[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Rules and Regulations]
[Pages 55632-55635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22112]



40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2011-0941; FRL-9398-7]
RIN 2070-AB27

Significant New Use Rule on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is 
finalizing the significant new use rule (SNUR) for three chemical 
substances which were the subject of premanufacture notices (PMNs) and 
subject to a TSCA section 5(e) consent order issued by EPA. This action 
requires persons who intend to manufacture (including import) or 
process any of these three chemical substances 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. The required 
notification will 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 October 11, 2013.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2011-0941, 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 

    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].


I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this final rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers or processors of the 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 Sec.  721.5. If you 
have questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
    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 a 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 a SNUR under TSCA section 5(a)(2) for three 
chemical substances that were the subject of PMNs and subject to a TSCA 
section 5(e) consent order issued by EPA. The SNUR is codified at 40 
CFR 721.10515. The final SNUR designates as a significant new use 
manufacture (including import) or processing in the presence of the 
restrictions required in the consent order. The final SNUR for these 
substances is based on and consistent with the provisions in the 
underlying consent order. This final action requires persons who intend 
to manufacture or process the chemical substances 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 23, 
2013 (78 FR 4806) (FRL-6369-9). EPA received no public comments in 
response to the proposal for PMNs P-10-58, P-10-59, and P-10-60. 
Therefore, the Agency is issuing a final SNUR, as proposed that:
    1. Revises significant new use requirements for specific uses 
identified in the consent order.
    EPA did receive and comments on the remaining chemical substance in 
the proposed rule, PMN P-07-0204 (Sec.  721.10509), and will address 
that in a future, separate action.

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 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 
or process the chemical substance for that use. Persons who must report 
are described in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements,

[[Page 55633]]

and applicability of the final 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 Sec.  14;721.1(c), persons 
subject to these SNURs must comply with the same SNUN 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 sections 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 activities for which it has received 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.

III. Rationale and Objectives of the Final Rule

A. Rationale

    During review of the PMNs submitted for the three chemical 
substances, 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 the 
chemical substances. Based on these findings, a TSCA section 5(e) 
consent order requiring the use of appropriate exposure controls were 
negotiated with the PMN submitter. The SNUR provisions for these 
chemical substances are consistent with the provisions of the TSCA 
section 5(e) consent order. This SNUR is promulgated pursuant to Sec.  
14;721.160. See the docket under docket ID number EPA-HQ-OPPT-2011-0941 
for the corresponding consent orders.

B. Objectives

    EPA is issuing this final SNUR 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 final rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to regulate prospective manufacturers 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 section 5(e), 5(f), 6, or 7.
     EPA will ensure that all manufacturers and processors of 
the same chemical substance that is subject to a TSCA section 5(e) 
consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 

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 
     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 authorized EPA to consider any other relevant factors. To 
determine what would constitute a significant new use for the three 
chemical substances that are the subject of this SNUR, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and 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) (FRL-3658-5) 
for a more detailed discussion of the cutoff date for ongoing uses.
    Any person, who began commercial manufacture or processing of the 
chemical substances for any of the significant new uses designated in 
the proposed SNUR 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.  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 developing any 
particular test data before submission of a SNUN. The 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 
    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 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing.
    In the TSCA section 5(e) consent orders for the chemical substances 
regulated under this final rule, EPA has established restrictions in 
view of the lack of data on the potential health and environmental 
risks that may be posed by the significant new uses or increased 
exposure to the chemical substances. These restrictions will not be 
removed until EPA determines that the unrestricted use will not present 
an unreasonable risk of injury or result in significant or substantial 
exposure or environmental release. This determination is usually made 
based on the results of the required or recommended toxicity tests. In 
cases where EPA issued a TSCA section 5(e)

[[Page 55634]]

consent order that requires or recommends certain testing, Unit IV. of 
the proposed rule lists tests required or recommended in each of the 
section 5(e) consent orders underlying the proposed section 5(e) 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.
    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 notification 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 submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and Sec.  721.25. E-PMN software is 
available electronically at http://www.epa.gov/opptintr/newchems.

VIII. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances during the development of the direct final rule. EPA's 
complete economic analysis is available in the docket under docket ID 
number EPA-HQ-OPPT-2011-0941.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes a SNUR for three new chemical 
substances that were the subject of PMNs and a 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, 

B. Paperwork Reduction Act (PRA)

    According to 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 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 
Information Collection Request (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 to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
    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 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 
    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 (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(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 SNUR 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 
final rule.
    This final 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 (UMRA)

    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 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

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

[[Page 55635]]

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 (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA 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, 

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 final 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

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: September 3, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 

    Therefore, 40 CFR parts 9 and 721 are amended as follows:


1. 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.

2. In Sec.  9.1, add the following section in numerical order under the 
undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

                    40 CFR citation                      OMB Control No.
                                * * * * *
               Significant New Uses of Chemical Substances
                                * * * * *
721.10515..............................................       2070-0012
                                * * * * *

* * * * *


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

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

4. Add Sec.  [emsp14]721.10515 to subpart E to read as follows:

Sec.  [emsp14]721.10515  Partially fluorinated alcohol substituted 
glycols (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
partially fluorinated alcohol substituted glycols (PMN P-10-58, P-10-
59, and P-10-60) are 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(k) (manufacture and import of the PMN 
substances according to the chemical synthesis and composition section 
of the TSCA section 5(e) consent order, including analysis, reporting, 
and limitations of maximum impurity levels of certain fluorinated 
impurities; manufacture and import of P-10-58 and P-10-59 only as 
intermediates for the manufacture of P-10-60), and (q).
    (ii) [Reserved]
    (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), and (i) are applicable to manufacturers, 
importers, and processors of these substances, except the recordkeeping 
requirements for Sec.  721.125(b) and (c) do not apply to importers or 
processors when any one of the substances are contained in a 
formulation at less than 3 weight percent.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

[FR Doc. 2013-22112 Filed 9-10-13; 8:45 am]