[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Rules and Regulations]
[Pages 30206-30210]
[FR Doc No: 2021-11840]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0138; FRL-10023-34]

Cellulose, Ethyl Ether; Exemption From the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of cellulose, ethyl ether; number average
molecular weight 13,000 Daltons when used as an inert ingredient in a
pesticide chemical formulation. Exponent, Inc. on behalf of Nutrition &
Biosciences USA 1, LLC, formerly DDP Specialty Electronic Materials US,
Inc. submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a

tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of cellulose, ethyl ether on food or
feed commodities.

DATES: This regulation is effective June 7, 2021. Objections and
requests for hearings must be received on or before August 6, 2021, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2021-0138. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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. 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 electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0138 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
August 6, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2021-0138, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a notification pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11484) filed by Exponent, Inc., 1150 Connecticut Ave. NW, Suite 1100,
Washington, DC 20036 on behalf of Nutrition & Biosciences USA 1, LLC,
3490 Winton Place, Rochester, NY 14623 formerly DDP Specialty
Electronic Materials US, Inc., 400 Arcola Road, Collegeville, PA 19426.
The petition requested that 40 CFR 180.960 be amended by establishing
an exemption from the requirement of a tolerance for residues of
cellulose, ethyl ether; CAS Reg. No. 9004-57-3. That notification
included a summary of the petition prepared by the petitioner and
solicited comments on the petitioner's request. The Agency did not
receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a

reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). cellulose, ethyl ether conforms to the
definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the Toxic Substances Control Act
(TSCA) Chemical Substance Inventory or manufactured under an applicable
TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40 CFR
723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria: Specified in 40 CFR 723.250(e):
    The polymer's number average MW is greater than or equal to 10,000
daltons. The polymer contains less than 2% oligomeric material below MW
500 and less than 5% oligomeric material below MW 1,000.
    Thus, cellulose, ethyl ether meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to cellulose, ethyl ether.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that cellulose, ethyl ether could be present
in all raw and processed agricultural commodities and drinking water,
and that non-occupational non-dietary exposure was possible. The number
average MW of cellulose, ethyl ether is 13,000 daltons. Generally, a
polymer of this size would be poorly absorbed through the intact
gastrointestinal tract or through intact human skin. Since cellulose,
ethyl ether conform to the criteria that identify a low-risk polymer,
there are no concerns for risks associated with any potential exposure
scenarios that are reasonably foreseeable. The Agency has determined
that a tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' EPA has not found cellulose, ethyl
ether to share a common mechanism of toxicity with any other
substances, and cellulose, ethyl ether does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that cellulose, ethyl
ether does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of cellulose, ethyl ether,
EPA has not used a safety factor analysis to assess the risk. For the
same reasons the additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of cellulose, ethyl ether.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as

required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint
U.N. Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for cellulose, ethyl ether.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of cellulose, ethyl
ether from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these rules from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this final rule has been exempted from
review under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it involve any technical standards that
would require Agency consideration of voluntary consensus standards
pursuant to section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes, or otherwise have any unique
impacts on local governments. Thus, the Agency has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not
apply to this final rule. In addition, this final rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).
    Although this action does not require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this rule in the Federal
Register. This rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 28, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, amend the table by adding in alphabetical order
the polymer ``Cellulose, ethyl ether, minimum number average molecular
weight (in amu), insert 13,000 Daltons'' to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Cellulose, ethyl ether, minimum number average molecular       9004-57-3
 weight (in amu), insert 13,000 Daltons.................

                              * * * * * * *
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[FR Doc. 2021-11840 Filed 6-4-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 31, 2008 (Volume 73, Number 21)]
[Notices]
[Page 5884-5885]
[DOCID:fr31ja08-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-28134]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

January 25, 2008.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
January 2008. A copy of each application may be obtained for a fee at
the SEC's Public Reference Branch (tel.<PHONE_NUMBER>). An order
granting each application will be issued unless the SEC orders a
hearing. Interested persons may request a hearing on any application by
writing to the SEC's Secretary at the address below and serving the
relevant applicant with a copy of the request, personally or by mail.
Hearing requests should be received by the SEC by 5:30 p.m. on February
19, 2008, and should be accompanied by proof of service on the
applicant, in the form of an affidavit or, for lawyers, a certificate
of service. Hearing requests should state the nature of the writer's
interest, the reason for the request, and the issues contested. Persons
who wish to be notified of a hearing may request notification by
writing to the Secretary, U.S. Securities and Exchange Commission, 100
F Street, NE., Washington, DC 20549-1090.

For Further Information Contact: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Zacks Series Trust

[File No. 811-9549]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant has never made a public offering of
its securities and does not propose to make a public offering or engage
in business of any kind.
    Filing Dates: The application was filed on November 8, 2007, and
amended on January 11, 2008.
    Applicant's Address: 100 N. Riverside Plaza, Suite 2200, Chicago,
IL 60606.

Van Kampen Income Trust

[File No. 811-5273]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On June 25,
2007, applicant made a final liquidating distribution to its
shareholders, based

on net asset value. Expenses of $4,500 incurred in connection with the
liquidation were paid by applicant.
    Filing Date: The application was filed on December 14, 2007.
    Applicant's Address: 522 Fifth Ave., New York, NY 10036.

BlackRock S&P 500 (R) Protected Equity Fund, Inc.

[File No. 811-9479]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On November
21, 2007, applicant made a liquidating distribution to its
shareholders, based on net asset value. Expenses of $37,425 incurred in
connection with the liquidation were paid by BlackRock Advisors, LLC
(``BlackRock''), applicant's investment adviser. On November 28, 2007,
assets of $257,156, representing an amount due to applicant, and an
offsetting liability in the same amount, representing monies advanced
to applicant for distribution to shareholders by BlackRock, were
transferred to BSP Liquidating Trust, resulting in applicant having no
assets or liabilities as of that date.
    Filing Date: The application was filed on December 19, 2007.
    Applicant's Address: c/o BlackRock Advisors, LLC, 100 Bellevue
Parkway, Wilmington, DE 19809.

USAA Mutual Fund, Inc.

[File No. 811-2429]

USAA Tax Exempt Fund, Inc.

[File No. 811-3333]

USAA Investment Trust

[File No. 811-4019]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On July 31, 2006, each applicant
transferred its assets to USAA Mutual Funds Trust, based on net asset
value. Expenses of $1,680,029, $272,077 and $650,851, respectively,
incurred in connection with the reorganizations were paid by each
applicant.
    Filing Dates: The applications were filed on December 14, 2007.
    Applicants' Address: 9800 Fredericksburg Rd., A-3-W, San Antonio,
TX 78288.

Sit Mutual Funds Trust

[File No. 811-21447]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 31, 2007, applicant transferred its
assets to Sit Tax-Free Income Fund, a series of Sit Mutual Funds II,
Inc., based on net asset value. Expenses of $22,795 incurred in
connection with the reorganization were paid by Sit Investment
Associates, Inc., applicant's investment adviser.
    Filing Dates: The application was filed on November 8, 2007, and
amended on January 7, 2008.
    Applicant's Address: Sit Mutual Funds, 3300 IDS Center, 80 South
8th St., Minneapolis, MN 55402.

Mezzacappa Long/Short Fund, LLC

[File No. 811-21469]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant is
not presently making a public offering of its securities and does not
propose to make a public offering. Applicant will continue to engage in
its regular business activities and will operate in reliance on section
3(c)(7) of the Act.
    Filing Dates: The application was filed on November 21, 2007 and
amended on December 21, 2007.
    Applicant's Address: 630 Fifth Ave., New York, NY 10111.

MDT Funds

[File No. 811-21141]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 17, 2006 and December 8, 2006,
applicant transferred its assets to corresponding series of Federated
MDT Series, based on net asset value. Expenses of approximately
$1,358,297 incurred in connection with the reorganization were paid by
Federated Investors, Inc., the parent of the surviving fund.
    Filing Dates: The application was filed on November 13, 2007, and
amended on December 21, 2007.
    Applicant's Address: Federated Investors Tower, 5800 Corporate Dr.,
Pittsburgh, PA 15237-7010.

The Jhaveri Trust

[File No. 811-8974]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant is not currently making a public
offering of its securities and does not propose to make a public
offering. Applicant has fewer than one hundred beneficial owners and
will continue to operate as a private investment vehicle in reliance on
section 3(c)(1) of the Act.
    Filing Dates: The application was filed on December 29, 2006, and
amended on March 5, 2007, and January 24, 2008.
    Applicant's Address: 27881 Clemens Rd., Westlake, OH 44145.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-1687 Filed 1-30-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Pages 78923-78928]
[FR Doc No: 2016-27212]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0655; FRL-9953-82]

2-Pyrrolidinone, 1-butyl-; Exemption From the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2-pyrrolidinone, 1-butyl- (CAS Reg. No.
3470-98-2) when used as an inert ingredient (solvent/cosolvent) in
pesticide formulations applied to growing crops only at a concentration
not to exceed 30% by weight under EPA regulations. SciReg. Inc. on
behalf of Taminco U.S., Inc. a subsidiary of Eastman Chemical Company
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting the establishment of an exemption from the
requirement of a tolerance. This rule eliminates the need to establish
a maximum permissible level for residues of 2-pyrrolidinone, 1-butyl-
when used in accordance with the regulations.

DATES: This regulation is effective November 10, 2016. Objections and
requests for hearings must be received on or before January 9, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0655, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0655 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 9, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0655, 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 CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 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.

II. Petition for Exemption

    In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-
9935-29), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10854) by SciReg Inc. (12733 Director's Loop, Woodbridge, VA 22192) on
behalf of Taminco U.S., Inc.

a subsidiary of Eastman Chemical Company (Two Windsor Plaza, Suite 400,
7540 Windsor Drive, Allentown, PA 18195). The petition requested that
40 CFR 180.920 be amended by establishing an exemption from the
requirement of a tolerance for residues of 2-pyrrolidinone, 1-butyl-
(CAS Reg. No. 3470-98-2), when used as an inert ingredient (solvent/
cosolvent) in pesticide formulations applied to growing crops only.
That document referenced a summary of the petition prepared by SciReg.
Inc. on behalf of Taminco U.S., Inc., the petitioner, which is
available in the docket, http://www.regulations.gov. No relevant
comments were received on the notice of filing.
    Based upon review of the data supporting the petition, EPA has
limited the concentration of 2-pyrrolidinone, 1-butyl- in final
pesticide formulation not to exceed 30% w/w. This limitation is based
on the Agency's risk assessment which can be found at http://www.regulations.gov in document Human Health Risk Assessment and
Ecological Effects Assessment to Support Proposed Exemption from the
Requirement of a Tolerance When Used as an Inert Ingredient in
Pesticide Formulations in docket ID number EPA-HQ-OPP-2015-0655.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for 2-pyrrolidinone, 1-butyl-
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with 2-
pyrrolidinone, 1-butyl- follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by 2-pyrrolidinone, 1-butyl- as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
this unit.
    The oral LD50 for 2-pyrrolidinone, 1-butyl- in the rat
is greater than 300 mg/kg. The dermal LD50 in the rat is >
2,000 mg/kg. It is moderately irritating to the eye of New Zealand
White rabbits. It is slightly irritating to the skin of New Zealand
White rabbits. It is not a skin sensitizer in mice in the local lymph
node assay.
    A 90-day subchronic oral toxicity study was conducted with Wistar
rats exposed to 2-pyrrolidinone, 1-butyl- via gavage dose of 0, 10,
100, and 500 mg/kg/day, according to OECD Test Guideline 408. The
following effects were considered to be treatment-related and adaptive
in nature and, therefore, not adverse:
    1. The microscopic liver changes in animals of either sex treated
with 500 mg/kg/day and males treated with 100 mg/kg/day; however, these
changes were not associated with blood chemistry changes. Therefore
they were considered as an adaptive response.
    2. The microscopic changes in the adrenals of males treated with
500 and 100 mg/kg/day and the microscopic thymus changes were not
associated with any changes in the organ weights, therefore they were
not considered as adverse effects. Minor changes in the kidney weights
were not associated with any clinical chemistry changes or treatment
related histopathological findings; therefore, it was not considered
adverse. The NOAEL is 500 mg/kg/day.
    A prenatal development toxicity study was conducted with 2-
pyrrolidinone, 1-butyl-, in accordance with OECD Test Guideline 414
using Pregnant Crl:CD(SD) rats exposed to the test item at
concentrations of 0, 5, 50, or 500 mg/kg/day by oral gavage. Maternal
toxicity was manifested as decreased food consumption and weight loss
on days 6 to 19 of gestation at a dose level of 500 mg/kg/day.
Developmental toxicity was manifested as decreased fetal weight in
female fetuses at the same dose as maternal toxicity, 500 mg/kg/day.
There was no evidence of fetal susceptibility. The NOAEL for
developmental toxicity of 2-pyrrolidinone, 1-butyl- was determined to
be 50 mg/kg/day.
    Since there is a wide dose spread in the developmental toxicity
study in rats, a benchmark dose (BMD) modeling was conducted using
decreased fetal weight

as an adverse effect. The BMD value is 306 mg/kg/day and the average
BMDL is 201 mg/kg/day for a 5% response in decreased fetal body weight.
    Carcinogenicity data are not available for 2-pyrrolidinone, 1-
butyl-. In the 90-day toxicity study, the liver, kidney, thymus, and
adrenals were target organs, however, they were considered as adaptive
response at the dose levels tested. Evaluation of the database for N-
methylpyrrolidone (NMP) shows similar target organ toxicity as 2-
pyrrolidinone, 1-butyl- (structurally related chemicals differing only
in carbon chain length (1 vs 4 carbon chain length)) and 1-
ethylpyrrolidin-2-one (NEP) (2 carbon chain length), as both chemicals
are considered suitable surrogates for evaluation. Neither 2-
pyrrolidinone, 1-butyl-, N-methylpyrrolidone, nor 1-ethylpyrrolidin-2-
one was found to be genotoxic or mutagenic in a number of assays. In
carcinogenicity studies, N-methylpyrrolidone was not carcinogenic in
two-year rat studies by the inhalation and dietary routes of exposure.
An increased incidence of liver adenomas and carcinomas was seen in
mice exposed to a dietary level of N-methylpyrrolidone exceeding 1,000
mg/kg/day for 18 months. However, based on the lack of mutagenicity or
genotoxicity and the similarity of 2-pyrrolidinone, 1-butyl- to n-
methylpyrrolidone, it can be concluded that 2-pyrrolidinone, 1-butyl-
should not be considered as potentially carcinogenic at doses below the
limit dose of 1,000 mg/kg/day.
    The mutagenic potential of 2-pyrrolidinone, 1-butyl- was assessed
in the Salmonella typhimurium reverse mutation assay, mammalian cell
gene mutation and micronucleus tests. 2-Pyrrolidinone, 1-butyl- was
negative in all assays. Therefore, 2-pyrrolidinone, 1-butyl- is not
considered mutagenic nor clastogenic.
    There were no studies/data directly related to the possible
neurotoxicity of 2-pyrrolidinone, 1-butyl. However, evidence of
potential neurotoxicity was not observed in functional observation
battery (FOB) performed in the 90-day oral toxicity study in the rat.
Therefore, pyrrolidinone, 1-butyl is not expected to be neurotoxic.
    There were no studies/data directly related to the immunotoxicity
of 2-pyrrolidinone, 1-butyl. Thymic atrophy was observed at >100 mg/kg/
day in rats treated with 2-pyrrolidinone, 1-butyl for 90 days via
gavage. However, microscopic changes in thymus were considered as an
adaptive response and not as an adverse effect.
    There were no studies/data directly related to the metabolism, of
2-pyrrolidinone, 1-butyl.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    For purposes of risk assessment, the Agency utilizes the toxicity
point of departure identified in the developmental toxicity study in
rats for chronic dietary assessment, residential exposure assessment
and all dermal and inhalation exposure durations. Since there was a
large dose spread, a benchmark dose modeling (BMD) assessment was
conducted. The average benchmark model lower confidence limit (BMDL) is
201 mg/kg/day for a 5% response which was based on a 5% decreased fetal
body weight. The BMDL of 201 mg/kg/day is used as a point departure for
the risk assessment. An uncertainty factor of 10X is applied for
interspecies extrapolation and an uncertainty factor of 10X is applied
for intraspecies variation. The Food Quality Protection Act factor is
reduced to 1X. Therefore, the Agency's level of concern is for Margins
of Exposure (MOE) less than 100. No endpoint of concern was identified
for acute dietary assessment in the database. Although there was a
decrease in body weights in maternal animals on GD7 in the
developmental toxicity study in rats, this effect is not considered
relevant for acute dietary exposure assessment since the body weights
returned to normal on GD8. A cancer risk assessment was not conducted
because the Agency concluded that 2-pyrrolidinone, 1-butyl is unlikely
to be carcinogenic at the anticipated dietary exposure levels. Dermal
and inhalation absorption is assumed 100% of the oral equivalent dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 2-pyrrolidinone, 1-butyl-, EPA considered exposure under
the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from 2-pyrrolidinone, 1-butyl- in food as
follows:
    Dietary exposure (food and drinking water) to 2-pyrrolidinone, 1-
butyl- can occur following ingestion of foods with residues from
treated crops. Because no adverse effects attributable to a single
exposure of 2-pyrrolidinone, 1-butyl- are seen in the toxicity
databases, an acute dietary risk assessment is not necessary. For the
chronic dietary risk assessment, EPA used the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCIDTM, Version 3.16, and food consumption information
from the U.S. Department of Agriculture's (USDA's) 2003-2008 National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA). One hundred percent crop treated was assumed, default
processing factors, and tolerance-level residues for all foods and use
limitations of not more than 30% by weight of 2-pyrrolidinone, 1-butyl-
in pesticide formulations applied to food.
    2. Dietary exposure from drinking water. For the purpose of the
screening-level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for residues of 2-
pyrrolidinone, 1-butyl- a conservative drinking water concentration
value of 100 ppb based on screening-level modeling was used to assess
the contribution to drinking water for the chronic dietary risk
assessment. This value was directly entered into the dietary exposure
model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).

    2-Pyrrolidinone, 1-butyl- may be used as an inert ingredient in
products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home.
The Agency conducted a screening level assessment to represent worst-
case residential exposure by assessing 2-pyrrolidinone, 1-butyl- in
pesticide formulations (Outdoor Scenarios) and in disinfectant-type
uses (Indoor Scenarios).
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found 2-pyrrolidinone, 1-butyl- to share a common
mechanism of toxicity with any other substances, and 2-pyrrolidinone,
1-butyl do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that 2-pyrrolidinone, 1-butyl- does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. A developmental toxicity
study in rats was available with 2-pyrrolidinone, 1-butyl. Fetal
susceptibility was not observed. Maternal and developmental toxicity
were observed at the same dose, 500 mg/kg/day, the highest dose tested.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for 2-pyrrolidinone, 1-butyl is adequate
for FQPA assessment. It includes a 90-day rat oral toxicity study with
FOB measurements, a prenatal developmental study in rats, acute
toxicity studies and mutagenicity studies.
    ii. There is no evidence of increased susceptibility in the
database. There are no concerns for the lack of 2-generation
reproduction study because the male and female reproductive parameters
were evaluated in the 90-day study and no evidence of fetal
susceptibility was seen in the rat developmental toxicity study in
rats.
    iii. There were no studies/data directly related to the possible
neurotoxicity of 2-pyrrolidinone, 1-butyl. However, no evidence of
potential neurotoxicity was observed in the functional observation
battery (FOB) performed in the 90-day oral toxicity study in the rat.
Therefore, pyrrolidinone, 1-butyl is not expected to be neurotoxic.
    iv. There were no studies/data directly related to the immunotoxic
potential of 2-pyrrolidinone, 1-butyl. However, no evidence of
potential immunotoxicity was observed in the 90-day oral toxicity study
in rats. EPA concluded that the immunotoxicity study is not required at
this time.
    v. The dietary food exposure assessment utilizes proposed tolerance
level or higher residues and 100% crop treated (CT) information for all
commodities. In addition, a conservative drinking water concentration
value of 100 parts per billion (ppb) was used to assess the
contribution to drinking water. By using these screening-level
assessments, chronic exposures/risks will not be underestimated.
    Taking into consideration the available information, EPA concludes
the additional 10X FQPA safety factor be reduced to 1X.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
2-pyrrolidinone, 1-butyl- is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to,
2-pyrrolidinone, 1-butyl- from food and water will utilize 21.1% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    2-Pyrrolidinone, 1-butyl- may be used as inert ingredients in
pesticide products that could result in short-term and intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term and intermediate-term residential exposures to 2-
pyrrolidinone, 1-butyl-. Using the exposure assumptions described
above, EPA has concluded that the combined short-term and intermediate-
term aggregated food, water, and residential exposures result in an MOE
of 350 for both adult males and females respectively. Adult residential
exposure combines high-end dermal and inhalation handler exposure from
indoor hard surface, wiping with a high-end post application dermal
exposure from contact with treated lawns. As the level of concern is
for MOEs that are lower than 100, this MOE is not of concern. EPA has
concluded the combined short-term and intermediate-term aggregated
food, water, and residential exposures result in an aggregate MOE of
218 for children. Children's residential exposure includes total
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). As the level of concern is for MOEs that are lower
than 100, this MOEs is not of concern.
    4. Aggregate cancer risk for U.S. population. Based on lack of
carcinogenicity for N-methyl pyrrolidone (a surrogate chemical of 2-
pyrrolidinone, 1-butyl-), 2-

pyrrolidinone, 1-butyl- is not expected to pose a cancer risk to
humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to 2-pyrrolidinone, 1-butyl- residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of 2-
pyrrolidinone, 1-butyl- in or on any food commodities. EPA is
establishing a limitation on the amount of 2-pyrrolidinone, 1-butyl-
that may be used in pesticide formulations applied to growing crops.
That limitation will be enforced through the pesticide registration
process under the Federal Insecticide, Fungicide, and Rodenticide Act
(``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register any pesticide
formulation for use on growing crops for sale or distribution that
exceed 30% of 2-pyrrolidinone, 1-butyl-.

B. Revision to Petitioned-for Tolerances

    The submitter requested an unlimited use of 2-pyrrolidinone, 1-
butyl in pesticide formulations under 180.920. However, MOEs for the
aggregate residential exposure exceeded the Agency's level of concern;
therefore the refinement was made using 30% maximum concentration in
the final formulation. At that concentration level, the Agency is able
to support the safety finding for the inert tolerance exemption;
therefore, the Agency is limiting the tolerance exemption to cover
residues of 2-pyrrolidinone, 1-butyl only when used at levels not to
exceed 30% by weight in pesticide formulations.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for residues of 2-pyrrolidinone, 1-
butyl- (CAS Reg. No. 3470-98-2) when used as an inert ingredient
(solvent/cosolvent) in pesticide formulations applied to growing crops
at a concentration not to exceed 30% by weight in the end-use
formulation.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption to the requirement for a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 20, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, add alphabetically the inert ingredient ``2-
Pyrrolidinone, 1-butyl- (CAS Reg. No. 3470-98-2)'' to the table to read
as follows:

Sec.  180.920   Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert ingredients                Limits                Uses
------------------------------------------------------------------------

                              * * * * * * *
2-Pyrrolidinone, 1-butyl- (CAS  Not to exceed 30% by    Solvent/
 Reg. No. 3470-98-2).            weight of pesticide     cosolvent.
                                 formulation.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-27212 Filed 11-9-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7731-7733]
[FR Doc No: 2023-02441]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-1972]

Determination of Regulatory Review Period for Purposes of Patent
Extension; OLUMIANT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for OLUMIANT and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by April 7, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 7, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 7, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-E-1972 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; OLUMIANT.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, OLUMIANT
(baricitinib). OLUMIANT is indicated for treatment of adult patients
with

moderately to severely active rheumatoid arthritis who have had an
inadequate response to one or more tumor necrosis factor antagonist
therapies. Subsequent to this approval, the USPTO received a patent
term restoration application for OLUMIANT (U.S. Patent No. 8,158,616)
from Eli Lilly and Co., and the USPTO requested FDA's assistance in
determining the patent's eligibility for patent term restoration. In a
letter dated June 21, 2019, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of OLUMIANT represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
OLUMIANT is 3,649 days. Of this time, 2,781 days occurred during the
testing phase of the regulatory review period, while 868 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
June 5, 2008. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 5,
2008.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: January 15,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for OLUMIANT (NDA 207924) was initially submitted on
January 15, 2016.
    3. The date the application was approved: May 31, 2018. FDA has
verified the applicant's claim that NDA 207924 was approved on May 31,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 723 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02441 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5735-5737]
[FR Doc No: 2016-01918]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-117-000]

Transcontinental Gas Pipe Line Company, LLC; Supplemental Notice
of Intent for the Proposed Dalton Expansion Project, Request for
Comments on Environmental Issues Related to New Route Modifications
Under Consideration

    You are receiving this letter because the staff of the Federal
Energy Regulatory Commission (FERC or Commission) is evaluating route
modifications to Transcontinental Gas Pipe Line Company, LLC's
(Transco) proposed Dalton Expansion Project (Project). The general
location of the Project is shown in appendix 1.\1\ Since the filing of
its March 19, 2015 application, Transco provided two supplemental
filings (July 15, 2015 and September 30, 2015) that identified several
modifications to its proposed pipeline route. These modifications were
incorporated based on the results of ongoing field surveys and to
address comments from agencies and other stakeholders. The majority of
the landowners potentially affected by these modifications have
received notification of the Commission's review of the Project.
However, some of the modifications would affect new landowners;
therefore, the Commission is issuing this supplemental notice (Notice)
to provide these new landowners an opportunity to comment on the
Project. You can access detailed mapping of the modifications to the

proposed pipeline route on the Commission's Web site (www.ferc.gov)
using eLibrary. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>.
---------------------------------------------------------------------------

    The FERC is the lead federal agency responsible for conducting the
environmental review of the Project. The Commission's staff is
preparing an environmental assessment (EA) that discusses the
environmental impacts of the Project. This EA will be used to inform
the Commission as it determines whether the Project is in the public
convenience and necessity.
    This Notice announces the opening of an additional scoping period
the Commission will use to gather input from the new landowners
potentially affected by the Project. Comments may be submitted in
writing as described in the public participation section of this
notice. Please note that comments on this Notice should be filed with
the Commission by February 29, 2016.
    The specific modifications being scoped by this Notice are listed
in the table below.

------------------------------------------------------------------------
       Route modification           Milepost range          County
------------------------------------------------------------------------
Route Variation AE..............  30.4 to 31.8......  Paulding
Route Variation AG..............  41.5 to 42.8......  Paulding
Route Variation AH..............  43.2 to 43.4......  Paulding
Route Variation BH..............  63.0 to 64.1......  Bartow
Major Route Alternative H.......  43.7 to 56.3......  Paulding and
                                                       Bartow
Route Variation BS..............  91.1 to 91.5......  Gordon
------------------------------------------------------------------------

    Information in this notice was prepared to familiarize you with the
new route modifications, the Project as a whole, the Commission's
environmental review process, and instruct you on how to submit
comments.
    A pipeline company representative may have already contacted you or
may contact you soon about surveys and/or to acquire an easement to
construct, operate, and maintain the pipeline. The company would seek
to negotiate a mutually acceptable agreement. However, if the
Commission approves the Project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    To help potentially affected landowners better understand the
Commission and its environmental review process, the ``For Citizens''
section of the FERC Web site (www.ferc.gov) provides information about
getting involved in FERC jurisdictional projects. A citizens' guide
entitled ``An Interstate Natural Gas Facility On My Land? What Do I
Need to Know?'' is also available in this section of the Commission's
Web site. This guide addresses a number of frequently asked questions,
including the use of eminent domain and how to participate in the
Commission's proceedings.

Summary of the Proposed Project

    Transco plans to construct and operate about 113 miles of new 16,
20, 24, and 30-inch-diameter natural gas pipeline and associated
facilities in Coweta, Carroll, Douglas, Paulding, Bartow, Gordon, and
Murray Counties, Georgia and a new compressor station in Carroll
County, Georgia. Additionally, Transco plans to modify existing
facilities along its mainline transmission system in Maryland,
Virginia, and North Carolina to accommodate bidirectional flow. Transco
has indicated that the Project would provide 448,000 dekatherms per day
of incremental firm transportation service to markets in northwest
Georgia.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as scoping. The main goal of the
scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the Project under these general
headings:
     Geology and soils;
     water resources, fisheries, and wetlands;
     vegetation and wildlife;
     endangered and threatened species;
     land use;
     socioeconomics;
     cultural resources;
     air quality and noise; and
     public safety.
    We will also evaluate possible alternatives to the Project or
portions of the Project, and make recommendations on how to lessen or
avoid impacts on the various resource areas.
    We began our NEPA review under the Commission's pre-filing process
on April 25, 2014. The purpose of the pre-filing process was to
encourage the early involvement of interested stakeholders and to
identify and resolve issues before the FERC receives an application. On
October 21, 2014, FERC staff issued an initial Notice of Intent to
Prepare an Environmental Assessment for the Planned Dalton Expansion
Project, Request for Comments on Environmental Issues, and Notice of
Public Scoping Meetings. FERC Staff also issued two supplemental NOIs
for the Project on November 14, 2014 and February 13, 2015.\3\
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    \3\ The November 14, 2014 and February 13, 2015 supplemental
NOIs can be viewed on the FERC Internet Web site at www.ferc.gov.
Using the ``eLibrary'' link, select ``Advanced Search'' from the
eLibrary menu and enter 20141114-3019 and 20150213-3012,
respectively, in the ``Accession Number'' field.
---------------------------------------------------------------------------

    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. We will also
publish and distribute the EA to the public for an allotted comment
period. We will consider all comments on the EA before we make our
recommendations to the Commission. To ensure we have the opportunity to
consider and address your comments, please carefully follow the
instructions in the Public Participation section of this notice.

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic

Preservation Act, we are using this notice to initiate consultation
with the applicable State Historic Preservation Office(s), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the Project's potential effects on
historic properties.\4\ We will define the Project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the Project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this Project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that the Commission receives them in Washington, DC on or before
February 29, 2016.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
Project docket number (CP15-117-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature located on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. This is an easy method for interested
persons to submit brief, text-only comments on a project;
    (2) You can file your comments electronically using the eFiling
feature located on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for Project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the Project.\5\ We will continue to update the
environmental mailing list as the analysis proceeds to ensure that we
send the information related to this environmental review to all
individuals, organizations, and government entities interested in and/
or potentially affected by the planned Project.
---------------------------------------------------------------------------

    \5\ Because the modifications involve only a subset of the
environmental mailing list, this Notice is being provided to only
the affected landowners.
---------------------------------------------------------------------------

    Copies of the EA will be sent to the environmental mailing list for
public review and comment. If you would prefer to receive a paper copy
of the document instead of the CD version or would like to remove your
name from the mailing list, please return the attached Information
Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the ``Document-less Intervention Guide'' under the ``e-filing'' link on
the Commission's Web site. Motions to intervene are more fully
described at http://www.ferc.gov/resources/guides/how-to/intervene.asp.

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP15-
117). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: January 27, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-01918 Filed 2-2-16; 8:45 am]
BILLING CODE 6717-01-P