[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Proposed Rules]
[Pages 18179-18181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06442]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2017-0575; FRL-10005-89]
RIN 2070-AB27
Revocation of Significant New Use Rule for a Certain Chemical
Substance (P-16-581)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke the significant new use rule (SNUR)
under the Toxic Substances Control Act (TSCA) for the chemical
substance identified generically as alpha 1,3-polysaccharide, which was
the subject of premanufacture notice (PMN) identified as P-16-581. EPA
issued a SNUR based on this PMN which designated certain activities as
significant new uses. EPA has received test data for the chemical
substance and is proposing to revoke the SNUR based on these new data.
DATES: Comments must be received on or before May 1, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0575, 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:
Kenneth Moss, 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 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
export notification rules under TSCA. 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 April 5, 2019 (84 FR 13531) (FRL-9991-
19), EPA promulgated a SNUR at 40 CFR 721.11193 for the chemical
substance identified generically as alpha 1,3-polysaccharide (P-16-
581). The SNUR designated certain activities as significant new uses.
EPA has received new data on the biosolubility of the chemical
substance. Based on its review of these data, EPA now proposes to
revoke the SNUR pursuant to 40 CFR 721.185. In this unit, EPA provides
a brief description of the chemical
[[Page 18180]]
substance, including the PMN number, generic chemical name, the Federal
Register publication date and reference, the docket number, the basis
for revoking the SNUR under 40 CFR 721.185, and the CFR citation of the
SNUR.
PMN Number: P-16-581
Chemical name: Alpha 1,3-polysaccharide (generic).
CAS number: Not available.
Federal Register publication date and reference: April 5, 2019 (84
FR 13531).
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 pose potential human health hazards.
Specifically, EPA identified a concern that adverse lung effects (i.e.,
lung overload) could occur if the chemical substance were manufactured,
processed, or used in a manner that generated respirable particles. To
address this hazard concern, EPA issued a SNUR under TSCA section
5(a)(2), which identified concerns for lung effects if the following
protective measures were not followed: (1) No use of the substance
other than the uses described in the PMN; and (2) no manufacture,
processing, or use with particle size less than 10 micrometers. EPA
also identified pulmonary effects toxicity testing as information
potentially useful to characterize the health effects of the PMN
substance. The PMN submitter performed biosolubility testing on the
ground PMN substance and provided the test data to EPA on February 14,
2019. EPA initiated an internal review of these data; however, it moved
forward with publishing the final SNUR on April 5, 2019 having not yet
completed its review. The following are the results and conclusions of
the Agency's review.
The biosolubility testing was conducted using a conservative
respiratory tract fluid volume of 0.3 mL/kg bw (rounded down to 20 mL
for a 70 kg individual). This equated to a loading concentration of 15
mg of the PMN substance per mL of simulated epithelial lung fluid
(SELF). The SELF represented the intraluminal volume of respiratory
tract fluid, without consideration of the daily turnover volume. The
estimated average alveolar fluid volume is approximately 37 mL, nearly
double the volume used for the biosolubility testing. In comparison,
the normal reference range for extra vascular lung water (EVLW) index
in humans is 7.3 2.8 mL/kg bw (n = 534) or 511 mL for a 70
kg individual. EVLW index corresponds to the ``sum of interstitial,
intracellular, alveolar, and lymphatic fluid, not including pleural
effusions.'' Therefore, the solubility of the PMN substance in SELF
represented a worst-case loading concentration for the PMN substance in
the intraluminal compartment, assuming an equivalent static volume of
20 mL. Given that humans accumulate respirable, poorly soluble
particles in the intra-alveolar, interstitial, subpleural, and broncho-
vascular bundle compartments, with a predominance of particles
eventually being found in the interstitium, the extrapolated in vitro
to in vivo concentration of the PMN substance would equal a loading
concentration of approximately 3 mg/mL of EVLW (i.e., 1,500 mg/(511 mL
for EVLW--37 mL for alveolar volume)) approximately 5 times lower than
the loading concentration tested in the biosolubility study.
This information supports EPA's determination that the substance
has inherently low toxicity and should not be considered a poorly
soluble particle with the associated hazard concern for lung overload.
Therefore, EPA proposes that the SNUR for this chemical substance be
revoked pursuant to 40 CFR 721.185(a)(1).
CFR citation: 40 CFR 721.11193
B. What is the agency's authority for taking this action?
Upon conclusion of the review for P-16-581, EPA designated certain
activities as significant new uses. Under 40 CFR 721.185, EPA may at
any time revoke 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 40 CFR 721.185(a)(1) through (a)(6). Revocation may occur on
EPA's initiative or in response to a written request. Under 40 CFR
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.
EPA has determined that the criteria set forth in 40 CFR
721.185(a)(1) have been satisfied for the chemical substance.
Therefore, EPA is proposing to revoke the SNUR for this chemical
substance. The significant new use notification and the recordkeeping
requirements at 40 CFR 721.11193 would terminate when this proposed
revocation becomes effective. In addition, export notification under
TSCA section 12(b) and 40 CFR part 707, subpart D triggered by the SNUR
would no longer be required.
III. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
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.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
The Office of Management and Budget (OMB) has exempted these types
of regulatory actions from review under Executive Orders 12866 (58 FR
51735, October 4, 1993) and 13563, entitled (76 FR 3821, January 21,
2011).
B. Paperwork Reduction Act (PRA)
This proposed rule does not contain any information collections
subject to approval under the PRA, (44 U.S.C. 3501 et seq.).
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b), 5 U.S.C. 601 et seq., the
Agency hereby that this SNUR revocation would not have a significant
economic impact on a substantial number of small entities. This
proposed rule would eliminate a reporting requirement.
D. Unfunded Mandates Reform Act (UMRA)
For the same reasons, this action does not require any action under
Title II of UMRA (2 U.S.C. 1531-1538 et seq.).
E. Executive Order 13132: Federalism
This proposed rule does not have 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 (64 FR 43255, August
10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This proposed rule does not have 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
[[Page 18181]]
responsibilities between the Federal Government and Indian Tribes, as
specified in Executive Order (65 FR 67249, November 9, 2000).
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
This action is not subject to Executive Order 13045 (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.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211 (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: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: March 5, 2020.
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).
Sec. 721.11193 [Removed]
0
2. Remove Sec. 721.11193.
[FR Doc. 2020-06442 Filed 3-31-20; 8:45 am]
BILLING CODE 6560-50-P