Source: http://www.health.ny.gov/regulations/nycrr/title_10/part_5/subpart_5-6.htm
Timestamp: 2013-05-25 17:19:06
Document Index: 752513440

Matched Legal Cases: ['art 5', 'art 5', 'art 5', 'art 5', 'art 5', '§225', 'art.\n5', 'art 129', 'art 136']

Part 5, Subpart 5-6 Bottled And Bulk Water Standards
> Part 5, Subpart 5-6 Bottled And Bulk Water Standards
Chapter I State Sanitary Code
Part 5Drinking Water Supplies(Statutory Authority: Public Health Law §225)
Room 400, 4th Floor
Tel.: (518) 402-7676
5-6.1 Applicability
5-6.2 Distribution of bottled or bulk water
5-6.3 Definitions
5-6.4 Sources of water
5-6.5 Required treatment
5-6.6 Bottling plant facilities
5-6.7 Production, equipment and packaging
5-6.8 Sanitation and maintenance
5-6.9 Sanitizing bottles
5-6.10 Maximum contaminant levels
5-6.11 Tables
5-6.12 Labeling
5-6.13 Sampling, methods and record keeping
5-6.14 Notification
5-6.15 Bulk water
5-6.16 Certification procedures
5-6.17 Violations
5-6.18 Separability
5-6.1 Applicability The provisions of sections 5-6.2 through 5-6.18 of this Subpart shall apply to bottled and bulk water produced, used and/or sold in New York State.
5-6.2 Distribution of bottled or bulk waterNo 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.
5-6.3 DefinitionsAs used in this Subpart, the following words or terms shall have the indicated meaning, except as otherwise specifically provided:
(b) Approved source shall mean the source of water from a spring, artesian well, drilled well, municipal water supply, or any other source which has been evaluated and found to be of satisfactory sanitary quality as determined by the State.
(d) Bottled water shall mean any product, including natural spring or well water taken from municipal or private utility systems or other water, distilled water, deionized water, or any of the foregoing to which chemicals may be added, which are put into sealed bottles, packages or other containers, to be sold for domestic consumption or culinary use, involving a likelihood of such water being ingested by human beings.
(f) Bulk water shall mean water intended for potable uses which is transported by tank truck.
(i) Food and Drugs 21 CFR shall mean the Code of Federal Regulations, Title 21, Food and Drugs, as published in the Federal Register, Volume 42, Page 14355, March 15, 1977, as amended by Volume 44, Page 12175, March 6, 1979 and found in 21 CFR, Part 129 - Processing and Bottling of bottled Drinking Water, Pages 137 through 141, revised as of April 1, 1988. A copy is available for public inspection at the offices of the Records Access Officer of the Department of Health, Empire State Plaza, Corning Tower, Albany, NY 12237.
(n) Person in charge shall mean the designated employee or employees who are appointed and in responsible charge of the bottling facility and who are present at all time during the bottling operation.
(6) Halogenated Non-aromatic Cyclic Hydrocarbons.
(p) Production line shall mean an assemblage of water bottling equipment which share product water contact surfaces and may be used to fill one or more container types/sizes or product types.
(q) Recommended Standards for Water Works shall mean the New York State Health Department publication, 1987, published by Health Research, Inc., P.O. Box 7126, Albany, NY 12224. A copy is available for public inspection at the offices of the Records Access Officer of the Department of Health, Empire State Plaza, Corning Tower, Albany, NY 12237.
(r) Rural Water Supply shall mean the New York State Department of Health publication by that name as copyrighted in 1966 and reprinted in 1988. A copy is available for public inspection at the offices of the Records Access Officer of the Department of Health, Empire State Plaza, Corning Tower, Albany, NY 12237
(u) Total trihalomethane (TTHM) shall mean the sum of the concentration of trichloromethane (chloroform), dibromochlormethane, bromodichloromethane and tribromomethane ( bromoform).
(w) Violation shall mean the failure to comply with or conform to the provisions of this subpart.
(x) Well water shall mean water that is taken from below the ground through piping or similar installed device using external force or vacuum.
5-6.4 Sources of waterAll sources of water must be approved before use.
(5) Spring water shall be collected only at the natural orifice of the spring or through a borehole that is adjacent to the natural orifice. Spring water collected with the assistance of external force or through a bore hole or through a spring head that is otherwise altered to protect the water source shall retain all the physical properties of and be of the same composition and quality as the water that flows naturally to the surface of the earth.
5-6.5 Required TreatmentAll bottled water facilities packaging water for distribution in New York State must provide satisfactory treatment of each water supply source used.
(2) A laboratory as described in section 5-6.13 of this Subpart is used by the bottling facility to provide monitoring of source and finished product water quality.
5-6.6 Bottling plant facilities Bottling plants must be constructed to facilitate cleanliness and be maintained to maximize sanitation and public health protection.
(b) The bottle filling operations shall be separated from other plant operations or storage areas by tight walls, ceilings, and self-closing doors or other appropriate barriers to isolate these areas and provide protection against incidental contamination. Conveyor openings shall not exceed the size required to permit passage of containers.
(c) Plant buildings shall be vermin proof.
(d) Walls and ceilings shall be smooth, light color, washable and kept in good repair. Overhead structures, fixtures, ducts, and pipes shall not be suspended over working areas so that drip or condensate may contaminate products or product contact surfaces.
(e) Floors shall be smooth, nonabsorbent and vermin proof. Floors are to be graded to adequate drains equipped with traps and grills.
(g) All rooms are to be provided with sufficient ventilation to keep them free of excessive heat, steam, condensation, vapors, odors, and fumes.
(h) Lighting, either natural or artificial, shall be provided in all rooms where bottled or packaged waters are produced. An intensity of not less than 50 foot-candles shall be provided in inspection areas; 30 foot-candles in work spaces, and five foot-candles in storage areas. Light bulbs, fixtures, skylights or other glass suspended over exposed production areas shall be of the safety type or otherwise protected from breakage to prevent finished product contamination.
(i) Washrooms shall be convenient, separate, and apart from any room or rooms where bottled or packaged water is processed and from areas where bottles and packages are sanitized. Toilets, urinals and wash basins shall be provided, as appropriate, for the number of employees. Washrooms shall be equipped with self-closing doors and fitted with windows or separate ventilation to the outside. Signs shall be posted directing employees to wash their hands after using the toilet.
5-6.7 Production, equipment, and packaging All bottled water production, including transporting, packaging, and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for chemical contamination, undesirable bacterial or other microbiological growth, toxic formation, deterioration, or contamination of the finished product.
(b) Fillers, piping, pumps and other process equipment used in the production of bottled water products may not be used for the production of milk and/or dairy products. Other beverage production that may impart deleterious substances to bottled water produced in the same equipment or cause microbiological contamination of the bottled water, may also be prohibited when the contamination is confirmed by two documented cases.
(c) All equipment shall be of sanitary design and shall be constructed of nontoxic, nonabsorbent material which will not impart flavor, color or odor to the bottled water. All equipment shall be installed and maintained to facilitate the cleaning of equipment and of all adjacent spaces. All material used in the design, construction and repair of the water transmission and/or production piping in a bottled or bulk water facility must be lead free. For this Subpart, lead free shall mean solder or flux which contains no more than 0.2 percent lead and pipes, pipefittings and any appurtenances which contain no more than eight percent lead.
(3) Protected from cross-connection and equipped with backflow prevention devices approved by the State or the governmental regulatory agency having jurisdiction over facilities located outside the State.
(e) There shall be no cross-connections between finished product water lines and any other water pipelines.
(g) Fillers shall have the inlet so designed as to prevent the entrance of condensation. Filling valves shall be equipped with a condensation-diverting apron.
(1) Packaging processes and materials shall not transmit contaminants or objectionable, toxic or deleterious substances to the bottled water.
5-6.8 Sanitation and maintenanceBuildings, fixtures and other physical facilities of the plant shall be kept in good repair and shall be maintained in a sanitary condition. Cleaning operations shall be conducted in such a manner as to minimize the danger of contamination of product and product contact surfaces. Detergents, sanitizers and other materials used in cleaning and sanitizing procedures shall be free of chemical or microbiological contamination and shall be safe and effective for their intended use. Only such materials as required to maintain sanitary conditions, for use in laboratory testing procedures, for plant and equipment maintenance and operation or used in manufacturing or processing operations, shall be stored in the plant. These materials shall be identified and used only in such manner and conditions that will be safe for their intended use.
(2) Cleaned on a monthly basis by sanitizing with one of the following and flushing with finished product water:
(iv) 0.1 ppm ozone water solution for or not less than 10 minutes contact time.
(ii) the continuous re-circulation of at least 0.1 ppm ozonated water.
(d) Personnel shall, at a minimum, meet the following requirements:
(1) Employees shall wear clean outer garments and caps while bottling; packaging water or sanitizing bottles and packages.
5-6.9 Sanitizing bottlesThe bottles shall be properly sanitized before use by using approved methods and approved sanitizing agents.
(b)The bactericidal procedure for the inside of bottles, as a minimum, shall be one of the following:
(2) Sanitize with a 2-1/2 percent caustic solution at a minimum temperature of 120 degrees Fahrenheit followed by a rinse containing not less than 10 ppm free chlorine. Note: When caustic is discharged by high-velocity jets, this procedure shall be considered to satisfy both cleaning and bactericidal requirements.
(4) Sanitize by exposing all surfaces to a three percent caustic solution at a minimum temperature of 120 degrees Fahrenheit for five minutes -- by automatic bottle washers using high-velocity, hydro-type jets or by soaker washers -- followed by a rinse containing not less than 10 ppm free chlorine.
(a) The MCLs listed in section 5-6.11 of this Subpart shall not be exceeded.
(c) If the result of a monitoring sample analysis exceeds the MCL for a physical contaminant, except for turbidity or an inorganic chemical contaminant, except for nitrate, the owner or operator of the bottled or bulk facility shall collect and analyze three more samples from the same production run, when feasible, but no later than 24 hours of learning of a potential violation. An MCL violation occurs when the average, rounded to the same number of significant figures as the MCL in question, of the four results exceeds the MCL. For nitrate, the owner or operator of the bottled or bulk water facility shall collect and analyze one more sample from the same production run, when feasible, but no later than 24 hours of learning of a potential violation. An MCL violation occurs when the average of the two results exceeds the MCL.
(e) The commissioner may exempt bottled water from the chemical and radiological MCLs based on justification, submitted by the owner or operator of the bottled water facility, that granting of the exemption would not result in public health hazard. If an exemption is granted, an appropriate label, approved by the commissioner, shall be conspicuously placed on all bottles and/or containers of such exempted bottled water produced, distributed and/or sold within New York State in accordance with subdivision 5-6.12(b) of this Subpart.
(f) All analyses for general organic chemicals must be performed in accordance with the U.S. Environmental Protection Agency (EPA) Methods 502.1, 503.1, 524.1, 524.2, or 502.2, at a detection limit not to exceed 0.0005 milligrams per liter. If the State has reason to believe that an MCL has been violated, the potential exists for an MCL violation or the contaminant may present a risk to public health, principal organic contaminant analyses shall also include EPA Methods 504, 625, 604, 605, 608, 609, 611, or 612, as appropriate. EPA Methods 502.1, 503.1, 524.1, 524.2, 502.2 and 504 mean, respectively, "Volatile Halogenated Organic Compounds in Water by Purge and Trap Gas Chromatography;" "Volatile Aromatic and Unsaturated Organic Compounds in Water by Purge and Trap Gas Chromatography;" "Volatile Organic Compounds in Water by Purge and Trap Gas Chromatography/Mass Spectrometry"; "Volatile Organic Compounds in Water by Purge and Trap Capillary Column Gas Chromatography/Mass Spectrometry," "Volatile Organic Compounds in Water by Purge and Trap Capillary Gas Chromatography with Photoionization and Electrolytic Conductivity Detectors in Series"; and "Measurement of 1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-chloropropane (DBCP) in Drinking Water by Microextraction and Gas Chromatography." These methods are contained in "Methods for Determination of Organic Compounds in Finished Drinking Water and Raw Source Water"; September 1986. Copies of this publication can be obtained from Environmental Monitoring and Support Laboratory, EPA, Cincinnati, Ohio 45268, and a copy is available for inspection and copying at the offices of the Records Access Officer of the Department of Health, Corning Tower, Empire State Plaza, Albany, NY 12237. EPA Methods 604, 605, 608, 609, 611, 612, and 625 mean respectively "Methods for Organic Chemical Analysis of Municipal and Industrial Wastewater; Methods 604 - Phenols; Method 605 - Benzidines; Method 608 - Organochlorine Pesticides and PCBs; Method 609 - Nitroaromatics and Isophorone; Method 611 - Haloethers; Method 612 - Chlorinated Hydrocarbons; and Method 625 - Base/Neutrals and Acids." These methods are contained in 40 CFR Part 136 as published in the Federal Register, Volume 49, page 43250, No. 209, Friday, October 26, 1984. Copies of this publication are available from U.S. Environmental Protection Agency, Public Information Reference Unit, 401 M Street, S.W., Washington, D.C. 20460 and a copy is available for inspection and copying at the offices of the Records Access Officer of the Department of Health, Corning Tower, Empire State Plaza, Albany, NY 12237.
Table 1 - Bottled Water Sampling Requirements
Frequency of Samples
See Table 1A
Less than 1 organism per 100 ml3
- Gross Alpha Particle Activity (including Radium 226 but excluding Radon and Uranium
- Combined Radium 226 and Radium 228
- Beta particle and photon activity from manmade radionuclides
4 millireams per year
Threshold Odor No. 3
Inorganic Chemical:
Barium (Ba)1.0
Cadmium (Cd)0.01 Chloride (Cl)250.0
Chromium (Cr)0.05
Copper (Cu)1.0
Fluoride (F)2.2
Iron (Fe)0.3 Lead (Pb)0.05
Manganese (Mn)0.3 Mercury (Hg)0.002
Nitrate (N)10.0
Selenium (Se)0.01
Silver (Ag)0.05
Sulfate (SO4)250.0
Zinc (Zn)5.0
Alkalinity*2
Corrosivity*2 Hardness *2
pH*2
Sodium (Na)*2
Total Dissolved Solids*2
Principal Organic Contaminant (See Table 1B for listing of monitored contaminants.)
Unspecified Organic Contaminants
Total of all POCs and UOCs
Samples shall be collected and analyzed for each production line and product type. If more than one container size is bottled at the facility, a plan to rotate sampling of container sizes shall be submitted to and approved by the Department.
No maximum contaminant level established.
No positive total coliform result.
All monitoring samples shall be collected and analyzed in the first quarter of the calendar year, unless otherwise specified by the State.
Every third year, beginning in 1992, or in the first full calendar year following certification, four quarterly monitoring samples shall be collected and analyzed.
The owner or operator of a bottled water facility shall require the approved laboratory performing the analyses to send a copy of the laboratory report directly to the Department. The owner or operator of a bottled water facility shall submit with the next monthly monitoring report following receipt of the laboratory report a letter to the Department, certifying that the aforementioned laboratory report accurately represents the quality of the described bottled water product and that the bottled water product complies with the organic, inorganic, radiological and other water quality standards in this Subpart.
Table 1A - Microbiological Sampling Frequency
Total Gallons Produced Per Month
Uncarbonated Bottled Water
Finished Product Per Week
Source Water Per Month
Finished Product Per Month
1 to 39,999
80,000 to 299,999
300,000 to 699,999
700,000 and more
Table 1B - Principal Organic Chemicals
Principal Organic Chemicals benzene
carbon tetrochloride
trans-1,3,-dichloropropene
Each bottle or container shall bear a label, to be affixed to each bottle or container before it leaves the plant. Wording shall be printed in English, in legible type which shall be in contrast by typography, layout or color, with other printed matter on the level, cap, or container.
(i) For water coming from springs: "Spring Water".
(ii) For artesian or pumped water taken from the ground, from drilled wells or approved dug wells: "Well Water".
(iii) For a municipal water supply source, the name of the municipal supply, such as "New York City Pubic Water Supply", "Buffalo City Public Water Supply", etc.
(iv) For bottled water identified on the label as being distilled, the type of source water does not need to be shown.
(a) Bottled water shall be sampled at the frequency and analyzed for the water quality parameters outlined in section 5-6.11 of this Subpart.
(b) Samples for any water quality parameter not specified in section 5-6.11 of this Subpart shall be collected and analyzed as may be required the State.
(5) Analysis shall be conducted by the analytical requirements set forth in Standard Methods for the Examination of Water and Wastewater, current edition, or alternate methods approved by the department's Environmental Laboratory Approval Program.
(3) Out-of-State bottlers shall submit their month operating reports no later than the 10th of the month following the month of the reporting period. The annual inspection report performed by the government agency having jurisdiction shall be submitted each year. The monthly operating reports and annual inspection report are to be sent directly to:
New York State Department of HealthBureau of Public Water Supply ProtectionFlanigan Square547 River StreetTroy, NY 12180-2216
Any person who owns or operates a bottled or bulk water facility must notify the State by telephone, facsimile (FAX) copy or other means when feasible, but no later than 24 hours of learning of the existence or potential existence of a violation of Section 5-6.11 of this Subpart.
All bulk water sources and facilities must be approved and maintained for sanitary quality at all times.
(c) Tank trucks, loading and unloading facilities and other equipment used to transport bulk water shall be maintained clean and sanitary at all times. Tanks previously used to transport toxic materials, petroleum products or other deleterious substances shall not be used to haul drinking water.
(1) Before filling, the tank interior shall be cleaned, flushed with potable water, sanitized with water containing not less than 100 ppm chlorine for a contact period of not less than 20 minutes and rinsed with potable water.
(8) The dome cover shall be closed and sealed after filing to volume desired.
(e) The number and type of sample, frequency and points of sampling shall be in accordance with requirements outlined in section 5-6.11 of this Subpart or a program approved or directed by the State.
All bottled or bulk water products sold or distributed in New York State must be certified. The following procedures must be met to apply for certification:
(1) Complete and submit a signed application form, GEN. 222 Application for Certification of Approval for Distribution of Bottled or Bulk Water.
(2) Submit a statement from the appropriate regulatory agency of the state or country having jurisdiction over the bottling operation, indicating that the facility has been approved to bottle or package water for human consumption. This approval may be a copy of a certificate, license, permit or a letter of approval from the agency. A copy of the laws and regulations on bottled water processing from the regulatory agency having jurisdiction must also be submitted. When another state or country has no program for inspection and approval of bulk or bottled water facilities, the commissioner may make a determination based on an inspection and evaluation by an independent individual or organization knowledgeable in bulk or bottled water handing practices.
(3) Submit an engineering report, plans and specifications for the proposal prepared by a registered Professional Engineer licensed to practice in New York State or in the state which the facility is located. This submittal must include, but not be limited to, the development of the source, methods used in the bottling operation, the water treatment used and laboratory control of water quality provided and a flow diagram from source through the bottling operation. The report submitted with the application must show compliance with the requirements of this Subpart.
(5) Submit complete inorganic chemical, organic chemical, microbiological and radiological analyses for contaminants listed in section 5-6.11 to this Subpart for each source and each finished bottled water product type to be distributed in New York State. Results of these analyses must be submitted with the application. Additional analyses may be required, if in the judgement of the commissioner they are needed to determine the acceptability of the source or treatment provided. All analyses must be performed by an approved laboratory and in accordance with the sampling methods as outlined in section 5-6.13 of this Subpart. All analyses must have been performed within the last six months from the date of the application for or certification, except for the microbiological analyses which must have been performed within thirty days from the date of the application for certification.
(2) Submit a statement from the appropriate regulatory agency of the state having jurisdiction over the bulk water operation indicating that an inspection of the water source, transporting vehicles and sanitation procedures has been made and is in conformance with the appropriate minimum standards as outlined in this Subpart. When another state has no program for inspection and approval of bulk water operators, the commissioner may make a determination based on an inspection and evaluation by an independent individual or organization knowledgeable in bulk water handing practices.
(4) Submit complete inorganic chemical, organic chemical, microbiological and radiological analyses for contaminants as listed in section 5-6.11 of this Subpart for each source to be used. Results of these analyses must be submitted with the application. Additional analyses may be required if, in the judgement of the commissioner, they are needed to determine the acceptability of the source or treatment provided. All analyses must be performed in accordance with the sampling methods as outlined in section 5-6.13 of this Subpart. All analyses must have been performed within the last six months from the date of the application for certification, except for the microbiological analyses which must have been performed within thirty days from the date of the application for certification.
(1) Each year, a statement must be submitted from the appropriate regulatory agency of the state or country having jurisdiction over the bottling facility indicating that the facility has been inspected and approved to bottled or package water for human consumption.
(2) Each month, a form GEN 221 Report on Bottled Water Operation, must be completed and submitted no later than the 10th of the month following the month of the reporting period. The microbiological sample results on source and finished products must conform to the requirements of sections 5-6.10, 5-6.11 and 5-6.13 of this Subpart. Results of each analysis must be entered on the GEN. 221 opposite the date the sample was collected. The quantity of water shipped for distribution in New York State must be entered on the GEN. 221 in the daily product column opposite the date of actual shipment.
(5) All exemptions requests must be submitted by July 1st for the calendar year. The required annual water quality monitoring data will be reviewed along with any other available data. Besides the submission of data for maintaining approval, the data as outlined in subdivision (b) of this section, must also be submitted.
Violations of this Subpart may subject the owner or operator of the bottled or bulk water facility to civil penalties of up to $2,000 per violation, revocation of their certificate of approval to distribute bottled or bulk water within New York State and/or a recall of all product on the market in New York State.
If any provision of this Part are held invalid, such invalidity shall not affect other portions which can be given effect without the invalid provisions.