[29 Pa.B. 2231]
[Continued from previous Web Page] § 109.1005. Permit requirements.
(a) General permit requirement. A person may not construct or operate a bottled water or vended water system, retail water facility or bulk water hauling system without first having obtained a public water system permit under subsection (b) or (e).
(b) Special permit by rule requirement for vended water systems.
(1) A person constructing and operating a vended water system shall obtain a separate and distinct permit under subsection (d) for each water vending machine owned by the same person unless the vended water system satisfies the conditions in this subsection. A separate and distinct permit by rule will be required for each Department region in which the water vending machines are located. The Department retains the right to require a vended water system that meets the requirements of this subsection to obtain a permit, if, in the judgment of the Department, the vended water system cannot be adequately regulated through the standardized specifications and conditions. A vended water system which is released from the obligation to obtain a permit shall comply with the other requirements of this subchapter, including design, construction and operation requirements.
(i) A vended water system in which all water vending machines are located in the same Department region.
(ii) A vended water system which has as its sole source of water, finished water from existing permitted community water systems and uses only NAMA approved water vending machines satisfies the permit requirement of the act.
(2) A vended water system covered under this subsection shall register with the Department on forms provided by the Department. Amendments to the registration shall be filed when a substantial modification is made to the system. Descriptions of modifications shall be filed within 30 days of operation of the modification.
(c) Special permit by rule requirement for bottled water systems. A person owning or operating a bottled water system in this Commonwealth permitted under this chapter shall obtain an amended permit before making substantial modifications to the processing and bottling facilities unless the bottled water system satisfies the conditions in paragraphs (1)--(5). The permit by rule does not apply to the collection facilities. The Department retains the right to require a bottled water system that meets the requirements of paragraphs (1)--(5) to obtain a permit, if, in the judgment of the Department, the bottled water system cannot be adequately regulated through the standardized specifications and conditions. A bottled water system which is released from the obligation to obtain a permit shall comply with the other requirements of this subchapter, including design, construction and operation requirements. The following are the conditions for a permit by rule:
(1) The bottled water system has as its sole source of water permitted groundwater sources which are not under the direct influence of surface water as determined through the Department's Guidance for Surface Water Identification protocol or finished water from a Department approved community water system.
(2) The water quality of the sources does not exceed the Food and Drug Administration quality standards for primary (that is, health-related) chemical and radiological contaminants specified in 21 CFR 165.110 (relating to bottled water) as determined under sampling conducted under subsection (e)(4)(ii) and requires treatment no greater than disinfection to provide water of a quality that meets the primary MCLs established under Subchapter B (relating to MCLs and treatment techniques).
(3) Proof that the facilities meet the standards of the Food and Drug Administration in 21 CFR Parts 110, 129 and 165 (relating to current good manufacturing practice in manufacturing, packing, or holding human food; processing and bottling of bottled drinking water; and beverages) and the IBWA Model Bottled Water Code as determined by an onsite evaluation conducted by a Nationally recognized, independent, not-for-profit third-party organization such as NSF or other organization acceptable to the Department. The onsite evaluation shall be conducted annually. The proof shall consist of the report issued by the organization which shall be submitted to the Department within 30 days following the completion of the onsite evaluation. To be acceptable to the Department, the organization shall:
(i) Be accredited by ANSI as a third-party inspection/evaluation organization.
(ii) Have well developed, documented policies, procedures and contracts to support Department enforcement actions for meeting compliance objectives.
(4) A bottled water system intending to operate under this subsection shall submit written notification to the Department with documentation that the system complies with paragraphs (1)--(3).
(5) A bottled water system operating under this subsection shall file descriptions of substantial modifications made to the system to the Department within 30 days of operation of the modification. The description shall include documentation that the modification meets the following requirements as applicable:
(i) Compliance with the product water-contact materials and treatment chemical additives toxicological requirements of § 109.606 (relating to chemicals, materials and equipment) or alternatively, the Food and Drug Administration standards in 21 CFR Part 129.
(ii) Validated treatment technologies for the reduction of contaminants. Validated treatment technologies are those that have been permitted by the Department under this chapter at the bottled water system operating under the permit by rule or certified to an applicable ANSI/NSF standard by NSF or other certification organization acceptable to the Department or verified under the EPA Environmental Technology Verification Program. To be acceptable to the Department, a certification organization other than NSF shall be accredited by ANSI as a third-party certification organization and meet the requirements under § 109.606(d) (relating to chemicals, materials and equipment) as applicable to the appropriate ANSI/NSF standard for the treatment technology.
(6) The Department will publish a notice in the Pennsylvania Bulletin of its determination that a bottled water system has complied with paragraphs (1)--(4) and is operating under the permit by rule. The Department will publish a notice in the Pennsylvania Bulletin of descriptions submitted under paragraph (5) of substantial modifications made by a bottled water system operating under the permit by rule.
(d) Permit amendments. A person may not substantially modify a bottled water or vended water system, retail water facility or bulk water hauling system operated under a public water system permit without obtaining a permit amendment from the Department or otherwise complying with subsection (f).
(e) Permit applications. An application for a public water system permit for a bottled water or vended water system, retail water facility or bulk water hauling system shall be submitted in writing on forms provided by the Department and shall be accompanied by plans, specifications, engineer's report, water quality analyses and other data, information or documentation reasonably necessary to enable the Department to determine compliance with the act and this chapter. The Department will make available to the applicant the Public Water Supply Manual, available from the Bureau of Water Supply Management, Post Office Box 8467, Harrisburg, Pennsylvania 17105-8467 which contains acceptable design standards and technical guidance. Water quality analyses shall be conducted by a laboratory certified under this chapter. An application for a public water system permit for a bottled water or vended water system, retail water facility or bulk water hauling system shall include:
(1) The signature of the appropriate individual identified in § 109.503(a)(1)(i) (relating to public water system construction permits).
(2) Plans, specifications and engineer's report or modules prepared by or under the supervision of a professional engineer registered to practice in this Commonwealth, or in the state in which the water system is located, except that manufacturer's drawings and specifications for equipment or vending machines may be submitted in lieu of plans and specifications, as prescribed in this section, for the equipment or machines.
(3) The front cover or flyleaf of each set of drawings, and of each copy of the specifications and engineer's report, except for manufacturer's drawings and specifications, shall bear the signature and imprint of the seal of the registered professional engineer. Each drawing shall bear an imprint or a legible facsimile of the seal.
(4) Information describing new sources as follows:
(i) A comprehensive sanitary survey of the physical surroundings of each new source of raw water.
(ii) An evaluation of the quantity and quality of the raw water available from each new source. The evaluation shall include data for each primary and secondary contaminant and other contaminants the Department determines necessary to evaluate potability of the source. When a new source is finished water from another public water system, the most recent quality data if in compliance with the monitoring requirements of this chapter, obtained from the public water system supplying the finished water may be submitted.
(5) An erosion and sedimentation control plan which meets the requirements in Chapter 102 (relating to erosion control) when earthmoving activities are involved.
(6) In lieu of compliance with paragraphs (2)--(5), the Department may accept approval of an out-of-State systems' source and facilities by the agency having jurisdiction over drinking water in that state if the supplier submits proof of the approval by the other State agency.
(7) In addition to the information required under paragraphs (1)--(6), an application for a bottled water system permit shall include:
(i) An analysis of the quality of the manufactured water for each bottled water product. The analysis shall include data for each primary and secondary contaminant under § 109.1002 (relating to MCLs or treatment techniques).
(ii) A copy of each label of identification to be affixed to each type of bottled water product and trade name distributed by the public water system.
(iii) Proof that the system is in compliance with the standards of the Food and Drug Administration contained in 21 CFR Part 129.
(A) For out-of-State bottled water systems, the proof shall consist of the report issued by a Nationally recognized organization which inspects bottled water systems for compliance with 21 CFR Part 129, such as NSF, or another organization, state or country which utilizes an inspection protocol as stringent as NSF's protocol.
(B) For in-State bottled water systems, the proof shall consist of an inspection report issued by the Department.
(8) In addition to the information required under paragraphs (1)--(6), an application for a bulk water hauling system shall include:
(i) A detailed description of each water transportation tank, fill connection, outlet valve, hose, pump and other appurtenances including the manner in which they will be protected from contamination.
(ii) A description of the exact location where withdrawals will be made from each source of supply.
(9) In addition to the information required under paragraphs (1)--(6), an application for a vended water system shall include:
(i) A description of the exact location of each water vending machine.
(ii) A copy of the system's operation and maintenance plan detailing machine maintenance schedules.
(iii) A copy of the NAMA certification for each type of machine, if a certification has been issued.
(10) In addition to the information required under paragraphs (1)--(6), an application for a retail water facility shall include:
(i) A copy of NSF certificates, when applicable, for system components.
(ii) A copy of product labels, when applicable.
(f) Permit amendment applications. A bottled water or vended water system, retail water facility or bulk water hauling system operating under a public water system permit shall obtain a permit amendment before making a substantial modification to the public water system.
(1) A water supplier shall submit an application for a major permit amendment in accordance with subsection (e), if the proposed modification constitutes a major change to the public water system.
(i) For bottled water systems and retail water facilities, typical modifications which may be considered major changes are proposed new sources, additions or deletions of treatment techniques or processes and new types of products.
(ii) For bulk water hauling systems typical modifications which may be considered major changes are proposed new sources, additions or deletions of treatment techniques or processes, pumping stations and storage reservoirs.
(iii) For vended water systems, typical modifications which may be considered major changes are proposed additions or deletions of treatment techniques or processes, new product lines or types of products and the addition to the system of machines not certified by NAMA. For new sources, the supplier shall obtain a separate and distinct permit in accordance with subsection (e) unless the system qualifies for a permit by rule under subsection (b).
(2) A water supplier shall submit a written request to the Department for a minor permit amendment if the proposed modification constitutes a relatively minor change to the public water system. A request for a permit amendment under this paragraph shall describe the proposed change in sufficient detail to allow the Department to adequately evaluate the proposal.
(i) For bottled water systems and retail water facilities, typical modifications which can generally be accomplished under this paragraph include:
(A) Changes in treatment chemicals.
(B) Construction of storage tanks designed to standard specifications.
(C) Installation of replacement equipment.
(D) Changes in legal status, such as transfers of ownership, incorporation or mergers.
(ii) For bulk water hauling systems, typical modifications which can generally be accomplished under this paragraph include:
(A) Changes in treatment chemicals.
(B) Replacement of tank or reservoir linings or similar materials in contact with the water supply.
(C) Additions and modifications to water carrier vehicles and standpipes designed to standard specifications.
(D) Transmission mains.
(E) Changes in legal status, such as transfers of ownership, incorporation or mergers.
(iii) For vended water systems, typical modifications which can generally be accomplished under this paragraph include changes in treatment chemicals, repair or replacement of machines, and the addition of new NAMA certified machines to a permitted vended water system.
(3) The Department determines whether a particular modification requires a permit amendment under subsection (f)(1) or a permit amendment under subsection (f)(2). The Department's determination will include consideration of the magnitude and complexity of the proposed change and the compliance history of the public water system.
(g) Emergency permits. In emergency circumstances, the Department may issue permits for construction, operation or modification to a bottled water or bulk water hauling system, which the Department determines may be necessary to assure that potable drinking water is available to the public.
(1) Emergency permits shall be limited in duration and may be conditioned on additional monitoring, reporting and the implementation of appropriate emergency response measures. The Department may revoke an emergency permit if it finds the water system is not complying with drinking water standards or the terms or conditions of the permit. An authorization for construction, operation or modifications obtained under an emergency permit will not extend beyond the expiration of the emergency permit unless the public water system receives a permit or permit amendment under subsection (e) or (f) for the construction, operation or modification initiated during the emergency.
(2) State and Federal agencies conducting emergency response bulk water hauling operations need not obtain a permit under this subchapter, if a Department-approved source is utilized and adequate monitoring specified by the Department is conducted to assure compliance with the microbiological MCL specified in § 109.1002.
(h) Department's review. Applications for public water system permits and permit amendments for bottled water and vended water systems, retail water facilities and bulk water hauling systems will be reviewed in accordance with the following procedures:
(1) Applications will be reviewed in accordance with accepted engineering practices. The approval of plans, specifications and engineer's reports by the Department is limited to the sanitary features of design and other features of public health significance.
(2) The Department will not accept an application for review until the application is determined to be complete. A complete application is one which includes the information specified in this chapter and other information necessary for the Department to ensure compliance with this chapter.
(3) As a condition of receiving a public water system permit, a bottled water system shall comply with the standards of the Food and Drug Administration contained in 21 CFR Part 129. Evidence shall be presented demonstrating compliance with subsection (e)(7)(iii).
(4) In reviewing a permit application under this chapter, the Department may consider the following:
(i) Adherence to standards of the Department in Subchapter F (relating to design and construction standards) and § 109.1006 (relating to design and construction standards).
(ii) Compliance by the proposed project with applicable statutes administered by the Commonwealth, river basin commissions created by interstate compact or Federal environmental statutes or regulations.
(i) Permit fees.
(1) An application for a new permit or major permit amendment under subsection (f)(1) for a bottled water or vended water system, retail water facility or bulk water hauling system shall be accompanied by a check in the amount of $750 payable to the ''Commonwealth of Pennsylvania,'' except that:
(i) An application from an out-of-State bottled water system submitting proof of out-of-State approval under subsection (e)(6) shall be accompanied by a fee of $100.
(ii) An application from a bottled water system, retail water facility or bulk water hauling system purchasing finished water, as its sole source of water, from a public water system operating under a permit issued under this chapter, and a vended water system permitted by rule, shall submit a fee of $300.
(2) A fee is not required for an emergency permit under subsection (g) or a minor permit amendment under subsection (f)(2).
§ 109.1007. Labeling requirements for bottled water systems, vended water systems and retail water facilities.
(a) General labeling requirements. Containers of bottled water distributed in this Commonwealth by bottled water systems, retail water facilities or, when appropriate, vended water systems, shall have labels which are designed to remain affixed to the container during use and which include the following information as required by this section. Labels with the following information on the caps of bottled water containers designed for reuse by the bottler are deemed to meet this requirement if the Department-issued identification number and the manufacture date, lot or batch number are on the bottle:
(1) The name and address of the water supplier together with the product trade name.
(2) The water source. When finished water is the source, the name of the public water system shall appear on the label.
(3) The Department identification number issued to the bottled or vended water system or retail water facility.
(4) The manufacture date, or a lot or batch number. The manufacturing date, or lot or batch number shall identify a specific set of primary containers or units of the same size, type and style, produced under conditions as nearly uniform as possible. A batch or lot may not extend for longer than 7 days.
(5) Labeling for mineral water shall include the words ''mineral water.'' Mineral water which exceeds the MCL for total dissolved solids shall include a statement on the label that the product exceeds the MCL for total dissolved solids.
(6) Labeling for artificially-fluoridated water shall include the words ''fluoridated water.''
(b) Corporate name and trade name. A bottled water system, vended water system or retail water facility whose corporate name contains the words ''Spring,'' ''Well,'' ''Artesian,'' ''Mineral'' or ''Natural'' or a derivative of those words, shall label each bottle with the trade name in typeface of at least equal size to the typeface of the corporate name.
(c) Special vending machine label. The name and address of the water supplier together with the Department identification number shall be provided in a conspicuous location on each machine. When water is prebottled from the water vending machine and made available on the shelf for sale, each container shall be labeled in accordance with subsections (a) and (b).
(d) Special retail water facility label. When water is prebottled from the retail water facility and made available on the shelf for sale, each container shall be labeled in accordance with subsections (a) and (b).
§ 109.1008. System management responsibilities.
(a) Reporting and recordkeeping requirements for bottled water and vended water systems, retail water facilities and bulk water hauling systems. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with the reporting requirements in § 109.701(a) and (d) (relating to reporting and recordkeeping).
(1) In addition to the requirements in § 109.701(a) and (d), bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with the following requirements:
(i) Annual product monitoring as required under § 109.1003 (relating to monitoring requirements) shall be reported to the Department by December 31 of each year.
(ii) Each bottled water system shall, by December 31 of each year, submit to the Department proof that the system is in compliance with the standards of the Food and Drug Administration in 21 CFR Part 129 (relating to processing and bottling of bottled drinking water) as required by § 109.1009(b) (relating to system operational requirements). Proof shall consist of the report issued by a Nationally-recognized organization which inspects bottled water systems for compliance with 21 CFR Part 129, such as NSF, or another organization, state or country which utilizes an inspection protocol as stringent as NSF's protocols.
(iii) A monthly operational report shall be prepared on forms provided by the Department or in a form acceptable to the Department. The report shall be maintained on file by the operator for at least 2 years and submitted upon request of the Department. The report shall include at least the following:
(A) The water produced daily.
(B) The chemicals added daily.
(C) The physical and chemical determinations taken daily.
(D) The maintenance performed.
(E) The operational problems and how they have been corrected.
(iv) By March 31, an Annual Water Supply Report for the previous calendar year shall be submitted on forms provided by the Department or in a form acceptable to the Department. This report shall include at least the following:
(A) Information related to water produced or hauled for the year.
(B) A summary of sanitary surveys conducted by the water supplier, including, when applicable, updates to the operation and maintenance plan and cross-connection control program.
(C) Updates to the plan for product recall required under subsection (e).
(2) The bottled water, vended water, retail water or bulk water supplier shall retain on the premises of the public water system or at a convenient location near the premises all records in accordance with the schedule in § 109.701(d).
(3) For bottled water systems and, if applicable, vended water systems and retail water facilities, new or additional proprietary labels shall be reported to the Department in writing, along with copies of the labels, within 10 days following production or distribution of the new or additional label product. The new or additional proprietary labels may be submitted to the Department prior to the product production if the water supplier desires initial Department review. The new or additional proprietary labels shall comply with § 109.1007 (relating to labeling requirements for bottled water systems, vended water systems and retail water facilities).
(b) Operation and maintenance plan requirements. Bottled water, vended water, retail water and bulk water suppliers shall develop an operation and maintenance plan for each system. The operation and maintenance plan shall conform to the guidelines contained in Part III of the Department's Public Water Supply Manual which is available from the Bureau of Water Supply Management, Post Office Box 8467, Harrisburg, Pennsylvania 17105-8467. The water supplier shall implement the operation and maintenance plan in accordance with this chapter, and if appropriate in accordance with accepted practices of the bottled water, vended water, retail water facility or bulk water hauling industry. The plan shall be reviewed and updated as necessary to reflect changes in the operation or maintenance of the water system. The plan shall be bound and placed in locations which are readily accessible to the water system's personnel, and shall be presented upon request to the Department.
(c) Operator requirements. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall have competent personnel qualified to operate and maintain the system's facilities.
(d) Sanitary survey requirements. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall conduct a sanitary survey of the water system at least annually, the survey to include the activities listed in paragraphs (1)--(4). A bottled water, vended water, bulk water hauling system or retail water facility obtaining finished water from a permitted public water system is not required to perform the activities in paragraphs (1) and (2) if the Department determines that there are no potential problems necessitating inspection and evaluation of the source.
(1) Watershed surveillance consisting of an inspection of portions of the drainage area necessary to identify and evaluate actual and probable sources of contamination.
(2) Evaluation of source construction and protection and, when appropriate, withdrawal and transmission facilities.
(3) Treatment facilities inspection consisting of an evaluation of the effectiveness of the operation and maintenance procedures and the condition and operability of permitted facilities.
(4) Evaluation of finished water storage facilities.
(e) Emergency response requirements.
(1) A bottled water, vended water, retail water or bulk water supplier who knows or has reason to believe that circumstances exist which may adversely affect the quality of drinking water supplied by the system, shall notify the Department immediately under § 109.1004 (relating to public notification).
(2) The bottled water, vended water, retail water or bulk water supplier shall develop a plan for product recall under emergency circumstances, and submit the plan to the Department for approval. The plan shall:
(i) Identify detailed procedures for implementing product recalls, including emergency communications and notifications.
(ii) Be kept on file in a readily accessible location by the bottled water, vended water, retail water or bulk water supplier.
(iii) Be reviewed and updated at least annually. A copy of the update shall be included in the annual water supply report to the Department under this section.
(f) Cross-connection control program. At the direction of the Department, the bottled water, vended water, retail water or bulk water supplier shall develop and implement a comprehensive control program for the elimination of existing cross-connections or the effective containment of sources of contamination, and prevention of future cross connections. A description of the program, including the following information, shall be submitted to the Department for approval:
(1) A description of the methods and procedures to be used.
(2) An implementation schedule for the program.
(3) A description of the methods and devices which will be used to protect the water system.
[Pa.B. Doc. No. 99-689. Filed for public inspection April 23, 1999, 9:00 a.m.]
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