[Federal Register Volume 69, Number 86 (Tuesday, May 4, 2004)]
[Rules and Regulations]
[Pages 24517-24524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9875]


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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.

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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report certain unpublished health and safety data to EPA: 3H-1,2,4-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: [email protected].
     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,

[[Page 24518]]

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: [email protected].
    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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. 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.

B. 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/.

C. 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.

II. Background

A. 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.

B. 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.

C. 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.

III. Final Rule

A. 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

[[Page 24519]]

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
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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
------------------------------------------------------------------------

B. 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.)
    1. 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.
    2. 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.
    3. 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.

[[Page 24520]]

C. 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.

D. 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:
    1. Site identification: $2,557
    2. 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.

IV. 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.

V. 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:
    1. 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/.

[[Page 24521]]

    2. 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/.
    3. 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/.
    4. 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/.
    5. 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/.
    6. 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.
    7. 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.

VI. Statutory and Executive Order Reviews

A. 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).

B. 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.

C. 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.

D. 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.

E. 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).

F. 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

[[Page 24522]]

(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).

G. 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.

H. 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.

I. 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).

J. 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.
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 24524]]

[FR Doc. 04-9875 Filed 5-3-04; 8:45 am]
BILLING CODE 6560-50-S