Source: https://www.health.ny.gov/environmental/water/drinking/bulk_bottle/report_2015.htm
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New York State Bottled and Bulk Water Program 2015 Annual Report
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The Bottled and Bulk Water Program 2015 Annual Report is a summary of certification program activities conducted by the New York State Department of Health (Department) as required by Section 225(5)(a) of the Public Health Law. 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;
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 2015, six bottled water facilities and one 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 2015, there were 219 bottled and bulk water facilities certified by the Department. Of these 219 certified bottled/bulk water facilities, 63 are located in New York State, 117 are located out-ofstate but within the United States and 39 are located in foreign countries.
2015 Bottled and Bulk Water Certifications
Bottled and Bulk Water Facility Location
Number of Certified Facilities
Within NYS 63
Out of State (within USA) 117
Out of Country 39
Uncertified Bottled and Bulk Water in New York State
As required under Section 5-6.2 of Subpart 5-6, "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 2015, four 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, one bulk water hauler was notified by the Department that it was 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 2015, the Department notified 28 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 28 bottled and bulk water facilities, 20 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 Title 2, Section 225 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.
156 certified bottled water facilities reported that of the approximately 4,429,669,379 gallons produced during 2014, approximately 447,145,807 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. 63 certified bulk water haulers reported that approximately 133,760,815 gallons of potable drinking water was distributed in New York State in 2014.
NOTE: 2015 production numbers will be reported in 2016.
An annual inspection must be made of each bottled and bulk water facility. The inspection may be conducted by a third party approved by the Department, local county health department or district office, or 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.
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 parameters in accordance with Subpart 5-6, Section 5-6.11, Table 1A - Microbiological Sampling Frequency.
Approximately five 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 (DOH-357) no later than the 10th of the month following the month of the reporting period, as outlined in Section 5-6.11, Table 1A of Subpart 5-6 of the State Sanitary Code.
In 2015, the Department sent 61 violation letters to certified bottled water facilities and 74 violation letters to certified bulk water haulers for non-submittal of Monthly Operating Reports. In addition, the Department sent 41 violation letters to certified bottled water facilities and 51 violation letters to certified bulk water haulers for non-submittal of monthly microbiological results from an ELAP certified laboratory (see Monthly Violations for 2015 table below). All data were complete at time of renewal of certified bottlers.
Monitoring/Reporting Violations for 2015
Failure to Submit Monthly
Bottled Water 61 41
Bulk Water 74 51
Total 135 92
In 2015, the Department sent seven 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 14 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 2015, 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. The Department’s response to recalls may include, but is not limited to, review of monitoring results, recall documents and engineering reports to determine if the contamination/potential contamination has been remediated. In addition, the Department may conduct or require, in the case of out-of-state facilities, inspections, direct the collection of water samples and require the bottled water facility to take additional corrective measures to prevent future contamination before the facility is allowed to sell, offer for sale and/or distribute bottled water in New York State.
In 2015, there were two 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 2015, approximately 20 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 foreign objects in multi-use containers, taste and/or odor problems associated with bottled water products or household contamination.
In 2015, 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.
Questions or comments: h2ocert@health.ny.gov