[Federal Register Volume 69, Number 10 (Thursday, January 15, 2004)] [Notices] [Pages 2468-2473] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 04-894] [[Page 2467]] ----------------------------------------------------------------------- Part V Environmental Protection Agency ----------------------------------------------------------------------- Fifty-Third Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments; Notice Federal Register / Vol. 69, No. 10 / Thursday, January 15, 2004 / Notices [[Page 2468]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPPT-2003-0068; FRL-7335-2] Fifty-Third Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its Fifty-Third Report to the Administrator of the EPA on December 2, 2003. In the 53\rd\ ITC Report, which is included with this notice, the ITC is revising the Priority Testing List by adding 3 pyridinamines and 20 tungsten compounds. The ITC is requesting that EPA add the 3 pyridinamines and 20 tungsten compounds to the TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule. In addition, the ITC is soliciting voluntary use, exposure, and effects information for 3 pyridinamines, 20 tungsten compounds, and 43 vanadium compounds through its Voluntary Information Submissions Innovative Online Network (VISION). DATES: Comments, identified by docket ID number OPPT-2003-0068, must be received on or before February 17, 2004. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Director, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (202) 554-1404; e-mail address: [email protected]. For technical information contact: John D. Walker, Director, TSCA Interagency Testing Committee (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-7527; fax: (202) 564-7528; e-mail address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This notice is directed to the public in general. It may, however, be of particular interest to you if you manufacture (defined by statute to include import) and/or process TSCA-covered chemicals. Potentially affected entities may include, but are not limited to: [sbull] Chemical Industry, e.g., NAICS 325, Manufacturers. [sbull] Petroleum Industry, e.g., NAICS 32411, Refineries. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPPT-2003-0068. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566- 0280. 2. Electronic access. This Federal Register document may be accessed electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. You may also access additional information about the ITC at http://www.epa.gov/opptintr/itc/ and VISION at http://www.epa.gov/opptintr/itc/vision.htm. An electronic version of the public docket is available through EPA's electronic public docket at http://www.epa.gov/edocket/. EPA's electronic public docket may be used to submit or view public comments, access the index of the docket's contents, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, any of the publicly available docket materials may be accessed through the docket facility identified in Unit I.B.1. Once in the system, select ``search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, 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 comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. [[Page 2469]] C. How and to Whom Do I Submit Comments? Comments may be submitted electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked ``late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. Once in the system, select ``search,'' and then key in docket ID number OPPT-2003-0068. The 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 comment. ii. E-mail. Comments may be sent by e-mail to [email protected], Attention: Docket ID Number OPPT-2003-0068. In contrast to EPA's electronic public docket, EPA's e-mail system is not an ``anonymous access'' system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. 3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT-2003-0068. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. D. How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? We invite you to provide your views and comments on the 53\rd\ ITC Report. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. 4. Provide specific examples to illustrate your concerns. 5. Make sure to submit your comments by the deadline in this notice. 6. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Background The Toxic Substances Control Act (TSCA) (15 U.S.C. 260let seq.) authorizes the Administrator of the EPA to promulgate regulations under section 4(a) requiring testing of chemicals and chemical mixtures in order to develop data relevant to determining the risks that such chemicals and chemical mixtures may present to health or the environment. Section 4(e) of TSCA established the ITC to recommend chemicals and chemical mixtures to the Administrator of the EPA for priority testing consideration. Section 4(e) of TSCA directs the ITC to revise the TSCA section 4(e) Priority Testing List at least every 6 months. A. The ITC's 53\rd\ Report The 53\rd\ ITC Report was transmitted to the EPA's Administrator on December 2, 2003, and is included in this notice. In the 53\rd\ ITC Report, the ITC revises the Priority Testing List by adding 3 pyridinamines and 20 tungsten compounds, requests that EPA add the pyridinamines and tungsten compounds to the TSCA section 8(a) PAIR rule and solicits voluntary use, exposure, and effects information for pyridinamines, tungsten compounds, and vanadium compounds. B. Status of the Priority Testing List The current TSCA 4(e) Priority Testing List as of November 2003 can be found in Table 1 of the 53\rd\ ITC Report, which is included in this notice. [[Page 2470]] List of Subjects Environmental protection, Chemicals, Hazardous substances. Dated: January 8, 2004. Charles M. Auer, Director, Office of Pollution Prevention and Toxics. Fifty-Third Report of the TSCA Interagency Testing Committee to the Administrator, U.S. Environmental Protection Agency Table of Contents Summary The TSCA Section 4(e) Priority Testing List I. Background II. TSCA Section 8 Reporting A. TSCA Section 8 Reporting Rules B. ITC's Use of TSCA Section 8 and Other Information C. New Requests to Add Chemicals to the TSCA Section 8(a) PAIR Rule D. Previous Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule III. ITC's Activities During this Reporting Period (May to November 2003) IV. Revisions to the TSCA Section 4(e) Priority Testing List V. References VI. The TSCA Interagency Testing Committee Summary In this 53\rd\ Report, the ITC is revising the Priority Testing List by adding 3 pyridinamines and 20 tungsten compounds. The ITC is requesting that EPA add the 3 pyridinamines and 20 tungsten compounds to the TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule. The TSCA section 4(e) Priority Testing List follows as Table 1 of this unit. Table 1.--The TSCA Section 4(e) Priority Testing List (November 2003) ---------------------------------------------------------------------------------------------------------------- ITC Report Date Chemical name/Group Action ---------------------------------------------------------------------------------------------------------------- 31 January 1993 13 Chemicals with Designated insufficient dermal absorption rate data ------------------------------------ 32 May 1993 16 Chemicals with Designated insufficient dermal absorption rate data ------------------------------------ 35 November 1994 4 Chemicals with Designated insufficient dermal absorption rate data ------------------------------------ 37 November 1995 4-tert-Butylphenol and Recommended Branched nonylphenol (mixed isomers) ------------------------------------ 41 November 1997 Phenol, 4-(1,1,3,3- Recommended tetramethylbutyl)- ------------------------------------ 42 May 1998 3-Amino-5-mercapto-1,2,4- Recommended triazole ------------------------------------ 42 May 1998 Glycoluril Recommended ------------------------------------ 47 November 2000 9 Indium compounds Recommended ------------------------------------ 48 May 2001 Benzenamine, 3-chloro-2,6- Recommended dinitro-N,N-dipropyl-4- (trifluoromethyl)- ------------------------------------ 49 November 2001 Stannane, dimethylbis[(1- Recommended oxoneodecyl)oxy]- ------------------------------------ 50 May 2002 Benzene, 1,3,5-tribromo-2- Recommended (2-propenyloxy)- ------------------------------------ 50 May 2002 1-Triazene, 1,3-diphenyl- Recommended ------------------------------------ 51 November 2002 43 Vanadium compounds Recommended ------------------------------------ 53 November 2003 3 Pyridinamines Recommended ------------------------------------ 53 November 2003 20 Tungsten compounds Recommended ---------------------------------------------------------------------------------------------------------------- I. Background The ITC was established by section 4(e) of the Toxic Substances Control Act (TSCA) ``to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the promulgation of rules for testing under section 4(a).... At least every six months ..., the Committee shall make such revisions to the Priority Testing List as it determines to be necessary and transmit them to the Administrator together with the Committee's reasons for the revisions'' (Public Law 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 et seq.). ITC Reports are available from the ITC's web site (http://www.epa.gov/opptintr/itc) within a few days of submission to the Administrator and from the EPA's web site http://www.epa.gov/fedrgstr/ after publication in the Federal Register. The ITC produces its revisions to the Priority Testing List with administrative and technical support from the ITC Staff, ITC Members and their U.S. Government organizations, and contract support provided by EPA. ITC Members and Staff are listed at the end of this report. II. TSCA Section 8 Reporting A. TSCA Section 8 Reporting Rules Following receipt of the ITC's Report (and the revised Priority Testing List) by the EPA Administrator, the EPA's Office of Pollution Prevention and Toxics (OPPT) adds the chemicals from the revised Priority Testing List to the TSCA section 8(a) PAIR and TSCA section 8(d) Health and Safety Data Reporting (HaSDR) rules. The PAIR rule requires producers and importers of Chemical Abstract Service (CAS)-numbered chemicals added to the Priority Testing List to submit production and exposure reports (http://www.epa.gov/opptintr/chemtest/pairform.pdf). The HaSDR rule requires producers, importers, and processors of all chemicals added to the Priority Testing List to submit unpublished health and safety studies under TSCA section 8(d) that must be in compliance with the revised HaSDR rule (Ref. 1). All submissions must be received by the EPA within 90 days of the reporting rules Federal Register publication date. [[Page 2471]] B. ITC's Use of TSCA Section 8 and Other Information The ITC's use of TSCA section 8 and other information is described in previous ITC Reports (http://www.epa.gov/opptintr/itc/rptmain.htm). C. New Requests to Add Chemicals to the TSCA Section 8(a) PAIR Rule The ITC is requesting that EPA add 3 pyridinamines and 20 tungsten compounds to the TSCA section 8(a) PAIR rule. The 3 pyridinamines and 20 tungsten compounds are discussed in Units IV.A.1. and IV.A.2. of this report. D. Previous Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule In previous ITC Reports it was requested that the following chemicals be added to the TSCA section 8(d) HaSDR rule: 3H-1,2,4- triazole-3-thione, 5-amino-1,2-dihydro- (3-amino-5-mercapto-1,2,4- triazole) (CAS No. 16691-43-3) and imidazo[4,5-d]imidazole- 2,5(1H,3H)-dione, tetrahydro- (glycoluril) (CAS No. 496-46-8) (42\nd\ ITC Report, Ref. 2), 9 indium compounds (47\th\ ITC Report, Ref. 3); benzenamine, 3-chloro-2, 6-dinitro-N,N-dipropyl-4- (trifluoromethyl)- (CAS No. 29091-20-1) (48\th\ ITC Report, Ref 4); and stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7), benzene, 1,3,5-tribromo-2-(2-propenyloxy)- (CAS No. 3278-89-5) and 1-triazene, 1,3-diphenyl- (CAS No.136-35-6) (50\th\ ITC Report, Ref. 5). The TSCA section 8(d) studies requested for these chemicals were listed in the ITC's 51\st\ Report (Ref. 6). III. ITC's Activities During this Reporting Period (May to November 2003) During this reporting period, the ITC received voluntary information submissions from the Color Pigments Manufacturers Association (CPMA) and the Vanadium Producers and Reclaimers Association (VPRA) in response to solicitations for the 43 vanadium compounds listed in the ITC's 51\st\ Report (Ref. 6). The procedures for submitting voluntary information through the ITC's Voluntary Information Submissions Innovative Online Network (VISION) are described on the ITC's web site (http://www.epa.gov/opptintr/itc/vision.htm). During this reporting period, the ITC reviewed the PAIR reports submitted in response to the June 11, 2003, PAIR rule (Ref. 7). This PAIR rule required submission of reports for benzenamine, 3-chloro- 2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- (CAS No. 29091-20-1); stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7); benzene, 1,3,5-tribromo-2-(2-propenyloxy)- (CAS No. 3278-89-5); and 1-triazene, 1,3-diphenyl- (CAS No. 136-35-6 ) and the 43 vanadium compounds listed in the ITC's 51\st\ Report. The ITC is continuing to analyze the data in those reports as well as data submitted voluntarily. For the 43 vanadium compounds listed in the ITC's 51\st\ Report (Ref. 6), the ITC is still soliciting voluntary submissions of: 1. Recent non-CBI estimates of annual production or importation volume data and trends, and use information, including percentages of production or importation that are associated with different uses. 2. Estimates of the number of humans and concentrations of vanadium compounds to which humans may be exposed during manufacturing or processing. 3. Health effects data including pharmacokinetics, genotoxicity, subchronic toxicity, reproductive and developmental toxicity, and any human data from occupationally exposed workers. The ITC is soliciting this information in order to adequately assess the extent and degree of exposure and potential hazard associated with the various forms of vanadium. In addition, the ITC is soliciting voluntary information submissions for the 3 pyridinamines and 20 tungsten compounds being added to the Priority Testing List to meet U.S. Government data needs. The information being solicited is summarized in Unit IV.A.1.c. and IV.A.2.c. of this report. IV. Revisions to the TSCA Section 4(e) Priority Testing List A. Chemicals Added to the Priority Testing List 1. Pyridinamines--a. Recommendation. Pyridinamines are being added to the Priority Testing List to obtain importation, production, use, exposure, and health effects information to meet U.S. Government data needs. Three pyridinamines are being recommended: 2-Pyridinamine (CAS No. 504-29-0), 3-pyridinamine (CAS No. 462-08-8) and 4-pyridinamine (CAS No. 504-24-5). b. Rationale for recommendation. Pyridinamines are readily absorbed through the skin and the gastrointestinal tract and widely distributed in the body, including the brain. They are not metabolized and are completely excreted through the kidneys. Studies in animals and humans have shown that pyridinamines are acutely toxic compounds. Part of this toxic response may be due to their ability to block K+ channels causing, among other effects, convulsions. The chronic toxicity of these compounds has not received adequate evaluation. To determine a priority for testing members of the pyridinamine class of compounds, additional information is needed to characterize human exposure potential. c. Information needs. For each individual pyridinamine: Recent data or estimates of annual production and importation volume and trends; information on specific uses, including percentages of production or importation volume associated with each of these uses; estimates of the number of persons potentially exposed to each pyridinamine during its manufacture and use and health effects, including chronic toxicity data. d. Supporting information. Pyridinamines are chemicals in commerce. The annual production volume of 2-pyridinamine exceeded 1 million pounds in 1998; it is used in hair colorants and as an intermediate in the manufacture of pharmaceuticals. 3-Pyridinamine is an intermediate in the production of agrochemicals and pharmaceuticals; it may have end-uses. In addition to its use as a chemical intermediate, 4-pyridinamine is the active ingredient in the registered pesticide Avitrol[reg] and has been evaluated as an experimental drug to treat several neurological syndromes. Under the Food and Drug Administration (FDA) Modernization Act of 1997 (http://www.fda.gov/opacom/7modact.html), 4-pyridinamine was nominated for inclusion on the list of bulk substances for use in pharmacy compounding but was not included by the FDA on the initial list. Human exposure data are limited for pyridinamines. A survey conducted between 1981 and 1983 by the National Institute for Occupational Safety and Health estimated that 4,618 workers in 452 facilities representing 3 industries were potentially exposed to 4- pyridinamine. 2. Tungsten compounds--a. Recommendation. Twenty tungsten compounds are being added to the Priority Testing List to obtain importation, production, use, exposure, and health effects information to meet U.S. Government data needs (Table 2). The ITC believes the list of tungsten compounds in Table 2 includes those most likely to be in current use. Table 2.--Tungsten Compounds Being Added to the TSCA Section 8(a) PAIR Rule ---------------------------------------------------------------------------------------------------------------- CAS No. Chemical name ---------------------------------------------------------------------------------------------------------------- 1314-35-8 Tungsten oxide (WO3) --------------------------------------------- 7440-33-7 Tungsten --------------------------------------------- 7783-82-6 Tungsten fluoride (WF6), (OC-6-11)- --------------------------------------------- 7790-85-4 Cadmium tungsten oxide (CdWO4) --------------------------------------------- 7790-60-5 Tungstate (WO4\2\-), dipotassium, (T-4)- --------------------------------------------- [[Page 2472]] 7783-03-1 Tungstate (WO4\2\-), dihydrogen, (T-4)- --------------------------------------------- 10213-10-2 Tungstate (WO4\2\-), disodium, dihydrate, (T-4)- --------------------------------------------- 11105-11-6 Tungsten oxide (WO3), hydrate --------------------------------------------- 11120-01-7 Sodium tungsten oxide --------------------------------------------- 11120-25-5 Tungstate (W12(OH)2 O40\10\-), decaammonium --------------------------------------------- 12067-99-1 Tungsten hydroxide oxide phosphate --------------------------------------------- 12028-48-7 Tungstate (W12(OH)2 O38\6\-), hexaammonium --------------------------------------------- 12027-38-2 Tungstate(4-),[.mu.12-[orthosilicato(4-)- .kappa.O:.kappa.O:.kappa.O:.kappa.O':.kappa.O':.kappa.O':.kappa.O ''.kappa.O'':.kappa.O'' :.kappa.O''':kappa.O''':.kappa.O''']] tetracosa-.mu.-oxododecaoxododeca-, tetrahydrogen --------------------------------------------- 12036-22-5 Tungsten oxide (WO2) --------------------------------------------- 12141-67-2 Tungstate (W12(OH)2 O38\6\-), hexasodium --------------------------------------------- 12138-09-9 Tungsten sulfide (WS2) --------------------------------------------- 13283-01-7 Tungsten chloride (WCl6), (OC-6-11)- --------------------------------------------- 13472-45-2 Tungstate (WO4\2\-), disodium, (T-4)- --------------------------------------------- 14040-11-0 Tungsten carbonyl (W(CO)6), (OC-6-11)- --------------------------------------------- 23321-70-2 Tungsten oxide (WO3), dihydrate ---------------------------------------------------------------------------------------------------------------- b. Rationale for recommendation. Tungsten was recently nominated for toxicology and carcinogenicity studies to the National Toxicology Program by the Centers for Disease Control and Prevention's National Center for Environmental Health (http://ntp-server.niehs.nih.gov/NomPage/2003Noms.html). The nomination was based on recent data showing elevated tungsten body burdens in residents of Fallon, NV, and the limited data available to assess the potential long-term adverse health effects of tungsten exposure (http://www.cdc.gov/nceh/clusters/Fallon). The source and pathways of exposure, and the form of tungsten to which Fallon, NV, residents are exposed is presently poorly understood. The Agency for Toxic Substances and Disease Registry (ATSDR) has completed community exposure and health investigations in Churchill County, NV (http://www.atsdr.cdc.gov/HAC/PHA/region_9.html#nevada) and is developing a toxicological profile for tungsten (http://www.atsdr.cdc.gov/toxprofiles/tp186.html). Tungsten and tungsten compounds have numerous important industrial uses. Other than workplace exposure limits, there are few regulatory controls on the use, emission, and disposal of tungsten compounds and few data on which to assess the ecological effects and human health impacts resulting from environmental and general population exposures. Further information is needed to more fully evaluate human and environmental exposures and health effects. c. Information needs. To meet U.S. Government data needs, the ITC needs: 1. Recent non-CBI estimates of annual production or importation volume data and trends, and chemical-specific use information, including percentages of production or importation that are associated with different uses. 2. Environmental release and monitoring information, including occurrence and concentrations in environmental media. 3. Fate and transport data. 4. Ecological effects data, especially for aquatic and sediment organisms, if there is evidence that tungsten compounds are mobilized and transported to groundwater, surface water, and sediments. 5. Estimates of the number of exposed humans and concentrations of tungsten compounds to which humans may be exposed in each relevant manufacturing, processing, or other occupational scenario. 6. Case studies from occupationally exposed workers and pharmacokinetics, dermal, inhalation, and oral acute toxicity, subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, neurotoxicity, reproductive and developmental toxicity, and epidemiology studies. The ITC is soliciting this information in order to adequately assess the extent and degree of exposure and potential hazard associated with the various forms of tungsten and to determine if additional test data are needed. d. Supporting information. Tungsten compounds are naturally released to the atmosphere by windblown dusts. Tungsten compounds can be released to surface waters from sources of human origin (e.g., water effluents from tungsten mining). Deposition of tungsten aerosols or dusts from both natural and anthropogenic sources is also a source of tungsten in surface waters. Individuals who work in manufacturing, fabricating, and reclaiming industries, especially individuals using hard-metal materials or tungsten carbide machining tools, may be exposed to higher levels of tungsten compounds than the general population. Occupational exposure is primarily via inhalation of dust particles of elemental (metallic) tungsten and/or its compounds. Pulmonary fibrosis, memory and sensory deficits, and increased mortality due to lung cancer have been associated with occupational exposure to dusts generated in the hard-metal industry. Historically, the respiratory and neurological effects observed in hard-metal workers have been attributed to cobalt, not tungsten. However, based on the presence of tungsten oxide fibers in air samples taken at some hard-metal facilities and demonstrations that tungsten oxide fibers are capable of generating hydroxyl radicals in human lung cells in vitro, it has been suggested that tungsten oxide fibers may contribute to the development of pulmonary fibrosis in hard-metal workers. Limited reports associate tungsten exposure with reproductive and developmental effects such as decreased sperm motility, increased embryotoxicity, and delayed fetal skeletal ossification in animals. Tungsten has been observed to cross the placental barrier and enter the fetus. Dermal or ocular exposure to tungsten may result in localized irritation. [[Page 2473]] V. References 1. EPA. 1998. Revisions to Reporting Regulations Under TSCA Section 8(d) Federal Register (63 FR 15765, April 1, 1998) (FRL- 5750-4). Available online at: http://www.epa.gov/fedrgstr/. 2. ITC. 1998. Forty-Second Report of the ITC. Federal Register (63 FR 42554, August 7, 1998) (FRL-5797-8). Available online at: http://www.epa.gov/fedrgstr/. 3. ITC. 2001. Forty-Seven Report of the ITC. Federal Register (66 FR 17768 April 3, 2001) (FRL-6763-6). Available online at: http://www.epa.gov/fedrgstr/. 4. ITC. 2001. Forty-Eighth Report of the ITC. Federal Register (66 FR 51276, October 5, 2001) (FRL-6786-7). Available online at: http://www.epa.gov/fedrgstr/. 5. ITC. 2002. Fiftieth Report of the ITC. Federal Register (67 FR 49530, July 30, 2002) (FRL-7183-7). Available online at: http://www.epa.gov/fedrgstr/. 6. ITC. 2002. Fifty-First Report of the ITC. Federal Register (68 FR 8976, February 26, 2003) (FRL-7285-7). Available online at: http://www.epa.gov/fedrgstr/. 7. EPA. 2003. Preliminary Assessment Information Reporting; Addition of Certain Chemicals. Federal Register (68 FR 34832, June 11, 2003) (FRL-7306-7). Available online at: http://www.epa.gov/fedrgstr/. VI. The TSCA Interagency Testing Committee Statutory Organizations and Their Representatives Council on Environmental Quality Vacant Department of Commerce National Institute of Standards and Technology Robert Huie, Member Barbara C. Levin, Alternate National Oceanographic and Atmospheric Administration Thomas P. O'Connor, Member, Vice Chair Teri Rowles, Alternate Environmental Protection Agency Gerry Brown, Member Paul Campanella, Alternate National Cancer Institute Alan Poland, Member David Longfellow, Alternate National Institute of Environmental Health Sciences Scott Masten, Member William Eastin, Alternate National Institute for Occupational Safety and Health Mark Toraason, Member, Chair Dennis W. Lynch, Alternate National Science Foundation Marge Cavanaugh, Member Parag R. Chitnis, Alternate Occupational Safety and Health Administration Val H. Schaeffer, Member Maureen Ruskin, Alternate Liaison Organizations and Their Representatives Agency for Toxic Substances and Disease Registry William Cibulas, Member Daphne Moffett, Alternate Consumer Product Safety Commission Treye Thomas, Member Jacqueline Ferrante, Alternate Department of Agriculture Clifford P. Rice, Member Laura L. McConnell, Alternate Department of Defense Barbara Larcom, Member Warren Jederberg, Alternate Department of the Interior Barnett A. Rattner, Member Food and Drug Administration Kirk Arvidson, Alternate Ronald F. Chanderbhan, Alternate National Library of Medicine Vera W. Hudson, Member National Toxicology Program NIEHS, FDA, and NIOSH Members Technical Support Contractor Syracuse Research Corporation ITC Staff John D. Walker, Director Norma S. L. Williams, Executive Assistant TSCA Interagency Testing Committee, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-7527; fax number: (202) 564-7528; e-mail address: [email protected]; url: http://www.epa.gov/opptintr/itc. [FR Doc. 04-894 Filed 1-14-04; 8:45 am] BILLING CODE 6560-50-S