Toxic and hazardous substances control: Health and safety data reporting,
[Federal Register: May 4, 2004 (Volume 69, Number 86)]
[Rules and Regulations]
[Page 24517-24524]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04my04-7]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 716
[OPPT-2003-0028; FRL-7322-8]
RIN 2070-AB11
Health and Safety Data Reporting; Addition of Certain Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This final rule, issued pursuant to section 8(d) of the Toxic Substances Control Act (TSCA) and its regulations, requires manufacturers (including importers) of the following 15 chemicals to report certain unpublished health and safety data to EPA: 3H-1,2,4- triazole-3-thione, 5-amino-1,2-dihydro-; imidazo[4,5-d]imidazole- 2,5(1H,3H)-dione, tetrahydro-; stannane, dimethylbis[(1- oxoneodecyl)oxy]-; benzene, 1,3,5-tribromo-2-(2-propenyloxy)-; 1- triazene,1,3-diphenyl-; benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl- 4-(trifluoromethyl)-; and 9 indium compounds. The Interagency Testing Committee (ITC), established under section 4(e) of TSCA to recommend chemicals and chemical mixtures to EPA for priority testing consideration, amends the TSCA section 4(e) Priority Testing List through periodic reports submitted to EPA. The ITC added the 15 chemicals in this rule to the Priority Testing List.
In addition, in order to display the approval of the information collection requirements contained in this final rule as required by the Paperwork Reduction Act (PRA), EPA is amending the table of PRA approval numbers that appear in 40 CFR part 9.
DATES: This final rule is effective on June 3, 2004. For purposes of judicial review, this rule shall be promulgated at 1 p.m. eastern daylight/standard time on May 18, 2004. (See 40 CFR 23.5)
A request to withdraw a chemical from this rule pursuant to 40 CFR 716.105(c) must be received on or before May 18, 2004. (See Unit IV. of the SUPPLEMENTARY INFORMATION.)
Reporting Requirements
The reporting described in Unit III.B. is required by August 2, 2004. Any person who manufactures or imports or who proposes to manufacture or import the listed substance from June 3, 2004 to August 2, 2004 must inform (by submitting a list) EPA of any studies initiated during the period from June 3, 2004 to August 2, 2004 within 30 days of their initiation, but in no case later than August 30, 2004. In addition, if any such person has submitted lists of studies that were ongoing or initiated during the period from June 3, 2004 to August 2, 2004 to EPA, such person must submit a copy of each study within 30 days after its completion, regardless of the study's completion date. See 40 CFR 716.60 and 716.65.
ADDRESSES: Submit your withdrawal request, identified by docket ID number OPPT-2003-0028, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/. Follow the on-line instructions for submitting
comments.
Agency Website: http://www.epa.gov/edocket/.
EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments. Follow the on-line instructions for submitting comments.
E-mail: oppt.ncic@epa.gov.
Fax: (202) 566-0282.
Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: 8(d) Auto-ITC.
Hand delivery/courier: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC, Attention: 8(d) Auto-ITC. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number OPPT-2003- 0028. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at http://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through EDOCKET, regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov websites are ``anonymous access'' systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit EDOCKET on-line or see the Federal Register of May 31, 2002 (67 FR 38102) (FRL-7181-7). Docket: All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket/. Although listed in the index,
some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material,
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is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room 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 OPPT Docket, which is located in the EPA Docket Center, is (202) 566-0280.
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 Harris, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8156; fax number: (202) 564-4765; e-mail address: ccd.citb@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in Sec. 716.120(a) and (d) of the regulatory text of this document. Entities potentially affected by this action may include, but are not limited to:
Chemical manufacturers (including importers), (NAICS 325, 324110), e.g., persons who manufacture (defined by statute to include import) one or more of the subject chemical substances.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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.
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How Can I Access Electronic Copies of this Document and Other Related Information?
In addition to EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 9 and
part 716 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .
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How Do I Submit CBI Information?
Do not submit this information to EPA through EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
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Background
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What Action is the Agency Taking?
EPA is issuing a final TSCA section 8(d) Health and Safety Data Reporting rule which will require manufacturers (including importers) of 15 chemicals on the ITC's TSCA section 4(e) Priority Testing List to submit certain unpublished health and safety data to EPA. The regulatory text of this document lists the 15 chemicals that are being added to the Health and Safety Data Reporting rule as a result of this document. It also lists the data reporting requirements imposed by this amendment to the rule.
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What is the Agency's Authority?
EPA promulgated the model Health and Safety Data Reporting rule under section 8(d) of TSCA (15 U.S.C. 2607(d)), and it is codified at 40 CFR part 716. EPA uses this TSCA section 8(d) model rule to quickly gather current information on chemicals. The TSCA section 8(d) model rule requires past, current, and prospective manufacturers, importers, and (if specified by EPA in a particular notice or rule under TSCA section 8(d)) processors of listed chemicals to submit to EPA copies and lists of unpublished health and safety studies on the listed chemicals that they manufacture, import, or (if specified by EPA in a particular notice or rule under TSCA section 8(d)) process. These studies provide EPA with useful information and have provided significant support for EPA's decisionmaking under TSCA sections 4, 5, 6, 8, and 9.
The TSCA section 8(d) model rule provides for the addition of TSCA section 4(e) Priority Testing List chemicals to the list of chemicals subject to the rule (see Table of Chemicals, 40 CFR 716.120). Whenever EPA announces the receipt of an ITC Report, EPA may, at the same time, amend the TSCA section 8(d) model rule by adding the recommended (or designated) chemicals. In doing so, EPA must provide a 14-day period (measured from the date of publication of the Federal Register document announcing the rule) for persons to submit information showing why a chemical substance, mixture, or category of chemical substances should be withdrawn from the amendment. The amendment adding these chemicals to the Health and Safety Data Reporting rule is effective June 3, 2004. If the Administrator withdraws a chemical from the amendment, a Federal Register document announcing this decision is to be published no later than on June 3, 2004.
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Why is this Action Being Issued as a Final Rule?
EPA is taking this action pursuant to TSCA section 8(d) and 40 CFR 716.105(b) and (c), which authorize this action to amend the TSCA 8 (d) Health and Safety Data Reporting rule.
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Final Rule
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What Chemicals are to be Added?
In this document, EPA is adding 15 chemicals to the TSCA section 8(d) Health and Safety Data Reporting rule. This document addresses the request of the TSCA ITC in its 43\rd\ Report (Ref. 1) by adding 3H- 1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- (CAS No. 16691-43-3, 3- amino-5-mercapto-1,2,4-triazole in the 43\rd\ ITC Report) and imidazo[4,5-d]imidazole-2,5(1H,3H)-dione, tetrahydro- (CAS No. 496-46- 8) (glycoluril in the 43\rd\ ITC Report) to the TSCA section 8(d) Health and Safety Data Reporting rule. It addresses the request of the ITC in its 50\th\ Report (Ref. 2) by adding stannane, dimethylbis[(1- oxoneodecyl)oxy]- (CAS No. 68928-76-7); benzene, 1,3,5-tribromo-2-(2- propenyloxy)- (CAS No. 3278-89-5); and 1-triazene, 1,3-diphenyl- (CAS No.136-35-6) to the Health and Safety Data Reporting rule. It also addresses
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the request of the ITC in its 51\st\ Report (Ref. 3) by adding benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)-(CAS No. 29091-20-1; added to the TSCA 4(e) Priority Testing List as 3- chlorotrifluralin in the 48\th\ ITC Report (Ref. 4)) to the Health and Safety Data Reporting rule. Finally, it addresses the request of the ITC in its 47\th\ Report (Ref. 5) as modified in the 51\st\ ITC Report (Ref. 3) by adding 9 indium compounds listed in Table 1 to the Health and Safety Data Reporting rule. (The CAS No. for indium tin oxide was incorrectly cited in the 51\st\ ITC Report as 17906-11-9. The correct CAS No. as given in the 47\th\ ITC Report is 50926-11-9 (Ref. 6)).
Table 1.--Indium Compounds
9\th\ Collective Name in 47\th\ ITC CAS No.
Index Name
Report
1312-43-2
Indium oxide
Indium (III) oxide (In2O3)
7440-74-6
Indium
Indium
10025-82-8
Indium chloride Indium (III) (InCl3)
chloride
13464-82-9
Sulfuric acid, Indium (III) indium(3+) salt sulfate (3:2)
20661-21-6
Indium hydroxide Indium (III) (In(OH)3)
hydroxide
22398-80-7
Indium phosphide Indium (I) (InP)
phosphide
25114-58-3
Acetic acid,
Indium (III) indium(3+) salt acetate
50926-11-9
Indium tin oxide Indium tin oxide
66027-93-8
Sulfamic acid, Indium (III) indium(3+) salt sulfamate
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What are the Reporting Requirements?
Listed in this unit are the reporting requirements for the 15 chemicals added by this amendment to the TSCA section 8(d) model rule. (The specific types of health and safety studies that must be reported for each of the 15 chemicals added to the Health and Safety Data Reporting rule as a result of this document can be found in Unit III.C.)
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Persons who, in the 10 years preceding the date a substance is listed, either have proposed to manufacture or import or have manufactured or imported the listed substance must submit to EPA, during the 60-day reporting period specified in Sec. 716.65 and according to the reporting schedule set forth at Sec. 716.60, a copy of each specified type of health and safety study which is in their possession at the time the substance is listed.
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Persons who, at the time the substance is listed, propose to manufacture or import; or are manufacturing or importing the listed substance must submit to EPA during the 60-day reporting period specified in Sec. 716.65 and according to the reporting schedule set forth at Sec. 716.60:
i. A copy of each specified type of health and safety study which is in their possession at the time the substance is listed.
ii. A list of the specified type of health and safety studies known to them but not in their possession at the time the substance is listed.
iii. A list of the specified type of health and safety studies that are ongoing at the time the substance is listed and are being conducted by or for them.
iv. A list of each specified type of health and safety study that is initiated after the date the substance is listed and is conducted by or for them.
v. A copy of each specified type of health and safety study that was previously listed as ongoing or subsequently initiated (i.e., listed in accordance with reporting requirements in Unit III.B.2.iii. and 2.iv., respectively) and is now complete--regardless of completion date.
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Persons who, after the time the substance is listed, propose to manufacture or import the listed substance must submit to EPA during the reporting period specified in Sec. 716.65 and according to the reporting schedule set forth at Sec. 716.60:
i. A copy of each specified type of health and safety study which is in their possession at the time they propose to manufacture or import the listed substance.
ii. A list of each specified type of health and safety studies known to them but not in their possession at the time they propose to manufacture or import the listed substance.
iii. A list of the specified type of health and safety studies that are ongoing at the time they propose to manufacture or import the listed substance, and are being conducted by or for them.
iv. A list of each specified type of health and safety study that is initiated after the time they propose to manufacture or import the listed substance, and is conducted by or for them.
v. A copy of each specified type of health and safety study that was previously listed as ongoing or subsequently initiated (i.e., listed in accordance with reporting requirements in Unit III.B.3.iii. and 3.iv., respectively) and is now complete--regardless of the completion date.
The reporting described in Unit III.B. is required by August 2, 2004. Any person who manufactures or imports or who proposes to manufacture or import the listed substance from June 3, 2004 to August 2, 2004 must inform (by submitting a list) EPA of any studies initiated during the period from June 3, 2004 to August 2, 2004 within 30 days of their initiation, but in no case later than August 30, 2004. In addition, if any such person has submitted lists of studies that were ongoing or initiated during the period from June 3, 2004 to August 2, 2004 to EPA, such person must submit a copy of each study within 30 days after its completion, regardless of the study's completion date. See 40 CFR 716.60 and 716.65.
Detailed guidance for reporting unpublished health and safety data is provided at 40 CFR part 716. Also found there are explanations of the reporting exemptions.
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What Types of Studies Must be Submitted?
Pursuant to Sec. 716.20(b)(5) and Sec. 716.50, the types of environmental fate, health, and/or environmental effects studies that must be reported and the chemical grade/purity requirements that must be met or exceeded in individual studies for the 15 chemicals added to the Health and Safety Data Reporting rule as a result of this document are as follows:
For 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- and imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro-, all unpublished environmental effects studies and health effects studies on pharmacokinetics, genotoxicity, subchronic toxicity, immunotoxicity, carcinogenicity, reproductive effects, and developmental toxicity where the purity of 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- orimidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro- is greater than or equal to 90% of the test substance by weight must be submitted. All other studies are exempt at this time from reporting.
For benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4- (trifluoromethyl)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation, and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, reproductive effects, developmental toxicity, and carcinogenicity where the purity of benzenamine, 3- chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- is greater than or equal to 90% of the test substance by weight must be submitted. All other studies are exempt at this time from reporting.
For stannane, dimethylbis[(1-oxoneodecyl)oxy]-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on hydrolysis and biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, neurotoxicity, reproductive effects, developmental toxicity, and carcinogenicity where the purity of stannane, dimethylbis[(1- oxoneodecyl)oxy]- is greater than or equal to 90% of the test substance by weight must be submitted. All other studies are exempt at this time from reporting.
For benzene, 1,3,5-tribromo-2-(2-propenyloxy)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, neurotoxicity, reproductive effects, developmental toxicity, and carcinogenicity where the purity of benzene, 1,3,5-tribromo-2-(2-propenyloxy)- is greater than or equal to 90% of the test substance by weight must be submitted. All other studies are exempt at this time from reporting.
For 1-triazene, 1,3-diphenyl-, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the purity of 1-triazene, 1,3-diphenyl- is greater than or equal to 90% of the test substance by weight must be submitted. All other studies are exempt at this time from reporting.
For the 9 chemicals in the indium compound category, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the purity of the indium compound is greater than or equal to 90% of the test substance by weight must be submitted. All other studies are exempt at this time from reporting.
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Economic Analysis
Only 5 of the 15 compounds in this document were located in EPA's Chemical Update System (CUS) utilizing the supplied CAS numbers, yielding 6 companies producing these chemicals at 6 sites. Because the threshold for reporting to CUS under the Inventory Update Rule is 10,000 pounds, and because there is no requirement that inorganic chemicals be reported to CUS (the majority of the indium compounds are inorganic), EPA assumed that one manufacturer exists per chemical to account for the possibility that there may be manufacturers producing these chemicals that are subject to this rule but that were not captured by CUS (Ref. 7).
EPA estimates of the total costs and burdens to industry and the Federal Government, i.e., EPA, for establishing TSCA section 8(d) reporting requirements for the 15 chemicals (Ref. 7) are as follows:
Industry Reporting Costs (dollars) a. Initial review of rule: $1,705 b. Site ID and file searches:
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Site identification: $2,557
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Site file searches: $3,120 c. Copying on-hand studies: $1,086 d. Listing studies ongoing and possessed elsewhere: $383 e. Review studies for CBI: $4,528 f. Newly initiated studies: $124 g. Submission of studies completed after initial reporting period: $54 Grand totals = $13,557
Industry Reporting Burden (Hours) a. Initial review: 32 b. Reporting: 268 Total reporting burden hours = 300 EPA Costs (dollars) and Burden (hours)
It is estimated that the annual cost to EPA will be 0.26 Full Time Equivalents (FTEs) or 541 hours annually. At an estimated $91,874 per FTE, the total of 0.26 FTEs will cost EPA $23,887.
As indicated in Sec. 716.20(b)(5), this final rule specifies the specific types of health and/or environmental effects studies that must be reported and the chemical grade/purity requirements that must be met or exceeded in individual studies. In order to provide a single location for these chemical or chemical category specific reporting requirements, EPA is establishing a new Sec. 716.21. The chemicals will continue to be listed in Sec. 716.120, with a reference to the specific reporting requirement described in Sec. 716.21.
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Requesting a Chemical be Withdrawn from the Rule
As specified in Sec. 716.105(c), EPA may, in its discretion, remove a chemical substance, mixture, or category of chemical substances from this rule for good cause prior to the effective date of this rule. Any person who believes that the reporting required by this rule is not warranted for a chemical listed in this rule, must submit to EPA detailed reasons for that belief. You must submit your request to EPA on or before May 18, 2004 and in accordance with the instructions provided in Sec. 716.105(c), which are briefly summarized here. In addition, to ensure proper receipt by EPA, you must identify docket ID number OPPT-2003-0028. If the Administrator withdraws a chemical substance, mixture, or category of chemical substances from the amendment, in accordance with 40 CFR 716.105(c), a Federal Register document announcing this decision will be published no later than on June 3, 2004.
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Materials in the Docket
The official docket for this rule has been established under docket ID number OPPT-2003-0028. The official public docket is available for review as specified in ADDRESSES. The following is a listing of the documents referenced in this preamble that have been placed in the official docket for this rule:
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ITC. 2000. Forty-Third Report of the ITC. Federal Register (65 FR 65234, October 31, 2000) (FRL-6049-5). Available on-line at: http://www.epa.gov/fedrgstr/ .
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ITC. 2002. Fiftieth Report of the ITC. Federal Register (67 FR 49530, July 30, 2002) (FRL-7183-7). Available on-line at: http://www.epa.gov/fedrgstr/ .
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ITC. 2003. Fifty-first Report of the ITC. Federal Register (68 FR 8976, February 26, 2003) (FRL-7285-7). Available on-line at: http://www.epa.gov/fedrgstr/ .
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ITC. 2001. Forty-Eighth Report of the ITC. Federal Register (66 FR 51276, October 5, 2001) (FRL-6786-7). Available on-line at: http://www.epa.gov/fedrgstr/ .
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ITC. 2001. Forty-Seventh Report of the ITC. Federal Register (66 FR 17767, April 3, 2001) (FRL-6763-6). Available on-line at: http://www.epa.gov/fedrgstr/ .
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EPA. 2003. Letter from John Walker to Charles M. Auer correcting the CAS No. for indium tin oxide in the 51\st\ ITC Report. April 17, 2003.
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EPA. 2003. TSCA Section 8(d): Economic Impact Analysis For Adding 15 Chemicals from the 43\rd\, 47\th\, 50\th\, and 51\st\ Report of the TSCA Interagency Testing Committee to the Health and Safety Data Reporting Rule. August 5, 2003.
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Statutory and Executive Order Reviews
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Executive Order 12866
The Office of Management and Budget (OMB) has exempted actions under TSCA section 8(d) related to the Health and Safety Data Reporting rule from the requirements of Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
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Paperwork Reduction Act
The information collection requirements contained in TSCA section 8(d) Health and Safety Data Reporting rules have already been approved by OMB under the provisions of PRA, 44 U.S.C. 3501 et seq., and OMB control number 2070-0004 (EPA ICR No. 0575). The collection activities in this final rule are captured by the existing approval and do not require additional review and/or approval by OMB.
EPA estimates that the information collection activities related to health and safety data reporting for all chemicals in this final rule will result in an annual public reporting burden of 20 hours per chemical, for a total of 300 hours for the 15 chemicals (Ref. 7). As defined by the PRA and 5 CFR 1320.3(b), ``burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. This includes the time needed to: Review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
Under PRA, an agency may not conduct or sponsor, and a person is not required to respond to, an information collection request unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and included on the related collection instrument. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this final rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment is unnecessary. As a result, EPA finds that there is ``good cause'' under section 553(b)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), to amend this table without further notice and comment.
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Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., the Agency hereby certifies that this final rule will not have a significant adverse economic impact on a substantial number of small entities. The factual basis for the Agency's determination is presented in the small entity impact analysis prepared as part of the economic analysis for this rule (Ref. 7), and is briefly summarized here.
For this final rule, EPA has analyzed the potential small business impacts using the size standards established under the default definition of ``small business'' established under section 601(3) of RFA, which basically uses the definition used in section 3 of the Small Business Act, 15 U.S.C. 632, under which the SBA establishes small business size standards for each industry sector. (13 CFR 121.201). The SBA size standards, which are primarily intended to determine whether a business entity is eligible for government programs and preferences reserved for small businesses (13 CFR 121.101), ``seek to ensure that a concern that meets a specific size standard is not dominant in its field of operation.'' (13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act.
For the chemical manufacturers potentially impacted by this rule, an ultimate corporate parent with 1,000 or fewer employees is considered a small business. Of the 6 companies identified in CUS as manufacturers of the chemicals covered by this rule (see the economic analysis for this rule (Ref. 7) as summarized in Unit III.D.), none meet the SBA definition of small business. Given these results, EPA concludes that there is not a significant adverse economic impact on these small entities as a result of this final rule.
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Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. In addition, EPA has determined that this rule will not significantly or uniquely affect small governments. Accordingly, the rule is not subject to the requirements of UMRA sections 202, 203, 204, or 205.
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Executive Order 13132 and 13175
Based on EPA's experience with past TSCA section 8(d) rules, State, local, and tribal governments have not been impacted by these rules, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rule. As a result, these rules are not subject to the requirements in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) or Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000).
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Executive Order 13045
Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23,1997), does not apply to this rule, because it is not ``economically significant'' as defined under Executive Order 12866, and does not concern an environmental health or safety risk that may have a disproportionate effect on children. This rule requires the reporting of health and safety data to EPA by manufacturers
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(including importers) of certain chemicals requested by the ITC to be added to the Health and Safety Data Reporting rule in its 43\rd\ Report (Ref. 1), 47\th\ Report (Ref. 5), 50\th\ Report (Ref. 2), and 51\st\ Report (Ref. 3).
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Executive Order 13211
This rule is not subject to Executive Order 13211, entitled Actions that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.
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National Technology Transfer and Advancement Act
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
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Executive Order 12898
This action does not involve special considerations of environmental justice-related issues pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
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Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 716
Environmental protection, Chemicals, Hazardous substances, Health and safety, Reporting and recordkeeping requirements.
Dated: April 22, 2004. Charles M. Auer, Director, Office of Pollution Prevention and Toxics.
0 Therefore, 40 CFR chapter I is amended as follows:
PART 9--[AMENDED]
0 1. By amending part 9 as follows:
0 a. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j- 2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.
0 b. In Sec. 9.1, the table is amended by revising the entries under the undesignated center heading ``Health and Safety Data Reporting'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
OMB control 40 CFR citation
No.
* * * * * Health and Safety Data Reporting
* * * * * Part 716................................................ 2070-0004 * * * * *
* * * * *
PART 716--[AMENDED]
0 2. By amending part 716 as follows:
0 a. The authority citation for part 716 continues to read as follows:
Authority: 15 U.S.C. 2607(d).
0 b. By adding a new Sec. 716.21 to subpart A to read as follows:
Sec. 716.21 Chemical specific reporting requirements.
(a) Health and safety studies reportable under part 716 for the following chemical substances, mixtures, or categories of chemical substances, as listed in Sec. 716.120, must be submitted or listed only as specified in this section:
(1) For 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- and imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro-, all unpublished environmental effects studies and health effects studies on pharmacokinetics, genotoxicity, subchronic toxicity, immunotoxicity, carcinogenicity, reproductive effects, and developmental toxicity where the purity of 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- or imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro- is greater than or equal to 90% of the test substance by weight must be submitted.
(2) For benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4- (trifluoromethyl)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation, and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- is greater than or equal to 90% of the test substance by weight must be submitted.
(3) For stannane, dimethylbis[(1-oxoneodecyl)oxy]-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on hydrolysis and biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, mutagenicity, neurotoxicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of stannane, dimethylbis[(1- oxoneodecyl)oxy]- is greater than or equal to 90% of the test substance by weight must be submitted.
(4) For benzene, 1,3,5-tribromo-2-(2-propenyloxy)-, all unpublished environmental effects studies including bioconcentration, environmental fate studies on biodegradation and health effects studies on pharmacokinetics, subchronic toxicity, neurotoxicity, reproductive effects, and developmental toxicity, and carcinogenicity where the purity of benzene, 1,3,5-tribromo-2-(2-propenyloxy)- is greater than or equal to 90% of the test substance by weight must be submitted.
(5) For 1-triazene, 1,3-diphenyl-, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the purity of 1-triazene,
[[Page 24523]]
1,3-diphenyl- is greater than or equal to 90% of the test substance by weight must be submitted.
(6) For the 9 chemicals in the indium compound category, all unpublished health effects studies on pharmacokinetics, genotoxicity, subchronic and chronic toxicity, reproductive effects, and developmental toxicity where the purity of the indium compound is greater than or equal to 90% of the test substance by weight must be submitted.
(b) [Reserved]
0 c. In Sec. 716.120, the table in paragraph (a) is amended by adding the chemicals: 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro-; imidazo[4,5-d]imidazole-2,5(1H,3H)-dione, tetrahydro-; benzenamine, 3- chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)-; stannane, dimethylbis[(1-oxoneodecyl)oxy]-; benzene, 1,3,5-tribromo-2-(2- propenyloxy)-; and 1-triazene, 1,3-diphenyl- listed in ascending CAS number order to read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart applies.
* * * * *
(a) * * *
CAS No.
Substance
Specific exemptions
Effective date
Sunset date
* * * * * * * 136-35-6 1-Triazene, 1,3-diphenyl-........... Sec. 716.21(a)(5)
June 3, 2004. August 2, 2004. * * * * * * * 496-46-8 Imidazo[4,5-d]imidazole-2,5(1H,3H)- Sec. 716.21(a)(1)
June 3, 2004. August 2, 2004. dione, tetrahydro-. * * * * * * * 3278-89-5 Benzene, 1,3,5-tribromo-2-(2-
Sec. 716.21(a)(4)
June 3, 2004. August 2, 2004. propenyloxy)-. * * * * * * * 16691-43-3 3H-1,2,4-Triazole-3-thione, 5-amino- Sec. 716.21(a)(1)
June 3, 2004. August 2, 2004. 1,2-dihydro-. * * * * * * * 29091-20-1 Benzenamine, 3-chloro-2,6-dinitro- Sec. 716.21(a)(2)
June 3, 2004. August 2, 2004. N,N-dipropyl-4-(trifluoromethyl)-. * * * * * * * 68928-76-7 Stannane, dimethylbis[(1-
Sec. 716.21(a)(3)
June 3, 2004. August 2, 2004. oxoneodecyl)oxy]-. * * * * * * *
* * * * *
0 d. In Sec. 716.120, the table in paragraph (d) is amended by adding in alphabetical order the category ``Indium Compounds'' containing 9 chemicals in alphabetical order to read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart applies.
* * * * *
(d) * * *
Category
CAS No.
Special Exemptions
Effective Date
Sunset Date
* * * * * * * Indium Compounds: Acetic acid, indium(3+) salt............. 25114-58-3..................
Sec. 716.21(a)(6)
June 3, 2004. August 2, 2004 Indium................................... 7440-74-6...................
Sec. 716.21(a)(6)
June 3, 2004. August 2, 2004. Indium chloride (InCl3).................. 10025-82-8..................
Sec. 716.21(a)(6)
June 3, 2004. August 2, 2004. Indium hydroxide (In(OH)3)............... 20661-21-6..................
Sec. 716.21(a)(6)
June 3, 2004. August 2, 2004. Indium oxide (In2O3)..................... 1312-43-2...................
Sec. 716.21(a)(6)
June 3, 2004. August 2, 2004. Indium phosphide (InP)................... 22398-80-7..................
Sec. 716.21(a)(6)
June 3, 2004 August 2, 2004. Indium tin oxide......................... 50926-11-9..................
Sec. 716.21(a)(6)
June 3, 2004 August 2, 2004 Sulfamic acid, indium(3+) salt........... 66027-93-8..................
Sec. 716.21(a)(6)
June 3, 2004 August 2, 2004 Sulfuric acid, indium(3+) salt (3:2)..... 13464-82-9..................
Sec. 716.21(a)(6)
June 3, 2004 August 2, 2004. * * * * * * *
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[FR Doc. 04-9875 Filed 5-3-04; 8:45 am]
BILLING CODE 6560-50-S
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