Sixtieth Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments, 41414-41418 [E7-14575]

Download as PDF 41414 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2007–0420; FRL–8137–6] Sixtieth Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments Environmental Protection Agency (EPA). ACTION: Notice. mstockstill on PROD1PC66 with NOTICES2 AGENCY: SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its 60th ITC Report to the Administrator of EPA on June 14, 2007. In the 60th ITC Report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by adding ‘‘lead and lead compounds’’ to the Priority Testing List so that EPA may expeditiously obtain unpublished health and safety studies that relate to the lead content of consumer products that are intended for use by children. DATES: Comments must be received on or before August 27, 2007. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2007–0420, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001. • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–OPPT–2007–0420. 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. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA–HQ–OPPT– 2007–0420. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. VerDate Aug<31>2005 17:10 Jul 26, 2007 Jkt 211001 Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov website is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket, visit the EPA Docket Center homepage at https:// www.epa.gov/epahome/dockets.htm. Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to https:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at https://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator, 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: TSCA-Hotline@epa.gov. 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 TSCAcovered chemicals and you may be identified by the North American Industrial Classification System (NAICS) codes 325 and 32411. Because this notice is directed to the general public and other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM that you mail to EPA, 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 claimed as CBI. In addition to one complete version of the comment that includes 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. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions E:\FR\FM\27JYN2.SGM 27JYN2 41415 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. 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. II. Background The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.) authorizes the Administrator of EPA to promulgate regulations under TSCA section 4(a) requiring testing of chemicals and chemical groups in order to develop data relevant to determining the risks that such chemicals and chemical groups may present to health or the environment. Section 4(e) of TSCA established the ITC to recommend chemicals and chemical groups to the Administrator of 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. You may access additional information about the ITC at https:// www.epa.gov/opptintr/itc. A. The ITC’s 60th Report The ITC is revising the TSCA section 4(e) Priority Testing List by adding ‘‘lead and lead compounds’’ to the Priority Testing List so that EPA may expeditiously obtain unpublished health and safety studies that relate to the lead content of consumer products that are intended for use by children. B. Status of the Priority Testing List The Priority Testing List includes 2 alkylphenols, 5 tungsten compounds, 12 lead compounds, 16 chemicals with insufficient dermal absorption rate data, and 243 High Production Volume (HPV) Challenge Program orphan chemicals. List of Subjects Environmental protection, Chemicals, Hazardous substances. Dated: July 23, 2007. Charles M. Auer, Director, Office of Pollution Prevention and Toxics. Sixtieth Report of the TSCA Interagency Testing Committee to the Administrator, U.S. Environmental Protection Agency 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(d) HaSDR Rule III. ITC’s Activities During this Reporting Period (December 2006 to May 2007) IV. Revisions to the TSCA Section 4(e) Priority Testing List: Chemicals Added to the Priority Testing List: Lead and Lead Compounds V. References VI. The TSCA Interagency Testing Committee Summary The ITC is revising the Toxic Substances Control Act (TSCA) section 4(e) Priority Testing List by adding ‘‘lead and lead compounds’’ to the Priority Testing List so that EPA may expeditiously obtain unpublished health and safety studies that relate to the lead content of consumer products that are intended for use by children. The TSCA section 4(e) Priority Testing List is Table 1 of this unit. Table of Contents Summary TABLE 1.—TSCA SECTION 4(E) PRIORITY TESTING LIST (MAY 2007) ITC Report Date Chemical Name/Group Action January 1993 2 Chemicals with insufficient dermal absorption rate data Designated 32 May 1993 10 Chemicals with insufficient dermal absorption rate data Designated 35 November 1994 4 Chemicals with insufficient dermal absorption rate data Designated 37 November 1995 Branched 4-nonylphenol (mixed isomers) Recommended 41 November 1997 Phenol, 4-(1,1,3,3-tetramethylbutyl)- Recommended 53 November 2003 5 Tungsten compounds Recommended 55 December 2004 238 High Production Volume (HPV) Challenge Program orphan chemicals Recommended 56 mstockstill on PROD1PC66 with NOTICES2 31 August 2005 5 HPV Challenge Program orphan chemicals Recommended 60 May 2007 Lead and lead compounds Recommended I. Background The ITC was established by TSCA section 4(e) ‘‘to make recommendations VerDate Aug<31>2005 17:10 Jul 26, 2007 Jkt 211001 to the Administrator respecting the chemical substances and mixtures to which the Administrator should give PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 priority consideration for the promulgation of rules for testing under section 4(a).... At least every six months E:\FR\FM\27JYN2.SGM 27JYN2 41416 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices ..., 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 website (https://www.epa.gov/ oppt/itc) within a few days of submission to the EPA Administrator and from EPA’s website (https:// 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) may add the chemicals from the revised Priority Testing List to the TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule (40 CFR part 712) and/or the TSCA section 8(d) Health and Safety Data Reporting (HaSDR) rule (40 CFR part 716). The PAIR rule requires manufacturers (including importers) of chemicals added to the Priority Testing List to submit to EPA certain production and exposure information (https:// www.epa.gov/oppt/chemtest/pubs/ pairform.pdf). The HaSDR rule requires manufacturers (including importers) of chemicals added to the Priority Testing List to submit unpublished health and safety studies to EPA. B. ITC’s Use of TSCA Section 8 and Other Information ITC’s use of TSCA section 8 and other information is described in the 52nd ITC Report (https://www.epa.gov/opptintr/ itc/rptmain.htm). • Brominated flame retardants. • Flavoring agents that cause airway obstruction during occupational exposures. Lead and lead compounds are discussed in Unit IV. of this report. 1. Alkylphenols. As noted in the 59th ITC Report, the ITC is leaving phenol, 4-(1,1,3,3-tetramethylbutyl)- (CAS No. 140–66–9) and phenol, 4-nonyl-, branched (CAS No. 84852–15–3) on the Priority Testing List (Ref. 1). The ITC made this decision because it needed time to: i. Determine if the existing fish reproductive effects data are sufficient to meet the ITC’s data needs. ii. Determine if phenol, 4-(1,1,3,3tetramethylbutyl)- or phenol, 4-nonyl-, branched should be tested for avian reproductive effects. While the ITC is considering whether phenol, 4-(1,1,3,3-tetramethylbutyl)- or phenol, 4-nonyl-, branched should be tested for avian reproductive effects, it has determined that existing fish reproductive effects data are sufficient to meet the ITC’s data needs (Tables 2 and 3 of this unit). TABLE 2.—FISH REPRODUCTIVE EFFECTS AND DEVELOPMENTAL TOXICITY STUDIES FOR PHENOL, 4NONYL-, BRANCHED (CAS NO. 84852–15–3) Study 91–Day early life stage test with Rainbow Trout embryos and fry (Ref. 2). Nearly all larvae were abnormal at ≥ 53.09 micrograms/Liter (µg/L). Based on growth, the No Observed Effect Concentration (NOEC) and Lowest Observed Effect Concentration (LOEC) were 6.0 and ≥ 10.3 µg/L, respectively. 33–Day early life stage test with Fathead Minnow embryos and larvae (Ref. 3). Embryos exposed to nonylphenol (NP) began hatching on day 4; control embryos hatched on day 3. Based on survival, the NOEC and LOEC were 7.4 µg/L and 14.0 µg/L, respectively. mstockstill on PROD1PC66 with NOTICES2 C. New Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule ITC is requesting that EPA add lead and lead compounds to the TSCA section 8(d) HaSDR rule. The lead and lead compounds are discussed in Unit IV. of this report. III. ITC’s Activities During this Reporting Period (December 2006 to May 2007) During this reporting period, the ITC discussed: • Lead and lead compounds. • Alkylphenols. VerDate Aug<31>2005 17:10 Jul 26, 2007 Jkt 211001 TABLE 3.—FISH REPRODUCTIVE EFFECTS AND DEVELOPMENTAL TOXICITY STUDIES FOR PHENOL, 4(1,1,3,3-TETRAMETHYLBUTYL)- (CAS NO. 140–66–9) Study Name 60–Day early life stage test with Rainbow Trout embryos and Trout fry (Ref. 4). Based on fry growth, the NOEC and LOEC were 6.1 µg/L and 11.0 µg/L, respectively. PO 00000 Frm 00004 Fmt 4701 Sfmt 4703 TABLE 3.—FISH REPRODUCTIVE EFFECTS AND DEVELOPMENTAL TOXICITY STUDIES FOR PHENOL, 4(1,1,3,3-TETRAMETHYLBUTYL)- (CAS NO. 140–66–9)—Continued Study Name 1.5–Generation test with Medaka (Ref. 5). Based on growth, the NOEC and LOEC were 20.0 µg/L and 50.0 µg/L, respectively. Based on survival during mating trials of exposed females and unexposed males, the NOEC and LOEC were 2.0 µg/L and 20.0 µg/L, respectively. 185–Day life-cycle test with Zebra Fish (Ref. 6). EC50 (fertilization success) = 28 µg/L. 185–Day life-cycle test with Zebra Fish (Ref. 7). Based on growth, time to first spawn, egg production, and fertilization success on fish maturing from fry to breeding adults, the NOEC and LOEC were 12.0 and 35.0 µg/L, respectively. 2. Brominated flame retardants. During discussions with the American Chemistry Council’s Brominated Flame Retardants Industry Panel (BFRIP), Canadian Wildlife Service, and McGill University scientists, the ITC learned that the BFRIP will be sponsoring avian reproductive testing of 1,2,5,6,9,10hexabromocyclododecane (CAS No. 3194–55–6) or hexabromocyclododecane (CAS No. 25637–99–4) using American Kestrels. The BFRIP provided the ITC with the International Uniform Chemical Information Database (IUCLID) data set for hexabromocyclododecane (CAS No. 25637–99–4) as well as the IUCLID data set and Voluntary Children’s Chemical Evaluation Program (VCCEP) Tier I and II data summary for decabromodiphenyl ether (DBDE) (CAS No. 1163–19–5). In addition, the ITC discussed the National Institute of Standards and Technology’s (NIST) ongoing work with the National Oceanic and Atmospheric Administration (NOAA), including the collaboration with the National Marine Fisheries Service (NMFS) via cooperation with the Marine Mammal Health and Stranding Response Program. The ITC also discussed the NOAA/NMFS Dolphin Health Assessments, and the Seabird Tissue Archival and Monitoring Project to measure persistent bioaccumulative contaminants, including brominated flame retardants. 3. Flavoring agents that cause airway obstruction during occupational exposures. The ITC discussed the National Institute for Occupational Safety and Health (NIOSH) alert, E:\FR\FM\27JYN2.SGM 27JYN2 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices ‘‘Preventing Lung Disease in Workers Who Use or Make Flavorings’’ (https:// www.cdc.gov/niosh/docs/2004–110), because of concerns related to occupational exposures to flavoring agents that may be respiratory irritants. defined at 40 CFR 710.43)1 (excluding children’s metal jewelry) and studies that assess children’s exposure to lead from such products (including studies of bioavailability). 2. Rationale for recommendation. In pursuit of the Federal goal of IV. Revisions to the TSCA Section 4(e) eliminating childhood lead poisoning Priority Testing List: Chemicals Added by 2010 (Ref. 8), EPA is looking beyond to the Priority Testing List: Lead and paint-related sources in an effort to Lead Compounds address risks from other potentially significant sources. Although the 1. Recommendation. EPA requests Consumer Product Safety Commission that the ITC add the category ‘‘lead and (CPSC) has an effort underway to lead compounds’’ to the Priority Testing address risks from children’s metal List (Table 4 of this unit). jewelry containing lead (Ref. 9), there is less information available on the lead TABLE 4.—EXAMPLES OF COMPOUNDS content of, and exposure to lead from, IN THE LEAD AND LEAD COMPOUNDS other children’s products.CPSC is currently addressing lead containing CATEGORY BEING ADDED TO THE children’s metal jewelry, but has not yet PRIORITY TESTING LIST established a definition of these products. Thus, EPA recommends that CAS No. Chemical Name the ITC include the category listing for lead and lead compounds described in 301–04–2 Acetic acid, Unit IV.1. Information obtained on this lead(2+) salt category may assist both EPA and CPSC in taking further action as appropriate to 598–63–0 Carbonic acid, lead(2+) salt protect children from lead poisoning (1:1) due to lead in products. It should be noted that for the purposes of regulating 1309–60–0 Lead oxide products by CPSC, products intended (PbO2) for children might not be defined in the same manner as for actions by EPA 1314–87–0 Lead sulfide under TSCA. (PbS) 3. Supporting information. EPA has a long-standing interest in limiting human 7428–48–0 Octadecanoic and environmental exposure to lead and acid, lead salt (1:?) lead compounds, with special concern for exposures to children. In the context 7439–92–1 Lead of its Toxic Release Inventory (TRI) Program, EPA has classified lead as a 7446–27–7 Phosphoric acid, ‘‘persistent, bioaccumulative, toxic lead(2+) salt chemical,’’ (TRI Lead Rule published in (2:3) the Federal Register of January 17, 2001 (66 FR 4500) (FRL–6722–4)) and in past 7758–95–4 Lead chloride (PbCl2) 7758–97–6 Chromic acid (H2CrO4), lead(2+) salt (1:1) 13814–96–5 Borate (1-), tetrafluoro-, lead(2+) (2:1) 53466–66–3 Silicic acid, lead salt, basic mstockstill on PROD1PC66 with NOTICES2 63653–42–9 Sulfuric acid, lead salt (1:?), basic EPA is making this request to obtain unpublished health and safety studies that relate to the lead content of consumer products that are ‘‘intended for use by children (as that term is VerDate Aug<31>2005 17:10 Jul 26, 2007 Jkt 211001 1 For the purposes of this recommendation, ‘‘Intended for use by children’’ has the meaning provided in 40 CFR 710.43 of the TSCA section 8(a) Inventory Update Rule. The definition was originally intended for a different audience (those submitting information under the Inventory Update Rule) but the same concepts can apply to the products at issue here. The definition reads as follows: Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers ‘‘yes’’ to at least one of the following questions for the product into which the submitter’s chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? PO 00000 Frm 00005 Fmt 4701 Sfmt 4703 41417 actions has presented evidence that lead can cause significant deleterious health effects, particularly in children (e.g., Identification of Dangerous Levels of Lead; Proposed Rule published in the Federal Register of June 3, 1998 (63 FR 30301) (FRL–5791–9)). A major focus of EPA has been on lead and lead compounds in paint, with a particular emphasis to limit lead exposures from paint following enactment of the ‘‘Residential Lead-Based Paint Hazard Reduction Act of 1992.’’ Public Law 102–550. In that Act, Congress emphasized its concerns about children’s exposure to lead. CPSC recently published an Advance Notice of Proposed Rulemaking (ANPRM) in the Federal Register of January 9, 2007 (72 FR 920) addressing certain products beyond paint; CPSC is considering whether there may be a need to ban children’s metal jewelry containing more than 0.06% lead by weight in metal components. In addition to children’s metal jewelry products, EPA also believes there may be potential risks to children’s health from exposure to other products intended for use by children that contain lead or lead compounds. However, information regarding such products is currently incomplete. 4. Information needs. EPA is interested in health and safety studies that relate to the lead content of consumer products that are ‘‘intended for use by children’’ (as defined at 40 CFR 710.43), but excluding ‘‘children’s metal jewelry’’ as described by the CPSC in its ANPRM of January 9, 2007. For all lead and lead compounds, EPA needs the following information to assess the extent and degree of exposure and potential hazard associated with these substances: • Studies that relate to the lead content of consumer products that are intended for use by children (includes studies showing any measurable lead content), and/or • Studies that assess children’s exposure to lead from such products (including studies of bioavailability). With regards to grade or purity, studies showing any measurable lead content in such products are of interest. V. References 1. ITC. 2007. Fifty-Ninth Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments. Federal Register (72 FR 2756, January 22, 2007) (FRL–8110–2). Available on-line at: https://www.epa.gov/fedrgstr. 2. Brooke, L.T. 1993. Acute and chronic toxicity of nonylphenol to ten E:\FR\FM\27JYN2.SGM 27JYN2 41418 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices mstockstill on PROD1PC66 with NOTICES2 species of aquatic organisms. Report to the U.S. EPA for Work Assignment No. 02 of Contract No. 68–C1–0034. Lake Superior Research Institute, University of Wisconsin-Superior, Superior, WI. March 24,1993. Amended October 18, 2005. 3. Ward, T.J. and Boeri, R.L. 1991. Early life stage toxicity of nonylphenol to the fathead minnow, Pimephales promelas. Study Number 8979 CMA. EnviroSystems, Hampton, NH. 4. Analytical Bio-Chemistry (ABC) Laboratories, Inc. 1986. Early life stage toxicity of para-tert octylphenol to Rainbow trout (salmo gairdneri). Report 34452. Columbia, MO. 5. Knorr, S. and Braunbeck, T. 2002. Decline in reproductive success, sex reversal, and developmental alterations in Japanese medaka (Oryzias latipes) after continuous exposure to octylpheno1. Ecotoxicology and Environmental Safety Journal. 51:187– 196. 6. Segner, H.; Navas, J. M.; Schafers, C.; and Wenzel, A. 2003. Potencies of estrogenic compounds in in vitro screening assays and in life cycle tests with zebraflsh in vitro. Ecotoxicology and Environmental Safety Journal. 54:315–322. 7. Wenzel, A.; Schafers, C.; Vollmer, G., et al. 2001. Research efforts towards the development and validation of a test method for the identification of endocrine disrupting chemicals. Final Report of European Commission Contract B6–7920/98/000015. Schmallenberg, Germany. 8. President’s Task Force on Environmental Health Risks and Safety Risks to Children. 2000. Eliminating Childhood Lead Poisoning: A Federal Strategy Targeting Lead Paint Hazards. Available on-line at: https:// www.epa.gov/oppt/lead/pubs/ fedstrategy2000.pdf. VerDate Aug<31>2005 17:10 Jul 26, 2007 Jkt 211001 9. CPSC. Children’s Jewelry Containing Lead; Advanced Notice of Proposed Rulemaking; Request for Comments and Information. Federal Register (72 FR 920, January 9, 2007). Available on-line at: https:// www.cpsc.gov/businfo/frnotices/fr07/ leadjewelry.pdf. 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 Dianne Poster, Member, Chair National Oceanographic and Atmospheric Administration Tony Pait, Member Environmental Protection Agency John Schaeffer, Member Gerry Brown, Alternate National Cancer Institute Vacant National Institute for Occupational Safety and Health Dennis W. Lynch, Member Vice-Chair Mark Toraason, Alternate National Science Foundation Cindy Lee, Member Marge Cavanaugh, Alternate Occupational Safety and Health Administration Maureen Ruskin, Member Frm 00006 Fmt 4701 Sfmt 4703 Liaison Organizations and Their Representatives Agency for Toxic Substances and Disease Registry Daphne Moffett, Member Glenn D. Todd, Alternate Consumer Product Safety Commission Jacqueline Ferrante, Member Department of Agriculture Clifford P. Rice, Member Laura L. McConnell, Alternate Department of Defense Laurie Roszell, Member 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 National Institute of Environmental Health Sciences John Bucher, Member Scott Masten, Alternate PO 00000 Thomas Nerad, Alternate ITC Staff John D. Walker, Director Carol Savage, Administrative Assistant TSCA Interagency Testing Committee, Office of Pollution Prevention and Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; e-mail address: savage.carol@epa.gov; url: https:// www.epa.gov/opptintr/itc. [FR Doc. E7–14575 Filed 7–26–07; 8:45 am] BILLING CODE 6560–50–S E:\FR\FM\27JYN2.SGM 27JYN2

Agencies

[Federal Register Volume 72, Number 144 (Friday, July 27, 2007)]
[Notices]
[Pages 41414-41418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14575]



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Part III





Environmental Protection Agency





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 Sixtieth 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. 72, No. 144 / Friday, July 27, 2007 / 
Notices

[[Page 41414]]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-0420; FRL-8137-6]


Sixtieth 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.

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SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing 
Committee (ITC) transmitted its 60\th\ ITC Report to the Administrator 
of EPA on June 14, 2007. In the 60\th\ ITC Report, which is included 
with this notice, the ITC is revising the TSCA section 4(e) Priority 
Testing List by adding ``lead and lead compounds'' to the Priority 
Testing List so that EPA may expeditiously obtain unpublished health 
and safety studies that relate to the lead content of consumer products 
that are intended for use by children.

DATES: Comments must be received on or before August 27, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2007-0420, by one of the following methods:
      Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
      Mail: Document Control Office (7407M), Office of 
Pollution Prevention and Toxics (OPPT), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
      Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2007-0420. 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. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0420. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. 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. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at https://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket materials are available electronically at https://
www.regulations.gov, or, if only available in hard copy, at the OPPT 
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at 
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. 
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding Federal holidays. The telephone 
number of the EPA/DC Public Reading Room is (202) 566-1744, and the 
telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 
are required to show photographic identification, pass through a metal 
detector, and sign the EPA visitor log. All visitor bags are processed 
through an X-ray machine and subject to search. Visitors will be 
provided an EPA/DC badge that must be visible at all times in the 
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator, 
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: TSCA-Hotline@epa.gov.

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 and you may be 
identified by the North American Industrial Classification System 
(NAICS) codes 325 and 32411. Because this notice is directed to the 
general public and other entities may also be interested, the Agency 
has not attempted to describe all the specific entities that may be 
interested in this action. If you have any questions regarding the 
applicability of this action to a particular entity, consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
that you mail to EPA, 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 claimed as CBI. In addition to one complete version 
of the comment that includes 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. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments, 
remember to:
     i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to 
specific questions

[[Page 41415]]

or organize comments by referencing a Code of Federal Regulations (CFR) 
part or section number.
     iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information 
and/or data that you used.
     v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
     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.

II. Background

    The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.) 
authorizes the Administrator of EPA to promulgate regulations under 
TSCA section 4(a) requiring testing of chemicals and chemical groups in 
order to develop data relevant to determining the risks that such 
chemicals and chemical groups may present to health or the environment. 
Section 4(e) of TSCA established the ITC to recommend chemicals and 
chemical groups to the Administrator of 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.
    You may access additional information about the ITC at https://
www.epa.gov/opptintr/itc.

A. The ITC's 60\th\ Report

    The ITC is revising the TSCA section 4(e) Priority Testing List by 
adding ``lead and lead compounds'' to the Priority Testing List so that 
EPA may expeditiously obtain unpublished health and safety studies that 
relate to the lead content of consumer products that are intended for 
use by children.

B. Status of the Priority Testing List

    The Priority Testing List includes 2 alkylphenols, 5 tungsten 
compounds, 12 lead compounds, 16 chemicals with insufficient dermal 
absorption rate data, and 243 High Production Volume (HPV) Challenge 
Program orphan chemicals.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.


    Dated: July 23, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

Sixtieth Report of the TSCA Interagency Testing Committee to the 
Administrator, U.S. Environmental Protection Agency

Table of Contents

Summary

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(d) HaSDR Rule
III. ITC's Activities During this Reporting Period (December 2006 to 
May 2007)
IV. Revisions to the TSCA Section 4(e) Priority Testing List: Chemicals 
Added to the Priority Testing List: Lead and Lead Compounds
V. References
VI. The TSCA Interagency Testing Committee

Summary

    The ITC is revising the Toxic Substances Control Act (TSCA) section 
4(e) Priority Testing List by adding ``lead and lead compounds'' to the 
Priority Testing List so that EPA may expeditiously obtain unpublished 
health and safety studies that relate to the lead content of consumer 
products that are intended for use by children.
    The TSCA section 4(e) Priority Testing List is Table 1 of this 
unit.

                          Table 1.--TSCA Section 4(e) Priority Testing List (May 2007)
----------------------------------------------------------------------------------------------------------------
              ITC Report                         Date             Chemical Name/Group             Action
----------------------------------------------------------------------------------------------------------------
31                                     January 1993             2 Chemicals with         Designated
                                                                 insufficient dermal
                                                                 absorption rate data
----------------------------------------------------------------------------------------------------------------
32                                     May 1993                 10 Chemicals with        Designated
                                                                 insufficient dermal
                                                                 absorption rate data
----------------------------------------------------------------------------------------------------------------
35                                     November 1994             4 Chemicals with        Designated
                                                                 insufficient dermal
                                                                 absorption rate data
----------------------------------------------------------------------------------------------------------------
37                                     November 1995            Branched 4-nonylphenol   Recommended
                                                                 (mixed isomers)
----------------------------------------------------------------------------------------------------------------
41                                     November 1997            Phenol, 4-(1,1,3,3-      Recommended
                                                                 tetramethylbutyl)-
----------------------------------------------------------------------------------------------------------------
53                                     November 2003            5 Tungsten compounds     Recommended
----------------------------------------------------------------------------------------------------------------
55                                     December 2004            238 High Production      Recommended
                                                                 Volume (HPV) Challenge
                                                                 Program orphan
                                                                 chemicals
----------------------------------------------------------------------------------------------------------------
56                                     August 2005              5 HPV Challenge Program  Recommended
                                                                 orphan chemicals
----------------------------------------------------------------------------------------------------------------
60                                     May 2007                 Lead and lead compounds  Recommended
----------------------------------------------------------------------------------------------------------------

I. Background

    The ITC was established by TSCA section 4(e) ``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

[[Page 41416]]

..., 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 website (https://www.epa.gov/oppt/
itc) within a few days of submission to the EPA Administrator and from 
EPA's website (https://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) may add the chemicals from the revised 
Priority Testing List to the TSCA section 8(a) Preliminary Assessment 
Information Reporting (PAIR) rule (40 CFR part 712) and/or the TSCA 
section 8(d) Health and Safety Data Reporting (HaSDR) rule (40 CFR part 
716). The PAIR rule requires manufacturers (including importers) of 
chemicals added to the Priority Testing List to submit to EPA certain 
production and exposure information (https://www.epa.gov/oppt/chemtest/
pubs/pairform.pdf). The HaSDR rule requires manufacturers (including 
importers) of chemicals added to the Priority Testing List to submit 
unpublished health and safety studies to EPA.

B. ITC's Use of TSCA Section 8 and Other Information

     ITC's use of TSCA section 8 and other information is described in 
the 52\nd\ ITC Report (https://www.epa.gov/opptintr/itc/rptmain.htm).

 C. New Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule

    ITC is requesting that EPA add lead and lead compounds to the TSCA 
section 8(d) HaSDR rule. The lead and lead compounds are discussed in 
Unit IV. of this report.

III. ITC's Activities During this Reporting Period (December 2006 to 
May 2007)

    During this reporting period, the ITC discussed:
     Lead and lead compounds.
     Alkylphenols.
     Brominated flame retardants.
     Flavoring agents that cause airway obstruction during 
occupational exposures.

Lead and lead compounds are discussed in Unit IV. of this report.

    1. Alkylphenols. As noted in the 59\th\ ITC Report, the ITC is 
leaving phenol, 4-(1,1,3,3-tetramethylbutyl)- (CAS No. 140-66-9) and 
phenol, 4-nonyl-, branched (CAS No. 84852-15-3) on the Priority Testing 
List (Ref. 1). The ITC made this decision because it needed time to:
    i. Determine if the existing fish reproductive effects data are 
sufficient to meet the ITC's data needs.
    ii. Determine if phenol, 4-(1,1,3,3-tetramethylbutyl)- or phenol, 
4-nonyl-, branched should be tested for avian reproductive effects.
While the ITC is considering whether phenol, 4-(1,1,3,3-
tetramethylbutyl)- or phenol, 4-nonyl-, branched should be tested for 
avian reproductive effects, it has determined that existing fish 
reproductive effects data are sufficient to meet the ITC's data needs 
(Tables 2 and 3 of this unit).

 Table 2.--Fish Reproductive Effects and Developmental Toxicity Studies
           for Phenol, 4-Nonyl-, Branched (CAS No. 84852-15-3)
------------------------------------------------------------------------
                                  Study
-------------------------------------------------------------------------
91-Day early life stage test with Rainbow Trout embryos and fry (Ref.
 2). Nearly all larvae were abnormal at >= 53.09 micrograms/Liter ([mu]g/
 L). Based on growth, the No Observed Effect Concentration (NOEC) and
 Lowest Observed Effect Concentration (LOEC) were 6.0 and >= 10.3 [mu]g/
 L, respectively.
------------------------------------------------------------------------
33-Day early life stage test with Fathead Minnow embryos and larvae
 (Ref. 3). Embryos exposed to nonylphenol (NP) began hatching on day 4;
 control embryos hatched on day 3. Based on survival, the NOEC and LOEC
 were 7.4 [mu]g/L and 14.0 [mu]g/L, respectively.
------------------------------------------------------------------------



 Table 3.--Fish Reproductive Effects and Developmental Toxicity Studies
      for Phenol, 4-(1,1,3,3-tetramethylbutyl)- (CAS No. 140-66-9)
------------------------------------------------------------------------
                              Study Name
-----------------------------------------------------------------------
60-Day early life stage test with Rainbow Trout embryos and Trout fry
 (Ref. 4). Based on fry growth, the NOEC and LOEC were 6.1 [mu]g/L and
 11.0 [mu]g/L, respectively...........................................
------------------------------------------------------------------------
1.5-Generation test with Medaka (Ref. 5). Based on growth, the NOEC
 and LOEC were 20.0 [mu]g/L and 50.0 [mu]g/L, respectively. Based on
 survival during mating trials of exposed females and unexposed males,
 the NOEC and LOEC were 2.0 [mu]g/L and 20.0 [mu]g/L, respectively....
------------------------------------------------------------------------
185-Day life-cycle test with Zebra Fish (Ref. 6). EC50 (fertilization
 success) = 28 [mu]g/L................................................
------------------------------------------------------------------------
185-Day life-cycle test with Zebra Fish (Ref. 7). Based on growth,
 time to first spawn, egg production, and fertilization success on
 fish maturing from fry to breeding adults, the NOEC and LOEC were
 12.0 and 35.0 [mu]g/L, respectively..................................
------------------------------------------------------------------------


    2. Brominated flame retardants. During discussions with the 
American Chemistry Council's Brominated Flame Retardants Industry Panel 
(BFRIP), Canadian Wildlife Service, and McGill University scientists, 
the ITC learned that the BFRIP will be sponsoring avian reproductive 
testing of 1,2,5,6,9,10-hexabromocyclododecane (CAS No. 3194-55-6) or 
hexabromocyclododecane (CAS No. 25637-99-4) using American Kestrels. 
The BFRIP provided the ITC with the International Uniform Chemical 
Information Database (IUCLID) data set for hexabromocyclododecane (CAS 
No. 25637-99-4) as well as the IUCLID data set and Voluntary Children's 
Chemical Evaluation Program (VCCEP) Tier I and II data summary for 
decabromodiphenyl ether (DBDE) (CAS No. 1163-19-5). In addition, the 
ITC discussed the National Institute of Standards and Technology's 
(NIST) ongoing work with the National Oceanic and Atmospheric 
Administration (NOAA), including the collaboration with the National 
Marine Fisheries Service (NMFS) via cooperation with the Marine Mammal 
Health and Stranding Response Program. The ITC also discussed the NOAA/
NMFS Dolphin Health Assessments, and the Seabird Tissue Archival and 
Monitoring Project to measure persistent bioaccumulative contaminants, 
including brominated flame retardants.
    3. Flavoring agents that cause airway obstruction during 
occupational exposures. The ITC discussed the National Institute for 
Occupational Safety and Health (NIOSH) alert,

[[Page 41417]]

``Preventing Lung Disease in Workers Who Use or Make Flavorings'' 
(https://www.cdc.gov/niosh/docs/2004-110), because of concerns related 
to occupational exposures to flavoring agents that may be respiratory 
irritants.

IV. Revisions to the TSCA Section 4(e) Priority Testing List: Chemicals 
Added to the Priority Testing List: Lead and Lead Compounds

    1. Recommendation. EPA requests that the ITC add the category 
``lead and lead compounds'' to the Priority Testing List (Table 4 of 
this unit).


 Table 4.--Examples of Compounds in the Lead and Lead Compounds Category
                Being Added to the Priority Testing List
------------------------------------------------------------------------
        CAS No.                           Chemical Name
------------------------------------------------------------------------
               301-04-2  Acetic acid, lead(2+) salt
------------------------------------------------------------------------
               598-63-0  Carbonic acid, lead(2+) salt (1:1)
------------------------------------------------------------------------
              1309-60-0  Lead oxide (PbO2)
------------------------------------------------------------------------
              1314-87-0  Lead sulfide (PbS)
------------------------------------------------------------------------
              7428-48-0  Octadecanoic acid, lead salt (1:?)
------------------------------------------------------------------------
              7439-92-1  Lead
------------------------------------------------------------------------
              7446-27-7  Phosphoric acid, lead(2+) salt (2:3)
------------------------------------------------------------------------
              7758-95-4  Lead chloride (PbCl2)
------------------------------------------------------------------------
              7758-97-6  Chromic acid (H2CrO4), lead(2+) salt (1:1)
------------------------------------------------------------------------
             13814-96-5  Borate (1-), tetrafluoro-, lead(2+) (2:1)
------------------------------------------------------------------------
             53466-66-3  Silicic acid, lead salt, basic
------------------------------------------------------------------------
             63653-42-9  Sulfuric acid, lead salt (1:?), basic
------------------------------------------------------------------------

     EPA is making this request to obtain unpublished health and safety 
studies that relate to the lead content of consumer products that are 
``intended for use by children (as that term is defined at 40 CFR 
710.43)\1\ (excluding children's metal jewelry) and studies that assess 
children's exposure to lead from such products (including studies of 
bioavailability).
---------------------------------------------------------------------------

    \1\ For the purposes of this recommendation, ``Intended for use 
by children'' has the meaning provided in 40 CFR 710.43 of the TSCA 
section 8(a) Inventory Update Rule. The definition was originally 
intended for a different audience (those submitting information 
under the Inventory Update Rule) but the same concepts can apply to 
the products at issue here. The definition reads as follows:
    Intended for use by children means the chemical substance or 
mixture is used in or on a product that is specifically intended for 
use by children age 14 or younger. A chemical substance or mixture 
is intended for use by children when the submitter answers ``yes'' 
to at least one of the following questions for the product into 
which the submitter's chemical substance or mixture is incorporated:
    (1) Is the product commonly recognized (i.e., by a reasonable 
person) as being intended for children age 14 or younger?
    (2) Does the manufacturer of the product state through product 
labeling or other written materials that the product is intended for 
or will be used by children age 14 or younger?
    (3) Is the advertising, promotion, or marketing of the product 
aimed at children age 14 or younger?
---------------------------------------------------------------------------

    2. Rationale for recommendation. In pursuit of the Federal goal of 
eliminating childhood lead poisoning by 2010 (Ref. 8), EPA is looking 
beyond paint-related sources in an effort to address risks from other 
potentially significant sources. Although the Consumer Product Safety 
Commission (CPSC) has an effort underway to address risks from 
children's metal jewelry containing lead (Ref. 9), there is less 
information available on the lead content of, and exposure to lead 
from, other children's products.CPSC is currently addressing lead 
containing children's metal jewelry, but has not yet established a 
definition of these products. Thus, EPA recommends that the ITC include 
the category listing for lead and lead compounds described in Unit 
IV.1. Information obtained on this category may assist both EPA and 
CPSC in taking further action as appropriate to protect children from 
lead poisoning due to lead in products. It should be noted that for the 
purposes of regulating products by CPSC, products intended for children 
might not be defined in the same manner as for actions by EPA under 
TSCA.
    3. Supporting information. EPA has a long-standing interest in 
limiting human and environmental exposure to lead and lead compounds, 
with special concern for exposures to children. In the context of its 
Toxic Release Inventory (TRI) Program, EPA has classified lead as a 
``persistent, bioaccumulative, toxic chemical,'' (TRI Lead Rule 
published in the Federal Register of January 17, 2001 (66 FR 4500) 
(FRL-6722-4)) and in past actions has presented evidence that lead can 
cause significant deleterious health effects, particularly in children 
(e.g., Identification of Dangerous Levels of Lead; Proposed Rule 
published in the Federal Register of June 3, 1998 (63 FR 30301) (FRL-
5791-9)). A major focus of EPA has been on lead and lead compounds in 
paint, with a particular emphasis to limit lead exposures from paint 
following enactment of the ``Residential Lead-Based Paint Hazard 
Reduction Act of 1992.'' Public Law 102-550. In that Act, Congress 
emphasized its concerns about children's exposure to lead.
    CPSC recently published an Advance Notice of Proposed Rulemaking 
(ANPRM) in the Federal Register of January 9, 2007 (72 FR 920) 
addressing certain products beyond paint; CPSC is considering whether 
there may be a need to ban children's metal jewelry containing more 
than 0.06% lead by weight in metal components. In addition to 
children's metal jewelry products, EPA also believes there may be 
potential risks to children's health from exposure to other products 
intended for use by children that contain lead or lead compounds. 
However, information regarding such products is currently incomplete.
    4. Information needs. EPA is interested in health and safety 
studies that relate to the lead content of consumer products that are 
``intended for use by children'' (as defined at 40 CFR 710.43), but 
excluding ``children's metal jewelry'' as described by the CPSC in its 
ANPRM of January 9, 2007.
    For all lead and lead compounds, EPA needs the following 
information to assess the extent and degree of exposure and potential 
hazard associated with these substances:
     Studies that relate to the lead content of consumer 
products that are intended for use by children (includes studies 
showing any measurable lead content), and/or
     Studies that assess children's exposure to lead from such 
products (including studies of bioavailability).
    With regards to grade or purity, studies showing any measurable 
lead content in such products are of interest.

V. References

    1. ITC. 2007. Fifty-Ninth Report of the TSCA Interagency Testing 
Committee to the Administrator of the Environmental Protection Agency; 
Receipt of Report and Request for Comments. Federal Register (72 FR 
2756, January 22, 2007) (FRL-8110-2). Available on-line at: https://
www.epa.gov/fedrgstr.
    2. Brooke, L.T. 1993. Acute and chronic toxicity of nonylphenol to 
ten

[[Page 41418]]

species of aquatic organisms. Report to the U.S. EPA for Work 
Assignment No. 02 of Contract No. 68-C1-0034. Lake Superior Research 
Institute, University of Wisconsin-Superior, Superior, WI. March 
24,1993. Amended October 18, 2005.
    3. Ward, T.J. and Boeri, R.L. 1991. Early life stage toxicity of 
nonylphenol to the fathead minnow, Pimephales promelas. Study Number 
8979 CMA. EnviroSystems, Hampton, NH.
     4. Analytical Bio-Chemistry (ABC) Laboratories, Inc. 1986. Early 
life stage toxicity of para-tert octylphenol to Rainbow trout (salmo 
gairdneri). Report 34452. Columbia, MO.
    5. Knorr, S. and Braunbeck, T. 2002. Decline in reproductive 
success, sex reversal, and developmental alterations in Japanese medaka 
(Oryzias latipes) after continuous exposure to octylpheno1. 
Ecotoxicology and Environmental Safety Journal. 51:187-196.
    6. Segner, H.; Navas, J. M.; Schafers, C.; and Wenzel, A. 2003. 
Potencies of estrogenic compounds in in vitro screening assays and in 
life cycle tests with zebraflsh in vitro. Ecotoxicology and 
Environmental Safety Journal. 54:315-322.
    7. Wenzel, A.; Schafers, C.; Vollmer, G., et al. 2001. Research 
efforts towards the development and validation of a test method for the 
identification of endocrine disrupting chemicals. Final Report of 
European Commission Contract B6-7920/98/000015. Schmallenberg, Germany.
    8. President's Task Force on Environmental Health Risks and Safety 
Risks to Children. 2000. Eliminating Childhood Lead Poisoning: A 
Federal Strategy Targeting Lead Paint Hazards. Available on-line at: 
https://www.epa.gov/oppt/lead/pubs/fedstrategy2000.pdf.
    9. CPSC. Children's Jewelry Containing Lead; Advanced Notice of 
Proposed Rulemaking; Request for Comments and Information. Federal 
Register (72 FR 920, January 9, 2007). Available on-line at: https://
www.cpsc.gov/businfo/frnotices/fr07/leadjewelry.pdf.

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
    Dianne Poster, Member, Chair

    National Oceanographic and Atmospheric Administration
    Tony Pait, Member

    Environmental Protection Agency
    John Schaeffer, Member
    Gerry Brown, Alternate

    National Cancer Institute
    Vacant

    National Institute of Environmental Health Sciences
    John Bucher, Member
    Scott Masten, Alternate

    National Institute for Occupational Safety and Health
    Dennis W. Lynch, Member Vice-Chair
    Mark Toraason, Alternate

    National Science Foundation
    Cindy Lee, Member
    Marge Cavanaugh, Alternate

    Occupational Safety and Health Administration
    Maureen Ruskin, Member
    Thomas Nerad, Alternate

    Liaison Organizations and Their Representatives

    Agency for Toxic Substances and Disease Registry
    Daphne Moffett, Member
    Glenn D. Todd, Alternate

    Consumer Product Safety Commission
    Jacqueline Ferrante, Member

    Department of Agriculture
    Clifford P. Rice, Member
    Laura L. McConnell, Alternate

    Department of Defense
    Laurie Roszell, Member

    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
    Carol Savage, Administrative Assistant

TSCA Interagency Testing Committee, Office of Pollution Prevention and 
Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; e-mail address: 
savage.carol@epa.gov; url: https://www.epa.gov/opptintr/itc.
[FR Doc. E7-14575 Filed 7-26-07; 8:45 am]
BILLING CODE 6560-50-S
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