Fifty-Fourth Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its Fifty-Fourth Report to the Administrator of EPA on April 23, 2004. In the 54th ITC Report, which is included with this notice, the ITC is revising the Priority Testing List by removing 25 vanadium compounds. In addition, the ITC is soliciting public comments on the idea of posting on the ITC's web site, broad non-Confidential Business Information (CBI) categories of worker numbers and worker hours created from TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule submissions.

DATES:

Comments, identified by docket ID number OPPT-2004-0090, must be received on or before July 15, 2004.

ADDRESSES:

Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

For general information contact: 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.

For technical information contact: John D. Walker, ITC Director (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-7527; fax: (202) 564-7528; e-mail address: walker.johnd@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 technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPPT-2004-0090. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include CBI or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744, and the telephone number for the Office of Pollution Prevention and Toxics (OPPT) Docket, which is located in EPA Docket Center, is (202) 566-0280.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/ . You may also access additional information about the ITC at http://www.epa.gov/opptintr/itc/ or through the web site for the Office of Prevention, Pesticides and Toxic Substances (OPPTS) at http://www.epa.gov/opptsfrs/home/opptsim.htm/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/ , and follow e online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPPT-2004-0090. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by e-mail to oppt.ncic@epa.gov, Attention: Docket ID Number OPPT-2004-0090. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By mail. Send your comments to: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT-2004-0090. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

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

We invite you to provide your views and comments on the ITC 54^th Report. You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. Provide specific examples to illustrate your concerns.

5. Make sure to submit your comments by the deadline in this notice.

6. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background

The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.) authorizes the Administrator of the 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.

A. The ITC's 54^th Report

The 54^th ITC Report was transmitted to the EPA's Administrator on April 23, 2004, and is included in this notice. In the 54^th ITC Report, the ITC is revising the Priority Testing List by removing 25 vanadium compounds. In addition, the ITC is soliciting public comments on the idea of posting on the ITC's web site, broad non-CBI categories of worker numbers and worker hours created from TSCA section 8(a) PAIR rule submissions.

B. Status of the Priority Testing List

The current TSCA 4(e) Priority Testing List as of April 2004 can be found in Table 1 of the 54^th ITC Report, which is included in this notice.

List of Subjects

• Environmental protection
• Chemicals
• Hazardous substances

Fifty-Fourth 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. Previous Requests to Add Chemicals to the TSCA Section 8(a) PAIR Rule

D. Previous Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule

III. ITC's Activities During this Reporting Period (November 2003 to April 2004)

IV. Revisions to the TSCA Section 4(e) Priority Testing List

V. References

VI. The TSCA Interagency Testing Committee

SUMMARY

In this 54^th ITC Report, the ITC is revising the Priority Testing List by removing 25 vanadium compounds. In this report public comments are requested on the idea of posting on the ITC's web site, broad non-Confidential Business Information (CBI) categories of worker numbers and worker hours created from Toxic Substances Control Act (TSCA) section 8(a) Preliminary Assessment Information Reporting (PAIR) rule submissions.

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

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 web site ( http://www.epa.gov/opptintr/itc/ ) within a few days of submission to the Administrator and from the EPA's web site http://www.epa.gov/fedrgstr/ after publication in the Federal Register. The ITC produces its revisions to the Priority Testing List with administrative and technical support from the ITC Staff, ITC Members and their U.S. Government organizations, and contract support provided by EPA. ITC Members and Staff are listed at the end of this report.

II. TSCA Section 8 Reporting

A. TSCA Section 8 Reporting Rules

Following receipt of the ITC's Report (and the revised Priority Testing List) by the EPA Administrator, the U.S. EPA's Office of Pollution Prevention and Toxics (OPPT) adds the chemicals from the revised Priority Testing List to the TSCA section 8(a) PAIR and TSCA section 8(d) Health and Safety Data Reporting (HaSDR) rules. The PAIR rule requires producers and importers of Chemical Abstract Service (CAS)-numbered chemicals added to the Priority Testing List to submit production and exposure reports ( http://www.epa.gov/opptintr/chemtest/pairform.pdf/ ). The HaSDR rule requires producers, importers, and processors of all chemicals added to the Priority Testing List to submit unpublished health and safety studies under TSCA section 8(d) that must be in compliance with the revised HaSDR rule (Ref. 1). All submissions must be received by EPA within 90 days of the reporting rules Federal Register publication date.

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

The ITC's use of TSCA section 8 and other information is described in previous ITC reports ( http://www. epa.gov/opptintr/itc/rptmain.htm/).

C. Previous Requests to Add Chemicals to the TSCA Section 8(a) PAIR Rule

In its 53^rd ITC Report, the ITC requested that EPA add 3 pyridinamines and 20 tungsten compounds to the TSCA section 8(a) PAIR rule (Ref. 2).

D. Previous Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule

In previous ITC reports it was requested that the following chemicals be added to the TSCA section 8(d) HaSDR rule: 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- (3-amino-5-mercapto-1,2,4-triazole) (CAS No. 16691-43-3) and imidazo[4,5-d]imidazole-2,5(1H,3H)-dione, tetrahydro- (glycoluril) (CAS No. 496-46-8) (42^nd ITC Report, Ref. 3), 9 indium compounds (47^th ITC Report, Ref. 4); benzenamine, 3-chloro-2, 6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- (CAS No. 29091-20-1) (48^th ITC Report, Ref. 5); and stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7) (49^th ITC Report, Ref. 6); benzene, 1,3,5-tribromo-2-(2-propenyloxy)- (CAS No. 3278-89-5) and 1-triazene, 1,3-diphenyl- (CAS No.136-35-6) (50^th ITC Report, Ref. 7). The TSCA section 8(d) studies requested for these chemicals were listed in the ITC's 51^st Report (Ref. 8). On May 4, 2004, EPA issued a final rule pursuant to TSCA section 8(d) requiring manufacturers (including importers) of these 15 chemicals to report certain unpublished health and safety data to EPA (Ref. 9).

III. ITC's Activities During this Reporting Period (November 2003 to April 2004)

During this reporting period, the ITC received voluntary submissions of exposure-related information on vanadium compounds. The ITC acknowledges and appreciates the submissions received from BASF Corporation; Cormetech, Inc.; Engelhard Corporation; OSRAM Sylvania, Inc.; W.R. Grace & Company; Color Pigments Manufacturers Association; Sud Chemie; Akzo Nobel Chemicals, Inc.; American Acryl L.P. International, Inc.; and the Vanadium Producers and Reclaimers Association (VPRA). The procedures for submitting voluntary information through the ITC's Voluntary Information Submissions Innovative Online Network (VISION) are described on the ITC's web site ( http://www.epa.gov/opptintr/itc/vision.htm/ ).

During this reporting period, the ITC reviewed the CBI PAIR reports submitted in response to the June 11, 2003, PAIR rule (Ref. 10). The ITC is exploring the idea of sanitizing the CBI data to create broad non-CBI categories of worker numbers and worker hours that it could share with the public. To accomplish this, the ITC is proposing the idea of posting these broad non-CBI categories of worker numbers and worker hours on the ITC's web site ( http://www.epa.gov/opptintr/itc/ ).

There is a precedent for the ITC to do this. In its November 30, 1999, 45^th ITC Report to the EPA Administrator (Ref. 11), the ITC discussed the idea of sharing non-CBI production volume ranges with the public. In May 2001, the EPA posted on its web site non-CBI production volume ranges for chemicals that were reported in response to the 1998 Inventory Update Rule (IUR) ( http://www.epa.gov/oppt/iur/iur98/index.htm/ ). Since then, these ranges have been revised and the non-CBI production volume ranges for chemicals that were reported in response to the 1986, 1990, 1994, and 2002 IUR have been posted on EPA's web site ( http://www.epa.gov/oppt/iur/iur02/index.htm/ ).

By making broad non-CBI categories of worker numbers and worker hours available to the public, the ITC is suggesting that this information could be used to make more recent occupational-exposure estimates then provided by the 1981-1983 NIOSH National Occupational Exposure Survey. The ITC is proposing posting the following broad non-CBI categories on its web site:

Worker ranges: <100;100-1,000; 1,000-10,000; and >10,000.

Worker hour ranges: <100, 100-1,000; 1,000-10,000; and >10,000.

Comments on these proposals should be sent to the ITC Director by July 15, 2004.

IV. Revisions to the TSCA Section 4(e) Priority Testing List

In its 45^th ITC Report (Ref. 11), the ITC removed 47 chemicals from the Priority Testing List, because EPA published a June 9, 1999, Federal Register notice proposing in vitro dermal absorption rate testing for these chemicals (Ref. 12). In its June 9, 1999, Federal Register notice, the EPA also mentioned that in vitro dermal absorption rate testing did not have to be conducted for tert-butyl alcohol (CAS No. 75-65-0) because an in vivo study of its dermal absorption rate was submitted to the EPA in 1998. The ITC is removing tert-butyl alcohol from the Priority Testing List in this 54^th ITC Report because the EPA found that the 1998 in vivo study was sufficiently adequate not to require in vitro dermal absorption rate testing of tert-butyl alcohol. On April 26, 2004, EPA issued a final rule pursuant to TSCA section 4(a) requiring manufacturers (including importers) to conduct in vitro dermal absorption rate testing for 34 of these chemicals (Ref. 13).

Forty-three vanadium compounds were added to the Priority Testing List in the ITC's 51^st Report (Ref. 8). Based on responses to the June 11, PAIR rule (Ref. 10), the ITC is removing 25 vanadium compounds from the Priority Testing List (Table 2). The 18 vanadium compounds remaining on the Priority Testing List are listed in Table 3.

V. References

1. EPA. 1998. Revisions to Reporting Regulations Under TSCA Section 8(d). Federal Register (63 FR 15765, April 1, 1998) (FRL-5750-4). Available online at: http://www.epa.gov/fedrgstr/ .

2. ITC. 2004. Fifty-Third Report of the ITC. Federal Register (69 FR 2467, January 15, 2004) (FRL-7335-2). Available online at: http://www.epa.gov/fedrgstr/ .

3. ITC. 1998. Forty-Second Report of the ITC. Federal Register (63 FR 42554, August 7, 1998) (FRL-5797-8). Available online at: http://www.epa.gov/fedrgstr/ .

4. ITC. 2001. Forty-Seventh Report of the ITC. Federal Register (66 FR 17768 April 3, 2001) (FRL-6763-6). Available online at: http://www.epa.gov/fedrgstr/ .

5. ITC. 2001. Forty-Eighth Report of the ITC. Federal Register (66 FR 51276, October 5, 2001) (FRL-6786-7). Available online at: http://www.epa.gov/fedrgstr/ .

6. ITC. 2002. Forty-Ninth Report of the ITC. Federal Register (67 FR 10298, March 6, 2002) (FRL-6820-8). Available online at: http://www.epa.gov/fedrgstr/ .

7. ITC. 2002. Fiftieth Report of the ITC. Federal Register (67 FR 49530, July 30, 2002) (FRL-7183-7). Available online at: http://www.epa.gov/fedrgstr/ .

8. ITC. 2002. Fifty-First Report of the ITC. Federal Register (68 FR 8976, February 26, 2003) (FRL-7285-7). Available online at: http://www.epa.gov/fedrgstr/ .

9. EPA. 2004. Health and Safety Data Reporting; Addition of Certain Chemicals. Federal Register (69 FR 24517, May 4, 2004) (FRL-7322-8). Available online at: http://www.epa.gov/fedrgstr/ .

10. EPA. 2003. Preliminary Assessment Information Reporting; Addition of Certain Chemicals. Federal Register (68 FR 34832, June 11, 2003) (FRL-7306-7). Available online at: http://www.epa.gov/fedrgstr/ .

11. ITC. 2000. Forty-Fifth Report of the ITC. Federal Register (65 FR 75544, December 1, 2000) (FRL-6399-5). Available online at: http://www.epa.gov/fedrgstr/ .

12. EPA. 1999. Proposed test rule for in vitro dermal absorption rate testing of certain chemicals of interest to the Occupational Safety and Health Administration. Federal Register (64 FR 31074, June 9, 1999) (FRL-5760-3). Available online at: http://www.epa.gov/fedrgstr/ .

13. EPA. 2004. In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration. Federal Register (69 FR 22402, April 26, 2004) (FRL-7312-2). Available online at: http://www.epa.gov/fedrgstr/ .

VI. The TSCA Interagency Testing Committee

Statutory Organizations and Their Representatives

Council on Environmental Quality

  Vacant

Department of Commerce

   National Institute of Standards and Technology

  Dianne Poster, Member

  Peter Barker, Alternate

   National Oceanographic and Atmospheric Administration

  Thomas P. O'Connor, Member, Chair

  Teri Rowles Alternate

Environmental Protection Agency

  Gerry Brown, Member

  Paul Campanella, Alternate

National Cancer Institute

  Alan Poland, Member

  David Longfellow, Alternate

National Institute of Environmental Health Sciences

  Barbara Shane, Member

  Scott Masten, Alternate

National Institute for Occupational Safety and Health

  Mark Toraason, Member

  Dennis W. Lynch, Alternate

National Science Foundation

  Marge Cavanaugh, Member

  Parag R. Chitnis, Alternate

Occupational Safety and Health Administration

  Maureen Ruskin, Member

Liaison Organizations and Their Representatives

Agency for Toxic Substances and Disease Registry

  William Cibulas, Member

  Daphne Moffett, Alternate

Consumer Product Safety Commission

  Treye Thomas, Member

  Jacqueline Ferrante, Alternate

Department of Agriculture

  Clifford P. Rice, Member, Vice Chair

  Laura L. McConnell, Alternate

Department of Defense

  Warren Jederberg, 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

  Norma S. L. Williams, Executive Assistant

TSCA Interagency Testing Committee, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-7527; fax number: (202) 564-7528; e-mail address: williams.norma@epa.gov; url: http://www.epa.gov/opptintr/itc/ .