The Arsenic Rule: Background and Rule Provisions

1. The Arsenic Rule:Background and Rule Provisions

2. Victorian ladies of fashion used arsenic for cosmetic purposes, as well as for killing husbands. In the 15th and 16th century, the Borgias used arsenic as their favorite poison for political assassinations. In WWII, arsenic used as a war gas Contact with the skin produced huge blisters Sinister Uses for Arsenic

3. Arsenic poisoning is thought to be responsible for the deaths of some well known historical figures such as: • Claudius • Pope Pius III and Clemente XIV • Charles Francis Hall • Napoleon

4. Was Napoleon Poisoned? • A toxicological study of Napoleon's hair showed “major exposure, and I stress 'major', to arsenic." • Natural upper limit of arsenic concentration in hair is one nanogram per milligram of hair. • In one of the samples tested, the concentration was 38 nanograms. June 1, 2001 CNN.com/world

5. Used in agriculture as ingredients in Insecticides Rat poisons Herbicides and wood preservatives Used as pigments in paints, wallpaper, ceramics Early syphilis treatment Fowler's Solution Solution of one-percent potassium arsenite Used in the treatment of psoriasis Altruistic Uses for Arsenic

6. Arsenic Occurrence • Naturally occurring element • Found throughout the United States • Weathers from rocks and soils • Primarily found in ground waters • Also associated with wood preserving, mining, agriculture, pulp and paper production, burning of fossil fuels

7. US EPA 2001 US EPA 2001

8. Health Effects • Cancer • Bladder cancer • Lung cancer • Non-Cancer • Heart disease • High blood pressure

9. Arsenic Regulatory History 1986 Safe Drinking Water Act (SDWA) Revise by 1989 1994 Court orders proposal by 11/95 1975 National Interim Primary Drinking Water Regulations 50 µg/L 1980 Clean Water Act 0.0022 µg/L-recalculated 1992 0.018 µg/L, Integrated Risk Information System update 1996 SDWA amended to propose by 1/00 final by 1/01 1942 Public Health Service 50 µg/L 1989 Citizen Suit Filed 2/95 EPA delays proposal 1993 SAB Criteria 1985 Recommended MCL proposed 50 µg/L 1989 Risk Assessment Science Advisory Board (SAB) review 1968 1977 Taiwan studies (Tseng) 1994 SAB methods occurrence treatment 1992 SAB research needs

10. Proposed Arsenic Rule June 22, 2000 5 ppb standard for arsenic EPA requested comment on 20 ppb, 10 ppb, and 3 ppb Final Arsenic Rule January 22, 2001 10 ppb standard for arsenic Arsenic Rulemaking

11. 2001 Expert Panel Reviews of Arsenic Regulation • National Academy of Sciences (NAS) • Risks of bladder and lung cancer are higher than EPA estimated • There are other health effects to consider • Arsenic Cost Working Group to the National Drinking Water Advisory Council (NDWAC) • EPA “produced a credible estimate of the cost....” • Provided recommendations to improve costs, including small system issues and waste disposal • Science Advisory Board (SAB) • Could consider time lag (after reducing arsenic exposure) before risk decreases • Could quantify benefits of reducing other health outcomes including noncancer effects (e.g., diabetes, high blood pressure)

12. As a Result... • On October 31, 2001 Administrator Whitman announced that there would be no further delay in implementing the January 2001 Rule

13. Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring Rule Provisions

14. Major Points • Dates • Monitoring requirements • Compliance determinations • Analytical methods • Consumer Confidence Report (CCR) and Public Notification (PN) Rules • Rule flexibilities

15. Arsenic: Summary of New Rule • Lowers maximum contaminant level (MCL) to 10 µg/L • Establishes maximum contaminant level goal (MCLG) at 0 • Applies to community water systems (CWSs) AND nontransient noncommunity water systems (NTNCWSs) • Incorporated into Standardized Monitoring Framework • Becomes enforceable on January 23, 2006 • Adds new requirements for consumer confidence reports (CCRs) • Requires Tier 2 public notification

16. 10 µg/L 50 µg/L 1/23/06 10 g/L Compliance Date 1/22/01 Rule Published 1/22/03 Primacy Revision Application Due 2/22/02 Rule Effective Date 1/22/04 IOCs, SOCs, VOCs & New Source Monitoring 1/22/05 Primacy Agencies With Extension Submit Final Primacy Application Implementation Milestones

17. Arsenic Monitoring • Placed in Standardized Monitoring Framework • Rule flexibilities allow systems to continue current monitoring schemes • Grandfathered data allowed • Extension of monitoring deadline • Waivers can be granted • New system/new sources requirements

18. COMPLIANCE CYCLE COMPLIANCE CYCLE 1st Compliance Period 2nd Compliance Period 3rd Compliance Period 1st Compliance Period 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Key One Sampling Event Standardized Monitoring Framework for Inorganic Contaminants (IOCs) GROUND WATER SURFACE WATER

19. COMPLIANCE CYCLE COMPLIANCE CYCLE 1st Period 2nd Period 3rd Period 1st Period 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Standardized Monitoring Framework: Ground Water Systems 50 µg/L MCL 10 µg/L MCL NO WAIVER WAIVER 12/31/07 Must complete initial monitoring or have an approved State waiver. 2/22/02 Rule Effective Date 1/23/06 The 10 µg/L MCL becomes enforceable. Key 1/1/05 Data collected after this date, may be grandfathered. One Sampling Event

20. COMPLIANCE CYCLE COMPLIANCE CYCLE 1st Period 2nd Period 3rd Period 1st Period 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Standardized Monitoring Framework: Surface Water Systems 10 µg/L MCL 50 µg/L MCL NO WAIVER WAIVER 12/31/06 Must complete initial monitoring or have an approved State waiver. 2/22/02 Rule Effective Date 1/23/06 The 10 µg/L MCL becomes enforceable. Key 1/1/06 If allowed, data collected after this date may be grandfathered. One SamplingEvent

21. Systems May Grandfather Data If: • State approves • Samples are less than 10 µg/L • Samples are taken: • 01/01/05 and 01/23/06 (Ground Water) • 01/01/06 and 01/23/06 (Surface Water) • Lab analyzed with approved method • Two inductively coupled plasma-atomic emission spectroscopy (ICP-AES) methods (EPA Method 200.7 and SM 3120 B) no longer allowed for compliance

22. 9-Year Waivers Allowed for IOCs • Ground water systems must have at least 3 rounds of monitoring results • Surface water systems must have at least 3 years of monitoring results • All previous samples must be under 10 ppb • Once waiver issued, system must sample once during each 9-year waiver period

23. IOC Waiver Criteria • 40 Code of Federal Regulations (CFR) 141.23(c) • Factors to Consider • All previous monitoring data • Quality and amount of data • Length of time covered • Proximity of results to MCL • Detection limit of method • Variations in reported concentrations • Factors that may affect concentrations

24. Source Water Assessments Can Help • Substitute Vulnerability Assessment for Waiver Criteria if: • It was completed under an approved Source Water Protection Program • State considered • All previous monitoring data • Variations in reported concentrations • Factors that may affect concentrations

25. New Source Contaminants Monitoring • For new systems and new sources beginning operation after January 22, 2004: • Must demonstrate compliance using State-specified sampling and compliance periods • For all IOCs, synthetic organic contaminants (SOCs), and volatile organic contaminants (VOCs)

26. Compliance • New compliance determination for IOCs, SOCs, VOCs • Violations • Rounding

27. IOC, VOC, & SOC Compliance -- New Requirements • For systems monitoring annually or less often • MCL exceedance triggers quarterly monitoring • Violation based on 4 quarters of monitoring • Unless a sample will cause the running annual average to exceed the MCL • Violation if annual average exceeds MCL

28. Compliance Determination Step 1 Sample each sampling point If >10 g/L Step 2a: Take any required confirmation samples and average results Step 2b: If average >10 g/L begin quarterly sampling Step 2 After 4 consecutive quarters determine running annual average by adding results and dividing by number of samples taken Step 3

29. Speaking of 10…. • 14  10

30. Determining Compliance & Rounding • Arsenic added to IOCs listed in the 40 CFR 141.62 (b) table as .01 mg/L • EPA guidance says round to same number of significant figures • HOWEVER: Special rule requirement for arsenic • Compliance governed by 40 CFR 141.23 • “Arsenic sampling results will be reported to the nearest 0.001 mg/L” 40 CFR 141.23(i)(4)

31. 10.5 ppb is a Violation • EPA clearly intended a standard of 10 ppb • Cost analysis in Rule is based on 10 ppb (0.010 mg/l) • Rule preamble consistently refers to 10 ppb (98 times) • EPA consistently discussed 10 ppb in press releases and stakeholder meetings

32. Analytical Methods

33. Approved Analytical Methods

34. Withdrawn Analytical Methods • ICP-AES 200.7 • Standard Method (SM) 3120B Rationale? They don’t detect low enough

36. Consumer Information for Arsenic • Consumer Confidence Reports (CCRs) • Effective 2/22/02 • New health effects requirement • New education statement • Public Notification Rule

37. CCR: Major Points • Applies to all CWSs • Reports due by July 1 annually • Includes: • Water system information • Sources • Detected contaminants • Violations information • Required educational information • Information on variance or exemption

39. Some people who drink water containing arsenic in excess of the MCL over many years could experience skin damage or problems with their circulatory system, and may have an increased risk of getting cancer. While your drinking water meets EPA’s standard for arsenic, it does contain low levels of arsenic. EPA’s standard balances the current understanding of arsenic’s possible health effects against the costs of removing arsenic from drinking water. EPA continues to research the health effects of low levels of arsenic which is a mineral known to cause cancer in humans at high concentrations and is linked to other health effects such as skin damage and circulatory problems. Health Effects Statement Informational Statement

40. Public Notification Rule: Requirements for Arsenic • In 2006, applies to NTNCWSs • Tier 2 public notice after MCL violation • Report to State within 24 hours • Send notice to customers within 30 days • Standard health effects language in Appendix B to Subpart Q • Population at risk & actions to take • Posted in conspicuous locations (e.g., newspapers) • Repeat every 3 months unless State decreases to annual • Tier 3 for arsenic monitoring & testing violations

41. Rule Flexibilities POU Treatment Strategies Variances Exemptions

42. Treatment Options • Rule listed Best Available Technologies (BATs) and Small System Compliance Technologies (SSCT) • Adsorptive media on a throwaway basis is expected to be most commonly used • Point-of-Use Treatment Devices (POU) listed as SSCT • Reverse Osmosis • Activated Alumina • Affordable option for very small water systems

43. Require programs to ensure proper long-term operation, maintenance, and monitoring Safe Drinking Water Act (SDWA) Requirements Must be owned, controlled and maintained by the system Must be equipped with mechanical warnings POU/POE (Point-of-Use/Point-of-Entry) EPA Is Developing POU Guidance for Water Systems and Primacy Agencies

44. Variances • No small system variances allowed [SDWA 1415(c)] • Small system compliance technologies identified • General variances allowed [SDWA 1415(a)] • The system must: • Install a BAT • Follow a compliance schedule established by the State

45. Exemptions [1416(a)] • Useful prioritization tool for states • Provides additional time for the most disadvantaged systems • Up to 9 additional years for small water systems • Puts system on path to compliance • EPA is developing guidance to streamline approach

46. Additional Information • www.epa.gov/safewater/ars/implement.html • Draft Arsenic Implementation Guidance • POU & Exemption Draft Guidance • Quick Reference Guide • January 22, 2001 Final Rule • Rulemaking documents • Proposed rule • Technologies & Costs, 4/99 and 12/00 (pdf) • Economic Analysis for Final Rule Safe Drinking Water Hotline (800) 426-4791 or (703) 285-1093 sdwa@epa.gov