[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Proposed Rules]
[Pages 35585-35586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15605]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2013-0399; FRL-9991-17]
RIN 2070-AB27
Proposed Revocation of Significant New Use Rule for Fatty Acid
Amide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke the significant new use rule (SNUR)
promulgated under the Toxic Substances Control Act (TSCA) for a
chemical substance which was identified generically as fatty acid amide
which was the subject of premanufacture notice (PMN) P-13-267. EPA
issued a SNUR based on the PMN designating certain activities as
significant new uses. EPA has received a significant new use notice
(SNUN) and test data for the chemical substance and is proposing to
revoke the SNUR based on the information in the submission.
DATES: Comments must be received on or before August 23, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2013-0399, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
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: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is 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:[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].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import), process, or use the chemical substance contained in
this rule. Potentially affected entities may include, but are not
limited to:
Manufacturers or processors of the 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 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. Importers
of the chemical, the subject of this action, would no longer be
required to certify compliance with the SNUR requirements if the
revocation becomes effective. In addition, if this proposed SNUR
revocation becomes effective, persons who export or intend to export
the chemical that is the subject of this action would no longer be
subject to the TSCA section 12(b) (15 U.S.C. 2611(b) export
notification requirements at 40 CFR part 707, that are currently
triggered by the SNUR.
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 email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the agency taking?
In the Federal Register of August 7, 2013 (78 FR 48051) (FRL-9393-
4), EPA promulgated a SNUR at Sec. 721.10691 for the chemical
substance identified generically as fatty acid amide (PMN P-13-267).
The SNUR designated release to water resulting in concentrations
greater than 1 part per billion as a significant new use. EPA has
received a SNUN that included human health and environmental toxicity
testing for the chemical substance and, based on its review of these
data, EPA now proposes to revoke the SNUR pursuant to Sec. 721.185. In
this unit, EPA provides a brief description of the chemical substance,
including the PMN and SNUN numbers, generic chemical name, the Federal
Register publication date and reference, the docket number, the basis
for revoking the SNUR under Sec. 721.185, and the CFR citation of the
SNUR.
PMN Number P-13-267 and SNUN S-15-9
Chemical name: Fatty acid amide (generic).
[[Page 35586]]
CAS number: Not available.
Federal Register publication date and reference: August 7, 2013 (78
FR 48051).
Basis for revocation of SNUR: EPA issued a SNUR for this substance
that designated certain activities as significant new uses based on a
finding that the substance may cause significant adverse environmental
effects and met the concern criteria at Sec. 721.170(b)(4)(ii). The
SNUR required notification before any use of the substance resulting in
surface water concentrations exceeding 1 part per billion (ppb).
Subsequently, a manufacturer of the substance submitted a SNUN to allow
surface water concentrations exceeding 1 ppb. Acute and chronic
toxicity values measured for fish, aquatic invertebrates, and algae in
the submitted data all demonstrated no effects at saturation in the
aqueous environment. In addition, the chronic toxicity value measured
for sediment-dwelling invertebrates is >788 milligrams/kilogram (mg/kg)
dry weight (Lowest Observed Effect Concentration). Test data on the
chemical substance were negative for the following human health
hazards: Mutagenicity, irritation to the eyes and skin, and skin
sensitization. A No-Observed Adverse Effect Level of 1,000 mg/kg-
bodyweight (bw)/day was identified based on no treatment-related
adverse effects at the highest dose tested in a 28-day oral repeated-
dose toxicity study (OECD Test Guideline 407). Based on the results of
the testing, EPA determined that the substance has inherently low
toxicity. The studies are available in the public docket. As a result,
EPA made a determination of not likely to present an unreasonable risk
under TSCA section 5(a)(3)(C) for the SNUN. EPA concludes that the
substance does not meet the criteria under Sec. 721.170(b). Therefore,
EPA proposes that the SNUR for these chemical substances be revoked
pursuant to Sec. 721.185(a)(4).
CFR citation: 40 CFR 721.10691.
B. What is the Agency's authority for taking this action?
Under Sec. 721.185, EPA may at any time revoke a SNUR for a
chemical substance which has been added to subpart E of Sec. 721 if
EPA makes one of the determinations set forth in Sec. 721.185(a)(1)
through (a)(6). Revocation 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 revoked, 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.
III. Statutory and Executive Order Reviews
This proposed rule would revoke or eliminate an existing regulatory
requirement and does not contain any new or amended requirements. As
such, the Agency has determined that this proposed SNUR revocation
would not have any adverse impacts, economic or otherwise.
The Office of Management and Budget (OMB) has exempted these types
of regulatory actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
proposed rule does not contain any information collections subject to
approval under the Paperwork Reduction Act (PRA), (44 U.S.C. 3501 et
seq.). Since this proposed rule eliminates a reporting requirement, the
Agency certifies pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this SNUR revocation
would not have a significant economic impact on a substantial number of
small entities.
For the same reasons, this action does not require any action under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4). This proposed rule has neither Federalism implications, because
it would not have substantial direct effects 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), nor Tribal implications, because it
would not have substantial direct effects on one or more Indian Tribes,
on the relationship between the Federal Government and Indian Tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian Tribes, as specified in Executive Order
13175 entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000).
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 under Executive Order 12866,
and it does not address environmental health or safety risks
disproportionately affecting children. This action is not subject to
Executive Order 1311, 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. Because 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. This action does
not involve special considerations of environmental justice related
issues as required by Executive Order 12898 entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 11, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be 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. Remove Sec. 721.10691.
Sec. 721.10691 [Removed]
[FR Doc. 2019-15605 Filed 7-23-19; 8:45 am]
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