[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Pages 6191-6192]
[FR Doc No: 2022-02255]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4508-DR; Docket ID FEMA-2022-0001]

Montana; Amendment No. 8 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Montana (FEMA-4508-DR), dated March 31, 2020, and
related determinations.

DATES: This change occurred on January 7, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Nancy J.
Dragani, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Tammy L. Littrell as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially

Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-02255 Filed 2-2-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33227-33229]
[FR Doc No: 2014-13459]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31071; 812-13951]

ValMark Advisers, Inc. and Northern Lights Variable Trust; Notice
of Application

June 4, 2014.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') for an exemption from section
15(a) of the Act and rule 18f-2 under the Act.

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    Summary of Application: Applicants request an order that would
permit them to enter into and materially amend subadvisory agreements
without shareholder approval.
    Applicants: ValMark Advisers, Inc. (``ValMark Advisers'' or the
``Adviser'') and Northern Lights Variable Trust (the ``Trust'').
    Filing Dates: The application was filed on August 30, 2011, and
amended on December 8, 2011, March 30, 2012, and May 9, 2014.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on June 30, 2014 and should be accompanied by proof of
service on the applicants, 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 Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: c/o James Ash,
Gemini Fund Services, LLC, 450 Wireless Boulevard, Hauppauge, New York
11788.

FOR FURTHER INFORMATION CONTACT: Deepak T. Pai, Senior Counsel, at
(202) 551-6876, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Trust, a Delaware statutory trust, is registered under the
Act as an open-end management investment company and is comprised of
multiple series, including the TOPS Protected Balanced ETF Portfolio,
TOPS Protected Moderate Growth ETF Portfolio, and TOPS Protected Growth
ETF Portfolio (collectively, the ``Protected Portfolios''). Each series
has its own investment objectives, policies and restrictions.\1\
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    \1\ Applicants also request relief with respect to any existing
or future series of the Trust and any other existing or future
registered open-end management investment company or series thereof
that: (a) Is advised by the Adviser or any entity controlling,
controlled by, or under common control with the Adviser or its
successors (included within the term ``Adviser''); (b) uses the
manager of managers structure (``Manager of Managers Structure'')
described in the application; and (c) complies with the terms and
conditions of the application (together with the Protected
Portfolios, the ``Funds'' and each individually, a ``Fund''). For
the purposes of the requested order, ``successor'' is limited to any
entity that results from a reorganization into another jurisdiction
or a change in the type of business organization. All existing
investment companies that currently intend to rely on the requested
order are named as applicants, and the Protected Portfolios are the
only Funds that currently intend to rely on the requested order.

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    2. ValMark Advisers, an Ohio corporation, is, and each other
Adviser will be, registered as an investment adviser under the
Investment Advisers Act of 1940, as amended (``Advisers Act''). ValMark
Advisers serves as the investment adviser of the Protected Portfolios,
and an Adviser will serve as investment adviser to the future Funds.
The Protected Portfolios have entered into an investment advisory
agreement with ValMark Advisers (``Advisory Agreement''),\2\ approved
by the Trust's board of trustees (``Board''),\3\ including a majority
of the trustees who are not ``interested persons,'' as defined in
section 2(a)(19) of the Act, of the Trust or the Adviser (``Independent
Trustees''), and by the shareholders representing a majority of each of
the Protected Portfolio's shares. The terms of each Advisory Agreement
comply or will comply with section 15(a) of the Act.
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    \2\ The Adviser will enter into substantially similar investment
advisory agreements to provide investment management services to
future Funds (``Future Advisory Agreements''). The terms of Future
Advisory Agreements will comply with section 15(a) of the Act and
Future Advisory Agreements will be approved by shareholders and by
the Board, including a majority of the Independent Trustees (as
defined below), in the manner required by sections 15(a) and 15(c)
of the Act and rule 18f-2 thereunder. References to any Advisory
Agreement or Advisory Agreements include Future Advisory Agreements
as they pertain to future Funds.
    \3\ The term ``Board'' also includes the board of trustees or
directors of a future Fund.
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    3. Under the terms of the Advisory Agreement, the Adviser is
responsible for the overall management of the Protected Portfolios'
business affairs and selecting investments according to each Protected
Portfolio's investment objectives, policies and restrictions. For the
investment management services that it provides to the Protected
Portfolios, the Adviser receives the fee specified in the Advisory
Agreement. The Advisory Agreement also permits the Adviser to retain
one or more subadvisers for the purpose of managing the investments of
all or a portion of the assets of each Protected Portfolio. Pursuant to
this authority, the Adviser has entered into an investment subadvisory
agreement with one unaffiliated investment subadviser (``Subadviser'')
to provide investment advisory services to the Protected Portfolios
(``Subadvisory Agreement'') and intends to enter into Subadvisory
Agreements with one or more Subadvisers to provide investment advisory
services to the Funds. The Subadviser is, and each future Subadviser
will be, an ``investment adviser'' as defined in section 2(a)(20)(B) of
the Act and registered as an investment adviser under the Advisers Act,
or not subject to such registration.\4\ The Adviser will supervise,
evaluate and allocate assets to the Subadvisers, and make
recommendations to the Board about their hiring, retention or release,
at all times subject to the authority of the Board. The Adviser will
compensate each Subadviser out of the fees paid to the Adviser under
the Advisory Agreement.
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    \4\ If the name of any Fund contains the name of a Subadviser
(as defined below), the name of the Adviser will precede the name of
the Subadviser.
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    4. Applicants request an order to permit the Adviser, subject to
Board approval, to select Subadvisers and enter into and materially
amend Subadvisory Agreements without obtaining shareholder approval.
The terms of the Subadvisory Agreements comply or will comply fully
with the requirements of section 15(a) of the Act. Each Subadvisory
Agreement has been, or will be, approved by the Board, including by a
majority of the Independent Trustees, in accordance with sections 15(a)
and 15(c) of the Act. Each Fund's prospectus has contained or will
contain, at all times following shareholder approval of the Manager of
Managers Structure, the disclosure required by condition 2 below.
    5. The requested relief will not extend to any subadviser that is
an affiliated person, as defined in section 2(a)(3) of the Act, of the
Trust, a Fund or the Adviser, other than by reason of serving as a
subadviser to one or more of the Funds (``Affiliated Subadviser'').
    6. Funds will inform shareholders of the hiring of a new Subadviser
pursuant to the following procedures (``Modified Notice and Access
Procedures''): (a) Within 90 days after a new Subadviser is hired for
any Fund, that Fund will send its shareholders either a Multi-manager
Notice or a Multi-manager Notice and Multi-manager Information
Statement; \5\ and (b) the Fund will make the Multi-manager Information
Statement available on the Web site identified in the Multi-manager
Notice no later than when the Multi-manager Notice (or Multi-manager
Notice and Multi-manager Information Statement) is first sent to
shareholders, and will maintain it on that Web site for at least 90
days.
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    \5\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Securities
Exchange Act of 1934 (``Exchange Act''), and specifically will,
among other things: (a) Summarize the relevant information regarding
the new Subadviser; (b) inform shareholders that the Multi-manager
Information Statement is available on a Web site; (c) provide the
Web site address; (d) state the time period during which the Multi-
manager Information Statement will remain available on that Web
site; (e) provide instructions for accessing and printing the Multi-
manager Information Statement; and (f) instruct the shareholder that
a paper or email copy of the Multi-manager Information Statement may
be obtained, without charge, by contacting the Funds.
    A ``Multi-manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement. Multi-
manager Information Statements will be filed electronically with the
Commission via the EDGAR system.
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Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of securities in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that the requested relief meets this standard.
    3. Applicants assert that the shareholders expect the Adviser and
the Board to select the Subadvisers for the Funds that are best suited
to achieve each Fund's investment objective. Applicants assert that,
from the perspective of the investor, the role of the Subadvisers is
substantially equivalent to that of the individual portfolio managers
employed by the Adviser. Applicants state that requiring shareholder
approval of each Subadvisory Agreement would impose costs and
unnecessary delays on the Funds, and may preclude the Adviser from
acting promptly in a manner considered advisable by the Board.

Applicants note that the Advisory Agreements and any Subadvisory
Agreement with an Affiliated Subadviser will remain subject to sections
15(a) and 15(c) of the Act and rule 18f-2 under the Act, including the
requirement for shareholder voting.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Fund may rely on the requested order, the operation of
the Fund in the manner described in the application will be approved by
a majority of the Fund's outstanding voting securities, as defined in
the Act, or in the case of a Fund whose public shareholders purchase
shares on the basis of a prospectus containing the disclosure
contemplated by condition 2 below, by the initial shareholder(s) before
offering shares of that Fund to the public.
    2. Each Fund relying on the requested order will disclose in its
prospectus the existence, substance, and effect of any order granted
pursuant to the application. Each Fund will hold itself out to the
public as utilizing the Manager of Managers Structure. The prospectus
will prominently disclose that the Adviser has ultimate responsibility
(subject to oversight by the Board) to oversee the Subadvisers and
recommend their hiring, termination, and replacement.
    3. Funds will inform shareholders of the hiring of a new Subadviser
within 90 days after the hiring of the new Subadviser pursuant to the
Modified Notice and Access Procedures.
    4. The Adviser will not enter into a subadvisory agreement with any
Affiliated Subadviser without such agreement, including the
compensation to be paid thereunder, being approved by the shareholders
of the applicable Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination of new or additional
Independent Trustees will be placed within the discretion of the then-
existing Independent Trustees.
    6. Whenever a subadviser change is proposed for a Fund with an
Affiliated Subadviser, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
applicable Board minutes, that such change is in the best interests of
the Fund and its shareholders, and does not involve a conflict of
interest from which the Adviser or the Affiliated Subadviser derives an
inappropriate advantage.
    7. The Adviser will provide general management services to each
Fund, including overall supervisory responsibility for the general
management and investment of each Fund's assets and, subject to review
and approval of the Board, will: (a) Set each Fund's overall investment
strategies; (b) evaluate, select and recommend Subadvisers to manage
all or a part of each Fund's assets; (c) allocate and, when
appropriate, reallocate each Fund's assets among one or more
Subadvisers; (d) monitor and evaluate the performance of Subadvisers;
and (e) implement procedures reasonably designed to ensure that the
Subadvisers comply with each Fund's investment objective, policies and
restrictions.
    8. No trustee or officer of the Trust or a Fund, or director,
manager, or officer of the Adviser, will own directly or indirectly
(other than through a pooled investment vehicle that is not controlled
by such person), any interest in a Subadviser, except for (a) ownership
of interests in the Adviser or any entity that controls, is controlled
by, or is under common control with the Adviser, or (b) ownership of
less than 1% of the outstanding securities of any class of equity or
debt of any publicly traded company that is either a Subadviser or an
entity that controls, is controlled by, or is under common control with
a Subadviser.
    9. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-13459 Filed 6-9-14; 8:45 am]
BILLING CODE 8011-01-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:	 	10/20/2006

SUBJECT:	PP# 3E6791.  Human Health Risk Assessment for Boscalid.
Proposal for Tolerances for Residues in/on Leafy Greens Subgroup 4A,
except Head and Leaf Lettuce, and Leaf Petioles Subgroup 4B.

DP Number:	354126

Chemical#:	128008

Class:	Fungicide

Trade Name:

	Endura(

Pristine(

	EPA Reg#:

EPA Reg#:

		7969-197

7969-199

40 CFR:	§180.589

TO:		Barbara A. Madden/Dan Rosenblatt PM 05

Risk Integration Minor Use Emergency Response Branch

Registration Division (7505P)

FROM:	Shaja R. Brothers, Risk Manager Reviewer

Minor Use Team/Risk Integration Minor Use Emergency Response Branch

Registration Division (7505P)

THROUGH:	William Cutchin, Chemist

Alternative Risk Integration Assessment Team/Technical Review Branch

Registration Division (7505P)

                     and

		Richard A. Loranger, Branch Senior Scientist

Registration Action Branch 2

Health Effects Division (7509P)

1.0   EXECUTIVE SUMMARY tc \l1 "1.0   EXECUTIVE SUMMARY

General Background

Boscalid, 3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), is a fungicide and a member
of the carboxamide (anilide) class of compounds.  The Interregional
Research Project Number 4 (IR-4) has proposed the establishment of
tolerances for the Leafy Greens Subgroup 4A, except head and leaf
lettuce, and leaf petioles subgroup 4B.  Tolerances are currently
established for the representative commodities celery and spinach at 60
ppm and 45 ppm, respectively.  IR-4 is subsequently requesting the
establishment of tolerances for the commodity subgroups, Leafy Greens
Subgroup 4A, except head and leaf lettuce at 60 ppm, and leaf petioles
subgroup 4B at 45 ppm.  BASF, the registrant, supports this action.

Permanent tolerances have been established in 40 CFR §180.589 for
residues of boscalid in/on numerous plant commodities.  These tolerances
include those for primary crops, rotational crops, and livestock
commodities.  A time-limited tolerance is also established for
tangerines in conjunction with a Section 18 emergency exemption request,
and is currently set to expire December 2008.  Tolerances are also
established for the combined residues of boscalid and its glucuronic
acid conjugate in/on animal commodities, eggs, and meat byproducts of
cattle, goats, horses, and sheep.  Additionally, the requested
tolerances for the Leafy Greens Subgroup 4A, except head and leaf
lettuce at 60 ppm, and leaf petioles subgroup 4B at 45 ppm will replace
the existing tolerances for celery and spinach.

The initial risk assessment for boscalid was performed by Y. Donovan (DP
Number 290022, September 8, 2003).  Please refer to this document for
information pertaining to the toxicological, and residue chemistry
databases.  To date, there have been no additions to the toxicological
database, and no changes in either the toxicological endpoints chosen
for hazard evaluation, or the FQPA Safety Factor determination.  The
databases referenced above are chemical specific and are not germane to
the commodities addressed in this assessment.

The following end-use products are used on the crops in this tolerance
petition (PP# 3E6791): Endura Fungicide (EPA Reg. No. 7969-197), and
Pristine Fungicide (EPA Reg. No. 7969-199).  Endura contains 70% by
weight boscalid, and 30% inert ingredients.  Pristine contains boscalid
and a second fungicide, pyraclostrobin, in a 2:1 ratio (25.2% boscalid,
12.8% pyraclostrobin).   Pristine and Endura are proposed for use on
Leafy Greens Subgroup 4A, except head and leaf lettuce, and leaf
petioles subgroup 4B.

The acute, chronic, and cancer hazard assessments for boscalid are
summarized as follows:

Acute:  There were no toxic effects attributable to a single dose.  An
endpoint of concern was not identified to quantitate acute-dietary risk
to the general population or to the subpopulation females 13-50 years
old.  Therefore, there is no acute reference dose (aRfD) or acute
population-adjusted dose (aPAD) for the general population or population
subgroup identified above.  Chronic:  Toxicity was seen in several
species of animals.  Effects were seen in the thyroid and liver.  The
chronic NOAEL was 21.8 mg/kg bw/day.  The uncertainty factor for
intraspecies variability and interspecies extrapolation was 100X, and
the FQPA Safety Factor was reduced to 1X.  As a result, the chronic
population adjusted dose (cPAD) is 0.218 mg/kg/day.  For the dermal
route, the absorption rate is 15% relative to oral.  For the inhalation
route, the absorption rate is assumed to be 100%.  The residential and
occupational level of concern (LOC) for all routes is a Margin of
Exposure (MOE) of 100.  Cancer: The Cancer Assessment Review Committee
(CARC) classified boscalid as having “suggestive evidence of
carcinogenicity, but not sufficient to assess human carcinogenic
potential.”  The quantification of human cancer risk was not
recommended.  Therefore, a cancer risk assessment was not performed.

Residential Exposure Estimates

The daily dermal dose and dermal MOE for the post-application activity,
golfing, are 0.0008 mg/kg/day, and 27,000, respectively, based on the
highest daily average transferable turf residue for wet turf.  The MOE
for the non-occupational dermal post-application exposure was greater
than the target MOE of 100.  Therefore residential/non-occupational risk
did not exceed the Agency’s level of concern.

Dietary Exposure Estimates

The chronic dietary exposure analysis was performed using DEEM-FCID(
(Version 2.03).  The analysis was based on tolerance level residues,
default processing factors, and assumed 100% crop treated.  Leafy Greens
Subgroup 4A, except head and leaf lettuce and leaf petioles subgroup 4B
were also incorporated at tolerance level residues.  Celery and spinach
(previously submitted) residue data were accepted as surrogate data for
the establishment of the requested tolerance.  The risk estimates are
below the Agency’s level of concern for the general U.S. population
and all population subgroups.  The most highly exposed population
subgroup is children 1-2 years, which utilizes 38% of the cPAD.  The
general U.S. population utilizes 11% of the cPAD.

Drinking Water Exposure Estimates

The Environmental Fate and Effects Division (EFED) provided the Tier I
estimated drinking water concentrations (EDWCs) for boscalid in surface
water and groundwater for use in the human health risk assessment.  EFED
used the simulation models FIRST to calculate the surface water EDWCs,
and SCI-GROW to calculate the groundwater concentration.  The turf use
represents the highest annual application rate.  The EDWCs from FIRST
are 87.53 for acute and 25.77 ppb for chronic.  The SCI-GROW estimate
for groundwater exposure is 0.63 ppb.

Aggregate Exposure and Risk Conclusions

Acute Aggregate Exposure and Risk

There were no toxic effects attributable to a single dose.  An endpoint
of concern was not identified to quantitate acute-dietary risk to the
U.S. general population or to the subpopulation females 13-50 years old.
 Therefore, an acute aggregate risk assessment was not performed.

Short-Term Aggregate Exposure and Risk

Post-application exposure from golf courses is considered short-term,
and is applicable to both adults and youth.  The non-occupational use to
be aggregated with dietary exposure is turf on golf courses.  The target
maximum daily exposure to boscalid residues is 0.22 mg/kg/day.  The sum
of the food, water, and residential exposures is 0.024 mg/kg/day.  The
estimated MOE is 1400, and exceeds the target MOE of 100.  Therefore the
short-term aggregate risk and exposure is not of concern to the Agency.

Intermediate-Term Aggregate Exposure and Risk

Intermediate-term exposures are not anticipated.  Therefore an
intermediate-term aggregate risk assessment was not performed.

Chronic Aggregate Exposure and Risk

The chronic dietary exposure analysis was performed using the DEEM-FCID
(Version 2.03) Model.  The assessment was based on tolerance level
residues, DEEM (Version 7.81) default processing factors, and assumed
100% crop treated.  The chronic aggregate assessment includes food and
drinking water only.  As a result, the chronic aggregate risk assessment
is equivalent to the chronic dietary risk assessment.  The most highly
exposed population subgroup is children 1-2 years, which utilizes 38% of
the cPAD.  The general U.S. population utilizes 11% of the cPAD.
Therefore, the aggregate chronic exposure is below the Agency’s level
of concern.

Occupational Estimated Exposure and Risk

There is potential for exposure to boscalid during activities performed
by occupational handlers and post-application workers.  The estimated
MOEs were from 4,500 to 17,000 (at the baseline level) for handlers
performing crop protection uses.  The estimated MOEs were from 450 to
61,000 (at the single layer level) for handlers performing seed
treatment uses.  MOE estimates exceed the target of 100, and are not of
concern to the Agency.

The crop protection post-application estimated MOEs were from 570 to
2,800 on the day of application.  The post-application estimated MOEs
for seed treatment uses were from 8,400 to 370,000.  These MOE estimates
also exceed the target of 100, and likewise are not of concern to the
Agency.

The technical material has a Toxicity Category IV for eye
irritation/skin irritation, and Category III for acute dermal toxicity.
Per the Worker Protection Standard (WPS), a 12-hour restricted entry
interval (REI) is required, and is appropriate for the label.

Conclusions

Boscalid, parent is the only residue of concern for both the tolerance
expression and risk assessment.  Therefore, the ARIA team concludes that
there is a reasonable certainty that no harm will result to the U.S.
general population, and all population subgroups from short-term and
chronic aggregate exposure.

Recommendation

The submitted field trials performed on celery and spinach are adequate
to support the proposed tolerances requested by IR-4.  No deficiencies
were noted in the submitted data that would preclude establishing new
tolerances for boscalid on the Leafy Greens Subgroup 4A, except head and
leaf lettuce at 60 ppm, and leaf petioles subgroup 4B at 45 ppm.  ARIA
recommends deleting celery and spinach tolerances in 40 CFR § 180.589.

2.0 PHYSICAL/CHEMICAL PROPERTIES tc \l1 "2.0 PHYSICAL/CHEMICAL
PROPERTIES  CHARACTERIZATION

The physical and chemical properties are specific to the chemical
boscalid.  For further information on the properties of boscalid, please
view the following assessments:  Boscalid Summary of Analytical
Chemistry and Residue Data (D. Dotson, DP Number 322235, 11/3/2005), and
Boscalid Human Health Risk Assessment (Y. Donovan, DP Number 290022,
9/8/2003).

3.0  HAZARD CHARACTERIZATION

The hazard characterization has not changed since the initial review of
boscalid.  For further information on the characterization of boscolid,
please view the following assessments:  HED HIARC Report (A. Levy, TXR
No. 0051613, 3/7/2003), and Boscalid Human Health Risk Assessment (Y.
Donovan, DP Number 290022, 9/8/2003).

4.0   EXPOSURE ASSESSMENT tc \l1 "4.0   EXPOSURE ASSESSMENT

4.1 Summary of Registered and Proposed Uses tc \l2 "4.1 Summary of
Registered and Proposed Uses

Permanent tolerances have been established in 40 CFR §180.589 for
residues of boscalid in/on numerous plant commodities.  These tolerances
include those for primary crops, rotational crops, and livestock
commodities.  A time-limited tolerance is also established for
tangerines in conjunction with a Section 18 emergency exemption request,
and is currently set to expire December 2008.  Tolerances are also
established for the combined residues of boscalid and its glucuronic
acid conjugate in/on animal commodities, eggs, and meat byproducts of
cattle, goats, horses, and sheep.  Additionally, IR-4 is requesting
tolerances for the Leafy Greens Subgroup 4A, except head and leaf
lettuce, and leaf petioles subgroup 4B.  The Agency has approved celery
and spinach residue data (previously submitted).  These data satisfy the
residue data requirements for the requested subgroups, and are accepted
as surrogate data for the use of establishing these tolerances.
Therefore, Leafy Greens Subgroup 4A, except head and leaf lettuce and
leaf petioles subgroup 4B will replace the existing tolerances for
celery and spinach, respectively.

The following end-use products are used on the crops in this tolerance
petition (PP# 3E6791): Endura Fungicide (EPA Reg. No. 7969-197),
Pristine Fungicide (EPA Reg. No. 7969-199).  Endura contains 70% by
weight boscalid, and 30% inert ingredients.  Pristine contains boscalid
and a second fungicide, pyraclostrobin, in a 2:1 ratio (25.2% boscalid,
12.8% pyraclostrobin).   Pristine and Endura are proposed for use on
Leafy Greens Subgroup 4A, except head and leaf lettuce, and leaf
petioles subgroup 4B.  Crops are to be treated with a broadcast spray
made by either ground or aerial equipment.  Celery and spinach may
receive a maximum of two treatments per season at a rate of 0.40 lb ai/A
for a total seasonal application rate of 0.80 lb ai/A.  The proposed
pre-harvest interval is 0 days.

4.2 Dietary Exposure/Risk Pathway

 tc \l2 "4.2 Dietary Exposure/Risk Pathway

4.2.1 Residue Profile

Leafy Greens Subgroup 4A, except head and leaf lettuce and leaf petioles
subgroup 4B were incorporated in DEEM-FCID TM at tolerance level
residues.  Celery and spinach (previously submitted) residue data were
accepted as surrogate data for the establishment of the requested
tolerances.  Therefore, tolerances for celery and spinach will be
deleted in the 40 CFR § 180.589.  For further information  tc \l3
"4.2.1 Residue Profile  for boscalid in/on celery and spinach (i.e.,
metabolism studies, analytical enforcement methods, frozen storage
stability studies), please view the following assessments:  Boscalid
Human Health Risk Assessments (D. Dotson, DP Number 290185, 2/10/2004,
Y. Donovan, DP Number 290022, 9/8/2003), Summary of Analytical Chemistry
and Residue Data (M. Nelson, DP Number 286787, 8/15/03), and MARC
Decision Memo (M. Nelson, DP Number 286786, 1/9/2003).

International Harmonization

There are currently no International or Codex Maximum Residue Levels
(MRLs) for boscalid.  Boscalid tolerances were initially established in
the U.S. in conjunction with a joint review with Canada’s Pesticide
Management Regulatory Agency.  MRLs have not been finalized in Canada at
this time.  The Agency recommended tolerances of 45 ppm on celery and 60
ppm on spinach exceed the proposed Canadian MRL of 1.0 ppm on these
crops.  However, the Canadian level is based on rotational crop
residues, whereas the U.S. is currently establishing celery and spinach
tolerances to cover direct use on these crops.

4.2.2 Chronic Dietary Exposure and Risk tc \l3 "4.2.2 Chronic Dietary
Exposure and Risk

The chronic dietary exposure analysis was performed using the DEEM-FCID
(Version 2.03) Model.  The assessment was based on tolerance level
residues, DEEM (Version 7.81) default processing factors, and assumed
100% crop treated.  The most highly exposed population subgroup is
children 1-2 years, which utilizes 38% of the cPAD.  The general U.S.
population utilizes 11% of the cPAD.  This analysis is very
conservative, and requires no further refinements.  As a result, the
risk estimates are well below the Agency’s level of concern.

Table 1.  Summary of Dietary Exposure and Risk for Boscalid

Population Subgroup

Acute Analysis

DEEM: Chronic Analysis

Cancer Analysis

Dietary Exposure (mg/kg/day)

% cPAD

General U.S. Population	Not Applicable:  No Acute Dietary Endpoint

0.023311

11

Not Applicable: No cancer risk assessment is required

All Infants (< 1 year old)

0.052281

24

Children 1-2 years old

0.082483

38

Children 3-5 years old

0.056792

26

Children 6-12 years old

0.028500

13

Youth 13-19 years old

0.016295

8

Adults 20-49 years old

0.017377

8

Adults 50+ years old

0.019261

9

Females 13-49 years old

0.017586

8

4.2.3 Cancer Dietary tc \l3 "4.2.3 Cancer Dietary

The CARC stated that boscalid exhibited “suggestive evidence of
carcinogenicity, but not sufficient to assess human carcinogenic
potential.”  The quantification of human cancer risk was not
recommended.  Therefore, a cancer risk assessment was not performed.

4.3 Water Exposure/Risk Pathway

 tc \l2 "4.3 Water Exposure/Risk Pathway   EFED provided Tier I EDWCs
for boscalid in surface water and in groundwater for use in the human
health risk assessment.  EFED used the simulation models FIRST to
calculate the surface water EDWCs and SCI-GROW to calculate the
groundwater concentration.  The turf use represents the highest annual
application rate for boscalid.  The EDWCs from FIRST for acute and
chronic exposures are 87.53 ppb and 25.77 ppb, respectively.  The
SCI-GROW estimate for groundwater exposure is 0.63 ppb.

4.4 Non-Occupational Exposure/Risk Pathway

A short-term non-occupational dermal post-application exposure risk
assessment for individuals golfing and harvesting fruit at “U-pick”
farms and orchards was previously conducted (S. Wang, DP Number 290072,
6/23/03).  The daily dermal dose and dermal MOE for golfing, the
post-application activity are 0.0008 mg/kg/day and 27,000, respectively,
based on the highest daily average transferable turf residue for wet
turf in Pennsylvania.  No new residential uses are proposed for this
request.  Therefore, a new residential exposure risk assessment is not
required.

4.5 Other (Spray Drift) tc \l2 "4.5 Other (Spray Drift, etc.)

Spray drift is always a potential source of exposure to residents living
in close proximity to spraying operations.  This situation is
particularly the case with aerial application.  However, to a lesser
extent, spray drift resulting from the ground application of boscalid
could also be a potential source of exposure.  The Agency has been
working with the Spray Drift Task Force (a membership of U.S. pesticide
registrants), EPA Regional Offices, State Lead Agencies for pesticide
regulation, and other parties to develop the best spray drift management
practices.  The Agency is now requiring interim mitigation measures for
aerial applications that must be placed on product labels/labeling.  The
Agency has completed its evaluation of the new database submitted by the
Spray Drift Task Force, and is developing a policy on how to apply
appropriately the data and the AgDRIFT computer model to its risk
assessments for pesticides applied by air, orchard airblast, and ground
hydraulic methods.  After the policy is in place, the Agency may impose
further refinements in spray drift management practices to reduce
off-target drift and risks associated with pesticide application.

5.0  AGGREGATE RISK ASSESSMENT AND RISK CHARACTERIZATION

5.1 Acute Risk tc \l2 "5.1 Acute Risk

There were no toxic effects attributable to a single dose.  An endpoint
of concern was not identified to quantitate an acute-dietary risk to the
U.S. general population or to the subpopulation females 13-50 years old.
 Therefore, an acute aggregate risk assessment was not performed.

5.2  Short-Term Risk tc \l2 "5.2  Short-Term Risk

Post-application exposure from golf courses is considered short-term,
and is applicable to both adults and youth.  The exposure estimate was
calculated using the general U.S. population, but is considered to be
representative of youth since youth and adults possess similar body
surface area to weight ratios, and the dietary exposure for youth (13-19
years old) is less than that of the general U.S. population.  The
non-occupational use to be aggregated with dietary exposure is turf on
golf courses.  The exposure to boscalid residues in drinking water was
included in the dietary exposure analysis.  The target maximum daily
exposure to boscalid residues is 0.22 mg/kg/day.  The sum of the food,
water, and residential exposures is 0.024 mg/kg/day.  The estimated MOE
is 1400, and exceeds the target MOE of 100.  Therefore the short-term
aggregate risk and exposure is not of concern to the Agency.

Table 2.  Short-Term Aggregate Risk and DWLOC Calculations for the
General U.S. Population

(Inhalation/Oral/Dermal Endpoints and NOAELs the Same)

Population

Short-Term Scenario

NOAEL

mg/kg/day

Target MOE

Max

Exposure2

mg/kg/day

Average

Dietary Exposure (food + water)

mg/kg/day

Residential Exposure3

mg/kg/day

Aggregate Food, Water, and Residential Exposure4

mg/kg/day

U.S.

21.8

100

0.218

0.023256

0.0008

0.0241

5.3  Intermediate-Term Risk

Intermediate-term exposures are not anticipated.  Therefore an
intermediate-term aggregate risk assessment was not performed.

5.4  Chronic Risk tc \l2 "5.4  Chronic Risk

The chronic dietary exposure analysis was performed using DEEM-FCID(
(Version 2.03).  The analysis was based on tolerance level residues,
default processing factors, and assumed 100% crop treated.  Although the
chronic aggregate risk assessment takes into account average exposure
estimates from the dietary consumption and residential uses, this
analysis includes food and drinking water only.  Exposure resulting from
turf grass on golf courses is considered short term and therefore was
not incorporated in this analysis.  The most highly exposed population
subgroup is children 1-2 years, which utilizes 38% of the cPAD.  The
general U.S. population utilizes 11% of the cPAD (see Table 1).
Therefore, risk estimates are below the Agency’s level of concern for
the general U.S. population and all population subgroups.

5.5  Cancer Risk tc \l2 "5.5  Cancer Risk

The CARC stated that boscalid exhibited “suggestive evidence of
carcinogenicity, but not sufficient to assess human carcinogenic
potential.”  The quantification of human cancer risk was not
recommended.  Therefore, a cancer risk assessment was not performed.

6.0	CUMULATIVE RISK tc \l1 "6.0	CUMULATIVE RISK

FQPA (1996) stipulates that when determining the safety of a pesticide
chemical, EPA shall base its assessment of the risk posed by the
chemical on, among other things, available information concerning the
cumulative effects to human health that may result from dietary,
residential, or other non-occupational exposure to other substances that
have a common mechanism of toxicity. The reason for consideration of
other substances is due to the possibility that low-level exposures to
multiple chemical substances that cause a common toxic effect by a
common mechanism could lead to the same adverse health effect as would a
higher level of exposure to any of the other substances individually.  A
person exposed to a pesticide at a level that is considered safe may in
fact experience harm if that person is also exposed to other substances
that cause a common toxic effect by a mechanism common with that of the
subject pesticide, even if the individual exposure levels to the other
substances are also considered safe.

The Agency did not perform a cumulative risk assessment as part of this
tolerance action for boscalid because the Agency has not yet initiated a
review to determine if there are any other chemical substances that have
a mechanism of toxicity common with that of boscalid.  For purposes of
this tolerance action, EPA has assumed that boscalid does not have a
common mechanism of toxicity with other substances.

On this basis, the registrant must submit, upon EPA’s request and
according to a schedule determined by the Agency, such information as
the Agency directs to be submitted in order to evaluate issues related
to whether boscalid shares a common mechanism of toxicity with any other
substance and, if so, whether any tolerances for boscalid need to be
modified or revoked.  If the Agency identifies other substances that
share a common mechanism of toxicity with boscalid, the Agency will
perform aggregate exposure assessments on each chemical, and will begin
to conduct a cumulative risk assessment.

The Office of Pesticides (OPP) has recently developed a framework that
it proposes to use for conducting cumulative risk assessments on
substances that have a common mechanism of toxicity.  This guidance was
issued for public comment on January 16, 2002 (67 FR 2210-2214) and is
available from the OPP Website at:
http://www.epa.gov/pesticides/trac/science/cumulative_guidance.pdf.  In
the guidance, it is stated that a cumulative risk assessment of
substances that cause a common toxic effect by a common mechanism will
not be conducted until an aggregate exposure assessment of each
substance has been completed.

Before undertaking a cumulative risk assessment, OPP will follow
procedures for identifying chemicals that have a common mechanism of
toxicity as set forth in the “Guidance for Identifying Pesticide
Chemicals and Other Substances that Have a Common Mechanism of
Toxicity” (64 FR 5795-5796, February 5, 1999).

7.0 OCCUPATIONAL EXPOSURE AND RISK tc \l1 "7.0 OCCUPATIONAL EXPOSURE AND
RISK

Pesticide workers performing their activities will be exposed to
boscalid during and after the application of the fungicide.  For further
information on the occupational exposure and risk from boscolid, please
view the following assessment:  Boscalid Occupational Residential
Exposure Assessment (S. Wang,  DP Number 321801, 9/20/2005).

DATA NEEDS

No deficiencies were noted in the submitted data that would preclude
establishing new tolerances for boscalid on the Leafy Greens Subgroup
4A, except head and leaf lettuce, and leaf petioles subgroup 4B.  For
further information on outstanding data needs that are not germane to
these uses, please view the following assessment:  Boscalid Human Health
Risk Assessment (Y. Donovan, DP Number 290022, 9/8/2003).

References:

Boscalid Chronic Dietary Exposure Assessment, S. Brothers, DP Number
332672, 10/17/2006

Boscalid Summary of Analytical Chemistry and Residue Data, D. Dotson, DP
Number 322235, 11/3/2005

Boscalid Occupational Residential Exposure Assessment, S. Wang, DP
Number 321801, 9/20/2005

Boscalid Human Health Risk Assessment, D. Dotson, DP Number 290185,
2/10/2004

Boscalid Human Health Risk Assessment, Y. Donovan, DP Number 290022,
9/8/2003

Summary of Analytical Chemistry and Residue Data, M. Nelson, DP Number
286787, 8/15/03

Boscalid Occupational Residential Exposure Assessment, S. Wang, DP
Number 290072, 6/23/03

HED HIARC Report, C. Levy, TXR No. 0051613, 3/7/2003

MARC Decision Memo, M. Nelson, DP Number 286786, 1/9/2003

 PAGE  1 / NUMPAGES  11


[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Rules and Regulations]
[Pages 78048-78052]
[FR Doc No: 2016-26866]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2016-0042; FRL-9954-40-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Revisions and Amendments to Regulations for Continuous
Opacity Monitoring, Continuous Emissions Monitoring, and Quality
Assurance Requirements for Continuous Opacity Monitors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the State of Maryland.
The revision pertains to changes and amendments to Maryland regulations
for continuous opacity monitoring (COM or COMs) and continuous
emissions monitoring (CEM or CEMs) and to an amendment adding
requirements for Quality Assurance and Quality Control (QA/QC) as they
pertain to COMs. EPA is approving these revisions to the COMs and CEMs
requirements in accordance with the requirements of the Clean Air Act
(CAA).

DATES: This final rule is effective on December 7, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2016-0042. All documents in the docket are listed on
the http://www.regulations.gov Web site. 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 through
http://www.regulations.gov, or please contact the person identified in
the ``For Further Information Contact'' section for additional
availability information.

FOR FURTHER INFORMATION CONTACT: Marilyn Powers,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 17, 2016 (81 FR 39605), EPA published a notice of proposed
rulemaking (NPR) for the State of Maryland. In the NPR, EPA proposed
approval of revisions and amendments to COMAR 26.11.01 General
Administrative Requirements related to requirements for COMs and CEMs
and the addition of new COMAR 26.01.31 Quality Assurance Requirements
for Continuous Opacity Monitors (COMs). The formal SIP revision (#15-
05) was submitted by Maryland through the Maryland Department of the
Environment (MDE) on November 24, 2015. On February 26, 2016, MDE
provided a supplemental letter indicating MDE was excluding portions of
COMAR <IP_ADDRESS> submitted in the November 24, 2015 SIP submittal from
EPA's review and consideration as a SIP revision. The February 26, 2016
letter from MDE is available in the docket for this rulemaking and is
available online at http://www.regulations.gov.\1\
---------------------------------------------------------------------------

    \1\ Specifically, in the February 26, 2016 letter from MDE to
EPA, MDE withdrew from EPA's review and consideration the text in
COMAR <IP_ADDRESS>.A(4), in COMAR 26.11 .01.10.B(4), in COMAR
<IP_ADDRESS>D(2)(c), and in COMAR <IP_ADDRESS>.F which had initially
been included in the November 25, 2015 SIP submittal. MDE excluded
provisions in COMAR <IP_ADDRESS> that refer to sections or
subsections of COMAR 26.11.09 that are not yet in the State's SIP.
MDE plans to submit the COMAR 26.11.09 revisions along with these
related provisions for approval into the SIP at a later date.
---------------------------------------------------------------------------

    EPA had previously approved Maryland regulation COMAR <IP_ADDRESS>
Continuous Emissions Monitoring (CEM) Requirements into the Maryland
SIP on February 28, 1996. 61 FR 7418. COMAR <IP_ADDRESS> required large
fuel-burning equipment burning coal and residual oil to install COMs
and demonstrate compliance using COM data. The regulation established
monitoring requirements, CEM installation requirements, CEM
installation and certification schedules, quality assurance procedures
for opacity monitors, and record keeping and reporting requirements.
The regulation had previously incorporated by reference Maryland's
Technical Memorandum 90-01 (TM 90), and required compliance
determinations for the State's visible emissions limits and QA/QC for
COMs in accordance with the procedures therein. The terms CEMs and COMs
were used interchangeably in COMAR <IP_ADDRESS>; therefore, MDE
determined it was necessary to establish separate requirements for
each.
    The November 24, 2015 SIP submittal, as clarified and amended on
February 26, 2016 by MDE, includes revisions to COMs and CEMs
definitions in COMAR <IP_ADDRESS>, administrative changes to reporting
and recordkeeping requirements in COMAR <IP_ADDRESS>, a revised COMAR
<IP_ADDRESS> for COMs, a new COMAR <IP_ADDRESS> for CEMs, and new COMAR
26.11.31 for QA/QC procedures related to COMs. The November 24, 2015
submittal, as amended by MDE's February 26, 2016 letter, removes the
requirement to use TM 90 for enforcement actions and for QA/QC
requirements on applicable fuel-burning equipment and removes
references to TM 90.

II. Summary of SIP Revision

    The SIP revision is comprised of four state actions pertaining to
adjusted requirements for COMs and CEMs in COMAR <IP_ADDRESS>, COMAR
<IP_ADDRESS> and COMAR <IP_ADDRESS>, new CEMs provisions in COMAR
<IP_ADDRESS>, and new QA/QC requirements in COMAR 26.11.31. These four
actions are a series of regulatory actions that result in a
recodification of some existing requirements for COMs and CEMs,
establishment of separate regulations and requirements for COMs and
CEMs, removal of applicability of TM 90 for certain fuel-burning
equipment and removal of references to TM 90, and codification of the
QA/QC requirements for COMs that were formerly incorporated by
reference in TM 90 into a new COMAR 26.11.31. Other specific
requirements of the revised and amended COMAR regulations, and the
rationale for EPA's approval action finding the regulations in
accordance with section 110 of the CAA are explained in the NPR and in
EPA's Technical Support Document (TSD) dated April 5, 2016, and will
not be restated here. The NPR and TSD can be found in the docket for
this rulemaking action available online at http://www.regulations.gov.

III. Public Comments and EPA Responses

    EPA received one set of comments on the proposal from the
Environmental Integrity Project and the Chesapeake Climate Action
Network (collectively referred to herein as ``Commenter''). This set of
these comments is provided in the docket for today's final rulemaking
action.
    Comment 1: The Commenter stated that it thought the SIP revision
would improve the Maryland SIP because it separates the requirements
for COMs from the requirements for CEMs. However, because of its
concern regarding some of Maryland's permitting and enforcement actions
on opacity and particulate matter (PM) issues, the Commenter submitted
comments ``to explain our understanding of the effect of the SIP
revision that EPA is proposing to approve.'' The Commenter expressed
concern with allowing ``ineffective technical methods'' in compliance
demonstrations for opacity limits. The Commenter stated that a COM is
an effective method of measuring compliance with Maryland's SIP opacity
limits and reserved judgment on whether it is ever appropriate to
substitute another technology for COMs to demonstrate compliance with
opacity limits. The Commenter stated that if a technology is to be
substituted for COMs, it should include PM CEMS paired with an approved
method that accounts for the condensable portion of PM. The Commenter
stated that, for various reasons, EPA Reference Method 9, by itself, is
not a sufficient substitute for COMs due to infrequency and weather
condition issues. The Commenter acknowledged that the proposed action
to approve revisions to COMAR <IP_ADDRESS>, <IP_ADDRESS> and <IP_ADDRESS>
for the Maryland SIP does not ``allow Method 9 observations as a
substitute for COM in compliance demonstrations for opacity.'' The
Commenter noted that COMAR <IP_ADDRESS>(A)(4), which allows fuel-burning
sources to discontinue use of COMs under certain circumstances is not
part of the November 24, 2015 SIP revision, as amended February 26,
2016, which EPA proposed to approve. Finally, the Commenter stated that
no part of COMAR <IP_ADDRESS> [which contains Maryland's opacity
limitation] was submitted with the November 24, 2015 SIP submittal, and
thus no

provision in the November 24, 2015 SIP submission allows
discontinuation of COM at fuel burning sources.
    Response 1: EPA thanks the Commenter for its statements. EPA
confirms Commenter's statement that the NPR did not propose any action
on COMAR <IP_ADDRESS>, which contains opacity limitations in Maryland,
as no part of that regulation was included in the November 24, 2015
submittal. The version of COMAR <IP_ADDRESS> which EPA approved in 2007
remains in the SIP. See 72 FR 41891 (August 1, 2007) (approving version
of COMAR <IP_ADDRESS> for SIP with State effective date of November 24,
2003). EPA also confirms that the NPR did not include proposed action
on the provisions in COMAR <IP_ADDRESS>(A)(4), addressing removal of
COMS, as that portion of COMAR <IP_ADDRESS> was removed from EPA's
consideration by a February 26, 2016 supplemental letter from MDE
requesting that certain sections be struck from the submittal. In EPA's
TSD which supported the NPR, EPA clearly explained the exclusions from
our proposed approval action, stating that none of the newly adopted
changes to COMAR 26.11.09 Control of Fuel-Burning Equipment, Stationary
Internal Combustion Engines, and Certain Fuel-Burning Installations
were included in the November 24, 2015 SIP submittal as MDE stated it
intended to make further revisions to COMAR 26.11.09 before separately
submitting for inclusion into the State's SIP. EPA also confirms that
the NPR and TSD clearly indicated COMAR <IP_ADDRESS>A(4), B(4), D(2)(c),
and F were excluded from the November 24, 2015 SIP submittal by MDE's
February 26, 2016 supplemental submission.
    As to the Commenter's statement regarding the use of substitutes
for COMs or the appropriateness of alternatives to use of COMs, EPA
first notes that the comment is not germane to the regulation EPA
proposed to approve in the NPR as COMAR <IP_ADDRESS> in the November 24,
2015 SIP submittal, as amended February 26, 2016, does not address
alternatives to use of COMs to demonstrate compliance nor address
substitutes. Thus, EPA provides no further response to the Commenter's
general statement regarding appropriateness of substituting for COMs.
    However, EPA notes generally that choice of compliance methods is
left to State's for due consideration. Congress established the CAA
such that each state has primary responsibility for assuring air
quality within the state and such that each state determines an
emission reduction program for its areas to attain and maintain air
quality, subject to EPA approval, with such approval dependent upon
whether the SIP as a whole meets the applicable requirements of the
CAA. See Commonwealth of Virginia, et al., v. EPA, 108 F.3d 1397, 1410
(D.C. Cir. 1997) (citing Natural Resources Defense Council, Inc. v.
Browner, 57 F.3d 1122, 1123 (D.C. Cir. 1995)). While the requirement
for Method 9 for compliance determinations is not part of the Maryland
regulation for which EPA proposed approval, EPA notes that states have
flexibility in devising and developing their choices as to the means of
achieving attainment and maintenance of a NAAQS. This flexibility has
been affirmed by the courts. Id. See also Train v. NRDC, 421 U.S. 60
(1975). EPA cannot disapprove a SIP revision simply based upon a
state's choice of a particular emission monitoring requirement, such as
a COM or CEM, as long as the SIP revision otherwise meets the
requirements of the CAA. As explained in the NPR and the TSD,
Maryland's November 24, 2015 SIP submission meets the requirements of
the CAA under section 110.
    With respect to the use of COMs, EPA Reference Method 9, or PM CEMs
for determining compliance with opacity requirements, the choice of
compliance methodology is a choice for the state as long as the state
does not prohibit the use of credible evidence. EPA's credible evidence
rule (62 FR 8314 (February 24, 1997)) provided clarifications regarding
the use of any relevant credible evidence or information for
determining compliance with an applicable emission limit or
requirement. The credible evidence revisions consisted of various
changes to 40 CFR 51.212, 52.12, 52.30, 60.11 and 61.12. These
revisions provided minor modifications to existing regulatory
provisions to clearly allow for the use of any credible evidence--that
is, both reference test and comparable non-reference test data--to
prove or disprove violations of the CAA in enforcement actions. These
revisions make clear that EPA, states and citizens acting pursuant to
section 304 of the CAA can prosecute actions for violations of CAA
provisions and federally approved SIPs based exclusively on any
credible evidence, without the need to rely on any data from a
particular reference test (such as EPA Reference Method 9). The
revisions also have the effect of eliminating any potential ambiguity
regarding the use of non-reference test data, including COMs and CEMs,
as a basis for supporting violations. 40 CFR 51.212 specifically
provides that ``[f]or the purpose of . . . establishing whether or not
a person has violated or is in violation of any standard in this part,
the plan must not preclude the use, including the exclusive use, of any
credible evidence or information, relevant to whether a source would
have been in compliance with applicable requirements if the appropriate
performance or compliance test or procedure had been performed.'' 40
CFR 51.212(c). In this rulemaking, EPA is approving a revision to COMAR
<IP_ADDRESS> into the Maryland SIP which requires the use of COMs for
determining compliance with SIP requirements. However, nothing in COMAR
<IP_ADDRESS> precludes the use of credible evidence such as PM CEMs data
or EPA Reference Method 9 readings to determine compliance with
regulatory requirements including opacity limitations. Thus, the
regulation at COMAR <IP_ADDRESS> submitted for SIP approval addresses
and meets 40 CFR 51.212 as it does not preclude the use of credible
evidence and addresses section 110 of the CAA for the Maryland SIP. The
revisions to COMAR <IP_ADDRESS> and <IP_ADDRESS> and new provisions in
COMAR <IP_ADDRESS> and 26.11.31 are approvable for the SIP. Because the
Maryland regulation at COMAR <IP_ADDRESS> submitted for SIP approval
does not specifically address substitution of other compliance methods
or discontinuation of COMs at stationary sources, EPA provides no
further response to Commenter's concerns regarding compliance
methodologies.
    Comment 2: The Commenter expressed concern about attempts to weaken
the opacity limits in the Maryland SIP and about State regulatory
changes that created exemptions to the opacity limits. However, the
Commenter acknowledged that the exceptions to the opacity limits are
contained in COMAR <IP_ADDRESS> and COMAR <IP_ADDRESS>(A)(4), both of
which are not a part of the SIP revision submittal that EPA proposed to
approve in the NPR. Commenter acknowledged EPA's approval of the
November 24, 2015 SIP submittal (as amended February 26, 2016) would
not incorporate these ``exceptions into the SIP.''
    Response 2: EPA thanks the Commenter for its acknowledgments. As
the Commenter clearly stated, EPA's NPR does not propose action on any
revised provisions in COMAR <IP_ADDRESS> nor propose any action on COMAR
<IP_ADDRESS>(A)(4), as MDE withdrew that provision from EPA's
consideration with the February 26, 2016 supplemental letter. Thus, no
further response is necessary to Commenter's statements.

III. Final Action

    Pursuant to section 110 of the CAA, EPA is approving for the
Maryland SIP the revisions to requirements for COMs and CEMs in COMAR
<IP_ADDRESS>, COMAR <IP_ADDRESS> and COMAR <IP_ADDRESS>, approving new
provisions for COMs and CEMs at COMAR <IP_ADDRESS> and approving new
requirements for quality assurance for CEMs at COMAR 26.11.31.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.5, EPA is finalizing the incorporation by reference of the
revised requirements for COMs and CEMs in COMAR <IP_ADDRESS>,
<IP_ADDRESS>, <IP_ADDRESS>, and <IP_ADDRESS> and QA/QC requirements for
COMs in new regulation COMAR 26.11.31. Therefore, these materials have
been approved by EPA for inclusion in the SIP, have been incorporated
by reference by EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of EPA's approval, and will be incorporated by
reference by the Director of the Federal Register in the next update to
the SIP compilation.\2\ EPA has made, and will continue to make, these
materials generally available through http://www.regulations.gov and/or
at the EPA Region III Office (please contact the person identified in
the ``For Further Information Contact'' section of this preamble for
more information).
---------------------------------------------------------------------------

    \2\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by January 6, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action approving COMs and CEMs revisions to Maryland
regulations may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements.

    Dated: September 29, 2016.
Shawn M. Garvin,
Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart V--Maryland

0
2. In Sec.  52.1070, the table in paragraph (c) is amended by:
0
a. Revising the entries for COMAR <IP_ADDRESS>, COMAR <IP_ADDRESS>, and
COMAR <IP_ADDRESS>; and
0
b. Adding the entries COMAR <IP_ADDRESS> and COMAR 26.11.31.
    The revisions and additions read as follows:

Sec.  52.1070  Identification of plan.

* * * * *
    (c) * * *

                 EPA-Approved Regulations, Technical Memoranda, and Statutes in the Maryland SIP
----------------------------------------------------------------------------------------------------------------
                                                                                Additional
        Code of Maryland                                    State                                explanation/
  Administrative  Regulations        Title/subject     effective date    EPA approval date    citation at 40 CFR
        (COMAR) citation                                                                           52.1100
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   26.11.01 General Administrative Provisions
----------------------------------------------------------------------------------------------------------------
<IP_ADDRESS>....................  Definitions.........       5/17/2010  11/7/2016 [Insert     New definition for
                                                                        Federal Register      COMs and clarify
                                                                        citation].            definition for
                                                                                CEMs.

                                                  * * * * * * *
<IP_ADDRESS>....................  Records and                5/17/2010  11/7/2016 [Insert     (c)(172)
                                  Information.                          Federal Register      Administrative
                                                                        citation].            changes to
                                                                                reporting and
                                                                                recordkeeping
                                                                                requirements.

                                                  * * * * * * *
<IP_ADDRESS>....................  Continuous Opacity         8/22/2010  11/7/2016 [Insert     (c)(106)
                                  Monitoring.                           Federal Register      Requirement to use
                                                                        citation].            TM 90-01 is
                                                                                removed.
                                                                                Exceptions: A(4),
                                                                                B(4), D(2)(c), and
                                                                                F.
<IP_ADDRESS>....................  Continuous Emissions       8/22/2010  11/7/2016 [Insert
                                  Monitoring.                           Federal Register
                                                                        citation].

                                                  * * * * * * *
26.11.31.......................  Quality Assurance          6/13/2011  11/7/2016 [Insert
                                  Requirements for                      Federal Register
                                  Opacity Monitors                      citation].
                                  (COMs).

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

* * * * *
[FR Doc. 2016-26866 Filed 11-4-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Page 38786]
[FR Doc No: 2022-13812]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95143; File No. SR-DTC-2021-017]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Designation of Longer Period for Commission Action on
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To Enhance Capital Requirements and Make Other Changes

 June 23, 2022.
    On December 13, 2021, The Depository Trust Company (``DTC'') filed
with the Securities and Exchange Commission (``Commission'') proposed
rule change SR-DTC-2021-017 (the ``Proposed Rule Change'') pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder.\2\ The Proposed Rule Change was published
for comment in the Federal Register on December 29, 2021,\3\ and the
Commission received no comment letters regarding the changes proposed
in the Proposed Rule Change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 93854 (December 22,
2021), 86 FR 74122 (December 29, 2021) (File No. SR-DTC-2021-017)
(``Notice'').
---------------------------------------------------------------------------

    On January 26, 2022, pursuant to Section 19(b)(2) of the Act,\4\
the Commission designated a longer period within which to approve,
disapprove, or institute proceedings to determine whether to approve or
disapprove the Proposed Rule Change.\5\ On March 23, 2022, the
Commission instituted proceedings, pursuant to Section 19(b)(2)(B) of
the Act,\6\ to determine whether to approve or disapprove the Proposed
Rule Change.\7\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
    \5\ Securities Exchange Act Release No. 94067 (January 26,
2022), 87 FR 5548 (February 1, 2022) (File No. SR-DTC-2021-017).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ Securities Exchange Act Release No. 94495 (March, 23, 2022),
87 FR 18451 (March, 30, 2022) (SR-DTC-2021-017).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \8\ provides that proceedings to
determine whether to approve or disapprove a proposed rule change must
be concluded within 180 days of the date of publication of notice of
filing of the proposed rule change. The time for conclusion of the
proceedings may be extended for up to 60 days if the Commission
determines that a longer period is appropriate and publishes the
reasons for such determination.\9\ The 180th day after publication of
the Notice in the Federal Register is June 27, 2022.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
    \9\ 15 U.S.C. 78s(b)(2)(B)(ii)(II).
---------------------------------------------------------------------------

    The Commission is extending the period for Commission action on the
Proposed Rule Change. The Commission finds that it is appropriate to
designate a longer period within which to take action on the Proposed
Rule Change so that the Commission has sufficient time to consider the
issues raised by the Proposed Rule Change and to take action on the
Proposed Rule Change. Accordingly, pursuant to Section
19(b)(2)(B)(ii)(II) of the Act,\10\ the Commission designates August
26, 2022, as the date by which the Commission should either approve or
disapprove the Proposed Rule Change SR-DTC-2021-017.
---------------------------------------------------------------------------

    \10\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-13812 Filed 6-28-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Page 15195]
[FR Doc No: 2018-07169]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2018-25]

Petition for Exemption; Summary of Petition Received; Southern
Utah University

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice; correction.

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

SUMMARY: The FAA published a document in the Federal Register on March
29, 2018, concerning the request for comments on the general curriculum
requirements provided for in 14 Code of Federal Regulations. The
document contained the incorrect Summary Notice Number.

FOR FURTHER INFORMATION CONTACT: Brenda Robeson<PHONE_NUMBER>

Correction

    In the Federal Register of March 29, 2018, in FR Notice Doc 2018-
06333, on page 13582, in the heading of the notice in the center
column, correct the Docket ID Summary Number to read as follows:
    ``Docket Id Summary Notice No. 2018-25''

    Issued in Washington, DC, on April 2, 2018.
Lirio Liu,
Executive Director, Office of Rulemaking.
[FR Doc. 2018-07169 Filed 4-6-18; 8:45 am]
 BILLING CODE 4910-13-P


Environmental commenter 1150 said the proposal lacks any reference to the gains accomplished by NSR, the ongoing enforcement actions, settlements reached as a result of those actions, or the potential gains from the investigations now pending. EPA's reliance on improvements in productive capacity as the measure of success fails to consider that productive capacity must be balanced with the interests of health and welfare.

Environmental commenter 1150 said it is critical to EPA's burden to consider all the relevant factors leading to its conclusion that the exemptions are necessary and appropriate is at the very least an assessment of the expected effects on emissions, which in turn will determine the public health benefits and costs of the proposed rule. Although data on emission reductions achieved under the existing program are available, EPA has stated that it cannot accurately quantify the effects the proposed rule will have on emissions. Before promulgating a final rule, EPA should provide such a quantitative assessment of the rule.

Federal commenter 1002 said that there was no explicit analysis or consideration of the impact that the proposal would have on " grandfathered" coal fired power plants or on the 6  Analyses of Proposed Regulatory Action Internal and Deliberative Draft August 6, 2003 Do not quote, cite, copy, or distribute 6 11 emissions from geographic regions such as the Midwest where many of the old power plants and industrial facilities are located. Such analyses would be important not only for assessing possible U. S. Canada transboundary air pollution consequences but also the possible air pollution transport impact that could exist within the United States between the Midwestern states where many of the " grandfathered" plants are located and the Northeastern states.

One State/ local commenter ( 946) said EPA owes the public a more convincing demonstration, based on location and region specific information using actual emissions data from actual facilities. Another State/ local commenter ( 1361) said EPA has not demonstrated that the RMRR proposal will have a net environmental benefit. This commenter was particularly concerned about the impact of the proposal on nonattainment areas that suffer from pollutant transport from upwind states.

One environmental commenter ( 540) said EPA failed to provide a basic analysis of the age of affected industrial units and the application of the NSR RMRR provisions. The commenter said EPA should evaluate the impacted industries by highlighting the impacted units, their age of operations, expected " normal life," and whether BACT has been installed.

One State/ local commenter ( 1443) said EPA and DOE have not considered the intangible benefits resulting from NSR programs. In particular, the emission limitations imposed through NSR have created incentives for sources to develop innovative means to control such emissions, which is particularly important to heavily polluted areas. Examples include development of low NOx burner technology and low VOC coatings and solvents.

Response:

As shown in the final RIA, it is clear that, for the electric generating sector, the overall scope of the routine maintenance exclusion has little practical impact on the benefits that would be achieved in the future under the NSR program. Capped SO 2 emissions remain unchanged, and NO x emissions change slightly depending upon which modeled scenario is closest to what actually occurs. This change is particularly insignificant when compared to the power sector's national NO x emissions of over 4 million tons per year, or the more than 7 million tons per year of NO x reductions expected from recently promulgated rules.

In addition, the EPA believes that the conclusions of this analysis are generally applicable to all industrial sectors. We do not have tools like IPM for modeling the response of non utility sectors, so our ability to present a quantitative bounding analysis specific to any other sector is limited. We also note that there are some important differences between the utility sector and other sectors. Unlike utilities, other sectors: ( 1) are not subject to a nationwide SO 2 cap, ( 2) are not interconnected and thus do not experience potentially large changes in utilization resulting from changes in dispatch order, ( 3) were, until March 2003, subject to the 6  Analyses of Proposed Regulatory Action Internal and Deliberative Draft August 6, 2003 Do not quote, cite, copy, or distribute 6 12 actual to potential test for NSR applicability, and ( 4) generally have lower emissions, such that emissions are not nearly as sensitive to small changes in utilization.

Despite these differences, the EPA believes that the overall conclusions of the IPM analysis are valid for other sectors. The largest stationary sources of SO2 and NOx emissions other electric utilities are industrial boilers. These units are very similar to boilers in the electric utility industry. They usually only provide steam or energy for the industrial facility where they are located though in some cases they may serve multiple facilities. We believe the IPM runs showing the impacts on NOx emissions, which were not subjected to a cap in our analysis, resulting from different scenarios which a range of effects on capacity or efficiency are equally valid related to SO2 and NOx emissions from industrial boilers. In some cases there may be small increases and in other cases there would be an overall reduction in emissions.

For all other industrial sources, we believe that, in general, facilities in these sectors have regular maintenance, repair and equipment replacement cycles. Work is performed during these cycles to ensure that a facility maintains its productive capacity and facilitates its safe and reliable operation. Equipment replacement activities generally just maintain the operational capability of the facility. In some cases, it may increase the production efficiency of the facility which will usually reduce the amount of emissions per product. These changes generally do not affect the overall emissions of the facility because the emissions are driven by total production at the facility which in turn is driven by the demand for the product   not by the fact that there has been an equipment replacement. We do not believe the final rule will lead to any increases in emissions for these sectors nationally. The EPA believes that the modeled effects of utilities dominate the effects for non utilities, and the overall conclusion of the utility analysis   that the structure of the RMRR replacement has no practical impact on emissions reductions under the NSR program   is valid, despite our inability to model these other sectors individually.

6.2.7 Comments on August 2002 Information Collection Request Comment:

Environmental commenter 1150 said the August 2002 ICR pertains solely to the burdens, costs and benefits to regulated sources. The fact that EPA did not seek comment on expected emission reductions or health benefits ( or costs), skews the analysis and renders any conclusion arbitrary and capricious. The commenter said in a rulemaking of this magnitude that EPA has the authority and obligation to conduct a thorough review of both the economic and emissions aspects of NSR through a systematic collection of data from the regulated industry. Instead, the commenter said EPA has been woefully deficient in collecting and maintaining data necessary to the proper enforcement of the program. The commenter cited conclusions summarized in a report by NAPA on the NSR program in support of his views.

Response: 6  Analyses of Proposed Regulatory Action Internal and Deliberative Draft August 6, 2003 Do not quote, cite, copy, or distribute 6 13 The primary purposes of the Paperwork reduction Act is minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, Federal contractors, State, local and tribal governments, and other persons resulting from the collection of information by or for the Federal Government and ensure the greatest possible public benefit from and maximize the utility of information created, collected, maintained, used, shared and disseminated by or for the Federal Government. The information collection request prepared for a regualtion is to document the paperwork burden being placed on individuals, small businesses, educational and nonprofit institutions, Federal contractors, State, local and tribal governments, and other persons EPA and the States have other means available to them under the Clean Air Act to collect information and to enforce applicable requirements. These are not the focus of an information collection request for a specific rule.

6.3 Executive Order 12866 Analyses Comment:

Six environmental commenters ( 712, 713, 714, 738, 1150, 1514) said EPA failed to meet its requirements under E. O. 12866 to provide the required RIA. They said one should be developed and the public should have a chance to review it.

One environmental commenter ( 1150) stated that EPA has failed to meet procedural requirements of E. O. 12866, including section 6( a), which requires EPA to involve those intended to benefit from and be burdened by the regulation before proposing it, section 6( a)( 3)( B)( ii), which requires EPA to explain the statutory basis for its proposal, and section 6( a)( 3)( C)( ii), which requires EPA to assess impacts on public health, safety, and the natural environment. The commenter concluded that any action by EPA to promulgate the proposed rule would be arbitrary, capricious, and otherwise not in accordance with law.

Other environmental commenters ( 712, 713, 714, 738) stated that EPA has failed to provide the required RIA, even though the OMB has found that the rule is economically significant. These commenters ( 712, 713, 714, 738, 1514) requested that EPA fully analyze the health and environmental impacts of the proposed rule and prepare an RIA. They suggested that the proposed rule will have major health and environmental impacts if implemented and cited various estimates of adverse impacts. For example, a study by AbT Associates concluded, among other things, that requiring power plants to install modern air pollution controls would prevent over 18,700 premature deaths each year and provide well over $ 100 billion per year in monetary benefits. Delaying these improvements will lead to tremendous health and monetary costs.

One commenter ( 1514) said the public should have an opportunity to review the RIA as part of the public comment process.

Response: 6  Analyses of Proposed Regulatory Action Internal and Deliberative Draft August 6, 2003 Do not quote, cite, copy, or distribute 6 14 To comply with the Executive Order, EPA prepared a draft Regulatory Impact Analysis ( RIA) at the time of proposal and made that available for public comment. Based on these comments EPA has prepared a final RIA which has been submitted and cleared by OMB and placed in the docket for this rulemaking.


[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Notices]
[Page 15976-15977]
[DOCID:fr08ap09-57]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0222; FRL-8409-4]

Notice of Receipt of a Pesticide Petition Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the Agency's receipt of an initial
filing of a pesticide petition proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before May 8, 2009.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number EPA-HQ-OPP-2009-0222 and the pesticide
petition number (PP) 8F7489, 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>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0222 and the pesticide petition number (PP) 8F7489. EPA's policy
is that all comments received will be included in the docket without
change and may be made available on-line at http://www.regulations.gov,
including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Do not submit information that you consider to be CBI or otherwise
protected through regulations.gov or e-mail. The regulations.gov
website is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: 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., 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 either 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 hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Cheryl Greene, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
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. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the

disk or CD-ROM as CBI and then identify electronically within the disk
or CD-ROM the specific information that is claimed as CBI. In addition
to one complete version of the comment that includes information
claimed as CBI, a copy of the comment that does not contain the
information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. 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. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have a typical or disproportionately high and adverse
human health impacts or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.

II. What Action is the Agency Taking?

    EPA is announcing receipt of a pesticide petition filed under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or modification of regulations
in 40 CFR part 174 or part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petition described in this notice contains data or information
prescribed in FFDCA section 408(d)(2); however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the pesticide petition. Additional data
may be needed before EPA can make a final determination on this
pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition that is the
subject of this notice, prepared by the petitioner, is included in a
docket EPA has created for this rulemaking. The docket for this
petition is available on-line at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerance Exemption

    EPA has received a pesticide petition PP 8F7489 from EcoSMART
Technologies, Inc., 3600 Mansell Road, Suite 150, Alpharetta, GA 30022
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to
establish an exemption from the requirement of a tolerance for the
biochemical pesticide 2-Phenethyl Propionate.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: April 1, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E9-7988 Filed 4-7-09; 8:45 am]

BILLING CODE 6560-50-S