Announcement of Final Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List, 13-19 [2015-32760]

Download as PDF Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels. List of Subjects in 33 CFR Part 165 broadcast notices to mariners of the enforcement periods for the safety zone as well as any changes in the schedule. Dated: December 15, 2015. R.S. Ogrydziak, Captain, U.S. Coast Guard, Captain of the Port, Port Arthur, Texas. Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: [FR Doc. 2015–33072 Filed 12–31–15; 8:45 am] PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS [EPA–HQ–OW–2012–0155; FRL–9940–64– OW] 1. The authority citation for part 165 continues to read as follows: Announcement of Final Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List BILLING CODE 9110–04–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 141 ■ Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1. 2. Add § 165.T08–1086 to read as follows: ■ tkelley on DSK3SPTVN1PROD with RULES § 165.T08–1086 Safety Zone; Intracoastal Waterway; Lake Charles, LA. (a) Location. The following area is a safety zone: all waters of the Intracoastal Waterway (ICW) extending 100-yards east and west of ICW Mile Marker 244.5 located at position 30°03′38″ N. 093°22′19″ W., Lake Charles, Louisiana. The coordinates are based on (NAD 83). (b) Effective periods. This rule is effective from 7 a.m. on January 4, 2016 through 6 p.m. on January 14, 2016. This rule will be enforced when personnel and equipment are on scene and conducting working on electrical lines. (c) Regulations. (1) Under the general safety zone regulations in § 165.23 of this part, entry into this zone is prohibited to all vessels except those vessels specifically authorized by the Captain of the Port, Port Arthur or a designated representative. (2) Persons or vessels requiring entry into or passage through must request permission from the Captain of the Port, Port Arthur, or a designated representative. They may be contacted on VHF Channel 13 or 16, or by telephone at (337) 912–0073. (3) All persons and vessels shall comply with the lawful orders or directions given to them by the Captain of the Port, Port Arthur or the Captain of the Port’s designated representative. On-scene U.S. Coast Guard patrol personnel include commissioned, warrant, and petty officers of the U.S. Coast Guard. (d) Information broadcasts. The Coast Guard will inform the public through VerDate Sep<11>2014 16:36 Dec 31, 2015 Jkt 238001 Environmental Protection Agency (EPA). ACTION: Final regulatory determinations. AGENCY: The U.S. Environmental Protection Agency (EPA) is announcing final regulatory determinations not to issue national primary drinking water regulations for four of the 116 contaminants listed on the Third Contaminant Candidate List. The Safe Drinking Water Act, as amended in 1996, requires the EPA to make regulatory determinations every five years on at least five unregulated contaminants. A regulatory determination is a decision about whether or not to begin the process to propose and promulgate a national primary drinking water regulation for an unregulated contaminant. On October 20, 2014, the agency published its preliminary determinations not to regulate dimethoate, 1,3-dinitrobenzene, terbufos, terbufos sulfone and begin the process to regulate strontium. The agency requested public comment on the determinations, process, rationale and supporting technical information. The agency received comments from 14 individuals or organizations on the preliminary regulatory determinations. After careful review and consideration of the public comments, the agency is making a final determination not to regulate dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. The agency, however, is delaying the final regulatory determination on strontium in order to consider additional data and decide whether there is a meaningful opportunity for health risk reduction by regulating strontium in drinking water. DATES: In accordance with 40 CFR 23.7 for purposes of judicial review, the SUMMARY: PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 13 regulatory determinations in this document are issued as of January 4, 2016. FOR FURTHER INFORMATION CONTACT: Zeno Bain, Standards and Risk Management Division, Office of Ground Water and Drinking Water, Office of Water (Mailcode 4607M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564–5970; email address: bain.zeno@ epa.gov. For general information, contact the Safe Drinking Water Hotline, telephone number: (800) 426–4791. The Safe Drinking Water Hotline is open Monday through Friday, excluding legal holidays, from 10 a.m. to 4 p.m., eastern time. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? These final regulatory determinations will not impose any requirements on anyone. Instead, this action notifies interested parties of the EPA’s final regulatory determinations for four contaminants and provides a summary of the major comments received on the October 20, 2014, preliminary determinations (USEPA, 2014c). B. How can I get copies of this document and other related information? Docket: The EPA has established a docket for this action under Docket ID No. EPA–HQ–OW–2012–0155. Publicly available docket materials are available either electronically at https:// www.regulations.gov or in hard copy at the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Water Docket Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the Water Docket is (202) 566–2426. Electronic Access: You may access this Federal Register document electronically from the Government Printing Office under the ‘‘Federal Register’’ listings at https:// www.gpo.gov/fdsys/browse/ collection.action?collectionCode=FR. Abbreviations Used in This Document CCL Contaminant Candidate List CCL 3 Third Contaminant Candidate List CFR Code of Federal Regulations EPA Environmental Protection Agency FR Federal Register HRL Health Reference Level MCL Maximum Contaminant Level MCLG Maximum Contaminant Level Goal MRL Minimum Reporting Limit E:\FR\FM\04JAR1.SGM 04JAR1 14 Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations NPDWR National Primary Drinking Water Regulation PWS Public Water System RD Regulatory Determination RD 3 Third Regulatory Determination RSC Relative Source Contribution SDWA Safe Drinking Water Act STORET Storage and Retrieval Data System UCMR Unregulated Contaminant Monitoring Regulation UCMR 1 First Unregulated Contaminant Monitoring Regulation UCMR 2 Second Unregulated Contaminant Monitoring Regulation UCMR 3 Third Unregulated Contaminant Monitoring Regulation USDA United States Department of Agriculture USGS United States Geological Survey mg/L micrograms per Liter Table of Contents I. General Information A. Does this action apply to me? B. How can I get copies of this document and other related information? II. Purpose and Background A. What is the purpose of this action? B. What are the statutory requirements for the Contaminant Candidate List (CCL) and regulatory determinations? C. What contaminants did the EPA consider for regulations? III. What process did the EPA use to make the regulatory determinations? IV. Summary of the EPA’s Findings on the Four Contaminants With Final Regulatory Determinations A. Dimethoate 1. Description 2. Agency Findings B. 1,3-Dinitrobenzene 1. Description 2. Agency Findings C. Terbufos and Terbufos Sulfone 1. Description 2. Agency Findings D. Public Comments on Four Contaminants With Final Regulatory Determinations V. Summary of Public Comments on Strontium and the Agency’s Responses A. Background on Strontium and the EPA’s Preliminary Determination B. What comments did the EPA receive on strontium? VI. Next Steps VII. References tkelley on DSK3SPTVN1PROD with RULES II. Purpose and Background A. What is the purpose of this action? The purpose of this action is to present a summary of the EPA’s findings related to the final regulatory determinations for four contaminants listed on the Third Contaminant Candidate List (CCL 3) (USEPA, 2009). The four contaminants include: Dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. Today’s action briefly summarizes the statutory requirements for targeting drinking water contaminants for regulatory determination, provides an overview of the contaminants the agency considered VerDate Sep<11>2014 16:36 Dec 31, 2015 Jkt 238001 for regulation and describes the approach used to make the final regulatory determinations. In addition, today’s action summarizes the public comments received on the agency’s preliminary determinations and the agency’s responses to those comments, including the status of the EPA’s evaluation of strontium. B. What are the statutory requirements for the Contaminant Candidate List (CCL) and regulatory determinations? The specific statutory requirements for the CCL and regulatory determinations can be found in the Safe Drinking Water Act (SDWA), section 1412(b)(1). The 1996 SDWA Amendments require the EPA to publish the CCL every five years. The CCL is a list of contaminants that are not subject to any proposed or promulgated national primary drinking water regulations (NPDWRs), are known or anticipated to occur in public water systems (PWSs) and may require regulation under SDWA. The 1996 SDWA Amendments also direct the agency to determine whether to regulate at least five contaminants from the CCL every five years. SDWA requires the agency to publish a Maximum Contaminant Level Goal (MCLG) 1 and promulgate an NPDWR 2 for a contaminant if the Administrator determines that: (a) The contaminant may have an adverse effect on the health of persons; (b) The contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern; and (c) In the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems. If the agency determines that all three of these statutory criteria are met, it makes a determination that a national primary drinking water regulation is needed. In that case, the agency has 24 months to publish a proposed MCLG and NPDWR. After the proposal, the agency has 18 months to publish a final 1 The MCLG is the ‘‘maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur, and which allows an adequate margin of safety. Maximum contaminant level goals are nonenforceable health goals’’ (40 CFR 141.2). 2 An NPDWR is a legally enforceable standard that applies to public water systems. An NPDWR sets a legal limit (called a maximum contaminant level or MCL) or specifies a certain treatment technique for public water systems for a specific contaminant or group of contaminants. PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 MCLG and promulgate a final NPDWR (SDWA section 1412(b)(1)(E)).3 C. What contaminants did the EPA consider for regulation? On October 20, 2014, the EPA published preliminary regulatory determinations for five contaminants on the third Contaminant Candidate List (CCL 3) that had sufficient information to support a regulatory determination (USEPA, 2014c). The five contaminants are 1,3-dinitrobenzene, dimethoate, terbufos, terbufos sulfone and strontium. The agency is making final regulatory determinations not to regulate dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. The agency is not making a final regulatory determination for strontium at this time. The agency’s decision to delay a final determination for strontium is based on public comments received and the plan to further evaluate scientific information that became available after publication of the preliminary regulatory determinations. The agency is currently conducting additional scientific analyses to determine if there is a need to develop a national drinking water regulation for strontium. For more information about the comments the agency received on strontium and the analyses that are underway, see section V.A of this notice. Information on the five contaminants can be found in the Regulatory Determinations 3 Support Document (USEPA, 2014b). More information is available at the Water Docket (Docket ID No. EPA–HQ–OW–2012–0155) and also on EPA’s Regulatory Determination 3 Web site at https://www2.epa.gov/ccl/ regulatory-determination-3. III. What process did the EPA use to make the regulatory determinations? This section gives a summary of the regulatory determination process the agency followed to identify and evaluate contaminants for the Third Regulatory Determination. For more detailed information on the process and the analyses performed, please refer to the ‘‘Protocol for the Regulatory Determination 3’’ document (USEPA, 2014a) and the Federal Register notice for the Preliminary Regulatory Determinations for Contaminants on CCL 3 (USEPA, 2014c). The CCL 3 identified 116 contaminants that are currently not subject to any proposed or promulgated national drinking water regulation, are known or anticipated to occur in public water systems, and may require 3 The statute authorizes up to a nine-month extension of this promulgation date. E:\FR\FM\04JAR1.SGM 04JAR1 Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations contaminants 4) to further evaluate in the second phase. During the second phase, the agency further evaluates each contaminant on the short list to identify those that have sufficient data (or are expected to have sufficient data within the timeframe allotted for the second phase) for the EPA to assess the three statutory criteria. As part of the second phase, the agency specifically focuses its efforts on identifying those contaminants or contaminant groups that are occurring or have substantial likelihood to occur at levels and frequencies of public health concern, based on the best The purpose of the first phase, the Data Availability Phase, is to determine if the agency ‘‘may have’’ sufficient data to characterize the potential health effects and known or likely occurrence in drinking water. Although contaminants must have sufficient data to evaluate the statutory criteria in Phase 3, the agency does not want to rule out any contaminants too early in the process; therefore, if sufficient health and occurrence data are likely available, the contaminants are considered in the Data Evaluation Phase, the second phase of the regulatory determination process. From the 116 CCL 3 contaminants, the agency identified 37 contaminants (35 CCL 3 contaminants and two non-CCL 3 VerDate Sep<11>2014 16:36 Dec 31, 2015 Jkt 238001 4 The non-CCL 3 contaminants, N-Nitroso-di-nbutylamine (NDBA) and NNitrosomethylethylamine (NMEA), were included because they are part of a larger group (nitrosamines) that also includes a number of CCL 3 contaminants. PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 (1) the Data Availability Phase, (2) the Data Evaluation Phase and (3) the Regulatory Determination Assessment Phase. The overall process is displayed in Exhibit 1. BILLING CODE 6560–50–P available peer reviewed data. If the agency finds that sufficient data are not available or not likely to be available to evaluate the three statutory criteria during the first and second phases, then the contaminant is not considered a candidate for making a regulatory determination. If sufficient data are available for a contaminant to characterize the potential health effects and known or likely occurrence in drinking water, the contaminant is evaluated against the three statutory criteria in the Regulatory Determination Assessment Phase, which is the third phase of the process. Of the 37 contaminants that were evaluated under Phase 2, 12 were designated for further evaluation in Phase 3. E:\FR\FM\04JAR1.SGM 04JAR1 ER04JA16.000</GPH> contaminants are candidates for regulatory determinations. Priority was given to identifying contaminants known to occur or with substantial likelihood to occur at frequencies and levels of public health concern. The three phases of the Third Regulatory Determination process are BILLING CODE 6560–50–C tkelley on DSK3SPTVN1PROD with RULES regulation under SDWA (USEPA, 2009). Since some of the CCL 3 contaminants do not have adequate health and/or occurrence data to evaluate against the three statutory criteria (see section II.B of this notice), the agency used a threephase process to identify which of the 15 16 Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations Of the 12 contaminants that were evaluated in Phase 3, the agency did not make preliminary regulatory determinations for seven contaminants. The seven contaminants include chlorate and six nitrosamines. Chlorate and the six nitrosamines are disinfection byproducts, and the agency is further evaluating these contaminants as part of the regulatory review of existing Microbial and Disinfection Byproduct regulations, as announced in the Preliminary Regulatory Determination 3 Federal Register notice published on October 20, 2014 (USEPA, 2014c). After evaluating the five remaining CCL 3 contaminants (dimethoate, 1,3dinitrobenzene, terbufos, terbufos sulfone and strontium) against the three statutory criteria and considering other relevant information (such as level and frequency of occurrence, population exposed and information on sensitive populations and lifestages), the agency made preliminary regulatory determinations to regulate strontium and to not regulate the remaining four contaminants. These preliminary determinations, with their supporting analyses and documentation, were published in the Federal Register on October 20, 2014, for public comment (USEPA, 2014c). The EPA received comments from 14 organizations and individuals on the October 20, 2014, Federal Register notice. These 14 organizations and individuals include four environmental organizations, six industry groups, one state association and three anonymous individuals. The agency prepared a Response to Comments document for this action that is available in the Public Docket at www.regulations.gov under Docket ID No. EPA–HQ–OW–2012– 0155. Comments on specific contaminants, and the EPA’s responses, are briefly summarized in the sections below. IV. Summary of the EPA’s Findings on the Four Contaminants With Final Regulatory Determinations After considering the public comments, the EPA is making final regulatory determinations not to regulate dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. This notice provides a brief description of the agency findings on these contaminants. Details on the background, health and occurrence information and analyses used to evaluate and make final determinations for these contaminants can be found in the Regulatory Determinations 3 Support Document (USEPA, 2015b) and the Federal Register notice for the Preliminary Regulatory Determination 3 (USEPA, 2014c). For each contaminant, the agency evaluated the available human and toxicological data, derived a health reference level (HRL),5 evaluated the potential and/or likely occurrence and examined the likely exposed population for the contaminant in public water systems. The agency also considered whether information was available on sensitive populations. The agency used the findings from these evaluations to determine whether the three SDWA statutory criteria are satisfied. Table 1 gives a summary of the health and occurrence information for the four contaminants with final determinations under RD 3. TABLE 1—SUMMARY OF THE HEALTH AND OCCURRENCE INFORMATION AND THE FINAL DETERMINATIONS FOR FOUR OF THE CONTAMINANTS CONSIDERED FOR RD 3 RD 3 contaminants Health reference level (HRL) (μg/L) Occurrence findings from primary data sources PWSs with at least 1 detection ≥1⁄2 HRL Population served by PWSs with at least 1 detection ≥1⁄2 HRL PWSs with at least 1 detection ≥HRL Population served by PWSs with at least 1 detection ≥HRL Final determination 15.4 0.7 UCMR 2 ... UCMR 2 ... 0% (0 of 4140) .......... 0% (0 of 4139) .......... 0% (0 of 229M) .............. 0% (0 of 229M) .............. 0% (0 of 4140) .......... 0% (0 of 4139) .......... 0% (0 of 229M) .............. 0% (0 of 229M) .............. Do not regulate. Do not regulate. 0.35 0.35 Dimethoate .... 1,3Dinitrobenzene. Terbufos ........ Terbufos sulfone. Primary database UCMR 1 ... UCMR 2 ... 0% (0 of 295) ............ 0.02% (1 of 4140) ..... 0% (0 of 41M) ................ 0.01% (44.6K of 229M) .. 0% (0 of 295) ............ 0.02% (1 of 4140) ..... 0% (0 of 41M). ............... 0.01% (44.6K of 229M) .. Do not regulate Do not regulate. A. Dimethoate 1. Description Dimethoate is an organophosphate pesticide, commonly used as an insecticide on field crops (e.g., wheat, alfalfa, corn and cotton), orchard crops, vegetable crops and in forestry. Synonyms for dimethoate include dimethogen, dimeton, dimevur and cygon (HSDB, 2010; USEPA, 2007). Dimethoate is considered highly mobile and relatively non-persistent in the environment (USEPA, 2007). tkelley on DSK3SPTVN1PROD with RULES 2. Agency Findings The agency is making a determination not to regulate dimethoate with an NPDWR. It does not occur at levels and 5 HRLs are risk derived concentrations against which to evaluate the occurrence data to determine if contaminants may occur at levels of public health VerDate Sep<11>2014 16:36 Dec 31, 2015 Jkt 238001 frequencies of public health concern. As a result, the agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction. The primary data for dimethoate are the 2008–2010 nationally representative drinking water monitoring data, generated through the EPA’s Second Unregulated Contaminant Monitoring Regulation (UCMR 2). Dimethoate was not detected in any of the 32,150 UCMR 2 samples collected by 4,140 PWSs (serving ∼230 million people) at levels greater than the 1⁄2 HRL (7.7 mg/L), the HRL (15.4 mg/L), or the minimum reporting level (MRL) (0.7 mg/L) (USEPA, 2015c). Based on the results of the UCMR 2 samples, the estimated population exposed to dimethoate at levels of public health concern is 0%. Other supplementary sources of finished water data from the State of California, the U.S. Department of Agriculture (USDA) and the U.S. Geologic Survey (USGS) indicate that the occurrence of dimethoate in PWSs is likely to be low to non-existent. Dimethoate occurrence data for ambient water from the USGS and the Storage and Retrieval (STORET) Data System are consistent with those for finished water. These data sources are discussed in the October 2014 Federal Register notice of the Preliminary Regulatory Determination 3 (USEPA, 2014c). concern. They are not the level of a contaminant in drinking water that must not be exceeded to protect any particular population (i.e., an HRL is not an MCL). PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\04JAR1.SGM 04JAR1 Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations B. 1,3-Dinitrobenzene 1. Description 1,3-Dinitrobenzene is a nitro aromatic compound that is used as an industrial chemical and formed as a by-product in the manufacture of munitions, as well as in the production of other substances (HSDB, 2009). There are no known natural sources of 1,3-dinitrobenzene. 1,3-Dinitrobenzene appears to be moderately persistent in environmental media and moderately mobile in soil and water, although in soils with high clay content it will be less mobile (USEPA, 2015b). 2. Agency Findings The agency is making a determination not to regulate 1,3-dinitrobenzene with an NPDWR. It does not occur at levels and frequencies of public health concern. As a result, the agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction. The primary data for 1,3dinitrobenzene are the 2008–2010 nationally representative drinking water monitoring data generated through the EPA’s UCMR 2 (USEPA, 2015c). UCMR 2 is the only dataset with finished water data for this contaminant. UCMR 2 collected 32,152 samples from 4,139 PWSs for 1,3-dinitrobenzene and it was not detected above the MRL (0.8 mg/L), which is only slightly higher than the HRL (0.7 mg/L). Based on the results of the UCMR 2 samples, the estimated population exposed to 1,3dinitrobenzene at or above the MRL is 0%. Findings from the available ambient water data for 1,3-dinitrobenzene are consistent with the results in finished water. Ambient water data in STORET included no measured results above 0.33 mg/L in 143 samples from 70 sites (USEPA, 2012). It should be noted that some occurrence above the HRL may have gone undetected since reporting levels are not documented. These data sources are discussed in the October 2014 Federal Register notice of the Preliminary Regulatory Determination 3 (USEPA, 2014c). C. Terbufos and Terbufos Sulfone tkelley on DSK3SPTVN1PROD with RULES 1. Description Terbufos is a phosphorodithioate pesticide (i.e., an organophosphate) used as an insecticide-nematicide to control a variety of insect pests, primarily used on corn and sugar beets (USEPA, 2006). Terbufos sulfone is a degradate of terbufos. Total toxic residues of terbufos and degradates are highly mobile and persistent in the VerDate Sep<11>2014 16:36 Dec 31, 2015 Jkt 238001 environment, with terbufos sulfone being more mobile and substantially more persistent than terbufos (USEPA, 2006). 2. Agency Findings The agency is making determinations not to regulate terbufos and terbufos sulfone with NPDWRs. They do not occur at levels and frequencies of public health concern. As a result, the agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction. The primary data for terbufos are from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) screening survey (2001–2003) (USEPA, 2008). The UCMR 1 screening survey collected 2,301 finished water samples from 295 PWSs for terbufos and it was not detected at levels at or above the MRL (0.5 mg/L), which is slightly higher than the HRL (0.35 mg/L) (USEPA, 2008). Based on the results of the UCMR 1 screening survey, the estimated population exposed to terbufos at or above the MRL is 0%. The primary data for terbufos sulfone are nationally representative finished water monitoring data generated through the EPA’s UCMR 2 (2008–2010) (USEPA, 2015c). UCMR 2 collected 32,149 finished water samples from 4,140 PWSs (serving ∼230 million people) for terbufos sulfone and it was detected in only one sample, at a concentration of 0.42 mg/L. The MRL is 0.4 mg/L, which is slightly higher than the HRL (0.35 mg/L) (USEPA, 2015c). Based on the results of the UCMR 2 samples, the estimated population exposed to terbufos sulfone at a level of public health concern (based on the HRL for terbufos) is 44,600 (0.02% of the population served by PWSs). Finished water data for terbufos and terbufos sulfone from California, Iowa, USDA and USGS are consistent with the UCMR 1 and UCMR 2 data. Terbufos and (very limited) terbufos sulfone occurrence data for ambient water from the EPA, STORET and several USGS programs or studies are also consistent with those for finished water. These data sources are discussed in the October 2014 Federal Register notice of the Preliminary Regulatory Determination 3 (USEPA, 2014c). D. Public Comments on Four Contaminants With Final Regulatory Determinations The agency received comments in support of the agency’s preliminary determinations not to regulate dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. The agency did PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 17 not receive any comments to the contrary. Agency Response: EPA agrees with the comments and, as previously explained, is making final determinations not to regulate dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. V. Summary of Public Comments on Strontium and the Agency’s Responses A. Background on Strontium and the EPA’s Preliminary Determination Strontium is a naturally occurring element (atomic number 38) and a member of the alkaline earth metals (ANL, 2007). There are several radioactive strontium isotopes formed by nuclear fission of uranium or plutonium. Since drinking water contamination by radioactive isotopes, including beta particle emitters, is covered under the existing Radionuclides Rule, this section describes the stable 88Sr isotope. In October 2014, the agency made a preliminary determination to regulate strontium with an NPDWR after evaluating the available health, occurrence and other related information against the three SDWA statutory criteria. Specifically, EPA made a preliminary determination that (a) strontium may have an adverse effect on the health of persons, (b) it is known to occur or there is substantial likelihood that strontium will occur in public water systems with a frequency and at levels of public health concern and (c) regulation of strontium with an NPDWR presents a meaningful opportunity to reduce health risks for persons served by PWSs. EPA describes the underlying science in support of these criteria in the Federal Register notice of the Preliminary Regulatory Determination 3 (USEPA, 2014c). In the Federal Register notice of the Preliminary Regulatory Determination 3, EPA calculated a non-cancer HRL of 1500 mg/L for strontium using the reference dose of 0.3 mg/kg/day, a default Relative Source Contribution (RSC) of 20% and age-specific exposure factors (i.e., drinking water intake expressed as liters per kg of body weight) for the sensitive population of birth through 18 years to reflect the most active period of bone growth and development. The RSC is the level of exposure believed to result from drinking water when compared to other sources (e.g., food, ambient air). In the Preliminary Regulatory Determination 3 EPA used the default 20% RSC to calculate the HRL. For more detailed information see the October 20, 2014, Federal Register notice of the E:\FR\FM\04JAR1.SGM 04JAR1 18 Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations Preliminary Regulatory Determination 3 (USEPA, 2014c). After consideration of public comments on the preliminary regulatory determination for strontium (see Section V.B.), the agency is delaying the final determination for strontium in order to consider additional scientific data and decide whether there is a meaningful opportunity for health risk reduction by regulating strontium in drinking water. tkelley on DSK3SPTVN1PROD with RULES B. What comments did the EPA receive on strontium? Some commenters supported the preliminary determination to regulate strontium. These commenters supported a regulation due to the adverse effect on bone growth and/or the potential for elevated levels of strontium in the environment as a result of spills and disposal of waste products related to gas production. Many comments called upon the agency to delay the final determination, collect more data and perform additional analyses before making a final determination for strontium. Specifically, the comments were focused on the following areas: The relationship between occurrence and health risk, the RSC of strontium, the costs and benefits of a potential strontium regulation and the feasibility of treating strontium. Three commenters questioned whether enough water systems show strontium at levels and frequency of concern that a meaningful reduction in health risk can be achieved through a national regulation. Two of these commenters suggested conducting an epidemiology study that evaluates whether adverse human health effects are occurring and at what drinking water concentrations (and frequency of occurrence) to determine whether there is a meaningful opportunity for health risk reduction of a regulation. Two commenters indicated the agency should quantify the RSC or provide stronger justification for using an RSC of 20%. One commenter stated the RSC has a significant impact on the reference dose. One commenter stated that defaults of 20% and 80% have utility in relatively simple circumstances where it is accepted that the drinking water component is either very small or large. The commenter indicated that it is essential to analyze and quantify the RSC when it is intermediate and there are data to perform a meaningful estimate. The commenter asserted that it is essential because the impact on the MCLG and ultimately the MCL and compliance costs can become significant. VerDate Sep<11>2014 16:36 Dec 31, 2015 Jkt 238001 Several commenters indicated concerns with the costs and benefits of a potential strontium regulation. One commenter urged the agency to update the current affordability standard under SDWA before promulgating any new NPDWRs in order to allow rural and small communities to utilize the most economical and safe treatment options. One commenter stated that the agency failed to estimate the social benefits and social costs in its analysis for the strontium determination, specifically the additional energy usage and its externalities. Several commenters compared the cost of a potential strontium regulation to that of the arsenic regulation, based on the percentage and type of systems with strontium occurrence at levels of concern. Several commenters supported the agency’s commitment to conducting more extensive treatment research prior to promulgating a regulation for strontium. Two commenters indicated that the treatment technology to remove strontium may remove beneficial alkaline earth metals, such as calcium, that partially counter the uptake of strontium. Agency Response: The agency is delaying the final determination for strontium in order to consider additional scientific data and decide whether there is a meaningful opportunity for health risk reduction by regulating strontium in drinking water. Strontium is known to occur in food, ambient air and soil. While data on levels in those media and estimates of intake from those sources were limited when EPA made the preliminary determination to regulate strontium, the EPA is evaluating recent additions to the exposure database to determine if the agency can develop a data-derived RSC rather than using a default 20% RSC in the calculation of the HRL. In the absence of this type of relevant exposure information, the agency supports the use of the default RSC and may ultimately use the default 20% RSC in the final regulatory determination for strontium and for other compounds in the future. The agency selects the default RSCs for regulatory determinations based on the Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (USEPA, 2000). If the agency makes a final determination to regulate strontium, the EPA will conduct tests on treatment technologies for strontium prior to developing a regulation. The agency understands that strontium may cooccur with beneficial calcium in some drinking water systems and treatment PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 technologies that remove strontium may also remove calcium. The agency is evaluating the effectiveness of treatment technologies under different water conditions, including calcium concentrations. The agency will continue to work with stakeholders in evaluating treatment technologies for strontium. At this time, the agency does not plan to initiate any longer term health effect studies, including human epidemiological studies on the relationship of skeletal effects and strontium exposure levels through consumption of drinking water and foods. The agency will continue to evaluate new health studies related to strontium exposure, including any epidemiology studies. It should be noted that while the agency is not precluded from conducting epidemiological studies, the agency is not required to do so to support the decision to regulate a contaminant. An evaluation of the costs and benefits of a potential strontium regulation is outside the scope of the regulatory determination process. If the agency decides to regulate strontium, as part of the regulation development process, the agency will conduct a health risk reduction and cost analysis, including an evaluation of the costs and benefits of regulating strontium. VI. Next Steps Prior to making a final regulatory determination for strontium, the agency will consider additional data gathered and analyses completed after publication of the preliminary determination (for further information, see discussion in section V.B. of this notice). The agency published the Draft Contaminant Candidate List 4 (CCL 4) on February 4, 2015 (USEPA, 2015a) and will issue a Final CCL 4 after consideration of public comments received. The agency will evaluate and consider contaminants on the Final CCL 4 for the Fourth Regulatory Determination. VII. References Argonne National Laboratory (ANL). 2007. Radiological and Chemical Fact Sheets to Support Health Risk Analyses for Contaminated Areas. Environmental Science Division. Available on the Internet at: https:// www.gfxtechnology.com/ ArgonneRadFacts.pdf. HSDB. 2010. Available on the Internet at: https://toxnet.nlm.nih.gov/cgi-bin/sis/ htmlgen?HSDB. Accessed September 2010. USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the E:\FR\FM\04JAR1.SGM 04JAR1 Federal Register / Vol. 81, No. 1 / Monday, January 4, 2016 / Rules and Regulations Protection of Human Health (2000). EPA 822–B–00–004. USEPA. 2006. Reregistration Eligibility Decision for Terbufos. Office of Pesticide Programs. Available on the Internet at: https://archive.epa.gov/pesticides/ reregistration/web/pdf/terbufos_red.pdf. Accessed Oct 2015. USEPA. 2007. Revised Interim Reregistration Decision for Dimethoate. Available on the Internet at: https://archive.epa.gov/ pesticides/reregistration/web/pdf/ dimethoate_ired_revised.pdf. Accessed October 2015. USEPA. 2008. The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List. EPA 815–R–08–012. June 2008. USEPA. 2009. Drinking Water Contaminant Candidate List 3—Final. Federal Register. Vol. 74, No. 194, p. 51850. October 8, 2009. USEPA. 2012. Storage and Retrieval (STORET) Data Warehouse. Available on the Internet at: https://www.epa.gov/ storet/. Data Warehouse. Accessed March 2012. USEPA. 2014a. Protocol for the Regulatory Determinations 3. Including Appendices A–F. EPA 815–R14–005. April 2014. USEPA. 2014b. Regulatory Determinations 3 Support Document. EPA 815–R14–003. April 2014. USEPA. 2014c. Announcement of the Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List; Proposed Rule. Federal Register. Vol. 79, No. 202, p. 62716. October 20, 2014. USEPA. 2015a. Drinking Water Contaminant Candidate List 4—Draft. Federal Register. Vol. 80, No. 23, p. 6076. February 4, 2015. USEPA. 2015b. Regulatory Determinations 3 Support Document (Final). EPA 815– R15–014. December 2015. USEPA. 2015c. Occurrence Data from the Second Unregulated Contaminant Monitoring Regulation (UCMR 2). EPA 815–R15–013. December 2015. Dated: December 22, 2015. Gina McCarthy, Administrator. [FR Doc. 2015–32760 Filed 12–31–15; 8:45 am] tkelley on DSK3SPTVN1PROD with RULES BILLING CODE 6560–50–P VerDate Sep<11>2014 16:36 Dec 31, 2015 Jkt 238001 DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket Nos. 120328229–4949–02 and 150121066–5717–02] RIN 0648–XE346 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; annual adjustment of Atlantic bluefin tuna Purse Seine and Reserve category quotas; inseason quota transfer from the Reserve category to the Longline category. AGENCY: NMFS is adjusting the Atlantic bluefin tuna (BFT) Purse Seine and Reserve category quotas for 2016, based on regulations implementing Amendment 7 to the 2006 Consolidated Highly Migratory Species Fishery Management Plan. NMFS also is transferring inseason 34 metric tons (mt) of BFT quota from the Reserve category to the Longline category. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments. The transfer to the Longline category is applied to eligible Atlantic Tunas Longline category permitted vessels with Individual Bluefin Quota (IBQ) shares, and as a result of this transfer, current IBQ vessel accounts will be distributed 0.25 mt of IBQ allocation each. DATES: Effective January 1, 2016, through December 31, 2016. FOR FURTHER INFORMATION CONTACT: Sarah McLaughlin, Tom Warren, or Brad McHale, 978–281–9260. SUPPLEMENTARY INFORMATION: Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated SUMMARY: PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 19 HMS FMP) (71 FR 58058, October 2, 2006), as amended by Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014). NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota. Annual Adjustment of the BFT Purse Seine and Reserve Category Quotas In 2015, NMFS implemented a final rule that increased the U.S. BFT quota and subquotas per ICCAT Recommendation 14–05 (80 FR 52198, August 28, 2015). As a result, based on the currently codified U.S. quota of 1,058.79 mt (not including the 25 mt allocated by ICCAT to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area), the baseline Purse Seine, Longline, and Reserve category quotas are codified as 184.3 mt, 148.3 mt, and 24.8 mt, respectively. See § 635.27(a). Pursuant to § 635.27(a)(4), NMFS has determined the amount of quota available to individual Atlantic Tunas Purse Seine category participants in 2016, based on their BFT catch (landings and dead discards) in 2015. Specifically, NMFS is making available to each Purse Seine category participant 100 percent, 75 percent, 50 percent, or 25 percent of the individual baseline quota allocations based on 2015 catch, as described in § 635.27(a)(4)(ii), and is reallocating the remainder to the Reserve category for 2016. NMFS has calculated the amounts of quota available to individual Purse Seine fishery participants based on their individual catch levels in 2015 and the codified process adopted in Amendment 7. Total Purse Seine category BFT catches were 38.8 mt (33.9 mt of landings and 4.9 mt of dead discards) in 2015. Consistent with § 635.27(a)(4)(v)(C), NMFS will notify Atlantic Tunas Purse Seine fishery participants of the amount of quota available for their use this year through the Individual Bluefin Quota electronic system established under § 635.15 and in writing. Based on the procedures described above and by summing the individual available allocations, NMFS has determined the 2016 Purse Seine category quota available to Purse Seine fishery participants is 82.9 mt. Thus, the amount of Purse Seine category quota to be reallocated to the Reserve category is 101.4 mt. This reallocation would result in a 2016 Reserve category quota of 126.2 mt (24.8 mt + 101.4 mt). However, NMFS also is taking action, as described E:\FR\FM\04JAR1.SGM 04JAR1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Rules and Regulations]
[Pages 13-19]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32760]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 141

[EPA-HQ-OW-2012-0155; FRL-9940-64-OW]

Announcement of Final Regulatory Determinations for Contaminants
on the Third Drinking Water Contaminant Candidate List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final regulatory determinations.

-----------------------------------------------------------------------

SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing
final regulatory determinations not to issue national primary drinking
water regulations for four of the 116 contaminants listed on the Third
Contaminant Candidate List. The Safe Drinking Water Act, as amended in
1996, requires the EPA to make regulatory determinations every five
years on at least five unregulated contaminants. A regulatory
determination is a decision about whether or not to begin the process
to propose and promulgate a national primary drinking water regulation
for an unregulated contaminant. On October 20, 2014, the agency
published its preliminary determinations not to regulate dimethoate,
1,3-dinitrobenzene, terbufos, terbufos sulfone and begin the process to
regulate strontium. The agency requested public comment on the
determinations, process, rationale and supporting technical
information. The agency received comments from 14 individuals or
organizations on the preliminary regulatory determinations. After
careful review and consideration of the public comments, the agency is
making a final determination not to regulate dimethoate, 1,3-
dinitrobenzene, terbufos and terbufos sulfone. The agency, however, is
delaying the final regulatory determination on strontium in order to
consider additional data and decide whether there is a meaningful
opportunity for health risk reduction by regulating strontium in
drinking water.

DATES: In accordance with 40 CFR 23.7 for purposes of judicial review,
the regulatory determinations in this document are issued as of January
4, 2016.

FOR FURTHER INFORMATION CONTACT: Zeno Bain, Standards and Risk
Management Division, Office of Ground Water and Drinking Water, Office
of Water (Mailcode 4607M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202)
564-5970; email address: bain.zeno@epa.gov. For general information,
contact the Safe Drinking Water Hotline, telephone number: (800) 426-
4791. The Safe Drinking Water Hotline is open Monday through Friday,
excluding legal holidays, from 10 a.m. to 4 p.m., eastern time.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

These final regulatory determinations will not impose any
requirements on anyone. Instead, this action notifies interested
parties of the EPA's final regulatory determinations for four
contaminants and provides a summary of the major comments received on
the October 20, 2014, preliminary determinations (USEPA, 2014c).

B. How can I get copies of this document and other related information?

Docket: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OW-2012-0155. Publicly available docket materials
are available either electronically at https://www.regulations.gov or in
hard copy at the Water Docket, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The Water Docket Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the Water Docket
is (202) 566-2426.
Electronic Access: You may access this Federal Register document
electronically from the Government Printing Office under the ``Federal
Register'' listings at https://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR.

Abbreviations Used in This Document

CCL Contaminant Candidate List
CCL 3 Third Contaminant Candidate List
CFR Code of Federal Regulations
EPA Environmental Protection Agency
FR Federal Register
HRL Health Reference Level
MCL Maximum Contaminant Level
MCLG Maximum Contaminant Level Goal
MRL Minimum Reporting Limit

[[Page 14]]

NPDWR National Primary Drinking Water Regulation
PWS Public Water System
RD Regulatory Determination
RD 3 Third Regulatory Determination
RSC Relative Source Contribution
SDWA Safe Drinking Water Act
STORET Storage and Retrieval Data System
UCMR Unregulated Contaminant Monitoring Regulation
UCMR 1 First Unregulated Contaminant Monitoring Regulation
UCMR 2 Second Unregulated Contaminant Monitoring Regulation
UCMR 3 Third Unregulated Contaminant Monitoring Regulation
USDA United States Department of Agriculture
USGS United States Geological Survey
[mu]g/L micrograms per Liter

Table of Contents

I. General Information
A. Does this action apply to me?
B. How can I get copies of this document and other related
information?
II. Purpose and Background
A. What is the purpose of this action?
B. What are the statutory requirements for the Contaminant
Candidate List (CCL) and regulatory determinations?
C. What contaminants did the EPA consider for regulations?
III. What process did the EPA use to make the regulatory
determinations?
IV. Summary of the EPA's Findings on the Four Contaminants With
Final Regulatory Determinations
A. Dimethoate
1. Description
2. Agency Findings
B. 1,3-Dinitrobenzene
1. Description
2. Agency Findings
C. Terbufos and Terbufos Sulfone
1. Description
2. Agency Findings
D. Public Comments on Four Contaminants With Final Regulatory
Determinations
V. Summary of Public Comments on Strontium and the Agency's
Responses
A. Background on Strontium and the EPA's Preliminary
Determination
B. What comments did the EPA receive on strontium?
VI. Next Steps
VII. References

II. Purpose and Background

A. What is the purpose of this action?

The purpose of this action is to present a summary of the EPA's
findings related to the final regulatory determinations for four
contaminants listed on the Third Contaminant Candidate List (CCL 3)
(USEPA, 2009). The four contaminants include: Dimethoate, 1,3-
dinitrobenzene, terbufos and terbufos sulfone. Today's action briefly
summarizes the statutory requirements for targeting drinking water
contaminants for regulatory determination, provides an overview of the
contaminants the agency considered for regulation and describes the
approach used to make the final regulatory determinations. In addition,
today's action summarizes the public comments received on the agency's
preliminary determinations and the agency's responses to those
comments, including the status of the EPA's evaluation of strontium.

B. What are the statutory requirements for the Contaminant Candidate
List (CCL) and regulatory determinations?

The specific statutory requirements for the CCL and regulatory
determinations can be found in the Safe Drinking Water Act (SDWA),
section 1412(b)(1). The 1996 SDWA Amendments require the EPA to publish
the CCL every five years. The CCL is a list of contaminants that are
not subject to any proposed or promulgated national primary drinking
water regulations (NPDWRs), are known or anticipated to occur in public
water systems (PWSs) and may require regulation under SDWA. The 1996
SDWA Amendments also direct the agency to determine whether to regulate
at least five contaminants from the CCL every five years. SDWA requires
the agency to publish a Maximum Contaminant Level Goal (MCLG) \1\ and
promulgate an NPDWR \2\ for a contaminant if the Administrator
determines that:
---------------------------------------------------------------------------

\1\ The MCLG is the ``maximum level of a contaminant in drinking
water at which no known or anticipated adverse effect on the health
of persons would occur, and which allows an adequate margin of
safety. Maximum contaminant level goals are nonenforceable health
goals'' (40 CFR 141.2).
\2\ An NPDWR is a legally enforceable standard that applies to
public water systems. An NPDWR sets a legal limit (called a maximum
contaminant level or MCL) or specifies a certain treatment technique
for public water systems for a specific contaminant or group of
contaminants.
---------------------------------------------------------------------------

(a) The contaminant may have an adverse effect on the health of
persons;
(b) The contaminant is known to occur or there is a substantial
likelihood that the contaminant will occur in public water systems with
a frequency and at levels of public health concern; and
(c) In the sole judgment of the Administrator, regulation of such
contaminant presents a meaningful opportunity for health risk reduction
for persons served by public water systems.
If the agency determines that all three of these statutory criteria
are met, it makes a determination that a national primary drinking
water regulation is needed. In that case, the agency has 24 months to
publish a proposed MCLG and NPDWR. After the proposal, the agency has
18 months to publish a final MCLG and promulgate a final NPDWR (SDWA
section 1412(b)(1)(E)).\3\
---------------------------------------------------------------------------

\3\ The statute authorizes up to a nine-month extension of this
promulgation date.
---------------------------------------------------------------------------

C. What contaminants did the EPA consider for regulation?

On October 20, 2014, the EPA published preliminary regulatory
determinations for five contaminants on the third Contaminant Candidate
List (CCL 3) that had sufficient information to support a regulatory
determination (USEPA, 2014c). The five contaminants are 1,3-
dinitrobenzene, dimethoate, terbufos, terbufos sulfone and strontium.
The agency is making final regulatory determinations not to regulate
dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. The
agency is not making a final regulatory determination for strontium at
this time. The agency's decision to delay a final determination for
strontium is based on public comments received and the plan to further
evaluate scientific information that became available after publication
of the preliminary regulatory determinations. The agency is currently
conducting additional scientific analyses to determine if there is a
need to develop a national drinking water regulation for strontium. For
more information about the comments the agency received on strontium
and the analyses that are underway, see section V.A of this notice.
Information on the five contaminants can be found in the Regulatory
Determinations 3 Support Document (USEPA, 2014b). More information is
available at the Water Docket (Docket ID No. EPA-HQ-OW-2012-0155) and
also on EPA's Regulatory Determination 3 Web site at https://www2.epa.gov/ccl/regulatory-determination-3.

III. What process did the EPA use to make the regulatory
determinations?

This section gives a summary of the regulatory determination
process the agency followed to identify and evaluate contaminants for
the Third Regulatory Determination. For more detailed information on
the process and the analyses performed, please refer to the ``Protocol
for the Regulatory Determination 3'' document (USEPA, 2014a) and the
Federal Register notice for the Preliminary Regulatory Determinations
for Contaminants on CCL 3 (USEPA, 2014c).
The CCL 3 identified 116 contaminants that are currently not
subject to any proposed or promulgated national drinking water
regulation, are known or anticipated to occur in public water systems,
and may require

[[Page 15]]

regulation under SDWA (USEPA, 2009). Since some of the CCL 3
contaminants do not have adequate health and/or occurrence data to
evaluate against the three statutory criteria (see section II.B of this
notice), the agency used a three-phase process to identify which of the
contaminants are candidates for regulatory determinations. Priority was
given to identifying contaminants known to occur or with substantial
likelihood to occur at frequencies and levels of public health concern.
The three phases of the Third Regulatory Determination process are
(1) the Data Availability Phase, (2) the Data Evaluation Phase and (3)
the Regulatory Determination Assessment Phase. The overall process is
displayed in Exhibit 1.
BILLING CODE 6560-50-P
[GRAPHIC] [TIFF OMITTED] TR04JA16.000

BILLING CODE 6560-50-C
The purpose of the first phase, the Data Availability Phase, is to
determine if the agency ``may have'' sufficient data to characterize
the potential health effects and known or likely occurrence in drinking
water. Although contaminants must have sufficient data to evaluate the
statutory criteria in Phase 3, the agency does not want to rule out any
contaminants too early in the process; therefore, if sufficient health
and occurrence data are likely available, the contaminants are
considered in the Data Evaluation Phase, the second phase of the
regulatory determination process. From the 116 CCL 3 contaminants, the
agency identified 37 contaminants (35 CCL 3 contaminants and two non-
CCL 3 contaminants \4\) to further evaluate in the second phase.
---------------------------------------------------------------------------

\4\ The non-CCL 3 contaminants, N-Nitroso-di-n-butylamine (NDBA)
and N-Nitrosomethylethylamine (NMEA), were included because they are
part of a larger group (nitrosamines) that also includes a number of
CCL 3 contaminants.
---------------------------------------------------------------------------

During the second phase, the agency further evaluates each
contaminant on the short list to identify those that have sufficient
data (or are expected to have sufficient data within the timeframe
allotted for the second phase) for the EPA to assess the three
statutory criteria. As part of the second phase, the agency
specifically focuses its efforts on identifying those contaminants or
contaminant groups that are occurring or have substantial likelihood to
occur at levels and frequencies of public health concern, based on the
best available peer reviewed data. If the agency finds that sufficient
data are not available or not likely to be available to evaluate the
three statutory criteria during the first and second phases, then the
contaminant is not considered a candidate for making a regulatory
determination.
If sufficient data are available for a contaminant to characterize
the potential health effects and known or likely occurrence in drinking
water, the contaminant is evaluated against the three statutory
criteria in the Regulatory Determination Assessment Phase, which is the
third phase of the process. Of the 37 contaminants that were evaluated
under Phase 2, 12 were designated for further evaluation in Phase 3.

[[Page 16]]

Of the 12 contaminants that were evaluated in Phase 3, the agency
did not make preliminary regulatory determinations for seven
contaminants. The seven contaminants include chlorate and six
nitrosamines. Chlorate and the six nitrosamines are disinfection
byproducts, and the agency is further evaluating these contaminants as
part of the regulatory review of existing Microbial and Disinfection
Byproduct regulations, as announced in the Preliminary Regulatory
Determination 3 Federal Register notice published on October 20, 2014
(USEPA, 2014c).
After evaluating the five remaining CCL 3 contaminants (dimethoate,
1,3-dinitrobenzene, terbufos, terbufos sulfone and strontium) against
the three statutory criteria and considering other relevant information
(such as level and frequency of occurrence, population exposed and
information on sensitive populations and lifestages), the agency made
preliminary regulatory determinations to regulate strontium and to not
regulate the remaining four contaminants. These preliminary
determinations, with their supporting analyses and documentation, were
published in the Federal Register on October 20, 2014, for public
comment (USEPA, 2014c).
The EPA received comments from 14 organizations and individuals on
the October 20, 2014, Federal Register notice. These 14 organizations
and individuals include four environmental organizations, six industry
groups, one state association and three anonymous individuals. The
agency prepared a Response to Comments document for this action that is
available in the Public Docket at www.regulations.gov under Docket ID
No. EPA-HQ-OW-2012-0155. Comments on specific contaminants, and the
EPA's responses, are briefly summarized in the sections below.

IV. Summary of the EPA's Findings on the Four Contaminants With Final
Regulatory Determinations

After considering the public comments, the EPA is making final
regulatory determinations not to regulate dimethoate, 1,3-
dinitrobenzene, terbufos and terbufos sulfone.
This notice provides a brief description of the agency findings on
these contaminants. Details on the background, health and occurrence
information and analyses used to evaluate and make final determinations
for these contaminants can be found in the Regulatory Determinations 3
Support Document (USEPA, 2015b) and the Federal Register notice for the
Preliminary Regulatory Determination 3 (USEPA, 2014c).
For each contaminant, the agency evaluated the available human and
toxicological data, derived a health reference level (HRL),\5\
evaluated the potential and/or likely occurrence and examined the
likely exposed population for the contaminant in public water systems.
The agency also considered whether information was available on
sensitive populations. The agency used the findings from these
evaluations to determine whether the three SDWA statutory criteria are
satisfied. Table 1 gives a summary of the health and occurrence
information for the four contaminants with final determinations under
RD 3.
---------------------------------------------------------------------------

\5\ HRLs are risk derived concentrations against which to
evaluate the occurrence data to determine if contaminants may occur
at levels of public health concern. They are not the level of a
contaminant in drinking water that must not be exceeded to protect
any particular population (i.e., an HRL is not an MCL).

Table 1--Summary of the Health and Occurrence Information and the Final Determinations for Four of the Contaminants Considered for RD 3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Health Occurrence findings from primary data sources
reference ----------------------------------------------------------------------------------------------------------------------------------
RD 3 contaminants level Population served by PWSs Population served by PWSs Final
(HRL) Primary PWSs with at least 1 with at least 1 detection PWSs with at least 1 with at least 1 detection determination
([mu]g/L) database detection >=\1/2\ HRL >=\1/2\ HRL detection >=HRL >=HRL
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dimethoate.................... 15.4 UCMR 2........ 0% (0 of 4140)........... 0% (0 of 229M).............. 0% (0 of 4140)........... 0% (0 of 229M).............. Do not regulate.
1,3-Dinitrobenzene............ 0.7 UCMR 2........ 0% (0 of 4139)........... 0% (0 of 229M).............. 0% (0 of 4139)........... 0% (0 of 229M).............. Do not regulate.
Terbufos...................... 0.35 UCMR 1........ 0% (0 of 295)............ 0% (0 of 41M)............... 0% (0 of 295)............ 0% (0 of 41M)............... Do not regulate
Terbufos sulfone.............. 0.35 UCMR 2........ 0.02% (1 of 4140)........ 0.01% (44.6K of 229M)....... 0.02% (1 of 4140)........ 0.01% (44.6K of 229M)....... Do not regulate.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

A. Dimethoate

1. Description
Dimethoate is an organophosphate pesticide, commonly used as an
insecticide on field crops (e.g., wheat, alfalfa, corn and cotton),
orchard crops, vegetable crops and in forestry. Synonyms for dimethoate
include dimethogen, dimeton, dimevur and cygon (HSDB, 2010; USEPA,
2007). Dimethoate is considered highly mobile and relatively non-
persistent in the environment (USEPA, 2007).
2. Agency Findings
The agency is making a determination not to regulate dimethoate
with an NPDWR. It does not occur at levels and frequencies of public
health concern. As a result, the agency finds that an NPDWR does not
present a meaningful opportunity for health risk reduction.
The primary data for dimethoate are the 2008-2010 nationally
representative drinking water monitoring data, generated through the
EPA's Second Unregulated Contaminant Monitoring Regulation (UCMR 2).
Dimethoate was not detected in any of the 32,150 UCMR 2 samples
collected by 4,140 PWSs (serving ~230 million people) at levels greater
than the \1/2\ HRL (7.7 [mu]g/L), the HRL (15.4 [mu]g/L), or the
minimum reporting level (MRL) (0.7 [mu]g/L) (USEPA, 2015c). Based on
the results of the UCMR 2 samples, the estimated population exposed to
dimethoate at levels of public health concern is 0%.
Other supplementary sources of finished water data from the State
of California, the U.S. Department of Agriculture (USDA) and the U.S.
Geologic Survey (USGS) indicate that the occurrence of dimethoate in
PWSs is likely to be low to non-existent. Dimethoate occurrence data
for ambient water from the USGS and the Storage and Retrieval (STORET)
Data System are consistent with those for finished water. These data
sources are discussed in the October 2014 Federal Register notice of
the Preliminary Regulatory Determination 3 (USEPA, 2014c).

[[Page 17]]

B. 1,3-Dinitrobenzene

1. Description
1,3-Dinitrobenzene is a nitro aromatic compound that is used as an
industrial chemical and formed as a by-product in the manufacture of
munitions, as well as in the production of other substances (HSDB,
2009). There are no known natural sources of 1,3-dinitrobenzene. 1,3-
Dinitrobenzene appears to be moderately persistent in environmental
media and moderately mobile in soil and water, although in soils with
high clay content it will be less mobile (USEPA, 2015b).
2. Agency Findings
The agency is making a determination not to regulate 1,3-
dinitrobenzene with an NPDWR. It does not occur at levels and
frequencies of public health concern. As a result, the agency finds
that an NPDWR does not present a meaningful opportunity for health risk
reduction.
The primary data for 1,3-dinitrobenzene are the 2008-2010
nationally representative drinking water monitoring data generated
through the EPA's UCMR 2 (USEPA, 2015c). UCMR 2 is the only dataset
with finished water data for this contaminant. UCMR 2 collected 32,152
samples from 4,139 PWSs for 1,3-dinitrobenzene and it was not detected
above the MRL (0.8 [mu]g/L), which is only slightly higher than the HRL
(0.7 [mu]g/L). Based on the results of the UCMR 2 samples, the
estimated population exposed to 1,3-dinitrobenzene at or above the MRL
is 0%.
Findings from the available ambient water data for 1,3-
dinitrobenzene are consistent with the results in finished water.
Ambient water data in STORET included no measured results above 0.33
[mu]g/L in 143 samples from 70 sites (USEPA, 2012). It should be noted
that some occurrence above the HRL may have gone undetected since
reporting levels are not documented. These data sources are discussed
in the October 2014 Federal Register notice of the Preliminary
Regulatory Determination 3 (USEPA, 2014c).

C. Terbufos and Terbufos Sulfone

1. Description
Terbufos is a phosphorodithioate pesticide (i.e., an
organophosphate) used as an insecticide-nematicide to control a variety
of insect pests, primarily used on corn and sugar beets (USEPA, 2006).
Terbufos sulfone is a degradate of terbufos. Total toxic residues of
terbufos and degradates are highly mobile and persistent in the
environment, with terbufos sulfone being more mobile and substantially
more persistent than terbufos (USEPA, 2006).
2. Agency Findings
The agency is making determinations not to regulate terbufos and
terbufos sulfone with NPDWRs. They do not occur at levels and
frequencies of public health concern. As a result, the agency finds
that an NPDWR does not present a meaningful opportunity for health risk
reduction.
The primary data for terbufos are from the First Unregulated
Contaminant Monitoring Regulation (UCMR 1) screening survey (2001-2003)
(USEPA, 2008). The UCMR 1 screening survey collected 2,301 finished
water samples from 295 PWSs for terbufos and it was not detected at
levels at or above the MRL (0.5 [mu]g/L), which is slightly higher than
the HRL (0.35 [mu]g/L) (USEPA, 2008). Based on the results of the UCMR
1 screening survey, the estimated population exposed to terbufos at or
above the MRL is 0%.
The primary data for terbufos sulfone are nationally representative
finished water monitoring data generated through the EPA's UCMR 2
(2008-2010) (USEPA, 2015c). UCMR 2 collected 32,149 finished water
samples from 4,140 PWSs (serving ~230 million people) for terbufos
sulfone and it was detected in only one sample, at a concentration of
0.42 [mu]g/L. The MRL is 0.4 [mu]g/L, which is slightly higher than the
HRL (0.35 [mu]g/L) (USEPA, 2015c). Based on the results of the UCMR 2
samples, the estimated population exposed to terbufos sulfone at a
level of public health concern (based on the HRL for terbufos) is
44,600 (0.02% of the population served by PWSs).
Finished water data for terbufos and terbufos sulfone from
California, Iowa, USDA and USGS are consistent with the UCMR 1 and UCMR
2 data. Terbufos and (very limited) terbufos sulfone occurrence data
for ambient water from the EPA, STORET and several USGS programs or
studies are also consistent with those for finished water. These data
sources are discussed in the October 2014 Federal Register notice of
the Preliminary Regulatory Determination 3 (USEPA, 2014c).

D. Public Comments on Four Contaminants With Final Regulatory
Determinations

The agency received comments in support of the agency's preliminary
determinations not to regulate dimethoate, 1,3-dinitrobenzene, terbufos
and terbufos sulfone. The agency did not receive any comments to the
contrary.
Agency Response: EPA agrees with the comments and, as previously
explained, is making final determinations not to regulate dimethoate,
1,3-dinitrobenzene, terbufos and terbufos sulfone.

V. Summary of Public Comments on Strontium and the Agency's Responses

A. Background on Strontium and the EPA's Preliminary Determination

Strontium is a naturally occurring element (atomic number 38) and a
member of the alkaline earth metals (ANL, 2007). There are several
radioactive strontium isotopes formed by nuclear fission of uranium or
plutonium. Since drinking water contamination by radioactive isotopes,
including beta particle emitters, is covered under the existing
Radionuclides Rule, this section describes the stable \88\Sr isotope.
In October 2014, the agency made a preliminary determination to
regulate strontium with an NPDWR after evaluating the available health,
occurrence and other related information against the three SDWA
statutory criteria. Specifically, EPA made a preliminary determination
that (a) strontium may have an adverse effect on the health of persons,
(b) it is known to occur or there is substantial likelihood that
strontium will occur in public water systems with a frequency and at
levels of public health concern and (c) regulation of strontium with an
NPDWR presents a meaningful opportunity to reduce health risks for
persons served by PWSs. EPA describes the underlying science in support
of these criteria in the Federal Register notice of the Preliminary
Regulatory Determination 3 (USEPA, 2014c).
In the Federal Register notice of the Preliminary Regulatory
Determination 3, EPA calculated a non-cancer HRL of 1500 [micro]g/L for
strontium using the reference dose of 0.3 mg/kg/day, a default Relative
Source Contribution (RSC) of 20% and age-specific exposure factors
(i.e., drinking water intake expressed as liters per kg of body weight)
for the sensitive population of birth through 18 years to reflect the
most active period of bone growth and development. The RSC is the level
of exposure believed to result from drinking water when compared to
other sources (e.g., food, ambient air). In the Preliminary Regulatory
Determination 3 EPA used the default 20% RSC to calculate the HRL. For
more detailed information see the October 20, 2014, Federal Register
notice of the

[[Page 18]]

Preliminary Regulatory Determination 3 (USEPA, 2014c).
After consideration of public comments on the preliminary
regulatory determination for strontium (see Section V.B.), the agency
is delaying the final determination for strontium in order to consider
additional scientific data and decide whether there is a meaningful
opportunity for health risk reduction by regulating strontium in
drinking water.

B. What comments did the EPA receive on strontium?

Some commenters supported the preliminary determination to regulate
strontium. These commenters supported a regulation due to the adverse
effect on bone growth and/or the potential for elevated levels of
strontium in the environment as a result of spills and disposal of
waste products related to gas production.
Many comments called upon the agency to delay the final
determination, collect more data and perform additional analyses before
making a final determination for strontium. Specifically, the comments
were focused on the following areas: The relationship between
occurrence and health risk, the RSC of strontium, the costs and
benefits of a potential strontium regulation and the feasibility of
treating strontium.
Three commenters questioned whether enough water systems show
strontium at levels and frequency of concern that a meaningful
reduction in health risk can be achieved through a national regulation.
Two of these commenters suggested conducting an epidemiology study that
evaluates whether adverse human health effects are occurring and at
what drinking water concentrations (and frequency of occurrence) to
determine whether there is a meaningful opportunity for health risk
reduction of a regulation.
Two commenters indicated the agency should quantify the RSC or
provide stronger justification for using an RSC of 20%. One commenter
stated the RSC has a significant impact on the reference dose. One
commenter stated that defaults of 20% and 80% have utility in
relatively simple circumstances where it is accepted that the drinking
water component is either very small or large. The commenter indicated
that it is essential to analyze and quantify the RSC when it is
intermediate and there are data to perform a meaningful estimate. The
commenter asserted that it is essential because the impact on the MCLG
and ultimately the MCL and compliance costs can become significant.
Several commenters indicated concerns with the costs and benefits
of a potential strontium regulation. One commenter urged the agency to
update the current affordability standard under SDWA before
promulgating any new NPDWRs in order to allow rural and small
communities to utilize the most economical and safe treatment options.
One commenter stated that the agency failed to estimate the social
benefits and social costs in its analysis for the strontium
determination, specifically the additional energy usage and its
externalities. Several commenters compared the cost of a potential
strontium regulation to that of the arsenic regulation, based on the
percentage and type of systems with strontium occurrence at levels of
concern.
Several commenters supported the agency's commitment to conducting
more extensive treatment research prior to promulgating a regulation
for strontium. Two commenters indicated that the treatment technology
to remove strontium may remove beneficial alkaline earth metals, such
as calcium, that partially counter the uptake of strontium.
Agency Response: The agency is delaying the final determination for
strontium in order to consider additional scientific data and decide
whether there is a meaningful opportunity for health risk reduction by
regulating strontium in drinking water.
Strontium is known to occur in food, ambient air and soil. While
data on levels in those media and estimates of intake from those
sources were limited when EPA made the preliminary determination to
regulate strontium, the EPA is evaluating recent additions to the
exposure database to determine if the agency can develop a data-derived
RSC rather than using a default 20% RSC in the calculation of the HRL.
In the absence of this type of relevant exposure information, the
agency supports the use of the default RSC and may ultimately use the
default 20% RSC in the final regulatory determination for strontium and
for other compounds in the future. The agency selects the default RSCs
for regulatory determinations based on the Methodology for Deriving
Ambient Water Quality Criteria for the Protection of Human Health
(USEPA, 2000).
If the agency makes a final determination to regulate strontium,
the EPA will conduct tests on treatment technologies for strontium
prior to developing a regulation. The agency understands that strontium
may co-occur with beneficial calcium in some drinking water systems and
treatment technologies that remove strontium may also remove calcium.
The agency is evaluating the effectiveness of treatment technologies
under different water conditions, including calcium concentrations. The
agency will continue to work with stakeholders in evaluating treatment
technologies for strontium.
At this time, the agency does not plan to initiate any longer term
health effect studies, including human epidemiological studies on the
relationship of skeletal effects and strontium exposure levels through
consumption of drinking water and foods. The agency will continue to
evaluate new health studies related to strontium exposure, including
any epidemiology studies. It should be noted that while the agency is
not precluded from conducting epidemiological studies, the agency is
not required to do so to support the decision to regulate a
contaminant.
An evaluation of the costs and benefits of a potential strontium
regulation is outside the scope of the regulatory determination
process. If the agency decides to regulate strontium, as part of the
regulation development process, the agency will conduct a health risk
reduction and cost analysis, including an evaluation of the costs and
benefits of regulating strontium.

VI. Next Steps

Prior to making a final regulatory determination for strontium, the
agency will consider additional data gathered and analyses completed
after publication of the preliminary determination (for further
information, see discussion in section V.B. of this notice). The agency
published the Draft Contaminant Candidate List 4 (CCL 4) on February 4,
2015 (USEPA, 2015a) and will issue a Final CCL 4 after consideration of
public comments received. The agency will evaluate and consider
contaminants on the Final CCL 4 for the Fourth Regulatory
Determination.

VII. References

Argonne National Laboratory (ANL). 2007. Radiological and Chemical
Fact Sheets to Support Health Risk Analyses for Contaminated Areas.
Environmental Science Division. Available on the Internet at: https://www.gfxtechnology.com/ArgonneRadFacts.pdf.
HSDB. 2010. Available on the Internet at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB. Accessed September 2010.
USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria
for the

[[Page 19]]

Protection of Human Health (2000). EPA 822-B-00-004.
USEPA. 2006. Reregistration Eligibility Decision for Terbufos.
Office of Pesticide Programs. Available on the Internet at: https://archive.epa.gov/pesticides/reregistration/web/pdf/terbufos_red.pdf.
Accessed Oct 2015.
USEPA. 2007. Revised Interim Reregistration Decision for Dimethoate.
Available on the Internet at: https://archive.epa.gov/pesticides/reregistration/web/pdf/dimethoate_ired_revised.pdf. Accessed October
2015.
USEPA. 2008. The Analysis of Occurrence Data from the First
Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of
Regulatory Determinations for the Second Drinking Water Contaminant
Candidate List. EPA 815-R-08-012. June 2008.
USEPA. 2009. Drinking Water Contaminant Candidate List 3--Final.
Federal Register. Vol. 74, No. 194, p. 51850. October 8, 2009.
USEPA. 2012. Storage and Retrieval (STORET) Data Warehouse.
Available on the Internet at: https://www.epa.gov/storet/.
Data Warehouse. Accessed March 2012.
USEPA. 2014a. Protocol for the Regulatory Determinations 3.
Including Appendices A-F. EPA 815-R14-005. April 2014.
USEPA. 2014b. Regulatory Determinations 3 Support Document. EPA 815-
R14-003. April 2014.
USEPA. 2014c. Announcement of the Preliminary Regulatory
Determinations for Contaminants on the Third Drinking Water
Contaminant Candidate List; Proposed Rule. Federal Register. Vol.
79, No. 202, p. 62716. October 20, 2014.
USEPA. 2015a. Drinking Water Contaminant Candidate List 4--Draft.
Federal Register. Vol. 80, No. 23, p. 6076. February 4, 2015.
USEPA. 2015b. Regulatory Determinations 3 Support Document (Final).
EPA 815-R15-014. December 2015.
USEPA. 2015c. Occurrence Data from the Second Unregulated
Contaminant Monitoring Regulation (UCMR 2). EPA 815-R15-013.
December 2015.

Dated: December 22, 2015.
Gina McCarthy,
Administrator.
[FR Doc. 2015-32760 Filed 12-31-15; 8:45 am]
BILLING CODE 6560-50-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.