Document ID: EPA-HQ-OPPT-2011-0308-0001
Agency: epa
Document Type: Notice
Title: 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
Posted Date: 2013-10-28T04:00Z

[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Pages 64210-64211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25386]

[[Page 64210]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2011-0308; FRL-8869-3]

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 the federal government shutdown related to the lack of 
authorized funding (i.e., a Fiscal Year 2014 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 October 1, 2013, and for which 
the review period had not expired as of October 1, 2013. Additionally, 
EPA did not receive notifications with respect to such submissions on 
or after October 1, 2013, and before the date on which the shutdown 
terminated on October 16, 2013, and the affected operations resumed on 
October 17, 2013. 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 operations resumed on October 17, 2013.

DATES: The duration of this extension period is equivalent to the 
duration of the shutdown, i.e., 16 days (equivalent to the number of 
days accruing from October 1, 2013 to October 16, 2013).

FOR FURTHER 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.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this document apply to me?

    You may be affected by this document if you are, or may in the 
future be, a manufacturer, importer, or processor of a chemical 
substance that requires submission of a PMN, MCAN, SNUN, or exemption 
notice under section 5 of TSCA (15 U.S.C. 2604) and applicable EPA 
regulations. Potentially affected entities may include:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    The North American Industrial Classification System (NAICS) codes 
listed are not intended to be exhaustive, but rather provides a guide 
to help readers determine whether this document applies to them.
    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 person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How can I get additional information?

    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 has authority for 
good cause to 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.) TSCA 
section 26(c), 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 received before October 1, 
2013, for which the notice review period would otherwise expire on or 
after October 1, 2013. 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., 16 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.
    TSCA section 5(h), 15 U.S.C. 2604(h), authorizes EPA to exempt 
manufacturers and/or processors of chemical substances from all or part 
of the requirements of section 5 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. 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.
    There are a number of exemptions from the above-described 90-day 
PMN, MCAN, and SNUN notice requirements. Several 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,

[[Page 64211]]

and the Tier I and Tier II Exemptions at 40 CFR part 725, subpart G.

B. What action is the agency taking?

    Effective October 1, 2013, due to the lack of authorized funding 
(i.e., a Fiscal Year 2014 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 October 1, 2013, and for which the review 
period had not yet expired as of October 1, 2013. Because of the 
shutdown, EPA is now extending, pursuant to TSCA sections 5(c) and 
26(c) and 40 CFR 720.75(c), the review periods of all TSCA section 5 
notifications received on or before October 1, 2013, and for which the 
review period has not yet expired as of October 1, 2013.
    There is a possibility that the chemical substances submitted for 
review in these TSCA section 5 notifications may need to be regulated 
by EPA under TSCA. The Agency requires an extension of the review 
periods to complete its risk assessment, to examine its regulatory 
options, and to prepare the necessary documents, should regulatory 
action be required. 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 duration 
of the shutdown, i.e., equivalent to the number of days accruing from 
October 1, 2013, and the date on which this shutdown terminated on 
October 16, 2013, and EPA operations resumed on October 17, 2013, or a 
total of 16 days. Under TSCA section 5(c), the total extensions of the 
review period for an individual PMN shall in no event 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 October 1, 2013, and before the date on which the affected 
operations resumed on October 17, 2013. 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 operations resumed on October 
17, 2013.
    Category 2--TSCA section 5 exemption notices scheduled to expire on 
or after October 1, 2013. For any exemption notices that have not been 
granted by EPA and for which the review period was scheduled to expire 
on or after October 1, 2013, EPA is hereby extending the notice review 
period by 16 days (the number of days equivalent to the duration of the 
shutdown). 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 October 1, 2013. For any PMN, MCAN, or SNUN for 
which the review period was scheduled to expire on or after October 1, 
2013, EPA is hereby extending the notice review period by 16 days (the 
number of days equivalent to the duration of the shutdown).

C. Congressional Review Act

    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 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 suspension of the 
review periods announced in this document 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 publication of this document in the Federal Register.

List of Subjects

    Environmental protection, Chemicals, Microbial Commercial Activity 
Notices, Microorganisms, Premanufacture Notices, Significant New Use 
Notices, Test Marketing Exemptions.

    Dated: October 21, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2013-25386 Filed 10-25-13; 8:45 am]
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