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### Regulatory Flexibility Act Section 610 Review of the **Arsenic National Primary Drinking Water Regulations**

**United States Environmental Protection Agency**

**Office of Water November 9**  **, 201 1** 2

**Results of Section 610 Review of the Arsenic Drinking Water Regulation**  **Background** On January

22, 2001 (66 FR 6976) EPA promulgated a new N ational Primary D rinking Water R egulation (NPDWR) for arsenic as authorized b y the Safe Drinking Water Act (SDWA). In this action, EPA changed the arsenic maximum contaminant level (MCL) from 50 μg/Lto 10 μg/L , set the arsenic maximum contaminant level goal (MCLG) at zero , and required arsenic monitoring for new s ys tems. The Arsenic Rule was to become effective 60 day s after publication, on March 23, 2001. However, the effec tive date was delay ed while the Agency sought independent reviews of the scientific and cost issues associated with the rule
. After reassessment of the Arsenic Rule , it became effective on February 22, 2002. Before the Arsenic Rule was promulgated EPA developed a Regulatory Flexibility

Analy sis. EPA also took several steps to lessen the impacts on small entities. These steps included: (1) Providing small sy stems additional time to comply through a provision for exemptions that would provide sy stems serving fewer than 3,300 persons up to an additional nine years to comply , and (2) developing a small entit y compliance guide to help small systems compl y with this rule. Section 610 of the Regulatory Flexibility

Act requires federal agencies to review regulations that have significant economic impact on a substantial number of small entities within 10 y ears of their adoption as final rules. This review was announced in the Regulatory Agenda which was published in the Federal Register o n December 20, 201 0 (75 FR 79856). As part of this review, EPA considered, and solicited comments on, the following factors: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule; (3) the complexity

of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal, State, or local government rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected b y the rule. EPA received ei ght comment letters in response to the December 20 , 2010 Federal Register notice. All the letters are available for public inspection in the rulemaking docket (docket number EPA

- HQ
- OW
- 2010
- 0728 at www.regulations.go v ). Pursuant to section 610 of the Regulatory

Flexibility

Act, EPA has reviewed this rule to determine if it should be continued without change, or should be rescinded or amended to minimize adverse economic impacts on small entities. The results of EPA’s Section 610 review of the Arsenic Rule are presented in this report. **Discussion of Factors required by Section 610 of the Regulatory Flexibility Act 1.**  **Continued need for the rule.** Most commenters explicitly stated the continued need for the Arsenic Rule because arsenic continues to be a public health concern for public water s ys tems across the country with high arsenic levels. None of the commenters suggested the rule should be res cinded.3

Two commenters s uggested that the continued need for the rule should be evaluated through EPA’s six year review process. EPA is required to review its existing NPDWRs at least every six years and to revise as appropriate. The six y ear review is a thorough review of current health effects assessments, changes in technology , and other factors that could support a regulatory revision that will maintain or improve public health protection. EPA will continue to review the Arsen ic Rule every

six years, as required by the SDWA , and revise the rule if appropriate. The next six year drinking water rule review is due in 2016. Two commenters challenged the revision of the arsenic MCLfrom 50 μg/L to 10 μg/L but did not contend that there was no continued need for the rule . Those commenters express ed the opinion that the MCLrevision was made with little scientific evidence of health risk and benefits. In deriving the 2001 MCL , EPA followed the recommendations from the National Academ y of Sciences R eport, Arsenic in Drinking Water (National Research Council, NRC, 1999) . N RC (1999) reviewed all the available human data on cancer and non

- cancer effects from exposure to arsenic in drinking water along with experimental evi dence on metabolism and mode of action. In addition, EPA requested reviews by 1) the National Academ y of Sciences (NAS) on the Agency 's interpretation and application of arsenic research, 2) the National Drinking Water Advisory Council (NDWAC) on the ass umptions and methodologies underlying the Agency 's estimate of arsenic compliance costs, and 3) its Science Advisory Board (SAB) on the benefits associated with the Rule. The EPA Administrator announced on October 31, 2001, that the 10 ppb standard for ars enic would remain stating that, "the 10 ppb protects public health based on the best available science and ensures that the cost of the standard is achievable." **2. Nature of complaints or comments received concerning the rule.**  There were five main issues for which the commenters requested that the rule be amended to ease burden on small sy stems. These issues were the cost associated with treatment, the disposal of treatment waste streams, the calculation for compliance with the MCL , the diffi culties associated with using alternative treatment technologies, and the difficulty in communicating the health risks of arsenic exposure to the public. We address each of these concerns and the actions that EPA has taken to resolve these concerns below:

 **Cost Associated with Treatment**  Nearl y all commenters cited the cost of adding arsenic treatment as a significant burden for water sy stems. EPA is aware that it is more difficult for small sy stems to spread the cost of adding treatment among their smaller customer base than it is for larger s ys tems. Sy stems needing to install treatment may appl y for financial assistance through EPA's Drinking Water State Revolving Fund (DWSRF). Between 1997 and 2010, states have used DWSRF funds to provide $7.6 billion in low

- interest loans to small public water systems and have entered into over 5,900 assistance agreements to fund projects to small sy stems to improve infrastructur e. The program also maintains its commitment to providing funding to s ys tems with the greatest demonstrated need. Thirt y - eight percent of all DWSRF assistance funded in 2009 went to sy stems serving4

10,000 or fewer people. EPA has been working with the states to better target DWSRF set

- asides to small sy stems likel y to be challenged b y particular rules. In addition EPA’s Drinking Water program has partnered with U.S. Department of Agriculture’s Rural Utilities Service (USDA

- RUS) to offer a wide array of as sistance options to address the SDWA compliance needs of small sy stems . More information about this partnership can be found at: http://water.epa.gov/t ype/drink/pws/smallsy stems /partners.cfm
. To help sy stems determine the best solution for complying with the Arsenic Rule the EPA Office of Research and Development (ORD) has invested more than $20 million in arsenic removal demonstration projects and installed 49 treatment sy stems in 26 states. ORD’s research is focused on the development and evaluation of innovative methods and co st - effective technologies for arsenic treatment. Sy stems are not required to use an y specific technology. Sy stems can use technologies not listed as best available technologies (BATs) if they are effective at removing arsenic from drinking water. EPA has also posted a significant amount of arsenic compliance assistance materials on the EPA website http://www.epa.gov/safewater/arsenic/compliance.html . EPA’s arsenic technology experts have provided many training sessions, hosted conferences, and provided direct assistance to sy stems. EPA also works with states and Federally

- funded technical assistance providers to get information out to states and small water s ys tems.

 **Disposal of Waste Stream**  Three commenters communicated the frustrations of impacted public water sy stems where on

site disposal of backwash water from arsenic treatment is prohibited. EPA is aware of the difficulties of disposing of treatment waste streams and that hazard ous waste regulations vary

from state to state. To address liquid waste streams, EPA has demonstrated through arsenic demonstration projects that treatment processes can be designed and operated to eliminate the need to dispose of wastewater flows. Backwa sh waters can be reincorporated into the beginning of the treatment process, rather than disposing of it. Solid wastes, from an iron filtration process or spent media from an adsorptive process, have been shown to pass EPA’s Toxicity Characteristic Leachi ng Procedure (TCLP), which ty pically would allow them to be disposed into a non

- hazardous sanitary landfill. Water s ys tems should review state hazardous waste regulations for liquids and solids so waste considerations can be addressed during the initial de sign or modification of a treatment facility.

 **Compliance Determination for the MCL** EPA received several comments on how compliance is determined for the Arsenic MCL. Those commenters were concerned that because compliance determination is based on a running annual average of quarterl y samples, public water s ys tems with newly installed treatment may

still be in violation of the MCLeven if their most recent result is below the MCL
. EPA drinking water rules, not only the Arsenic Rule, have been written to ensure contaminant levels are reliabl y and consistently below the regulated level before returning a s ys tem to5

compliance with a rule. The state cannot make a determination that the system is reliably and consistently

below the MCLuntil a minimum of two consecutive ground water, or four consecutive surface water samples, have been collected (§141.23(c)(8)). Thus, sy stems installing treatment (or making other adjustments to comply over the long term) are out of compliance; but the concern raised b y co mmenters is a onetime occurrence. A sy stem can include a statement in the public notice and Consumer Confidence Report (CCR) indicating the sy stem has addressed the issue (via treatment, blending, etc.) and is currently sampling to ensure the process is working correctl y and does not exceed the MCL
.
 **Difficulty Using Alternative Treatment Technologies** EPA received two comments on the difficulty of using point

- of

- use (POU) devices as an alternative treatment technology due to the resource intensive oversight required for these ty pes of devices. Bef ore the Arsenic Rule was promulgated EPA identified affordable small sy stem compliance technologies. Among these small sy stem compliance technologies is a point

- of

- use (POU) device option operated and maintained by the public water s ys tem, allowed by the 1996 SDWA Amendments in SDWA Section 1412(b)(4)(E)(ii). At least one western state developed its own guidance for how a POU program would be administered b y water s ys tems in the state. EPA recognizes that complying with the requirements for point

- of

- use treatment technologies can be challenging. EPA developed guidance to promote Point

- of

- Use devices (

Point

- of

- Use or Point

- of Entry Treatment Options for Small Drinking W ater Systems EPA 815
- R
- 06
- 010). EPA has also developed a tool to assess the capital and operational & maintenance cost for POUs ( Cost Evaluation of Point

- of

- Use and Point

- of

-Entry Treatment Units for Small Systems: Cost Estimating Tool and User Guide . EPA 815
- B
- 07
- 001).

 **Risk Communication** EPA received a comment that the consumer confidence report (CCR) public health information required when arsenic levels are below the MCLof 10 ppb but above 5 ppb is confusing and difficult for the general public to understand. While EPA provides arsen ic education language in the Revised State Implementation Guidance for Consumer Confidence Report (CCR) Rule (EPA 816

- R
- 09
- 010), EPA allows water s ys tems the flexibility

to tailor their information to specific local situations. Sy stems that want to use language significantl y different than that provided by EPA must develop comparable language in consultation with the state. **3. Complexity of the rule.**  Overall, commenters did not find the Arsenic Rule overly complex. Comments regarding the complexity

of the rule were focused on the determination of compliance with the rule. After considering the comments EPA believes that there are adequate guidance do cuments available on the EPA website to help sy stems and states understand the correct implementation of the rule. In addition to providing guidance documents, EPA also conducts periodic training courses to help6

the regulated community understand the requi rements of the Arsenic Rule. More information on past training courses can be found at: http://www.epa.gov/safewater/arsenic/compliance.html
. **4. Extent to which the rule overlaps, duplicates,**  **or conflicts with other federal, state, or local government rules.**  Some commenters expressed concerns about the burden that results from complying with the rule as it relates to the appropriate disposal of wastes generated after the treatment of water sources with elevated levels of arsenic. The main concern is that some sy stems might have to comply with other environmental statues as a result of the generation of wastes from the treatment of water to remove arsenic. EPA has developed guidance documents to help the regulated communit y comply with the rule while reducing th e amount of waste generated. Given the targeted nature of the rule towards drinking water, and the guidance provided for compl yi ng with other rules, EPA does not believe that the Arsenic Rule overlaps, duplicates or conflicts with other rules. Two comme nters noted that since Arsenic is an organic chemical, the rule can be interpreted as overlapping with the Phase II/V Rules. The Phase II/V Rules were promulgated by the EPA in 1991 and 1992 and did not include arsenic, while the original Arsenic Rule was promulgated b y EPA in 1975. EPA does not believe that the Arsenic Rule overlaps, duplicates or conflicts with the Phase II/V Rules. **5. The degree to which technology, economic conditions, or other factors have changed in**  **the area affected by the rule.** Co mmenters noted that there are new treatment technologies for arsenic and that EPA’s arsenic removal demonstration studies provided valuable information regarding technologies that are effective in removing arsenic. However, the economic condition of many small communities has worsened in recent ye ars. Most commenters expressed concern over the increasing difficulty for many s ys tems to devote sufficient resources to ensure compliance. The concern over the cost of adding arsenic treatment was addressed und er section (2): Nature of complaints of comments received concerning the rule. Many commenters also expressed concern that EPA will further lower the MCLfor arsenic. This concern may

stem from the draft IRIS Toxicological Review for Inorganic Arsenic which provides new estimated cancer risks from arsenic exposure that are five to ten fold greater than EPA’s estimates when the MCLwas promulgated in 2001. The new risk assessment is still ongoing. The draft IRI S inorganic arsenic risk assessment was released to the Science Advisory Board (SAB) and simultaneously to the public for review and comment in February

2010. EPA received the final SAB report on March 1, 2011. The SAB approved of EPA’s scientific basis to estimate cancer risk and made a numb er of recommendations to improve clarity and transparency

of the 2010 draft assessment. EPA will consider SAB’s recommendations to refine the IR IS inorganic arsenic risk assessment before the final assessment will be posted to the IRI S database. Up
- to - date information regarding the arsenic risk assessment can be found at:7

http://cfpub.epa.gov/ncea/cfm/recordisplay .cfm?deid=219111 While the final revised arsenic risk assessment will provide critical information for EPA’s review of the existing MCL , it is only one of the key

elements considered by

the Agency

in determining if it is appropriate to revise the standard. In reviewing NPDWRs, EPA evaluates five key elements as appropriate: anal yt ical and treatment feasibility , implementation related issues, occurrence and exposure, economic impact and health effects. EPA will continue to periodically review the effectiveness of the Arsenic Rule through the framework provided b y the SDW A. SDWA requires that EPA review all of its drinking water regulations every

six y ears and revise them if appropriate. The purpose of the review is to identify current health effects assessments, changes in technology , and other factors that could support a regulatory

revision that will maintain or strengthen public health protection. EPA completed its first Six Year Review in 2003 and its second Six Year Review in 2010. The conclusion of the second Six Year Review was that the Agency did not believe a revision to the NPDWR for arsenic was appropriate because the reassessment of the he alth risks resulting from exposure to arsenic is ongoing. Once the final inorganic arsenic risk assessment is issued, EPA will have to decide if the Agency will undertake a review to the arsenic standard at that time or if the Agency

wants to defer to the next drinking water rule review due in 2016. **Conclusion** After reviewing all the comments regarding this Regulatory Flexibility Act Section 610 review, the Agency

has concluded that revisions or amendments to minimize economic impacts on small entities from the Arsenic Rule are not warranted at this time. EPA has taken a number of actions related to the Arsenic Rule and its implementation including:  Providing small sy stems additional time to comply through a provision for exemptions.  Requesting reviews by NAS, NDWAC and SAB in 2001.  Conducting 49 arsenic treatment demonstration projects in 26 states.  Providing $7.6 billion in DWSRF low

- interest loans between 1997 and 2010 small public water s ys tem assistance.  Working with USDA

- RUS to assist smal l sy stems in achieving compliance with the Arsenic Rule.  Providing training, guidance and other materials to support implementation of the Arsenic Rule. EPA will continue to evaluate the effectiveness of the Arsenic Rule and the potential to decrease the rule’s implementation burden within the Six Year Review framework provided by the SDWA and through other Agency initiatives.