Document ID: EPA-HQ-OPPT-2012-0864-0009
Agency: epa
Document Type: Rule
Title: Modification of Significant New Uses: Ethaneperoxoic Acid, 1,1-Dimethylpropyl Ester
Posted Date: 2013-07-31T04:00Z

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46283-46287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18180]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2012-0864; FRL-9392-4]
RIN 2070-AB27

Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1-
Dimethylpropyl Ester

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is 
finalizing an amendment to the significant new use rule (SNUR) for the 
chemical substance identified as ethaneperoxoic acid, 1,1-
dimethylpropyl ester, which was the subject of premanufacture notice 
(PMN) P-85-680. This action requires persons who intend to manufacture 
or process the chemical substance for a use that is designated as a 
significant new use by this final rule to notify EPA at least 90 days 
before commencing that activity. EPA believes that this action is 
necessary because new uses of the

[[Page 46284]]

chemical substance may be hazardous to human health. 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: This final rule is effective August 30, 2013.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2012-0864, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), EPA West Bldg., Rm. 3334, 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 telephone 
number for the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPPT Docket is (202) 566-0280. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim 
Alwood, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8974; email address: alwood.jim@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substance identified as ethaneperoxoic 
acid, 1,1-dimethylpropyl ester, (PMN P-85-680). Potentially affected 
entities may include, but are not limited to:
    Manufacturers or processors of the subject chemical substance 
(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 Sec.  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. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127, 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to a SNUR must certify their 
compliance with the 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 the chemical 
substance that is the subject of a proposed or final SNUR are subject 
to the export notification provisions of TSCA section 12(b)(15 U.S.C. 
2611(b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the agency taking?

    EPA is finalizing an amendment to the SNUR for the chemical 
substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester, 
(PMN P-85-680), codified at 40 CFR 721.3020. This final action requires 
persons who intend to manufacture or process the chemical substance for 
an activity that is designated as a significant new use by this final 
rule to notify EPA at least 90 days before commencing that activity.
    This rule was proposed in the Federal Register issue of January 28, 
2013 (78 FR 5761) (FRL-9370-5). EPA received no public comments in 
response to the proposal. Therefore, the Agency is issuing a final 
SNUR, as proposed that:
    1. Removes the significant new use requirements for protective 
equipment, hazard communication, and specific uses identified in the 
consent order.
    2. Modifies significant new use requirements for environmental 
releases by removing notification requirements for disposal and adding 
notification requirements for water releases above 61 parts per billion 
(ppb).
    3. Revises the recordkeeping requirements to reflect the modified 
SNUR requirements.

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 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 the four bulleted TSCA section 5(a)(2) 
factors, listed in Unit IV. of this document. 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 or process the 
chemical substance for that use. Persons who must report are described 
in Sec.  721.5.

III. Rationale for the Rule

    During review of PMN P-85-680, the chemical substance identified as 
ethaneperoxoic acid, 1,1-dimethylpropyl ester, EPA concluded that 
regulation was warranted under TSCA section 5(e), pending the 
development of information sufficient to make reasoned evaluations of 
the health or environmental effects of this chemical substance. The 
basis for such findings is outlined in Unit II. of the proposed rule to 
amend this SNUR, included in the Federal Register issue of January 28, 
2013 (78 FR 5761) (``proposed amended rule''), and in the original 
final rule Federal Register document of June 26, 1990 (55 FR 26102). 
Based on these findings, a TSCA section 5(e) consent order requiring 
the use of hazard communication and appropriate exposure, use, and 
disposal controls was negotiated with the PMN submitter. The SNUR 
provisions for this chemical substance were consistent with the 
provisions of the original TSCA section 5(e) consent order. The SNUR 
was promulgated pursuant to Sec.  721.160, and codified at Sec.  
721.1560 and redesignated as Sec.  721.3020.
    After the review of new test data subsequent to issuance of the 
TSCA section 5(e) consent order for P-85-680 and associated SNUR (see 
Unit II. of the proposed amended rule), and consideration of the 
factors included in TSCA section 5(a)(2) (see Unit IV.), EPA determined 
that the chemical substance meets one or more of the concern criteria 
in Sec.  721.170(b), but that these criteria are no longer met for the 
personal protective equipment, hazard communication, and specific use 
notification requirements. Consequently, EPA is proposing this 
modification to the SNUR at Sec.  721.3020 according to procedures in 
Sec. Sec.  721.160 and 721.185.

[[Page 46285]]

IV. 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 for the chemical 
substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester, 
(PMN P-85-680), EPA considered relevant information about the toxicity 
of the chemical substance, likely human exposures, and environmental 
releases associated with possible uses, taking into consideration the 
four bulleted TSCA section 5(a)(2) factors listed in this unit.

V. Applicability of the Significant New Use Designation

    If uses begun after the proposed rule was published were considered 
ongoing rather than new, any person could defeat the SNUR by initiating 
the significant new use before the final rule was issued. Therefore, 
EPA has designated the date of publication of the proposed rule as the 
cutoff date for determining whether the new use is ongoing. Consult the 
Federal Register document of April 24, 1990 (55 FR 17376) for a more 
detailed discussion of the cutoff date for ongoing uses.
    Any person who began commercial manufacture or processing of the 
chemical substance identified as ethaneperoxoic acid, 1,1-
dimethylpropyl ester, (PMN P-85-680), for any of the significant new 
uses designated in the proposed SNUR modification after the date of 
publication of the proposed SNUR, must stop that activity before the 
effective date of the final rule. Persons who ceased those activities 
will have to first comply with all applicable SNUR notification 
requirements and wait until the notice review period, including any 
extensions, expires, before engaging in any activities designated as 
significant new uses. If a person were to meet the conditions of 
advance compliance under Sec.  [emsp14]721.45(h), the person would be 
considered to have met the requirements of the final SNUR for those 
activities.

VI. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development 
of any particular test data before submission of a SNUN. There are two 
exceptions:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section 
5(b)(4) listing covering the chemical substance, 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 (see Sec.  
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In this case, EPA recommends 
persons, before performing any testing, to consult with the Agency 
pertaining to protocol selection.
    The recommended testing specified in Unit II.A. of the proposed 
rule may not be the only means of addressing the potential risks of the 
chemical substance. However, SNUNs submitted 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 PMN or SNUN 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.

VII. SNUN Submissions

    According to Sec.  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 Sec.  720.50. SNUNs must be 
on EPA Form No. 7710-25, generated using e-PMN software, and submitted 
to the Agency in accordance with the procedures set forth in Sec. Sec.  
721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

VIII. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN requirements 
for potential manufacturers and processors of the chemical substance 
during the development of the direct final rule. The Agency's complete 
Economic Analysis is available in the docket under docket ID number 
EPA-HQ-OPPT-2012-0864.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action modifies a SNUR for a chemical substance that is the 
subject of a PMN and TSCA section 5(e) consent order. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993).

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 PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control 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. EPA has amended the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in this 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.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to 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

[[Page 46286]]

to average between 30 and 170 hours per response. 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

    On February 18, 2012, EPA certified pursuant to section 605(b) of 
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that 
promulgation of a SNUR does not have a significant economic impact on a 
substantial number of small entities where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUN submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
rule.
    This rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit VIII. 
and EPA's experience promulgating SNURs (discussed in the 
certification), EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300. Therefore, the promulgation of the SNUR 
would not have a significant economic impact on a substantial number of 
small entities.

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 will be impacted by this final rule. 
As such, EPA has determined that this final rule does 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) (Pub. L. 104-4).

E. Executive Order 13132

    This action will 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 final rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
final rule does not significantly nor uniquely affect the communities 
of Indian Tribal governments, nor does 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 9, 2000), do not apply 
to this final 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 action 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 and 
because this action is not a significant regulatory action under 
Executive Order 12866.

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).

X. Congressional Review Act (CRA)

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

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

    Dated: July 16, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

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

0
2. Amend Sec.  721.3020 as follows:
0
a. Revise the section heading.
0
b. Revise paragraphs (a)(1) and (a)(2)(i).
0
c. Remove and reserve paragraph (a)(2)(ii) and remove paragraphs 
(a)(2)(iii) and (iv).
0
d. Revise paragraph (b)(1).
0
e. Remove paragraph (b)(3).
    The revisions read as follows:

Sec.  721.3020  Ethaneperoxoic acid, 1,1-dimethylpropyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethaneperoxoic 
acid, 1,1-dimethylpropyl ester (PMN P-85-680; CAS No. 690-83-5) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=61).
    (ii) [Reserved]
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in

[[Page 46287]]

Sec.  721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
* * * * *
[FR Doc. 2013-18180 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P