# Presentation: 812796

## EPA’s Final Arsenic in Drinking Water Rule and Clarifications to Compliance and New Source Contaminants Monitoring Rules

- Presented for
- Date presented

## Overview and Summary of Rules

- SDWA Requirements
- MCL development
- Proposed arsenic rule
- Monitoring, waivers, and clarifications
- State program revisions
- Notice of Data Availability (NODA)
- Final rule
- Outreach since June 2000
- Summary of comments
- Consumer Confidence and Public Notification reporting
- Compliance time line

## SDWA Requirements

- Propose by January 1, 2000 and issue final rule by January 1, 2001.
- Develop research plan and conduct studies to reduce uncertainty in assessing health risks at low levels of arsenic.
- Final rule statutory deadline amended in October 2000 to issue final arsenic standard no later than June 22, 2001.
- Primary drinking water regulation lists technologies that can meet the MCL, including treatments for systems serving 10,000 people or less.  §1412(b)(3)(E)
- States can grant small system variances if no affordable technologies applicable.  Systems must install EPA-listed variance technologies.  §1415(e)(1)
- Effective date 3 years after promulgation, 2-year extension if time is needed to make capital improvements.  §1412(b)(10)

## SDWA Requirements, continued

- Publish a health risk reduction analysis (HRRCA) when proposing an MCL.  §1412(b)(3)(C)(i)
- Identifies quantifiable and non-quantifiable costs and benefits of each alternative, assesses effects on sensitive sub-populations, co-occurrence, and incremental costs and benefits.
- Excludes costs and benefits resulting from compliance with other proposed or final regulations.
- Use best science available and specify studies that support or fail to support estimate of health effects and how inconsistencies resolved.  §1412(b)(3)
- MCL set as close to MCLG as feasible §1412(b)(4)(B)
- Unless benefits would not justify the costs. §1412(b)(6)
- Review MCLs every 6 years or sooner. §1412(b)(9)

- SDWA Requirements, continued

## Proposed MCL:  Health Effects

- EPA had a cooperative agreement with the National Academy of Sciences (NAS) to have their National Research Council (NRC) study EPA’s arsenic standards and current health effects research.
- Human studies confirm that arsenic is linked to bladder, lung and skin cancer and noncancer effects (e.g., cardiovascular system effects).
- In foreign countries, human health effects usually observed at exposure to several hundred μg/L arsenic.
- While arsenic’s possible cellular effects may all follow less than a linear dose-response relationship, research on cellular changes is not sufficient to determine shape of a dose-response curve.
- Taiwan studies data from 1980’s and 1990’s are currently the best data available for risk assessment.
- U.S. adults consume about 10 μg inorganic arsenic per day in food.
- NRC study concluded that EPA’s MCL for arsenic needed to be decreased.

## Proposed MCL:  Test Methods

- Approved analytical methods measure total arsenic.
- Analysis costs range from $10 to $50.
- Only one technique has a method detection limit (MDL) too high for new MCL.  (MDL is the minimum concentration that can be reported with 99% certainty that the substance concentration is greater than zero.)
- Practical Quantitation Limit (PQL) is the lowest concentration that can be reliably measured during routine laboratory use.
- 1999 PQL derived from results of Performance Evaluation Studies for 26 to 45 EPA and State laboratories measuring 1.5 to 5.7 μg/L.
- PQL calculated as 3 μg/L within ±30% acceptance range.
- Existing laboratory capacity estimated to be adequate at PQL.

## Proposed MCL:  Occurrence

- National estimate based on available finished drinking water system data from 25 States.
- Merged State system distributions into seven geographical regions that assigned the regional distribution to the other 25 States.
- National estimate derived from regional estimates, weighted by number of systems in each region.
- EPA’s national occurrence estimates compare closely with those of the industry and USGS.
- 1999 NRC report cited studies that organic arsenic forms are rarely found in water supplies, especially > 1 μg/L.

## Proposed MCL:  Treatment Costs

- Used list of proven technologies presented at stakeholder meetings, treatment costs from 3 models, published data for membrane costs, and costs assessed against vendor costs.
- Concluded from case studies that most arsenic treatment residuals would not be classified as hazardous waste.
- Developed a decision tree to predict treatment options chosen for compliance, based on source water characteristics (e.g., ground vs. surface, sulfate and iron concentration), system size, water scarcity, existing treatment, and waste disposal costs.
- Identified affordable technologies for small systems even though costs per household much higher for smaller size categories.

## Proposed MCL:  Benefits

- Quantified benefits of avoiding fatal and non-fatal bladder cancers from the number of cases avoided and assigned dollar values.  Other health effects were not quantifiable at that time.
- Used wage-risk based value of $6.1 million per fatal cancer.
- Estimated non-fatal cancer benefit at $0.6 million a person.
- Estimated number of bladder cancer cases avoided in U.S. population considering amount of water consumed by age, sex, weight, socio-economic, and region for a lifetime exposure.  Used risk distributions NRC derived from Taiwanese studies.
- Estimated potential benefits of avoiding lung cancer from a nonquantified statement in the NRC report.  Results of EPA’s “What If” analysis projected the risk of contracting lung cancer in the U.S. would be approximately the same as the risk of contracting bladder cancer.

## Proposed MCL:  Cost and Benefits

- Listed estimated national annual costs and benefits, including the possible benefits of decreasing lung cancer.  Arsenic    Costs          Bladder       “What If” Lung         Potential   μg/L    in millions     benefits      potential benefits   non-quantified                                 in millions        in millions            benefits                                                                                                   3      $645-756      $44-104           $42-448          Skin, kidney     5      $379-445      $32-90             $35-384          nasal, liver, and   10     $165-195      $18-52             $20-224          prostate cancers   20       $63-77         $8-30               $9-128          Cardiovascular,                                                                                    lung, immune,                                                                                    nerve, gland, &                                                                               reproductive effects

## June 22, 2000 Proposal

- Proposed MCLG = 0; MCL = 5 μg/L
- 90-day comment period ended 9/20/00.
- Feasible level (3 μg/L).
- Requested comments on 3, 10, and 20 μg/L.
- Gave quantified benefits for bladder cancer and estimated benefits for lung cancer (2-5 times more deaths than bladder cancer) based on 1999 National Academy of Sciences report.
- Proposed to cover all CWSs but only require monitoring and reporting for NTNCWSs  (Final rule could require full coverage or no coverage of NTNCWS.)
- Provided no small system variances, because proposal listed affordable technologies.  §1415(e)(1)
- Moved to Standardized Monitoring Framework for inorganics.
- Gave 3 years to comply for large systems; 5 years for small systems, based on time needed to make capital improvements.  §1412(b)(10)

## Arsenic Monitoring Frequency

- Monitoring every entry point to the distribution system.
- Arsenic moved from §141.23(l) to §141.23(c) standardized monitoring framework for inorganics.
- Surface water once a year.
- Ground water once every three years.

**Distribution system of a CWS**
**A well or surface water source **
**Magnitude of flow at entry point **

## Arsenic Waivers

- Currently no monitoring waivers for 50 ppb MCL arsenic, because §141.23(c) applies to antimony, barium, beryllium, cadmium, chromium, cyanide, mercury, nickel, selenium, and thallium.
- Under final regulation States can give monitoring waivers for arsenic.  §141.23(c)(4)
- For grandfathered data need 3 sets of analysis < new lower MCL of 10 ppb (2002-2005).
- Requires one sampling set during the 9-year compliance period.

## Clarifications to Compliance and NewSource Contaminants Monitoring Rules

- Inorganics, volatile organics, and synthetic organics which exceed an MCL begin monitoring quarterly the quarter after the violation occurs.
- Averages initial and any State-required confirmation samples in compliance monitoring.
- Establishes that compliance average will be based on the number of samples, not automatically divided by four.
- Reduces ambiguity of averaging for systems that previously only reported monitoring violations and increases their MCL violations.
- New systems and new sources will demonstrate compliance for inorganic, volatile organic, and synthetic organic MCLs using State-specified sampling and compliance periods.

## State Program Revisions for Arsenic and Clarifications for Existing Contaminants §§ 142.16(j) & (k)

- Submit revision to adopt revised regulations (§142.12).
- Within 2 years of issuing a final rule (January 22, 2003).
- State can request up to a two-year extension if needed to obtain legislative and regulatory authority changes.
- Does not require all materials listed in §142.16.
- Side-by-side comparison of Federal and State regulations.
- Attorney General’s statement.
- States with primacy continue to have enforcement authority for new or revised regulations during application review (§142.12(e)).
- Uses approved monitoring and waiver plans, as revised.

## October 20, 2000 NODA

- Based on peer-reviewed article published in July 2000 of new analyses of quantified lung and bladder cancer risks using Taiwan data.
- Presented EPA ranges for bladder and lung cancer risks in U.S.
- Included a lower-bound risk adjusted for arsenic in Taiwanese water used to cook food.
- Showed lung cancer risks approximately equal to bladder cancer risks.
- Expected benefits to fall within range presented in June proposal.
- Contained a correction for the record on the cost curves used in the cost of compliance calculations.
- 30-day comment period ended 11/20/00.
- EPA noted that the information did not change the overall technical approach.
- EPA requested comment on risk analysis, development of cost estimates, and any other comments that would change because of the information provided in the NODA.

## Arsenic Outreach

- 5 Stakeholder meetings 1997-1999
- May25, 2000 prepublication proposal on web page
- June 2000:  Presentations at AWWA Annual Meeting (Denver, CO).
- June-August 2000:  Briefings for House Energy & Commerce Committee & Senate Environment & Public Works Committee staff.
- August 2000:  Stakeholders meeting (Reno, NV).
- October 2000:  Update briefing for ASDWA at Annual Meeting (Portland, OR).
- November 2000:  Overview at Annual AWWA Water Quality Technology and Conference (Salt Lake City, UT).

## Arsenic Commenters 

- Over 1,000 commenters, covering 6500 pages
- Proposal had 895 on time and 94 late
- NODA had 27 on time and 5 late
- Numbers of comments by type of commenter:
- Environmental Groups:  10
- Trade Associations:  43
- Drinking Water Utilities:  140
- States and tribes:  58
- Private citizens:  162
- Local government:  362
- Industry:  46
- Misc.:  195 (other Fed. Agencies, Academia, Science Advisory Board (SAB), 130 wastewater utilities, Small System FACA group).

## Revised Occurrence

- Revised national estimate used essentially the same methodology as the proposed rule.
- Obtained additional data from 7 States.
- Revised system inventory in occurrence using same timeframe used in the final economic analysis.
- Did separate ground water NTNCWS estimates, based on peer review comments.
- Improved system variability estimates.
- Used all groundwater data because most existing treatments had little effect on arsenic concentrations.
- Revised estimate is only slightly different than estimate in proposal.

## Revised Cost Analysis

- Adjusted decision tree to use technologies to change waste disposal options.
- Based on Science Advisory Board review and comments about feasibility of discharging brines to publicly owned treatment works.
- Decreased disposal options for and use of anion exchange.
- Costed use of disposable activated alumina media, even for large systems.
- Listed reverse osmosis and electrodialysis reversal, but did not use in decision tree.
- Added oxidation/filtration (greensand filtration) to decision tree at iron to arsenic ratio of 20:1.
- Revised cost estimate is only slightly higher than proposal.

## Revised Risk Analysis

- Studies published in 2000 show that trivalent organic forms of arsenic are more toxic than inorganic arsenic, so total arsenic standard remains appropriate.
- Current studies do not identify infants and children as being at greater risk.
- Science has not yet identified the key events in cells that lead to tumors, so EPA used a linear dose-response to select MCLG of zero and to analyze risk.
- Calculated combined risk of lung and bladder cancer.
- Lower-bound risk estimates adjusted for the amount of arsenic in Taiwan used to cook and in Taiwanese food.
- Further examined Utah data; indicates that unadjusted risk derived in NODA is probably the high-end risk estimate.

## MCL:  Cost and Benefits Comparison

-             Proposed   Proposed    Potential        **Final           Final**Arsenic  Cost          Bladder     “What If”        **Cost          Benefits**  μg/L    in millions  benefits      benefits        **in $M          in $M**    3      $645-756   $44-104    $42-448     **$698-792   $214-491**      5      $379-445    $32-90    $35-384      **$415-472   $191-356**    10      $165-195    $18-52     $20-224     **$180-206   $140-198**         20       $63-77       $8-30      $9-128        **$67-76        $66-75**
- Potential nonquantifiable health benefits for cancers of the skin, kidney, nasal passages, liver, and prostate and noncancer effects on the cardiovascular, immune, nervous, and glandular systems.
- Performed sensitivity analysis on monetized benefit estimates for final rule, recommended by the SAB Economics Committee:
- Downward adjustment for latency factors of 5, 10, and 20 years.
- Upward adjustments for rising income and willingness to pay more to avoid involuntary exposures.

## Non-Transient Non-Community Systems Coverage (NTNCWSs)

- NTNCWSs were not covered in the original 1975 arsenic rule (most inorganic rules cover NTNCWSs)
- Proposed requiring monitoring and reporting only because risk appeared within target risk range (less than 10-4) without coverage.  Proposal provided costs of full regulation.
- Few comments supported proposed approach; preferred full or no coverage.
- Final rule requires full coverage based on uncertainties in the health risks.  EPA will review this issue in the future.

## Elements of Final Rule

- MCLG = 0; MCL = 10 μg/L.
- Used §1412(b)(6) authorities to move from feasible level (3 μg/L).
- Required full coverage of Community Water Systems and Non-Transient Non-Community Water Systems.
- Rule affordable for small systems, so no small system variances offered.
- Moved to Standardized Monitoring Framework for inorganics.
- Extended compliance to 5 years for all system sizes.

## Other Health Issues Raised

- “Use Utah study for U.S. risk, which did not observe cancers, because foreign studies overestimate risk.”
- EPA made adjustments for Taiwanese arsenic exposure from food and cooking water in risk assessment for final rule.
- Not all people in the U.S. are well nourished and genetically different than the Asian studies.
- EPA’s separate risk analysis for exposed rural Utah population (not compared to urban parts of the State):  Population not statistically large enough to detect risk at levels predicted by NODA.
- “Use other studies which did not observe cancer.”
- Study data not sufficient to develop a dose-response relationship.

## Other Health Issues Raised, continued

- “Consider effect of MCL on cost of complying with other programs (e.g., Superfund cleanups).”
- HRRCA specifically excludes these costs.
- “Wait until more research is completed.”
- EPA will use results of new studies to evaluate MCLG and MCL in the 6-year review of MCLs.
- “Set standard as low as possible to protect sensitive subpopulations.”
- NRC and SAB concluded data insufficient to estimate risks for subpopulations.
- EPA considering whether a health advisory needed to address greater consumption per body weight in infants.

## Other Issues Raised by Commenters

- Comments that EPA’s costs underestimate co-occurrence.
- Based on NWIS data from USGS, only 8% of systems will exceed arsenic MCL and 300 pCi/L radon.  Of these, 85% have radon at concentrations that will be removed incidentally by arsenic treatments.
- For final rule anion exchange applicable when sulfate <50 mg/L.
- Using NWIS, most comprehensive database of ambient water, would tend to overestimate co-occurrence.
- “Matrix interferences affect compliance and PQL.”
- Doubtful, given approved methods used for years for compliance.
- Not appropriate to use matrix in PQL performance determinations among labs.  Drinking water testing corrects for matrix interference.

## Other Treatment Issues Raised

- “Many small systems will need certified, trained operators.”
- Adequate training courses should be available within 5 years.
- Certified operators do not have to be on site 24 hrs/day, 7 days/week. On call status is acceptable.
- EPA accounted for costs of more highly certified operators.
- Concerns about transporting, storing, handling, and using chemicals in residential areas.
- Covered by maintaining safety and emergency response procedures, inspections, supervision, and training.
- Small systems use hypochlorite, lower handling risk than forms used by larger systems.
- Costed small systems treating at less than optimal pH.

## Other Treatment Issues, continued

- Concern about disposal for POU/POE activated alumina in septic systems or to sewers.
- Small volume of household water treated (1%) will have minimal impact.
- “Should manage residuals as hazardous wastes.”
- Removed technologies which may produce hazardous waste from decision tree.
- “Industry estimated much higher costs.”
- Using median flow rates overestimates flows in size category.
- EPA used average flow, not design flow.
- EPA used cost-effective cost equations for specific conditions.
- Industry may have used cost of a complete activated alumina system instead of vessel costs.

## Other Compliance Issues 

- Believe 10 μg/L will be affordable for small systems.
- Financial help available over 5 years.
- Total capital costs are 57% lower than they would have been for the proposed standard of 5 μg/L.
- Large increases in water bill may reflect historic underpricing.
- National affordability used to list small system affordable technologies, not to determine individual system affordability.
- “Having total arsenic standard (instead of inorganic) may require systems to add treatment.”
- Standard considers toxicity of organic arsenic species, which are rarely observed in drinking water.
- Avoids cost of developing inorganic arsenic analytical methods.

## Health Risk Reduction and Cost Analysis (HRRCA) Comments

- “Wanted HRRCA published prior to proposal.”
- SDWA requires that EPA publish HRRCAs when proposing an MCL.  §1412(b)(3)(C)
- SDWA specifically required radon’s HRRCA be published six months before the radon proposal. §1412(b)(13)(C)
- “Show more incremental costs and benefits in HRRCA.”
- EPA increased the text for the final rule.
- SDWA did not intend EPA to use only incremental analysis to determine if the benefits justify costs.  Decision based on all seven elements of the HRRCA. §1412(b)(4)(C)

## Arsenic Consumer Confidence Reports

** ****§141.165(b) **(Subpart O) below MCL reporting    - July 1, 2001 report (covers 2000 calendar year) requires CWSs     detecting between 25 μg/L and 50 μg/L to provide additional     health information (in addition to providing standard health     language when > 50  μg/L detected).   - Subsequent reports provide additional health information if     detected between 5 and 10 μg/L, before compliance date.
-  **§141.165(f) **beginning July 1, 2002 CCR requires  CWSs detecting > 10 μg/L to provide health language  in Appendix A to Subpart O, before compliance date for   lower MCL.

## Arsenic Public Notification 

** ****§141.32 applies until Oct. 31, 2000 for EPA-supervised****  programs and no later than May 6, 2002 for States with****   primacy.****  -  CWSs > arsenic MCL provide notice.**** **
**  ****§141.203 Subpart Q applies **after Oct. 31, 2000 or **by****    May 6, 2002 when primacy State rule effective. ****   - When MCL is 10 μg/L in 2006, also applies to NTNCWSs.**** **  -  **Tier 2 public notice when MCL exceeded w/in 30 days.**       Standard health effects language in Appendix B to Subpart Q.       Population at risk & actions to take.       Posted in conspicuous locations, newspapers.          Repeat every 3 months unless State decreases to annual.       Report to State within 24 hours.      **-  Tier 3 for arsenic monitoring & testing violations.**

## Arsenic Compliance

**June 22, 2000**
**proposal in Federal Register **

**January 22, 2001 final rule in Federal Register **

**2006**
** ****compliance **** date for **
**10 μg/L**
** ****(PN adds**
**NTNCWSs)**

- 2001
- guidance
- manuals

**July 1, 2002**
**CCR for 2001**
**Health language >10μg/L**
**Plus language 5-10 μg/L **

- Nov. 20
- NODA
- comments
- due

- October 20,
- 2000 NODA

- Sept.20
- proposal
- comments
- due

- No later than 5/6/02
- States’ effective
-  date for tiered PN for CWS @ 50 μg/L

-  2005
- compliance
-  monitoring
- 3-yr cycle
- begins

- July 1, 2001 CCR for 2000
- > 50 μg/L
-  &Health
- 25-50 μg/L
- §141.154(b)

- 5/4/200
- final rule
- 3-tier
- PN

## For further information...

_**www.epa.gov/safewater/arsenic.html**_
- June 22, 2000 proposal (pdf)- Fact sheet- Regulatory Impact Analysis (pdf)- Technologies & costs, April 1999 (pdf) - Notice of Data Availability (pdf)- Correction Notice
- January 22, 2001 final rule (pdf)- Fact sheets- Quick reference guide (pdf)- Economic Analysis (pdf)- Technologies & costs, December 2000 (pdf)
**Safe Drinking Water Hotline** (800) 426-4791  or (703) 285-1093                                               hotline-sdwa@epa.gov
- To get hard copies of the final rule, proposal, or fact sheets.