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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Rules and Regulations a. Adverse Health Effects b. Occurrence c. Meaningful Opportunity d. Summary of Public Comments on Methyl Bromide and Agency Responses E. Metolachlor 1. Description 2. Agency Findings a. Adverse Health Effects b. Occurrence c. Meaningful Opportunity d. Summary of Public Comments on Metolachlor and Agency Responses F. Nitrobenzene 1. Description 2. Agency Findings a. Adverse Health Effects b. Occurrence c. Meaningful Opportunity d. Summary of Public Comments on Nitrobenzene and Agency Responses G. RDX
1. Description 2. Agency Findings a. Adverse Health Effects b. Occurrence c. Meaningful Opportunity d. Summary of Public Comments on RDX
and Agency Responses H. Strontium I. 1,4-Dioxane J. 1,2,3-Trichloropropane V. Next Steps VI. References
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II. Purpose and Background A. What is the purpose of this action?
The purpose of this action is to present a summary of EPAs final regulatory determinations for eight contaminants listed on the Fourth Contaminant Candidate List CCL 4
USEPA, 2016a. The eight contaminants are:
Perfluorooctanesulfonic acid PFOS, perfluorooctanoic acid PFOA, 1,1dichloroethane, acetochlor, methyl bromide bromomethane, metolachlor, nitrobenzene, and Royal Demolition eXplosive RDX. The Agency is making final determinations to regulate two contaminants PFOS and PFOA and to not regulate the remaining six contaminants 1,1-dichloroethane, acetochlor, methyl bromide bromomethane, metolachlor, nitrobenzene, and RDX. The Agency is not making any determination at this time on any other CCL contaminants, including strontium, 1,4-dioxane, and 1,2,3-trichloropropane. This action summarizes the statutory requirements for targeting drinking water contaminants for regulatory determination, provides an overview of the contaminants that the Agency considered for regulation, and describes the approach used to make the final regulatory determinations. In addition, this action summarizes the public comments received on the Agencys preliminary determinations
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announcement and the Agencys responses to those comments.
B. What are the statutory requirements for the Contaminant Candidate List CCL and regulatory determinations?
Section 1412b1Bi of SDWA
requires EPA to publish the CCL every five years after public notice and an opportunity to comment. The CCL is a list of contaminants which are not subject to any proposed or promulgated National Primary Drinking Water Regulations NPDWRs but are known or anticipated to occur in public water systems PWSs and may require regulation under SDWA. SDWA section 1412b1Bii directs EPA to determine, after public notice and an opportunity to comment, whether to regulate at least five contaminants from the CCL every five years.
Under Section 1412b1A of SDWA, EPA makes a determination to regulate a contaminant in drinking water 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 after considering public comment on a preliminary determination, the Agency makes a determination to regulate a contaminant, EPA will initiate the process to propose and promulgate an NPDWR. In that case, the statutory time frame provides for Agency proposal of a regulation within 24 months and action on a final regulation within 18 months of proposal. When proposing and promulgating drinking water regulations, the Agency must conduct a number of analyses.
C. What contaminants did EPA consider for regulation?
On March 10, 2020, EPA published preliminary regulatory determinations for eight contaminants on the fourth Contaminant Candidate List CCL 4 85
FR 14098 USEPA, 2020a. The eight contaminants are PFOS, PFOA, 1,1dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene, and RDX. The Agency is making final regulatory determinations to regulate two contaminants i.e., PFOS and PFOA and to not regulate six
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contaminants i.e., 1,1-dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene, and RDX.
Information on the eight contaminants with regulatory determinations can be found in the Final Regulatory Determination 4 Support Document USEPA, 2021a. More information is available in the Public Docket at www.regulations.gov Docket ID No.
EPAHQOW20190583 and also on EPAs Regulatory Determination 4
website at https www.epa.gov/ccl/
regulatory-determination-4.
III. What process did EPA use to make the regulatory determinations?
A. How EPA Identified and Evaluated Contaminants for the Fourth Regulatory Determination This section summarizes the process the Agency followed to identify and evaluate contaminants for the Fourth Regulatory Determination. For more detailed information on the process and the analyses performed, please refer to the Protocol for the Regulatory Determination 4 found in Appendix E
of the Final Regulatory Determination 4
Support Document USEPA, 2021a and the Federal Register publication for the preliminary regulatory determinations USEPA, 2020a.
The CCL 4 identified 109
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 regulation under SDWA USEPA, 2016a. Since some of the CCL 4
contaminants do not have adequate health and/or occurrence data to evaluate against the three statutory criteria see section II.B of this document, as when EPA evaluated the previous CCLs, the Agency used a threephase 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.
Because the regulatory determination process includes consideration of human health effects, the Agencys Policy on Evaluating Health Risks to Children USEPA, 1995a reaffirmed by Administrator Wheeler in a memorandum dated October 11, 2018 to Agency staff USEPA, 2018a, applies to this document. The policy requires EPA
to consistently and comprehensively address childrens unique vulnerabilities. We have explicitly considered childrens health in the RD
4 process by reviewing all the available
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