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, 2851-2853 [2019-01684]

Download as PDF Federal Register / Vol. 84, No. 27 / Friday, February 8, 2019 / Notices ENVIRONMENTAL PROTECTION AGENCY 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. [EPA–HQ–OPPT–2019–0021; FRL–9989–21] SUPPLEMENTARY INFORMATION: the Agency’s Strategic Plan focus on vulnerable populations, as well as the interagency Federal Lead Action Plan. Finally, the public is invited to propose any other areas for consideration as new NCIs. E. Public Comments The EPA will consider all comments to these proposals as it moves forward in the decision-making process. NCIs will be incorporated into the EPA Office of Enforcement and Compliance Assurance FY 2020–2021 National Program Guidance (NPG) that provides national program direction for all EPA regional offices. Information in support of this Notice of Public Comment is available online at: http://www.epa.gov/ enforcement/national-complianceinitiatives. VI. Can the deadline for comments be extended? The EPA will include NCIs in the Office of Enforcement and Compliance Assurance (OECA) draft NPG that will be released for public comment to allow the EPA regions, as well as states and federally-recognized tribes with approved programs, to consider the guidance fully in their annual planning processes that direct the use of resources according to the fiscal calendar. As a result, EPA must receive public comments on potential NCIs by March 11, 2019 in order to complete consideration of NCIs before the NPG is released for public comment. However, the public will have a second opportunity to provide comments on the NCIs when commenting on OECA’s draft NPG. Dated: December 20, 2018. Susan Parker Bodine, Assistant Administrator, Office of Enforcement and Compliance Assurance. [FR Doc. 2019–01548 Filed 2–7–19; 8:45 am] amozie on DSK3GDR082PROD with NOTICES1 BILLING CODE 6560–50–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: Due to a partial Federal government shutdown related to the SUMMARY: VerDate Sep<11>2014 17:18 Feb 07, 2019 Jkt 247001 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 2851 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 E:\FR\FM\08FEN1.SGM 08FEN1 2852 Federal Register / Vol. 84, No. 27 / Friday, February 8, 2019 / Notices 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. amozie on DSK3GDR082PROD with NOTICES1 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; VerDate Sep<11>2014 17:18 Feb 07, 2019 Jkt 247001 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 90day 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- PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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 E:\FR\FM\08FEN1.SGM 08FEN1 Federal Register / Vol. 84, No. 27 / Friday, February 8, 2019 / Notices 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 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OAR–2007–0358; FRL–9988–84– OAR] Proposed Agency Information Collection Request; Comment Request; Responsible Appliance Disposal Program (Renewal) Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ‘‘EPA’s Responsible Appliance Disposal (RAD) Program (Renewal)’’ (EPA ICR No. 2254.02, OMB Control No. 2060– 0703) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through August 31, 2019. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. DATES: Comments must be submitted on or before April 9, 2019. ADDRESSES: Submit your comments, referencing Docket ID No. EPA–HQ– OAR–2007–0358, online using www.regulations.gov (our preferred method), by email to a-and-r-docket@ amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:18 Feb 07, 2019 Jkt 247001 epa.gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA’s policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. FOR FURTHER INFORMATION CONTACT: Sally Hamlin, Stratospheric Protection Division, Office of Atmospheric Programs (Mail Code 6205T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 343– 9711; fax number: (202) 343–2362; email address: Hamlin.Sally@epa.gov. SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202–566–1744. For additional information about EPA’s public docket, visit https://www.epa.gov/dockets. Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., allowing electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 2853 Abstract: The Responsible Appliance Disposal Program (RAD) is a voluntary partnership program sponsored by the Environmental Protection Agency (EPA) that reduces emissions of ozone depleting substances (ODS) that can be attributed to improper disposal of appliances. Appliances can contain ozone depleting refrigerants and foams as well as universal wastes such as mercury, used oil, and polychlorinated biphenyls (PCB). Federal law requires refrigerant recovery and proper management of universal waste but does not require the recovery of appliance foam. In addition to being ODS, foam blowing agents and refrigerants in appliances may also have high global warming potentials (GWPs). The RAD program works with utilities, retailers, manufacturers, state agencies, affiliates, and others to dispose of appliances using best environmental practices. Form Numbers: 5900–32 Respondents/affected entities: The following is a list of North American Industry Classification System (NAICS) codes for organizations potentially affected by the information requirements covered under this ICR are: 2211 Utilities 3352 Manufacturers 443141 Retailers 611310 Universities 999300 State/Municipality Respondent’s obligation to respond: Voluntary. Estimated number of respondents: 48 (over three years). Frequency of response: Annual, and when desired. Total estimated burden: 292 hours (per year). Burden is defined at 5 CFR 1320.03(b). Total estimated cost: $36,753 (per year), includes $0 annualized capital or operation & maintenance costs. Changes in estimates: There is a decrease of 33 hours in the total estimated respondent burden compared with the 325 hours for the ICR currently approved by OMB. This decrease is due in part to a decrease in the number of respondents due to recycling industry changes, as well as a reduction in the number of partners participating in the program each year. Dated: December 14, 2018. Cynthia A. Newberg, Director, Stratospheric Protection Division. [FR Doc. 2019–01536 Filed 2–7–19; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\08FEN1.SGM 08FEN1

Agencies

[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.

-----------------------------------------------------------------------

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

[[Page 2852]]

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

[[Page 2853]]

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