bulk water facilities are required to monitor for organic chemical, inorganic chemical and radiological analyses, on an annual basis, for each source and finished product type. All monitoring required by Subpart 5-6 of the State Sanitary Code must be conducted by a laboratory certified by the Department's Environmental Laboratory Approval Program (ELAP).
- Monthly Requirements
New York State certified bottled and bulk water facilities are required to monitor, on a monthly basis, microbiological analyses in accordance with Subpart 5-6, Section 5-6.11, Table 1A - Microbiological Sampling Frequency.
- Surveillance Monitoring
Approximately 30 bottled and bulk water surveillance and/or complaint investigation samples were collected by Department (both field and central office) staff which were analyzed for either inorganic chemical, organic chemical, microbiological and/or particle identification parameters. These samples were collected primarily in response to consumer complaints or to verify results received for initial certification of new products.
Bottled and bulk water facilities are required to submit a Monthly Operating Report (Production Bacteriological Samples - DOH-357) no later than the 10th of the month following the month of the reporting period. The required amount of monthly monitoring is determined by the number of gallons produced for New York State distribution or the number of potable water gallons hauled in New York State and is outlined in Section 5-6.11, Table 1A of Subpart 5-6 of the State Sanitary Code.
In 2012, the Department sent 104 violation letters to certified bottled water facilities and 85 violation letters to certified bulk water haulers for non-submittal of Monthly Operating Reports. In addition, the Department sent 33 violation letters to certified bottled water facilities and 29 violation letters to certified bulk water haulers for non-submittal of monthly microbiological results from an ELAP certified laboratory (see Monthly Violations for 2012 table below). All data were complete at time of renewal of certified bottlers.
|Certification Type||Failure to Submit Monthly
|Failure to Submit|
In 2012, the Department sent 6 violation letters to New York State certified bottled and bulk water facilities when monthly microbiological sample results tested positive for coliform and/or E. coli for their source or their finished products. The facilities were required to take follow-up samples, determine the source of the problem and take the necessary corrective action. The Department also sent 20 action letters to bottled and bulk water facilities when results of a Standard Plate Count (SPC) or Heterotrophic Plate Count (HPC) was greater than 500 cfu/mL. Bottled and bulk water facilities that were in violation of Subpart 5-6, as outlined in this section, have satisfactorily provided corrective measures to address the violations.
In 2012, the Department did not have any administrative tribunal enforcement actions against bottled and bulk water facilities for violations of Subpart 5-6 in addition to issuing notices of violation and conducting subsequent follow-up investigations.
Subpart 5-6, specifically Subdivision 5-6.7(i), requires bottled water facilities to have on file a written recall plan which details the procedures for recall of any particular batch as identified by the production date code. This recall plan may be initiated when it is determined (by the bottler and/or Department) that a potential contamination incident has occurred.
In 2012, there were no incidents of contamination of bottled water products that constituted a recall of bottled water products.
The Department addresses bottled and bulk water complaints based upon the nature and severity of the complaint at hand. For complaints related to distribution or financial issues, the complainant is referred to the vendor or the bottler. Complaints that suggest illness, possible water quality standard exceedances, imminent or widespread public danger will be referred for investigation to the Department which works in concert with the appropriate local county health department or district office in which the bottler is located. Complaints dealing with aesthetic concerns are addressed by either the bottling facility or the appropriate level of health department.
In 2012, approximately 30 consumer complaints were received and/or referred to the Department for investigation and follow-up. The majority of the consumer complaints consisted of isolated incidents involving taste and/or odor problems associated with bottled water products or household contamination of the product. In most cases, sealed bottled water products from the same production run, or as close as possible to the production run, were sent to the Department's Wadsworth Laboratory for testing.
Public Education and Outreach
In 2012, the Department's Bureau of Water Supply Protection (BWSP) fielded numerous telephone, e-mail and letter inquiries concerning the Bottled and Bulk Water Program. Typical inquiries included regulation questions, certification questions and complaints. These inquiries were received from consumers, field staff, bottlers, bulk water haulers and other state and foreign agencies.