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: 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.

EPA, in cooperation with the Association of State Drinking Water Administrators (ASDWA), will soon issue a Public Notification Handbook to assist water systems 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. A draft of this handbook can be found on EPA's website at: www.epa.gov/safewater/pn.html. EPA is not taking comments on the draft handbook since it was reviewed previously. Currently it is going through final EPA review and no major changes are expected. The final handbook will be available in late May or early June.

Background: 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: 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: The Proposed Filter Backwash Rule appeared in the Federal Register on April 10, 2000. A pre-publication copy was sent to members as Bulletin 00-06. The EPA set a 60-day comment period for this rule and comments are due to EPA on June 9, 2000. Please submit comments to AMWA for inclusion in the Association's comments.

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.

Background: 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 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 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 2000.

Current Status and Near-Term Action: The Radionuclides Rule Notice of Data Availability (NODA) appeared in the Friday, April 21, 2000 Federal Register (65 FR 21576). The Radionuclides Rule was originally proposed in 1991. Comments on the NODA are due to EPA by June 20, 2000. Please submit comments to AMWA by June 7, 2000, for inclusion in the Association's comments.

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.

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

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 next meetings of the FACA considering the Stage-2 MDBP Rules are scheduled for June 1-2 and June 27-28 in Washington, DC. At these meetings, the FACA representatives are expected to continue discussion of possible Stage-2 options and to review cost estimates of options being reviewed by the Technical Workgroup. The FACA extended the deadline for completion of a Stage-2 agreement until July 2000. This extension was needed due to the lack of key tools for evaluating risk reduction benefits and costs of regulatory alternatives.

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:

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.

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 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: The proposed rule completed OMB review on May 17, 2000. As part of OMB's review, EPA will request comment in the proposed rule on an MCL of 20 ppb as well as 3, 5, and 10 ppb. The rule could be signed as early as May 22, 2000 and published in the Federal Register in early June.

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. It is expected that the committee will draft formal recommendations on the Arsenic Rule at the June meeting.

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.

EPA has indicated that an MCL below 10 ppb for arsenic may be proposed. While levels as low as 2 or 3 ppb have been mentioned, an MCL of 5 ppb will most likely be the level chosen. OMB will also review the accompanying Arsenic Health Risk Reduction and Cost Analysis (HRRCA).

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: 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.

National Primary Drinking Water Regulations: Ground Water Rule; Proposed Rules

Federal Register: May 10, 2000 (Volume 65, Number 91)
Proposed Rules
Page 30193-30274

ENVIRONMENTAL PROTECTION AGENCY

National Primary Drinking Water Regulations: Ground Water Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking.

SUMMARY: EPA is proposing to require a targeted risk-based regulatory strategy for all ground water systems. The proposed 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. The proposed strategy addresses risks through a multiple-barrier approach that relies on five major components: periodic sanitary surveys of ground water systems requiring the evaluation of eight elements and the identification of significant eficiencies; hydrogeologic assessments to identify wells sensitive to fecal contamination; source water monitoring for systems drawing from sensitive wells without treatment or with other indications of risk; a requirement for correction of significant deficiencies and fecal contamination (by eliminating the source of contamination, correcting the significant deficiency, providing an alternative source water, or providing a treatment which achieves at least 99.99% (4-log) inactivation or removal of viruses), and compliance monitoring to insure disinfection treatment is reliably operated where it is used.

EPA believes that the combination of these components strikes an appropriate regulatory balance which tailors the intensity or burden of protective measures and follow-up actions with the risk being addressed. In addition to proposing requirements for ground water systems, EPA requests comment on ways to address the problem of transient providers of water who furnish drinking water to large numbers of people for a limited period of time. One possible solution is to adopt alternative definitions for ``public water systems'' which is currently defined as ``one that serves 25 or more people or has 15 or more service connections and operates at least 60 days per year. EPA is only requesting comment on this issue. The Agency is not today proposing to change the definition of ``public water system ,'' or modify related provisions. If EPA decides to take action on this issue, EPA will publish a proposal at a later date.

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

Federal Register: May 4, 2000 (Volume 65, Number 87)
Rules and Regulations
Page 25981-26049

ENVIRONMENTAL PROTECTION AGENCY

National Primary Drinking Water Regulations: Public Notification Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: Today, EPA is publishing final regulations to revise the general public notification regulations for public water systems to implement the public notification requirements of the 1996 Safe Drinking Water Act (SDWA) amendments. The regulations set the requirements that public water systems must follow regarding the form, manner, frequency, and content of a public notice. Public notification of violations is an integral part of the public health protection and consumer right-to-know provisions of the 1996 SDWA amendments. Owners and operators of public water systems are required to notify persons served when they fail to comply with the requirements of the National Primary Drinking Water Regulations (NPDWR); have a variance or exemption from the drinking water regulations; or are facing other situations posing a risk to public health. EPA is also publishing today revisions to the Consumer Confidence Report (CCR) regulation to be consistent with the final public notification regulation.

Note: A copy of the final rule was forwarded to all members with Bulletin 00-08

Introduction

The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to comment on the Direct Final/Proposed Rule 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.

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. AMWA member agencies provide clean, safe drinking water to over 110 million Americans.

Submission of Adverse Comments and Request for Additional Comment Period

AMWA is submitting adverse comments on EPA's effort to make revisions to the IESWTR and Stage 1 DBPR. AMWA the regulation of consecutive systems to be a significant regulatory undertaking that requires a full evaluation of the impacts of the proposed change. The evaluation of this change should involve input from states and water systems on the best approach for effectively addressing this issue.

AMWA requests that EPA withdraw the proposed direct final rule based on the consecutive system rule change. AMWA believes that the consecutive system issue is sufficiently complex to require a standard rulemaking process with additional analysis of the impacts of the change and a 60-day comment period. A new proposed rule addressing consecutive systems will allow EPA to better characterize the impacts and to consult with state agencies and public water systems that will be affected by the change. A 60-day comment period will allow adequate time for affected entities to review the rule and respond with comments.

The remaining issues in the current direct final rule could be dealt with under the current proposed direct rule format after addressing public comments.

Regulation of Consecutive Systems (p. 20306)

AMWA recognizes that the levels of disinfectant residuals and formation of disinfection byproducts (DBPs) in consecutive systems (i.e., systems that purchase their water from another water system) is a concern under the Stage-1 rules. AMWA, however, believes that the impact of this change on water systems and state agencies warrants a full regulatory review including an analysis of costs, benefits, and public comment. The impacts of this proposed rule change will include significant changes in treatment, changes in monitoring, and re-negotiation of numerous legal agreements between wholesale and purchase systems.

AMWA believes that an additional proposed rule on the regulation of consecutive systems is needed for the following reasons:

• The costs and impacts of this change were not fully evaluated in the proposed and final Stage 1 DBPR and IESWTR. A large number of systems are impacted by this rule change. According to EPA, there are about 4,874 consecutive community water systems in the United States. Of these purchased systems, EPA estimates that 4,531 (~92 percent) serve less than 10,000 people, 326 (~7 percent) serve between 10,000 and 100,000 people, and 45 (~1 percent) serve over 100,000 people. AMWA recommends that EPA re-propose a rule addressing consecutive systems that includes the following: a list of impacts including the number of systems out of compliance with the Stage 1 DBPR and IESWTR MCLs and MRDLs, estimates of costs, a decision tree of compliance choices, and other relevant analyses specific to these systems.
  
• EPA needs to review the various formal and informal arrangements between wholesale and purchase systems before the implementation of this rule change. There are a variety of formal contract arrangements and informal understandings that determine the relationships between wholesale systems and purchase systems. The implication of this rule change on these arrangements needs to be examined. To implement this rule change, agreements between wholesale and purchase systems would have to be reviewed to assess changes such as sampling points, additional treatment, cost impacts, fee adjustments, etc., and the agreements would have to be renegotiated accordingly. AMWA recommends that EPA consult with water systems about the impact of this rule change and the most appropriate approaches to implement the change.
  
• EPA needs to evaluate the impact of this rule change on existing state implementation requirements. States currently have the flexibility to address consecutive system compliance under 40 CFR 141.29 where these systems can be treated as extensions of the wholesale systems. The impacts of the rule change on how states treat consecutive systems in general, and under section 141.29 specifically, need to be evaluated. AMWA recommends that EPA consult with state agencies about the impact of this rule change and the most appropriate approaches to implement the change.
  
• EPA needs to evaluate the implementation timelines associated with this rule change. Based on AMWA's understanding of the Stage 1 DBPR and IESWTR timelines, systems serving over 10,000 people have to be in compliance with the new MCLs and MRDLs as of December 2001. Therefore, systems must start their monitoring in January 2001 in order to have one year of monitoring data for compliance purposes. If the direct rule becomes final in June, as EPA proposes, consecutive systems serving over 10,000 people would have only six months to make appropriate arrangements with their wholesalers and state primacy agencies. This does not appear to be a reasonable amount of time to institute this type of change.
  
• EPA needs to assess the impact of the rule change on small systems. As noted earlier, approximately 92 percent of consecutive systems are small (i.e., serve less than 10,000 people). Small systems have less technical, financial, and operations capabilities to evaluate and comply with the proposed rule change. Potential impacts could include changes to treatment, monitoring, and recordkeeping. AWMA suggests that EPA conduct an assessment of the impacts on all systems, including small systems.

System Reporting and Recordkeeping (p. 20306)

AMWA recommends that the requirement for reporting to the state of turbidity exceedances of 1.0 NTU from an individual filter should be for two consecutive measurements taken 15 minutes apart rather than from a single turbidity exceedance. This change would be consistent with the rule language used in the final IESWTR. That language was:

(1) For any individual filter that has a measured turbidity level of greater than 1.0 NTU in two consecutive measurements taken 15 minutes apart, the system must report the … (63 FR 69519)

Filtration Provisions (p. 20307)

AMWA does not support the provision that a violation exists if an individual filter turbidimeter is broken or under repair for more than five working days. The provision in the final IESWTR requiring broken tubidimeters be fixed or replaced within five working days is sufficient incentive for systems to maintain, repair, and replace their equipment. Attributing a violation to this requirement would unnecessarily increase the workload for systems and states through expanded reporting requirements and enforcement actions.

Introduction

The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to comment on the Advance Notice of Proposed Rulemaking on: Methyl Tertiary Butyl Ether (MTBE); Advance Notice of Intent to Initiate Rulemaking Under the Toxic Substance Control Act to Eliminate or Limit the Use of MTBE as a Fuel Additive in Gasoline.

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. AMWA member agencies provide clean, safe drinking water to over 110 million Americans.

Support for MTBE Regulation under TSCA

AMWA supports EPA's efforts to pursue a regulation under section 6 of the Toxic Substances Control Act (TSCA) to ban or severely limit the use of MTBE as a fuel additive since MTBE represents an unreasonable risk to health and the environment. Evidence of MTBE contamination of the nation's drinking water supplies is well documented and new findings seem to appear by the day.

MTBE contamination at even low concentrations renders water supplies unusable as drinking water. MTBE has an offensive, turpentine-like taste and odor that can be detected in water at very low levels. As EPA noted in the Federal Register introduction, consumers can discern MTBE in their water at concentrations as low as 2.5 parts per billion (ppb) for odor and 2 ppb for taste. When supplies become contaminated, consumers often choose to buy bottled water at a cost 500 to 1,000 times more than the cost of tap water.

MTBE also is a known animal carcinogen and a probable human carcinogen. However, even though it has become the third most common chemical manufactured in the United States, little is actually known about its health risk to people.

Due to MTBE contamination, many drinking water sources are being lost around the country. It is estimated that over 10,000 wells in California alone are contaminated with MTBE, mainly through leaking underground storage tanks (USTs). MTBE has created a significant and unacceptable risk to drinking water sources. In addition, surface water supplies are contaminated from spills, emissions from marine engines into lakes and reservoirs, and air deposition.

Integrated Regulatory Approach

AMWA, however, is concerned that the regulation of MTBE under TSCA will not be able to address the problem in a timely way and AMWA suggests that a more integrated regulatory approach is needed. In announcing the intention to regulate MTBE under TSCA, the Clinton Administration and EPA acknowledged that a proposal under TSCA would take at least six months (and probably closer to a year) with additional time necessary for public comment and finalizing a rule. In addition, an estimated three to five years would be needed to implement the rule. During this lengthy rule-making procedure, more and more drinking water sources will be contaminated with MTBE. AMWA understands that the Clinton Administration has also released a legislative framework to encourage immediate Congressional action on MTBE due to the time requirements to develop and implement a rule under TSCA.

Based on the limitations of regulating MTBE under TSCA and the uncertainty of a Congressional fix for MTBE, AMWA believes that an integrated regulatory approach involving efforts on several fronts is needed to address the MTBE contamination problem. An integrated approach would include regulatory action under TSCA as well as research, regulatory, and enforcement actions under other EPA programs. Components of this integrated approach should include the following:

• Proceed to ban (or at least severely limit) the use of MTBE under section 6 of TSCA since MTBE represents an unreasonable risk to health and the environment.
  
• Accelerate the enforcement of the replacement of leaking USTs under EPA's Underground Storage Tank Program. The majority of MTBE contamination results from leakage from gasoline storage and distribution systems. EPA estimates that only 85 percent of the regulated USTs meet current standards for upgrading or replacement, leaving over 100,000 substandard USTs around the country. In California alone, the number of USTs leaking MTBE is estimated at over 10,000. In addition, only 60 percent of USTs are in compliance with the leak detection requirements, according to EPA. Additional efforts under the UST program should include:

  have states prohibit fuel deliveries to non-upgraded tanks;

  increase enforcement and compliance resources;

  strengthen early detection and remediation mechanisms;

  require monitoring and reporting of MTBE at all storage tank release sites; and

  encourage states to require that land-use planning consider the impact of USTs on water supplies.

• Develop a secondary drinking water standard for MTBE which address the aesthetic qualities that relate to public acceptance of drinking water. Secondary standards are non-enforceable guidance but do provide information for states and water systems. AMWA understands that EPA's Office of Ground Water and Drinking Water is planning to propose a secondary standard for MTBE this summer.
  
• Enhance the focus on MTBE under the Safe Drinking Water Act's source water assessment program, contaminant monitoring initiatives, and wellhead protection program.
  
• Under EPA's Office of Research and Development, conduct research on possible MTBE replacements to ensure that these substances will not contaminate drinking water sources. Research should address groundwater behavior of MTBE and other gasoline additives including other oxygenates. Also, conduct research on MTBE, other ethers, and other potential oxygenates to determine their health effects.
  
• Expand federal resources for the treatment of drinking water supplies contaminated with MTBE and for securing alternatives sources of water.

EPA should also consider other actions that would address MTBE contamination, including suggestions by EPA's 1999 Blue Ribbon Panel on MTBE. These actions would help to ensure public health and environmental protection from the threat of MTBE contamination. Specific suggestions include:

• Encourage state and local governments to restrict the use of gasoline-powered watercraft in lakes and reservoirs that serve as drinking water supplies.
  
• Expand programs to protect private drinking water well users.
  
• Expand public education programs on the proper handling and disposal of gasoline.

The nation's drinking water suppliers are deeply concerned about MTBE contamination. MTBE poses a significant threat to health, the environment, and the continued provision of affordable, safe drinking water. MTBE contamination requires an immediate solution in the form of an integrated regulatory approach to address the wide scope of the problem.

Scope of MTBE Restriction under TSCA

AMWA strongly believes that MTBE should be completely phased out under this TSCA regulation. As described in the advanced notice of rulemaking, EPA's review of existing information on the contamination of drinking water sources by MTBE indicates substantial evidence of significant risk to the nation's drinking water supplies. As a result, EPA is initiating this rulemaking process under the unreasonable risk provision in TSCA section 6. As noted in the Federal Register notice, EPA is considering a complete ban on the use of MTBE as a gasoline additive or less comprehensive limits on the use of MTBE (e.g., by limiting the amount that could be used in gasoline, limiting use in particular geographic areas or during particular times of the year, limiting the types of facilities in which MTBE can be stored, or limiting the manner in which MTBE is transported).

AMWA suggests that dealing with MTBE before it is added to gasoline may be the best solution for mitigating the risks associated with MTBE. In the United States, very large quantities of gasoline are used and transported. The number of different possible avenues for release into the environment include leakage from storage tanks and pipelines, spills resulting from loading/unloading gasoline at tanks, spills from transportation accidents, uncombusted gasoline from boat engines, and emissions from automobile exhaust resulting in deposition from the atmosphere. Leaking USTs result in much of the MTBE contamination and while there are over 760,000 regulated USTs in the United States an additional three to four million USTs are exempt from regulation (due to size, contents, location, etc.). MTBE is highly soluble in water, resists biodegradation, and moves rapidly with ground water. Based on these factors, it may not be practical to prevent significant quantities of MTBE from entering the environment and contaminating surface and ground water once the chemical is added to gasoline.

MTBE contaminates ground water primarily through leaking USTs. Over 75 percent of public drinking water systems in the United States use only ground water and many of the remaining systems use ground water to some extent. In addition, thousands of minimally regulated private wells across the United States are used for drinking water. The importance of ground water as a source for drinking water cannot be understated, and the number of studies finding MTBE in ground water is becoming overwhelming. Once MTBE does contaminate ground water, the costs and difficulties of treating the contaminated water can be prohibitive. Treating contaminated water cannot be the preferred strategy for mitigating risks associated with MTBE.

Other Gasoline Additives and MTBE Substitutes

MTBE dominates the discussion of gasoline entering the environment through leaks, spills, etc., but there are potentially harmful other additives in gasoline. Also, any substitute for MTBE could have the same environmental characteristics as MTBE and may have even worse aesthetic characteristics or health effects. Other components of concern in gasoline include benzene, toluene, ethylbenzene, and xylenes (collectively known as BTEX). MTBE is the largest problem because it is more capable of traveling through soil rapidly, more soluble in water, and more resistant to biodegradation than BTEX. However, these contaminants are also entering the environment through gasoline leaks, spills, etc. EPA needs to enforce current regulations addressing USTs to minimize leaks and to enable early detection systems.

In developing this regulation under TSCA, EPA plans to consider the costs and impacts of alternatives to MTBE including other ether compounds and ethanol. Whereas the environmental fate of ethanol degradates is somewhat known, this information for other ether compounds is not well known. EPA does not have much data to characterize the risks that these alternatives might pose to drinking water supplies. However, they are chemically similar to MTBE and they may move through soil and water like MTBE.

AMWA strongly recommends that EPA evaluate the likelihood that alternatives to MTBE will cause similar risks to drinking water supplies. EPA should obtain data on health effects and fate and transport for these substances before proposing them as substitutes for MTBE. EPA needs to make decisions based on risks to public health and on the lessons learned from the MTBE experience. Alternatives to MTBE that will not cause contamination of drinking water sources must be chosen.

Treatment of MTBE-Contaminated Drinking Water Supplies

Once MTBE contaminates a drinking water source, its chemical nature makes it difficult and expensive to remediate. Because of its affinity for water, it is much harder and more expensive to remove MTBE from drinking water than it is to remove other organic components of gasoline. MTBE's chemical properties make it difficult and costly to remediate using conventional processes such as air stripping and granular activated carbon (GAC).

AMWA recommends that funding be made available for public water systems with MTBE-contaminated water sources to research treatment alternatives and explore alternative water sources. Even if a ban on MTBE use is implemented, the problem of contaminated drinking water sources will still exist.

Health Effects Research

Most of the human health related research conducted on MTBE has focused on adverse effects that may result from inhalation of MTBE. At high doses by inhalation, MTBE has caused non-cancer health effects as well as tumors in laboratory animals. However, there have been no human or animal health effects studies concerning the ingestion of MTBE in drinking water. Based on the available studies, MTBE has been characterized as an animal carcinogen. EPA has classified MTBE as a "possible" human carcinogen based on the inhalation cancer tests. Although no quantitative estimate of the cancer potency of MTBE has been established by EPA, the Agency has suggested that MTBE be regarded as posing a potential carcinogenic hazard to humans. As a result of these uncertainties, the National Academy of Science (NAS) has recommended that additional studies be conducted on MTBE.

AMWA is aware that several studies are ongoing by EPA and other organizations and that these should provide more information to assess the health risks associated with MTBE. However, AMWA suggests that additional resources be used to ascertain the risks associated with MTBE as well as possible MTBE substitutes.

Introduction

The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to comment on the Food and Drug Administration's (FDA) draft report on the Feasibility of Appropriate Methods of Informing Customers of the Contents of Bottled Water.

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. AMWA members from Anchorage to Miami and Los Angeles to New York serve clean, safe drinking water to over 110 million people.

The Public's Right to Know

AMWA supports the concept of the public's right-to-know regarding the quality of their drinking water and supported the consumer confidence report (CCR) provisions of the 1996 Amendments to the Safe Drinking Water Act (SDWA). AMWA also supported the inclusion in the 1996 SDWA Amendments of the provision that FDA publish for notice and comment a study on the feasibility of appropriate methods of informing customers of the contents of bottled water.

CCRs are intended to inform consumers of chemical and microbial contaminant detection, the standards and health goals for those contaminants, information on the system's compliance with EPA rules, and details on the water source. CCRs also provide special health notices for sensitive subpopulations. AWMA played a leading role in developing the CCR Rule and has been active in assisting our member systems in complying with the CCR provisions. Indeed, AMWA encouraged members to distribute water quality reports even before the CCR Rule was developed.

Currently, there are no equivalent right-to-know requirements for bottled water, and AMWA encourages FDA to correct this. The popularity of bottled water and perceptions of quality warrant it.

Bottled water has become increasingly popular in recent years. One reason for this is the perception of quality. Widespread claims are made that bottled water is safer than tap water, particularly for the immunocompromised community, including people with HIV and AIDS, children, pregnant women, and other sensitive subpopulations. But the accuracy of such claims varies with each brand and each community water system. Just as community water systems rely on different sources of raw water, from rivers to lakes to groundwater, so do bottled water companies. And just as the quality of tap water is influenced by the type of treatment provided, so is the quality of bottled water.

In addition, there are situations in which bottled water is used as a replacement for tap water. In emergency situations, such as after a natural disaster, bottled water may be the only option available. Bottled water may also be the only option available for rural families who are not connected to a community water system.

Based on the number of people consuming bottled water and the variety of situations in which bottled water is used, it is important that consumers have accurate, current, and accessible information on the quality of bottled water. This information is needed for consumers to make informed decisions.

For these reason, AMWA recommends that bottled water suppliers be subject to right-to-know requirements analogous to water utility CCRs under the SDWA. Specifically, AMWA recommends that the FDA develop a regulation under the Federal Food, Drug, and Cosmetics Act (FFDCA) for the following two provisions: 1) minimum label requirements to provide a minimum level of information for all bottled water; and 2) bottled water CCRs addressing the full complement of source, treatment, product recall, and contaminant testing information. Both of these are discussed below.

Minimum Label Requirements

AMWA supports the use of minimum label requirements on all bottled water. The type of information required to appear on all bottled water labels should inlcude:

• the source of the water;
• how the water was treated;
• microbial contaminant levels;
• a toll-free phone number for further information (such as requesting a CCR); and,
• a website address for further information (optional).

AMWA considers the inclusion of this information on the label feasible and practical. In fact, many current bottled water labels already contain most of this information. Bottled water companies have this information readily available, and printing it on a label is simple and inexpensive. A federal requirement would ensure that labels are consistent from brand to brand and easily accessible to consumers. Noting microbial contaminant levels is particularly important for immunocompromised persons, as they may suffer acute health problems related to the presence of harmful microbes.

A toll-free phone number would provide consumers with the ability to get information with the greatest amount of ease. Providing a mailing address would add more wording to the label and would serve as a disincentive for requesting information. A website can also be used to provide information; however, many consumers do not have access to the Internet. Therefore, website address and posting a web-based CCR should be encouraged &endash; just as it is for community water systems &endash; but cannot replace the need for a toll-free phone number to request a hardcopy CCR.

Bottled Water Consumer Confidence Reports

AMWA supports a requirement for bottled water CCRs analogous to the water utility CCRs under the SDWA. Bottled water CCRs should include the following information:

• the source of the water;
• how the water was treated;
• incidences of product recalls and violations of relevant regulations;
• levels of contaminants, regardless of whether a violation occurred;
• contaminant health goals;
• descriptions of the health concerns of detected contaminants; and,
• EPA, FDA, and Center for Disease Control hotline numbers.

CCRs including the information outlined above will give the bottled water consumer a well-rounded, fact-based perception, rather than one based on commercial marketing, anecdote and rumor. Making this information readily available will help consumers make better choices about protecting their health.

In addition, to be effective, bottled water CCRs should be revised on a yearly basis and should be available to consumers on request via toll-free phone numbers. The information should also be posted on FDA's website or bottled water companies' websites. The feasibility of this proposal has already been proven by the distribution of community water system CCRs and the posting of CCRs on EPA's website and the water system websites. In fact, CCRs are posted on AMWA's website (www.amwa-water.org).

Also, bulk water suppliers should be required to provide bottled water CCRs to their customers on a yearly basis during delivery or with invoices. AMWA believes that providing additional information by request and in the delivery/invoice process of bulk sales is feasible and practical.