Legal Deadlines: The SDWA requires EPA to add new public notification requirements for violations posing a serious adverse effect on human health but imposes no legal deadline. EPA proposed the rule in the May 13, 1999, Federal Register (64 FR 25963).

Current Status and Near-Term Action: EPA is planning to finalize the Public Notification Handbook in late June. EPA is developing the Handbook in cooperation with the Association of State Drinking Water Administrators (ASDWA) to assist water systems and states in implementing the new rule. In the handbook, templates for notices and other aids to help water systems develop notices for violations will be provided.

Background: The Final Public Notification Rule was published in the Federal Register on May 4, 2000. A pre-publication copy of the rule was sent to members in Bulletin 00-08.

This new rule is intended to:

• require faster public notification in emergencies and fewer notices overall;
• result in notices that better communicate the potential health risks from drinking water violations and how to avoid such risks;
• enable water systems to better target notices based on the risks; and,
• make the process less burdensome for water suppliers and easier for consumers to understand.

The new requirements do not apply to water systems in states with primacy programs until two years from publication, unless states choose to adopt the new requirements earlier. However, water systems in Wyoming, Washington, D.C., and tribal lands, where EPA directly implements the drinking water programs, must comply with the new requirements 180 days after publication.

The following are the major changes to the public notification requirements based on this new rule:

• 24-hour notice. Water systems are required to distribute notices within 24 hours (the previous requirement was 72 hours) for violations posing health risks due to short-term exposure (i.e., a Tier 1 violation).
  
• Consultation requirement. Water systems must consult with the state or EPA within 24 hours of a Tier 1 violation to receive direction on subsequent requirements.
  
• 30-day notice for other serious violations. The notice deadline for violations of maximum contaminant levels or treatment techniques which do not pose an immediate threat to human health is extended from 14 to 30 days, with possible extension to 3 months (i.e., a Tier 2 violation).
  
• 12-month notice for non-serious violations. The notice deadline for all other violations is extended from 3 to 12 months, allowing a single annual report where applicable (i.e., a Tier 3 violation). Systems may choose to include this notice in their annual Consumer Confidence Reports (CCR).
  
• Simplified standard language. The existing standard health effects language is simplified, consistent with the CCR requirements. New standard language is now required for monitoring violations.
  
• Reduced number of notices. Formerly, water systems were required to use specific multiple delivery methods when distributing notices. Water systems now have the flexibility to chose the delivery method that will reach their customers best, even if that is a single method.

The proposed Public Notification Rule was provided to all AMWA members with Bulletin 99-24. The comment period closed July 12, 1999.

The following is a summary of the major requirements from the proposed rule:

• Public Notification requirements would fall into three tiers:

  Tier 1 for violations and situations with significant potential to have serious adverse effects on human health as a result of short-term exposure. Notice is required within 24 hours of the violation.

  Tier 2 for other violations and situations with potential to have serious adverse effects on human health. Notice is required within 30 days, with extension up to three months at the discretion of the state or primacy agency.

  Tier 3 for all other violations and situations requiring a public notice not included in Tier 1 and Tier 2. Notice is required within 12 months of the violation, and may be included in the Consumer Confidence Report at the option of the water system.

• In general, Tier 1 violations would include violation of standards based on acute health effects such as: a waterborne disease outbreak; violation of the MCL for total coliforms when fecal coliform or E. coli are present; violation of the MCL for nitrate, nitrite, or their combination; or violation of the MRDL for chlorine dioxide. Tier 2 would include all MCL, MRDL, and treatment technique violations not falling under Tier 1. Tier 3 would include minor violations such as minor monitoring oversights, or operating under a variance or exemption.
  
• The form, manner and frequency of the public notification would be keyed to the tier to which the violation is assigned.

Legal Deadlines: EPA must promulgate a Ground Water Rule by May 2002.

Current Status and Near-Term Action: The proposed Ground Water Rule was published in the Federal Register on May 10, 2000. EPA extended the comment period by 30 days to August 9, 2000. Please submit comments to AMWA by July 25 for inclusion in the Association's comments.

On April 17, the EPA announced the signing of the Proposed Ground Water Rule. The EPA said that the rule was designed to protect ground water sources of public drinking water supplies from disease-causing viruses and bacteria. In general, the rule is intended to strengthen monitoring, prevention, inactivation, and removal of microbial contaminants in ground water systems.

The rule applies to public ground water systems and to systems that mix surface water and ground water if the ground water is added directly to the distribution system and provided to consumers without treatment. This ostensibly includes untreated stand-alone ground water wells and untreated ground water plants that have their own entry points to the distribution system as well as untreated ground water blended with treated surface water prior to the entry point to the distribution system. Treatment in this case is defined as 4-log inactivation/removal of viruses.

The specific requirements proposed in the rule include the following:

• System sanitary surveys conducted by the state and identification of significant deficiencies.

  - Applies to all ground water and mixed surface water/ground water systems.

  - Includes the identification of "significant deficiencies" (i.e., those that require corrective action).

• Hydrogeologic sensitivity assessments for undisinfected systems.

  - Applies to all untreated ground water and mixed surface water/untreated ground water systems.

  - Includes the identification of aquifers as "sensitive" to microbial contamination.

• Source water microbial monitoring by systems that do not disinfect and draw from hydrogeologically sensitive aquifers or have detected fecal indicators within the system's distribution system.

  - Applies to all untreated ground water and mixed surface water/untreated ground water systems that: 1) are considered hydrogeologically "sensitive," or 2) have contamination in their distribution system (based on total coliform sampling under the Total Coliform Rule).

  - Routine monitoring is required when hydrogeologically sensitive (sampling monthly for 12 months).

  - Triggered monitoring is required if a total coliform positive sample is found in the distribution systems (one ground water source sample for a fecal indicator).

• Corrective action by any system with significant deficiencies or positive microbial samples indicating fecal contamination.

  - Applies to ground water systems and mixed surface water/ground water systems that have a "significant deficiency" or have detected a fecal indicator in their ground water source.

  - The significant deficiencies must be corrected in 90 days or treatment is required (i.e., 4-log virus inactivation/removal).

• Compliance monitoring for systems which disinfect to ensure that they reliably achieve 4-log inactivation or removal of viruses.

  - Applies to all ground water systems and mixed surface water/ground water systems that currently disinfect and to systems that disinfect as a corrective action.

Background: In March 2000, SAB's Drinking Water Committee met in Washington and drafted comments on the Ground Water Rule. Draft comments were developed on the use of fecal indicators, the use of hydrogeological assessments, and source water monitoring. On fecal indicators, the committee recommended that the Agency propose monitoring for both bacterial (E. coli or enterococci) and viral indicators (coliphages) for both routine and triggered monitoring. The committee strongly felt that no single indicator adequately captures all fecal contamination. On which indicators should be used under the rule, the committee felt that both E. coli and enterococci are effective bacterial indicators. However, the committee recommended that EPA use both somatic and male-specific coliphage because together they will detect a larger population of coliphage and laboratory methods will be available in the near term to detect both at the same time.

Hydrogeological assessments are being considered by the Agency as a basis for distinguishing between groundwater sources that are more or less vulnerable to fecal contamination. The committee expressed concern about the ability to accurately assess the sensitivity of specific ground water sources. Therefore, the committee recommended that all ground water sources be required to monitor for bacterial indicators and coliphage for at least one year, regardless of the sensitivity determinations.

The committee also stated the general concern that in the current rule many untreated ground water systems will not be monitored at the source. It is possible that after an initial monitoring period of one year, states could require less or even no source monitoring if the initial sampling is negative.

In the 1996 Amendments to the SDWA, a schedule was set for the Ground Water Rule (previously called the Ground Water Disinfection Rule. The key change in the Act extends the time frame for the final Ground Water Rule stating that it can be issued "at any time after August 6, 1999, but not later than the promulgation of the Stage-2 MDBP rules." The new law makes clear that the option of not requiring disinfection for all ground water systems is allowable. This distinction was not clear in the old law.

EPA held a series of public meetings to receive input on various aspects of the rule. Past AMWA Bulletins covering development of the proposed rule are 96-51, 96-66, 96-68, 97-03, 97-14, and 97-60.

Legal Deadlines: EPA has completed an arsenic research plan that was required by February 1997. EPA must propose an arsenic rule by January 2000 and finalize it by January 2001.

Current Status and Near-Term Action: EPA published the proposed Arsenic Rule in the Federal Register on June 22, 2000. A pre-publication version of the rule was sent to Members in Bulletin 00-15. The comment period will last 90 days with comments due to EPA by September 20. Please submit comments to AMWA by September 1 for inclusion in the Association's comments.

In March 2000, SAB's Drinking Water Committee met in Washington to discuss issues related to the Arsenic Rule, but the committee did not make any formal recommendations. However, the committee has planned a follow-up meeting in June, shortly after the Arsenic Rule is proposed, to discuss several health effects and cost issues. The committee will be charged with applying the findings of the National Academy of Science's (NAS) report on arsenic to EPA's proposed regulation and with reviewing the cost of implementing the proposed rule.

In June 2000, the SAB's Drinking Water Committee continued its review of the proposed Arsenic Rule. Two subcommittees &endash; health effects and engineering &endash; appear ready to recommend a less stringent standard for arsenic than the 5 ppb proposed by EPA. A standard in the 10 to 20 ppb range was discussed. The recommendations remain to be finalized and approved by the full committee.

The committee was concerned that EPA "overinterpreted" last year's report from the NAS in developing the risk estimates. Particularly, the committee pointed out that the extent of possible lung cancer cases was overstated by a substantial factor. The committee also discussed the uncertainties surrounding arsenic's effects at low levels in drinking water. It suggests that EPA has overestimated potential risk. For example, while a study in Taiwan is used to justify a low MCL based on excess bladder and lung cancer, an EPA study in Utah found no evidence of either at arsenic levels of 200 ppb. Overall, it appears that EPA overestimated the benefit of the rule, according to the committee.

The committee also questioned EPA's cost-benefit analysis. The costs are likely to be underestimated due to underestimating treatment residuals disposal costs, a finding supported by the recent AWWARF report on arsenic.

EPA submitted the proposed arsenic rule for review by OMB in February. According to sources, the proposed rule was sent with concurrence by EPA's Office of Congressional and Intergovernmental Relations (OCIR). OCIR had objected to a 5 ppb MCL for arsenic during internal agency review. Reportedly, revisions were made to the preamble of the rule, but at this time the nature of the change is not known. OMB's review is expected to take 90 days. It is expected that the proposed rule will be published in the Federal Register in June 2000. EPA has stated that it will issue a Health Advisory for arsenic at the same time the proposal is issued.

An internal dispute at EPA over the appropriate regulatory level for arsenic delayed publication of the proposed rule. EPA's OCIR objected to a 5 ppb MCL for arsenic during internal agency review. OCIR cited the inadvisability of data from a study in Taiwan to establish U.S. standards, holding that the study did not support any substantial lowering of the existing standard of 50 ppb. OCIR also cited the high costs to small systems, noting that these costs were excessive given the weakness of the health data. Additionally, the office noted that the costs were likely understated in the draft proposal.

A new study in the September 1999 issue of Environmental Health Perspectives found an association between bladder cancer with arsenic levels greater than 0.5 ppb.

Background: Arsenic regulation remains active under the SDWA Amendments of 1996. The key changes in the Act extend the time frame for arsenic regulation and require needed research. EPA completed the arsenic research plan. The plan was reviewed by EPA's Board of Scientific Counselors (BOSC) which provided a variety of comments including their feeling that a threshold likely exists for skin cancer in the neighborhood of 100 to 200 ug/L (compared to the present standard of 50 ug/L), and the need for further, long-term epidemiology studies to help resolve major uncertainties. Additionally, the BOSC suggested a two-step approach to regulation, which would take a small step by January 2000 with later, more definitive regulation when the results of long-term studies were available.

On March 23, 1999, the National Research Council (NRC) released a report recommending that the EPA revise the existing 50 ug/L standard for arsenic "downward as quickly as possible." NRC also recommended that EPA improve its arsenic toxicity analysis and risk characterization, conduct additional human studies, identify proximate markers of arsenic-induced cancers, and provide wider safety margins. Further, NRC concluded that chronic ingestion of inorganic arsenic causes bladder and lung cancer, as well as skin cancer (see AMWA Bulletin No. 99-14 for more details).

At a June 1999 stakeholders meeting, EPA stated that the practical quantitation level (PQL) for arsenic (which is one factor in setting how low the arsenic MCL can be) has been determined to be 3 ug/L. The general discussions at the meeting indicate that EPA is considering an MCL in the range of 2 to 20 ug/L with their focus being toward the lower end of the range.

Since October 1997, Representative Tom Bliley (R-VA), Chair of the House Commerce Committee with jurisdiction over the Safe Drinking Water Act, has expressed continuing concern in writing about EPA's delay in starting arsenic research and in reporting to him its status and how funds have been obligated.

Legal Deadlines: None.

Current Status and Near-Term Action: Since EPA received adverse comments on the direct final rule on the Interim Enhanced Surface Water Treatment Rule (IESWTR) and the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR), EPA withdrew the direct rule in a June 13 Federal Register notice. EPA plans to address the comments in a final rule and has reopened the comment period. Comments must be submitted to EPA by July 13, 2000. A copy of the direct final rule was sent to members in the April Regulatory Report.

AMWA submitted comments on the direct final rule addressing technical corrections to the Stage-1 DBPR and IESWTR in May. AMWA requested that EPA withdraw the direct final rule and re-propose the rule after conducting additional analyses to address the issue of monitoring requirements for consecutive systems. AMWA also requested that EPA provide a 60-day public comment period on the re-proposed rule. AMWA believes that the issues addressed in these revisions to the Stage-1 rules are significant and require a standard rulemaking process.

Background: On April 14, EPA published to two Federal Register notices on proposed revisions to the IESWTR and the Stage-1 DBPR. The first notice was a notice of direct final rule and second notice was a notice of a proposed rule, both concerning minor revisions tot he IESWTR and the Stage-1 DBPR.

EPA issued the direct final rule for the revision because the Agency viewed the revisions as minor and non-controversial and anticipated no adverse comment. If EPA did not receive any adverse comments during the comment period that closed May 15, the direct rule would have become effective immediately. Since EPA did receive adverse comment, the Agency withdrew the direct final rule and is now proceeding with promulgation of the proposed rule. The Agency will review and address all comments received in response to the proposal in a subsequent final rule and all comments received in response to the recently reopened comment period.

Specific changes addressed in the notice included: 1) revising compliance dates for the two rules to facilitate implementation; 2) extending the use of new analytical methods under the rules to the longstanding TTHM rule; 3) monitoring for the new standards under the Stage 1 DBPR by consecutive systems (i.e., those systems that purchase finished water); and 4) clarifying regulatory language.

Legal Deadlines: EPA met the February 1999 deadline for publication of a radon Health Risk Reduction and Cost Analysis (HRRCA). The agency missed the deadline for proposing a radon rule by August 1999. The final rule must be promulgated by August 2000.

Current Status and Near-Term Action: The comment period for the proposed Radon Rule ended February 4, 2000. The proposed rule was published in the Federal Register on November 2, 1999. EPA still plans on meeting the SDWA deadline of August 2000 for promulgating the final Radon Rule. However, the EPA has acknowledged that meeting this deadline will be a challenge.

The proposed rule includes a multimedia approach to radon control stressing that actions to reduce radon in air offer superior risk reduction to controlling typical levels of radon in drinking water. EPA assumes in the proposal that the multimedia approach, mandated by the SDWA, will be adopted by most states and systems, avoiding the high costs of water treatment at the proposed MCL of 300 picoCuries per liter (pCi/L). Where multimedia programs are in place, systems would only have to meet an alternative MCL (AMCL) of 4,000 pCi/L.

AMWA made three major suggestions in comments to EPA on the Proposed Radon Rule: adopt an alternative regulatory framework proposed by AMWA; simplify the Multimedia Mitigation (MMM) program concept to ensure state-sponsored programs; and develop guidance and other technical assistance to implement the final rule. Each of these is summarized below:

• Alternative Regulatory Framework: In the proposed rule, water systems may choose to comply with one of two regulatory options: (1) an MCL of 300 pCi/L or (2) an Alternative MCL (AMCL) of 4,000 pCi/L for systems that would participate in a MMM program. The use of two separate standards presents water systems with serious risk communication challenges. Specifically, if a system chose to participate in a MMM program and thus comply with the 4,000 pCi/L AMCL, it could be perceived as violating the seemingly safer MCL. To eliminate this risk, AMWA offers an alternative framework in which the MCL would be 4,000 pCi/L, and 300 pCi/L (or the number EPA chooses in the final rule) would be called an Action Level. Systems choosing to participate in a MMM program would comply with the MCL of 4,000 pCi/L. Systems that choose to control radon through water treatment alone would be subject to the Action Level. With this approach, the perception that a water system is choosing to avoid compliance with the MCL is gone.
  
• Simplify MMM Program Concept: AMWA strongly suggests that EPA review the proposed rule for opportunities to simplify the current MMM program concept to find ways to encourage state-sponsored MMM programs. This would eliminate the need for water systems to develop such programs on their own.
  
• EPA Guidance and Technical Assistance for Final Rule: AMWA stresses the need for EPA guidance and technical assistance materials to support the implementation of the final rule. AMWA strongly suggests that EPA provide sufficient resources and public review for the development of all guidance and technical assistance materials.

Background: A September 1998 report by the National Research Council (NRC) on risks from radon concludes that "radon in household water supplies increases peoples' overall exposure to the gas, but waterborne radon poses few risks to human health." The report, nevertheless, generally agrees with EPA's 1994 estimates of the number of cancer deaths that may be attributable to radon in drinking water. EPA's comments on the report stress this fact indicating that changes from previously proposed regulatory levels in the neighborhood of 300 pCi/L of water remain in contention as a future regulatory level. The report was required by the 1996 Amendments to the SDWA.

The NRC report also looked at ways of implementing an AMCL for radon, recommending that such level be in the 4,000 pCi/L range. The SDWA provides for an AMCL that drinking water systems would be allowed to meet provided that effective multimedia programs for mitigating risks from indoor air are implemented in their communities. The report notes that such programs may be problematic since risk reduction may only take place in relatively few residences compared to the across-the-board reductions expected from treating drinking water. Additionally, the report notes that education and outreach programs designed to entice homeowners to reduce indoor radon, on their own, would probably not be effective.

The required HRRCA was released in February 1999. The HRRCA is the first to be completed under the cost-benefit provisions of the SDWA and is intended to provide the public with key information prior to proposal of the radon regulation.

The HRRCA carefully lays out all methods and assumptions used in the analysis and requests comments on their appropriateness and adequacy. Overall, the analysis finds that at any level of radon regulation from 100 to 4,000 pCi/L, the best estimate of total costs exceeds the best estimate of benefits. However, an analysis of impacts on large (>100,000) systems with radon shows just the opposite for that category of systems. Further, the report finds that at any of the MCL levels studied, the costs to customers of large water systems impacted would be $6 to $7 per year. The report estimates that 85 percent of any cancer cases avoided would be among current or former smokers. The HRRCA also presents information on the costs and benefits of implementing a multimedia mitigation program (MMM).

On April 12, 1999 AMWA filed comments with EPA on its HRRCA for radon. Included in AMWA's comments was a request that EPA strive to clearly articulate to the public: "What risks do I face from radon in drinking water?" and "If my water system implements radon control, what will be the benefits and costs to my community?" AMWA suggested to EPA that by better informing the public and EPA's own decision makers, better public health decisions and ultimately better regulations would be developed. Additionally, AMWA urged EPA to take a more direct look at the costs and benefits to communities from a public health decision viewpoint and noted that the HRRCA had aggregated and considered benefits only at the national level.

Note: An advance copy of the proposed rule was forwarded to all AMWA members with Bulletin 99-39.

Legal Deadlines: EPA plans to promulgate a Long Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR) covering systems serving fewer than 10,000 people by November 2000. Of interest to AMWA members is the Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) covering large systems which will be promulgated along with the Stage-2 Disinfection Byproducts Rule (DBPR) by May 2002. The two rules collectively are called the Stage-2 Microbial and Disinfection Byproducts (MDBP) Rules. EPA plans to propose the rules in February 2001.

Current Status and Near-Term Action: The Stage-2 FACA has two remaining scheduled meetings on June 27-28 and July 27-28 in Washington, DC to hammer out negotiated rules. The FACA has several specific rule options on the table for both byproducts and microbials. At these meetings, the FACA representatives are expected to continue discussion of these possible Stage-2 options including such details as monitoring, compliance, and implementation issues.

Background: The LT2ESWTR and the Stage-2 D/DBPR are the subject of ongoing FACA discussions, which formally started in March 1999. The FACA is a continuation of the regulatory negotiations which led to the Stage-1 MDBP Rules. During the first regulatory negotiations, the parties agreed to undertake a similar process for further MDBP rulemaking when additional data from the Information Collection Rule and health effects, treatment and other research was available. The FACA is scheduled to meet through July 2000 and make recommendations to EPA on how the rules should be modified in light of new information.

Summaries of all Stage-2 FACA meetings are reported to members by special AMWA Bulletins. The following Bulletins have been issued to date:

Bulletin	Meeting Date/Place	Subject
98-64	December 15-16, 1998 Washington, DC	General background on the FACA process
99-10	February 10-12, 1999 Washington, DC	Health Effects Workshop covering disinfection by-products and microbial contaminants
99-13	March 10-12, 1999 Washington, DC	ICR data analysis, analytical methods research, pathogen and DBP treatment effectiveness, pathogens in distribution systems, and information on source water characterization
99-16	March 30, 1999 Washington, DC	First formal stakeholders meeting of the FACA covering schedules and ground rules
99-25	May 20 - 21, 1999 Washington, DC	The FACA committee reviewed and discussed toxicological and epidemiological cancer health effects data
99-29	July 21-22, 1999 Washington, DC	The FACA committee reviewed and discussed reproductive and developmental health effects data
99-36	September 8-9, 1999 Washington, DC	The FACA committee reviewed and discussed microbial and Information Collection Rule issues.
99-38	September 22-23, 1999 Washington, DC	The FACA committee reviewed 9 months of ICR data and received a primer/overview of drinking water treatment technologies.
99-40	October 27-28, 1999 Washington, DC	The FACA committee reviewed the status of health risk assessments, reviewed 12 months of ICR data, and heard an overview of cross connection control and backflow prevention programs.
99-44	December 8-9, 1999 Washington, DC	The FACA committee reviewed the status of compliance estimates for Stage-1, microbial risk characterizations, treatment costs, and Stage-2 options.
00-01	January 12-13, 2000 Washington, DC	The FACA committee discussed possible Stage-2 rule problems and solutions and reviewed the status of DBP health effects data.
00-07	March 29-30, 2000	The FACA committee reviewed the baseline of compliance with the State-1 rules and potential technologies and costs for DBP control. the FACA began to discuss a range of options under State-2.
00-11	April 12-13, 2000 Washington, DC	The FACA committee was presented preliminary results of initial Stage-2 options. The FACA held additional discussions on rule options and alternatives for Technical Workgroup impact analysis.
00-14	June 1-2, 2000 Washington, DC	The FACA committee was presented estimates of the impacts of various rule options. The FACA also reviewed the microbial framewok, the status of UV technology, and held additional discussions on rule options and alternatives for Technical Workgroup impact analysis.

Legal Deadlines: The SDWA requires EPA to issue a final rule governing filter backwash recycle practices by August 2000, but imposes no deadline for the proposed rule.

Current Status and Near-Term Action: AMWA submitted comments on June 9 on the proposed FBR requesting that EPA withdraw and repropose the rule. The comments pointed out several deficiencies in the proposed rule including the fact that the proposal does not inform water systems impacted by the rule what they will be required to do. EPA has deferred such information to guidance documents that will not be subject to formal review and comment. AMWA believes that such documents are an integral part of this rule and must be proposed with the rule.

The Association also objected to the Agency mandating plant design parameters under the rule. Specifying how existing plants should be redesigned without regard to their present levels of operations is inappropriate according to the comments. AMWA pointed out that arbitrary selection of points of recycle return absent indications of deficiencies in treatment could have unintended negative impacts on process control. Additionally, AMWA pointed out that mandating how future plants should be designed inhibits innovation. The comments in this area echoed the recommendations of the Science Advisory Board's Drinking Water Committee.

The Association also objected to EPA using old, inadequate Cryptosporidium occurrence data, since the data from the ICR is the best data available. Moreover, the ICR data shows that national Cryptosporidium occurrence is at least 10 times lower than the old data would indicate. This factor is significant in cost-benefit analyses since the potential benefits would be decreased by a factor of 10 or more. AMWA pointed out that this change could lead to different risk management decisions than those reflected in the proposal.

AMWA recommended that any final rule acknowledge the importance of operating parameters and the rule not apply to any system in compliance with the combined filter effluent provisions of the Interim ESWTR. A copy of the comments is attached.

Background: The Proposed Filter Backwash Rule appeared in the Federal Register on April 10, 2000. The comment period on the proposed rule closed on June 9, 2000.

Unfortunately, the EPA proposed the Long-Term 1 Enhanced Surface Water Treatment and Filter Backwash efforts as one rule. This will make review of the Filter Backwash portion of the rule more difficult. However, it is expected that the two efforts will be separated into two rules for final promulgation to meet the SDWA deadline for the Filter Backwash Rule of August 2000 and the deadline for the Long-Term 1 Enhanced Surface Water Treatment Rule LT1ESWTR) of November 2000.

Under the Filter Backwash Rule, EPA is establishing filter backwash requirements that address the potential risk associated with recycling of contaminants removed during the filtration process. The LT1ESWTR extends the large system requirements of the ESWTR, promulgated in 1998, to systems serving under 10,000 people.

The Filter Backwash Rule will apply to all public water systems using surface water or ground water under the direct influence of surface water with a recycle flow. The three major provisions of the rule are:

• Recycle systems will be required to return spent filter backwash water, thickener supernatant, and liquids from dewatering process prior to the point of primary coagulant addition unless the State specifies an alternative location;
  
• Direct filtration systems recycling to the treatment process must provide detailed recycle treatment information to the State, which may require that modifications to recycle practice be made; and,
  
• Conventional systems that practice direct recycle, employ 20 or fewer filters to meet production requirements during a selected month, and recycle spent filter backwash water, thickener supernatant, and/or liquids from dewatering process within the treatment process must perform a one-month, one-time recycle self-assessment. The self-assessment requires hydraulic flow monitoring and that certain data be reported to the State, which may require modifications to recycle practice be made to protect public health.

In March 2000, SAB's Drinking Water Committee discussed several aspects of the Filter Backwash Rule. Based on their discussions, the committee prepared draft recommendations on the rule. In their comments, the committee cautioned EPA against requiring that washwater be recycled to a point ahead of the coagulant addition point. According to the committee, experience has shown that returning the flow ahead of the coagulant addition point can adversely affect the coagulation process due to the resulting variations in loadings. Rather, the committee recommended that the EPA conduct studies to determine if gravity settling of the washwater return flows is sufficient or if additional treatment is required. If problems are demonstrated, then a requirement for direct treatment of the backwash water should be considered. Additionally, current solids recirculation practices are often integral to the process and changes could have detrimental effects. Therefore, the committee also recommended against requirements that would alter the design of these direct recycle processes.

In other comments, when determining if a water treatment plant is exceeding its capacity, the committee suggested that EPA require monitoring of performance parameters such as settled water and filtered water turbidity instead of using capacity parameters such as filter rate and basin overflow rate. Use of capacity capabilities is problematic since states do not define these in the same ways, especially for recycled flows. The committee also looked at the most appropriate time to monitor under the rule. The committee recommended that EPA require monitoring during periods of the year when unit processes are most challenged by water quality characteristics instead of focusing on high demand periods alone. The committed also recommended that EPA study the treatment of recycle flows in direct filtration plants to determine the level of treatment that is appropriate. Lastly, the committee made the general recommendation that in developing the rule, EPA should try to address the control of outbreaks as well as endemic disease. The committee noted that waterborne disease is dominated by outbreaks and may not be addressed if only endemic disease is reduced.

Last year, EPA held a number of stakeholder meetings to gather information and views on regulating filter backwash recycle. Through the meetings, EPA learned that there is a general lack of information on the risks that may be associated with recycle streams and on present recycle practices and problems. This will make estimating the costs and benefits of the rule difficult. EPA's early thinking on rule elements, as outlined in Bulletin 99-09, tended to be rather prescriptive. A draft preamble for the proposed rule provided in May 1999 reflects more flexibility in the Agency's thinking.

EPA issued a draft preamble for the proposed rule in May 1999 requesting stakeholder comment. The comment period closed June 30, 1999. AMWA submitted comments on the draft. EPA submitted the rule to OMB for review in December 1999. OMB finished its review of the rule in March 2000.

Legal Deadlines: EPA is under a court order to either finalize the 1991 proposal for radionuclides or to ratify the existing standards by November 2000. For uranium, the court also required a final standard by November 2000.

Current Status and Near-Term Action: AMWA submitted comments on EPA's Radionuclides Notice of Data Availability (NODA) on June 20. In the comments, AMWA recommended that the uranium MCL be based on toxicity rather than on cancer due to the available health effects data. AMWA also suggested that the available cost-benefit data does not support a uranium standard of 20 ug/L and the standard should be based on the best available science. Copies of AMWA's comments are attached.

Background: The Radionuclides Rule NODA appeared in the Friday, April 21, 2000 Federal Register (65 FR 21576). The Radionuclides Rule was originally proposed in 1991. The NODA is intended to update the information that was presented in the proposal and to present EPA's current thinking on appropriate regulatory levels for radionuclides. A copy of the NODA was provided to members in Bulletin 00-12.

The NODA proposes the following:

• Radium MCL: Maintain present MCL of 5 picoCuries/liter (pCi/L), but monitoring would change affecting compliance.
  
• Beta/Photon Emitters MCL: Maintain present MCL of 4 mrem.
  
• Gross Alpha MCL: Maintain present MCL of 15 pCi/L.
  
• Polonium-210: Presently included in gross alpha, possible future action based on Unregulated Contaminant Monitoring Rule monitoring results.
  
• Lead-210: Do not regulate at present, possible future action based on Unregulated Contaminant Monitoring Rule monitoring results.
  
• Uranium MCL: Three options under consideration: 20, 40, and 80 ug/L and pCi/L. (The units of measure determination is an interesting twist on normal MCL measures and is discussed on page 21587 of the NODA.)
  
• Ra-224: Continue regulation as part of gross alpha as at present, possible future regulation.

Additionally, the NODA proposes changes to the monitoring schemes for radionuclides and updates analytical methods.

The Radionuclides Rule was originally proposed July 18, 1991. The rule will cover uranium, radium, beta particles and photon and alpha emitters.

Legal Deadlines: None.

Current Status and Near-Term Action: EPA had planned to issue a direct final rule early in 1998. EPA is presently reassessing whether or not to continue with the effort.

Background: This rule would reformat the current drinking water regulations to make them easier to understand and follow. This rule is not intended to change any of the regulatory requirements. EPA planned to publish the proposed rule in late 1996, but now is targeting June 1999 for promulgation. Direct final rules are those that the agency feels do not require a proposed rule due to their nature.

Legal Deadlines: EPA, in conjunction with CDC, completed a required study on dose-response relationships in February 1999. EPA will use the results of the study to decide whether or not to regulate sulfate by August 2001.

Current Status and Near-Term Action: With the sulfate study completed, EPA will decide whether or not to regulate sulfate by August 2001.

Background: Sulfate regulation remains active under the SDWA Amendments of 1996. The key changes in the Act are replacement of the requirement to regulate sulfate with the regulation at the discretion of the EPA Administrator, and the requirement of a joint study with CDC. Sulfate is required to be included on the Contaminant Candidate List (CCL) with a decision to regulate or not made by August 2001. If the decision is to regulate, a proposal would be required by August 2003, and a final regulation by February 2005.

EPA and CDC were unable to complete a sulfate study on infants since CDC was unable to find enough infants exposed to sulfate levels above 250 mg/L to conduct the study. A study in non-acclimated adults was completed with no evidence of problems up to the highest level tested (1200 mg/L). An expert workshop was called to review the results of the study. The experts concluded that there was insufficient scientific evidence to support regulation and instead recommended a Health Advisory for drinking water with levels above 500 mg/L.

Legal Deadlines: None.

Current Status and Near-Term Action: EPA had planned to finalize the regulation in the fall of 1997. The final rule has been delayed due to negotiations with states and Indian tribes concerning the implementation aspects of the rule. The agency now expects to submit the final rule to OMB for review in early 2000 with a promulgation of the final rule in late spring or early summer 2000. It is expected that the final rule will cover alachlor, atrazine, cyanazine, metolachlor, and simazine, which are the most frequently detected pesticides in ground water.

Background: This regulation, proposed June 26, 1996, would revise the criteria for restricted use classification of pesticides to ensure consideration of their ability to contaminate ground water. The proposed control mechanism is implementation of State Management Plans. The proposal was open for comment through October 24, 1996. A copy of the proposal was forwarded to AMWA members with Bulletin 96-36.

Legal Deadlines: None

Current Status and Near-Term Action: It is not certain whether a final PBMS rule will be promulgated or if the system will be adopted in relevant analytical method rules and notices.

Background: EPA plans to adopt a system that would be designed to increase the flexibility to select suitable analytical methods for compliance monitoring, and would significantly reduce the need for prior EPA approval of methods. The system under development is the Performance-Based Measurement System (PBMS). The Office of Water developed a PBMS implementation plan based on EPA's March 28, 1997 proposed rule (62 FR 14976) and the October 6, 1997, (62 FR 52098) notice of intent to adopt PBMS Agency-wide.

A performance based measurement system would allow the regulated community to use any appropriate analytical test method for compliance purposes provided it met specified data quality needs. EPA believes that making this change will have the overall effect of improving data quality and encouraging the advancement of analytical methods.

EPA will modify the regulations that require exclusive use of Agency-approved methods for compliance monitoring of regulated contaminants in drinking water regulatory programs. Under PBMS, EPA will only specify "performance standards" for methods, which the Agency will derive from the existing approved methods. EPA would continue to approve and publish compliance methods for laboratories that choose not to use PBMS.

Legal Deadlines: There are no legal deadlines associated with these rules. EPA developed these rules to evaluate EPA's and states' implementation of their TMDL responsibilities.

Current Status and Near-Term Action: The following rules were proposed in the Federal Register on August 23, 1999: Proposed Regulatory Revisions to the Total Maximum Daily Load (TMDL) Program and Associated Proposed Regulatory Revisions to the National Pollutant Discharge Elimination System (NPDES) and the Water Quality Standards Programs. The comment period ended on January 20, 2000.

AMWA submitted comments endorsing EPA's efforts to clarify and strengthen the current regulatory requirements for establishing TMDLs to apply to drinking water sources. A copy of the comments is attached to this month's report. Specifically, AMWA supported the inclusion of contaminants regulated by the SDWA in the definition of "pollutant" for the purposes of developing TMDLs. This will help focus attention on contaminants that the CWA currently overlooks in many cases. Also, AMWA requested that EPA give a high priority to waterbodies where pollutants contribute to violations of MCLs and force drinking water systems to install costly treatment to avoid these violations. And in response to EPA's proposal to only "encourage" states to consider nonpoint sources of pollution when developing impaired or threatened waterbody lists, AMWA called on EPA to establish equitable controls for both point and nonpoint sources of pollution.

Background: These two rules were proposed by EPA to revise, clarify, and strengthen the current regulatory requirements for identifying impaired waters and establishing TMDLs under Section 303(d) of the Clean Water Act and revising the NPDES and Water Quality Standards regulations to facilitate implementation of TMDLs.

These proposed regulatory revisions address issues related to pollution in the nation's waters. EPA expects that the listing of impaired and threatened waters and establishing TMDLs are tools for identifying sources of water pollution and achieving water quality goals. EPA intends that clean-up plans will be developed that are consistent with the regulatory proposals and will restore thousands of miles of river and shorelines.

The purpose of the proposed regulations is to provide states with clear, consistent, and balanced direction for listing waters and developing TMDLs. These objectives would be accomplished by clarifying and revising the existing regulations. The types of changes include but are not limited to:

• Ensure that state 303(d) listing methodologies are more specific, subject to public review, and submitted to EPA for review.
• Establish a new format for state 303(d) lists that will create a more comprehensive list of waterbodies impaired and threatened by pollution and pollutants.
• Include a new requirement that states establish and submit to EPA schedules for establishing TMDLs.
• Ensure that states establish TMDLs for high priority waterbodies.
• Include a new requirement that states assign a high priority to waterbody and pollutant combinations which are designated as public drinking water supplies and which cause a violation of the maximum contaminant level.
• Clarify the elements that a TMDL must contain.
• Include a new requirement that an approvable TMDL must have an implementation plan consisting of required elements.
• Clarify that TMDLs may be expressed in terms appropriate to the desired condition of the waterbody or the characteristics of the pollutant load.
• Ensure that the public will be notified and have the opportunity to comment on lists, priority rankings, schedules, and TMDLs prior to submission to EPA.
• Allow the public to petition EPA to establish TMDLs where a state has substantially failed to do so consistent with the state's schedule.

The purpose of the proposed revisions to the NPDES and water quality standards regulations is to achieve reasonable progress toward attainment of water quality standards in impaired waterbodies after listing and pending TMDL establishment, and to provide reasonable assurance that TMDLs, once completed, will be adequately implemented. A copy of the proposed rule was forwarded to AMWA members with Bulletin 99-34.

Note: Changes since the last Federal Report are underlined.

Federal Register: June 22, 2000 (Volume 65, Number 121)
Proposed Rules
Page 38887-38983

ENVIRONMENTAL PROTECTION AGENCY

National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking.

SUMMARY: The Environmental Protection Agency (EPA) is proposing a drinking water regulation for arsenic, as required by the 1996 amendments to the Safe Drinking Water Act (SDWA). The proposed health-based, non-enforceable goal, or Maximum Contaminant Level Goal (MCLG), for arsenic is zero, and the proposed enforceable standard, or maximum contaminant level (MCL), for arsenic is 0.005 mg/L. EPA is also requesting comment on 0.003 mg/L, 0.010 mg/L and 0.020 mg/L for the MCL. EPA is listing technologies that will meet the MCL, including affordable compliance technologies for three categories of small systems serving less than 10,000 people. This proposal also includes monitoring, reporting, public notification, and consumer confidence report requirements and State primacy revisions for public drinking water programs affected by the arsenic regulation.

In addition, in this proposal the Agency is clarifying compliance for State-determined monitoring after exceedances for inorganic, volatile organic, and synthetic organic contaminants. Finally, EPA is proposing that States will specify the time period and sampling frequency for new public water systems and systems using a new source of water to demonstrate compliance with the MCLs. The requirement for new systems and new source monitoring will be effective for inorganic, volatile organic, and synthetic organic contaminants.

Note: A copy of the proposed rule was forwarded to all members with Bulletin 00-15.

Federal Register: June 14, 2000 (Volume 65, Number 115)
Proposed Rules
Page 37331-37332

ENVIRONMENTAL PROTECTION AGENCY

National Primary Drinking Water Regulations; Ground Water Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Extension of Public Comment Period for the Proposed Ground Water Rule.

SUMMARY: Today, the Environmental Protection Agency (EPA) is providing notice to extend the public comment period for the proposed Ground Water Rule (GWR). The proposed GWR was published in the Federal Register on May 10, 2000 (65 FR 30194). The proposed GWR requirements provide a meaningful opportunity to reduce public health risk associated with the consumption of waterborne pathogens from fecal contamination for a substantial number of people served by ground water sources.

Note: A copy of the proposed rule was forwarded to all members with Bulletin 00-10.

Federal Register: June 13, 2000 (Volume 65, Number 114)
Rules and Regulations
Page 37052-37053

ENVIRONMENTAL PROTECTION AGENCY

Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule; withdrawal.

SUMMARY: Because we received adverse comments, EPA is withdrawing the direct final rule regarding the Interim Enhanced Surface Water Treatment Rule, the Stage 1 Disinfectant and Disinfection Byproducts Rule, and the Primacy Rule that published on April 14, 2000 (65 FR 20304).

In the direct final rule, we stated that if we received adverse comments by May 15, 2000, we would publish a timely withdrawal in the Federal Register. EPA subsequently received adverse comments. We will address those comments in a final rule based upon the proposed rule also published on April 14, 2000 (65 FR 20314).

Because of the degree of public interest in the rule, we are reopening the comment period on the proposed rule. For additional information, see the document that reopens the comment period, which is published in the ``Proposed Rules'' section of this issue of the Federal Register.

Federal Register: June 13, 2000 (Volume 65, Number 114)
Proposed Rules
Page 37092

ENVIRONMENTAL PROTECTION AGENCY

Reopening of Comment Period on Revisions to the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) and Revisions to State Primacy Requirements to Implement the Safe Drinking Water Act (SDWA) Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule, notice of reopening of comment period.

SUMMARY: EPA is reopening the comment period for the proposed rule revising the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Stage 1 Disinfectant and Disinfection Byproducts Rule (Stage 1 DBPR), and the Primacy Rule which was published in the Federal Register April 14, 2000 (65 FR 20314). The reopening of the comment period will allow all interested parties to submit written comments on the proposal.

General

Since the Association of Metropolitan Water Agencies (AMWA) represents large, municipal water systems, the Association's comments are limited to the proposed Filter Backwash Rule (FBR).

AMWA believes that EPA has done an exceptional job of capturing and portraying in the proposal and the accompanying Regulatory Impact Analysis (RIA) the available information for public health decision-making. AMWA appreciates the frank discussion of that information and the underlying uncertainties and deficiencies. AMWA also appreciates the generally clear statements of assumptions used in developing the proposal.

Nevertheless, AMWA believes that there are several significant deficiencies in the FBR proposal which indicate that the rule should be reproposed. Additionally, AMWA believes that the FBR should not have been proposed jointly with the Long Term 1 Enhanced Surface Water Treatment Rule, nor should the two rules share a common Health Risk Reduction and Cost Analysis (HRRCA). These two rules should be developed separately with separate HRRCAs.

In light of the severe information gaps surrounding the FBR, AMWA supports the Agency's approach of looking for measured responses to the requirement to issue a regulation governing filter backwash recycle. Should the Agency decide not to repropose the rule, it should explore obvious alternative approaches which, if implemented, would lead to a better final rule.

There are three major deficiencies. The first is that the Agency retrospectively and prospectively defines how water treatment plants should be designed. The second is lack of guidance documents for review that should be an integral part of the proposed rule. The third is the failure to incorporate the most recent Cryptosporidium occurrence data.

Given the lack of scientific and technical data available for informed decision making, the improvements in approach recommended by AMWA center on reversing the present "guilty until proven innocent" approach. Doing so will lead to similar benefits under the rule while lessening the risk of unintended, adverse consequences and reducing unnecessary transactional costs.

The following comments address the major deficiencies first. These deficiencies lead AMWA to the conclusion that the FBR rule should be reproposed in order to meet legal requirements and ensure that the public is best served by the rule. Suggestions for improving the proposed rule are offered should the Agency choose not to repropose the rule. Finally, other issues are discussed and suggestions are offered that would assist the affected communities and the public in understanding and evaluating this and future proposals.

Major Proposal Deficiencies &endash; Specification of Design Parameters

Given the present void of data, the Agency should approach with some timidity mandating design criteria such as return of recycle flows to a point prior to the point of primary coagulant addition for a subset of systems. The requirement makes little sense applied retrospectively to existing plants meeting applicable operating parameters under existing rules or those under the final Interim Enhanced Surface Water Treatment Rule (IESWTR), or the proposed LT1ESWTR.

This requirement is based on EPA's belief that this is a good idea, to wit:

"EPA believes that introducing recycle flow prior to the point of primary coagulant addition, is the best recycle return location because it limits the possibility of residual treatment chemicals in the recycle flow will disrupt treatment chemistry." (p. 19106).

"Today's proposal requires these flows to be returned prior to the point of primary coagulant addition because these streams are either of sufficient volume to cause hydraulic disruption within the treatment process…" (p. 19110).

As discussed in the handbook "Optimizing Water Treatment Plant Performance Using the Composite Correction Program" (USEPA 1998), disruption of chemical treatment or hydraulic disruptions will likely be reflected in the inability to meet performance goals. In fact, it is unlikely that the IESWTR or LT1ESWTR operating requirements of a combined filter effluent of 0.3 NTU 95 percent of the time could be sustained if process control measures were not in place to control chemical treatment and hydraulic loading for direct recycle plants. The present proposal gives little attention to process control as demonstrated by meeting current standards, and this is the factor that should be looked at rather than point of recycle returns.

Given the lack of information surrounding this rule requirement, it is reasonable that states will look to effluent turbidity measures in order to make determinations as to whether process control is adequate and whether unacceptable risks might be introduced. It is impossible to project from the proposal whether EPA will approve state criteria using such criteria for public water systems applying for a waiver.

AMWA believes that a demonstration of proper process control by meeting existing filter effluent standards must be a part of this proposal. This belief is supported by the recommendations of the EPA Science Advisory Board's Drinking Water Committee (DWC) in their comments on the rule. The DWC stated:

"Based on the evidence now available, the SAB recommends against requiring that washwaters be recycled ahead of the point of coagulant addition."

"Based on the information currently available, the SAB recommends against requirements which would alter the design of these direct recycle processes." (SAB DWC, May 2000).

AMWA also cautions that arbitrary selection of a point of recycle absent indications of deficiencies in process control can lead ultimately to problems with process control. For example a major Cryptosporidium outbreak has been associated in part with a change in the type of coagulant used. Operators, unfamiliar with process control using the new coagulant, were unable to respond appropriately to source water condition changes. It should be noted that this was a rather simple change when compared to retrospectively redesigning treatment facilities.

From a prospective sense, the point of return requirement may serve to curtail innovations in water treatment plant design and the treatment of recycle flows in particular. Such an outcome could be driven by an overly simplistic point of return requirement that necessitates a state waiver for deviation. For new designs, the proper questions are proper process control with regard to chemical treatment and hydraulic disruptions and the degree of treatment of return flows and their overall quality.

Recommendation: Repropose the FBR rule as a separate rule and include all guidance documents, or, as an alternative, propose the guidance documents for review prior to finalizing the rule. Requirements should be modified to focus on process control as evidenced by compliance or noncompliance with the IESWTR or LT1ESWTR combined turbidity provisions.

Major Proposal Deficiencies &endash; Lack of Guidance Documents

As noted in the proposed rule (p. 19117), EPA is currently developing guidance on implementing Filter Backwash and Recycling. This guidance will assist states in making the following determinations:

• the criteria for determining whether public water systems completing self assessments under §141.76(c) are required to modify recycle practice and the criteria that will be used to specify modifications to recycle practice;
  
• the criteria to determine whether direct filtration systems reporting data under §141.76(d) are required to change recycle practice and the criteria that will be used to specify changes to recycle practice; and
  
• the criteria states will use to determine whether public water systems applying for a waiver to return recycle to a location other than prior to the point of primary coagulant addition, will be granted a waiver for alternative recycle location (p. 19118 and §142.16).

It is clear that a water system cannot evaluate the potential effects of this proposal without knowing the above criteria, and, therefore, cannot reasonably anticipate what action the proposal might require. The guidance document, therefore, must go far beyond mere implementation matters to matters at the heart of the proposal. As such, the criteria for action constitute a critical part of the proposal and should be formally proposed and made available for public comment in accordance with the Administrative Procedures Act.

As stated in the proposal, decisions based on such criteria as outlined above, and particularly criteria for granting waivers, will apparently be based on states evaluating what constitutes unacceptable risk. For example:

"The Agency encourages states to closely examine recycle self assessments by direct recycle plants to determine whether direct recycle poses an unacceptable risk to finished water quality and public health and needs to be modified…". (p. 19113).

Yet throughout the proposal, the Agency acknowledges that information to assess such risks is lacking. Since EPA is unable in the proposal to address potential risks in other than speculative terms, it is unclear how states possessing similar or less information that the Agency has at its disposal can make other than arbitrary decisions regarding potential risk, risk reduction, unacceptable risk, and appropriate action for systems to take.

Recommendation: Repropose the FBR rule as a separate rule and include all guidance documents, or, as an alternative, propose the guidance documents for review prior to finalizing the rule. While AMWA acknowledges that the Agency has an obligation to finalize an FBR rule by August 2000, the Agency also has an obligation to ensure that rules fully inform the affected entities of what will be required of them.

Major Proposal Deficiencies &endash; Cryptosporidium Occurrence Data

A major component of the public health decisions inherent in the proposal is the evaluation of potential risks attributable to Cryptosporidium. One factor in the development of risk, risk reduction, and benefit estimates is the occurrence of Cryptosporidium.

Exhibit 5-12 of the RIA (EPA 2/15/2000) lists the source water concentration of Cryptosporidium corrected for recovery but uncorrected for viability as a mean value of 470 oocysts/100L with a standard deviation of 841 oocysts/100L. The corresponding values corrected for viability using the average assumption from Exhibit 5-12 are 47 oocysts/100L and 84 oocysts/100L.

Independent analysis of the Cryptosporidium occurrence data from the ICR survey indicates that actual mean occurrence levels (considering recovery and viability) are likely to be an order of magnitude or more lower than the figures used in the RIA. Additionally, the standard deviation is significantly tighter.

As a very simplistic exercise, applying a one order of magnitude difference to the RIA benefits for the LT1ESWTR would reduce the annualized benefits from an estimated mean value range between $70.1 million to $259.4 million to $7.0 million and $25.9 million. The annualized costs would remain $87.6 million to $97.5 million.

Applying the same reasoning to the weighing of benefits and costs in the RIA in section 1.7 to the above figures yields a net benefit range of minus $90.5 million to minus $61.7 million. These figures lead to the conclusion that the benefits will most likely not exceed costs &endash; the opposite of the conclusion reached in section 1.7.

A similar exercise using the sensitivity analysis approach as an indication of the potential benefits of recycle provisions would show a positive benefit for only one of the eight scenarios listed in Exhibits 5-20 and 5-21. The only positive scenario would be for large systems providing that simply moving a point of recycle return could enhance log removal by 0.5 log.

AMWA believes that changes in potential benefit estimates similar to those above could have an impact on decision-makers looking to maximize the benefits derived from public health expenditures and could lead to consideration of other alternatives for the rules.

EPA states in the proposal and in the RIA that the Agency is aware of new occurrence data from the ICR and Supplemental Surveys. EPA goes on to say that the data has not been peer reviewed and will be considered under the Long-Term 2 ESWTR. This would normally be adequate if the potential degree of impact on the proposal were not so significant. To the extent that EPA believes from its own analyses of the ICR and Supplemental Survey data that occurrence levels are as much as one order of magnitude lower than projected in the proposal, the Agency should strive to analyze the data and have the analysis peer reviewed prior to publishing a final rule. This is the only way to prevent misinforming the public of the benefits they will likely receive for what they will be asked to pay.

The agency should also note that the Safe Drinking Water Act allows, in addition to peer-reviewed science, "data collected by acceptable methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data)." (Section 1412 (b)(3)(A)(2)). There is no doubt that the ICR Cryptosporidium occurrence data is by far the best and most comprehensive data ever gathered. Nor should there be any doubt that the nature of the decision fully justifies its use.

Recommendation: Repropose the FBR rule separately and include all guidance documents and the RIA. Analyze the ICR Crytposporidium and other recent occurrence data and complete peer reviews as soon a possible and revise the RIA accordingly. While AMWA acknowledges that the Agency has an obligation to finalize a FBR rule by August 2000, the Agency also has an obligation to insure that the public is fully informed of potential costs and benefits of the rule.

Alternative Approaches

Although AMWA would like to see the rule reproposed because of the major deficiencies noted in the preceding section, the following alternatives are suggested whether or not the rule is reproposed.

Recycle Return Location: The proposal would require all subpart H systems employing conventional filtration or direct filtration and returning spent filter backwash, thickener supernatant, or liquids from dewatering processes to return those flows prior to the point of primary coagulant addition.

The reasons for rejecting this approach have been outlined in the preceding. To summarize, the approach is not recommended by the SAB DWC review, the approach does not recognize that process control is the key factor not point of recycle return, and the approach retrospectively and prospectively prescribes design practices which may or may not be appropriate for any given design. Additionally, the approach entails high transactional costs for systems and states.

An alternative approach should be based on operational parameters. This recommendation is supported in general by the SAB DWC comment:

"The SAB recommends that the Agency require monitoring of performance parameters, like settled water turbidity and filtered water turbidity instead of trying to determine capacity." (SAB DWC, May 2000).

While the comment refers to capacity determinations, it acknowledges the use of performance parameters.

Recommendation: The appropriate performance parameters are the turbidity provisions of the IESWTR and the LT1ESWTR. Systems required to take action under the FBR should be limited to those systems not meeting IESWTR or LT1ESWTR requirements. Additionally, relocation of the point of return should not be mandated. Such changes to existing design should only be considered if a given plant design is so defective that reasonable operating controls cannot be implemented.

Twenty Filter Cutoff: The proposal would require that plants that are part of subpart H public water systems that employ conventional rapid granular filtration, employ 20 or fewer filters to meet production requirements, and recycle specified flows, shall complete a recycle self assessment.

The 20 filter cutoff evaluation has little bearing on reality. The issue devolves to whether hydraulic flow changes caused by recycle adversely impact process control and ultimately performance parameters. As discussed above, the focus should be on performance parameters.

Recommendation: The appropriate performance parameters are the turbidity provisions of the IESWTR and the LT1ESWTR. Systems required to take action under this provision of the rule should be limited to those systems not meeting those requirements. Additionally, relocation of the point of return should not be mandated. Such changes to existing design should only be considered if a given plant design is so defective that reasonable operating controls cannot be implemented. Effectively, AMWA recommends that the point of return requirement and the self-assessment requirement be combined into one self-assessment requirement triggered by turbidity requirement violations.

Direct Filtration Systems: The proposal would require all direct filtration systems to report recycle practices to the state and for the state to determine if such practices were satisfactory or posed an unacceptable risk to public health according to some set of criteria yet to be established.

As noted by the SAB review, direct filtration systems are not designed to be "closed loop" systems. All have some type of removal treatment.

"It is not necessary to require treatment of recycled flows in direct filtration plants. This is because all direct filtration plants must treat their recycle stream to prevent recycling of particulates in order to meet conventional standards." (SAB DWC, May 2000).

AMWA believes the Agency's concern with direct filtration systems is misplaced, and would like to point out that the same reasons the Agency outlined below apply in this case:

"(1) data on the occurrence of oocysts in spent filter backwash of direct filtration plants." (is needed) Direct filtration plants generally have higher quality source water than conventional plants (AWWA, 1990) and it would be inaccurate to use spent filter backwash occurrence data from conventional plants to assess the level of treatment direct recycle plants may need;

(2) Data regarding the ability of sedimentation and other clarification processes to remove oocysts from recycle flows is needed to determine what may be a feasible level of treatment. This data need was treated to a detailed discussion in a previous section of the preamble;

(3) An easy to measure and accurate surrogate for oocyst removal is currently unavailable; without such a surrogate, it is not feasible to monitor the performance of recycle treatment units, and;

(4) Data on the applicability of microfiltration and ultrafiltration for spent filter backwash produced by direct filtration plants. This data need was discussed in detail in the previous section." (p. 19117)

The Agency goes on to say that, given the lack of data and limited knowledge, "the Agency does not currently believe it is possible to identify a treatment standard for direct filtration plants." (p. 19117). Nevertheless, the Agency would have individual states do just that. Moreover, the Agency would require States to make risk and treatment determinations that the Agency acknowledges are not possible given current data limitations. This does not make sense as a regulation.

Recommendation: AMWA supports the SAB DWC recommendation that EPA conduct appropriate research to determine what may be appropriate for direct filtration plants. Because direct filtration plants with dramatically inadequate particle removal capabilities would not be able to meet IESWTR or LT1ESWTR turbidity requirements, AMWA recommends that such plants be considered along with all other plants and be required to complete a self assessment only if turbidity levels are exceeded.

Suggestions &endash; Section 1412 (b)(4)(C) Determination Requirement

The Safe Drinking Water Act (SDWA) requires that:

"At the time the Administrator proposes a national primary drinking water regulation under this paragraph, the Administrator shall publish a determination as to whether the benefits of the maximum contaminant level justify, or do not justify, the costs based on the analysis conducted under paragraph (3)(c)."

This requirement should be listed in the proposal under section I(A) "Statutory Requirements and Legal Authority". The determination should be more formal (as indicated by its prominence in the Act) than a few words under the heading of costs and benefits.

Suggestions &endash; Availability of Health Risk Reduction and Cost Analysis

AMWA believes that the HRRCA is a key public right-to-know provision of the SDWA. The Act requires that a HRRCA be published for public comment when proposing any regulation. In the present case, the Agency has prepared an RIA and is using it to meet the HRRCA requirement.

AMWA recommends that the Agency explore how to make the findings of the HRRCA more readily available to the public. It is not clear with the HRRCA buried within the RIA analysis whether, where and how the individual HRRCA requirements under the Act are covered. AMWA believes that having the HRRCA available on the Internet meets the intent of the law that it is provided to the public at the same time a rule is proposed. However, the fact that a HRRCA is available, that comments are requested, and the applicable Internet URL should be called out prominently in the first section of the proposed rule under the "Summary".

Introduction

The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to comment on the U.S. Environmental Protection Agencies' (EPA) Notice of Data Availability (NODA) on the proposed Radionuclides Rule. AMWA was formed in 1981 by the general managers of the nation's largest drinking water suppliers to represent them before Congress and federal agencies. Collectively, AMWA member agencies serve over 110 million Americans.

General

AMWA believes that EPA has effectively summarized the data available on radionuclides since EPA's proposed Radionuclides Rule of 1991. EPA has characterized the recently available data on health effects, occurrence, and analytical methods to support the development of the final radionuclides rule. AMWA supports the use of the best available, peer-reviewed science as required by the 1996 Safe Drinking Water Act (SDWA) Amendments in developing drinking water regulations.

However, AMWA does have several comments on the development of the radionuclides rule as detailed in this NODA by EPA. AMWA has specific comments on:

• the use of a linear multistage model for dose-response;
• health end-point for uranium
• the most appropriate MCL alternative for uranium;
• the question of regulating non-transient, non-community (NTNC) water systems;
• several issues related to monitoring;
• the assessment of systems serving over 1 million people;
• the basis for assigning non-treatment options in the decisions trees;
• general economic analysis assumptions; and
• need for guidance manuals.

Each of these issues is addressed separately below.

The Use of a Linear Multistage Model

EPA has chosen to use a linear, non-threshold model for dose-response to set the MCLG for radionuclides. EPA is assuming that any exposure can potentially cause harm and that risk associated with the exposure increases proportionally with the concentration of the radionuclide. However, EPA acknowledges the inherent uncertainties that exist in estimating health impacts at the low levels of exposure and exposure rates expected to be present in the environment. EPA also acknowledges that at the levels of concern, the actual health impact from ingested radionuclides is difficult, if not impossible, to distinguish from natural disease incidences using epidemiological studies employing advanced statistical analysis.

Recommendation. Based on available dose-response data suggesting a non-linear dose-response relationship for radionuclides, AMWA recommends that EPA examine the use of non-linear, threshold models for the radionuclides rules since linear models may significantly overestimate risks. At a minimum, EPA could use the non-linear, threshold model as a sensitivity analysis to bound the risk ranges. Non-linear dose-response relationships could be explained by research showing that the radiation could act more as cancer promoting agents rather than as initiating agents.

Health End-Point for Uranium

EPA has proposed setting the uranium MCL on both toxicity (based on mass as defined by ug/L) and cancer (based on activity as defined by pCi/L) whichever presents the greatest risk for a water system. This approach would require each water system to perform an isotopic analysis to determine the relative amounts of each uranium isotope. Once the concentration ratio is known, then each water system would be required to measure mass or activity and select which analytical method or methods that is most appropriate for them. AMWA considers this approach to be unnecessarily complicated and would be burdensome to water utilities and state primacy agencies in terms of additional analytical costs and compliance determinations.

Recommendation. AMWA suggests that the regulation of uranium be based on toxicity (as measured by mass as ug/L) alone as the most appropriate health endpoint since the available data linking uranium to cancer is insufficient. To support the regulation of uranium based on toxicity, EPA would have to evaluate the actual incidence and risk associated with kidney toxicity and uranium in drinking water as the health basis of the regulatory impact analysis.

Uranium MCL

AMWA supports the use of the discretionary authority under Section 1412(b) of the SDWA, which allows for a regulatory level to be set higher than the feasible level after the determination has been made that the benefits do not justify the costs at a feasible level. AMWA's assessment of the uranium benefit-cost analysis leads to the conclusion that an MCL of 20 ug/L is not supported and that the MCL for uranium should be set at 40 or 80 ug/L.

Based on EPA's NODA and supporting documentation, AMWA compiled the following data on uranium for the three MCL alternatives being considered:

MCL (ug/L)	Risk	Cancer Cases Avoided Annually	Average Net Benefits (Millions)*	Cost per Cancer Case Avoided (Millions)*
20	5x10-5	2.1	$-31.0 to $-148.8	$74.1 to $210.7
40	1x10-4	1.5	$-6.6 to $-62.0	$44.2 to $167.5
80	2x10-4	1.0	$-5.0 to $-25.9	$29.0 to $500

* Ranges are based of two approaches conducted by EPA (a direct proportional approach and a lognormal distribution approach).

At 20 ug/L, the average net benefits, which are extremely low, and the cost per cancer case avoided, which are very high, do not support regulation at this level. At a level of 40 ug/L, the risk is still within EPA's usual range of acceptable risk (i.e., 10-4 to 10-6) and the average net benefits and the cost per cancer case avoided are much more favorable than at 20 ug/L. At 80 ug/L the average net benefits improve even more and the cost per cancer case avoided at the lower end is also much improved. However, even though the risk at 80 ug/L is outside of EPA's typically used range of acceptable risk, the risk is still very close to the lower end of the risk range (2x10-4 versus 1x10-4).

Recommendation: AMWA recommends that EPA consider an MCL for uranium of 40 or 80 ug/L rather than at 20 ug/L based on the unfavorable average net benefits and extremely high costs per cancer cases avoided. The decision of 40 or 80 ug/L as the MCL for uranium should be made in the development of the final rule based on the revised benefit-cost analysis. One option would be for the EPA to set the MCL at 80 ug/L at this time until additional health research has been completed and revise the standard under the six-year review process if needed.

Exclusion of Non-Transient, Non-Community Water Systems

The exclusion by EPA's of non-transient non-community (NTNC) systems from this rule is a difficult and complicated subject. EPA has also proposed this approach under the radon rule. One issue is that this type of approach is inconsistent with the rationale and regulatory approach that the Agency has historically taken for NTNC water systems (e.g., regulating them as community water systems).

If the Agency plans to change how these systems will be regulated in the future, it should establish a clear protocol or guidelines by which a decision to include these systems for regulation can be made. Clearly, the driver of these guidelines should be public health considerations and the decisions should be based on sound science and on all relevant provisions of the SDWA. Such guidelines should be developed with input and consultation with stakeholder groups.

EPA should not choose to exclude these systems from a rule just because the high cost of NTNC system compliance with the rule cannot be justified. In fact, inclusion of NTNC systems in the rule may change the benefit-cost outcomes for all systems so that they are even more unfavorable than they are depicted in the NODA.

Monitoring Issues

Entry Points to the Distribution System. AMWA supports the concept of radionuclide compliance monitoring at the Entry Points to the Distribution System (EPTDS). This allows for simultaneous monitoring for regulated and unregulated contaminants at the same sampling location. However, flexibility should be written into the final rule that allows states the ability to designate alternative sampling points that would be representative of the system. For example, a state should have the flexibility to reduce the number of monitoring points for a large system with numerous EPTDS due to multiple wells from the same aquifer.

Grandfathering of Data. AMWA supports the concept of grandfathering of data provided that the data meet appropriate analytical requirements.

Sample Compositing. AMWA supports the concept of sample compositing as discussed in the NODA. Sample compositing provides financial flexibility since systems will be able to combine multiple samples into fewer overall samples. AMWA believes that it is feasible to composite either spatially (separate entry points collected in the same monitoring periods) or temporally (a single entry point collected over more than one monitoring period within the analytical holding time). EPA needs to address specific examples of compositing in guidance for the rule.

Decreased Monitoring. AMWA supports increased or decreased monitoring depending on the results of the most recent monitoring. However, individual states may be the best choice for making these determinations and should be provided flexibility to make decisions concerning changes in monitoring frequency.

Assessment of Systems Serving Over 1 Million People

In the NODA and supporting documents (e.g., the preliminary HRRCA), EPA has separated out systems serving over a million people (retail) and is addressing them separately. EPA noted that the focus on retail populations was designed to avoid double counting of the purchased water. EPA collected data on 16 systems. The data came from water quality reports (i.e., Consumer Confidence Reports &endash; CCR) available on the Internet. However, uranium is not currently regulated so data on uranium is not included on the water quality reports.

Although AMWA supports EPA efforts in characterizing large systems individually, AWMA has the following recommendations regarding EPA's approach:

Recommendation. EPA should not limit the system size cutoff of 1 million to retail population only. Many of the largest systems in the United States are wholesale systems and many large systems wholesale a large percentage of their water. EPA should evaluate the occurrence of radionuclides at all systems that serve over 1 million people (combined retail and wholesale). The factor that is important here is the size of the water system not the make-up of the population served. In fact, in EPA analyses, 100 percent purchased systems are not accounted for in the occurrence analysis; only their populations are accounted for on the exposure side. It is important for EPA to assess the cost for these very large systems because they can potentially be large components of the overall cost and its makes sense to get these systems right. According to the Arsenic rule, there are 25 systems that serve over 1 million people.

Recommendation. EPA has conducted a preliminary analysis of the largest systems but has not collected appropriate data on uranium occurrence. According to EPA's support documents, uranium data from a source other than the water systems were used to assess uranium occurrence. The data was only based on the whether the system is located in a state with potentially elevated uranium levels. AMWA suggests that EPA only make uranium occurrence assumptions for individual water systems based on actual monitoring data. AMWA does not support the use of "potential" occurrence as an appropriate approach for individual large water systems.

Recommendation. AMWA does not support the use of a generic decision tree to assess compliance decision choices by individual water systems. Compliance decisions, including treatment, should be based solely on discussions with the individual systems.

Decision Tree Assumption for Non-Treatment Options

AMWA questions EPA's assumption that 34 percent of all systems will select a non-treatment option for compliance with the standards under the radionuclides rule. EPA defines non-treatment options as blending, incorporating some form of regionalization of water, purchasing water from another system, and switching to a new water source. EPA bases this assumption on the review of radium compliance for the State of Illinois and nitrate/nitrite and atrazine compliance in 14 states.

AMWA agrees that in certain situations and specific circumstances, non-treatment options are a viable alternative. However, AMWA does not think that 34 percent of all systems will be able to choose non-treatment options for compliance under this rule. These type of options may be routine for large systems to employ, whereas small systems will not be able to pursue these options with the same ease. Large systems have routine experience with shutting down contaminated wells, drilling new wells, blending water, and purchasing water. Small systems and rural systems will not have the same experience or the same opportunities.

AMWA believes that it is erroneous to base compliance options with radionuclides on what water systems have been able to do with contaminants that are not naturally occurring such as nitrate/nitrite and atrazine. AMWA also believes that it is in not appropriate to extrapolate what systems have done in Illinois on only radium to the whole nation for all the radionuclide standards.

Recommendation. AMWA suggests that EPA collect additional data on the use of non-treatment options to comply with the radionuclide standards prior to finalizing the Radionuclides Rule. EPA needs a more comprehensive set of data before proposing that 34 percent of systems will choose non-treatment options. There is no precedent in previous drinking water regulations to support this claim. In addition, it is not clear how the costs on these non-treatment options is "half the cost of the cheapest treatment technology." The costs associated with non-treatment options need to be supported by appropriately robust analysis that represents sound science and the best peer-reviewed data available.

Economic Issues

Treatment of Monetized Benefits. The decision not to account for latency periods for cancer introduces significant bias in the estimated benefits of treatment. The full benefits of an immediate reduction in radionuclides exposure will not be enjoyed until decades in the future. Assuming that they take place immediately upon installation of treatment is unrealistic. A reasonable assumption should be made to account for latency, and the issue should be included in the discussion of uncertainties in risk reduction.

Discounting. In benefit-cost analysis, it is appropriate and standard practice to ensure that costs and benefits are evaluated on the same basis to avoid apple and orange comparisons. Specifically, this is true in the area of discounting. EPA benefit-cost comparisons should discount both or neither.

Need for Guidance Documents

Based on the nature of radionuclides and the complexities of the rule, there is a clear need for detailed guidance and technical assistance to assist both utilities and primacy agencies in complying with the rule requirements. EPA recently released a Draft Implementation Guidance for Radionuclides; however, this document is geared toward state primacy agencies and EPA Regional Offices rather than water systems.

Guidance should be clear and easily understood for both water systems and primacy agencies. Guidance is needed on monitoring requirements and sampling techniques, treatment options, and disposal of residuals.

Other Issues

Radium-224. AMWA supports EPA's decision not to include radium-224 in this rulemaking. Additional occurrence research is needed before radium-224 can be addressed.

Beta Particle and Photon Radioactively MCL. AMWA supports using the six-year review cycle as the regulatory mechanism to review and revise if necessary the beta particle and photon radioactivity MCL. Currently, there does not appear to be any evidence of occurrence of man-made beta emitters in water supplies.

Polonium-210 or Radium-224 Sub-Limits within Gross Alpha MCL. AMWA does not support the use of sub-limits for polonium-210 or radium-224 with the gross alpha MCL. This type of major regulatory change would require a re-proposal of the rule since it was not considered in the 1991 proposed rule. Also, incorporating radium-224 into the gross alpha MCL would require that all gross alpha samples must be processed within a 48 to 72 hour time frame. This would be a major analytical change from the current monitoring requirement. Since the occurrence data on polomiu-210 and radium-224 is so limited, the appropriate action at this time is additional occurrence research and placement on the Unregulated Contaminant Monitoring Rule.