Notice and request for public comment.
The U.S. Environmental Protection Agency (EPA) is requesting nominations of chemical and microbial contaminants for possible inclusion in the fourth drinking water Contaminant Candidate List (CCL 4). EPA is also requesting supporting information that has been made available since the development of the third CCL (CCL 3), or existing information that was not considered for CCL 3, which shows that the nominated contaminant may have an adverse health effect on people and occurs or is likely to occur in public water systems.
Nominations must be received on or before June 22, 2012.
Submit your nominations by one of the following methods:
- To the CCL 4 Nominations Web site: http://water.epa.gov/scitech/drinkingwater/dws/ccl/ccl4.cfm by following the on-line instructions for submitting nominations.
Mail: Water Docket, U.S. Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460. Identify your nominations by Docket ID No. EPA-HQ-OW-2012-0217.
Hand Delivery: Water Docket, U.S. EPA Docket Center (EPA/DC). Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. The EPA Docket Center, Water Docket is located in Room 3334, 1301 Constitution Ave. NW., Washington, DC 20004. The telephone number for the Water Docket is (202) 566-2426.
FOR FURTHER INFORMATION CONTACT:
For general information contact the EPA Safe Drinking Water Hotline at (800) 426-4791 or email: firstname.lastname@example.org. For technical questions about this notice and/or inquires regarding EPA's CCL 4 Nominations Web site, please contact Clifton Townsend, Standards and Risk Management Division, Office of Ground Water and Drinking Water, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., MC:4607M, Washington, DC 20460; telephone number: (202) 564-1576; email address: email@example.com.
I. General Information
A. Does this action apply to me?
This notice does not impose any requirements on anyone; it only requests drinking water contaminant candidate nominations and provides information on how the public can submit nominations to the agency.
B. How can I get copies of this document and other related information?
1. Docket. EPA has established a docket for this action under Docket ID No. EPA-HQ-OW-2012-0217. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Water Docket in the EPA Docket Center (see ADDRESSES section)
2. Electronic Access. You may access this Federal Register document electronically through the EPA Web site under the “Federal Register” listings at http://www.epa.gov/fedrgstr/.
A. What is the CCL?
The CCL is a list of contaminants that are currently not subject to any proposed or promulgated national primary drinking water regulations, that are known or anticipated to occur in public water systems, and which may require regulation under the Safe Drinking Water Act (SDWA). EPA uses this list of unregulated contaminants to help the agency determine whether it should regulate a specific contaminant and to prioritize research and data collection efforts. SDWA requires that EPA publish the CCL every five years (SWDA Section 1412(b)(1)). EPA is also required to consult with the scientific community and provide notice and opportunity for public comment prior to publication of the CCL.
SDWA also requires EPA to determine whether to regulate at least five contaminants from the CCL every five years (SWDA Section 1412(b)(1)) with a national primary drinking water regulation (NPDWR). In making a determination to regulate a contaminant, SDWA specifies that three criteria must be met:
1. The contaminant may have an adverse effect on the health of persons;
2. 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
3. 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.
B. How did EPA develop previous contaminant candidate lists?
EPA published the first CCL (CCL 1), which contained 60 chemical and microbiological contaminants, on March 2, 1998 (63 FR 10273). EPA consulted with the scientific community and the National Drinking Water Advisory Council (NDWAC) on the process used to develop CCL 1. Based on the NDWAC recommendations, the agency developed and used screening and evaluation criteria to identify the list of chemical contaminants for CCL 1. For microbiological contaminants, the agency followed the NDWAC recommendations and sought external expertise to identify and select potential waterborne pathogens. The agency convened a workshop of microbiologists and public health experts who developed criteria for screening and evaluation and subsequently developed an initial list of potential microbiological contaminants. On July 18, 2003 (68 FR 42897), EPA announced its final regulatory determination for 9 of the 60 contaminants listed on CCL 1 and concluded that sufficient data and information were available to make the determination not to regulate these 9 contaminants (8 chemicals and 1 microbial) with an NPDWR.
EPA published the second CCL (CCL 2) on February 24, 2005 (70 FR 9071), and carried forward the remaining 51 chemical and microbial contaminants listed on CCL 1. On July 30, 2008 (73 FR 44251), EPA announced its final regulatory determination for 11 of the 51 contaminants listed on CCL 2 and concluded that sufficient data and information were available to make the determination not to regulate these 11 contaminants with an NPDWR.
EPA published the third CCL (CCL 3), which listed 116 contaminants, on October 8, 2009 (74 FR 51850). In developing CCL 3, EPA improved and built upon the process that was used for CCL 1 and CCL 2. EPA based the new CCL 3 process on substantial expert input and recommendations from the National Academy of Science's (NAS) National Research Council (NRC) and the National Drinking Water Advisory Council (NDWAC) as well as input from the public. Based on these consultations and input, EPA developed a multi-step process to select candidates for the final CCL 3, which included the following key steps:
(a) Identification of a broad universe of ~7,500 potential drinking water contaminants (the CCL 3 Universe);
(b) screening the CCL 3 Universe to a preliminary CCL (PCCL) of ~600 contaminants based on the potential to occur in public water systems and the potential for public health concern; and
(c) evaluation of the PCCL contaminants based on a more detailed review of the occurrence and health effects data to identify a final list of 116 CCL 3 contaminants.
A complete summary of the key steps used to identify contaminants for CCL 3 and a more detailed discussion of the analyses and decisions made to develop the final CCL 3 can be found in the draft and final CCL 3 Federal Register notices (73 FR 9628, February 21, 2008, and 74 FR 51850, October 8, 2009, respectively) and related supporting documents. More information can also be found on the CCL 3 Web site: http://water.epa.gov/scitech/drinkingwater/dws/ccl/ccl3.cfm.
The agency is currently in the process of further evaluating CCL 3 contaminants to determine whether any of these contaminants require regulation with an NPDWR.
C. What data sources did EPA use to identify contaminants for the CCL 3?
A complete summary of how EPA evaluated data sources to identify chemical contaminants for the CCL 3 can be found in the draft and final CCL 3 Federal Register notices (73 FR 9628, February 21, 2008, and 74 FR 51850, October 8, 2009, respectively). A list of the data sources used to evaluate contaminants for the CCL 3 as well as a more detailed summary of the process EPA used to evaluate data sources can be found in the CCL 3 support document (Contaminant Candidate List 3 Chemicals: Identifying the Universe (EPA 815-R-09-006)). These documents can be found on the Web at: http://water.epa.gov/scitech/drinkingwater/dws/ccl/ccl3_processflowdiagram.cfm or in the CCL 3 docket (docket number EPA-HQ-OW-2007-1189) at www.regulations.gov.
A summary of how EPA evaluated data sources to identify microbial contaminants for CCL 3 can be found in the draft and final CCL 3 Federal Register notices (73 FR 9628, February 21, 2008, and 74 FR 51850, October 8, 2009, respectively), as well as the CCL 3 support document, Contaminant Candidate List 3 Microbes: Identifying the Universe (EPA 815-R-R-09-004), which can be found on the Web at: http://water.epa.gov/scitech/drinkingwater/dws/ccl/upload/CCL3MicrobesUniverse_7_22_09.pdf or in the CCL 3 docket (docket number EPA-HQ-OW-2007-1189) at www.regulations.gov.
EPA will use the nominations process to ensure that the CCL 4 process captures emerging chemicals and pathogens.
D. Why is EPA soliciting contaminant nominations?
EPA is requesting contaminant nominations from the public to ensure that contaminants that may not be identified for consideration as part of the CCL process are considered.
While NAS and NDWAC recommended that the CCL be a data driven, step-wise approach to classifying contaminants, these experts also recognized the importance of providing an additional pathway for the public to identify new and emerging contaminants that may not be identified in an evaluation of the data sources. A public nominations process allows the agency to consider new and emerging contaminants that might not otherwise be considered because new information has not been widely reported or recorded.
Following the recommendations of NAS and NDWAC, the agency implemented a process to screen and identify contaminants for inclusion in the CCL 3. The nominated contaminants will be considered as EPA evaluates contaminants for inclusion on the CCL 4.
III. EPA CCL Nominations Process
This contaminant nominations process is the first opportunity to make nominations to the CCL 4. The agency will also accept nominations during the notice and comment period following EPA's publication of the draft CCL 4.
A. How can stakeholders, other agencies, industry and the public nominate contaminants for the CCL 4?
EPA's preferred method for submission of contaminant nominations is through the EPA CCL 4 Nomination Web site. Interested parties can also nominate chemicals, microbes or other materials for consideration on the new CCL by sending information electronically or in hard copy to EPA. Do not submit confidential business information (CBI) through email. If you wish to submit CBI, first contact EPA (see FOR FURTHER INFORMATION CONTACT section) for instructions on how to submit CBI. When submitting a nomination, it is preferred that the nominators include a name, affiliation, phone number, mailing address, and email address; however, this information is not required and nominations can be submitted anonymously. The nominator should also address the following questions for each contaminant nominated to the CCL:
1. What is the contaminant's name, CAS number, and/or common synonym (if applicable)?
2. What factors make this contaminant a priority for the CCL 4 process (e.g., widespread occurrence; anticipated toxicity to humans; potentially harmful effects to susceptible populations (e.g., children, elderly or immunocompromised); potentially contaminated source water (surface or ground water) and/or finished water; release to air, land and/or water; contaminant is manufactured in large quantities with a potential to occur in source waters)?
3. What are the new significant health effects and occurrence data that are available since CCL 3, or existing information that was not considered in CCL 3, which you believe supports the CCL requirement(s) that a contaminant may have an adverse effect on the health of persons and is known or anticipated to occur in public water systems?
4. Please provide complete citations, including author(s), title, journal and date. Contact information for the primary investigator would also be helpful.
B. How do I submit nominations through EPA's nominations Web site?
The Web site is designed to provide key information to the agency, as described in Section III.A of this notice, for each contaminant nominated to the CCL process.
The Web address where you can nominate a contaminant is http://water.epa.gov/scitech/drinkingwater/dws/ccl/ccl4.cfm
C. How do I submit nominations in hard copy?
You may submit nominations through the mail. To allow full agency consideration of your nomination, please ensure that your nominations are received or postmarked by midnight June 22, 2012. The addresses for submittal of nominations by mail are listed in the ADDRESSES section of this document.
D. What will happen to my nominations after I submit them?
The agency will evaluate the information available for the nominated contaminants to determine the appropriateness of inclusion on the CCL 4. EPA does not intend to respond to the nominations directly or individually. The agency will publish a document summarizing the nominations received along with the draft CCL 4 list.
Copies of these documents are found at www.regulations.gov, Docket ID No. EPA-OW-2012-0217.
NAS 2001. National Academy of Sciences, National Research Council. 2001. Classifying Drinking Water Contaminants for Regulatory Consideration. National Academy Press. Washington, DC. Available at http://books.nap.edu/books/0309074088/html/index.html.
NDWAC 2004. National Drinking Water Advisory Council. National Drinking Water Advisory Council Report on the CCL Classification Process to the U.S. Environmental Protection Agency, May 18, 2004. Available at http://www.epa.gov/safewater/ndwac/pdfs/report_ccl_ndwac_07-06-04.pdf.
USEPA. 2008. Drinking Water Contaminant Candidate List 3—Draft Notice. Federal Register. Vol, 73. No 35. p. 9628. February 21, 2008.
USEPA. 2009a. SAB Advisory on EPA's Draft Third Drinking Water Contaminant List (CCL 3). EPA-SAB-09-011. January 2009. http://yosemite.epa.gov/sab/sabproduct.nsf/WebProjectsbyNameBOARD!OpenView.
USEPA. 2009b. Summary of Nominations for the Third Contaminants Candidate List. EPA 815-R-09-011. Final. August, 2009.
USEPA. 2009c. Final Contaminant Candidate List 3 Chemicals: Identifying the Universe. EPA. 815-R-09-006. August, 2009.
USEPA. 2009d. Final Contaminant Candidate List 3 Microbes: Identifying the Universe. EPA. 815-R-09-004. August, 2009.
Dated: April 27, 2012.
Nancy K. Stoner,
Acting Assistant Administrator, Office of Water.
[FR Doc. 2012-11048 Filed 5-7-12; 8:45 am]
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