Document ID: EPA-HQ-OPPT-2014-0649-0105
Agency: epa
Document Type: Rule
Title: Significant New Uses of Certain Chemical Substances; Modifications
Posted Date: 2015-11-13T05:00Z

[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Rules and Regulations]
[Pages 70171-70175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28844]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2014-0649; FRL-9935-43]
RIN 2070-AB27

Modification of Significant New Uses of Certain Chemical 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending the significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for five 
chemical substances which were the subject of premanufacture notices 
(PMNs). This action amends the SNURs to allow certain uses without 
requiring a significant new use notice (SNUN), and extends SNUN 
requirements to certain additional uses. EPA is amending these SNURs 
based on review of new data for each chemical substance. This action 
requires persons who intend to manufacture (including import) or 
process any of these chemical substances for an activity that is 
designated as a significant new use by this 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

[[Page 70172]]

prohibit or limit that activity before it occurs.

DATES: This final rule is effective January 12, 2016.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2014-0649, 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), West William Jefferson Clinton 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, 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 substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    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 modified 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 final rule 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.

II. Background

A. What action is the agency taking?

    In the Federal Register of April 9, 2015 (80 FR 19307) (FRL-9924-
10), EPA proposed amendments to the SNURs for 24 chemical substances in 
40 CFR part 721 subpart E. This action would require persons who intend 
to manufacture or process these chemical substances for an activity 
that is designated as a significant new use by these amended rules to 
notify EPA at least 90 days before commencing that activity. Receipt of 
such notices allows EPA to assess risks that may be presented by the 
intended uses and, if appropriate, to regulate the proposed use before 
it occurs. The proposed rule included 23 chemical substances where EPA 
determined, based on new information, there is no need to require 
additional notice from persons who propose to engage in identical or 
similar activities, or a rational basis no longer exists for the 
findings that activities involving the substance may present an 
unreasonable risk of injury to human health or the environment required 
under section 5(e)(1)(A) of the Act. The proposed rule also included a 
chemical substance, P-01-781, where EPA is modifying the chemical 
identity information. In the Federal Register of June 30, 2015 (80 FR 
37161) (FRL-9928-93), EPA issued amendments to the SNURs for 19 of 
those chemical substances in 40 CFR part 721 subpart E. EPA is now 
issuing a final SNUR amendment for the other five chemical substances. 
EPA received public comments for the proposed SNUR amendments for the 
remaining five chemical substances of the 24 included in the proposed 
rule subject to SNURs at 40 CFR 721.5575, 721.9675, and 721.10515. As 
described in Unit III., EPA is finalizing the SNURs as proposed for the 
SNURs at 40 CFR 721.9675, and 721.10515 and is finalizing the SNUR at 
40 CFR 721.5575 with one change. EPA is now amending the SNURs of these 
five chemical substances pursuant to 40 CFR 721.185.

B. What is the agency's authority for taking this action?

    Upon conclusion of the review of the five chemical substances in 
this SNUR amendment, EPA designated certain activities as significant 
new uses. Under Sec.  721.185, EPA may at any time amend a SNUR for a 
chemical substance which has been added to subpart E of 40 CFR part 721 
if EPA makes one of the determinations set forth in Sec.  721.185. 
Amendments may occur on EPA's initiative or in response to a written 
request. Under Sec.  721.185(b)(3), if EPA concludes that a SNUR should 
be amended, the Agency will propose the changes in the Federal 
Register, briefly describe the grounds for the action, and provide 
interested parties an opportunity to comment. Pursuant to Sec.  721.185 
and as described in Unit IV. of the proposed rule for the five chemical 
substances, EPA determined, based on new information, that there is no 
need to require additional notice from persons who propose to engage in 
identical or similar activities, or a rational basis no longer exists 
for the findings that activities involving the substance may present an 
unreasonable risk of injury to human health or the environment required 
under section 5(e)(1)(A) of the Act.

III. Response to Comments on Proposed SNURs

    Comment 1: One commenter stated that for the chemical substance 
subject to 40 CFR 721.5575 SNUR requirements should be excluded when 
the substance is incorporated or encapsulated in plastic as there would 
no longer be exposure.
    Response: EPA reviewed uses of the chemical substance during PMN/
SNUN reviews where it was incorporated or encapsulated into plastic. 
EPA estimated limited human and environmental exposures that were not 
expected to cause an unreasonable risk. Therefore, the final SNUR will 
remove from the scope of the SNUR any use where the chemical substance 
is incorporated or encapsulated into plastic.
    Comment 2: One commenter stated that, for the chemical substance 
subject to 40 CFR 721.9675, one of the SNUN submitters cited in the 
proposed rule was actually manufacturing a different chemical 
substance, which was instead the subject of P-06-0149 and a SNUR at 40 
CFR 721.10553.
    Response: Each of the SNUNs cited in the proposed SNUR modification 
were

[[Page 70173]]

submitted to EPA pertained to the chemical substance titanate 
[Ti6O13 (2-)], dipotassium, which is the chemical 
substance subject to 40 CFR 721.9675. But regardless of whether any of 
the SNUN submitters are manufacturing or processing a different 
chemical substance, any manufacturer and processor who is manufacturing 
potassium titanium oxide (which was the chemical substance submitted 
for P-06-149 and subject to the SNUR at 40 CFR 721.10553) is subject to 
the requirements of the SNUR at 40 CFR 721.10553.
    Comment 3: EPA proposed to modify the SNUR at 40 CFR 721.10515 to 
include P-10-184, because P-10-184 pertains to the same chemical 
substance as P-10-60, which is already the subject of 40 CFR 721.10515. 
A commenter asked EPA to clarify if the SNUR would require the PMN 
submitter of P-10-184 to conduct the same triggered testing required in 
the consent order for P-10-60.
    Response: The consent order for P-10-60 requires certain fate and 
physical property testing to be conducted at five different aggregate 
production volume limits. The consent order for P-10-184 does not 
require any testing to be conducted by production volume limits. The 
SNUR, however, requires notification before exceeding the manufacture 
of the five aggregate production volume limits. While the SNUR does not 
require the submitter of P-10-184, or any other manufacturer, to 
conduct testing, the SNUR does require that a SNUN be submitted before 
exceeding the aggregate production volume limit. If EPA receives a SNUN 
from the submitter of P-10-184, or any other manufacturer, EPA will 
then determine what testing, if any, would be required. This could be 
the testing required in the consent order for P-10-60 or other 
appropriate testing. This is the same procedure EPA uses for SNURs of 
consent orders with testing requirements at certain production volume 
or time limits.

IV. Applicability of the 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. As discussed in the Federal Register issue of April 
24, 1990 (55 FR 17376) (FRL-3658-5), EPA has decided that the intent of 
TSCA section 5(a)(1)(B) is best served by designating a use as a 
significant new use as of the date of publication of the proposed SNUR 
rather than as of the effective date of the final rule. If uses begun 
after publication 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 proposed significant new 
use before the rule became effective, and then argue that the use was 
ongoing as of the effective date of the final rule.
    Thus, any persons who begin commercial manufacture or processing 
activities with the chemical substances that are not currently a 
significant new use under the current rule but which would be regulated 
as a ``significant new use'' when this rule is finalized, 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.

V. 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. The two 
exceptions are:
    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 40 CFR 
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. To access the OCSPP test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' The 
Organisation for Economic Co-operation and Development (OECD) test 
guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. ASTM 
International standards are available at http://www.astm.org/Standard/index.shtml.
    The recommended testing specified in Unit IV. 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.

VI. SNUN Submissions

    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 
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.

VII. Economic Analysis

    EPA evaluated the potential costs of SNUN requirements for 
potential manufacturers and processors of the chemical substances in 
the rule. The Agency's complete Economic Analysis is available in the 
docket under docket ID number EPA-HQ-OPPT-2014-0649.

VIII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action will modify SNURs for five chemical substances that 
were the subject of PMNs. 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).

[[Page 70174]]

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 
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 comment.
    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 
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 (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 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 VI 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 rule would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the UMRA sections 202, 203, 204, or 205 (2 
U.S.C. 1501 et seq.).

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 rule would not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This rule 
would 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 
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, 
1994).

IX. 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.

[[Page 70175]]

    Dated: November 2, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, 40 CFR chapter I 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.  721.5575 by revising paragraphs (a)(1) and (a)(2)(iii) 
to read as follows:

Sec.  721.5575  Oxirane, 2,2'-(1,6-hexanediylbis (oxymethylene)) bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2,2'-(1,6-
hexanediylbis(oxymethylene))bis- (PMN P-88-2179; PMN P-89-539; and SNUN 
S-08-3; CAS No. 16096-31-4) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The reporting requirements of this rule do not apply once the 
chemical substance has been incorporated or encapsulated into plastic.
    (2) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). A significant new use of the chemical 
substance is any commercial use other than the commercial use described 
in S-08-3.
* * * * *

0
3. Amend Sec.  721.9675 by revising paragraphs (a)(1) and (a)(2)(i), 
remove and reserve paragraph (a)(2)(ii), and revise paragraph (b)(1).
    The revisionso read as follows:

Sec.  721.9675  Titanate [Ti6O13 (2-)], 
dipotassium.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as titanate 
[Ti6O13 (2-)], dipotassium (PMN P-90-226; SNUNs 
P-96-1408, S-08-6, S-09-4, and S-13-49; CAS No. 12056-51-8)) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f) and (l). In addition, a significant 
new use of the substance is importation of the chemical substance if:
    (A) Manufactured by other than the method described in 
premanufacture notice P-90-226 and significant new use notices P-96-
1408, S-08-6, S-09-4, and S-13-49.
    (B) Manufactured producing respirable, acicular fibers with an 
average aspect ratio of greater than 5. The average aspect ratio is 
defined as the ratio of average length to average diameter.
* * * * *
    (b) * * *
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers and processors of this substance as 
specified in Sec.  721.125 (a), (b), (c) and (i).
* * * * *

0
4. Amend Sec.  721.10515 by revising paragraphs (a)(1) and (a)(2)(i) to 
read as follows:

Sec.  721.10515  Partially fluorinated alcohol substituted glycols 
(generic).

    (a) * * *
    (1) The chemical substances identified generically as partially 
fluorinated alcohol substituted glycols (PMNs P-10-58, P-10-59, P-10-
60, and P-10-184) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture 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-10-60 and P-10-184 other than 
when the mean number of moles of the ethoxy group is between 3 and 11 
or the average number molecular weight is between 496 and 848 daltons 
based on the amounts of raw materials charged to the reactor; 
manufacture and import of P-10-58 and P-10-59 only as intermediates for 
the manufacture of P-10-60), and (q).
* * * * *
[FR Doc. 2015-28844 Filed 11-12-15; 8:45 am]
 BILLING CODE 6560-50-P