RULES AND REGULATIONS
Title 25--ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CH. 109]
Bottled Water Systems--Permit by Rule
[29 Pa.B. 2231] The Environmental Quality Board (Board) by this order amends Chapter 109 (relating to safe drinking water). The amendments establish a permit by rule for in-State permitted bottled water systems that meet certain specified criteria, reduce compliance monitoring for radionuclides for bottled water systems, retail water facilities and bulk water hauling systems, allow label information on the cap of returnable containers and allow new or additional proprietary labels to be submitted to the Department following production or distribution of the new or additional label product. Other minor revisions are also included pertaining to the submission of the coliform monitoring siting plan applicable to all public water systems and clarifying consecutive water system monitoring for lead and cadmium.
The Board approved these final amendments at its February 16, 1999, meeting.
A. Effective Date
These amendments are effective upon publication in the Pennsylvania Bulletin as final rulemaking.
B. Contact Persons
For further information, contact Frederick Marrocco, Acting Director, Bureau of Water Supply Management, P. O. Box 8467, Rachel Carson State Office Building, Harrisburg, PA 17105-8467, (717) 787-9035 or Pamela Bishop, Assistant Counsel, Bureau of Regulatory Counsel, P. O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-7060. Persons with a disability may use the AT&T Relay Service by calling (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This rulemaking is available electronically through the Department of Environmental Protection's (Department) Web site (http://www.dep.state.pa.us).
C. Statutory Authority
These amendments are being promulgated under the authority of section 4 of the Pennsylvania Safe Drinking Water Act (act) (35 P. S. § 721.4), which grants the Board the authority to adopt rules and regulations governing the provision of drinking water to the public and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P. S. §§ 510-7 and 510-20).
D. Background and Summary
The act authorizes the Department to regulate public water systems in this Commonwealth. The act defines ''public water system'' to include ''a system which provides water for bottling or bulk hauling for human consumption.'' Systems providing water for bottling include:
(1) Bottled water systems, which provide water for bottling in sealed containers.
(2) Vended water systems, which provide water for bottling through the use of water vending machines.
(3) Retail water facilities which provide water for bottling by dispensing at a store counter unit servings of water in a customer's or the system's containers.
Beginning in December 1984, the overall requirements in Chapter 109 pertaining to systems providing water for bottling or bulk handling became effective. Chapter 109 was amended at 20 Pa.B. 2621 (May 16, 1992) to place all requirements pertaining to these types of systems in one subchapter rather than having the requirements interspersed among requirements for other public water systems throughout Chapter 109.
Representatives of the large in-State bottled drinking water operations have expressed concerns over the time and expense involved in obtaining permit amendments and the types of in-plant modifications which require permit amendments. The primary reason for the concern was that the requirements were affecting their ability to implement timely business decisions. In response, a workgroup was formed consisting of several bottlers in the Commonwealth, the International Bottled Water Association (IBWA), NSF International (NSF), representatives of a large tap water system, an engineering/consulting firm and the League of Women Voters in addition to representatives of the Department and the Departments of Agriculture and Health. The purpose of the workgroup was to develop a framework for a permit by rule for bottled water systems to streamline the permitting process and minimize business disruption while ensuring regulatory efficiency, compliance and protection of public health. This is part of the Governor's PRIME (Privatize, Retain, Innovate, Modify and Eliminate) Initiative to provide better services to the regulated community and to make government smaller, more efficient and responsive.
Bottled water is regulated at the Federal level as a food product by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.A. §§ 301--397). The Federal requirements applicable to bottled water include: food adulteration and misbranding provisions of Federal law; general food and specific bottled water Good Manufacturing Practice (GMP) regulations; standards of identity and quality for bottled water; and both civil and criminal penalties for noncompliance with these FDA requirements. The Commonwealth's existing regulations require compliance with the FDA requirements under 21 CFR 129 (relating to processing and bottling of bottled drinking water).
The IBWA is the trade organization for the bottled water industry. In addition to the FDA requirements, IBWA's Model Bottled Water Code for IBWA members provides information and standards on bottled water manufacturing practices, operational requirements and quality control for the bottled water industry.
The NSF is an internationally recognized third-party inspection and certification agency. The NSF's bottled water certification program verifies that a bottling facility and product waters meets the requirements of the Federal FDA regulations governing bottled water. The NSF conducts an annual unannounced audit of the bottling and processing facilities including source/product water testing. Bottlers meeting the certification requirements are allowed to use the registered NSF listing mark in their advertising, promotional activities and product listing. The IBWA members have an annual unannounced onsite audit conducted by NSF; however, the NSF certification is not a requirement of IBWA membership.
The Bottled Water Workgroup met on several occasions resulting in the cooperative development of a proposed permit by rule framework for in-State bottlers which addresses the bottled water industry concerns.
The permit by rule provides in-State permitted bottlers an option to obtaining a permit amendment for substantial modifications to the bottling, processing or manufacturing facilities provided certain specified criteria are met. Specific criteria include: the source type (groundwater not under the direct influence of surface water or finished water from a community water system or both); the source water quality (does not exceed FDA quality standards for health related chemical and radiological contaminants and requires only disinfection to meet the Pennsylvania primary maximum contaminant levels); use of acceptable treatment technologies; and demonstrated compliance with the National standards of the FDA and the IBWA Model Bottled Water Code as determined by an annual onsite evaluation conducted by a third-party organization such as the NSF. The bottler would first notify the Department of the intent to operate under the permit by rule. A bottled water system operating under the permit by rule would file with the Department descriptions of substantial modifications such as replacement of equipment or addition of a new product line within 30 days of operation of the modification.
New in-State bottled water systems would still be required to obtain a public water system permit for the construction and operation of the bottled water system after which they could operate under the permit by rule option if qualified. The permit by rule does not include modifications to the collection facilities, including the addition of new sources, which would continue to require a permit amendment from the Department under the present permitting requirements. Any bottler seeking to use the permit by rule would have to comply with other applicable laws administered by the Department as required by section 7 of the act (35 P. S. § 721.7) and comply with other requirements of Chapter 109 including design, construction, operation, monitoring and reporting.
The amendments pertaining to radionuclide compliance monitoring, labeling requirements for returnable containers and coliform monitoring site plan submission address issues determined through the Regulatory Basics Initiative (RBI) which identified regulations for possible revision that were obsolete, prescriptive, redundant, needing clarification or more stringent than Federal regulations.
The monitoring for compliance with radiological maximum contaminant levels (MCLs) for bottled water systems, retail water facilities and bulk water hauling systems was reduced from ''. . . annually . . .'' to ''. . . once every 4 years. . . .'' The present requirement was identified under the RBI as more stringent than the Federal requirements. The radionuclide compliance monitoring results (annual monitoring) over the past 8 years indicates there has not been any violation of the radionuclide MCLs.
For submission of a siting plan for coliform monitoring, the ''. . . November 16, 1992 . . .'' date is deleted and replaced with ''. . . within 30 days of receipt of the Department's request for this information.'' The present requirement was identified under the RBI as obsolete.
The present regulation requires containers of bottled water to have labels which are designed to remain affixed to the container during usage. Through guidance, the Department has included the cap on returnable bottles under the ''...affixed to the container during use...'' The present requirements were identified under the RBI as being unclear. The amendments reflect the guidance.
The final rulemaking was presented to the Water Resources Advisory Committee (WRAC) at its September 9, 1998, meeting. The WRAC approved the final rulemaking.
The Department, by policy published in the Preamble at 20 Pa.B. 2621 to Chapter 109, announced its intention to regulate only those bottled water systems providing water for bottling in 1/2 gallon or larger containers. In the Preamble to the proposed rulemaking at 28 Pa.B. 2265 (May 9, 1998), the Department requested comments with supporting data on whether it should modify its policy on regulating small bottled products (less than one-half gallon) and bottlers of small bottled products. Since the Department did not receive any comments, the present policy will be continued until data is forthcoming which indicates the need to regulate this segment of the bottled water market.
E. Summary of Comments and Responses on the Proposed Rulemaking
The proposed rulemaking was published at 28 Pa.B. 2265 with a 30-day public comment period. The Board received comments from two commentators during the public comment period. The Board also received comments from the Independent Regulatory Review Commission (IRRC). Summaries of all comments received and the Department's responses may be found in a Comment and Response Document which is available from the contact persons listed in Section B of this Preamble.
Some sections have been modified from the proposed rulemaking based on the comments received in addition to other modifications. A list of the modified sections and a summary of the major comments received are provided as follows:
1. § 109.1005(a). Permit requirements. A minor change revising subsections (d) to (e) in the last sentence.
2. § 109.1005(c). Permit requirements. The commentators expressed concern that the provision requiring a permit amendment for ''. . . the expanded use of existing permitted sources used by the bottled water system . . .'' would unintentionally expand or enlarge the scope of the permit amendment requirements. IRRC commented this should be clarified since the intent of the permit by rule was not to expand the permitting requirements.
The Department agrees that the intent of the permit by rule was not to expand the permit requirements. The language under question was intended to specify that the permit by rule only applies to the processing, manufacturing and bottling facilities. The specific language dealing with new sources and expanded use of existing sources is deleted in the final amendments and replaced with language specifying that the permit by rule does not apply to the collection facilities. Collection is defined as ''the parts of a public water system occurring prior to treatment, including source, transmission facilities and pretreatment storage facilities.'' This clarifies that the permit by rule only applies to the bottling, processing and manufacturing facilities for bottled water.
3. § 109.1005(c)(1). Permit requirements. In response to the IRRC comment that the Department identify the protocols that may be used by the Department in making the determination whether the bottled water system uses groundwater sources that are not under the direct influence of surface water, paragraph (1) has been modified to identify the Guidance for Surface Water Identification Protocol as the protocol the Department will use.
4. § 109.1005(c)(3)(i). Permit requirements. The commentators expressed concern over the requirement that the third-party evaluator demonstrate that it is independent of the bottled water systems using the organization's services. The concern was that this would eliminate from consideration industry organizations (which have membership in IBWA or receive financial support from the bottled water industry) with the knowledge and information that would enable them to serve as particularly effective evaluators. IRRC commented that how ''independence'' from the bottled water industry will be determined should be further explained or defined.
The independence of the inspection or evaluation organization is a key element of the permit by rule in assuring regulatory compliance and public health protection. In response to the comments, language has been added requiring the evaluation/inspection organization be accredited by the American National Standards Institute (ANSI) as a third-party evaluation/inspection organization. ANSI is a Nationally recognized accreditation agency for third-party certification organizations and agencies including testing/inspection organizations. Accredited inspection organizations certify compliance with specific requirements and standards including government regulations. ANSI evaluates the accreditation applicant's organizational structure to determine if the organization is ''controlled'' by the party that would be inspected or evaluated. If there is a potential conflict of interest, ANSI will recommend corrective measures to enable the organization to be accredited as a third-party inspection organization.
For accreditation by ANSI, the third-party organization must also have a method for handling complaints, a system for appeal of unresolved or other complaints or disagreements, an effective internal quality control system appropriate to the type, range and volume of work performed, and sufficient staff with the necessary education, training and experience to carry out the work for which it claims to be competent and subject to effective supervision. Requiring ANSI accreditation for a third-party inspection agency or organization is addressed, in the proposed rulemaking, in subsection (c)(3)(i) pertaining to independent of the bottled water systems, subsection (c)(3)(iii) pertaining to having an established system for investigating complaints and an appeals process, subsection (c)(3)(iv) pertaining to a documented quality assurance and control program and subsection (c)(3)(v) pertaining to the capability through experience or training, or both, to conduct the onsite evaluation program.
In the final amendments, the requirement that the inspection organization be accredited by ANSI as a third-party inspection agency replaces the proposed language in subsection (c)(3)(i) and (iii)--(v) are deleted.
5. § 109.1005(c)(3)(ii). Permit requirements. Added ''Department'' to clarify the third-party organization has policies and procedures that would support any required Department enforcement actions.
6. § 109.1005(c)(5)(ii). Permit requirements. For validation of treatment technologies, IRRC questioned what other organizations will be acceptable and recommended the Department publish a list of acceptable organizations annually. Evaluating organizations and protocols for conformance with the requirement could be resource intensive. The intent was to minimize the need for Department approval of protocols and evaluation organizations. In the final amendments, the reference to protocols is deleted and the subsection revised to reference treatment technologies certified under the appropriate ANSI/NSF Standard by a third-party acceptable to the Department and those verified under the EPA Environmental Technology Verification Program. Language was added that treatment facilities approved by the Department for the bottled water system operating under the permit by rule are also considered validated treatment technologies. This allows a bottler operating under the permit by rule to add or use these permitted treatment technologies to a new product line or for an expansion of the bottling facilities.
For certifying treatment technologies under the appropriate ANSI/NSF Standard, the final amendments specify the certification organization (other than the NSF) must be accredited by ANSI as a third-party certification organization and meet the requirements, as applicable, under § 109.606(d).
7. § 109.1005(c)(6). Permit requirements. Paragraph (6) was added requiring publication in the Pennsylvania Bulletin of the Department's determination that the bottled water system has complied with subsection (c)(1)--(4) and is operating under the permit by rule and of notices submitted under subsection (c)(5) for modifications to the bottling and processing facilities. Presently, major permit amendments require publication in the Pennsylvania Bulletin. The Department believes these notifications under the permit by rule should also be published in the Pennsylvania Bulletin.
8. § 109.1005(g) Permit requirements. The term ''circumstances'' which was replaced with ''situations'' in the proposed rulemaking is retained in the final rulemaking.
9. § 109.1008(b). System management responsibilities. The four digit extension was added to the Bureau's Zip Code.
F. Benefits, Costs and Compliance
Executive Order 1996-1 requires a cost/benefit analysis of the amendments.
Benefits
Bottlers in this Commonwealth who elect to operate under the permit by rule should realize time and cost savings from the streamlined permitting process by being able to make timely business decisions such as installation of a new or additional production line or replacement equipment without first obtaining a Department permit amendment. Along with the revised requirements for submitting new or additional product labels, this will provide bottlers in this Commonwealth greater flexibility and opportunity to respond to market conditions and increase competitiveness with out-of-State bottlers. The consumers of bottled water may also benefit from lower prices; however, this is difficult to quantify, due to the many factors affecting the retail price in producing bottled water products.
Over 90 bottled water systems, retail water facilities and bulk water hauling systems will benefit from the reduction in the compliance monitoring for radionuclides from annually to once every 4 years.
Compliance Costs
There should be no additional costs to State and local government or the regulated community to implement the amendments.
The permit by rule is an option and bottlers in this Commonwealth are not required to operate under the permit by rule. Under the permit by rule option, there would be an annual cost estimated at $600 to $800 for the third-party evaluation. Bottlers in this Commonwealth who are IBWA members or NSF certified should not experience an annual cost for the third-party inspection since this cost is included in IBWA's membership fee or NSF's certification fee. Bottlers in this Commonwealth who do not have an annual third-party evaluation and elect to operate under the permit by rule would experience the annual evaluation cost. However, this cost should be offset by the bottler not being required to pay a permit application fee of $300 to $750 for major amendments to the bottling process under the present permitting procedures and the cost savings from reducing the radionuclide compliance monitoring from annually to once every 4 years. Since the permit by rule is an option, it is difficult to estimate the additional costs (if any) to bottlers in this Commonwealth.
Compliance Assistance Plan
It is anticipated that extensive compliance assistance will not be necessary. The permit by rule is an option for bottlers in this Commonwealth. The other amendments update, modify or clarify present requirements.
The Department will notify the regulated community through the Environmental Protection Update Weekly Newsletter and through revised Key Requirements summaries affected by the amendments. The Key Requirements summaries are available to the regulated community and placed on the Department's Web site. If necessary, the Department will directly notify the regulated community, including out-of-State bottlers, through mailings. Department staff will be available to assist the regulated community and any bottler in this Commonwealth considering operating under the permit by rule.
Paperwork Requirements
There should be no increase in the amount of paperwork. Overall, with the exception of the permit by rule, the final rulemaking updates, clarifies or revises present requirements and should not have any major impact on existing reporting, recordkeeping or other paperwork requirements.
Compared to obtaining a permit amendment under the present permitting process, bottlers in this Commonwealth would first notify the Department of the intent to operate under the permit by rule, file descriptions of substantial modifications within 30 days of operation of the modification and submit annual proof of compliance with the FDA standards and the IBWA Model Bottled Water Code based on the third-party evaluation. Bottlers operating under the permit by rule would still be required to comply with the other provisions of the act and regulations including design, construction, operation, reporting and recordkeeping. The Department anticipates the permit by rule would decrease paperwork requirements compared to obtaining a Department permit for modifications to the bottling, processing and manufacturing of bottled water. The reduction in radionuclide monitoring would reduce reporting and paperwork requirements for over 90 bottled water systems, retail water facilities and bulk water hauling systems.
G. Sunset Review
These final-form regulations will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which they were intended.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 28, 1998, the Department submitted a copy of the proposed rulemaking, published at 28 Pa.B. 2265, to IRRC, and the Chairpersons of the Senate and House Environmental Resources and Energy Committees for review and comment. In compliance with section 5(c) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of the comments as well as other documentation.
In preparing these final-form regulations, the Department has considered all comments received from IRRC and the public. The Committees did not provide comments on the proposed rulemaking.
These final-form regulations were deemed approved by the House Environmental Resources and Energy Committee and the Senate Environmental Resources and Energy Committee on March 15, 1999. IRRC met on March 25, 1999, and approved the final-form regulations in accordance with section 5.1(e) of the Regulatory Review Act (71 P. S. § 745.5a(e)).
I. Findings of the Board
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and regulations promulgated in 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law, and all comments were considered.
(3) These final-form regulations do not enlarge the purpose of the proposal published at 28 Pa.B. 2265.
(4) These final-form regulations are necessary and appropriate for the administration and enforcement of the authorizing acts identified in Section C of this Preamble.
J. Order of the Board
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapter 109, are amended by amending §§ 109.1, 109.301, 109.701, 109.1003, 109.1005, 109.1007 and 109.1008 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson shall submit this order and Annex A to IRRC and the Senate and House Environmental Resources and Energy Committees as required by the Regulatory Review Act.
(d) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau, as required by law.
(e) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
JAMES M. SEIF,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 29 Pa.B. 1957 (April 10, 1999).)
Fiscal Note: Fiscal Note 7-337 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart C. PROTECTION OF NATURAL RESOURCES
ARTICLE II. WATER RESOURCES
CHAPTER 109. SAFE DRINKING WATER
Subchapter A. GENERAL PROVISIONS § 109.1. Definitions:
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * IBWA--The International Bottled Water Association, Alexandria, Virginia 22314.
* * * * * NSF--NSF International, Ann Arbor, Michigan 48105.
* * * * *
Subchapter C. MONITORING REQUIREMENTS § 109.301. General monitoring requirements.
The monitoring and analytical requirements, including approved sampling procedures and analytical techniques, established by the EPA under the National Primary Drinking Water Regulations, 40 CFR Part 141 (relating to national primary drinking water regulations), as of December 8, 1984, are incorporated by reference. Public water suppliers shall monitor for compliance with MCLs in accordance with the requirements established in the National Primary Drinking Water Regulations, except as otherwise established by this chapter unless increased monitoring is required by the Department under § 109.302 (relating to special monitoring requirements). Alternative monitoring requirements may be established by the Department and may be implemented in lieu of monitoring requirements for a particular National Primary Drinking Water Regulation if the alternative monitoring requirements are in conformance with the Federal act and regulations. The monitoring requirements shall be applied as follows:
(1) Performance monitoring for filtration and disinfection. A public water supplier providing filtration and disinfection of surface water sources shall, beginning July 1, 1990, conduct the performance monitoring requirements established by the EPA under the National Primary Drinking Water Regulations, unless increased monitoring is required by the Department under § 109.302.
(i) Except as provided under subparagraphs (ii) and (iii), a public water supplier:
(A) Shall determine the turbidity level of representative samples of the system's filtered water at least once every 4 hours that the system is in operation, except as provided in clause (B).
(B) May substitute continuous turbidity monitoring for grab sample monitoring if it validates the continuous measurement for accuracy on a regular basis using a protocol approved by the Department. For systems using slow sand filtration or filtration treatment other than conventional filtration, direct filtration or diatomaceous earth filtration, the Department may reduce sampling frequency to once per day.
(C) Shall continuously monitor the residual disinfectant concentration of the water being supplied to the distribution system and record both the lowest value for each day and the number of periods each day when the value is less than .2 mg/l for more than 4 hours. If a public water system's continuous monitoring equipment fails, the public water supplier may, upon notification of the Department under § 109.402 (relating to emergency public notification), substitute grab sampling every 4 hours in lieu of continuous monitoring. Grab sampling may not be substituted for continuous monitoring for longer than 5 days after the equipment fails.
(D) Shall measure the residual disinfectant concentration at representative points in the distribution system no less frequently than the frequency required for total coliform sampling for compliance with the MCL for microbiological contaminants.
(ii) For a public water supplier serving 3,300 or fewer people, the Department may reduce the residual disinfectant concentration monitoring for the water being supplied to the distribution system to a minimum of 2 hours between samples at the grab sampling frequencies prescribed as follows if the historical performance and operation of the system indicate the system can meet the residual disinfectant concentration at all times:
System Size (People) Samples/Day <500 1 500--1,000 2 1,001--2,500 3 2,501--3,300 4 If the Department reduces the monitoring, the supplier shall nevertheless collect and analyze another residual disinfectant measurement as soon as possible, but no longer than 4 hours from any measurement which is less than .2 mg/l.
(iii) For a public water supplier serving fewer than 500 people, the Department may reduce the filtered water turbidity monitoring to one grab sample per day, if the historical performance and operation of the system indicate effective turbidity removal is maintained under the range of conditions expected to occur in the system's source water.
(2) Performance monitoring for unfiltered surface water. A public water supplier using unfiltered surface water sources shall conduct the following source water and performance monitoring requirements on an interim basis until filtration is provided, unless increased monitoring is required by the Department under § 109.302:
(i) Except as provided under subparagraphs (ii) and (iii), a public water supplier:
(A) Shall perform fecal coliform or total coliform density determinations on samples of the source water immediately prior to disinfection. Regardless of source water turbidity, the minimum frequency of sampling for fecal or total coliform determination may be no less than the following:
System Size (People) Samples/Week <500 1 500--3,299 2 3,300--10,000 3 10,001--25,000 4 25,001 or more 5 (B) Shall measure the turbidity of a representative grab sample of the source water immediately prior to disinfection at least once every 4 hours that the system is in operation, except as provided in clause (C).
(C) May substitute continuous turbidity monitoring for grab sample monitoring if it validates the continuous measurement for accuracy on a regular basis using a protocol approved by the Department.
(D) Shall continuously monitor the residual disinfectant concentration required under § 109.202(c)(1)(iii) (relating to State MCLs and treatment technique requirements) of the water being supplied to the distribution system and record the lowest value for each day. If a public water system's continuous monitoring equipment fails, the public water supplier may, upon notification of the Department under § 109.402, substitute grab sampling every 4 hours in lieu of continuous monitoring. Grab sampling may not be substituted for continuous monitoring for longer than 5 days after the equipment fails.
(E) Shall measure the residual disinfectant concentration at representative points in the distribution system no less frequently than the frequency required for total coliform sampling for compliance with the MCL for microbiological contaminants.
(ii) For a public water supplier serving 3,300 or fewer people, the Department may reduce the residual disinfectant concentration monitoring for the water being supplied to the distribution system to a minimum of 2 hours between samples at the grab sampling frequencies prescribed as follows if the historical performance and operation of the system indicate the system can meet the residual disinfectant concentration at all times:
System Size (People) Samples/Day <500 1 500--1,000 2 1,001--2,500 3 2,501--3,300 4 If the Department reduces the monitoring, the supplier shall nevertheless collect and analyze another residual disinfectant measurement as soon as possible, but no longer than 4 hours from any measurement which is less than the residual disinfectant concentration approved under § 109.202(c)(1)(iii).
(iii) For a public water supplier serving fewer than 500 people, the Department may reduce the source water turbidity monitoring to one grab sample per day, if the historical performance and operation of the system indicate effective disinfection is maintained under the range of conditions expected to occur in the system's source water.
(3) Monitoring requirements for coliforms. Public water systems shall determine the presence or absence of total coliforms for each routine or check sample; and, the presence or absence of fecal coliforms or E. coli for a total coliform positive sample in accordance with analytical techniques approved by the Department under § 109.304 (relating to analytical requirements). A system may forego fecal coliform or E. coli testing on a total coliform-positive sample if the system assumes that any total coliform-positive sample is also fecal coliform-positive. A system which chooses to forego fecal coliform or E. coli testing shall, under § 109.402(1), notify the Department within 1 hour of when the system is first notified of the total coliform-positive sample result.
(i) Frequency. Public water systems shall collect samples at regular time intervals throughout the monitoring period as specified in the system distribution sample siting plan under § 109.303(a)(2) (relating to sampling requirements). Systems which use groundwater and serve 4,900 persons or fewer, may collect all required samples on a single day if they are from different sampling sites in the distribution system.
(A) Except as provided under § 109.705(b) (relating to sanitary surveys), the number of monthly total coliform samples that community water systems shall take is based on the population served by the system as follows:
Minimum Number of Population Served Samples per Month 25 to 1,000 1 1,001 to 2,500 2 2,501 to 3,300 3 3,301 to 4,100 4 4,101 to 4,900 5 4,901 to 5,800 6 5,801 to 6,700 7 6,701 to 7,600 8 7,601 to 8,500 9 8,501 to 12,900 10 12,901 to 17,200 15 17,201 to 21,500 20 21,501 to 25,000 25 25,001 to 33,000 30 33,001 to 41,000 40 41,001 to 50,000 50 50,001 to 59,000 60 59,001 to 70,000 70 70,001 to 83,000 80 83,001 to 96,000 90 96,001 to 130,000 100 130,001 to 220,000 120 220,001 to 320,000 150 320,001 to 450,000 180 450,001 to 600,000 210 600,001 to 780,000 240 780,001 to 970,000 270 970,001 to 1,230,000 300 1,230,001 to 1,520,000 330 1,520,001 to 1,850,000 360 1,850,001 to 2,270,000 390 2,270,001 to 3,020,000 420 3,020,001 to 3,960,000 450 3,960,001 or more 480 (B) Except as provided under § 109.705(c), the number of periodic total coliform samples that noncommunity water systems shall take is as follows:
(I) A noncommunity water system using only groundwater and serving 1,000 or fewer persons per day on a permanent basis, January through December each year, shall take one sample each calendar quarter that the system provides water to the public.
(II) A noncommunity water system using surface water (in total or in part) or serving more than 1,000 persons per day during a given month shall take the same number of samples as a community water system serving the same number of persons specified in clause (A) for each month the system provides water to the public, even if the population served is temporarily fewer than 1,000 persons per day. A groundwater system determined to be under the influence of surface water shall begin monitoring at this frequency 6 months after the Department determines that the source water is under the direct influence of surface water.
(C) A public water system that uses a surface water source and does not practice filtration in compliance with Subchapter B (relating to MCLs or treatment technique requirements) shall collect at least one total coliform sample at the entry point, or an equivalent location as determined by the Department, to the distribution system within 24 hours of each day that the turbidity level in the source water, measured as specified in paragraph (2)(i)(B), exceeds 1.0 NTU. The Department may extend this 24-hour collection limit to a maximum of 72 hours if the system adequately demonstrates a logistical problem outside the system's control in having the sample analyzed within 30 hours of collection. A logistical problem outside the system's control may include a source water turbidity result exceeding 1.0 NTU over a holiday or weekend in which the services of a Department certified laboratory are not available within the prescribed sample holding time. These sample results shall be included in determining compliance with the MCL for total coliforms established under § 109.202(a)(2).
(ii) Repeat monitoring. A public water system shall collect a set of check samples within 24 hours of being notified of a total coliform-positive routine or check sample. The Department may extend this 24-hour collection limit to a maximum of 72 hours if the system adequately demonstrates a logistical problem outside the system's control in having the check samples analyzed within 30 hours of collection. A logistical problem outside the system's control may include a coliform-positive sample result received over a holiday or weekend in which the services of a Department certified laboratory are not available within the prescribed sample holding time.
(A) A system which collects more than one routine sample per monitoring period shall collect at least three check samples for each total coliform-positive sample found.
(B) A system which collects only one routine sample per monitoring period shall collect at least four check samples for each total coliform-positive sample found.
(C) The system shall collect at least one check sample from the sampling tap where the original total coliform-positive sample was taken, at least one check sample at a tap within five service connections upstream of the original coliform-positive sample and at least one check sample within five service connections downstream of the original sampling site. If a total coliform-positive sample occurs at the end of the distribution system or one service connection away from the end of the distribution system, the water supplier shall collect an additional check sample upstream of the original sample site in lieu of a downstream check sample.
(D) A system shall collect all check samples on the same day, except that a system with a single service connection may collect the required set of check samples all on the same day or consecutively over a 4-day period.
(E) If a check sample is total coliform-positive, the public water system shall collect additional check samples in the manner specified in this subparagraph. The system shall continue to collect check samples until either total coliforms are not detected in check samples, or the system determines that the MCL for total coliforms as established under § 109.202(a)(2) has been exceeded and notifies the Department.
(F) If a system collecting fewer than five routine samples per month has one or more valid total coliform-positive samples, the system shall collect at least five routine samples during the next month the system provides water to the public. The number of routine samples for the month following a total coliform-positive sample may be reduced by the Department to at least one sample the next month if the reason for the total coliform-positive sample is determined and the problem has been corrected or will be corrected before the end of the next month.
(G) Results of all routine and check samples not invalidated by the Department shall be included in determining compliance with the MCL for total coliforms as established under § 109.202(a)(2).
(iii) Invalidation of total coliform samples. A total coliform sample invalidated under this paragraph does not count towards meeting the minimum monitoring requirements of this section.
(A) The Department may invalidate a total coliform-positive sample if one of the following applies:
(I) The laboratory which performed the analysis establishes that improper sample analysis caused the total coliform-positive result.
(II) A domestic or other nondistribution system plumbing problem exists when a coliform contamination incident occurs that is limited to a specific service connection from which a coliform-positive sample was taken in a public water system with more than one service connection. The Department's determination to invalidate a sample shall be based on a total coliform-positive check sample collected at the same tap as the original total coliform-positive sample and all total coliform-negative check samples collected within five service connections of the original total coliform positive sample. This type of sample invalidation does not apply to public water systems with only one service connection.
(III) A total coliform-positive sample result is due to a circumstance or condition which does not reflect water quality in the distribution system. The Department's decision to invalidate a sample shall be based on evidence that the sample result does not reflect water quality in the distribution system. In this case, the system shall still collect all check samples required under subparagraph (ii) to determine compliance with the MCL for total coliforms as established under § 109.202(a)(2).
(B) A laboratory shall invalidate a total coliform sample if no total coliforms are detected and one of the following occurs:
(I) The sample produces a turbid culture in the absence of gas production using an analytical method where gas formation is examined.
(II) The sample exhibits confluent growth or produces colonies too numerous to count with an analytical method using a membrane filter.
(C) If a laboratory invalidates a sample because of interference as specified in clause (B), the laboratory shall notify the system within 1 business day to collect another sample from the same location as the original sample within 24 hours of being notified of the interference and have it analyzed for the presence of total coliforms. The system shall resample within 24 hours of being notified of interference and continue to resample every 24 hours until it receives a valid result. The Department may extend this 24-hour limit to a maximum of 72 hours if the system adequately demonstrates a logistical problem outside the system's control in having the resamples analyzed within 30 hours. A logistical problem outside the system's control may include a notification of a laboratory sample invalidation, due to interference, which is received over a holiday or weekend in which the services of a Department certified laboratory are not available within the prescribed sample holding time.
(iv) Special purpose samples, such as those taken to determine whether disinfection practices are sufficient following pipe placement, replacement or repair, may not be used to determine compliance with the MCL for total coliform. Check samples taken under subparagraph (ii) are not considered special purpose samples, and shall be used to determine compliance with the monitoring and MCL requirements for total coliforms established under this paragraph and § 109.202(a)(2).
(4) Exception. For a water system which complies with the performance monitoring requirements under paragraph (2), the monitoring requirements for compliance with the turbidity MCL do not apply.
(5) Monitoring requirements for VOCs. Community water systems and nontransient noncommunity water systems shall monitor for compliance with the MCLs for VOCs established by the EPA under 40 CFR 141.61(a) (relating to MCLs for organic contaminants). The monitoring shall be conducted according to the requirements established by the EPA under 40 CFR 141.24(f) (relating to organic chemicals other than total trihalomethanes, sampling and analytical requirements), incorporated herein by reference, except as modified by this chapter. Initial or first year monitoring mentioned in this paragraph refers to VOC monitoring conducted on or after January 1, 1993.
(i) Vinyl chloride. Monitoring for compliance with the MCL for vinyl chloride is required only for groundwater entry points at which one or more of the following two-carbon organic compounds have been detected: trichloroethylene, tetrachloroethylene, 1,2-dichloroethane, 1,1,1-trichloroethane, cis-1,2-dichloroethylene, trans-1,2-dichloroethylene or 1,1-dichloroethylene.
(ii) Initial monitoring schedule. The initial monitoring shall consist of four consecutive quarterly samples at each entry point in accordance with the following monitoring schedule during the compliance period beginning January 1, 1993, except for systems which are granted reduced initial monitoring in accordance with clauses (E) and (F). A system which monitors during the initial monitoring period, but begins monitoring before its scheduled initial monitoring year specified in this subparagraph, shall begin monitoring every entry point during the first calendar quarter of the year it begins monitoring, except as provided in clause (E).
(A) Systems serving more than 10,000 persons shall begin monitoring during the quarter beginning January 1, 1994.
(B) Systems serving 3,301 persons to 10,000 persons shall begin monitoring during the quarter beginning January 1, 1995.
(C) Systems serving 500 to 3,300 persons shall begin monitoring during the quarter beginning January 1, 1993.
(D) Systems serving fewer than 500 persons shall begin monitoring during the quarter beginning January 1, 1994.
(E) For systems serving 3,300 or fewer people which monitor at least one quarter prior to October 1, 1993, and do not detect VOCs at an entry point during the first quarterly sample, the required initial monitoring is reduced to one sample at that entry point. For systems serving 500 to 3,300 people to qualify for this reduced monitoring, the initial monitoring shall have been conducted during the quarter beginning January 1, 1993.
(F) For systems serving more than 3,300 people, which were in existence prior to January 1, 1993, initial monitoring for compliance with the MCLs for VOCs established by the EPA under 40 CFR 141.61(a) is reduced to one sample for each entry point which meets the following conditions:
(I) VOC monitoring required by the Department between January 1, 1988, and December 31, 1992, has been conducted and no VOCs regulated under 40 CFR 141.61(a) were detected.
(II) The first quarter monitoring required by this paragraph has been conducted during the first quarter of the system's scheduled monitoring year under this paragraph, with no detection of a VOC.
(G) Initial monitoring of new entry points associated with new sources which are permitted under Subchapter E (relating to permit requirements) to begin operation after December 31, 1992, shall conduct initial monitoring as follows:
(I) Entry points at which a VOC is detected during new source monitoring shall be monitored quarterly beginning the first quarter the entry points begin serving the public. Quarterly monitoring shall continue until reduced monitoring is granted in accordance with subparagraph (iii)(D).
(II) Entry points at which no VOC is detected during new source monitoring shall begin initial quarterly monitoring during the first calendar quarter of the year after the entry point begins serving the public. If no VOC is detected during the first quarter of monitoring, first year monitoring is reduced to one sample at that entry point.
(iii) Repeat monitoring for entry points at which a VOC is detected.
(A) For entry points at which a VOC is detected at a level equal to or greater than its MCL during the first year of quarterly monitoring, the monitoring shall be repeated quarterly beginning the quarter following detection at a level equal to or greater than the MCL, for VOCs for which the EPA has established MCLs under 40 CFR 141.61(a), except for vinyl chloride as provided in subparagraph (i), until reduced monitoring is granted in accordance with clause (D).
(B) For entry points at which a VOC is detected, and reduced monitoring is granted in accordance with clause (D), and a VOC is thereafter detected at a level greater than the MCL, the monitoring shall be repeated quarterly beginning the quarter following detection at a level for the VOCs for which the EPA has established MCLs under 40 CFR 141.61(a), except for vinyl chloride as provided in subparagraph (i), until reduced monitoring is granted in accordance with clause (D).
(C) For entry points at which no VOC is detected during the first year of monitoring but a VOC is detected thereafter, the monitoring shall be repeated quarterly beginning the quarter following detection at a level for the VOCs for which the EPA has established MCLs under 40 CFR 141.61(a), except for vinyl chloride as provided in subparagraph (i), or until reduced monitoring is granted in accordance with clause (D).
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