[Federal Register: May 12, 2008 (Volume 73, Number 92)]
[Notices]               
[Page 27449-27453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my08-88]                         


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Part IV





Environmental Protection Agency





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 Sixty-Second Report of the TSCA Interagency Testing Committee to the 
Administrator of the Environmental Protection Agency; Receipt of Report 
and Request for Comments; Notice


[[Page 27450]]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2008-0309; FRL-8363-2]

 
Sixty-Second 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 sixty-second report to the 
Administrator of EPA on April 17, 2008. In the 62\nd\ ITC Report, which 
is included with this notice, the ITC is revising the TSCA section 4(e) 
Priority Testing List by removing four tungsten compounds and four 
cresols.

DATES: Comments must be received on or before June 11, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0309, by one of the following methods:
      Federal eRulemaking Portal: http://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-2008-0309. 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-
2008-0309. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://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 http://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 
http://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 http://
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-DOM 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 or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.

[[Page 27451]]

     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. 260l 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 62\nd\ ITC Report

    The ITC is revising the TSCA section 4(e) Priority Testing List by 
removing four tungsten compounds and four cresols.

B. Status of the Priority Testing List

    The Priority Testing List includes 2 alkylphenols, 1 tungsten 
compound, 12 lead compounds, 16 chemicals with insufficient dermal 
absorption rate data, and 208 High Production Volume (HPV) Challenge 
Program orphan chemicals.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.


    Dated: May 5, 2008.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

Sixty-Second Report of the TSCA Interagency Testing Committee to the 
Administrator of the 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
III. ITC's Activities During this Reporting Period (December 2007 to 
May 2008)
IV. Revisions to the TSCA Section 4(e) Priority Testing List: Chemicals 
Removed from the Priority Testing List
A. Tungsten Compounds
B. Cresols
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 removing four tungsten compounds and four 
cresols. The TSCA section 4(e) Priority Testing List is Table 1 of this 
unit.

                          Table 1.--TSCA Section 4(e) Priority Testing List (May 2008)
----------------------------------------------------------------------------------------------------------------
              ITC Report                         Date             Chemical Name/Group             Action
----------------------------------------------------------------------------------------------------------------
31                                     January 1993             2 Chemicals with         Designated
                                                                 insufficient dermal
                                                                 absorption rate data
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32                                     May 1993                 10 Chemicals with        Designated
                                                                 insufficient dermal
                                                                 absorption rate data
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35                                     November 1994            4 Chemicals with         Designated
                                                                 insufficient dermal
                                                                 absorption rate data
----------------------------------------------------------------------------------------------------------------
37                                     November 1995            Branched 4-nonylphenol   Recommended
                                                                 (mixed isomers)
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41                                     November 1997            Phenol, 4-(1,1,3,3-      Recommended
                                                                 tetramethylbutyl)-
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53                                     November 2003            Sodium tungstate (Na2    Recommended
                                                                 (WO4)), dihydrate
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55                                     December 2004            204 High Production      Recommended
                                                                 Volume (HPV) Challenge
                                                                 Program orphan
                                                                 chemicals
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56                                     August 2005              4 HPV Challenge Program  Recommended
                                                                 orphan chemicals
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60                                     May 2007                 12 Lead and lead         Recommended
                                                                 compounds
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I. Background

    The ITC was established by section 4(e) of 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 
website (http://www.epa.gov/opptintr/itc) within a few days of 
submission to the EPA Administrator and from the 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

[[Page 27452]]

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, 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) or TSCA section 8(d) Health and Safety 
Data Reporting (HaSDR) rules. 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). As provided for in the 
PAIR rule, whenever EPA announces the receipt of an ITC report, EPA 
amends, unless otherwise instructed by the ITC, the PAIR rule by adding 
the recommended (or designated) chemicals that have been added to the 
Priority Testing List by the ITC.
    The HaSDR rule requires certain past, current, and proposed 
manufacturers, importers, and (if specified by EPA) processors of 
listed chemicals to submit to EPA copies and lists of unpublished 
health and safety studies on the listed chemicals that they 
manufacture, import, or (if specified by EPA) process. As provided for 
in the HaSDR rule, whenever EPA announces the receipt of an ITC report, 
EPA amends, unless otherwise instructed by the ITC, the HaSDR rule by 
adding the recommended (or designated) chemicals that have been added 
to the Priority Testing List by the ITC.

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 the 52\nd\ ITC Report (http://www.epa.gov/opptintr/itc).

III. ITC's Activities During this Reporting Period (December 2007 to 
May 2008)

    During this reporting period, the ITC discussed tungsten compounds 
and cresols.

IV. Revisions to the TSCA Section 4(e) Priority Testing List: Chemicals 
Removed from the Priority Testing List

A. Tungsten Compounds

    Of the 22 tungsten compounds added to the Priority Testing List in 
the 53\rd\ ITC Report (Ref. 1) and the 56\th\ ITC Report (Ref. 2), 12 
were removed in the 58\th\ ITC Report (Ref. 3), and 5 were removed in 
the 59\th\ ITC Report (Ref. 4). At this time the ITC is removing 4 
tungsten compounds from the Priority Testing List (see Table 2 of this 
unit).

  Table 2.--Tungsten Compounds Being Removed From the Priority Testing
                                  List
------------------------------------------------------------------------
                  CAS No.                           Chemical Name
------------------------------------------------------------------------
1314-35-8                                    Tungsten oxide (WO3)
------------------------------------------------------------------------
7440-33-7                                    Tungsten
------------------------------------------------------------------------
11120-25-5                                  Tungstate (W12(OH)2O40\10\-
                                             ), ammonium (1:10)
------------------------------------------------------------------------
13472-45-2                                   Tungstate (WO4\2\-), sodium
                                             (1:2), (T-4)-
------------------------------------------------------------------------

    Prior to removing these 4 tungsten compounds, the PAIR reports 
submitted in response to the December 7, 2004, PAIR rule (Ref. 5) were 
reviewed. The ITC is removing tungstate 
(W12(OH)2O40\10\-), 
ammonium (1:10) and tungstate (WO4\2\-), sodium 
(1:2), (T-4)- because the data submitted in response to the December 7, 
2004 PAIR rule suggested low potential for occupational exposure. The 
ITC is removing tungsten from the Priority Testing List because the 
toxicological profile for tungsten (http://www.atsdr.cdc.gov/
toxprofiles/tp186.html) summarizes the health effects information. The 
ITC is removing tungsten oxide (WO3), a.k.a. tungsten 
trioxide because of the voluntary information provided by the 
International Tungsten Industry Association and their cooperation in a 
National Toxicology Program/National Institute for Occupational Safety 
and Health research program to address exposure and toxicity data 
needs. The ITC is retaining tungstate (WO4\2\-), 
disodium, dihydrate, (T-4)-, a.k.a. sodium tungstate (Na2 
(WO4)), dihydrate (CAS No. 10213-10-2), on the Priority 
Testing List because of ongoing discussions with the International 
Tungsten Industry Association to obtain:
     1. Recent non-Confidential Business Information 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. Estimates of the number of exposed humans and concentrations of 
sodium tungstate, dihydrate to which humans may be exposed in each 
relevant manufacturing, processing, or other occupational scenario.
    3. Case studies from occupationally exposed workers and 
pharmacokinetics, dermal, inhalation, as well as any oral acute 
toxicity, subchronic toxicity, chronic toxicity, genotoxicity, 
carcinogenicity, neurotoxicity, reproductive and developmental 
toxicity, and epidemiology studies.

B. Cresols

    Cresols were added to the Priority Testing List in the 61\st\ ITC 
Report to obtain unpublished data on dermal sensitization (Ref. 6). The 
four cresols are listed in Table 3 of this unit.

     Table 3.--Cresols Being Removed From the Priority Testing List
------------------------------------------------------------------------
                                    TSCA Inventory
             CAS No.                     Name             Common Name
------------------------------------------------------------------------
95-48-7                            Phenol, 2-methyl-  o-Cresol
------------------------------------------------------------------------
106-44-5                           Phenol, 4-methyl-  p-Cresol
------------------------------------------------------------------------
108-39-4                           Phenol, 3-methyl-  m -Cresol
------------------------------------------------------------------------
1319-77-3                          Phenol, methyl-     Mixed Cresols
------------------------------------------------------------------------

    In response to the 61\st\ ITC Report, the Cresols Panel of the 
American Chemistry Council (ACC) submitted a February 27, 2008 letter 
to EPA's Office of Pollution Prevention and Toxics Document Control 
Office (Ref. 7). The Cresols Panel also submitted several references 
which are summarized in this unit. In a 1972 report to the Research 
Institute for Fragrance Materials, Kligman performed a maximization 
test on 25 volunteers and determined that p-cresol at 4% concentration 
in petrolatum produced no sensitization reactions (Ref. 8). In a 1980 
report to the Research Institute for Fragrance Materials, Kligman 
performed a maximization test on 25 volunteers and determined that o-
cresol at 4% concentration in petrolatum produced no sensitization 
reactions (Ref. 9).
    In later reports, Bruze (1986) showed that guinea pigs sensitized 
with 2-methylolphenol (CAS No. 623-05-2) or 4-methylolphenol (CAS No. 
90-01-7) and challenged with o-cresol or p-cresol following a guinea 
pig maximization test protocol react positively at re-challenge with 
both o- and p-cresol (Ref. 10). Bruze and Zimerson (1997) challenged 
patients with known contact allergy to phenol-formaldehyde resin and 
methylol phenol to o-cresol and p-cresol and found that 4 of 10 
patients were sensitive to o-cresol, and 1 of 2 patients were sensitive 
to p-cresol (Ref.

[[Page 27453]]

11). Bruze and Zimerson (2002) established a dose-response relationship 
to cresol sensitization (Ref. 12). Seidenari et al. (1991) patch-tested 
adult patients that were sensitized to textile dyes for reaction to m-
cresol and found that there were positive effects in 2 of 81 patients 
tested with 2% m-cresol (Ref. 13). These findings were summarized in 
the 2006 Cosmetic Ingredient Review (Ref. 14). At this time there do 
not appear to be any dermal sensitization studies with mixed cresols.
    After reviewing the studies submitted by the Cresols Panel, it was 
determined that the information contained in this voluntary submission 
met the data needs. As a result, the ITC is removing o-cresol, p-
cresol, m-cresol and mixed cresols from the Priority Testing List.

V. References

    1. ITC. Fifty-Third Report of the ITC. Federal Register (69 FR 
2468, January 15, 2004) (FRL-7335-2). Available on-line at: http://
www.epa.gov/fedrgstr.
    2. ITC. Fifty-Sixth Report of the ITC. Federal Register (70 FR 
61520, October 24, 2005) (FRL-7739-9). Available on-line at: http://
www.epa.gov/fedrgstr.
    3. ITC. Fifty-Eighth Report of the ITC. Federal Register (71 FR 
39188, July 11, 2006) (FRL-8073-7). Available on-line at: http://
www.epa.gov/fedrgstr.
    4. ITC. Fifty-Ninth Report of the ITC. Federal Register (72 FR 
2756, January 22, 2007) (FRL-8110-2). Available on-line at: http://
www.epa.gov/fedrgstr.
    5. EPA. Preliminary Assessment Information Reporting; Addition of 
Certain Chemicals. Federal Register (69 FR 70552, December 7, 2004) 
(FRL-7366-8). Available on-line at: http://www.epa.gov/fedrgstr.
    6. ITC. Sixty-First Report of the ITC. Federal Register (73 FR 
5080, January 28, 2008) (FRL-8347-1). Available on-line at: http://
www.epa.gov/fedrgstr.
    7. ACC. 2008. February 27, 2008 letter from the Cresols Panel of 
the American Chemistry Council (ACC) to EPA's Office of Pollution 
Prevention and Toxics Document Control Office. Docket ID Number: EPA-
HQ-OPPT-2007-1124.
    8. Kligman, A.M. Report to Research Institute for Fragrance 
Materials (RIFM). November 22, 1972. As cited in: Opdyke D.L. J. 
(1974). Food Cosmetology Toxicology. 12: 389 and 390. Fragrance raw 
materials monographs. p-Cresol.
    9. Kligman, A.M. Report to Research Institute for Fragrance 
Materials (RIFM). March 26, 1980.
    10. Bruze, M. 1986. Sensitizing capacity of 2-methylol phenol, 4-
methylol phenol, and 2,4,6-trimethylol phenol in the guinea pig. 
American Journal of Contact Dermatitis. 14: 32-38.
    11. Bruze, M. and Zimerson, E. 1997. Cross-reaction patterns in 
patients with contact allergy to simple phenols. American Journal of 
Contact Dermatitis. 37: 82-86.
    12. Bruze, M. and Zimerson, E. 2002. Contact allergy to o-cresol - 
A sensitizer in phenol-formaldehyde resin. American Journal of Contact 
Dermatitis. 13: 198-200.
    13. Seidenari, S. Manzini, B.M., and Danese, P. 1991. Contact 
sensitization to textile dyes: description of 100 subjects. American 
Journal of Contact Dermatitis. 24: 253-258.
     14. Cosmetic Ingredient Review (CIR). 2006. Final report on the 
safety assessment of sodium p-chloro-m-cresol, p-chloro-m-cresol, 
chlorothymol, mixed cresols, m-cresol, o-cresol, p-cresol, 
isopropylcresols, thymol, o-cymen-5-ol, and carvacrol. International 
Journal of Toxicology. 25 (Supplement l): 29-127.

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, 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
    Scott Masten, Alternate

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

    National Science Foundation
    Judy Raper, Member
    Margaret Cavanaugh, Alternate

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

    Technical Support Contractor
    Syracuse Research Corporation

    ITC Staff
    John D. Walker, Director
    Carol Savage, Administrative Assistant

TSCA Interagency Testing Committee (7401M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; e-mail address: 
savage.carol@epa.gov; url: http://www.epa.gov/opptintr/itc.
[FR Doc. E8-10511 Filed 5-9-08; 8:45 am]

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