00-27926. Forty-Third Report of the TSCA Interagency Testing Committee to the Administrator; Receipt of Report and Request for Comments
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AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice.
SUMMARY:
The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its Forty-Third Report to the Administrator of the EPA on November 19, 1998. In the 43rd Report, which is included with this notice, the ITC revised the TSCA section 4(e) Priority Testing List by removing 9 High Production Volume Chemicals (HPVCs), 7 alkylphenols, and 2 octylphenol ethoxylates. The ITC is also asking EPA to promulgate a TSCA section (d) reporting rule for 18 alkylphenols; 15 nonylphenol ethoxylates; 3-amino-5-mercapto-1,2,4-triazole; glycoluril; and methylal recommended by the ITC for testing in several previous ITC Reports. There are no recommended, designated, or recommended with intent-to-designate chemicals or chemical groups in the 43rd Report. EPA invites interested persons to submit written comments on the Report.
DATES:
Comments, identified by docket control number OPPTS-41051, must be received on or before November 30, 2000.
ADDRESSES:
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-41051 in the subject line on the first page of your response.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics (7408), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
For technical information contact: John D. Walker, ITC Executive Director (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 260-1825; fax: (202) 260-7895; e-mail address: walker.johnd@epa.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action 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) any of the chemicals listed and you may be identified by the North American Industrial Classification System (NAICS) codes 325 and 32411. Because this action 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. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents?
1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
You may also access additional information about the ITC and the TSCA testing program through the web site for the Office of Prevention, Pesticides and Toxic Substances (OPPTS) at http://www.epa.gov/internet/oppts/,, or go directly to the ITC Home Page at http://www.epa.gov/opptintr/itc/.
2. In person. The Agency has established an official record for this action under docket control number OPPTS-41051. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-41051 in the subject line on the first page of your response.
1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. 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) 260-7093.
3. Electronically. You may submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-41051. Electronic comments may also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI Information That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 Start Printed Page 65235the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record 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's 43rd 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 control number OPPTS-41051 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 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 the 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.
EPA has received the TSCA ITC's 43rd Report to the Administrator. The most recent revisions to the Priority Testing List are included in the ITC's 43rd Report. The Report was received by the EPA Administrator on November 19, 1998, and is included in this notice. The ITC revised the TSCA section 4(e) Priority Testing List by removing 9 HPVCs that were recommended in the 36th Report (60 FR 42982, August 17, 1995) (FRL-4965-6) and 7 alkylphenols and 2 octylphenol ethoxylates that were recommended in the 37th Report (61 FR 4188, February 2, 1996) (FRL-4991-6).
The ITC is also asking EPA to promulgate a TSCA section 8(d) reporting rule for 15 nonylphenol ethoxylates that were recommended in the 39th Report (62 FR 8578, February 25, 1997) (FRL-5580-9), 18 alkylphenols that were recommended in the 41st Report (63 FR 17658, April 8, 1998) (FRL-5773-5), and 3-amino-5-mercapto-1,2,4-triazole; glycoluril; and methylal that were recommended in the 42nd Report (63 FR 42553, August 7, 1998) (FRL-5797-8) to determine if there are unpublished data to meet previously determined U.S. Government data needs.
1. Promulgation of a TSCA section 8(d) reporting rule. The ITC's Voluntary Information Submissions Innovative Online Network (VISION) is accessible through the world wide web (http://www.epa.gov/opptintr/itc/vision.htm) and is designed to promote more efficient use of TSCA section 8 resources through submission of electronic information. As part of VISION, the Voluntary Information Submission Policy clearly states that if the ITC does not receive voluntary electronic information submissions to meet the data needs for recommended chemicals, then it will ask the EPA to promulgate a TSCA section 8(d) reporting rule to determine if there are unpublished studies to meet those data needs. The EPA is being asked to promulgate a TSCA section 8(d) reporting rule for the chemicals referenced in this unit, because studies submitted to the VISION did not adequately meet the data needs for those chemicals. The ITC is requesting that the EPA promulgate a TSCA section 8(d) reporting rule to meet only those data needs listed in certain previous ITC Reports.
2. Data needs—i. Nonylphenol ethoxylates and alkylphenols. Data needs for 15 nonylphenol ethoxylates recommended in the 39th ITC Report and 18 alkylphenols recommended in the 41st ITC Report are identical and are listed in this unit as they were expressed in the 41st ITC Report:
a. Fish and amphibian multi-generation reproductive effects data.
b. Avian acute toxicity data (oral feeding and egg exposure studies).
c. Avian reproductive effects data.
d. Fish and wildlife studies data.
e. Bioaccumulation or bioavailability data.
f. Health effects data, including absorption, toxicokinetics, systemic toxicity, endocrine disruption, reproductive effects, and carcinogenicity data.
ii. 3-Amino-5-mercapto-1,2,4-triazole. Data needs for 3-amino-5-mercapto-1,2,4-triazole are listed in this unit as they were expressed in the 42nd ITC Report: Health effects.
iii. Glycoluril. Data needs for glycoluril are listed in this unit as they were expressed in the 42nd Report: Health effects.
iv. Methylal. Data needs for methylal are listed in this unit as they were expressed in the 42nd Report: Health effects, especially, in vivo mammalian metabolism and chronic effects.
3. Status of the Priority Testing List. The TSCA section 4(e) Priority Testing List as of November 1998 can be found in Table 1 of the 43rd ITC Report which is included in this notice.
Start List of SubjectsList of Subjects
- Environmental protection
- Chemicals
- Hazardous substances
Dated: October 24, 2000.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and Toxics.
Forty-Third 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 Rules
B. ITC's Use of TSCA Section 8 and “Other Information”
C. Promoting More Efficient Use of Information Submission Resources
D. Request to Promulgate a TSCA Section 8(d) Rule
E. Chemicals for Which the ITC is Requesting That EPA Promulgate a TSCA Section 8(d) Rule
III. ITC's Dialogue Group Activities During This Reporting Period (May to November 1998)
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Summary Table of Changes
B. Chemicals Removed From the Priority Testing List
V. TSCA Interagency Testing Committee
Summary
This is the 43rd Report of the TSCA Interagency Testing Committee (ITC) to the Administrator of the U.S. Environmental Protection Agency (EPA). In this Report, the ITC is revising its TSCA section 4(e) Priority Testing List by removing 9 High Production Volume Chemicals (HPVCs), 7 alkylphenols, and 2 octylphenol ethoxylates. In this Report, the ITC is also asking EPA to promulgate a TSCA section 8(d) Health and Safety Data Reporting (HaSD) rule for 18 Start Printed Page 65236alkylphenols, 15 nonylphenol ethoxylates, 3-amino-5-mercapto-1,2,4-triazole, glycoluril, and methylal to determine if there are unpublished data to meet previously determined U.S. Government data needs. The revised TSCA section 4(e) Priority Testing List follows as Table 1.
Table 1.—The TSCA Section 4(e) Priority Testing List (November 1998) 1
Report Date Chemical/Group Action 26 May 1990 8 Isocyanates Recommended with intent-to-designate 27 November 1990 62 Aldehydes Recommended with intent-to-designate 28 May 1991 Chemicals with Low Confidence Reference Dose (RfD) Acetone Thiophenol Designated 30 May 1992 5 Siloxanes Recommended 31 January 1993 24 Chemicals with insufficient dermal absorption rate data Designated 32 May 1993 32 Chemicals with insufficient dermal absorption rate data Designated 35 November 1994 24 Chemicals with insufficient dermal absorption rate data Designated 37 November 1995 16 Alkylphenols and 3 alkylphenol polyethoxylates Recommended 39 November 1996 15 Nonylphenol ethoxylates and 8 alkylphenol polyethoxylates Recommended 41 November 1997 18 Alkylphenols, 5 polyalkyphenols, and 6 alkylphenol polyethoxylates Recommended 42 May 1998 3-Amino-5-mercapto-1,2,4-triazole Recommended 42 May 1998 Glycoluril Recommended 42 May 1998 Methylal Recommended 42 May 1998 Ethyl silicate2 Recommended 1 The Priority Testing List is available from the ITC's web site (http://www.epa.gov/opptintr/itc). 2 Data requested through the ITC's Voluntary Information Submissions Innovative Online Network (VISION) (see http://www.epa.gov/opptintr/itc/vision.htm). I. Background
The ITC was established by section 4(e) of the Toxic Substances Control Act (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 a rule 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.)). Since its creation in 1976, the ITC has submitted 42 semi-annual (May and November) Reports to the EPA Administrator transmitting the Priority Testing List and its revisions. In 1989, the ITC began recommending chemical substances for information reporting, screening, and testing to meet the data needs of its member U.S. Government organizations. ITC Reports are available from http://www.epa.gov/opptintr/itc/ within a few days of submission to the Administrator and from http://www.epa.gov/fedrgstr/ after publication in the Federal Register. The ITC meets monthly and produces its revisions to the List with administrative and technical support from the ITC staff 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 Rules
Following receipt of the ITC's Report by the EPA Administrator and addition of chemicals to the Priority Testing List, the EPA's Office of Pollution Prevention and Toxics (OPPT) promulgates TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) and TSCA section 8(d) HaSD Reporting rules for chemicals added to the Priority Testing List. These rules require producers and importers of chemicals recommended by the ITC to submit production and exposure reports under TSCA section 8(a) and producers, importers, and processors of chemicals recommended by the ITC to submit unpublished health and safety studies under TSCA section 8(d). These rules are automatically promulgated by OPPT unless requested not to do so by the ITC.
B. ITC's Use of TSCA Section 8 and “Other Information”
The ITC reviews the TSCA section 8(a) PAIR reports, TSCA section 8(d) HaSD studies, and “other information” that becomes available after the ITC adds chemicals to the Priority Testing List. “Other information” includes TSCA section 4(a) and 4(d) studies, TSCA section 8(c) submissions, TSCA section 8(e) “substantial risk” notices, “For Your Information” (FYI) submissions, ITC voluntary submissions, unpublished data submitted to U.S. Government organizations represented on the ITC, published papers, as well as use, exposure, effects, and persistence data that are voluntarily submitted to the ITC by manufacturers, importers, processors, and users of chemicals recommended by the ITC. The ITC reviews this information and determines if data needs should be revised, if chemicals should be removed from the Priority Testing List or if recommendations should be changed to designations.
C. Promoting More Efficient Use of Information Submission Resources
The Voluntary Information Submissions Innovative Online Network (VISION) is accessible through the world wide web (http://www.epa.gov/opptintr/itc/vision.htm). VISION is the vehicle that is used to promote more efficient use of resources through submission of electronic information. VISION currently includes the Voluntary Information Submissions Policy (VISP), links to the TSCA Electronic HaSD Reporting Form (http://cyber22.dcoirm.epa.gov/oppt/Start Printed Page 65237tsca.nsf/HaSDForm?openform) and instructions for the Form (http://www.epa.gov/opptintr/itc/tsca-hlp.htm). The VISP provides examples of data needed by ITC member U.S. Government organizations, examples of studies that should not be submitted, the 60-, 90-, and 120-day milestones for meeting the objectives of the VISP, guidelines for using the TSCA Electronic HaSD Reporting Form, and instructions for electronically submitting full studies. The TSCA Electronic HaSD Reporting Form is used to provide electronic information on ITC and TSCA section 8(d) studies (to meet data needs of the ITC member U.S. Government organizations), FYI, and TSCA section 8(e) studies, and studies to meet the needs of the HPV Chemical Challenge Program (http://www.epa.gov/opptintr/chemtest/hpv.htm).
D. Request to Promulgate a TSCA Section 8(d) Rule
The ITC encourages producers, importers, processors, and users of its recommended chemicals to use VISION to voluntarily provide electronic information and establish a dialogue with the ITC to discuss needed data. As part of VISION, the VISP clearly states that if the ITC does not receive voluntary electronic information submissions to meet its data needs, then it will ask the EPA to promulgate a TSCA section 8(d) HaSD rule to determine if there are unpublished data to meet those needs. As noted in Unit 2.C. of this Report, the TSCA Electronic HaSD Reporting Form is used to provide electronic information on TSCA section 8(d) studies. The ITC strongly encourages those companies that must respond to a TSCA section 8(d) rule to provide only the data requested by the ITC and to provide data by using the TSCA Electronic HaSD Reporting Form. At this time, the ITC is requesting that the EPA promulgate a TSCA section 8(d) rule for several chemicals with the understanding that submissions that were voluntarily provided as ITC submissions, do not have to be re-submitted under the TSCA section 8(d) HaSD rule. The ITC is requesting that the EPA promulgate a TSCA section 8(d) HaSD rule to meet only those data needs listed in previous ITC Reports.
E. Chemicals for Which the ITC is Requesting That EPA Promulgate a TSCA Section 8(d) Rule
1. 39th and 41st Report chemicals. The ITC considered structures and annual production and importation volumes for nonylphenol ethoxylates and nonylphenol polyethoxylates recommended in the 39th Report (62 FR 8578, February 25, 1997) (FRL-5580-9) and for alkylphenols, polyalkylphenols, and alkylphenol polyethoxylates recommended in the 41st Report (63 FR 17658, April 9, 1998) (FRL-5773-5). In addition, the ITC considered use and health and safety data voluntarily submitted to the ITC by the Chemical Manufacturers Association (CMA) Alkylphenols and Ethoxylates (AP&E) Panel before VISION was developed, health and safety data voluntarily submitted through VISION as well as TSCA section 8(d) health and safety data submitted for structurally related chemicals in the 37th Report (61 FR 4188, February 2, 1996) (FRL-4991-6). After considering this information, and determining that it was not adequate to meet the data needs for these chemicals, the ITC decided to ask EPA to promulgate a TSCA section 8(d) HaSD rule for the nonylphenol ethoxylates recommended in the 39th Report and the alkylphenols recommended in the 41st Report. These chemicals are listed in Table 2.
2. 42nd Report chemicals. The ITC sent its 42nd Report (63 FR 42554, August 7, 1998) (FRL-5797-8) to manufacturers of 3-amino-5-mercapto-1,2,4-triazole, glycoluril, and methylal and requested that they use VISION to provide data to meet the U.S. Government data needs described in the 42nd Report. Since no information to meet these data needs was received, the ITC is asking EPA to promulgate a TSCA section 8(d) HaSD rule for these chemicals to determine if there are unpublished data to meet those needs. The ITC also contacted the Silicones Environmental Health and Safety Council (SEHSC) about providing data for ethyl silicate. The SEHSC agreed to meet with the ITC to discuss data needs. If needed data are not provided, the ITC will consider asking EPA to promulgate a TSCA section 8(d) HaSD rule for ethyl silicate.
Table 2.—Chemicals for Which the ITC is Requesting That EPA Promulgate a TSCA Section 8(d) HaSD Rule
CAS No. Chemical name ITC Report describing U.S. Government data needs Pentylphenols 136-81-2 Phenol, 2-pentyl- 41 3279-27-4 Phenol, 2-(1,1-dimethylpropyl)- 41 25735-67-5 Phenol, 4-sec-pentyl- 41 26401-74-1 Phenol, 2-sec-pentyl- 41 Hexylphenols 2446-69-7 Phenol, 4-hexyl- 41 Heptylphenols 1987-50-4 Phenol, 4-heptyl- 41 72624-02-3 Phenol, heptyl derivs. 41 84605-25-4 Phenol, 1-methylhexyl derivs. 41 Octylphenols 140-66-9 Phenol, 4(1,1,3,3-tetramethylbutyl) 41 71902-25-5 Phenol, octenylated 41 Nonylphenols 68081-86-7 Phenol, nonyl derivs. 41 91672-41-2 Phenol, 2-nonyl-, branched 41 Decylphenols 27157-66-0 Phenol, tetradecyl- 41 Start Printed Page 65238 Dodecylphenols 74499-35-7 Phenol, (tetrapropenyl) derivs. 41 Tetradecylphenols 70682-80-3 Phenol, tetradecyl- 41 Hexadecylphenols 2589-78-8 Phenol, hexadecyl 41 25401-86-9 Phenol, 2-hexadecyl- 41 Other Alkylphenols 68784-24-7 Phenol, C18-30-alkyl derivs. 41 Nonylphenol Ethoxylates 7311-27-5 Ethanol, 2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]- 39 20427-84-3 Ethanol, 2-[2-(4-nonylphenoxy)ethoxy] 39 20636-48-0 3,6,9,12-Tetraoxatetradecan-1-ol, 14-(4-nonylphenoxy) 39 26264-02-8 3,6,9,12-Tetraoxatetradecan-1-ol, 14-(nonylphenoxy)- 39 26571-11-9 3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol, 26-(nonylphenoxy)- 39 27176-93-8 Ethanol, 2-[2-(nonylphenoxy)ethoxy]- 39 27177-01-1 3,6,9,12,15-Pentaoxaheptadecan-1-ol, 17-(nonylphenoxy)- 39 27177-05-5 3,6,9,12,15,18,21-Heptaoxatricosan-1-ol, 23-(nonylphenoxy) 39 27177-08-8 3,6,9,12,15,18,21,24,27-Nonaoxanonacosan-1-ol, 29-(nonylphenoxy)- 39 27986-36-3 Ethanol, 2-(nonylphenoxy)- 39 65455-72-3 3,6,9,12,15,18,21,24,27-Nonaoxanonacosan-1-ol, 29-(isononylphenoxy)- 39 98113-10-1 Nonoxynol-9 39 NA1 Nonoxynol-2 39 NA1 Nonoxynol-3 39 NA1 Nonoxynol-7 39 Other Chemicals 109-87-5 Methylal 42 496-46-8 Glycoluril 42 16691-43-3 3-Amino-5-mercapto-1,2,4-triazole 42 1 Not available III. ITC's Dialogue Group Activities During This Reporting Period (May to November 1998)
The CMA-ITC AP&E Dialogue Group was formed by the CMA's AP&E Panel and the ITC's AP&E Subcommittee in March 1996 following the submission of the ITC's 37th Report to the EPA Administrator in November 1995. The Group was created to facilitate the ITC's retrieval of information on uses, exposures, and health and ecological effects of alkylphenols and alkylphenol ethoxylates, and the Panel's understanding of data needed by the U.S. Government organizations represented on the Subcommittee. Since the creation of this Dialogue Group, numerous activities have occurred: See the ITC's 38th Report (61 FR 39832, July 30, 1996) (FRL-5379-2); 39th Report; 40th Report (62 FR 30580, June 4, 1997) (FRL-5718-3); 41st Report, and 42nd Report.
After the 42nd Report was delivered to the EPA Administrator, some members of the CMA's AP&E Panel formed the APE Research Council (APERC). The APERC-ITC AP&E Dialogue Group met twice during this reporting period. On August 12 and October 15, 1998, the Dialogue Group met to discuss:
1. Status of TSCA section 8(a) PAIR and TSCA section 8(d) rules for the 39th and 41st ITC Reports.
2. Number and type of studies on alkylphenols and alkylphenol ethoxylates sent to VISION.
3. Status of research related to U.S. Government data needs for alkylphenols and alkylphenol ethoxylates (e.g., multigeneration fish studies to determine offspring reproductive capabilities).
4. Progress and results of ongoing environmental and toxicological studies being conducted or sponsored by chemical manufacturers on the Council, (e.g., mammalian in vitro and in vivo toxicology, mammalian pharmacokinetic, biodegradation, aquatic toxicity, and avian acute toxicity studies).
5. Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) dossiers on nonylphenol and nonylphenol ethoxylates.
6. Alkylphenols that may be removed from the Priority Testing List.
7. Alkylphenols and nonylphenol ethoxylates being considered for Quantitative Structure Activity Relationship (QSAR) studies.
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Summary Table of Changes
Revisions to the TSCA section 4(e) Priority Testing List are summarized in Table 3. Start Printed Page 65239
Table 3.—Revisions to the TSCA section 4(e) Priority Testing List
CAS No. Chemical name Action Date Remove November 1998 HPVCs 80-51-3 p,p'-Oxybis(benzenesulfonylhydrazide) do. do. 81-84-5 Naphthalenedicarboxylic anhydride do. do. 99-54-7 3,4-Dichloronitrobenzene do. do. 100-29-8 4-Ethoxynitrobenzene do. do. 119-33-5 4-Methyl-2-nitrophenol do. do. 121-60-8 4-(Acetylamino) benzenesulfonyl chloride do. do. 626-17-5 1,3-Dicyanobenzene do. do. 929-06-6 2-(2-Aminoethoxy) ethanol do. do. 3089-11-0 Hexa(methoxymethyl) melamine do. do. Butylphenols 3180-09-4 2-Butylphenol do. do. 27178-34-3 tert-Butylphenol mixed isomers do. do. Pentylphenols 94-06-4 4-(1-Methylbutyl)phenol do. do. Octylphenols 949-13-3 2-Octylphenol do. do. 27985-70-2 (1-Methylheptyl)phenol do. do. Nonylphenols 11066-49-2 Isononylphenol (mixed isomers) do. do. 17404-66-9 4-(1-Methyloctyl)phenol do. do. Octylphenol Ethoxylates 2315-66-4 Decaethylene glycol 4-isooctylphenyl ether do. do. 2497-58-7 Hexaethylene glycol 4-isooctylphenyl ether do. do. B. Chemicals Removed From the Priority Testing List
1. HPVCs—a. Rationale. The ITC is removing 9 HPVCs (Table 3) from the Priority Testing List because:
i. EPA, CMA, and the Environmental Defense Fund have agreed, that by the year 2003, data will be provided or developed for about 3,000 HPVCs produced or imported into the United States.
ii. The 3,000 HPVCs includes the 9 HPVCs on the Priority Testing List.
iii. At this time, there are no specific U.S. Government data needs for these chemicals that would not be met by the HPV Chemical Challenge Program.
b. Supporting information. HPVCs are chemicals with annual domestic production or importation volumes greater than 1 million pounds. Information on ITC's review of HPVCs is contained in Reports 27th (56 FR 9534, March 6, 1991) (FRL-3845-3), 35th (59 FR 67596, December 29, 1994) (FRL-4923-2), 36th (60 FR 42982, August 17, 1995) (FRL-4965-6), 37th, 38th, and 40th.
The “Screening Information Data Set (SIDS) Manual of the OECD Programme on the Co-operative Investigation of High Production Volume Chemicals,” provides test guidance for developing data for HPVCs. The basic screening endpoints are listed in section 2.2 (page 2) of this Manual (the “SIDS Manual;” available at http://www.epa.gov/opptintr/sids/sidsman.htm).
2. Alkylphenols and alkylphenol ethoxylates— a. Rationale. The ITC is removing 2 butylphenols, 1 pentylphenol, 2 octylphenols, 2 nonylphenols, and 2 octylphenol ethoxylates (Table 3) from the Priority Testing List because no domestic production or importation volumes were reported to the EPA in response to 1986, 1990, and 1994 Information Update Rules (indicating that volumes were less than 10,000 pounds per site in 1985, 1989, and 1993), no domestic production or importation volumes were reported to the EPA in response to the February 28, 1996, PAIR rule (indicating that volumes were less than 1,000 pounds per site in 1995), no TSCA section 8(d) studies were submitted to the EPA in response to the February 28, 1996, HaSD rule and because no TSCA section 8(e), FYI, or ITC studies were available for these chemicals as of September 1998.
b. Supporting information. Information on the ITC's review of alkylphenols and alkylphenol ethoxylates is contained in Reports 37, 38, 39, 40, and 41. The ITC reviewed use and health and safety data voluntarily submitted to the ITC by the CMA-ITC AP&E Dialogue Group before VISION was developed and health and safety data voluntarily submitted through VISION.
V. TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
Brad Campbell, Member
Department of Commerce
National Institute of Standards and Technology
Malcolm W. Chase, Member
Barbara C. Levin, Alternate
National Oceanographic and Atmospheric Administration
Nancy Foster, Member
Teri Rowles, Alternate
Richard S. Artz, Alternate
Environmental Protection Agency
Paul Campanella, Member
David R. Williams, Alternate
National Cancer Institute
Victor Fung, Member, Chair
Harry Seifried, Alternate
National Institute of Environmental Health Sciences
William Eastin, Member, Vice Chair
H.B. Matthews, Alternate
National Institute for Occupational Safety and Health
Albert E. Munson, Member
Christine Sofge, Alternate
National Science Foundation
A. Frederick Thompson, Member
Joseph Reed, Alternate
Occupational Safety and Health Administration
Lyn Penniman, Member
Val H. Schaeffer, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Consumer Product Safety Commission
Jacqueline Ferrante, Member
Department of Agriculture Start Printed Page 65240
;Clifford P. Rice, Member
Department of the Interior
Barnett A. Rattner, Member
Food and Drug Administration
Edwin J. Matthews, Member
Raju Kammula, Alternate
National Library of Medicine
Vera W. Hudson, Member
National Toxicology Program
NIEHS, FDA, and NIOSH Members
Counsel
Scott Sherlock, OPPT, EPA
Technical Support Contractor
Syracuse Research Corporation
ITC Staff
John D. Walker, Executive Director
Norma S. L. Williams, Executive Assistant
TSCA Interagency Testing Committee, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone: (202) 260-1825; fax: (202) 260-7895; e-mail address: williams.norma@epa.gov; url: http://www.epa.gov/opptintr/itc.
End Supplemental Information[FR Doc. 00-27926 Filed 10-30-00; 8:45 am]
BILLING CODE 6560-50-F
Document Information
- Published:
- 10/31/2000
- Department:
- Environmental Protection Agency
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 00-27926
- Dates:
- Comments, identified by docket control number OPPTS-41051, must be received on or before November 30, 2000.
- Pages:
- 65233-65240 (8 pages)
- Docket Numbers:
- OPPTS-41051, FRL-6049-5
- PDF File:
- 00-27926.pdf