00-30545. Forty-Fifth 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-Fifth Report to the Administrator of the EPA on November 30, 1999. In the 45th Report, which is included with this notice, the ITC: Describes an EPA effort to organize mostly discrete organic chemicals from the TSCA Inventory into non-Confidential Business Information (CBI) production/importation volume categories; announces the public availability of information on chemicals that are being screened for persistence and bioconcentration potential; requests information from the manufacturers, importers, and processors of these chemicals; and removes 119 chemicals from the Priority Testing List.--
EPA invites interested persons to submit written comments on the Report.
DATES:
Comments, identified by docket control number OPPTS-41053, must be received on or before January 2, 2001.
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-41053 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 (7408), Office of Pollution Prevention and Toxics, 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 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 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 Office of Pollution Prevention and Toxics (OPPT) at http://www.epa.gov/opptintr/,, 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-41053. 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 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-41053 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 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-41053. 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 the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Start Printed Page 75545Information 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 45th 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 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 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.
1. The ITC's 45th Report. The 45th Report was received by the EPA Administrator on November 30, 1999, and is included in this notice. In the 45th Report, the ITC: -
i. Describes an EPA effort to organize mostly discrete organic chemicals from the TSCA Inventory into non-CBI production/importation volume categories.-
ii. Announces the public availability of information on chemicals that are being screened for persistence and bioconcentration potential.-
iii. Requests information from the manufacturers, importers, and processors of these chemicals.-
2. Status of the Priority Testing List. The current TSCA section 4(e) Priority Testing List as of November 1999 can be found in Table 1 of the 45th ITC Report which is included in this notice. In the 45th ITC Report, the ITC removed 119 chemicals from the TSCA section 4(e) Priority Testing List. These chemicals are discussed in the 45th Report.
Start List of SubjectsList of Subjects
- Environmental protection
- Chemicals
- Hazardous substances
Dated: November 20, 2000.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and Toxics.
Forty-Fifth 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
III. ITC's Activities During This Reporting Period (May to November 1999)
A. Organizing TSCA Inventory Chemicals into Production/Importation Volume Categories
B. Screening Chemicals for Persistence and Bioconcentration Potential
C. Soliciting Measured Bioconcentration Data for Chemicals With BCFs >1,000
D. Soliciting Use and Exposure Information
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Removed From the Priority Testing List
1. Isocyanates
2. Aldehydes
3. Chemicals with insufficient dermal absorption rate data
V. References
VI. TSCA Interagency Testing Committee
Summary
This is the 45th 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:
1. Describing an EPA effort to organize mostly discrete organic chemicals from the TSCA Inventory into non-Confidential Business Information (CBI) production/importation volume categories.
2. Announcing the public availability of information on chemicals that are being screened for persistence and bioconcentration potential.
3. Requesting information from the manufacturers, importers, and processors of these chemicals by February 29, 2000.
4. Removing 119 chemicals from the Priority Testing List.
The revised TSCA section 4(e) Priority Testing List follows as Table 1.
Table 1.—The TSCA Section 4(e) Priority Testing List (November 1999)1
Report Date Chemical/group Action 28 May 1991 Chemicals with Low Confidence Reference Dose (RfD) Designated Acetone Thiophenol 30 May 1992 5 Siloxanes Recommended 31 January 1993 13 Chemicals with insufficient dermal absorption rate data Designated 32 May 1993 16 Chemicals with insufficient dermal absorption rate data Designated 35 November 1994 4 Chemicals with insufficient dermal absorption rate data Designated 37 November 1995 16 Alkylphenols and 3 alkylphenol polyethoxylates2 Recommended 39 November 1996 15 Nonylphenol ethoxylates and 8 alkylphenol polyethoxylates2 Recommended 41 November 1997 18 Alkylphenols, 5 polyalkyphenols and 6 alkylphenol polyethoxylates2 Recommended 42 May 1998 3-Amino-5-mercapto-1,2,4-triazole2 Recommended 42 May 1998 Glycoluril2 Recommended 42 May 1998 Methylal2 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). Start Printed Page 75546 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 44 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 the ITC's web site (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 Priority Testing 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) Health and Safety Data (HaSD) 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
VISION is accessible through the world wide web (http://www.epa.gov/opptintr/itc/vision.htm). VISION includes the Voluntary Information Submissions Policy (VISP) and links to the TSCA Electronic HaSD Reporting Form (http://www.epa.gov/opptintr/newchms/hasd.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 submitting information, 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 voluntary submissions, TSCA section 8(d) studies (to meet data needs of the ITC member U.S. Government organizations), FYI, and TSCA section 8(e) studies.
In conjunction with this Report, the ITC will be announcing the public availability of information on chemicals that are being screened for persistence and bioconcentration potential and requesting specific use and exposure data for these chemicals from the manufacturers, importers, and processors. In addition, the ITC is requesting measured bioconcentration data for chemicals with estimated bioconcentration factors (BCFs) >1,000 from the manufacturers, importers, and processors of these chemicals. The ITC is requesting that the use, exposure, and bioconcentration data be submitted before February 29, 2000, consistent with the 90-day milestone of the VISP (http://www.epa.gov/opptintr/itc/visp.htm) for submitting data through the TSCA Electronic HaSD Reporting Form.
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. 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. The ITC strongly encourages those companies that must respond to a TSCA section 8(d) rule to provide data by using the TSCA Electronic HaSD Reporting Form. At this time, the ITC is not adding any chemicals to the Priority Testing List and therefore not requesting the EPA to promulgate a TSCA section 8(d) rule.
III. ITC's Activities During This Reporting Period (May to November 1999)
A. Organizing TSCA Inventory Chemicals into Production/Importation Volume Categories
The EPA will be organizing discrete organic chemicals from the TSCA Inventory into non-Confidential Business Information (CBI) production/importation volume categories based on information submitted to EPA under the Inventory Update Rules (IURs). These categories could include:
Very Low Production Volume (VLPV)—no production/importation volume data reported to EPA.
Low Production Volume (LPV)—production/importation volumes ≥10,000 pounds (lbs) and <100,000 lbs.
Moderate Production Volume (MPV)—production/importation volumes ≥100,000 lbs and <1 million lbs.
High Production Volume (HPV)—production/importation volumes ≥1 million lbs and <1 billion lbs.
Very High Production Volume (VHPV)—production/importation volumes ≥1 billion lbs.
These categories are currently based on data reported to EPA in response to the 1986, 1990, 1994, or 1998 IURs (EPA, 1986, 1990, 1994, or 1998). It should be noted that the VLPV and LPV categories were created to accommodate a flexible lowest-reporting threshold. Based on the 1986, 1990, 1994, and 1998 IURs the lowest-reporting threshold is 10,000 lbs. However, based on a proposed IUR, this threshold could increase to 25,000 lbs in 2002 (EPA, 1999a).
B. Screening Chemicals for Persistence and Bioconcentration Potential
During this reporting period, the ITC implemented strategies to screen chemicals for persistence and bioconcentration potential. These strategies are referred to as Degradation Effects Bioconcentration Information Testing Strategies (DEBITS) because they facilitate testing for the availability of degradation, ecological, or human health effects and bioconcentration information. DEBITS can be applied to any group of discrete organic chemicals. This Report describes the use of DEBITS to screen discrete organic TSCA Inventory chemicals with U.S. production or importation volumes >10,000 lbs/year for persistence and bioconcentration potential (Figure 1).
Start Printed Page 75547 Start Printed Page 75548The ITC will continue to develop DEBITS as part of an effort to screen chemicals for potential to persist, bioconcentrate, and cause ecological or human health effects. As part of this effort, Structure-Activity Relationships (SARs) are likely to be created to predict toxicity and promote more efficient use of chemical testing resources. SARs are used to screen for chemicals that are structurally related to chemicals which are known to be toxic or for which the mode of toxic action is known, but for which there are few, if any, toxicity data, especially data that are of interest to the U.S. Government organizations represented on the ITC.
1. Incorporating non-CBI production/importation volume categories into DEBITS. Non-CBI production/importation volume categories were incorporated into DEBITS to facilitate creation of SARs that can predict toxicity across production/importation volume categories, e.g., predicting toxicity of LPV or MPV chemicals from structurally related HPV or VHPV chemicals. The non-CBI production/importation volume categories that were incorporated into DEBITS were developed from 1986, 1990, and 1994 IUR data, because only these data were available when the ITC implemented DEBITS. These data were reported for 12,557 mostly discrete organic chemicals with production/importation volumes >10,000 lbs that were associated with 4 non-CBI production/importation volume categories (Figure 1).
The ITC recognizes the historical significance of obtaining basic ecological effects, environmental fate or health effects data on chemicals with international production or importation volumes >1 million lbs/year that was established by the Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) program (http://www.oecd.org). The ITC also recognizes the relevance of EPA's HPV Chemical Challenge program (http://www.epa.gov/opptintr/chemrtk/volchall.htm) to continue that tradition for chemicals with U.S. production or importation volumes >1 million lbs/year. Nonetheless, the ITC realizes the importance of considering chemicals in VLPV, LPV, and MPV categories, because they are likely to have: Even fewer basic ecological effects, environmental fate or health effects data, speciality chemical uses in consumer or other end-use products, and a need for SARs that can be used to predict persistence, bioconcentration, or toxicity from chemicals in HPV and VHPV categories that are related by structure or mode of toxic action and for which data are available or being developed through the OECD SIDS, HPV Chemical Challenge, and related programs.
2. Predicting persistence. The ITC used estimates of ultimate aerobic biodegradation potential (degradation of a chemical by microorganisms (mostly bacteria) under aerobic conditions to carbon dioxide and cellular material) as a preliminary screen to predict a chemical's persistence in the environment. Syracuse Research Corporation's BIOWIN program was used to provide aerobic biodegradation probability predictions (http://esc-plaza.syrres.com/interkow/biodeg.htm). These predictions were based on expert opinions that different structural groups could be used to estimate a chemical's biodegradation potential (Boethling et al., 1994). As a criterion for persistence, the ITC selected chemicals with biodegradation probabilities <2 because it has been predicted that these chemicals would persist for at least 2-3 months in sediment, soil, and water. This screening criterion is more conservative than the 2-month persistence half-life criterion used by EPA (EPA, 1999b). Quantitative Structure Activity Relationships (QSARs) described by Howard et al. (2000) were used to estimate persistence in air.
3. Screening chemicals for bioconcentration potential. The ITC used log octanol-water partition coefficients (log P) values between 3-6 to select a group of non-ionic, discrete organic chemicals that could be screened for bioconcentration potential. Log P values 3-6 were based on data of Bintein and Devillers (1993). Syracuse Research Corporation's KOWWIN program was used to provide measured and estimated log P values (http://esc-plaza.syrres.com/interkow/logkow.htm). The KOWWIN program is based on data indicating that different structural groups quantitatively contribute to a chemical's ability to partition to water or octanol (Meylan and Howard, 1995).
A BCF is the ratio of the concentration of a chemical in tissues of organisms (almost always aquatic organisms and mostly fish) to the concentration of a chemical in water at steady state. Syracuse Research Corporation's BCFWIN program was used to provide measured and estimated BCF values (http://esc-plaza.syrres.com/interkow/bcfwin.htm). The program is based on the methods of Meylan et al. (1999). The ITC used a BCF >1,000 to screen chemicals for bioconcentration potential. A BCF >1,000 is used by the EPA, International Joint Commission (IJC) and others (EPA, 1999b; IJC, 1993) .
Of the 12,557 chemicals with production/importation volumes >10,000 lbs, 435 have biodegradation probabilities <2 and log P values of 3-6, 355 have BCFs ≤1,000 and 80 have BCFs >1,000 (Figure 1).
C. Soliciting Measured Bioconcentration Data for Chemicals With BCFs >1,000
Of the 80 chemicals with BCFs >1,000, the ITC will list chemicals with estimated BCFs on its web site and provide opportunities for manufacturers, importers, and processors of these chemicals to voluntarily submit measured bioconcentration data through VISION using the TSCA Electronic HaSD Reporting Form (see Unit II. C. of this Report for more details). The ITC would appreciate receiving any measured bioconcentration data and information on methods for making those measurements before February 29, 2000, after which time, the ITC will consider asking EPA to promulgate a TSCA section 8(d) rule to require submission of these data.
D. Soliciting Use and Exposure Information
Several sources were searched in an attempt to obtain use information for the 435 chemicals (Ashford, 1994; Budavari, 1996; Clayton and Clayton, 1993-1994; Kirk-Othmer, 1991-1998; Lewis, 1993; Ullmann, 1985-1994). In addition, sites on the world wide web and EPA's Use Cluster Scoring System were searched. Uses were identified for only about one third of the 435 chemicals; they were general and may not be current. The ITC needs more specific information on uses and exposures for many of these chemicals to evaluate potential for environmental releases and human exposures, e.g., are any of the chemicals used as on-site intermediates in closed production processes. Without this information, the ITC can only use production/importation volume categories as indicators of potential environmental releases and human exposures.
The ITC will list chemicals for which it needs current use and exposure information on its web site to provide an opportunity for manufacturers, importers, and processors of these chemicals to voluntarily provide more specific use and exposure information. This information should be submitted through VISION using section 3.2 of the TSCA Electronic HaSD Reporting Form (see Unit II. C. of this Report). The ITC will consider any use and exposure information that is submitted before February 29, 2000, after which time, the ITC will consider asking EPA to promulgate a TSCA section 8(a) rule to require submission of data.
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Removed From the Priority Testing List
1. Isocyanates. In its 26th Report, the ITC added 43 isocyanates to the Priority Testing List and recommended them for physical and chemical property testing based on U.S. Government data needs (55 FR 23050, June 5, 1990). In its 35th and 37th Reports, the ITC removed 28 and 5 isocyanates from the Priority Testing List, respectively (59 FR 67596, December 29, 1994 (FRL-4923-2); 61 FR 4188, February 2, 1996 (FRL-4991-6)). In its 37th Report, the ITC also solicited consumer use information for 9 of 10 isocyanates (9 diisocyanates) remaining on the Priority Testing List and announced that the review of isocyanates was being expanded from information on physical and chemical properties to exposures, health effects and SARs. In November 1996, the ITC established a Dialogue Group with the Diisocyanates Panel of the Chemical Manufacturers Association (CMA). The Panel provided the ITC with unpublished physical and chemical property data and as a result 2 more isocyanates were removed from the Priority Testing List in the ITC's 40th Report (62 FR 30580, June 4, 1997 (FRL-5718-3)). In addition, the Panel provided the ITC with extensive product use information on the diisocyanates. At this time, the ITC is removing the remaining eight isocyanates from the Priority Testing List, because:
i. Two of the eight isocyanates are being tested under the OECD SIDS program.
ii. The requested consumer use information has been provided to the ITC.
iii. All eight isocyanates remaining on the Priority Testing List are in the EPA's HPV Chemical Challenge program. The SIDS and HPV programs are likely to provide basic Start Printed Page 75549ecological effects, environmental fate, and health effects data for these eight isocyanates.
2. Aldehydes. In its 27th Report, the ITC added 89 aldehydes to the Priority Testing List and recommended them for ecological effects testing based on U.S. Government data needs. In addition, the ITC deferred testing for 429 aldehydes because they had production/importation volumes <10,000 lbs in 1986 (56 FR 9534, March 6, 1991). In its 35th Report, the ITC removed 27 of the 89 aldehydes from the Priority Testing List. In this 45th Report, the ITC is removing the remaining 62 aldehydes from the Priority Testing List because 10 of 62 aldehydes are being tested under the OECD SIDS program, 30 are in the EPA's HPV Chemical Challenge program or because SARs have been created (since the chemicals were recommended) to predict some ecological effects (Karabunarliev et al., 1996; Schultz et al., 1994; Walker and Printup, 2000; Walker et al., 2000). The SIDS and HPV programs and SARs are likely to provide basic data for some of these 62 aldehydes.
3. Chemicals with insufficient dermal absorption rate data. In its 31st, 32nd, and 35th Reports, the ITC added 24, 34, and 25 chemicals, respectively, to the Priority Testing List and designated them for testing to develop dermal absorption rate data based on U.S. Government data needs (58 FR 26898, May 5, 1993; 58 FR 38490, July 16, 1993; 59 FR 67596, December 29, 1994). In previous Reports, the ITC removed 3 of the designated chemicals from the Priority Testing List (59 FR 35720, July 13, 1994 (FRL-4870-4); 60 FR 42982, August 17, 1995 (FRL-4965-6)). In this 45th Report, the ITC is removing 11, 16 and 20 chemicals (a total of 47 chemicals) from the Priority Testing List, that were designated in the ITC's 31st, 32nd, and 35th Reports, respectively. The ITC is removing 47 of the 80 chemicals on the Priority Testing List with insufficient dermal absorption rate data, because EPA published a June 9, 1999, Federal Register notice (64 FR 31074) (FRL-5760-3) proposing dermal absorption rate testing for these chemicals.
V. References
1. Ashford, R.D. (1994). Ashford's Dictionary of Industrial Chemicals: Properties, Production, Uses. London, England. Wavelength Publications Ltd.
2. Bintein, S. and Devillers, J. (1993). Nonlinear Dependence of Fish Bioconcentration on n-Octanol/Water Partition Coefficient. SAR and QSAR. Environmental Research. 1:29-39.
3. Boethling, R.S.; Howard, P.H.; Meylan, W.M.; Stiteler, W.; Beauman, J.; and Tirado, N. (1994). Group contribution method for predicting probability and rate of aerobic biodegradation. Environmental Science and Technology. 28:459-65.
4. Budavari, S., et al (1996). The Merck Index: An Encyclopedia of Chemicals And Drugs. 12th Ed. Whitehouse Station, NJ. Merck and Company, Inc.
5. Clayton, G.D. and Clayton, F.E. (1993-1994). Patty's Industrial Hygiene and Toxicology. 4th Ed. John Wiley and Sons, New York City, NY. Vol. IIA-IIF.
6. Howard, P.H.; Walker, J. D.; Boethling, R.S.; and Meylan, W. M. (2000). Persistent, Bioaccumulative and Toxic Substances (PBTS): Role of Quantitative Structure Activity Relationships (QSARs) in the Identification of Persistent Substances. J.D. Walker (Ed.) Handbook on Quantitative Structure Activity Relationships (QSARs) for Predicting Environmental Fate of Chemicals. SETAC Press. Pensacola, FL. In Press.
7. IJC (1993). A Strategy for the Virtual Elimination of Persistent Toxic Substances. Vol. 1, Report of the Virtual Elimination Task Force to the IJC.
8. Karabunarliev, S.; Mekenyan, O.G.; Karcher, W.; Russom, C.L.; and Bradbury, S.P. (1996). Quantum-chemical descriptors for estimating the acute toxicity of electrophiles to the fathead minnow (Pimephales promelas): An analysis based on molecular mechanisms. Quantitative Structure-Activity Relationship. 15:302-310.
9. Kirk-Othmer Encyclopedia of Chemical Technology. (1991-1998). 4th Ed. Vol. 1 to 25. New York City, NY. John Wiley and Sons.
10. Lewis, R.J.S.R. (1993). Hawley's Condensed Chemical Dictionary. 12th Ed. New York City, NY. Van Nostrand Reinhold Company.
11. Meylan, W.M. and P.H. Howard. (1995). Atom/fragment contribution method for estimating octanol-water partition coefficients. Journal of Pharmacological Science. 84:83-92.
12. Meylan, W.M.; Howard, P.H.; Boethling, R.S.; Aronson, D.; Printup, H.; and Gouchie, S. (1999). Improved method for estimating bioconcentration/bioaccumulation factor from octanol/water partition coefficient. Environmental Toxicology and Chemistry. 18:664-672.
13. Russom, C.L.; Bradbury, S.P.; Braiders, S.J.; Hammermeister, D.E.; and Drummond, R.A. (1997). Predicting modes of toxic action from chemical structure: Acute toxicity in the fathead minnow (Pimephales Promelas). Environmental Toxicology and Chemistry. 16(5):948-967.
14. Schultz, T. W.; Bryant, S. E.; and Lin, D. T. 1994. Structure-toxicity relationships for Tetrahymena: Aliphatic Aldehydes. Bulletin of Environmental Contamination and Toxicology. 52(2):279-285.
15. Ullmann's Encyclopedia of Industrial Chemistry. (1985-1994). 5th Ed. Vol. A1-A28 Deerfield Beach, FL. VCH Publishers.
16. EPA. (1986). Partial Updating of TSCA Inventory Data Base; Production and Site Reports. Federal Register (51 FR 21438-21452, June 12, 1986).
17. EPA. (1990). Partial Updating of TSCA Inventory Data Base; Production and Site Reports; Technical Amendment. Federal Register (55 FR 39586-39588, September 27, 1990).
18. EPA. (1994). Partial Updating of TSCA Inventory Data Base; Production and Site Reports; Technical Amendment. Federal Register (59 FR 30652-30654, October 24, 1994 (FRL-4910-4)).
19. EPA. (1998). Partial Updating of TSCA Inventory Data Base; Production and Site Reports; Technical Amendment. Federal Register (63 FR 45950-45953, August 28, 1998 (FRL-6028-3)).
20. EPA. (1999a). TSCA Inventory Update Rule Amendments; Proposed Rule. Federal Register (64 FR 46772-46812, August 26, 1999 (FRL-6097-4)).
21. EPA. (1999b). Category for persistent, bioaccumulative and toxic new chemical substances. Federal Register (64 FR 60194-60204, November 4, 1999 (FRL-6097-7)).
22. Walker, J.D. and Printup, H. (2000). Using the Substructure-based Computerized Chemical Selection Expert System (SuCCSES) to analyze aldehydes I. Development of structural subclasses and structure activity relationships (SARs). J.D. Walker (Ed). Handbook on Quantitative Structure Activity Relationships (QSARs) for Predicting Ecological Effects of Chemicals. SETAC Press. Pensacola, FL. In Press.
23. Walker, J.D.; Printup, H.; Karabunarliev, S.H.; Mekenyan, O.G.; and Veith, G.D. (2000). Using the Substructure-based Computerized Chemical Selection Expert System (SuCCSES) to analyze aldehydes II. Development of quantitative structure activity relationships (QSARs). J.D. Walker (Ed). Handbook on Quantitative Structure Activity Relationships (QSARs) for Predicting Ecological Effects of Chemicals. SETAC Press. Pensacola, FL. In Press.
VI. 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
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
Harry Seifried, Member
Victor Fung, Alternate
National Institute of Environmental Health Sciences
William Eastin, Member, Chair
H.B. Matthews, Alternate
National Institute for Occupational Safety and Health
Albert E. Munson, Member
Mark Toraason, Alternate
National Science Foundation
A. Frederick Thompson, Member
Marge Cavanaugh, Alternate
Occupational Safety and Health Administration
Val H. Schaeffer, Member
Lyn Penniman, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Consumer Product Safety Commission
Jacqueline Ferrante, Member, Vice Chair
Department of Agriculture
Clifford P. Rice, Member
Department of Defense
Barbara Larcom, Member
Janet Whaley, Alternate
José Centeno, Alternate Start Printed Page 75550
Department of the Interior
Barnett A. Rattner, Member
Food and Drug Administration
Raju Kammula, Member
Ronald Lorentzen, Alternate
David Hatten, 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, 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. 00-30545 Filed 11-30-00; 8:45 am]
BILLING CODE 6560-50-S
Document Information
- Published:
- 12/01/2000
- Department:
- Environmental Protection Agency
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 00-30545
- Dates:
- Comments, identified by docket control number OPPTS-41053, must be received on or before January 2, 2001.
- Pages:
- 75543-75550 (8 pages)
- Docket Numbers:
- OPPTS-41053, FRL-6399-5
- PDF File:
- 00-30545.pdf