SUMMARY: Today, EPA is promulgating an information collection rule (ICR) which establishes monitoring and data reporting requirements for large public water systems (PWSs). This rule is intended to provide EPA with information on the occurrence in drinking water of (1) chemical byproducts that form when disinfectants used for microbial control react with chemicals already present in source water (disinfection byproducts (DBPs)) and (2) disease-causing microorganisms (pathogens), including Cryptosporidium. Also, EPA will collect engineering data on how PWSs currently control such contaminants. All data collected pursuant to this rule will be available to the public via the Internet. This information is being collected because a Regulatory Negotiation on disinfectants and DBPs concluded that additional information is needed to assess the potential health problem created by the presence of DBPs and pathogens in drinking water and to assess the extent and severity of risk in order to make sound regulatory and public health decisions. These contaminants may have adverse human health effects, including cancer, liver and kidney damage, and may cause microbial disease such as cryptosporidiosis and hepatitis. EPA will use information generated by this rule, along with concurrent research, to determine whether revisions need to be made to EPA's current drinking water filtration and disinfection rule and to determine the need for new regulations for disinfectants and DBPs. EPA has determined that the rule's objectives can be satisfied, and sufficient information collected, by requiring only large PWSs to collect the data. Surface water systems serving at least 100,000 people and ground water systems serving at least 50,000 must monitor. EPA will supplement this information with EPA-funded surveys that target smaller PWSs. The specific information required is based on the number of people served, the source of water (i.e., surface water or ground water), and the type(s) of treatment used. Although Cryptosporidium is an important drinking water pathogen, it poses difficult measurement challenges. To ensure quality of data, EPA has and will continue to take extraordinary steps. The first is to continue an extensive method analysis and possible improvements. The second is to establish stringent laboratory approval criteria to increase Cryptosporidium data quality for developing a national occurrence data base and conducting a national cost assessment of possible future rules. Finally, EPA will supplement the collection of Cryptosporidium data in this rule with a separate, EPA-funded survey. EPA believes this combination of data collection activities will produce the best data possible. DATES: The effective date for this final rule is June 18, 1996. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of June 18, 1996. This rule shall remain effective until December 31, 2000. The information collection requirements contained in subpart M of part 141 have not been approved by the Office of Management and Budget (OMB) and are not effective until OMB has approved them. EPA will publish a final rule announcing the effective date when OMB approves the information collection requirements. ADDRESSES: Copies of the public comments received, EPA responses, and all other supporting documents (including references included in this notice) are available for review at the U.S. Environmental Protection Agency (EPA) Drinking Water Docket (MC-4101), 401 M Street SW, Washington, DC 20460. For access to Docket materials, call (202) 260- 3027 between 9 am and 3:30 pm (Eastern) for an appointment. Copies of major supporting documents cited in the reference section of this notice are available for inspection at EPA's regional offices, listed below. Copies of ``ICR Sampling Manual'', ``DBP/ICR Analytical Methods Manual'', ``ICR Manual for Bench- and Pilot-scale Studies'', ``ICR Microbial Laboratory Manual'', ``Reprints of EPA Methods for Chemical Analyses under the Information Collection Rule'', and ``ICR Water Utility Database System Users' Guide'' are available for a fee from the National Technical Information Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161. The toll-free number is 800-336-4700, local 703-487-4650. Copies of ``Standard Methods for the Examination of Water and Wastewater'', 19th Ed., 1995, are available from the American Public Health Association, 1015 Fifteenth Street, NW, Washington, DC 20005. Copies of ``Guidance Manual for Compliance with the Filtration and Disinfection Requirements for Public Water Systems using Surface Water Sources'', Appendices C and O, 1991, are available from American Water Works Association, 6666 West Quincy Avenue, Denver, CO 80235. FOR FURTHER INFORMATION CONTACT: The Safe Drinking Water Hotline, Telephone (800) 426-4791. The Safe Drinking Water Hotline is open Monday through Friday, excluding Federal holidays, from 9:00 am to 5:30 pm Eastern Time. Since this rule will be directly implemented by EPA rather than States, EPA recommends that inquiries be directed to EPA. For technical inquiries, contact Tom Grubbs or Paul S. Berger, Ph.D., Office of Ground Water and Drinking Water (4603), U.S. Environmental Protection Agency, 401 M Street SW, Washington, DC 20460, telephone (202) 260-7270 (Grubbs) or (202) 260-3039 (Berger). For implementation inquiries, contact Barbara Wysock, Technical Support Division, U.S. Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, OH 45268, telephone (513) 569-7906, or your EPA regional office. SUPPLEMENTARY INFORMATION: EPA Regional Office Points of Contact for the Information Collection Rule I. Kevin Reilly, Water Supply Section, JFK Federal Bldg., Room 203, Boston, MA 02203, (617) 565-3619 II. Michael Lowy, Water Supply Section, 290 Broadway, 24th Floor, New York, NY 10007-1866, (212) 637-3830 III. Ghassan Khaled, Drinking Water Section (3WM41), 841 Chestnut Building ,Philadelphia, PA 19107, (215) 597-8992 IV. David Parker, Water Supply Section, 345 Courtland Street, Atlanta, GA 30365, (404) 347-2913 ext. 6493 V. Kimberly Harris, Water Supply Section, 77 W. Jackson Blvd., Chicago, IL 60604, (312) 353-2650 VI. Blake L. Atkins, Team Leader, Water Supply Section, 1445 Ross Avenue, Dallas, TX 75202, (214) 665-2297 VII. Stan Calow, State Programs Section, 726 Minnesota Ave., Kansas City, KS 66101, (913) 551-7410 VIII. Bob Benson or Bob Clement, Public Water Supply Section (8WM- DW), 999 18th Street, Suite 500, Denver, CO 80202-2466, (303) 312- 6243 (Benson), (303) 312-6079 (Clement) IX. Barry Pollock, Water Supply Section, 75 Hawthorne Street, San Francisco, CA 94105, (415) 744-1913 X. Wendy Marshall, Drinking Water Unit, 1200 Sixth Avenue (OW-136), Seattle, WA 98101, (206) 553-1890 Regulated Entities Entities potentially regulated by this action are public water systems that treat surface water and serve at least 100,000 people and public water systems that treat ground water and serve at least 50,000 people. Regulated categories and entities include: ------------------------------------------------------------------------ Category Example of regulated entities ------------------------------------------------------------------------ Public water systems......... Public water systems that treat surface water and serve at least 100,000 people. Public water systems that treat ground water and serve at least 50,000 people. ------------------------------------------------------------------------ This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in this table could also be regulated. To determine whether your public water system is regulated by this action, you should carefully examine the applicability criteria in Sec. 141.141 of the rule. If you have questions regarding the applicability of this action to a particular entity, contact the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. Table of Contents I. Summary of Regulation II. Statutory Authority III. Regulatory Background IV. Description of Today's Action A. New Terms B. General Applicability C. Applicability of ICR Requirements to Specific Classes of PWSs D. Disinfection Byproducts and Related Monitoring E. Microbiological Monitoring Requirements F. Disinfection Byproduct Precursor Removal Studies G. Dates, Schedules, and Reporting Requirements H. Summary V. Significant Changes to the Proposed Rule VI. State Implementation VII. Cost of Rule VIII. Other Statutory Requirements A. Executive Order 12866 B. Regulatory Flexibility Act C. Paperwork Reduction Act D. Enhancing the Intergovernmental Partnership E. Unfunded Mandates Reform Act IX. References Abbreviations Used in This Notice deg.C--degrees Celsius CFR--Code of Federal Regulations CT--product of disinfectant residual concentration (C (mg/l)) and contact time (T (minutes)) DBP--disinfection byproduct D/DBPR--Disinfectants/Disinfection Byproducts Rule DSE--distribution system equivalent EPA--Environmental Protection Agency ESWTR--Enhanced Surface Water Treatment Rule equ--equivalents ft--foot or feet ft \2\--square feet ft \3\--cubic feet FR--Federal Register GAC--granular activated carbon gpd--gallons per day GWUDI--ground water under the direct influence of surface water HAA5--haloacetic acids (five) HAA6--haloacetic acids (six) HAN--haloacetonitriles HK--haloketones ICR--Information Collection Rule MGD--million gallons per day mg/l--milligrams per liter nm--nanometers OMB--Office of Management and Budget PE--performance evaluation psi--pounds per square inch PWS--public water system PWSID--public water system identification RSSCT--rapid small-scale column test SCFM--standard cubic feet per minute SDS--simulated distribution system THM4--trihalomethanes (four) TOC--total organic carbon TOX--total organic halides TTHM--total trihalomethanes
m--micrometers UFCTOX--Uniform formation conditions for total organic halides U.S.C.--United States Code WIDB--Water Industry Data Base I. Summary of Regulation Acting under the requirement of the Safe Drinking Water Act to regulate additional contaminants that may cause adverse health effects, EPA convened a regulatory negotiation in 1992 due to concerns over the health effects of chemical byproducts (known as disinfection byproducts (DBPs)). DBPs form in drinking water when disinfectants used for microbial control react with organic and inorganic chemicals already present in source water. The regulatory negotiation was convened to determine how the risk-risk issue of controlling the level of DBPs in drinking water on the one hand while controlling exposure to disease- causing microbes (pathogens) on the other hand is best addressed. The Negotiating Committee, consisting of representatives of State and local regulatory and public health agencies, local elected officials, consumer groups, public water systems (PWSs), environmental groups, and EPA, met for more than six months to develop a plan to concurrently control DBPs and microorganisms. The Committee determined that an important component of their plan would be to develop additional information to better define the problem and better identify possible solutions. To develop this information, the Committee agreed that PWSs should be required to collect occurrence and treatment data to characterize disinfectants, DBPs, and microorganisms in drinking water. The Committee also decided that some PWSs should conduct treatment studies to evaluate the use of granular activated carbon or membranes to remove DBP precursors. The information collected, in addition to concurrently conducted health effects and technology research, will be used to evaluate the need for possible changes to the current Surface Water Treatment Rule (SWTR) and to evaluate the need for future regulations for disinfectants and DBPs. All data collected pursuant to this rule will be available to the public via the Internet. (See Section III below and the preamble to the proposed Information Collection Rule (ICR) [59 FR 6332, February 10, 1994] for a more detailed discussion of the regulatory negotiation process). Today, EPA is promulgating an information collection rule (ICR) which requires large PWSs to generate and provide the Agency with specific monitoring data and other information characterizing their water systems. There are three classes of PWSs affected, each somewhat differently, by this rule. The three general classes are: (1) PWSs that serve at least 100,000 people and use surface water; (2) PWSs that serve at least 100,000 people, and use only ground water as the source; and (3) PWSs that serve at least 50,000, but less than 100,000, people and use ground water as the source. Throughout this rule and preamble, requirements for PWSs or treatment plants that use ground water under the direct influence of surface water as a source are the same as those for surface water. Table I-1 contains a summary of today's rule, which will appear in subpart M to 40 CFR Part 141. Table I-1.--General Subpart M Requirements \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Treatment Studies Type of PWS \2\ DBP and related monitoring \3\ Microbial Monitoring \4\ \5\ -------------------------------------------------------------------------------------------------------------------------------------------------------- PWS using surface water \6\ Yes--monthly for 18 months...................... Yes--monthly for 18 months...................... Yes. serving 100,000. PWS using ground water serving Yes--monthly for 18 months...................... NA.............................................. Yes. 100,000. PWS using ground water serving NA.............................................. NA.............................................. Yes. 50,000 to <100,000. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ These are general requirements and do not include regulatory allowances for reduced monitoring and other specific provisions provided in the rule. \2\ Population served will include both retail and wholesale populations. Specific instructions for calculating population served are included in the rule. \3\ DBP and related monitoring includes monitoring for DBPs and other parameters at specified locations throughout the treatment plant. Also, PWSs will be required to characterize treatment processes in the treatment plant. Monitoring includes disinfectant residuals, trihalomethanes, haloacetic acids, haloacetonitriles, haloketones, chloral hydrate, chlorite, chlorate, bromide, bromate, total organic halides (TOX), total organic carbon (TOC), and general water quality parameters. \4\ Microbiological monitoring includes monitoring for specific pathogens and microbial indicators: total culturable viruses, total coliforms, fecal coliforms or E. coli, Giardia, and Cryptosporidium. \5\ PWSs must conduct treatment study applicability monitoring and, unless avoidance criteria are met, bench- or pilot-scale treatment studies to determine the effectiveness of granular activated carbon (GAC) or membranes in reducing the levels of precursors to the formation of disinfection byproducts. \6\ Includes PWSs using ground water under the direct influence of surface water. A major issue with this rule is the adequacy of the protozoa analytical method to generate meaningful occurrence information for Cryptosporidium. The analytical method is relatively new and difficult to conduct. Even experienced laboratories have had widely varying results. EPA has worked over the last couple of years to improve the method and evaluate its performance under field conditions. The most recent round of testing showed laboratories recovering between 5% and 21% of the Cryptosporidium known to be present. However, despite its generally acknowledged limitations, this method is the best method either currently available or anticipated to be available in the near future and EPA is confident that data produced by approved laboratories will enable the Agency to develop a reliable national occurrence data base and national cost impact estimates for various scenarios of regulations. In making its determination whether the protozoa analytical method is adequate to yield meaningful results, EPA focussed on how the data were to be used. Specifically, the data generated under this rule will be used to develop a national occurrence data base and national cost impact estimates for various scenarios of regulations which could be promulgated to reduce microbiological risk. Also, these data may be used in conjunction with results of dose-response health effects research to develop benefit estimates for regulatory options. ICR data would not be used, except at the option of the PWS, to make compliance determinations with future rules. At the national level, EPA will aggregate data from PWS samples analyzed at different laboratories so that the range of relative error is much smaller, nationally, than it would be for a single PWS. EPA developed statistically based data quality objectives which indicated that, even if Cryptosporidium recovery averaged only 8%, the range of uncertainty in cost estimates would be no greater than with previously issued drinking water rules. The reason the recovery rate can be this low is because of the large number of PWSs (over 300) which would be generating data. With a much smaller sample size, a higher range of recovery would be needed. With such a large data base, EPA's independently evaluated statistical analysis shows that an 8% recovery rate can provide a reliable adjustment factor from which to estimate national occurrence. EPA believes that, with the stringent laboratory approval requirements contained in this rule, recovery rates will meet this minimum requirement. As added insurance that the data will be useful, EPA intends to conduct a companion survey of 50 PWSs where the data are analyzed by a single laboratory meeting even more stringent requirements than those imposed in this rule. The results from this survey will augment the ICR-generated data and improve their statistical reliability. II. Statutory Authority The Safe Drinking Water Act (SDWA, or the Act), as amended in 1986, requires EPA to publish maximum contaminant level goals (MCLGs) for contaminants which may have an adverse effect on human health and are known or anticipated to occur in PWSs. For such contaminants, EPA must also promulgate national primary drinking water regulations (NPDWRs) which specify either maximum contaminant levels (MCLs) or treatment techniques (42 U.S.C. 300g-1). An MCL must be set as close to the MCLG as feasible. Under the Act, PWSs can be required to ``establish and maintain such records, make such reports, conduct such monitoring, and provide such information as the Administrator may reasonably require by regulation to assist him in establishing regulations, [or] * * * in evaluating the health risks of unregulated contaminants''. 40 U.S.C. 300j-4. This provision authorizes EPA to require systems to monitor and provide the Agency with these data as well as other data characterizing the systems, including source and treated water quality. In addition, the Act defines NPDWRs to include ``criteria and procedures to assure a supply of drinking water which dependably complies with such maximum contaminant levels; including quality control and testing procedures * * *''. 40 U.S.C. 300f(1)(D). This provision authorizes EPA to require systems and laboratories to use Agency-approved methods and quality assurance criteria for collecting and analyzing water samples. EPA is using these information collection authorities as the basis for promulgating the ICR. III. Regulatory Background EPA has issued two regulations intended to control pathogens in public water supplies--the Total Coliform Rule (54 FR 27544, June 29, 1989) and the Surface Water Treatment Requirements (SWTR) (54 FR 27486, June 29, 1989). A third regulation, the Groundwater Disinfection Rule, is currently under development and will add further protection for systems using ground water. In addition to these regulations, EPA concluded that it was necessary to address disinfectants and chemical byproducts that form when disinfectants used for microbial control in drinking water react with various organic and inorganic chemicals in the source water. Chronic exposure to various DBPs may cause cancer, liver and kidney damage, heart and neurological effects, and effects to unborn children. In 1992, EPA instituted a formal regulatory negotiation (reg-neg) process to develop the Disinfectants/Disinfection Byproducts Rule (D/ DBPR) (57 FR 53866, November 13, 1992). This negotiation was discussed in the proposed rule. In the course of the discussions, the Negotiating Committee determined that insufficient data were available on DBPs to make appropriate regulatory decisions. The Committee was concerned about the risk from DBPs, on one hand, and microbial risk on the other. As disinfectant use is decreased to decrease the formation of DBPs, the risk of microbial illness increases. Microbes cause many diseases, including giardiasis, cryptosporidiosis, dysentery, and hepatitis. For individuals with weakened immune systems, these diseases can be fatal. The Committee recommended that additional data be developed on health effects, occurrence of and exposure to these contaminants, and on the capabilities of treatment technologies to reduce levels of these contaminants. Committee members were also concerned about limited data available on microbial contaminants in water. (See preamble of proposed ICR for a more detailed discussion of the need for additional data and rationale for the proposed monitoring and reporting requirements. 59 FR 6332 (February 10, 1994).) The Committee agreed to proceed with the proposal of regulatory actions but at the same time to initiate a process for developing additional data for future regulatory decisions. Accordingly, the Committee developed three proposed rules: (a) the Information Collection Rule (ICR) (59 FR 6332, February 10, 1994), (b) the ``interim'' Enhanced Surface Water Treatment Rule (ESWTR) (59 FR 38832, July 29, 1994), and (c) the D/DBPR (59 FR 38668, July 29, 1994). It is the ICR that is the subject of this final rulemaking. The Negotiating Committee's development of the three proposed rules was based on: (1) the need to take prudent immediate steps by proposing a Stage 1 D/DBP rule and an interim ESWTR and (2) the need to develop additional data through monitoring and research for future regulatory decisions that would support refinements to the proposed interim ESWTR, and development of the long-term ESWTR and Stage 2 D/DBP rule. The information collected under this rule will be used to determine the most effective regulatory option(s) to reduce exposure to pathogens, disinfectants, and DBPs. All can have adverse effects on human health. Over 200 million people will benefit from these rules once they are fully effective. Preliminary estimates of the annual benefits of the rules could be the avoidance of many cases of disease, including as many as several thousand cancer cases and 500,000 cases of giardiasis, and control of the parasite Cryptosporidium. Accordingly, today's final rule, which requires this additional information, meets the direction and objectives of the Negotiating Committee. The ICR is designed to obtain both microbial and DBP occurrence, exposure, and treatment data for input into the ESWTR and Stage 2 D/DBP rule, as outlined below, and is expected to require the expenditure of an estimated $130 million over three years by a segment of PWSs. The commitment by the public water supply community to support this collection of additional data is linked to EPA's commitment to provide (1) adequate quality control procedures for collecting and managing the information obtained under the ICR and (2) additional funding, especially on health effects research, for properly interpreting ICR data. The Negotiating Committee also agreed that more data, especially monitoring data, should be collected under the ICR to assess possible shortcomings of the SWTR and to develop appropriate remedies, if needed, to prevent increased risk from microbial disease as systems begin complying with the Stage 1 D/DBP Rule. It was also agreed that EPA would propose an interim ESWTR for systems serving at least 10,000 people that included a wide range of regulatory alternatives. Data gathered under the ICR will form the basis for developing the most appropriate criteria among the options presented in the proposed interim ESWTR. Eventually a long-term ESWTR would include possible refinements to the interim ESWTR and be applicable to all system sizes. The interim and long-term ESWTR rules would become effective concurrently with the requirements of the Stage 1 D/DBP rule for the respective different system sizes. The Negotiating Committee also agreed that additional data on the occurrence of disinfectants, DBPs, and potential surrogates for DBPs; source water and within-treatment plant conditions affecting the formation of DBPs; and bench- and pilot-scale information on the removal of DBP precursors would be useful for developing Stage 2 D/DBP regulatory criteria beyond those currently being considered for proposal in Stage 1. Additional data will be developed on potential consumer exposures, acute short-term health effects, and chronic health effects through a concurrent EPA-sponsored research program. These data will support important decisionmaking that will be required when promulgating the Stage 2 D/DBPR. IV. Description of Today's Action This preamble briefly summarizes the background of the ICR, the major elements of the regulations, and the major changes from the proposal. The proposed ICR (59 FR 6332, February 10, 1994) includes a detailed discussion of the lengthy regulatory negotiation process that led to the development of the ICR and is an essential part of the record for the decisions made in this final action. While the discussions from the proposed ICR are not generally repeated here, this preamble occasionally cites the proposed rule where such references are useful. The purpose of the ICR is to establish specific data collection requirements for PWSs and to identify the exact manner in which the data are to be collected and transmitted to the Agency. Most of the requirements are presented in the rule in tabular format, because of the diverse characteristics of the PWSs subject to the ICR. EPA also concluded that technical manuals would be the most efficient way of communicating the detailed requirements of the ICR to those who are actually responsible for implementing the regulations. These technical manuals are incorporated by reference into the ICR. These manuals will be sent by EPA to those PWSs subject to the requirements of the rule. These technical manuals can also be obtained through the National Technical Information Service. A. New Terms (Sec. 141.140) EPA has developed new definitions to address specific issues raised by the ICR and to respond to commenters' questions concerning applicability and monitoring requirements. The definitions in Sec. 141.140 apply only to the regulatory requirements of this rule (i.e., 40 CFR Part 141, subpart M). B. General Applicability 1. Notice of Applicability (Secs. 141.142(c)(2)(i) and 141.143(c)(3)(i)) In Appendix B of the proposed ICR, EPA included lists of PWSs that it expected would have to comply with at least some of the proposed ICR requirements, based on the Agency's own data system, on the Water Industry Data Base (WIDB), or both. EPA requested comment on the accuracy of these lists. Based on public comments and input from EPA regions and States, the Agency developed an updated list of PWSs that are expected to comply with subpart M requirements. Each of these PWSs will receive a Notice of Applicability. Upon receiving a Notice of Applicability, a PWS must reply within 35 days, specifically identifying the subpart M requirements that apply to each treatment plant operated by the PWS. A PWS that believes that it does not meet applicability criteria must so indicate in its response to EPA's Notice of Applicability. Although EPA has expended considerable effort to identify all of the PWSs subject to subpart M, it is possible that an affected PWS may not have been identified. Failure to receive a Notice of Applicability does not relieve a PWS of its responsibility for compliance. A PWS that meets the applicability requirements, but does not receive an EPA Notice of Applicability, must contact the ICR Utilities Coordinator, TSD, USEPA, 26 West Martin Luther King Drive, Cincinnati, OH 45268, so the Agency can send the necessary materials. 2. Applicability Determinations In order to account for both retail and wholesale populations served by treated water produced by a PWS, and to determine specific monitoring requirements for each treatment plant operated by the PWS, each PWS subject to this regulation must calculate the population served by its entire system and by each of its plants. To make these calculations, the PWS must complete Appendix A to Sec. 141.141(a). A PWS that serves no retail population is required to use an EPA- developed equation to calculate the wholesale population that it serves and determine applicability (Cummins, 1987). This equation, included in Appendix A, was developed from hundreds of data points showing the relationship between flow and population served. For the ICR, a treatment plant includes any site where a disinfectant or oxidant is added to the water prior to the water entering the distribution system (e.g., a chlorinator at a well). A PWS that uses multiple wells drawing from the same aquifer and has no central treatment plant is considered to have one treatment plant for those wells and must monitor accordingly. C. Applicability of ICR Requirements to Specific Classes of PWSs The following discussion identifies the ICR requirements that are applicable to each class of PWSs covered by this final rule. Sections D-G explain each of these requirements in greater detail. 1. PWSs Serving at Least 100,000 People and Using Surface Water, or Ground Water Under the Direct Influence of Surface Water, as a Source a. Monitoring for DBPs and Related Parameters All PWSs in this class must monitor for DBPs, DBP precursors, and other chemical parameters at specific locations throughout each treatment plant operated by the PWS on a monthly basis for a period of 18 months. Such PWSs also must characterize treatment processes (e.g., filtration or sedimentation) monthly for the 18 month period. The only exception to this requirement is that PWSs receiving all of their water from a supplier and not further disinfecting that water at the entrance to their distribution system are not required to conduct such monitoring. In addition, for each treatment plant that uses chloramines, hypochlorite solution, ozone, or chlorine dioxide for treatment or disinfection residual maintenance, a PWS must conduct an analysis of parameters related to those disinfectants, such as cyanogen chloride for PWSs that use chloramines. This additional monitoring must also be conducted by PWSs that disinfect finished water at the entrance to their distribution system and receive that water from a PWS that treated the water with chloramines, hypochlorite solution, ozone, or chlorine dioxide. b. Monitoring for Disease-causing Microorganisms and Microbial Indicators Unless a PWS meets the requirements for reduced monitoring (as described in section E), all PWSs in this class must: (1) monitor their source water at the intake of each treatment plant that treats surface water for Cryptosporidium, Giardia, total culturable viruses, total coliforms, and fecal coliforms or Escherichia coli (E. coli); and (2) monitor their finished water for these microorganisms when Cryptosporidium and Giardia exceed 10 per liter in the source water, or when total culturable virus levels exceed one per liter in the source water. c. Treatment Studies i. Treatment Study Applicability (Total Organic Carbon (TOC)) Monitoring All PWSs must monitor for TOC to determine at which treatment plants they must conduct treatment studies. PWSs must conduct TOC monitoring at the following locations: --At the influent of each treatment plant that treats surface water and serves a population of 100,000 people or more. --On finished water at each treatment plant serving a population of 100,000 people or more and using ground water as the source. --For PWSs that serve at least 100,000 people but have no individual treatment plant serving 100,000 or more, PWSs must conduct TOC monitoring at the treatment plant serving the largest population. PWSs must monitor for TOC at the influent of the treatment plant if it treats surface water and must monitor finished water if it treats ground water. ii. Bench- and Pilot-scale Treatment Studies Unless a PWS qualifies for one of the exceptions discussed in section F of this preamble, PWSs in this class must conduct bench- and/ or pilot-scale treatment studies to determine the effectiveness of granular activated carbon (GAC) or membranes in reducing the levels of DBP precursors. 2. PWSs Serving at Least 100,000 People, Using Only Ground Water as a Source a. Monitoring for DBPs and Related Parameters All PWSs in this class must monitor for DBPs, DBP precursors, and other chemical parameters at specific locations throughout each treatment plant operated by the PWS on a monthly basis for a period of 18 months. Such PWSs also must characterize treatment processes (e.g., aeration or ion exchange) monthly for the 18 month period. The only exception to this requirement is that PWSs receiving all of their water from a supplier and not further disinfecting that water at the entrance to their distribution system are not required to conduct such monitoring. In addition, for each treatment plant that uses chloramines, hypochlorite solution, ozone, or chlorine dioxide for treatment or disinfection residual maintenance, a PWS must conduct an analysis of parameters related to those disinfectants. This additional monitoring must also be conducted by PWSs that disinfect finished water at the entrance to their distribution system and receive that water from a PWS that treated the water with chloramines, hypochlorite solution, ozone, or chlorine dioxide. b. Treatment Studies i. Treatment Study Applicability (TOC) Monitoring All PWSs must monitor for TOC to determine at which treatment plants they must conduct treatment studies. PWSs must conduct TOC monitoring at the following locations: --On finished water at each treatment plant serving a population of 100,000 people or more and using ground water as the only source. --For PWSs that serve at least 100,000 people but have no individual treatment plant serving 100,000 or more, PWSs must conduct TOC monitoring on finished water at the treatment plant serving the largest population. ii. Bench- and Pilot-scale Treatment Studies Unless a PWS qualifies for one of the exceptions provided in section F of this preamble, PWSs in this class must conduct bench- and/ or pilot-scale treatment studies to determine the effectiveness of granular activated carbon (GAC) or membranes in reducing the levels of DBP precursors. 3. PWSs Serving at Least 50,000 People, But Less Than 100,000, and Using Ground Water as a Source PWSs serving at least 50,000, but less than 100,000, (with at least 50,000 served by ground water) are required to monitor for TOC in the finished water at the treatment plant serving the largest population. Subsequently, unless a PWS qualifies for one of the exceptions provided in section F, PWSs in this class must conduct bench- and/or pilot-scale treatment studies to determine the effectiveness of granular activated carbon (GAC) or membranes in reducing the levels of DBP precursors. D. Disinfection Byproducts (DBPs) and Related Monitoring Requirements 1. General Monitoring (Secs. 141.141(c) and 141.142(a)) PWSs affected by this requirement must conduct monthly monitoring for DBPs, DBP precursors, and other chemical parameters at each treatment plant and in the distribution system. These PWSs will also be required to characterize treatment processes (e.g., filtration and sedimentation) in the treatment plant on a monthly basis for 18 months. PWSs receiving all of their water from a supplier and not further disinfecting that water at the entrance to the distribution system are not required to conduct any monitoring under this rule. 2. Additional Monitoring Requirements for PWSs Using Chloramines, Hypochlorite Solution, Ozone, or Chlorine Dioxide (Secs. 141.142(a) (2)-(5)) For each treatment plant that uses chloramines, hypochlorite solution, ozone, or chlorine dioxide for treatment or disinfection residual maintenance, a PWS must also conduct an analysis of such parameters as cyanogen chloride, chlorate, pH, temperature, free residual chlorine, bromide, bromate, ammonia, and aldehydes. For consecutive systems (i.e., PWSs receiving finished water from another PWS), the receiving PWS must consult with the provider to ensure that all such additional analyses are completed. For example, the rule requires a PWS covered by the ICR that receives finished water that has been treated with chlorine dioxide to conduct additional monitoring of parameters such as chlorite, chlorate, chlorine dioxide residual, and aldehydes. A PWS receiving finished water has the obligation to determine whether the water it receives has been treated with chloramines, chlorine dioxide, ozone, or hypochlorite solution and what additional monitoring, if any, is required, and to conduct the necessary monitoring. 3. Analytical Methods (Sec. 141.142(b)) For conducting the required analyses, PWSs are required to use the methods specifically approved for subpart M. With the exception of optional analyses for assimilable organic carbon (AOC) and biodegradable organic carbon (BDOC), only results from laboratories that have been approved by EPA to perform sample analyses for DBPs will be acceptable. Laboratories may apply for approval under the provisions of Sec. 141.142(b)(2). E. Microbiological Monitoring Requirements 1. Monitoring (Secs. 141.141(d) and 141.143(a)) a. Source Water Monitoring Microbiological monitoring requirements include monitoring for disease-causing microorganisms, such as Cryptosporidium and Giardia, total culturable viruses, and indicator organisms. To be eligible for reduced monitoring, a PWS must notify EPA in its response to the EPA Notice of Applicability of its plans to reduce monitoring, which is available under the following provisions: --A PWS may avoid the requirement to conduct finished water monitoring of Cryptosporidium and Giardia (Sec. 141.143(a)(2)(iii)) by complying instead with alternative monitoring requirements, including particle counting at several locations within the treatment plant. --A PWS may avoid virus monitoring (Sec. 141.143(a)(2)(iv)), if the PWS has monitored for total coliforms, fecal coliforms, or E. coli in the treatment plant influent for at least five days/week for any consecutive six month period beginning January 1, 1994, and 90 percent of all samples taken in that six-month period contain no greater than 100 total coliforms/100 milliliters (ml), or 20 fecal coliforms/100 ml, or 20 E. coli/100 ml. For purposes of making this determination, PWSs may use source water coliform data collected under the SWTR. EPA and the Negotiating Committee agreed that raw waters that contained densities of total coliforms, fecal coliforms, or E. coli lower than the specified density value were unlikely to contain measurable levels of viruses. b. Finished Water Monitoring PWSs must conduct finished water monitoring at any treatment plant at which it detects, during the first 12 months of monitoring, 10 or more Giardia cysts, or 10 or more Cryptosporidium oocysts, or one or more total culturable viruses, per liter of water. The PWS must analyze finished water samples for the same organisms analyzed for in source water until 18 months of source water microbial monitoring are completed. c. Archiving If either i or ii below occurs, PWSs must arrange to submit samples of treatment plant influent and finished water to EPA for virus archiving each month until the 18 months of microbial monitoring are complete. i. After the PWS learns that viruses were detected in any previous sample of finished water. ii. After the PWS learns that a density of at least 10 viruses per liter was detected in any previous treatment plant influent sample. 2. Analytical Methods (Sec. 141.143(b)) PWSs are required to use the analytical methods approved for subpart M for pathogens and indicator organisms. In addition, systems are required to use EPA-approved laboratories for analysis of Giardia, Cryptosporidium, and total culturable viruses. As proposed, a PWS must use laboratories certified for microbiology analyses under the EPA or State drinking water program for the analysis of total coliforms, fecal coliforms, and E. coli. Laboratory approval criteria for Giardia, Cryptosporidium, and total culturable viruses are found in the ``ICR Microbial Laboratory Manual'', EPA 600/R-95/178, April 1996. Periodically, the Agency will update the list of EPA-approved laboratories under this rule. F. Disinfection Byproduct Precursor Removal Studies: Bench- and Pilot- Scale Treatment Studies and Treatment Study Applicability Monitoring 1. Determination of Treatment Study Requirements: Treatment Study Applicability (TOC) Monitoring (Sec. 141.141(e) (2)-(3) To determine which treatment plants will be required to conduct bench- and/or pilot-scale testing, PWSs are required to conduct treatment study applicability monitoring. Treatment study applicability monitoring requires monitoring for TOC for 12 consecutive months. PWSs must monitor for TOC in the influent of each treatment plant that treats surface water and serves a population of 100,000 people or more. For treatment plants serving a population of 100,000 people or more and using ground water as the source, TOC monitoring must be conducted on finished water. For PWSs that serve at least 100,000 people but have no individual treatment plant serving 100,000 or more, TOC monitoring must be conducted at the treatment plant serving the largest population. PWSs serving at least 50,000, but fewer than 100,000 (with at least 50,000 served by ground water), are required to monitor finished water TOC at the treatment plant serving the largest population. A PWS operating multiple treatment plants using the same source is only required to conduct one treatment study for those treatment plants. 2. Treatment Study Requirements (Sec. 141.144(b)) Treatment studies will consist of bench- and/or pilot-scale testing systems for at least one of the two appropriate candidate technologies (granular activated carbon (GAC) or membrane processes) for the reduction of organic DBP precursors. The treatment studies must be designed to yield representative performance data and to allow the development of treatment cost estimates for different levels of organic DBP control. To simulate the most likely treatment scenario, treatment studies will need to be conducted with the effluent from the treatment processes that are already in place to remove DBP precursors and TOC. PWSs are required to conduct pilot-scale studies at treatment plants serving 500,000 people or more and may conduct either bench- or pilot- scale studies at those serving fewer than 500,000. a. Bench-scale Testing (Sec. 141.144(b)(1)) Bench-scale tests are continuous flow tests using the rapid small scale column test (RSSCT) for GAC and either flat sheet or single- element bench test apparatus for membranes. Water to be used in bench- scale tests must be representative of water which would be applied to the advanced treatment full-scale technology. The testing will include the information specified in this rule and in the ``Manual for Bench- and Pilot-scale Treatment Studies'', EPA 814-B-96-003, April 1996. EPA has provided utilities flexibility to select a bench-scale protocol appropriate for its circumstances. b. Pilot-scale Testing (Sec. 141.144(b)(2)) PWSs must conduct pilot-scale tests as continuous flow tests. For GAC, the PWS must use GAC of a particle size representative of that used in full-scale practice, a pilot GAC column with a minimum inner diameter of 2.0 inches, and hydraulic loading rate (volumetric flow rate/column cross-sectional area) representative of that used in full- scale practice. For membranes, the PWS must use a staged array to achieve a recovery of at least 75%. Pilot-scale testing must include the information specified in this rule and in the ``Manual for Bench- and Pilot-scale Treatment Studies'', EPA 814-B-96-003, April 1996. 3. Treatment Study Exceptions (Secs. 141.141(e)(3) and 141.141(e)(7)(i)) PWSs that would otherwise be required to conduct a bench- and/or pilot-scale treatment study are exempt from treatment study requirements if they operate treatment plants that: --Use chlorine as both the primary and residual disinfectant and have, as an annual average, levels less than 40 micrograms per liter ( g/l) for THM4 and less than 30 g/l for HAA5. The quarterly average is calculated by averaging results from all individual distribution system samples taken during the quarter. The annual average is calculated by averaging the four quarterly averages. --Use surface water that does not exceed a TOC level of 4.0 milligrams per liter (mg/l) in the treatment plant influent, when calculated by averaging the 12 monthly TOC samples. --Use ground water not under the direct influence of surface water that does not exceed a TOC level of 2.0 mg/l in the finished water, when calculated by averaging the 12 monthly TOC samples. --Already use full-scale GAC or membrane technology. These PWSs must submit full-scale plant data and data that show that the technology effectively removes DBP precursors and must monitor the full-scale process to comply with DBP and related monitoring requirements. 4. Joint Studies (Secs. 141.141(e)(4) and 141.141(e)(7)(ii)) PWSs that use common water resources and similar treatment trains (e.g., conventional filtration treatment or softening) may conduct joint treatment studies with other PWSs. A PWS operating more than one treatment plant using similar treatment trains on the same source is not required to conduct multiple studies. PWSs wishing to conduct joint studies must submit a letter of intent to EPA signed by all PWSs planning to participate in the study, as well as the additional information specified in Sec. 141.141(e)(7)(ii) of the rule. Once all applicability monitoring is complete, each PWS must formally apply for EPA approval of a joint study. The minimum number and type of treatment studies to be conducted in a joint study are specified in Sec. 141.141(e)(4) of the rule. 5. Alternatives to Treatment Studies (Secs. 141.141(e)(5) and 141.141(e)(7)(iii)) In lieu of conducting a treatment study, a PWS may apply to EPA to contribute funds to a cooperative research effort. The PWS must show in its application to EPA that the treatment plant for which the waiver of the treatment study is sought uses a common water resource which is being studied by another PWS or a cooperative of PWSs. If EPA approves the application, the PWS shall contribute funds for use in a dedicated cooperative research program related to disinfectants, DBPs, and enhanced surface water treatment. The mandatory contributions that must be made under this option are as follows: $300,000 for a treatment plant serving a population of 500,000 or more, and $100,000 for a treatment plant serving a population of fewer than 500,000. 6. Grandfathered Studies (Secs. 141.141(e)(6) and 141.141(e)(7)(iv)) PWSs that have conducted studies of precursor removal using GAC or membrane technology and which meet specified criteria may use the results of those studies, if approved by EPA, in lieu of conducting another treatment study. PWSs using grandfathered studies must submit appropriate information on the earlier studies, such as data, study description, equipment used, protocol, analytical methods, and information to develop a full-scale cost estimate, and obtain EPA approval. G. Dates, Schedules and Reporting Requirements EPA intends to notify PWSs that they are subject to this rule. PWSs receiving a Notice of Applicability from EPA must respond within 35 days of receipt. 1. Sampling Plans (Sec. 141.141(f)) PWSs required to comply with subpart M requirements must submit sampling plans to EPA for review and approval no later than eight weeks after receiving sampling software and requirements from EPA. Once EPA notifies the PWS that the plan has been approved, the PWS must begin monitoring the following month. 2. Monitoring PWSs must begin treatment study applicability monitoring (i.e., TOC monitoring) no later than three months from the date the rule is published in the Federal Register, regardless of whether the sampling plan has been approved. For other applicable monitoring requirements, a PWS must begin monitoring the month after receiving notice that the PWS's sampling plan has been approved by EPA. If the PWS must conduct both DBP and microbiological monitoring, the PWS must begin monitoring for both in the same month. 3. Data Reporting (Secs. 141.142(c) and 141.143(c)) PWSs must submit monthly monitoring reports electronically on diskettes in the format that EPA has prescribed and will be providing to affected PWSs. This electronic reporting is necessary because of the need for EPA to evaluate and manipulate the data. 4. Treatment Studies (Sec. 141.141(f)(4)) A PWS must begin treatment studies not later than 23 months from the date that the ICR is published in the Federal Register. PWSs must submit a report of each completed treatment study not later than 38 months after the final rule appears in the Federal Register. H. Summary Table IV-1 below provides a listing of the requirements contained in today's rule cross-referenced to the section of the rule where each requirement appears. Table IV-1.--Summary of Subpart M Regulatory References -------------------------------------------------------------------------------------------------------------------------------------------------------- Subject DBP and related monitoring Microbiological monitoring Treatment studies -------------------------------------------------------------------------------------------------------------------------------------------------------- Definitions...................... Sec. 141.140......................... Sec. 141.140......................... Sec. 141.140 PWS applicability................ Sec. 141.141(b)...................... Sec. 141.141(b)...................... Sec. 141.141(b) Treatment plant applicability.... Sec. 141.141 (b), (c)................ Sec. 141.141 (b), (d)................ Sec. 141.141 (b), (e) Schedule......................... Sec. 141.141(f)(2)................... Sec. 141.141(f)(3)................... Sec. 141.141(f)(4) Monitoring requirements.......... Sec. 141.142(a)...................... Sec. 141.143(a)...................... Sec. 141.144 (a), (b) Analytical methods............... Sec. 141.142(b)...................... Sec. 141.143(b)...................... Sec. 141.144(c) Reporting requirements........... Sec. 141.142(c)...................... Sec. 141.143(c)...................... Sec. 141.144(d) -------------------------------------------------------------------------------------------------------------------------------------------------------- V. Significant Changes to the Proposed Rule In response to comments received during the public comment period, EPA made many changes to the rule. All comments were evaluated, and EPA has prepared a comment-response document that contains EPA's responses to those public comments. That document, along with other documents that support the rule, is available in the Drinking Water Docket. The following sections provide a discussion of the most significant comments considered. A. Rule Applicability The most far-reaching change in rule applicability was removing PWSs serving 10,000 to 99,999 that use surface water from any ICR requirements. EPA decided to take this action because the analytical method for protozoan measurement had proven to be very complex and difficult, and EPA was concerned about whether an adequate number of laboratories would be able to meet the approval criteria, which include passing a performance evaluation sample. Many commenters noted that the DBP and related monitoring and reporting required in the proposed rule were not applicable to their PWS. These commenters believed that many of the proposed requirements would not make sense based on the configuration or operational practices of their PWS. During development of the ICR data system, EPA held a number of public meetings with representatives of PWSs and others to evaluate the applicability of the proposed requirements for the universe of treatment plants. These meetings helped EPA to: (1) Clarify the categories of PWSs that would appropriately be required to meet the different requirements of the ICR and (2) clarify treatment plant monitoring and data collection requirements. For example, the Agency modified proposed rule language to include PWSs that sell or buy large amounts of water in the appropriate applicability category. Also, EPA has reorganized the rule to make it easier to find applicability and monitoring requirements. EPA has coordinated with the American Water Works Association (AWWA) to form a group of technical experts that will be available to PWSs to answer questions about this rule concerning applicability, sampling plans, and monitoring. PWSs may contact these experts at 800- 200-0984 or on the Internet at firstname.lastname@example.org. B. Data Quality Objectives Several commenters noted that EPA did not clearly identify data quality objectives for the large amount of data to be generated by this rule. In response, EPA participated in several public workshops that addressed this issue. During the workshops, statisticians, data managers, scientists, and engineers reviewed the proposed requirements to ensure that the data reporting is necessary and adequate to achieve the goals of the rule. Also, EPA has developed a quality control program to ensure that data used in modeling are appropriate for regulatory development. C. Data System Commenters noted that EPA's data system for PWSs at the time of proposal, the Federal Reporting Data System (FRDS), was inadequate to handle and manipulate the large amount of data that will be reported under this rule. Commenters stated that the Agency needed to develop a new data system that is able to receive, store, retrieve, manipulate, and analyze data submitted by PWSs. Additionally, commenters noted that once such a data system became available, EPA would have to test the data system to ensure its smooth operation. EPA used a contractor as the primary data systems developer for this project. The contractor worked closely with EPA personnel and a broad array of technical experts from drinking water suppliers and other interested parties to understand the regulatory requirements, develop data manipulation procedures and report capability, produce adequate user instructions, and ensure the data system could perform necessary data handling and manipulation. The utility data system has undergone alpha, beta, and gamma testing and revision and has been found to meet EPA's needs. Other data systems, for laboratory quality assurance data and mainframe data storage and manipulation, are undergoing similar testing and revision. Testing and revision will be completed before data entry begins under the rule. D. Data Base Development Many commenters stated that EPA, not PWSs, should fund the development of a data base adequate to meet the objectives of the ICR (i.e., determine what regulatory requirements are necessary for the control of disinfectants, DBPs, and pathogens). Under section 1445(a)(1) of the Act, however, EPA is authorized to require PWSs to conduct monitoring and provide information necessary to establish drinking water regulations, including evaluating the health risks of unregulated contaminants. The information collected under this rule will enable EPA to determine current occurrence levels and patterns for unregulated contaminants. Because the ICR will provide EPA with detailed information on what treatment PWSs already have in place and how well such treatment processes work, the rule will also allow the Agency to develop predictive models to evaluate the effect that various changes in treatment will cause. Participants in the regulatory negotiation process understood the importance of the data collection effort as it relates to the objectives of the SDWA and agreed, as part of the negotiation, to participate in the effort. E. Protozoan Analytical Method Many commenters expressed concern that EPA lacks an analytical method to provide adequate quality data for Cryptosporidium. Also, some commenters believed that the method that the Agency proposed was too complex and difficult for reliable use by most laboratories. EPA has taken several steps to address these concerns. The first was to establish stringent laboratory approval criteria to assure adequate quality analyses and ensure that data quality objectives are met. EPA developed data quality objectives after consultation with outside parties, including statisticians and microbiologists, to determine minimum percentage recoveries and precision to meet data analytical objectives (i.e., to characterize national occurrence of Cryptosporidium for the purpose of conducting a regulatory impact analysis). Based on performance evaluation testing of microbiological laboratories, EPA believes that only laboratories that maintain high standards will be able to comply with the EPA criteria. In the ICR proposal, any PWS that treated surface water and served a population of at least 10,000 would have been required to sample at each treatment plant, with more sampling required for PWSs serving at least 100,000. However, because only a small number of laboratories would be available to analyze samples, EPA reduced the universe of PWSs that must collect and analyze Cryptosporidium samples. In the final rule, only PWSs that treat surface water and serve a population of at least 100,000 are required to sample for Cryptosporidium. A PWS serving fewer than 100,000 is not required to take any microbiological samples. By reducing both the number of PWSs that are required to sample and the number of samples that some of the remaining PWSs are required to take, EPA expects that the number of laboratories who will qualify to conduct testing will be able to handle the workload. Since PWSs serving fewer than 100,000 people are no longer required to conduct microbiological monitoring, EPA intends to conduct two sample surveys to collect microbiological occurrence data at smaller PWSs to determine the correlation with the data collected at PWSs serving at least 100,000 people. These sample surveys will be conducted at PWSs using surface water serving (1) 10,000 to 100,000 people and (2) fewer than 10,000 people. A secondary purpose of these sample surveys will be to collect occurrence data for areas where no PWSs will be collecting microbiological occurrence data because there are no PWSs serving at least 100,000 people that use surface water (e.g., the upper Great Plains and Rocky Mountain area). EPA has determined that the purposes of the ICR will not be adversely affected by reducing the number of PWSs required to provide data. In conjunction with requiring fewer samples, EPA has continued to refine the analytical method and validate its accuracy and precision in non-EPA laboratories. Results of field testing that used various source waters in multiple laboratories indicate that a well-operated laboratory will be able to exceed EPA's minimum recoveries. The field testing results also indicate that well-operated laboratories will be able to provide adequate data for deriving national occurrence data that will be used in national cost estimates for evaluating different ESWTR regulatory option
National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements
Today, EPA is promulgating an information collection rule (ICR) which establishes monitoring and data reporting requirements for large public water systems (PWSs). This rule is intended to provide EPA with information on the occurrence in drinking water of (1) chemical byproducts that form when disinfectants used for microbial control react with chemicals already present in source water (disinfection byproducts (DBPs)) and (2) disease-causing microorganisms (pathogens), including Cryptosporidium. Also, EPA will collect engineering data on how PWSs currently control such contaminants. All data collected pursuant to this rule will be available to the public via the Internet.