Document ID: EPA-HQ-OPPT-2006-0898-0066
Agency: epa
Document Type: Proposed Rule
Title: Proposed Significant New Use Rules on Certain Chemical Substances; Proposed Rule
Posted Date: 2008-06-09T04:00Z

[Federal Register: June 9, 2008 (Volume 73, Number 111)]
[Proposed Rules]               
[Page 32508-32514]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn08-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2006-0898; FRL-8351-4]
RIN 2070-AB27

 
Proposed Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two 
chemical substances which were the subject of premanufacture notices 
(PMNs). The two substances are dodecandioic acid, 1, 12-dihydrazide 
(CAS No. 4080-98-2; PMNs P-01-759 and P-05-555) and thiophene, 2,5-
dibromo-3-hexyl- (CAS No. 116971-11-0; PMN P-07-283). This action would 
require persons who intend to manufacture, import, or process either of 
these two substances for an activity that is designated as a 
significant new use by this proposed rule to notify EPA at least 90 
days before commencing that activity. The required notification would 
provide EPA with the opportunity to evaluate the intended use and, if 
necessary, to prohibit or limit that activity before it occurs.

DATES: Comments must be received on or before July 9, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2006-0898, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2006-0898. 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 DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0898. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, 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 regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
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 regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the 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 the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket materials are available electronically at http://
www.regulations.gov, or, if only available in hard copy, at the OPPT

[[Page 32509]]

Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at 
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. 
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding Federal holidays. The telephone 
number of the EPA/DC Public Reading Room is (202) 566-1744, and the 
telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 
are required to show photographic identification, pass through a metal 
detector, and sign the EPA visitor log. All visitor bags are processed 
through an X-ray machine and subject to search. Visitors will be 
provided an EPA/DC badge that must be visible at all times in the 
building and returned upon departure.

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: Tracey Pennington, Chemical 
Control Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-2209; e-mail 
address: pennington.tracey@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this 
proposed rule. Potentially affected entities may include, but are not 
limited to:
    Manufacturers, importers, or processors of one or both subject 
chemical substances (NAICS codes 325 and 324110), e.g., Chemical 
manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR 721.5. 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.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final SNUR are subject 
to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations at 19 CFR 12.118 through 
12.127 and 19 CFR 127.28. Those persons must certify that the shipment 
of the chemical substance complies with all applicable rules and orders 
under TSCA, including any SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule on or after July 9, 
2008 are subject to the export notification provisions of TSCA section 
12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the 
export notification requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
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 
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.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing significant new use rules (SNURs) under section 
5(a)(2) of TSCA for two chemical substances which were the subject of 
premanufacture notices (PMNs). The two substances are dodecandioic 
acid, 1, 12-dihydrazide (CAS No. 4080-98-2; PMNs P-01-759 and P-05-555) 
and thiophene, 2,5-dibromo-3-hexyl- (CAS No. 116971-11-0; PMN P-07-
283). These SNURs would require persons who intend to manufacture, 
import, or process either of these two substances for an activity 
designated as a significant new use to notify EPA at least 90 days 
before commencing that activity.
    In the Federal Register of September 19, 2007 (72 FR 53470) (FRL-
8135-8), EPA issued direct final SNURs on these two substances in 
accordance with the procedures at 40 CFR 721.170(d)(4)(i)(A). EPA 
received notices of intent to submit adverse comments on these SNURs. 
Therefore, as required by 40 CFR 721.170(d)(4)(i)(B), on November 19, 
2007 (72 FR 64951) (FRL-8340-8), EPA withdrew the direct final SNURs on 
these two substances and is now proposing these SNURs. The record for 
the direct final SNURs for these substances was established as docket 
EPA-HQ-OPPT-2006-0898. That record includes information considered by 
the Agency in developing the direct final rules and the notices of 
intent to submit adverse comments.
    The rationale for this proposed rule as well as requests for public 
comment on specific issues is included in Unit IV.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine

[[Page 32510]]

that a use of a chemical substance is a ``significant new use.'' EPA 
must make this determination by rule after considering all relevant 
factors, including those listed in TSCA section 5(a)(2). Once EPA 
determines that a use of a chemical substance is a significant new use, 
TSCA section 5(a)(1)(B) requires persons to submit a significant new 
use notice (SNUN) to EPA at least 90 days before they manufacture, 
import, or process the chemical substance for that use (15 U.S.C. 
2604(a)(1)(B)). As described in unit II.C., the general SNUR provisions 
are found at 40 CFR part 721, subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart 
A. These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to 40 CFR 721.1(c), persons subject to these SNURs must 
comply with the same notice requirements and EPA regulatory procedures 
as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, 
these requirements include the information submission requirements of 
TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA 
section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 
CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action 
under TSCA section 5(e), 5(f), 6, or 7 to control the significant new 
use activities described in the SNUN. If EPA does not take action, EPA 
is required under TSCA section 5(g) to explain in the Federal Register 
its reasons for not taking action.
    Persons who export or intend to export a chemical substance 
identified in a proposed or final SNUR are subject to the export 
notification provisions of TSCA section 12(b). The regulations that 
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. 
Persons who import a chemical substance identified in a final SNUR are 
subject to the TSCA section 13 import certification requirements, 
codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such 
persons must certify that the shipment of the chemical substance 
complies with all applicable rules and orders under TSCA, including any 
SNUR requirements. The EPA policy statement in support of the import 
certification appears at 40 CFR part 707, subpart B.

III. Substances Subject to this Rule

    EPA is proposing to establish significant new use and recordkeeping 
requirements for two chemical substances under 40 CFR part 721, subpart 
E. In this unit, EPA provides the following information for each 
chemical substance:
     PMN number.
     Chemical name (generic name if the specific name is 
claimed as CBI).
     CAS number (if assigned for non-confidential chemical 
identities).
     Basis for the SNUR.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VI. for more information).
     CFR citation assigned in the regulatory text section of 
this proposed rule.
    The specific activities designated as significant new uses are 
listed in 40 CFR part 721, subpart E.
PMN Numbers P-01-759 and P-05-555
Chemical name: Dodecandioic acid, 1, 12-dihydrazide.
CAS number: 4080-98-2.
Basis for action: The PMNs (submitted by two different chemical 
manufacturing companies) state that the generic (non-confidential) uses 
of the substance will be as a raw material for coating and sealants and 
as a curing agent, respectively. Based on the molecular structure of 
the PMN substance and test data on analogous substances, EPA believes 
the PMN substance may cause carcinogenicity, developmental toxicity, 
and irritation to mucous membranes. Also, based on test data on the PMN 
substance, it may cause dermal sensitization. As described in the 
companies' PMNs and accompanying Material Safety Data Sheets, workers 
will be warned that the substance may cause dermal sensitization and 
will wear gloves and National Institute for Occupational Safety and 
Health (NIOSH) approved respirators with an assigned protection factor 
(APF) of 50 or greater. Based on this expectation that adequate hazard 
communication and personal protective equipment will be used, EPA 
believes significant worker exposure is unlikely. Further, consumer use 
is not expected. EPA has determined, however, that potential use of the 
substance without workers wearing gloves and a respirator, and without 
an appropriate hazard communication program, may cause serious human 
health effects. Respirators must provide a NIOSH APF of at least 50. 
The following NIOSH-approved respirators meet the minimum requirement 
for Sec.  721.63(a)(4): Air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters; powered air-purifying respirator equipped with a tight-fitting 
full facepiece and High Efficiency Particulate Air (HEPA) filters; 
supplied air respirator operated in pressure demand or continuous flow 
mode and equipped with a tight-fitting full facepiece. Because the 
substance is a dermal sensitizer and irritates mucous membranes, half-
face respirators do not provide adequate protection. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
oral toxicity test in rats (OPPTS 870.3100 test guideline) and a 
mammalian erythrocyte micronucleus test (OPPTS 870.5395 test guideline) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10057.
PMN Number P-07-283
Chemical name: Thiophene, 2,5-dibromo-3-hexyl-.
CAS number: 116971-11-0.
Basis for action: The PMN states that the substance will be used as a 
reactive intermediate monomer for use in manufacturing a p-type organic 
semiconductor polymer. The polymer will be used in printed organic 
electronics applications. Based on structure activity relationship 
analyses for thiophenes, EPA is concerned that toxicity to aquatic 
organisms may occur at concentrations above 1 part per billion (ppb) of 
the PMN substance in surface waters. At the production volume stated 
for the company in the PMN, releases of the PMN substance are not 
expected to result in surface water concentrations above 1 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance, as described in the PMN, may 
present an unreasonable risk. EPA has determined, however, that 
potential increased production or importation volumes or other uses of 
the substance resulting in surface water concentrations above 1 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS 850.1400 test guideline (public 
draft)); a daphnid chronic toxicity test (OPPTS 850.1300 test guideline 
(public draft)); and an algal toxicity test, tiers I and II (OPPTS 
850.5400 test guideline (public draft)) would help characterize the

[[Page 32511]]

environmental effects of the PMN substance. The fish and daphnid tests 
should use flow-through conditions and measured concentrations.
CFR citation: 40 CFR 721.10088.

IV. Objectives and Rationale of the Rule

A. Rationale

    During review of the PMNs submitted for these two chemical 
substances, EPA determined that one or more of the criteria of concern 
established at 40 CFR 721.170 were met, as discussed in Unit III.
    1. Rationale for the proposed SNUR for dodecandioic acid, 1, 12-
dihydrazide (CAS No. 4080-98-2). The hazard communication terms of the 
SNUR being proposed today for dodecandioic acid, 1, 12-dihydrazide (CAS 
No. 4080-98-2) differ from the terms in the direct final SNUR, based on 
submitted comments that clarified existing uses of the substance. The 
notice of intent to submit adverse comment states that hazard 
communication materials currently in use for this substance in the 
marketplace do not contain two of the health hazard statements included 
in the direct final SNUR. The two statements are, ``this substance may 
cause cancer'' and ``this substance may cause developmental toxicity.'' 
As EPA interprets its SNUR authority under section 5(a)(2) of TSCA, if 
an activity is already ongoing before EPA first publishes a Federal 
Register notice of intent to designate that activity as a significant 
new use, then EPA may not issue a SNUR designating that activity as a 
significant ``new'' use. Therefore, EPA is proposing a SNUR that would 
not designate as a ``significant new use'' the failure to identify 
cancer and developmental toxicity in workplace hazard communication 
materials accompanying this chemical substance (under 40 CFR 721.72). 
However, for the reasons described in this paragraph and in the direct 
final rule preamble, the Agency's concerns for these toxic endpoints 
remain. Therefore, the Agency encourages companies to voluntarily 
include these potential health concerns in their hazard communication 
materials for the substance. The workplace personal protective 
equipment requirements (under 40 CFR 721.63) and other requirements 
listed in the direct final rule would remain unchanged in today's 
proposed SNUR. The Agency requests comments on the approach being taken 
in the proposed SNUR for this substance.
    2. Rationale for the proposed SNUR for thiophene, 2,5-dibromo-3-
hexyl- (CAS No. 116971-11-0). The Agency is requesting comments on the 
proposed SNUR for this substance as well as two alternative approaches. 
A discussion of the rationale behind each option and specific issues on 
which the Agency is requesting comment follows. EPA requests that 
commenters making specific recommendations include supporting 
documentation where appropriate.
    i. Proposed SNUR - maximum surface water concentration of 1 ppb 
from manufacturing, processing, or use activities and annual company 
production limit of 500 kg. The terms of the SNUR being proposed today 
for thiophene, 2,5-dibromo-3-hexyl- (CAS No. 116971-11-0) remain the 
same as in the direct final SNUR. See proposed Sec.  721.10088 
(a)(2)(i) and (a)(2)(ii). EPA is proposing to designate the surface 
water release and production volume limits as significant new uses for 
the reasons stated in Unit V., including concerns associated with 
potential changes in the extent to which these activities could 
increase the magnitude and duration of exposure of human beings or the 
environment to the chemical substance. Inclusion of a production volume 
limit gives the Agency an opportunity to review the substance again at 
a higher production volume.
    ii. Alternative A -maximum surface water concentration of 1 ppb 
from manufacture, processing, or use activities up to an annual 
production volume of 500 kg, and no release to surface water at annual 
company production volumes higher than 500 kg. This option was 
suggested in the notice of intent to submit adverse comment on the 
direct final SNUR for this substance. The commenter also stated that 
they recognize the Agency's concern for water releases of the 
substance. While this option would be protective of the aquatic 
environment, the Agency requests comment on whether industry compliance 
would be impractical or confusing.
    iii. Alternative B - SNUR for no release to surface water. If the 
substance is not currently being released to water during 
manufacturing, processing, or use activities, the Agency could consider 
finalizing a SNUR designating any release to water during those 
activities as a significant new use. This option would be sufficiently 
protective of the aquatic environment and is less complicated than 
Alternative A. To implement this option, EPA would need to be satisfied 
that there are no ongoing releases to water, taking into account 40 CFR 
721.90 (a)(1), (b)(1), and (c)(1). EPA solicits comment on whether 
there are ongoing releases to water during manufacturing, processing, 
or use activities.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this proposed rule:
     EPA would receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA would be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.

V. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of the two 
chemical substances that are the subject of this proposed rule, EPA 
considered relevant information about the toxicity of the substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four factors listed in section 5(a)(2) of TSCA. 
In these cases, EPA did not find that the use scenarios described in 
the three PMNs triggered the determinations set forth

[[Page 32512]]

under section 5(e) of TSCA. EPA did, however, believe that certain 
changes from the use scenarios described in the PMNs could result in 
increased exposures, and constitute ``significant new uses.'' These so-
called ``Non-5(e) SNURs'' (i.e., SNURs for chemicals that are not 
regulated by a section 5(e) Consent Order under Sec.  721.160) are 
promulgated pursuant to 40 CFR 721.170. EPA has determined that every 
activity designated as a ``significant new use'' in all the non-5(e) 
SNURs issued under 40 CFR 721.170 satisfies the two requirements 
stipulated in Sec.  721.170(c)(2), i.e., these significant new use 
activities, ``(i) are different from those described in the 
premanufacture notice for the substance, including any amendments, 
deletions, and additions of activities to the premanufacture notice, 
and (ii) may be accompanied by changes in exposure or release levels 
that are significant in relation to the health or environmental 
concerns identified'' for the PMN substance.

VI. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. EPA solicits comments on whether any of the uses 
proposed as significant new uses are ongoing. As discussed in the 
Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that 
the intent of section 5(a)(1)(B) of TSCA is best served by designating 
a use as a significant new use as of the date of publication of the 
proposed rule, rather than as of the effective date of the final rule. 
If uses begun after publication of the proposed rule were considered 
ongoing rather than new, it would be difficult for EPA to establish 
SNUR notice requirements, because a person could defeat the SNUR by 
initiating the significant new use before the rule became final, and 
then argue that the use was ongoing as of the effective date of the 
final rule. Thus, persons who begin commercial manufacture, import, or 
processing activities with the chemical substances that would be 
regulated as a ``significant new use'' through this proposed rule, must 
cease any such activity as of the effective date of the rule if and 
when finalized. To resume their activities, these persons would have to 
comply with all applicable SNUR notice requirements and wait until the 
notice review period, including all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this 
SNUR before the effective date. If a person were to meet the conditions 
of advance compliance under Sec.  721.45(h), the person would be 
considered to have met the requirements of the final SNUR for those 
activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN. Persons are required 
only to submit test data in their possession or control and to describe 
any other data known to or reasonably ascertainable by them (15 U.S.C. 
2604(d); 40 CFR 721.25 and 720.50). However, upon review of PMNs and 
SNUNs, the Agency has the authority to require appropriate testing. 
Unit III. lists recommended testing for the two chemical substances 
that are the subject of these proposed SNURs. Descriptions of tests are 
provided for informational purposes. EPA strongly encourages persons, 
before performing any testing, to consult with the Agency pertaining to 
protocol selection. Many test guidelines are now available on the 
Internet at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    The recommended tests may not be the only means of assessing the 
potential toxicity, exposure, and risks of the chemical substances 
regulated under this rule. However, submitting SNUNs without any test 
data may increase the likelihood that EPA will take action under TSCA 
section 5(e), particularly if satisfactory test results have not been 
obtained from a prior submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what data may be useful in evaluating a 
significant new use. Discussions with the Agency prior to notice 
submission can afford ample time to conduct any tests that might be 
helpful in evaluating risks posed by the substance. According to 40 CFR 
721.1(c), persons submitting a SNUN must comply with the same notice 
requirements and EPA regulatory procedures as persons submitting a PMN, 
including submission of test data on health and environmental effects 
as described in 40 CFR 720.50.
    SNUNs must be mailed to the Environmental Protection Agency, OPPT 
Document Control Office (7407M), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Information must be submitted in the form 
and manner set forth in EPA Form No. 7710-25. This form is available 
from the Environmental Assistance Division (7408M), 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001 (see 40 CFR 721.25 and 720.40). 
Forms and information are also available electronically at http://
www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances at the time of the direct final rule. The 
Agency's complete economic analysis is available in the public docket 
for the direct final rule (EPA-HQ-OPPT-2006-0898). The difference in 
hazard communication requirements in the direct final SNUR and this 
proposed rule (i.e., removal of the requirement for specific 
identification of cancer and developmental toxicity endpoints in 
workplace hazard communication materials) could slightly reduce 
estimated costs to regulated entities. The difference in a production 
volume trigger and type of release to water restriction in the direct 
final SNUR and this proposed rule will not impact the estimated costs 
to regulated entities.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that this proposed rule is not a 
``significant regulatory action'' because it does not meet the criteria 
in section 3(f) of the Executive order.

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires OMB 
approval under the PRA, unless it has been approved by OMB and displays 
a currently valid OMB control number. The OMB control

[[Page 32513]]

numbers for EPA's regulations in title 40 of the CFR, after appearing 
in the Federal Register, are listed in 40 CFR part 9, and included on 
the related collection instrument or form, if applicable.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to the PRA under OMB control 
number 2070-0012 (EPA ICR No. 574). This action does not impose any 
burden requiring additional OMB approval. If an entity were to submit a 
SNUN to the Agency, the annual burden is estimated to average between 
30 and 170 hours per submission. This burden estimate includes the time 
needed to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

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 promulgation 
of these SNURs would not have a significant adverse economic impact on 
a substantial number of small entities. The rationale supporting this 
conclusion is as follows. A SNUR applies to any person (including small 
or large entities) who intends to engage in any activity described in 
the proposed rule as a ``significant new use.'' By definition of the 
word ``new,'' and based on all information currently available to EPA, 
it appears that no small or large entities presently engage in such 
activity. Since a SNUR only requires that any person who intends to 
engage in such activity in the future must first notify EPA by 
submitting a SNUN, no economic impact would even occur until someone 
decides to engage in those activities. Although some small entities may 
decide to conduct such activities in the future, EPA cannot presently 
determine how many, if any, there may be. However, EPA's experience to 
date is that, in response to the promulgation of over 1,000 SNURs, the 
Agency receives on average only 10 notices per year. Of those SNUNs 
submitted, none appear to be from small entities in response to any 
SNUR. In addition, the estimated reporting cost for submission of a 
SNUN (see Unit IX.) are minimal regardless of the size of the firm. 
Therefore, EPA believes that the potential economic impacts of 
complying with these SNURs are not expected to be significant or 
adversely impact a substantial number of small entities. In a SNUR that 
published on June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that SNURs are not expected to have 
a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government would be impacted by this 
rulemaking. As such, EPA has determined that this regulatory action 
would not impose any enforceable duty, contain any unfunded mandate, or 
otherwise have any affect on small governments subject to the 
requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).

E. Executive Order 13132

    This action would not have a substantial direct effect on States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly or uniquely affect the 
communities of Indian Tribal governments, nor would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), do not apply to this proposed rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations 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.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical 
standards, 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), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

K. Executive Order 12988

    In issuing this proposed rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: May 30, 2008.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 would continue to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

[[Page 32514]]

    2. By adding new Sec.  721.10057 to subpart E to read as follows:

Sec.  721.10057  Dodecanedioic acid, 1, 12-dihydrazide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as dodecanedioic acid, 
1, 12-dihydrazide (PMNs P-01-759 and P-05-555; CAS No. 4080-98-2) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6)(i), 
(a)(6)(ii), (b), and (c). Respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
(APF) of at least 50. The following NIOSH-approved respirators meet the 
minimum requirement for Sec.  721.63(a)(4): Air-purifying, tight-
fitting full-face respirator equipped with N100 (if oil aerosols 
absent), R100, or P100 filters; powered air-purifying respirator 
equipped with a tight-fitting full facepiece and High Efficiency 
Particulate Air (HEPA) filters; supplied air respirator operated in 
pressure demand or continuous flow mode and equipped with a tight-
fitting full facepiece. Because the substance is a dermal sensitizer 
and irritates mucous membranes, half-face respirators do not provide 
adequate protection.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(i), and (g)(2)(i).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (f), (g), and (h) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    3. By adding new Sec.  721.10088 to subpart E to read as follows:

Sec.  721.10088  Thiophene, 2,5-dibromo-3-hexyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as thiophene, 2,5-
dibromo-3-hexyl- (PMN P-07-283; CAS No. 116971-11-0) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(s) (500 kilograms).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. E8-12862 Filed 6-6-08; 8:45 am]

BILLING CODE 6560-50-S