New York State Bottled and Bulk Water Program 2004 Annual Report
New York State Department of Health
Bureau of Water Supply Protection
Bottled and Bulk Water Program
2004 Annual Report
The Bottled and Bulk Water Program 2004 Annual Report is a summary of those 2004 certification program activities under the purview of Section 225(u) of the Public Health Law (PBH) of the Laws of New York. The standards for bottled and bulk water facilities are contained in Subpart 5-6, Bottled and Bulk Water Standards, of the State Sanitary Code. 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 New York State Department of Health (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 2004, 14 bottled water facilities and 7 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 2004, the total number of bottled water facilities certified by the Department reached 241. Of these 241 certified bottled/bulk water facilities, 91 are located in New York State, 105 are located out-of-state and 45 are located in foreign countries.
|Out of State (within USA)
|Out of Country
|Initial Certification Total
|Out of State (within USA)
|Out of Country
|Renewal of Certification Total
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 2004, six bottled water companies 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. One bulk water hauler was 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 2004, the Department decertified 24 bottled and bulk water facilities 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. The majority of decertifications resulted from bottled or bulk water facilities failing to submit complete documentation in order to be eligible for recertification.
In 2004, 160 certified bottled water facilities reported, that of the approximately 4,219,098,460 total gallons they produced during 2003, approximately 345,674,500 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, sparkling and glacial waters. In 2004, certified bulk water haulers reported that approximately 111,317,961 gallons of potable drinking water was distributed in New York State.
NOTE: 2004 production numbers will be reported in 2005.
An annual inspection must be made of each bottled and bulk water facility. The inspection may be conducted by the New York State Department of Health, 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 within New York 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.
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).
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.
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 product recalls, 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 (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 2004, the Department sent 164 violation letters to certified bottled water facilities and 86 violation letters to certified bulk water haulers for non-submittal of Monthly Operating Reports. Also, the Department sent 189 violation letters to certified bottled water facilities and 85 violation letters to certified bulk water haulers for non-submittal of monthly microbiological results from a New York State Health Department certified laboratory (see Monthly Violations for 2004 table below).
|Failure to Submit Monthly
|Failure to Submit
In 2004, the Department sent 36 violation letters to New York State certified bottled and bulk water facilities when monthly microbiological sample results tested positive for coliform and E.coli for their source or their finished products. Also, the Department sent 35 violation letters to bottled and bulk water facilities when results of a Standard Plate Count (SPC) or Heterotrophic Plate Count (HPC) result was greater than 500 cfu/mL.
In 2004, the Department initiated enforcement actions against bottled/bulk water facilities on 524 occasions by issuing notices of violation letters for failure to submit required monthly forms and documents.
The New York State Sanitary Code Subdivision 5-6.7(i), requires bottled water facilities 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 State Health Department) that a potential contamination incident has occurred.
In 2004, there was one incident of contamination of bottled water products in New York State. The Department was notified that the bottler had received a positive microbiological result of coliform and E.coli from samples taken from a five gallon finished bottled water product. A recall of the product was initiated by the bottler. Four repeat samples were collected from the same production run and were sent for analysis. The four repeat samples all tested negative for coliform and e.coli. It was determined that the initial positive results were attributed to laboratory or sample collection error.
Also in 2004, a bulk water hauler had a coliform positive result from a sample taken from a tanker. The bulk hauler was instructed by the Department to cease all hauling operations and to have additional bacteriological samples analyzed from the tanker. Three of the four samples came back with a coliform positive result. The bulk hauler was instructed, by the Department, to disinfect the tanker and hoses as well as take another four bacteriological samples. These samples all tested negative and the bulk hauler was allowed to resume bulk water hauling.
The Department addresses bottled/bulk water complaints based upon the nature and severity of the complaint at hand. For complaints related to aesthetic concerns, 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 appropriate local county health department or district office in which the bottler is located.
In 2004, approximately 40 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. No recalls resulted from these investigations. 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. All results received from Wadsworth Laboratory met the requirements outlined in Subpart 5-6 for all parameters indicative of the individual complaint.
Public Education and Outreach
In 2004, the Department's Bureau of Water Supply Protection (BWSP) fielded hundreds of 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, media, field staff, bottlers, bulk water haulers and other state and foreign agencies. In addition, BWSP staff provided program presentations at conferences as well as for field staff training purposes.