Integrated Risk Information System (IRIS); Announcement of 2008 Program, 72715-72719 [E7-24844]

Download as PDF Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. mstockstill on PROD1PC66 with NOTICES II. Background A. What Action is the Agency Taking? Under section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to ensure that they meet current scientific and regulatory standards. EPA has completed a RED for the pesticide, polypropylene glycol under section 4(g)(2)(A) of FIFRA. Butoxypolypropylene glycol (BPG) is the only active ingredient in the polypropylene glycol chemical case with any registered products. BPG is a repellant that is used to control flying and crawling insects. BPG was first registered for use in 1960, and can be applied to animals such as pets or horses directly, or to areas where animals live, like animal housing, bedding, or other areas animals may occupy. There are no food uses, and no uses on animals intended for slaughter. EPA has determined that the data base to support reregistration is substantially complete and that products containing polypropylene glycol are eligible for reregistration, provided the risks are mitigated in the manner described in the RED. Upon submission of any required product specific data under section 4(g)(2)(B) of FIFRA and any necessary changes to the registration and labeling (either to address concerns identified in the RED or as a result of product specific data), EPA will make a final reregistration decision under section 4(g)(2)(C) of FIFRA for products containing polypropylene glycol. EPA is applying the principles of public participation to all pesticides undergoing reregistration and tolerance reassessment. The Agency’s Pesticide Tolerance Reassessment and Reregistration; Public Participation Process, published in the Federal Register on May 14, 2004, (69 FR 26819) (FRL–7357–9) explains that in conducting these programs, EPA is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of issues, and degree of public concern associated with each pesticide. Due to its uses, risks, and other factors, polypropylene glycol was reviewed through the modified 4–Phase process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for polypropylene glycol. VerDate Aug<31>2005 18:37 Dec 20, 2007 Jkt 214001 The reregistration program is being conducted under congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. The Agency is issuing the polypropylene glycol RED for public comment. This comment period is intended to provide an additional opportunity for public input and a mechanism for initiating any necessary amendments to the RED. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. These comments will become part of the Agency Docket for polypropylene glycol. Comments received after the close of the comment period will be marked ‘‘late.’’ EPA is not required to consider these late comments. The Agency will carefully consider all comments received by the closing date and will provide a Response to Comments Memorandum in the Docket and regulations.gov. If any comment significantly affects the document, EPA also will publish an amendment to the RED in the Federal Register. In the absence of substantive comments requiring changes, the polypropylene glycol RED will be implemented as it is now presented. B. What is the Agency’s Authority for Taking this Action? Section 4(g)(2) of FIFRA, as amended, directs that, after submission of all data concerning a pesticide active ingredient, the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration, before calling in product specific data on individual end-use products and either reregistering products or taking other ‘‘appropriate regulatory action.’’ List of Subjects Environmental protection, Pesticides and pests. Dated: December 12, 2007. Steven Bradbury, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [FR Doc. E7–24771 Filed 12–20–07; 8:45 am] BILLING CODE 6560–50–S PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 72715 ENVIRONMENTAL PROTECTION AGENCY [FRL–8509–7; Docket ID No. EPA–HQ–ORD– 2007–0664] Integrated Risk Information System (IRIS); Announcement of 2008 Program Environmental Protection Agency (EPA). ACTION: Notice; request for information. AGENCY: SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing the IRIS 2008 agenda and requesting scientific information on health effects that may result from exposure to the chemical substances on the agenda, including assessments that EPA is starting this year. The Integrated Risk Information System (IRIS) is an EPA database that contains the Agency’s scientific positions on human health effects that may result from exposure to chemical substances in the environment. Assessments currently in progress are listed in this notice. DATES: While EPA is not expressly soliciting comments on this notice, the Agency will accept information related to the substances included herein. Please submit any information in accordance with the instructions provided below. ADDRESSES: Please submit relevant scientific information identified by docket ID number EPA–HQ–ORD–2007– 0664, online at http:// www.regulations.gov (EPA’s preferred method); by e-mail to ord.docket@epa.gov; mailed to Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD–ROM should be formatted in Word or as an ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above. FOR FURTHER INFORMATION CONTACT: For information on the IRIS program, contact Dr. Abdel-Razak Kadry, IRIS Program Director, National Center for Environmental Assessment, (mail code: 8601D), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: (202) 564–1645, facsimile: (202) 565–0075; or e-mail: kadry.abdel@epa.gov. E:\FR\FM\21DEN1.SGM 21DEN1 72716 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices For general questions about access to IRIS, or the content of IRIS, please call the IRIS Hotline at (202) 566–1676 or send electronic mail inquiries to hotline.iris@epa.gov. SUPPLEMENTARY INFORMATION: Background IRIS is a database of human health effects that may result from exposure to various chemical substances found in the environment. (EPA notes that information in the IRIS database has no preclusive effect and does not predetermine the outcome of any rulemaking. When EPA uses such information to support a rulemaking, the scientific basis for, and the application of, that information are subject to comment.) IRIS currently provides information on health effects associated with more than 500 chemical substances. The database includes chemicalspecific summaries of qualitative and quantitative health information in support of the first two steps of the risk assessment process, i.e., hazard identification and dose-response evaluation. Combined with specific situational exposure assessment information, the information in IRIS is an important source in evaluating potential public health risks from environmental contaminants. EPA’s overall process for developing IRIS assessments consists of: (1) Publication of an annual Federal Register announcement of EPA’s IRIS agenda and call for scientific information from the public on selected chemical substances; (2) a comprehensive search of the current scientific literature; (3) development of a draft IRIS health assessment utilizing state of the art scientific methods and guidelines; (4) internal EPA review of the draft assessment; (5) interagency review of the draft assessment; (6) public comment followed by independent external peer review of the draft assessment; (7) a public external peer review meeting related to the draft assessment; (8) preparation of a final IRIS assessment that reflects public comments and independent expert review; (9) interagency review of the final assessment; (10) EPA review and clearance of the final assessment; and (11) posting of the final IRIS assessment on the IRIS database (http:// www.epa.gov/iris). The IRIS Annual Agenda Each year, EPA develops a priority list of chemicals and an annual agenda for the IRIS program and announces new assessments under review. EPA uses five general criteria to set these priorities: (1) Potential public health impact; (2) EPA statutory, regulatory, or program-specific implementation needs; (3) availability of new scientific information or methodology that might significantly change the current IRIS information; (4) interest to other governmental agencies or the public; and (5) availability of other scientific assessment documents that could serve as a basis for an IRIS assessment. The decision to assess any given chemical substance depends on available Agency resources. Availability of risk assessment guidance, guidelines, and science policy decisions may also have an impact on the timing of EPA’s decision to assess a chemical substance. EPA is soliciting public involvement in assessments on the IRIS agenda, including new assessments starting in 2008. While EPA conducts a thorough literature search for each chemical substance, there may be unpublished studies or other primary technical sources that are not available through the open literature. EPA would appreciate receiving scientific information from the public during the information gathering stage for the assessments listed in this notice. Interested persons should provide scientific analyses, studies, and other pertinent scientific information. While EPA is primarily soliciting information on new assessments starting in 2008, the public may submit information on any chemical substance at any time. This notice provides: (1) A list of IRIS assessments in progress; (2) a list of new IRIS assessments starting in 2008; and (3) instructions to the public for submitting scientific information to EPA pertinent to the development of assessments. Assessments in Progress The following assessments are underway. The status and planned milestone dates for each assessment can be found on the IRIS Track system, accessible from the IRIS database. All health endpoints due to chronic exposure, cancer and noncancer, are being assessed unless otherwise noted. For all endpoints assessed, both qualitative and quantitative assessments are being developed where information is available. mstockstill on PROD1PC66 with NOTICES Substance name CAS No. acetaldehyde ............................................................................................................................................................................ acrylamide ................................................................................................................................................................................ acrylonitrile ............................................................................................................................................................................... antimony .................................................................................................................................................................................. arsenic, inorganic ..................................................................................................................................................................... asbestos ................................................................................................................................................................................... benzo[a]pyrene ........................................................................................................................................................................ beryllium (cancer) .................................................................................................................................................................... bromobenzene ......................................................................................................................................................................... butyl benzyl phthalate .............................................................................................................................................................. cadmium .................................................................................................................................................................................. carbon tetrachloride ................................................................................................................................................................. cerium oxide and cerium compounds ..................................................................................................................................... chlordecone (kepone) .............................................................................................................................................................. chloroethane ............................................................................................................................................................................ chloroform ................................................................................................................................................................................ chloroprene .............................................................................................................................................................................. cobalt ....................................................................................................................................................................................... copper ...................................................................................................................................................................................... dibutyl phthalate ....................................................................................................................................................................... 1,2-dichlorobenzene ................................................................................................................................................................ 1,3-dichlorobenzene ................................................................................................................................................................ 1,4-dichlorobenzene ................................................................................................................................................................ cis-1,2-dichloroethylene ........................................................................................................................................................... trans-1,2-dichloroethylene ....................................................................................................................................................... VerDate Aug<31>2005 18:37 Dec 20, 2007 Jkt 214001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1 75–07–0 79–06–1 107–13–1 7440–36–0 7440–38–2 1332–21–4 50–32–8 7440–41–7 108–86–1 85–68–7 7440–43–9 56–23–5 1306–38–3 143–50–0 75–00–3 67–66–3 126–99–8 7440–48–4 7440–50–8 84–74–2 95–50–1 541–73–1 106–46–7 156–59–2 156–60–5 72717 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices Substance name CAS No. mstockstill on PROD1PC66 with NOTICES dichloromethane (methylene chloride) .................................................................................................................................... di(2-ethylhexyl)adipate ............................................................................................................................................................. di(2-ethylhexyl)phthalate .......................................................................................................................................................... 1,4-dioxane .............................................................................................................................................................................. ethanol ..................................................................................................................................................................................... ethyl tert-butyl ether ................................................................................................................................................................. ethylbenzene ............................................................................................................................................................................ ethylene dichloride ................................................................................................................................................................... ethylene glycol monobutyl ether .............................................................................................................................................. ethylene oxide (cancer) ........................................................................................................................................................... formaldehyde ........................................................................................................................................................................... hexachlorobutadiene ................................................................................................................................................................ hexachloroethane .................................................................................................................................................................... hexahydro-1,3,5-trinitro-triazine (RDX) .................................................................................................................................... 2-hexanone .............................................................................................................................................................................. hydrogen cyanide .................................................................................................................................................................... isopropanol .............................................................................................................................................................................. methanol .................................................................................................................................................................................. methyl tert-butyl ether (MTBE) ................................................................................................................................................ mirex ........................................................................................................................................................................................ naphthalene ............................................................................................................................................................................. nickel (soluble salts) ................................................................................................................................................................ nitrobenzene ............................................................................................................................................................................ pentachlorophenol ................................................................................................................................................................... perfluorooctanoic acid—ammonium salt ................................................................................................................................. perfluorooctane sulfonate—potassium salt ............................................................................................................................. platinum ................................................................................................................................................................................... polycyclic aromatic hydrocarbon (PAH) mixtures .................................................................................................................... polybrominated diphenyl ethers tetraBDE .................................................................................................................................................................................. pentaBDE ................................................................................................................................................................................. hexaBDE .................................................................................................................................................................................. decaBDE .................................................................................................................................................................................. polychlorinated biphenyls (PCBs) (noncancer) ....................................................................................................................... propionaldehyde ...................................................................................................................................................................... refractory ceramic fibers .......................................................................................................................................................... styrene ..................................................................................................................................................................................... 2,3,7,8-tetrachlorodibenzo-p-dioxin ......................................................................................................................................... and related compounds .................................................................................................................................................... 1,1,2,2-tetrachloroethane ......................................................................................................................................................... tetrachloroethylene (perchloroethylene) .................................................................................................................................. tetrahydrofuran ......................................................................................................................................................................... thallium ..................................................................................................................................................................................... trichloroacetic acid ................................................................................................................................................................... trichloroethylene ....................................................................................................................................................................... 1,2,3-trichloropropane .............................................................................................................................................................. uranium compounds ................................................................................................................................................................ vinyl acetate ............................................................................................................................................................................. The following assessments were completed in FY2006 and FY2007: nhexane; phosgene; 1,1,1-trichloroethane; 2,2,4-trimethylpentane. The following assessments are being withdrawn from the IRIS agenda at the request of the EPA Office of Water: aldicarb, aldicarb sulfoxide, and aldicarb sulfone. Assessments of these chemicals will be completed by the EPA Office of Pesticide Programs. The following assessments are being withdrawn by the EPA Office of Research and Development: acrolein (acute), benzene (acute), ethylene oxide (acute), phosgene (acute), hexachlorocyclopentadiene (acute), and hydrogen sulfide (acute). IRIS assessments for all substances listed as on-going assessments will be provided on the IRIS Web site at http://www.epa.gov/iris as they are completed. This publicly available Web site is EPA’s primary location for IRIS documents. In addition, external peer review drafts of IRIS assessments are posted for public information and comment. These drafts will continue to be accessible via the IRIS and NCEA Information Requested on New Assessments for 2008 EPA developed a list of priority chemicals for 2008 from nominations from the EPA programs and from the public received in response to the December 22, 2006, Federal Register notice requesting public nominations (71 FR 77017). The following chemicals were nominated and have been selected for inclusion in the IRIS agenda. CAS No. alkylates .............................................................................................................................................................................. ammonia .............................................................................................................................................................................. tert-amyl methyl ether ......................................................................................................................................................... 18:37 Dec 20, 2007 Jkt 214001 PO 00000 Frm 00053 Fmt 4703 5436–43–1 60348–60–9 68631–49–2 1163–19–5 1336–36–3 123–38–6 not applicable 100–42–5 1746–01–6 various 79–34–5 127–18–4 109–99–9 7440–28–0 76–03–9 79–01–6 96–18–4 7440–61–1 108–05–4 Web sites. Note that these drafts are intended for public information. Substance name VerDate Aug<31>2005 75–09–2 103–23–1 117–81–7 123–91–1 64–17–5 637–92–3 100–41–4 107–06–2 111–76–2 75–21–8 50–00–0 87–68–3 67–72–1 121–82–4 591–78–6 74–90–8 67–63–0 67–56–1 1634–04–4 2385–85–5 91–20–3 (various) 98–95–3 87–86–5 3825–26–1 2795–39–3 7440–06–4 various Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1 various. 7664–41–7 994–05–8 72718 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices CAS No. bisphenol A ......................................................................................................................................................................... biphenyl ............................................................................................................................................................................... n-butanol ............................................................................................................................................................................. tert-butanol .......................................................................................................................................................................... carbonyl sulfide ................................................................................................................................................................... chromium VI ........................................................................................................................................................................ diethyl phthalate .................................................................................................................................................................. diisopropyl ether .................................................................................................................................................................. 4,4-dimethyl-3-oxahexane ................................................................................................................................................... hexabromocyclododecane (mixed stereoisomers) ............................................................................................................. manganese .......................................................................................................................................................................... toxaphene (weathered) ....................................................................................................................................................... 1,2,4-trimethylbenzene ........................................................................................................................................................ 1,3,5-trimethylbenzene ........................................................................................................................................................ tungsten ............................................................................................................................................................................... urea ..................................................................................................................................................................................... vanadium pentoxide ............................................................................................................................................................ mstockstill on PROD1PC66 with NOTICES Substance name 80–05–7 92–52–4 71–36–3 75–65–0 463–58–1 18540–29–9 84–66–2 108–20–3 919–94–8 3194–55–6; 25637–99–4 7439–9 8001–35–2 95–63–6 108–67–8 7440–33–7 57–123–6 1314–62–1 EPA is conducting literature searches for these chemicals in 2008. Based on the results of the literature searches and as EPA resources allow, assessments will be started for those chemicals with data that may support development of one or more toxicity values. With this IRIS agenda announcement, EPA is starting a new process to actively solicit information from the public at the beginning of assessment development. As literature searches are completed, the results will be posted on the IRIS Web site (http://www.epa.gov/ iris). The public is invited to review the literature search results and submit additional information to EPA. Literature search results are currently available at http://www.epa.gov/iris for tert-amyl methyl ether, biphenyl, n-butanol, tert-butanol, carbonyl sulfide, diethyl phthalate, diisopropyl ether, hexabromocyclodecane, weathered toxaphene, tungsten, and urea. Additional literature searches will be posted in batches as they are completed. Availability will be announced in the Federal Register. Instructions on how to submit information are provided below under General Information. While the annual prioritization process responds to the needs expressed by IRIS users, EPA is also systematically updating the IRIS database. On a cyclical basis, the IRIS Program conducts screening-level reviews of the available scientific literature for all chemicals in the IRIS database that are not under active reassessment. The purpose of EPA’s screening level review is to reach preliminary determinations regarding the likelihood that a full reassessment based on an evaluation of new health effects literature could potentially result in significant changes to existing toxicity values or cancer weight-of-evidence designations. The process consists of a preliminary search and review of the literature through VerDate Aug<31>2005 18:37 Dec 20, 2007 Jkt 214001 standard toxicological bibliographic databases (titles and abstracts) and selected literature compilations to identify new major studies that have become available since the existing IRIS assessment was completed. The results of the screening-level review for an IRIS chemical can be found on the IRIS Web site (http://www.epa.gov/iris) by selecting the specific IRIS Summary of Interest. EPA has started a program to systematically update assessments on the IRIS database. This program addresses assessments that were completed more than 10 years ago and have one or more toxicity values for which new data or new methods of analysis have been identified that could possibly change a toxicity value or a cancer weight-of-evidence descriptor. EPA is developing a protocol for prioritizing and updating these assessments. We continue to request the submission of any scientific information that you would like EPA to consider in confirming the results of the literature screening review and literature screen verification. Instructions for submitting information are provided below. General Information As of Monday, November 28, 2005, EPA’s EDOCKET was replaced by the Federal Docket Management System (FDMS), the new federal governmentwide system. FDMS was created to provide a single point of access to all federal rulemaking activities. All materials previously found in EDOCKET are now available on the internet at http://www.regulations.gov. A. How Can I Get Copies of Related Information? EPA has established an official public docket for this action under Docket ID No. EPA–HQ–ORD–2007–0664. The PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 official public docket is the collection of materials that is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 OEI Docket is (202) 566–1752. An electronic version of the public docket is available through EPA’s electronic public docket and comment system. EPA Dockets at http:// www.regulations.gov may be used to submit or view public submissions, to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ‘‘search,’’ then key in the appropriate docket identification number. It is important to note that EPA’s policy is that public submissions, whether submitted electronically or in paper, will be made available for public viewing in EPA’s electronic public docket as EPA receives them and without change, unless the submission contains copyrighted material, confidential business information (CBI), or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute are not included in the official public docket or in EPA’s electronic public docket. EPA’s policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA’s electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket E:\FR\FM\21DEN1.SGM 21DEN1 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center. ENVIRONMENTAL PROTECTION AGENCY B. How and to Whom Do I Submit Information? Draft Integrated Science Assessment for Oxides of Nitrogen and SulfurEnvironmental Criteria mstockstill on PROD1PC66 with NOTICES Information on chemical substances listed in this notice may be submitted as provided in the ADDRESSES section. If you submit electronic information, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your submission and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the information and allows EPA to contact you in case EPA cannot read your information due to technical difficulties or needs further information on the substance of your submission. Any identifying or contact information provided in the body of submitted information will be included as part of the submission information that is placed in the official public docket, and made available in EPA’s electronic public docket. If EPA cannot read your information due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your information. EPA’s preferred method for receiving submissions is via EPA’s electronic public docket. The electronic public docket system is an ‘‘anonymous access’’ system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your submission. In contrast to EPA’s electronic public docket, EPA’s electronic mail (e-mail) system is not an ‘‘anonymous access’’ system. If you send e-mail directly to the docket without going through EPA’s electronic public docket, your e-mail address is automatically captured and included as part of the submission that is placed in the official public docket, and made available in EPA’s electronic public docket. Dated: December 6, 2007. Peter Preuss, Director, National Center for Environmental Assessment. [FR Doc. E7–24844 Filed 12–20–07; 8:45 am] BILLING CODE 6560–50–P VerDate Aug<31>2005 18:37 Dec 20, 2007 Jkt 214001 [FRL–8509–8; Docket ID No. EPA–HQ–OAR– 2007–1145] Environmental Protection Agency (EPA). ACTION: Notice of public comment period for draft Integrated Science Assessment for Oxides of Nitrogen and Sulfur—Environmental Criteria. AGENCY: SUMMARY: The EPA is announcing the public comment period for the draft document titled, ‘‘Integrated Science Assessment for Oxides of Nitrogen and Sulfur—Environmental Criteria; First External Review Draft’’ (EPA/600/R–07/ 145A). The draft document was prepared by the National Center for Environmental Assessment within EPA’s Office of Research and Development as part of the Agency’s review of the secondary (welfare-based) national ambient air quality standards (NAAQS) for nitrogen dioxide (NO2) and sulfur dioxide (SO2). EPA is releasing this draft document solely for the purpose of seeking comment from the public and the Clean Air Scientific Advisory Committee (CASAC). The document is being distributed solely for the purpose of pre-dissemination review under applicable information quality guidelines. It does not represent and should not be construed to represent any Agency policy, viewpoint, or determination. EPA will consider any public comments submitted in accordance with this notice when revising the document. DATES: The public comment period begins on or about December 21, 2007. Comments must be received on or before February 21, 2008. ADDRESSES: The draft, ‘‘Integrated Science Assessment for Oxides of Nitrogen and Sulfur—Environmental Criteria; First External Review Draft,’’ will be available primarily via the Internet on the National Center for Environmental Assessment’s home page under the Recent Additions and Publications menus at http:// www.epa.gov/ncea. A limited number of CD–ROM or paper copies will be available. Contact Ms. Emily Lee by phone: 919–541–4169, fax: 919–541–1818, or e-mail: (lee.emily@epa.gov) to request either of these, and please provide your name, your mailing address, and the draft document title, ‘‘Integrated Science Assessment for Oxides of Nitrogen and PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 72719 Sulfur—Environmental Criteria; First External Review Draft’’ (EPA/600/R–07/ 145A) to facilitate processing of your request. Comments may be submitted electronically via http:// www.regulations.gov, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions provided in the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: Ms. Emily Lee, NCEA; telephone: 919–541– 4169, facsimile: 919–541–1818, or email: lee.emily@epa.gov. For technical information, contact Tara Greaver, PhD, NCEA; telephone: 919–541–2435; facsimile: 919–541–1818; or e-mail: Greaver.Tara@epa.gov. SUPPLEMENTARY INFORMATION: I. Information About the Document Section 108(a) of the Clean Air Act directs the Administrator to identify certain pollutants which ‘‘may reasonably be anticipated to endanger public health and welfare’’ and to issue air quality criteria for them. These air quality criteria are to ‘‘accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air.’’ Under section 109 of the Act, EPA is then to establish national ambient air quality standards (NAAQS) for each pollutant for which EPA has issued criteria. Section 109(d) of the Act subsequently requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health and welfare. EPA is also to revise the NAAQS, if appropriate, based on the revised air quality criteria. Oxides of nitrogen and sulfur are two of six principal (or ‘‘criteria’’) pollutants for which EPA has established air quality criteria and NAAQS. EPA periodically reviews the scientific basis for these standards by preparing an Integrated Science Assessment (ISA) (formerly called an Air Quality Criteria Document). The ISA and supplementary annexes, in conjunction with additional technical and policy assessments, provide the scientific basis for EPA decisions on the adequacy of a current NAAQS and the appropriateness of new or revised standards. The Clean Air Scientific Advisory Committee (CASAC), an independent science advisory committee established pursuant to section 109 of the Clean Air Act and part of the EPA’s Science Advisory Board (SAB), provides E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72715-72719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24844]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8509-7; Docket ID No. EPA-HQ-ORD-2007-0664]


Integrated Risk Information System (IRIS); Announcement of 2008 
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for information.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
the IRIS 2008 agenda and requesting scientific information on health 
effects that may result from exposure to the chemical substances on the 
agenda, including assessments that EPA is starting this year. The 
Integrated Risk Information System (IRIS) is an EPA database that 
contains the Agency's scientific positions on human health effects that 
may result from exposure to chemical substances in the environment. 
Assessments currently in progress are listed in this notice.

DATES: While EPA is not expressly soliciting comments on this notice, 
the Agency will accept information related to the substances included 
herein. Please submit any information in accordance with the 
instructions provided below.

ADDRESSES: Please submit relevant scientific information identified by 
docket ID number EPA-HQ-ORD-2007-0664, online at http://
www.regulations.gov (EPA's preferred method); by e-mail to 
ord.docket@epa.gov; mailed to Office of Environmental Information (OEI) 
Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; or by hand delivery 
or courier to EPA Docket Center, EPA West, Room 3334, 1301 Constitution 
Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday 
through Friday, excluding legal holidays. Comments on a disk or CD-ROM 
should be formatted in Word or as an ASCII file, avoiding the use of 
special characters and any form of encryption, and may be mailed to the 
mailing address above.

FOR FURTHER INFORMATION CONTACT: For information on the IRIS program, 
contact Dr. Abdel-Razak Kadry, IRIS Program Director, National Center 
for Environmental Assessment, (mail code: 8601D), Office of Research 
and Development, U.S. Environmental Protection Agency, Washington, DC 
20460; telephone: (202) 564-1645, facsimile: (202) 565-0075; or e-mail: 
kadry.abdel@epa.gov.

[[Page 72716]]

    For general questions about access to IRIS, or the content of IRIS, 
please call the IRIS Hotline at (202) 566-1676 or send electronic mail 
inquiries to hotline.iris@epa.gov.

SUPPLEMENTARY INFORMATION:

Background

    IRIS is a database of human health effects that may result from 
exposure to various chemical substances found in the environment. (EPA 
notes that information in the IRIS database has no preclusive effect 
and does not predetermine the outcome of any rulemaking. When EPA uses 
such information to support a rulemaking, the scientific basis for, and 
the application of, that information are subject to comment.) IRIS 
currently provides information on health effects associated with more 
than 500 chemical substances.
    The database includes chemical-specific summaries of qualitative 
and quantitative health information in support of the first two steps 
of the risk assessment process, i.e., hazard identification and dose-
response evaluation. Combined with specific situational exposure 
assessment information, the information in IRIS is an important source 
in evaluating potential public health risks from environmental 
contaminants.
    EPA's overall process for developing IRIS assessments consists of: 
(1) Publication of an annual Federal Register announcement of EPA's 
IRIS agenda and call for scientific information from the public on 
selected chemical substances; (2) a comprehensive search of the current 
scientific literature; (3) development of a draft IRIS health 
assessment utilizing state of the art scientific methods and 
guidelines; (4) internal EPA review of the draft assessment; (5) 
interagency review of the draft assessment; (6) public comment followed 
by independent external peer review of the draft assessment; (7) a 
public external peer review meeting related to the draft assessment; 
(8) preparation of a final IRIS assessment that reflects public 
comments and independent expert review; (9) interagency review of the 
final assessment; (10) EPA review and clearance of the final 
assessment; and (11) posting of the final IRIS assessment on the IRIS 
database (http://www.epa.gov/iris).

The IRIS Annual Agenda

    Each year, EPA develops a priority list of chemicals and an annual 
agenda for the IRIS program and announces new assessments under review. 
EPA uses five general criteria to set these priorities: (1) Potential 
public health impact; (2) EPA statutory, regulatory, or program-
specific implementation needs; (3) availability of new scientific 
information or methodology that might significantly change the current 
IRIS information; (4) interest to other governmental agencies or the 
public; and (5) availability of other scientific assessment documents 
that could serve as a basis for an IRIS assessment. The decision to 
assess any given chemical substance depends on available Agency 
resources. Availability of risk assessment guidance, guidelines, and 
science policy decisions may also have an impact on the timing of EPA's 
decision to assess a chemical substance.
    EPA is soliciting public involvement in assessments on the IRIS 
agenda, including new assessments starting in 2008. While EPA conducts 
a thorough literature search for each chemical substance, there may be 
unpublished studies or other primary technical sources that are not 
available through the open literature. EPA would appreciate receiving 
scientific information from the public during the information gathering 
stage for the assessments listed in this notice. Interested persons 
should provide scientific analyses, studies, and other pertinent 
scientific information. While EPA is primarily soliciting information 
on new assessments starting in 2008, the public may submit information 
on any chemical substance at any time.
    This notice provides: (1) A list of IRIS assessments in progress; 
(2) a list of new IRIS assessments starting in 2008; and (3) 
instructions to the public for submitting scientific information to EPA 
pertinent to the development of assessments.

Assessments in Progress

    The following assessments are underway. The status and planned 
milestone dates for each assessment can be found on the IRIS Track 
system, accessible from the IRIS database. All health endpoints due to 
chronic exposure, cancer and noncancer, are being assessed unless 
otherwise noted. For all endpoints assessed, both qualitative and 
quantitative assessments are being developed where information is 
available.

------------------------------------------------------------------------
           Substance name                           CAS No.
------------------------------------------------------------------------
acetaldehyde........................  75-07-0
acrylamide..........................  79-06-1
acrylonitrile.......................  107-13-1
antimony............................  7440-36-0
arsenic, inorganic..................  7440-38-2
asbestos............................  1332-21-4
benzo[a]pyrene......................  50-32-8
beryllium (cancer)..................  7440-41-7
bromobenzene........................  108-86-1
butyl benzyl phthalate..............  85-68-7
cadmium.............................  7440-43-9
carbon tetrachloride................  56-23-5
cerium oxide and cerium compounds...  1306-38-3
chlordecone (kepone)................  143-50-0
chloroethane........................  75-00-3
chloroform..........................  67-66-3
chloroprene.........................  126-99-8
cobalt..............................  7440-48-4
copper..............................  7440-50-8
dibutyl phthalate...................  84-74-2
1,2-dichlorobenzene.................  95-50-1
1,3-dichlorobenzene.................  541-73-1
1,4-dichlorobenzene.................  106-46-7
cis-1,2-dichloroethylene............  156-59-2
trans-1,2-dichloroethylene..........  156-60-5

[[Page 72717]]

 
dichloromethane (methylene chloride)  75-09-2
di(2-ethylhexyl)adipate.............  103-23-1
di(2-ethylhexyl)phthalate...........  117-81-7
1,4-dioxane.........................  123-91-1
ethanol.............................  64-17-5
ethyl tert-butyl ether..............  637-92-3
ethylbenzene........................  100-41-4
ethylene dichloride.................  107-06-2
ethylene glycol monobutyl ether.....  111-76-2
ethylene oxide (cancer).............  75-21-8
formaldehyde........................  50-00-0
hexachlorobutadiene.................  87-68-3
hexachloroethane....................  67-72-1
hexahydro-1,3,5-trinitro-triazine     121-82-4
 (RDX).
2-hexanone..........................  591-78-6
hydrogen cyanide....................  74-90-8
isopropanol.........................  67-63-0
methanol............................  67-56-1
methyl tert-butyl ether (MTBE)......  1634-04-4
mirex...............................  2385-85-5
naphthalene.........................  91-20-3
nickel (soluble salts)..............  (various)
nitrobenzene........................  98-95-3
pentachlorophenol...................  87-86-5
perfluorooctanoic acid--ammonium      3825-26-1
 salt.
perfluorooctane sulfonate--potassium  2795-39-3
 salt.
platinum............................  7440-06-4
polycyclic aromatic hydrocarbon       various
 (PAH) mixtures.
polybrominated diphenyl ethers
tetraBDE............................  5436-43-1
pentaBDE............................  60348-60-9
hexaBDE.............................  68631-49-2
decaBDE.............................  1163-19-5
polychlorinated biphenyls (PCBs)      1336-36-3
 (noncancer).
propionaldehyde.....................  123-38-6
refractory ceramic fibers...........  not applicable
styrene.............................  100-42-5
2,3,7,8-tetrachlorodibenzo-p-dioxin.  1746-01-6
    and related compounds...........  various
1,1,2,2-tetrachloroethane...........  79-34-5
tetrachloroethylene                   127-18-4
 (perchloroethylene).
tetrahydrofuran.....................  109-99-9
thallium............................  7440-28-0
trichloroacetic acid................  76-03-9
trichloroethylene...................  79-01-6
1,2,3-trichloropropane..............  96-18-4
uranium compounds...................  7440-61-1
vinyl acetate.......................  108-05-4
------------------------------------------------------------------------

    The following assessments were completed in FY2006 and FY2007: n-
hexane; phosgene; 1,1,1-trichloroethane; 2,2,4-trimethylpentane. The 
following assessments are being withdrawn from the IRIS agenda at the 
request of the EPA Office of Water: aldicarb, aldicarb sulfoxide, and 
aldicarb sulfone. Assessments of these chemicals will be completed by 
the EPA Office of Pesticide Programs. The following assessments are 
being withdrawn by the EPA Office of Research and Development: acrolein 
(acute), benzene (acute), ethylene oxide (acute), phosgene (acute), 
hexachlorocyclopentadiene (acute), and hydrogen sulfide (acute).
    IRIS assessments for all substances listed as on-going assessments 
will be provided on the IRIS Web site at http://www.epa.gov/iris as 
they are completed. This publicly available Web site is EPA's primary 
location for IRIS documents. In addition, external peer review drafts 
of IRIS assessments are posted for public information and comment. 
These drafts will continue to be accessible via the IRIS and NCEA Web 
sites. Note that these drafts are intended for public information.

Information Requested on New Assessments for 2008

    EPA developed a list of priority chemicals for 2008 from 
nominations from the EPA programs and from the public received in 
response to the December 22, 2006, Federal Register notice requesting 
public nominations (71 FR 77017). The following chemicals were 
nominated and have been selected for inclusion in the IRIS agenda.

------------------------------------------------------------------------
          Substance name                           CAS No.
------------------------------------------------------------------------
alkylates.........................  various.
ammonia...........................  7664-41-7
tert-amyl methyl ether............  994-05-8

[[Page 72718]]

 
bisphenol A.......................  80-05-7
biphenyl..........................  92-52-4
n-butanol.........................  71-36-3
tert-butanol......................  75-65-0
carbonyl sulfide..................  463-58-1
chromium VI.......................  18540-29-9
diethyl phthalate.................  84-66-2
diisopropyl ether.................  108-20-3
4,4-dimethyl-3-oxahexane..........  919-94-8
hexabromocyclododecane (mixed       3194-55-6; 25637-99-4
 stereoisomers).
manganese.........................  7439-9
toxaphene (weathered).............  8001-35-2
1,2,4-trimethylbenzene............  95-63-6
1,3,5-trimethylbenzene............  108-67-8
tungsten..........................  7440-33-7
urea..............................  57-123-6
vanadium pentoxide................  1314-62-1
------------------------------------------------------------------------

    EPA is conducting literature searches for these chemicals in 2008. 
Based on the results of the literature searches and as EPA resources 
allow, assessments will be started for those chemicals with data that 
may support development of one or more toxicity values.
    With this IRIS agenda announcement, EPA is starting a new process 
to actively solicit information from the public at the beginning of 
assessment development. As literature searches are completed, the 
results will be posted on the IRIS Web site (http://www.epa.gov/iris). 
The public is invited to review the literature search results and 
submit additional information to EPA. Literature search results are 
currently available at http://www.epa.gov/iris for tert-amyl methyl 
ether, biphenyl, n-butanol, tert-butanol, carbonyl sulfide, diethyl 
phthalate, diisopropyl ether, hexabromocyclodecane, weathered 
toxaphene, tungsten, and urea. Additional literature searches will be 
posted in batches as they are completed. Availability will be announced 
in the Federal Register. Instructions on how to submit information are 
provided below under General Information.
    While the annual prioritization process responds to the needs 
expressed by IRIS users, EPA is also systematically updating the IRIS 
database. On a cyclical basis, the IRIS Program conducts screening-
level reviews of the available scientific literature for all chemicals 
in the IRIS database that are not under active reassessment. The 
purpose of EPA's screening level review is to reach preliminary 
determinations regarding the likelihood that a full reassessment based 
on an evaluation of new health effects literature could potentially 
result in significant changes to existing toxicity values or cancer 
weight-of-evidence designations. The process consists of a preliminary 
search and review of the literature through standard toxicological 
bibliographic databases (titles and abstracts) and selected literature 
compilations to identify new major studies that have become available 
since the existing IRIS assessment was completed. The results of the 
screening-level review for an IRIS chemical can be found on the IRIS 
Web site (http://www.epa.gov/iris) by selecting the specific IRIS 
Summary of Interest.
    EPA has started a program to systematically update assessments on 
the IRIS database. This program addresses assessments that were 
completed more than 10 years ago and have one or more toxicity values 
for which new data or new methods of analysis have been identified that 
could possibly change a toxicity value or a cancer weight-of-evidence 
descriptor. EPA is developing a protocol for prioritizing and updating 
these assessments.
    We continue to request the submission of any scientific information 
that you would like EPA to consider in confirming the results of the 
literature screening review and literature screen verification. 
Instructions for submitting information are provided below.

General Information

    As of Monday, November 28, 2005, EPA's EDOCKET was replaced by the 
Federal Docket Management System (FDMS), the new federal government-
wide system. FDMS was created to provide a single point of access to 
all federal rulemaking activities. All materials previously found in 
EDOCKET are now available on the internet at http://
www.regulations.gov.

A. How Can I Get Copies of Related Information?

    EPA has established an official public docket for this action under 
Docket ID No. EPA-HQ-ORD-2007-0664. The official public docket is the 
collection of materials that is available for public viewing at the 
Office of Environmental Information (OEI) Docket in the EPA Docket 
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, 
DC. The EPA Docket Center 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 OEI Docket is (202) 566-1752.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system. EPA Dockets at 
http://www.regulations.gov may be used to submit or view public 
submissions, to access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once in the system, select 
``search,'' then key in the appropriate docket identification number.
    It is important to note that EPA's policy is that public 
submissions, whether submitted electronically or in paper, will be made 
available for public viewing in EPA's electronic public docket as EPA 
receives them and without change, unless the submission contains 
copyrighted material, confidential business information (CBI), or other 
information whose disclosure is restricted by statute. Information 
claimed as CBI and other information whose disclosure is restricted by 
statute are not included in the official public docket or in EPA's 
electronic public docket. EPA's policy is that copyrighted material, 
including copyrighted material contained in a public comment, will not 
be placed in EPA's electronic public docket but will be available only 
in printed, paper form in the official public docket. Although not all 
docket

[[Page 72719]]

materials may be available electronically, you may still access any of 
the publicly available docket materials through the EPA Docket Center.

B. How and to Whom Do I Submit Information?

    Information on chemical substances listed in this notice may be 
submitted as provided in the ADDRESSES section. If you submit 
electronic information, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your submission and with any disk or CD ROM you submit. 
This ensures that you can be identified as the submitter of the 
information and allows EPA to contact you in case EPA cannot read your 
information due to technical difficulties or needs further information 
on the substance of your submission. Any identifying or contact 
information provided in the body of submitted information will be 
included as part of the submission information that is placed in the 
official public docket, and made available in EPA's electronic public 
docket. If EPA cannot read your information due to technical 
difficulties and cannot contact you for clarification, EPA may not be 
able to consider your information.
    EPA's preferred method for receiving submissions is via EPA's 
electronic public docket. The electronic public docket system is an 
``anonymous access'' system, which means EPA will not know your 
identity, e-mail address, or other contact information unless you 
provide it in the body of your submission. In contrast to EPA's 
electronic public docket, EPA's electronic mail (e-mail) system is not 
an ``anonymous access'' system. If you send e-mail directly to the 
docket without going through EPA's electronic public docket, your e-
mail address is automatically captured and included as part of the 
submission that is placed in the official public docket, and made 
available in EPA's electronic public docket.

    Dated: December 6, 2007.
Peter Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E7-24844 Filed 12-20-07; 8:45 am]
BILLING CODE 6560-50-P