
[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: 
schweer.greg@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. 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]
 BILLING CODE 6560-50-P


