[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2851-2853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01684]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0021; FRL-9989-21]
Extension of Review Periods Under the Toxic Substances Control
Act; Certain Chemicals and Microorganisms; Premanufacture, Significant
New Use, and Exemption Notices; Delay in Processing Due to Lack of
Authorized Funding
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Due to a partial Federal government shutdown related to the
lack of authorized funding (i.e., a Fiscal Year 2019 Appropriations
Bill or a Continuing Resolution), EPA is extending the review periods
for all Premanufacture Notices (PMNs), Significant New Use Notices
(SNUNs), Microbial Commercial Activity Notices (MCANs), and exemption
notices submitted to the Agency under section 5 of the Toxic Substances
Control Act (TSCA) received by EPA on or before December 29, 2018, and
for which the review period had not expired as of December 29, 2018.
Additionally, EPA did not receive notifications or process such
submissions on or after December 29, 2018, and before the date on which
the shutdown terminated on January 25, 2019, and the affected
operations for the TSCA New Chemicals Program fully resumed on January
31, 2019. Also, during the shutdown, submissions made through e-PMN/CDX
or other methods were not processed by EPA. Consequently, the review
period for any TSCA section 5 notice submitted during the shutdown did
not begin until TSCA New Chemical operations fully resumed on January
31, 2019.
DATES: The duration of this extension period is equivalent to the time
period from December 29, 2018 (i.e., the date on which EPA operations
shutdown) and the date on which EPA operations for the TSCA New
Chemicals Program fully resumed (i.e., January 31, 2019), or a total of
33 days.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Greg Schweer, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-8469; 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 are a
manufacturer (which includes importers) or processor of a chemical
substance that requires submission under section 5 of TSCA (15 U.S.C.
2604) and applicable EPA regulations. 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.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0021, 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.
Information on the shutdown can be found at http://www.opm.gov.
Information about the TSCA section 5 requirements can be found at
http://www.epa.gov/oppt/newchems/.
C. What is the Agency's authority for taking this action?
Under TSCA section 5(c), 15 U.S.C. 2604(c), EPA may unilaterally
extend the notice review period for PMNs, MCANs, and SNUNs, thereby
extending the period before manufacturing or processing the subject
chemical substances may begin. (See also 40 CFR 720.75(c) for PMNs and
SNUNs, and 40 CFR 725.56 for MCANs.) Section 26(c) of TSCA (15 U.S.C.
2625(c)), authorizes EPA to take action with respect to a category of
chemical substances; in this case, the category is all chemical
substances that are the subject of the specified notices and exemption
applications, for which the notice review period would otherwise expire
on or after December 29, 2018. Under TSCA section 5(c), extensions of
the review period for an individual TSCA section 5 notice shall not
total more than 90 days. Because the extension described in this
Federal Register notice (i.e., 33 days) is less than 90 days, EPA
reserves the right under TSCA section 5(c) to issue, for good cause,
future additional extensions for individual cases up to a total of 90
days.
Section 5(h) of TSCA (15 U.S.C. 2604(h)) authorizes EPA to exempt
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manufacturers and/or processors of chemical substances from all or part
of the requirements of section 5 of TSCA if EPA determines that the
proposed manufacture, processing, distribution in commerce, use, or
disposal of such chemical substance will not present an unreasonable
risk to health or the environment. Pursuant to this and other
authorities, EPA has concluded that the additional time specified in
this notice is required to evaluate the exemption applications
described in Unit II.A. and determine whether the chemical substances
that are the subject of these exemption applications will not present
an unreasonable risk.
II. Extension of Review Periods
A. Which TSCA review periods are affected?
Section 5 of TSCA and 40 CFR part 720 require any person who
intends to manufacture (defined by statute to include import) a new
chemical substance (i.e., a chemical not on the TSCA section 8(b)
Inventory) to notify EPA at least 90 days before commencing non-exempt
commercial manufacture in the form of a PMN. Similarly, at least 90
days advance notice for manufacture of new microorganisms is required
under 40 CFR part 725, in the form of an MCAN. Under section 5 of TSCA
and 40 CFR part 721, any person intending to manufacture or process a
chemical substance for a significant new use, as designated by EPA in a
SNUR, must also give EPA at least 90 days advance notice in the form of
a SNUN. SNURs for microorganisms appear at 40 CFR part 725, subpart M.
The required notifications initiate EPA's evaluation of the new
chemical or the intended significant new use within the applicable
review period. Persons may not commence manufacture of a new chemical
substance, or manufacture of processing of a chemical substance for a
significant new use, until EPA has conducted a review of the relevant
notice, made an appropriate determination on the notice, and has taken
such actions as are required with that determination.
There are several of exemptions from the above-described 90-day
PMN, MCAN, and SNUN notice requirements. Many of these exemptions
require submitting to EPA a written notice or application, which is
subject to a review period shorter than 90 days. For example, pursuant
to TSCA section 5(h)(1) EPA has promulgated a Test Market Exemption
(TME) from the PMN, MCAN, and SNUN 90-day notice requirements. The TME
from the PMN requirement appears at 40 CFR 720.38; the TME from the
MCAN requirement is codified in 40 CFR part 725, subpart F (40 CFR
725.300 through 725.370); and the TME from the SNUN requirement appears
at 40 CFR 721.45(a). Under TSCA section 5(h)(4), EPA promulgated at 40
CFR 723.50 a Low Volume Exemption (LVE) and a Low Release/Low Exposure
(LOREX) Exemption from the PMN requirement. The regulations at 40 CFR
part 725 pertaining to genetically engineered microorganisms provide
several exemptions from the 90-day MCAN requirement, including the TSCA
Experimental Release Application (TERA) at 40 CFR part 725, subpart E,
and the Tier I and Tier II Exemptions at 40 CFR part 725, subpart G.
B. What action is the Agency taking?
Effective December 29, 2018, due to the lack of authorized funding
(i.e., a Fiscal Year 2019 Appropriations Bill or a Continuing
Resolution), certain EPA functions were suspended. During the shutdown,
no review work was performed on the TSCA section 5 notifications
received by EPA on or before December 29, 2018, and for which the
review period had not yet expired as of December 29, 2018. Because of
the shutdown, EPA is now extending, pursuant to sections 5(c) and 26(c)
of TSCA and 40 CFR 720.75(c), the review periods of all TSCA section 5
notifications received on or before December 29, 2018, and for which
the review period has not yet expired as of December 29, 2018.
The Agency requires an extension of the review periods to complete
its risk assessments, to examine its regulatory options, and to prepare
the necessary documents associated with the relevant determination
under TSCA section 5(a)(3). Therefore, EPA has determined that good
cause exists to extend, under TSCA section 5(c), the review period for
each such TSCA section 5 notification.
The duration of this extension period is equivalent to the time
period from December 29, 2018 (i.e., the date on which EPA operations
shutdown) and the date on which EPA operations for the TSCA New
Chemicals Program fully resumed (i.e., January 31, 2019), or a total of
33 days. Although EPA reopened following the partial government
shutdown on January 28, 2019, EPA set January 31 as the day that normal
operations of the TSCA section 5 New Chemicals Program fully resumed.
These additional days beyond January 28 reflect the additional time
that was needed to ensure that: EPA data systems were fully
operational; EPA and contractor staff have ID badges, passwords and
access to systems were reset; EPA and contractor staff whose 1-year
approvals to access TSCA CBI expired during the shutdown were
reestablished; and contractor staff who were reassigned to other
contracts not affected by the shutdown were reassigned to contracts
supporting the New Chemicals Program.
Under TSCA section 5(c), the total extensions of the review period
for an individual PMN shall not exceed 90 days. Thus, since the
extension described in this notice is for less than 90 days, EPA
reserves the right to issue additional extensions under TSCA section
5(c) in the future for good cause up to a total of 90 days.
Because of these circumstances, EPA is taking the following actions
and is requesting the assistance of notifiers as described in this
unit:
Category 1--TSCA section 5 notices and exemptions submitted to EPA
on or after December 29, 2018, and before the date on which the
affected operations fully resumed on January 31, 2019. During the
shutdown, submissions made through e-PMN/CDX or other methods were not
processed. Consequently, the review period for any TSCA section 5
notice submitted during the shutdown did not begin until TSCA New
Chemicals Program operations fully resumed on January 31, 2019.
Category 2--TSCA section 5 exemption notices scheduled to expire on
or after December 29, 2018. For any exemption notices that have not
been granted by EPA and for which the review period was scheduled to
expire on or after December 29, 2018, EPA is hereby extending the
notice review period by 33 days (the number of days equivalent to the
duration of the shutdown until affected operations fully resumed). This
additional time is required to ensure there is sufficient opportunity
to determine that the chemical substances that are the subject of the
exemption applications will not present an unreasonable risk.
Category 3--TSCA section 5 PMNs, MCANs, and SNUNs scheduled to
expire on or after December 29, 2018. For any PMN, MCAN, or SNUN for
which the review period was scheduled to expire on or after December
29, 2018, EPA is hereby extending the notice review period by 33 days
(the number of days equivalent to the duration of the shutdown until
affected operations fully resumed).
C. Was this action submitted to Congress and the Comptroller General?
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before the Agency can impose binding requirements like
those contained in a rule, the Agency must
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submit a rule report, which includes a copy of the document, to each
House of the Congress and to the Comptroller General of the United
States. Although this document is not a rule, it is binding in the
sense that the suspensions announced in here are binding. EPA has
submitted a report to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to its publication in the Federal Register. This action is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
Environmental protection, Chemical, Microorganisms, Premanufacture
Notices, Test Marketing Exemptions.
Dated: February 1, 2019.
Lynn Vendinello, Acting,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2019-01684 Filed 2-7-19; 8:45 am]
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