Federal Register: July 27, 2007 (Volume 72, Number 144)
DOCID: fr27jy07-111 FR Doc E7-14575
ENVIRONMENTAL PROTECTION AGENCY
Western Area Power Administration
EPA ID: [EPA-HQ-OPPT-2007-0420; FRL-8137-6]
NOTICE: Part III
DOCUMENT ACTION: Notice.
Sixtieth Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments
DATES: Comments must be received on or before August 27, 2007.
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Testing List by adding ``lead and lead compounds'' to the Priority Testing List so that EPA may expeditiously obtain unpublished health and safety studies that relate to the lead content of consumer products that are intended for use by children.
Environmental Protection Agency,
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 email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CDROM that you mail to EPA, mark the outside of the disk or CDROM that you mail to EPA, mark the outside of the disk or CDROM as CBI and then identify electronically within the disk or CDROM 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
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.
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 http://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
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
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 4nonylphenol 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
..., 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 94469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 et seq.). ITC reports are available from the ITC's website (http://www.epa.gov/oppt/itc ) within a few days of submission to the EPA Administrator and from EPA's website (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) 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 (http://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 (http://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 are discussed in Unit IV. of this report.
1. Alkylphenols. As noted in the 59\th\ ITC Report, the ITC is leaving phenol, 4(1,1,3,3tetramethylbutyl) (CAS No. 140669) and phenol, 4nonyl, branched (CAS No. 84852153) 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,
4nonyl, branched should be tested for avian reproductive effects. While the ITC is considering whether phenol, 4(1,1,3,3
tetramethylbutyl) or phenol, 4nonyl, 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. 84852153)
91Day 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.
33Day 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(1,1,3,3tetramethylbutyl) (CAS No. 140669) Study Name
60Day 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........................................... 1.5Generation 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.... 185Day lifecycle test with Zebra Fish (Ref. 6). EC50 (fertilization success) = 28 [mu]g/L................................................ 185Day lifecycle 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 1,2,5,6,9,10hexabromocyclododecane (CAS No. 3194556) or hexabromocyclododecane (CAS No. 25637994) using American Kestrels. The BFRIP provided the ITC with the International Uniform Chemical Information Database (IUCLID) data set for hexabromocyclododecane (CAS No. 25637994) 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. 1163195). 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,
``Preventing Lung Disease in Workers Who Use or Make Flavorings'' (http://www.cdc.gov/niosh/docs/2004110), 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
301042 Acetic acid, lead(2+) salt
598630 Carbonic acid, lead(2+) salt (1:1)
1309600 Lead oxide (PbO2)
1314870 Lead sulfide (PbS)
7428480 Octadecanoic acid, lead salt (1:?)
7446277 Phosphoric acid, lead(2+) salt (2:3) 7758954 Lead chloride (PbCl2)
7758976 Chromic acid (H2CrO4), lead(2+) salt (1:1) 13814965 Borate (1), tetrafluoro, lead(2+) (2:1) 53466663 Silicic acid, lead salt, basic
63653429 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 paintrelated 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 longstanding 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) (FRL67224)) 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 57919)). 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 LeadBased Paint Hazard Reduction Act of 1992.'' Public Law 102550. 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:
With regards to grade or purity, studies showing any measurable lead content in such products are of interest.
1. ITC. 2007. FiftyNinth 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) (FRL81102). Available online at: http://www.epa.gov/fedrgstr .
2. Brooke, L.T. 1993. Acute and chronic toxicity of nonylphenol to ten
species of aquatic organisms. Report to the U.S. EPA for Work Assignment No. 02 of Contract No. 68C10034. Lake Superior Research Institute, University of WisconsinSuperior, 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 BioChemistry (ABC) Laboratories, Inc. 1986. Early life stage toxicity of paratert 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. 51:187196.
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. 54:315322.
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 B67920/98/000015. 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 online at: http://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 online at: http://www.cpsc.gov/businfo/frnotices/fr07/leadjewelry.pdf .
VI. The TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
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
National Institute of Environmental Health Sciences
John Bucher, Member
Scott Masten, Alternate
National Institute for Occupational Safety and Health
Dennis W. Lynch, Member ViceChair
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
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 204600001; email address:
firstname.lastname@example.org; url: http://www.epa.gov/opptintr/itc. [FR Doc. E714575 Filed 72607; 8:45 am]
BILLING CODE 656050S
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 204600001; telephone number: (202) 5541404; email address: TSCAHotline@epa.gov.