2012-30615. Seventy-First Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its 71st ITC Report to the EPA Administrator on November 14, 2012. In the 71st ITC Report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing 16 High Production Volume (HPV) Challenge Program orphan chemicals. The ITC is removing these 16 chemicals because actions have been taken to assess their hazardous potential.

DATES:

Comments must be received on or before January 18, 2013.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2012-0820, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 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. ATTN: Docket ID Number EPA-HQ-OPPT-2012-0820. 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 [phone]. 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-2012-0820. EPA's policy is that all comments received will be included in the docket without change and may be made available online 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 email. The regulations.gov Web site 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 email comment directly to EPA without going through regulations.gov, your email 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.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. 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 legal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. 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:

For technical information contact: John D. Walker, TSCA Interagency Testing Committee (7401M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

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.

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 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.

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 EPA Administrator 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 EPA Administrator 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/​oppt/​itc.

A. The 71st ITC Report

The ITC is revising the TSCA section 4(e) Priority Testing List by removing 16 HPV Challenge Program orphan chemicals.

B. Status of the Priority Testing List

The Priority Testing List includes 16 chemicals with insufficient dermal absorption rate data, 2 alkylphenols, 148 HPV Challenge Program orphan chemicals, cadmium, a category of cadmium compounds including any unique chemical substance that contains cadmium as part of that chemical's structure, 6 non-phthalate plasticizers, 25 phosphate ester flame retardants, 2 other flame retardants, 9 chemicals to which children living near hazardous waste sites may be exposed, and a category of 69 diisocyanates and related compounds.

List of Subjects

Environmental protection, Chemicals, Hazardous substances.

Dated: December 11, 2012.

Wendy C. Hamnett,

Director, Office of Pollution Prevention and Toxics.

Seventy-First Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency

Table of Contents

Summary

I. Background

II. ITC's Activities During This Reporting Period (June to October 2012)

III. HPV Challenge Program Orphan Chemicals Removed From the TSCA Section 4(e) Priority Testing List

IV. References

V. The TSCA Interagency Testing Committee

Summary

The ITC is revising the Toxic Substances Control Act (TSCA) section 4(e) Priority Testing List by removing 16 High Production Volume (HPV) Challenge Program orphan chemicals.

The TSCA section 4(e) Priority Testing List is Table 1 of this unit.

Table 1—TSCA Section 4(e) Priority Testing List

[October 2012]

ITC report	Date	Chemical name/group	Action
31	January 1993	2 Chemicals with insufficient dermal absorption rate data, methylcyclohexane and cyclopentane	Designated.
32	May 1993	10 Chemicals with insufficient dermal absorption rate data	Designated.
35	November 1994	4 Chemicals with insufficient dermal absorption rate data, cyclopentadiene, formamide, 1,2,3-trichloropropane, and m-nitrotoluene	Designated.
37	November 1995	Branched 4-nonylphenol (mixed isomers)	Recommended.
41	November 1997	Phenol, 4-(1,1,3,3-tetramethylbutyl)-	Recommended.
55	December 2004	147 High Production Volume (HPV) Challenge Program orphan chemicals	Recommended.
56	August 2005	1 HPV Challenge Program orphan chemical, naphtha (petroleum), clay-treated light straight-run	Recommended.
68	May 2011	Cadmium	Recommended.
69	November 2011	Cadmium compounds	Recommended.
69	November 2011	6 Non-phthalate plasticizers	Recommended.
69	November 2011	25 Phosphate ester flame retardants	Recommended.
69	November 2011	2 Other flame retardants	Recommended.
69	November 2011	9 Chemicals to which children living near hazardous waste sites may be exposed	Recommended.
69	November 2011	69 Diisocyanates and related 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 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 et seq.). ITC reports are available from the ITC's Web site (http://www.epa.gov/​oppt/​itc) and from regulations.gov (http://www.regulations.gov) 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 and ITC members. ITC members and staff are listed at the end of this report.

II. ITC's Activities During This Reporting Period (June to October 2012)

During this reporting period, the ITC discussed the 164 High Production Volume (HPV) Challenge Program orphan chemicals remaining on the TSCA section 4(e) Priority Testing List. As a result of these discussions, the ITC removed 16 HPV Challenge Program orphan chemicals from the TSCA section 4(e) Priority Testing List. Orphan chemicals are those HPV chemicals for which no sponsors have volunteered to develop and submit robust summaries of basic hazard and fate testing data to the EPA. The hazard and fate testing data requested by the ITC for HPV Challenge Program orphan chemicals are necessary to establish a screening level understanding of their potential human health and environmental impacts.

III. HPV Challenge Program Orphan Chemicals Removed From the TSCA Section 4(e) Priority Testing List

The Chemical Abstract Service (CAS) Registry numbers and names of the 16 HPV Challenge Program orphan chemicals being removed from the Priority Testing List are listed in Table 2 of this unit. Also listed in Table 2 of this unit are the ITC reports in which the HPV Challenge Program orphan chemicals were added to the Priority Testing List and the rationale for their removal. The Universal Resource Locators (URLs or Web site addresses) provide additional information about the disposition of these chemicals and are included as footnotes to Table 2 of this unit.

Table 2—HPV Orphan Chemicals Being Removed From the Priority Testing List in This 71st ITC Report

CAS No.	Chemical name	ITC report	Removal rationale
62-56-6	Thiourea	55	EPA NPRM.a
81-16-3	1-Naphthalenesulfonic acid, 2-amino-	55	OECD SIDS.b
84-69-5	1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester	55	EPA NPRM.a
91-68-9	Phenol, 3-(diethylamino)-	55	Sponsored chemical.c
110-18-9	1,2-Ethanediamine, N1,N1,N2,N2-tetramethyl-	55	Sponsored chemical.d
119-33-5	Phenol, 4-methyl-2-nitro-	55	OECD SIDS program.e
121-69-7	Benzenamine, N,N-dimethyl-	55	Sponsored chemical.c
131-57-7	Methanone, (2-hydroxy-4-methoxyphenyl)phenyl-	55	EPA NPRM.a
870-72-4	Methanesulfonic acid, 1-hydroxy-, sodium salt (1:1)	55	EPA NPRM.a
6473-13-8	2-Naphthalenesulfonicacid, 6-[2-(2,4-diaminophenyl)diazenyl]-3-[2-[4-[[4-[2-[7-[2-(2,4-diaminophenyl)diazenyl]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]phenyl]amino]-3-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:3)	55	EPA NPRM.a
28188-24-1	Octadecanoic acid, 1,1'-2-(hydroxymethyl)-2-[[(1-oxooctadecyl)oxy]methyl]-1,3-propanediyl ester	55	EPA NPRMa
61788-44-1	Phenol, styrenated	56	Sponsored chemical.f
68334-01-0	Disulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products	55	Sponsored chemical.g
68457-74-9	Phenol, isobutylenated methylstyrenated	56	Sponsored chemical.f
68915-39-9	Cyclohexane, oxidized, aq. ext., sodium salt	55	Analog to CAS No. 68915-38-8.h
90640-80-5	Anthracene oil	55	OECD SIDS program.i
Footnotes:
a EPA Notice of Proposed Rulemaking (NPRM). Federal Register (65 FR 81658, December 26, 2000) (FRL-6758-4).
b http://webnet.oecd.org/​hpv/​UI/​Result.aspx?​Q=​2e64bf75-689c-4499-95c8-bb0a5616c03d.
c http://www.epa.gov/​chemrtk/​pubs/​summaries/​aroamin/​c13310tc.htm.
d http://www.epa.gov/​HPV/​pubs/​summaries/​nnnntetr/​c14715rs.pdf.
e http://webnet.oecd.org/​hpv/​UI/​Result.aspx?​Q=​df187798-b971-44f0-8323-b841fff85856.
f http://www.epa.gov/​HPV/​pubs/​summaries/​hndrdphn/​c13382tp.pdf.
g http://www.epa.gov/​HPV/​pubs/​summaries/​resbscat/​c14906.pdf.
h http://www.epa.gov/​chemrtk/​pubs/​summaries/​cyclhxox/​c15012tc.htm.
i http://webnet.oecd.org/​hpv/​UI/​SIDS_​Details.aspx?​id=​289cb585-0b2f-4d84-bece-59184368cc20.
Note: OECD SIDS program = Organization for Economic Cooperation and Development Screening Information Data Set program.

Fourteen of the HPV Challenge Program orphan chemicals that were removed from the Priority Testing List in this 71st ITC Report were added to the Priority Testing List in the 55th ITC Report (Ref. 1). Two of the HPV Challenge Program orphan chemicals that were removed from the Priority Testing List in this 71st ITC Report were added to the Priority Testing List in the 56th ITC Report (Ref. 2). Six of the HPV Challenge Program orphan chemicals were removed because they were added to a Notice of Proposed Rulemaking (NPRM) that proposed to require manufacturers and processors of these chemicals to conduct testing for acute toxicity, repeated dose toxicity, developmental and reproductive toxicity, genetic toxicity, ecotoxicity, and environmental fate (Ref. 3). Three of the HPV Challenge Program orphan chemicals were removed because they were in the Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) program (http://www.epa.gov/​opptintr/​chemtest/​pubs/​oecdsids.html). The URLs for the three OECD SIDS chemicals are provided as footnotes b, e, and i to Table 2 of this unit. Six of the HPV Challenge Program orphan chemicals were removed because their testing was sponsored by the chemical's producers. The URLs for the six sponsored chemicals are provided as footnotes c, d, f, and g to Table 2 of this unit. One chemical was removed because it was an analog to a chemical with robust summaries and test plans. The URL for that chemical is provided as footnote h to Table 2 of this unit.

IV. References

1. ITC. Fifty-Fifth Report of the ITC; Notice. Federal Register (70 FR 7364, February 11, 2005) (FRL-7692-1). Available online at: http://www.regulations.gov. Docket ID Number: EPA-HQ-OPPT-2012-0820.

2. ITC. Fifty-Sixth Report of the ITC; Notice. Federal Register (70 FR 61520, October 24, 2005) (FRL-7739-9). Available online at: http://www.regulations.gov. Docket ID Number: EPA-HQ-OPPT-2012-0820.

3. EPA. Testing of Certain High Production Volume Chemicals; Proposed Rule. Federal Register (65 FR 81658, December 26, 2000) (FRL-6758-4). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2012-0820.

V. The TSCA Interagency Testing Committee

Statutory Organizations With Representatives

Department of Commerce

National Institute of Standards and Technology

Dianne L. Poster, Alternate

Environmental Protection Agency

Robert W. Jones, Member

John E. Schaeffer, Alternate

National Institute of Environmental Health Sciences

Nigel Walker, Member

Scott Masten, Alternate

National Institute for Occupational Safety and Health

Gayle DeBord, Member

Dennis W. Lynch, Alternate

Occupational Safety and Health Administration

Janet Carter, Member

Thomas Nerad, Alternate

Liaison Organizations With Representatives

Agency for Toxic Substances and Disease Registry

Glenn D. Todd, Member

Consumer Product Safety Commission

Dominique Johnson, Member

Department of Agriculture

Clifford P. Rice, Member

Cathleen J. Hapeman, Alternate

Department of Defense

Laurie E. Roszell, Member

Department of the Interior

Barnett A. Rattner, Member

Food and Drug Administration

Kirk Arvidson, Member

Ronald F. Chanderbhan, Alternate

ITC Staff

John D. Walker, Director

Carol Savage, Administrative Assistant (NOWCC Employee)

TSCA Interagency Testing Committee (7401M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; email address: [e-mail]; url: http://www.epa.gov/​oppt/​itc.