[31 Pa.B. 3895]
[Continued from previous Web Page] (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 and sediment 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, MRDLs 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).
§ 109.1006. Design and construction standards.
(a) Application of standards. Standards in this section apply to design and construction or modification of bottled water and vended water systems, retail water facilities and bulk water hauling systems regardless of whether a Department permit or permit amendment is required. The standards apply to new facilities and facility modifications unless otherwise specifically indicated.
(b) Acceptable design. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall be designed to provide an adequate quality of water to the public. The design shall ensure that the system will, upon completion, be capable of providing water that complies with the primary and secondary MCLs, MRDLs and treatment techniques established in § 109.1002 (relating to MCLs, MRDLs or treatment techniques). The Department may approve control techniques, such as nonremoval processes, which abate the problems associated with a secondary contaminant, and achieve the objective of the secondary MCL.
(1) Designs of bottled water and vended water systems, retail water facilities and bulk water hauling systems shall conform to accepted standards of engineering and design in the water supply, bottled water, retail water or bulk water hauling industry, as applicable.
(2) Designs of bottled water and vended water systems, retail water facilities and bulk water hauling systems shall be in accordance with Subchapter F (relating to design and construction standards) except that § 109.607 (relating to pressures) does not apply.
§ 109.1009. System operational requirements.
(a) General facilities operation. Facilities of bottled water and vended water systems, retail water facilities and bulk water hauling systems approved by written permit from the Department shall be operated in a manner consistent with the terms and conditions of the permit to achieve the level of treatment for which the facilities were designed.
(b) Special bottled water system requirements. Bottled water systems shall be operated in accordance with the standards of the Food and Drug Administration in 21 CFR Part 129 (relating to processing and bottling of bottled drinking water). Proof of this determination shall be submitted to the Department annually under § 109.1008(a)(1)(ii) (relating to system management responsibilities).
(c) Disinfectant residual requirements. A disinfectant residual acceptable to the Department shall be maintained at the entry point of the bottled water or vended water system, retail water facility or bulk water hauling system sufficient to assure compliance with the microbiological MCL specified in § 109.1002 (relating to MCLs, MRDLs or treatment techniques). The Department will determine the acceptable residual of the disinfectant considering factors such as type and form of disinfectant, temperature and pH of the water, and other characteristics of the water system.
(d) Disinfection of facilities following construction, modification or repair. After repairing, constructing or modifying a bottled water, vended water, retail water or bulk water hauling facility and before the facility is placed in service, it shall be properly cleaned and disinfected. Cleaning shall be in accordance with 21 CFR 129.80(c) and (d) (relating to processes and controls) and disinfection shall be with 50 ppm chlorine for 1 minute at 75°F or the equivalent.
(e) Dedicated equipment. Bottled water, vended water, retail water and bulk water may not be transported, stored or processed through equipment or lines used for any nonfood product. Bottled water, vended water, retail water and bulk water transported, stored or processed through equipment used for a food product other than water shall comply with the following cleaning and disinfection procedures:
(1) When foods other than milk or dairy products have been transported, stored, processed or bottled, each time before water is transported, stored, processed or bottled through the same lines or equipment, product contact surfaces shall be thoroughly cleaned and disinfected in accordance with subsection (d).
(2) When milk or other dairy products are transported, stored or processed or bottled through the same lines or equipment as bottled water, vended water, retail water and bulk water, the feed line used to convey water to the filler shall be dedicated to water only. Each time before water is transported, stored or processed or bottled, other product contact surfaces shall be disassembled and cleaned in accordance with subsection (d).
(f) Special operational requirements for bottled water systems and retail water facilities.
(1) Bottled water systems and retail water facilities using ozone as a final disinfectant shall maintain an ozone residual of 0.1--0.4 ppm in the bottle immediately after filling.
(2) When ozone is used as a disinfectant for bottled water or retail water, gaskets, o-rings and similar flexible material shall be made of silicone rubber, teflon or other ozone-resistant material. These flexible parts shall be replaced when they show evidence of surface deterioration.
(g) Special operational requirements for water vending machine systems.
(1) Each vending machine shall be cleaned, serviced and sanitized in accordance with the manufacturer's service manuals, but at least once every 2 weeks. A record of all cleaning and maintenance operations for each machine shall be kept by the operator with a copy retained in the interior of the machine.
(2) A notice to consumers listing the industry's recommendations for the care, cleaning and type of container suitable for use with the water vending machine shall be posted at each water vending machine.
(h) Special operational requirements for bulk water hauling systems.
(1) Transportation tanks or containers shall be sealed at all times except when being cleaned, filled or when water is being delivered.
(2) Hoses, pumps, connections and fittings shall be sanitized prior to delivering water using a disinfectant solution containing at least 50 ppm of chlorine at 75°F for 1 minute or the equivalent.
(3) Hoses, pumps, connections and fittings used for loading and delivering potable water shall be stored, capped or covered and used so as to be protected from contamination at all times.
(4) A record of cleaning and sanitizing activities conducted on the interior of the transportation tank or transfer equipment shall be maintained with the vehicle and shall be available to the Department upon request.
Subchapter K. LEAD AND COPPER § 109.1105. Permit requirements.
(a) General permit requirements. A person may not construct, substantially modify or operate corrosion control treatment facilities to comply with this subchapter without having obtained the appropriate permit approvals under Subchapter E (relating to permit requirements) and this section.
(b) Construction permits and permit amendments. The water supplier shall submit an application for a public water system construction permit for a newly-created system or an amended construction permit for a currently-permitted system for corrosion control treatment facilities by the applicable deadline established in § 109.1102(b)(2) (relating to action levels and treatment technique requirements), unless the system complies with paragraph (1) or (2) or otherwise qualifies for a minor permit amendment under § 109.503(b) (relating to public water system construction permits). The permit application shall comply with § 109.503 and contain the applicable information specified therein. The application shall include recommended water quality parameter performance requirements for optimal corrosion control treatment as specified in § 109.1102(b)(5) and other data, information or documentation necessary to enable the Department to consider the application for a permit for construction of the facilities.
(1) Community water system minor permit amendments. The community water supplier may submit a written request for an amended construction permit to the Department if the system satisfies the conditions under subparagraphs (i)--(iv). A request for an amended construction permit under this paragraph shall describe the proposed change in sufficient detail to allow the Department to adequately evaluate the proposal.
(i) The system is a small water system.
(ii) The sources of supply for the system are not surface water sources.
(iii) Except for corrosion control treatment, the sources require treatment no greater than disinfection to provide water of a quality that meets the MCLs and treatment technique requirements established under Subchapter B (relating to MCLs, MRDLs or treatment technique requirements).
(iv) The proposed corrosion control treatment is limited to alkalinity or pH adjustment, or both.
(2) Nontransient noncommunity water system permits. The nontransient noncommunity water supplier is not required to obtain a construction permit or permit amendment under subsection (b) if the system satisfies the following specifications and conditions:
(i) The system is a small water system.
(ii) The sources of supply for the system are not surface water sources.
(iii) Except for corrosion control treatment, the sources require treatment no greater than disinfection to provide water of a quality that meets the MCLs and treatment technique requirements established under Subchapter B.
(iv) The proposed corrosion control treatment is limited to alkalinity or pH adjustment, or both.
(v) The water supplier files a brief description of the proposed treatment, including recommended water quality parameter performance requirements for optimal corrosion control treatment as specified in § 109.1102(b)(5), on forms acceptable to the Department. Descriptions of modifications may be filed prior to construction if the water supplier desires technical assistance, but shall be filed within 30 days of initiation of operation of the modification.
(c) Operation permits. Except for nontransient noncommunity water systems complying with subsection (b)(2), the water supplier shall obtain an operation permit or amended operation permit following completion of construction and prior to initiation of operation of corrosion control treatment facilities. The permit will be issued in accordance with § 109.504 (relating to public water system operation permits). The Department will not issue an operation permit under this subchapter unless the water system complies with the operation and maintenance plan requirements under § 109.1107(b) (relating to system management responsibilities) and the operator certification and training requirements under § 109.1107(c). The water supplier for a community water system or nontransient noncommunity water system shall submit a request for Department designation of optimal corrosion control treatment performance requirements in accordance with § 109.1102(b)(2) and the Department will issue an amended operation permit designating the performance requirements as specified in § 109.1102(b)(5).
[Pa.B. Doc. No. 01-1304. Filed for public inspection July 20, 2001, 9:00 a.m.]
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