MEMORANDUM  SEQ CHAPTER \h \r 1

TO:		Melanie King, EPA OAQPS/SPPD/ESG

FROM:	Bradley Nelson, EC/R, Inc.

DATE:		September 21, 2009

SUBJECT:	Summary of the September 15, 2009 Meeting with the Operators of
Landfill Gas Engines and the U.S. Environmental Protection Agency to
discuss the Proposed NESHAP for Existing Stationary Reciprocating
Internal Combustion Engines

1.0	INTRODUCTION

Several companies that operate landfill gas (LFG) engines requested this
meeting with EPA to discuss issues with the proposed national emission
standards for hazardous air pollutants (NESHAP) for existing stationary
reciprocating internal combustion engines (RICE).  This meeting summary
will be available in the docket for this rulemaking (Docket ID No.
EPA-HQ-OAR-2008-0708).  The proposed NESHAP for existing stationary RICE
was published in the Federal Register on March 5, 2009 (74 FR 9698).

2.0	ATTENDEES

U.S. Environmental Protection Agency

Melanie King, OAQPS/SPPD/ESG

Michael Horowitz, OGC (by phone)

Swarupa Ganguli, Landfill Methane Outreach Program  (by phone)

Victoria Ludwig, Landfill Methane Outreach Program (by phone)

Landfill Gas Engine Operators

Mike LaFramboise, Landfill Energy Systems

Bill Deckert, Energy Developments Inc.

Mike Dae, Energy Developments Inc.

Steve King, PNGC Power

Dennis Plaster, Innovative Energy Systems

Pete Zeliff, Innovative Energy Systems

Ben Benson, Energyneering

William Song, Energyneering

Billy Malone

EC/R Incorporated (EPA Contractor)

Bradley Nelson

3.0	SUMMARY OF MEETING

Industry representatives opened the meeting by stating that they
represent a small segment of the landfill gas-to-energy operators in the
U.S.  Industry had requested the meeting with EPA to help understand how
decisions regarding landfill gas engines were made for the proposed
rule.  EPA responded that the RICE NESHAP was promulgated in 2004 for
engines greater than 500 horsepower (HP) located at major sources.  In
that rule, EPA determined that the maximum achievable control technology
(MACT) floor for landfill gas engines was no control.  EPA noted that
the landfill gas engines were not exempt in that rule, but that there
were no emissions requirements.  EPA stated that in March 2007, the
courts ruled that “no control” MACT floors are not emission
standards, and required EPA to establish emission requirements for major
sources.  The ruling is commonly referred to by EPA as the Brick MACT
ruling.  Therefore, for this proposed rule, EPA was required to
establish emission requirements for the landfill gas engines less than
500 HP located at major sources.  EPA asked industry if landfill gas
engines are mainly located at areas sources or major sources.  Industry
responded that it varies and that the determining factor is the size of
the landfill.

Industry representatives stated that the proposed carbon monoxide (CO)
emission limit (177 parts per million (ppm)) for landfill gas engines is
not achievable and that a CO emission standard similar to the spark
ignition NSPS of 610 ppm of CO would be more appropriate.  EPA stated
that the approach and criteria used to develop emission standards under
the NSPS program are different than those used for developing emission
standards under the NESHAP program.  EPA stated that it relied on the
test data from the emission database for determining the top 12 percent
for setting the MACT standard.  Industry responded that it cannot use
control technologies to reduce CO and indicated that there are no
landfill gas engines capable of achieving 177 ppm CO.  Industry further
stated that the only option would be to shut down the engines, which
would cause a problem with many facilities due to long term power
agreements.  Industry noted that Caterpillar and Jenbacher only
guarantee emissions for the first 100 hours of operation for landfill
gas engines.  Industry also referred to a study done by the Bay Area Air
Quality Management District, which determined based on source test
results and operator experience that it is impractical to expect
reductions in both nitrogen oxides (NOX) and CO emission levels
simultaneously, without the use of downstream controls.  Therefore, if
engines are turned to achieve low CO emissions, the emissions of NOX
increase beyond NOX permit limits, according to industry.

Industry asked EPA if only 12 percent of the landfill gas engine can
achieve the proposed 177 ppm CO limit, how are the other 88 percent of
landfill gas engines expected to comply with this standard.  EPA
responded that it is required by Congress to establish the standards
based on the requirements in the Clean Air Act.  EPA can, however,
consider variability when setting the emission standards.  EPA also
stated that it could consider management practice standards for engines
greater than 500 HP at area sources.  For engines less than 500 HP
located at area sources, EPA required management practices in the
proposed rule.  The already promulgated 2004 NESHAP has no emission
requirements for landfill gas engines greater than 500 HP located at
major sources.  However, EPA noted that the promulgated RICE NESHAP will
be reviewed in 2012.  EPA recommended that industry provide new test
data to show the current emissions from landfill gas engines.  EPA also
asked industry to provide information on management practice standards
for landfill gas engines.  EPA stated that the management practice
standards must measurable and enforceable.

EPA stated that it would need the management practice information and
test data by the end of September to be able to include the information
in the final rule, which is scheduled to be signed on February 10, 2010.
 EPA also stated that it would look at the variability of CO emissions
from the landfill gas engines.  Industry stated that most engines are
overhauled before the compliance tests, and that the reported emissions
should be considered as the best case scenario.

 Revisiting BACT for Lean Burn Landfill Gas Fired Internal Combustion
Engines, Bay Area Air Quality Management District, February 26, 2009.
HYPERLINK
"http://hank.baaqmd.gov/pmt/bactworkbook/white_paper-lb_lfg_ice_bact_2-2
6-09_final.pdf"
http://hank.baaqmd.gov/pmt/bactworkbook/white_paper-lb_lfg_ice_bact_2-26
-09_final.pdf

E C/R Incorporated	Providing Environmental Technical Support Since 1989

  PAGE   \* MERGEFORMAT  3


  SEQ CHAPTER \h \r 1 Form for Compliance with E.O. 12866 Docket
Requirements

Title of Regulation:         Final Rule on Application of Pesticides to
Waters of the United States in Compliance with FIFRA

Contact person:    Virginia Garelick, Water Permits Division, Office of
Wastewater Management

Phone number:

202-564-2218

Was this regulation reviewed by OMB under Executive Order 12866 -
Regulatory Planning and Review?

Yes          No

If you checked “no”, you are done with this form.  Simply place it
in the docket for your regulation.  If you checked “yes”, please
fill out the remainder of the form before placing it in the docket.
Also docket any relevant documents referenced in the form.

For regulations that are checked “Yes” above:

This regulation was reviewed by OMB under Executive Order 12866 -
Regulatory Planning and Review.

Attached is the draft regulation and any other documents sent to OMB for
review, such as analyses and assessments.   E.O. 12866 requires agencies
to make these publicly available.

E.O. 12866 also requires agencies to identify the substantive changes
between the draft regulation sent to OMB for review and the regulation
subsequently announced  [Please check the appropriate box below:]

     	EPA made substantive changes to this regulation

(includes changes initiated by EPA or OMB).

Attached is a document which: (1) identifies all the substantive changes
made, and (2) notes those changes OMB suggested or recommended.

 X 	No substantive changes were made to this regulation

EPA made only editorial rather than substantive changes to the rule and
preamble in response to comments from OMB.  EPA is attaching is the
draft regulation and preamble sent to OMB for review as well as the
changes made due to OMB’s comments.

If you have questions about this regulation, please call the EPA contact
person listed above.


[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Rules and Regulations]
[Pages 28741-28742]
[FR Doc No: 2019-12956]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0364]
RIN 1625-AA00

Safety Zone; Ohio River, Miles 90.8 to 91.4, Wheeling, WV

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Ohio River from mile 90.8 to mile 91.4. The
safety zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by a land based fireworks
display. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by Captain of the Port Marine Safety
Unit Pittsburgh.

DATES: This rule is effective from 8:30 p.m. through 10:30 p.m. on July
27, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2019-0364 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh,
U.S. Coast Guard, at telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. It would be
impracticable to complete the full NPRM process for this safety zone
because we need to establish it by July 27, 2019 and lack sufficient
time to provide a reasonable comment period and then consider those
comments before issuing the rule.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Marine
Safety Unit Pittsburgh (COTP) has determined that a safety zone is
needed to protect personnel, vessels, and the marine environment from
potential hazards created from a land based firework display.

IV. Discussion of the Rule

    This rule establishes a safety zone on July 27, 2019, from 8:30
p.m. through 10:30 p.m. The safety zone will cover all navigable waters
on the Ohio River from mile 90.8 to mile 91.4. The duration of the
safety zone is intended to protect personnel, vessels, and the marine
environment from potential hazards created by a land based firework
display.
    No vessel or person is permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard (USCG) assigned to units under the operational
control of the COTP. To seek permission to enter, contact the COTP or a
designated representative via VHF-FM channel 16, or through Marine
Safety Unit Pittsburgh at<PHONE_NUMBER>. Persons and vessels permitted
to enter the safety zone must comply with all lawful orders or
directions issued by the COTP or designated representative. The COTP or
a designated representative will inform the public of the effective
period for the safety zone as well as any changes in the dates and
times of enforcement through Local Notice to Mariners (LNMs), Broadcast
Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins
(MSIBs), as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. This safety zone impacts a
one half-mile stretch of the Ohio River for a limited duration of two
hours. Vessel traffic will be informed about the safety zone through
local notices to mariners. Moreover, the Coast Guard will issue LNMs,
MSIBs, and BNMs via VHF-FM marine channel 16 about the zone and the
rule allows vessels to seek permission to transit the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a

significant economic impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting less than two
hours that will prohibit entry on the Ohio River from mile 90.8 to mile
91.4, during the land based firework event. It is categorically
excluded from further review under paragraph L60(a) in Table 3-1 of
U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1.
A Record of Environmental Consideration supporting this determination
is available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0364 to read as follows:

Sec.  165.T08-0364  Safety Zone; Ohio River, Miles 90.8 to mile 91.4,
Wheeling, WV.

    (a) Location. The following area is a safety zone: All navigable
waters of the Ohio River from mile 90.8 to mile 91.4.
    (b) Effective period. This section is effective from 8:30 p.m.
through 10:30 p.m. on July 27, 2019.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of persons and vessels into this zone is prohibited
unless authorized by the Captain of the Port Marine Safety Unit
Pittsburgh (COTP) or a designated representative.
    (2) Persons or vessels requiring entry into or passage through the
zone must request permission from the COTP or a designated
representative. The COTP's representative may be contacted at 412-221-
0807.
    (3) All persons and vessels shall comply with the instructions of
the COTP or a designated representative. Designated COTP
representatives include United States Coast Guard commissioned,
warrant, and petty officer.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public through Local Notice to Mariners (LNMs),
Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information
Bulletins (MSIBs), as appropriate.

A.W. Demo,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2019-12956 Filed 6-19-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: October 20, 2006 (Volume 71, Number 203)]
[Notices]
[Page 61972-61973]
[DOCID:fr20oc06-45]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2005-0026; FRL-8232-9]

Final Section 106 Tribal Grant Guidance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This document provides notice of the final Guidance on Awards
of Grants to Indian Tribes under Section 106 of the Clean Water Act:
For Fiscal Year 2007 and Future Years. This Guidance provides the
Environmental Protection Agency and Tribes with a consistent framework
of procedures and guidelines for awarding and administering grants to
federally recognized Tribes under the authority of Section 106 of the
Clean Water Act. Specifically, this Guidance will assist Tribal water
quality program managers, staff, and other Tribal environmental
decision-makers in designing and implementing an effective and
successful water quality program utilizing Section 106 funds. The
Section 106 Tribal Guidance focuses on Tribal water quality programs at
all levels of sophistication and development. For new programs, it
explains how to successfully initiate and develop a water quality
program. For Tribes with well-established programs, it contains
information on expanding a water quality program. To meet the needs of
Tribes at all levels of development, this Guidance presents the basic
steps a Tribe would take to collect the information it will need to
make effective decisions about its program, its goals, and its future
direction. This final Guidance will take effect for grants issued by
the Environmental Protection Agency's Regional Offices in fiscal year
2007. This action affects all Tribal environmental programs that
receive Section 106 Tribal grants.

DATES: This final Guidance is effective on October 20, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OW-2005-0026. All documents in the docket are listed in the
http://www.regulations.gov index. 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 publicly available only in hard copy.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at

the Water Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave.,
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Water Docket is<PHONE_NUMBER>.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation, for people who wish to visit the Public Reading Room to
view documents. Consult EPA's Federal Register Notice at 71 FR 38147
(July 5, 2006) or the EPA Web site at http://www.epa.gov/epahome/dockets.htm
 for current information on docket status, locations, and

telephone numbers.

FOR FURTHER INFORMATION CONTACT: Lena Ferris, Office of Water, Office
of Wastewater Management, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., 4201M, Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

    Affected Entities: Tribes that are eligible to receive grants under
Section 106 of the Clean Water Act.

II. Background

    Over the past 10 years, funding available for Section 106 grants to
Indian Tribes has increased from $3 million to $25 million per year.
This Guidance more clearly defines expectations and requirements for
Tribal Section 106 grant recipients and provides a framework for
evaluating program results. This document is an effort to provide
unified guidance that helps Tribes develop and implement water quality
programs and defines what EPA expects from Tribal programs. It provides
an overview of all programmatic and technical requirements, discusses
common considerations across programs and links to technical resources
available to develop Tribal programs. This document outlines new
reporting requirements and data management expectations for all Tribal
programs receiving Section 106 funds. Data collected as a result of the
new reporting requirements will help EPA measure environmental results
of the Section 106 Tribal Program and comply with the Government
Performance and Results Act (GPRA) and other Federal mandates. EPA
published a Notice of Availability regarding a draft version of this
Guidance on April 27, 2006 (71 FR 24852). The Agency provided a sixty-
day public comment period, in which more than two-hundred comments were
received. These comments encompassed four major areas: (1) Monitoring/
data reporting (including STORET-related issues); (2) funding
(including EPA's future plans with respect to linking Section 106
funding to the various Tribal program activity levels outlined within
the Guidance document); (3) training/technical assistance; and (4)
miscellaneous comments (i.e., Guidance implementation issues and
aligning the Guidance to the Agency's Strategic Plan). As a result of
these comments, various communication efforts were undertaken in order
to effectively and efficiently provide resolution. Responding to these
comments, EPA made minor changes to the actual Guidance text. The
Agency has developed a comprehensive Response to Comments (RTC)
document outlining details of submitted comments and their associated
responses. This document also provides specific locations of the actual
Guidance text that have been modified and outlines the exact
modifications that were made. This RTC document and final Guidance can
be found at the Environmental Protection Agency's Web site at http://www.epa.gov/
[fxsp0]owm/cwfinance/106tgg07.htm, or by contacting the

point of contact listed under the section entitled FOR FURTHER
INFORMATION CONTACT.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and is therefore not
subject to OMB review. Because this grant action is not subject to
notice and comment requirements under the Administrative Procedures Act
or any other statute, it is not subject to the Regulatory Flexibility
Act (5 U.S.C. 601 et.) or sections 202 and 205 of the Unfunded Mandates
Reform Act of 1999 (UMRA) (Pub. L. 104-4). In addition, this action
does not significantly or uniquely affect small governments. Although
this action does not generally create new binding legal requirements,
where it does, such requirements do not substantially and directly
affect Tribes under Executive Order 13175 (63 FR 67249, November 9,
2000). Informal consultation has been conducted with Tribes, and a
formal comment period was also provided. This action will not have
federalism implications, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999). This action is not subject to Executive Order
13211, ``Actions Concerning Regulations that Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001),
because it is not a significant regulatory action under Executive Order
12866. This action does not involve technical standards; thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action
does not impose an information collection burden under the provisions
of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The
Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that
before certain actions may take effect, the agency promulgating the
action must submit a report, which includes a copy of the action, to
each House of the Congress and to the Comptroller General of the United
States. Since this grant action contains legally binding requirements,
it is subject to the Congressional Review Act, and EPA will submit this
final Guidance in its report to Congress under the Act.

    Dated: October 13, 2006.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
 [FR Doc. E6-17570 Filed 10-19-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76474-76481]
[FR Doc No: 2022-27130]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0417; FRL-10108-01-OCSPP]

Chlorpyrifos; Notice of Intent To Cancel Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), the Environmental Protection Agency (EPA)
hereby announces its intent to cancel the registrations of three
pesticide products containing the insecticide chlorpyrifos due to the
Agency's revocation of all tolerances for chlorpyrifos. This document
identifies the products at issue, summarizes EPA's basis for this
Notice of Intent to Cancel (NOIC), and explains how adversely affected
persons may request a hearing and the consequences of requesting or
failing to request such a hearing.

DATES: The affected registrant must request a hearing within 30 days
from the date that the affected registrant receives EPA's NOIC, or on
or before January 13, 2023, whichever occurs later. Other adversely
affected parties must request a hearing on or before January 13, 2023.
Please see unit VII. for specific instructions.

ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPP-2022-0417, is available online at
https://www.regulations.gov. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
    All persons who request a hearing must comply with the Agency's
Rules of Practice Governing Hearings, 40 CFR part 164. Requests for
hearing must be filed with the Hearing Clerk in EPA's Office of
Administrative Law Judges (OALJ), in conformance with the requirements
of 40 CFR part 164. The OALJ uses different addresses depending on the
delivery method. Please see unit VII. for specific instructions.

FOR FURTHER INFORMATION CONTACT: Elissa Reaves, Pesticide Re-Evaluation
Division (7508M), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    EPA is announcing its intent to cancel the registrations of three
pesticide products containing the insecticide chlorpyrifos due to the
revocation of all chlorpyrifos tolerances. Specifically, EPA intends to
cancel each of the following pesticide products, which allow for use on
food crops, listed in sequence by EPA registration number.
     EPA Reg. No. 93182-3 Chlorpyrifos Technical.
     EPA Reg. No. 93182-7 Pilot 4E Chlorpyrifos Agricultural
Insecticide.
     EPA Reg. No. 93182-8 Pilot 15G Chlorpyrifos Agricultural
Insecticide.
    The following information is the address on record for Gharda, the
registrant of the products listed in this unit and subject to this
notice, and includes the company number which corresponds to the first
part of the EPA registration number of the products:
     EPA Co. No. 93182--Gharda Chemicals International, Inc.,
4932 Crockers Lake Blvd., Suite 818, Sarasota, Florida 34238.
    In addition, this document summarizes EPA's legal authority for the
proposed cancellation (see unit II.); the revocation of tolerances for
residues of chlorpyrifos on food commodities (see unit III.); the
Agency's rationale for issuance of this NOIC (see unit IV.); the timing
of the proposed cancellations, EPA's existing stocks determination, and
the potential scope of any final cancellation order (see unit V.); the
results of the Agency's coordination with the U.S. Department of
Agriculture (USDA) and the FIFRA Science Advisory Panel (SAP) (see unit
VI.); and how eligible persons may request a hearing and the
consequences of requesting or failing to request such a hearing (unit
VII.).

B. What is the Agency's authority for this action?

    The Agency's authority to cancel a pesticide that does not comply
with the provisions of FIFRA is contained in FIFRA section 6(b), 7
U.S.C. 136d(b).

C. Who may be affected by this action?

    This announcement will directly affect the pesticide registrant
listed in

unit I.A., supplemental distributors, and others who may distribute,
sell, or use the products listed in unit I.A. This announcement may
also be of particular interest to a wide range of stakeholders
including environmental, human health, farmworker, and agricultural
advocates; the chemical industry; pesticide users; and members of the
public interested in the sale, distribution, or use of pesticides. EPA
believes the stakeholders described above encompass those likely to be
affected; however, more remote interests may also be affected, and the
Agency has not attempted to describe all specific entities that may be
affected by this action.

II. Legal Authority

    With minor exceptions not at issue here, as provided in FIFRA
section 3(a), a pesticide product may not be lawfully sold or
distributed in the United States unless and until the product is
registered by EPA. 7 U.S.C. 136a(a). A pesticide registration is a
license allowing a pesticide product to be sold and distributed and
includes a label with use instructions that delineates the specific
uses for which the pesticide may be used, including precautions and
other terms and conditions established by EPA when it grants the
registration.
    As a general matter, in order to obtain or maintain a registration
for a pesticide under FIFRA, an applicant or registrant must
demonstrate that the pesticide satisfies the statutory standard for
registration. 7 U.S.C. 136a(c)(5). That standard requires, among other
things, that the pesticide perform its intended function without
causing ``unreasonable adverse effects on the environment.'' Id. The
term ``unreasonable adverse effects on the environment'' is defined
under FIFRA section 2(bb) as including two parts: (1) ``[A]ny
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide'' and (2) ``[A] human dietary risk from residues that
result from a use of a pesticide in or on any food inconsistent with
the standard under section 346a of title 21.'' 7 U.S.C. 136(bb). It is
under the second part of the definition that the FIFRA registration
standard incorporates the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, safety standard.
    EPA establishes, modifies, or revokes tolerances for pesticide
residues under FFDCA section 408. 21 U.S.C. 346a. A ``tolerance''
represents the maximum level for residues of a pesticide legally
allowed in or on raw agricultural commodities and processed food. Under
the FFDCA, ``any pesticide chemical residues in or on a food shall be
deemed unsafe,'' unless a tolerance or exemption for such residues ``is
in effect''. 21 U.S.C. 346a(a)(1). In other words, without a tolerance
or an exemption from the requirement of a tolerance, pesticide residues
in or on food are considered unsafe, as a matter of law. The
consequence of having pesticide residues in or on food that are not
covered by a tolerance, or an exemption is that the food containing
such residues is rendered adulterated under the FFDCA. 21 U.S.C.
342(a)(2)(B). It is a violation of the FFDCA to introduce adulterated
food into interstate commerce. 21 U.S.C. 331(a).
    Because the FIFRA registration standard incorporates the FFDCA
safety standard, a pesticide that results in residues in or on food
that are unsafe, which includes residues not covered by a tolerance or
tolerance exemption, does not meet the FIFRA registration standard. EPA
will not approve any application to register a pesticide with food uses
that may reasonably be expected to result in pesticide residues on food
without appropriate tolerances or exemptions in place, see 40 CFR
152.112(g), and registrations bearing labeling for food use must be
modified or cancelled, pursuant to FIFRA section 6(b).
    The burden of demonstrating that a pesticide product satisfies the
statutory criteria for registration is at all times on the proponents
of the initial or continued registration and continues as long as the
registration is in effect. 40 CFR 164.80(b); see also Industrial Union
Dept. v. American Petroleum Institute, 448 U.S. 607, 653 n.61 (1980);
Stearns Electric Paste v. EPA, 461 F.2d 293 (7th Cir. 1972);
Environmental Defense Fund v. EPA, 510 F.2d 1292, 1297 (D.C. Cir.
1975).
    Under FIFRA section 6(b), the Agency may issue a notice of its
intent to cancel a registration of a pesticide product whenever it
appears either that ``a pesticide or its labeling or other material
required to be submitted does not comply with FIFRA, or when used in
accordance with widespread and commonly recognized practice, the
pesticide generally causes unreasonable adverse effects on the
environment.'' 7 U.S.C. 136d(b). The cancellation proposed in the
notice shall become final 30 days after publication of the notice, or
the date the registrant receives the notice, whichever is later, unless
the registrant makes the necessary corrections to the registrations, or
a hearing is requested by a person adversely affected by the notice. If
a hearing is requested by an adversely affected person, the final order
concerning cancellation of the product is not issued until after an
administrative hearing.
    A cancellation hearing shall be conducted in accordance with the
regulations establishing the procedures for hearings under FIFRA set
forth at 40 CFR part 164. Under those regulations, the Agency has the
burden of presenting an affirmative case for cancellation. 40 CFR
164.80(a). However, the ultimate burden of proof is on the proponent of
the registration. 40 CFR 164.80(b); Industrial Union Dept., 448 U.S. at
653, n. 61; Stearns Electric Paste v. EPA, 461 F.2d 293 (7th Cir.
1972). Once the Agency makes its prima facie case that a product's
continued use fails to meet the FIFRA standard for registration, the
responsibility to demonstrate that the product meets the FIFRA standard
is upon the proponents of continued registration. 40 CFR 164.80(b); Dow
v. Ruckelshaus, 477 F.2d 1317, 1324 (8th Cir. 1973).

III. Revocation of Chlorpyrifos Tolerances

    Chlorpyrifos is a broad-spectrum, chlorinated organophosphate
insecticide that is registered for a wide variety of food and non-food
uses. In September 2007, Pesticide Action Network North America and
Natural Resources Defense Council filed a petition with EPA requesting
revocation of all chlorpyrifos tolerances alleging that, among other
things, the pesticide caused adverse neurodevelopmental effects in
children at exposure levels below the Agency's regulatory standard
(i.e., 10% acetylcholinesterase inhibition). See Petition to Revoke All
Tolerances and Cancel All Registrations for the Pesticide Chlorpyrifos,
available at https://www.regulations.gov, using document identification
number EPA-HQ-OPP-2007-1005-0005. Following several years of proposed
responses and litigation, EPA issued a final response to the petition
on March 29, 2017. See 82 FR 16581, April 5, 2017 (FRL-9960-77). That
response denied the many claims of the petition, including by
concluding that, despite several years of study, the science addressing
neurodevelopmental effects remained unresolved and that further
evaluation of the science on this issue during the remaining time for
completion of registration review was warranted. See id. at 16590. As
permitted under the FFDCA, objections to EPA's denial were filed, and
EPA responded to those objections on July 18, 2019. See 84 FR 35555,
July 18, 2019 (FRL-9997-06). In its denial of those objections, rather
than issuing a

determination concerning the safety of chlorpyrifos, EPA denied the
objections in part on the grounds that the data concerning
neurodevelopmental toxicity were not sufficiently valid, complete, and
reliable to meet the petitioners' burden. See id. at 35562. EPA's
denial of the petition and denial of objections were subsequently
challenged by several advocacy groups and states in the Ninth Circuit.
    On April 29, 2021, the Ninth Circuit Court of Appeals ruled against
EPA in litigation involving the question of whether the chlorpyrifos
tolerances should be revoked. See League of United Latin American
Citizens et al., v. Regan, 996 F.3d 673 (9th Cir. 2021) (``LULAC''). In
that case, the Court concluded that EPA violated the FFDCA by not
making a safety determination to support the retention of the
chlorpyrifos tolerances, as required under the FFDCA. Consequently, the
Court ordered EPA to issue a final rule in which the Agency would
either revoke the tolerances (if it could not make the requisite safety
finding to leave tolerances in place) or modify the existing
chlorpyrifos tolerances, provided that the Agency concurrently issued a
safety determination supporting the modified tolerances. The Court
imposed a tight deadline for EPA to issue the final rule and told EPA
not to engage in further fact-finding or delay. Specifically, the court
said: ``To be clear, however, this is not an open-ended remand or a
remand for further factfinding. The EPA must act based upon the
evidence and must immediately revoke or modify chlorpyrifos tolerances.
For these reasons, the Court remands this matter to the EPA with
instructions to publish a legally sufficient final response to the 2007
Petition within 60 days of the issuance of the mandate.''
    In implementing the Court's order within the mandated timeframe,
EPA found that it could not make a safety finding to support leaving
the current tolerances for residues of chlorpyrifos in place, as
required under the FFDCA section 408(b)(2). 21 U.S.C. 346a(b)(2). Under
the FFDCA, a tolerance may be left in place only if the Agency
determines that the tolerances are safe, i.e., that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residues, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' Id. Because EPA found that at the time it could not
determine that there was a reasonable certainty that no harm would
result from aggregate exposure to chlorpyrifos residues, including all
anticipated dietary (food and drinking water) exposures and all other
exposures, EPA published the final rule revoking all tolerances for
chlorpyrifos in the Federal Register on August 30, 2021. 86 FR 48315,
August 30, 2021 (FRL-5993-04-OCSPP) (the Final Rule). As described in
greater detail in the Final Rule, the Agency's analysis indicated that
aggregate exposures (i.e., exposures from food, drinking water, and
residential exposures), which stem from then-currently registered uses,
exceeded safe levels. Id. at 48317. That analysis relied on the well-
established 10% red blood cell acetylcholinesterase (RBC AChE)
inhibition level as an endpoint for risk assessment and included the
FFDCA default tenfold (10X) margin of safety to account for
uncertainties related to the potential for adverse neurodevelopmental
effects to infants, children, and pregnant women. Id. The Final Rule
revoked the chlorpyrifos tolerances but provided a transition period of
six months, until February 28, 2022. Id. at 48334.
    Pursuant to FFDCA section 408(g)(2), EPA provided an opportunity to
file objections to the Final Rule and seek an evidentiary hearing on
those objections. See also 21 U.S.C. 346a(g)(2); 40 CFR 178.32(b). In
response to the Final Rule, several objections, hearing requests, and
requests to stay the Final Rule were filed by parties representing a
wide variety of growers and pesticide users. On February 28, 2022, EPA
published its order denying all objections, hearing requests, and
requests to stay the Final Rule in the Federal Register (87 FR 11222,
February 28, 2022) (FRL-5993-05-OCSPP) (the Denial Order). EPA's
publication of the Denial Order completed the Agency's administrative
process for the Final Rule. Pursuant to the terms of the Final Rule,
all chlorpyrifos tolerances expired on February 28, 2022. EPA notes
that EPA's Final Rule revoking chlorpyrifos tolerances is a separate
final agency action, and as such, comments challenging EPA's action in
that Final Rule are outside the scope of this Notice. Gharda and
several other grower groups have challenged that rule in the U.S. Court
of Appeals for the Eighth Circuit, see Red River Valley Sugarbeet
Growers Ass'n et al., v. Regan (9th Cir. No. 22-1422).
    Because at this time there are no tolerances or exemptions from the
requirement of a tolerance for chlorpyrifos residues in or on food,
there is no basis for allowing food uses to remain on chlorpyrifos
registered products. See 21 U.S.C. 346a(a)(1). Therefore, between March
1 and March 9 of 2022, after EPA's publication of the Denial Order, EPA
issued letters to all registrants of chlorpyrifos products with food
uses confirming revocation of the tolerances and recommending that such
registrants consider various cancellation and label amendment options.
EPA requested that registrants submit a letter formally expressing
their intention to submit registration amendments to remove food uses
from product labels or to submit a voluntary cancellation for products
where all uses are subject to the tolerance revocation by March 30,
2022. All chlorpyrifos registrants to whom that letter was sent have
submitted requests to voluntarily cancel their pesticide products and/
or label amendments to remove food uses from their chlorpyrifos
pesticide product labels, with the exception of Gharda, the registrant
of products listed in this Notice. While Gharda submitted requests for
voluntary cancellation for some uses and some label amendments, that
request does not fully align with the revocation of chlorpyrifos
tolerances (i.e., it does not result in the removal of all food uses
from those registered products); therefore, Gharda's products
identified in unit I.A. are subject to this Notice.

IV. Basis for Issuance of Notice of Intent To Cancel

    EPA has determined that the chlorpyrifos registrations listed in
unit I.A. must be cancelled because they each bear labeling for use on
food crops. Due to the lack of tolerances for residues of chlorpyrifos,
these products, bearing labeling for use on food crops, (i) pose
unreasonable adverse effects on the environment under FIFRA section
2(bb)(2), 7 U.S.C. 136(bb)(2), because use of chlorpyrifos on food
results in unsafe pesticide residues under the FFDCA and (ii) are
misbranded and thus not in compliance with FIFRA, 7 U.S.C.
136j(a)(1)(E).
    As noted in unit II., tolerances establish the maximum amount of
pesticide residues that are allowed in or on a food. In situations
where no tolerance exists to cover residues of a particular pesticide
in or on food, those residues are ``deemed unsafe,'' as a matter of law
under the FFDCA. 21 U.S.C. 346a(a)(1). As a consequence, a pesticide
resulting in residues in or on food for which there is no tolerance
does not meet the FIFRA standard for registration. See 7 U.S.C.
136(bb). Moreover, any food containing ``unsafe'' pesticide chemical
residues is ``deemed to be adulterated,'' and introduction of that food
into interstate commerce is a violation of the FFDCA. 21 U.S.C.
342(a)(2)(B), 331(a).

A. The Pesticide Generally Causes Unreasonable Adverse Effects on the
Environment Because It Is Unsafe as a Matter of Law

    As discussed in unit II., in order to maintain a registration for a
pesticide under FIFRA, a registrant has the burden to demonstrate that
the pesticide satisfies the statutory standard for registration. 40 CFR
164.80(b); see also 7 U.S.C. 136a(c)(5). One element of that standard
is that the pesticide performs its intended function without
unreasonable adverse effects on the environment, which is defined under
FIFRA section 2(bb) to include ``a human dietary risk from residues
that result from a use of a pesticide in or on any food inconsistent
with the standard under section 346a of title 21.'' 7 U.S.C. 136(bb).
The standard referenced in the FIFRA definition is the FFDCA safety
standard, i.e., that tolerances, which cover the amount of pesticide
residues in or on food, must be safe. See 21 U.S.C. 346a(b)(2).
    Also noted in unit II., it is a matter of law that pesticide
chemical residues in or on food are ``deemed unsafe,'' unless covered
by a tolerance or exemption. 21 U.S.C. 346a(a)(1). Any residues from
pesticides used on food where no tolerances exist for those residues
are, therefore, unsafe. Unsafe residues are not consistent with the
FFDCA safety standard. Thus, any pesticide resulting in such residues,
causes, as a legal matter, unreasonable adverse effects on the
environment. Such pesticide is subject to cancellation under FIFRA
section 6(b).
    Because all tolerances for chlorpyrifos have been revoked,
chlorpyrifos residues in or on food are unsafe as a matter of law.
Because the chlorpyrifos registrations listed in unit I.A. bear
labeling for use on food, use of which would result in unsafe pesticide
residues on food, these products pose unreasonable adverse effects on
the environment under FIFRA section 2(bb)(2). 7 U.S.C. 136(bb)(2).

B. The Pesticide and Its Labeling Do Not Comply With FIFRA

    Additionally, because the chlorpyrifos products in unit I.A. bear
labeling for use on food, for which the registrant did not submit the
necessary label amendments and/or cancellations to remove all food
uses, and because all tolerances for chlorpyrifos have been revoked,
these products are misbranded and thus not in compliance with FIFRA. It
is a violation of FIFRA to sell and distribute pesticides that are
misbranded. 7 U.S.C. 136j(a)(1)(E). FIFRA's definition of
``misbranded'' provides many ways in which a pesticide may be
misbranded, including if its labeling ``bears any statement . . . that
is false or misleading.'' 7 U.S.C. 136(q)(1)(A). Pesticide labeling
bearing directions for use on food crops that results in adulterated
food is misleading because it is illegal to distribute that food in
commerce. A commercial farmer complying with approved use directions
would apply the pesticide to crops but then, in the absence of
necessary tolerances or an exemption, would be producing adulterated
food, which cannot be delivered into interstate commerce without
violating the FFDCA. Thus, the label misleads the consumer into
believing a pesticide can be applied to food crops, but ultimately
results in adulterated food or feed crops that cannot be sold. To avoid
this conflict, EPA's regulations prevent EPA from issuing a
registration for a pesticide that ``bears labeling with directions for
use on food, animal feed, or food or feed crops, or may reasonable be
expected to result, directly or indirectly, in pesticide residues (or
results of any active or inert ingredient of the product, or of any
metabolite or degradate thereof) in or on food or animal feed,'' unless
tolerances or exemptions covering such residues have been issued. 40
CFR 152.112(g).
    In summary, because the aforementioned products would result in
pesticide residues in or on food that are, as a matter of law, unsafe,
the products pose unreasonable adverse effects on the environment.
Moreover, EPA has determined that because the aforementioned products
are misbranded, continued sale and distribution would not comply with
the provisions of FIFRA. Consequently, EPA has determined that these
products must be cancelled.

V. Status of Products That Become Cancelled

A. Timing of Cancellation

    The cancellation of registration for the specific products
identified in unit I.A. of this document will be final and effective 30
days after the affected registrant receives notice of EPA's intent to
cancel the pesticide registrations listed in unit I.A., or on January
13, 2023, unless within that time the registrant makes the necessary
corrections (see unit V.C.) or a hearing is requested by an adversely
affected person regarding such product. 7 U.S.C. 136d(b).
    In the event a hearing is held concerning a particular product, the
cancellation of the registration for that product will not become
effective except pursuant to (i) an initial decision of the presiding
Administrative Law Judge that becomes a final order pursuant to 40 CFR
164.90(b) or (ii) if the Administrative Law Judge's initial decision is
appealed or subject to Administrator review pursuant to 40 CFR 164.101,
a final order issued by the Environmental Appeals Board or (if the
matter is referred to the Administrator pursuant to 40 CFR 164.2(g))
the Administrator. Final cancellation orders following a public hearing
are subject to judicial review within 60 days of the entry of the
order. 7 U.S.C. 136d(h).

B. Existing Stocks Issues

    FIFRA section 6(a)(1) allows the Agency to permit the continued
sale and use of existing stocks of pesticides whose use has been
cancelled, to the extent the Administrator determines that such sale or
use would not be inconsistent with the purposes of this Act. 7 U.S.C.
136d(a)(1). EPA has defined ``existing stocks'' as ``those stocks of a
registered pesticide which are currently in the United States and which
have been packaged, labeled, and released for shipment prior to the
effective date of the cancellation action.'' 56 FR 29362, June 26, 1991
(FRL-3846-4). This section addresses how the Agency intends to treat
existing stocks when and if pesticide registrations are cancelled
pursuant to this Notice.
    The Agency does not believe that continued sale or use of existing
stocks of any chlorpyrifos registrations identified in this Notice
following cancellation would be consistent with FIFRA. The continued
sale and distribution of products cancelled in a proceeding pursuant to
this Notice would be the sale and distribution of misbranded products,
which, if used in accordance with the labeling, would lead to the
production of adulterated food and the use of products that would pose
unreasonable adverse effects on human health due to residues in or on
food that are inconsistent with the FFDCA safety standard. Accordingly,
EPA has determined that the continued sale and distribution of existing
stocks of pesticide products cancelled pursuant to this Notice should
not be permitted, with the exception of movement of existing stocks for
the sole purposes of lawful export consistent with FIFRA; disposal
consistent with applicable state disposal requirements; or return to
the registrant consistent with the terms of a return program agreement
with EPA, if any. Moreover, EPA does not intend to allow existing
stocks in the hands of end-users to continue to be used, unless they
are being used for non-food uses. Any use

of chlorpyrifos on food would result in adulterated food, which is
illegal to deliver into interstate commerce; therefore, use of existing
stocks for use on food cannot be permitted.
    It is settled law that existing stocks issues are not required to
be a part of a cancellation proceeding, and that the treatment of
existing stocks issues is only included as an issue in a cancellation
proceeding when the Notice giving rise to the right to a hearing
voluntarily identifies and includes existing stocks as an issue for
examination. See In the Matter of Cedar Chemical Co., et al., 2 E.A.D.
584, nn. 7, 9, 1988 WL 525242 (June 9, 1988) (Decision of the
Administrator). The Administrator's decision in Cedar Chemical on
whether existing stocks had to be included as an issue in the hearing
was affirmed by the United States Court of Appeals for the Ninth
Circuit in Northwest Food Processors Association v. Reilly, 886 F. 2d
1075, 1078 (9th Cir. 1989). In the case of this Notice, EPA has
determined not to include existing stocks as an issue in any hearing
arising from this Notice, since the lack of tolerances means that any
continued sale, distribution, or use of the pesticide would be
inconsistent with the purposes of FIFRA. Instead, the only issue for
hearing under this Notice is whether the subject products should be
cancelled.

C. Potential Scope of Final Action

    FIFRA section 6(b) allows the registrant, within the 30 days
following publication or receipt of EPA's notice, to ``make the
necessary corrections, if possible''. 7 U.S.C. 136d(b). As noted in
unit IV., the chlorpyrifos products listed in unit I.A. must be
cancelled because they bear labeling for use on food although no
tolerances exist to cover chlorpyrifos residues in or on food for those
uses. Terminating food uses and removing those uses from labels would
resolve the violations EPA has identified in this Notice. Therefore,
EPA recognizes that the registrant has an opportunity to make
corrections by requesting cancellation of these uses and amending
labels.
    FIFRA section 6(b) also states ``in taking any final action under
this subsection, the Administrator shall consider restricting a
pesticide's use or uses as an alternative to cancellation and shall
fully explain the reasons for these restrictions, and shall include
among those factors to be taken into account the impact of such final
action on production and prices of agricultural commodities, retail
food prices, and otherwise on the agricultural economy, and the
Administrator shall publish in the Federal Register an analysis of such
impact.'' Id.
    Accordingly, in any final action on this Notice, EPA may consider,
as an alternative to cancellation of the whole registrations,
cancelling only those uses that result in residues in or on food. As
part of its registration review of chlorpyrifos, EPA considered the
potential economic impacts on growers if chlorpyrifos use was
eliminated for various registered food crops. See Revised Benefits of
Agricultural Uses of Chlorpyrifos (PC# 059101) (November 18, 2020),
available at https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969; Chlorpyrifos Revocation Small Business and Employment Analysis
(August 12, 2021), available at https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031. Although EPA may consider benefits for
certain uses under FIFRA, economic impacts to growers is not a
consideration for EPA in making a safety determination under the FFDCA.
Because EPA determined that the tolerances did not meet the safety
standard under the FFDCA, EPA revoked all chlorpyrifos tolerances. See
86 FR 48315. As a result, chlorpyrifos may not be used in or on food
without resulting in adulterated food, which cannot be distributed in
interstate commerce. Restricting the chlorpyrifos products listed in
unit I.A. to only those uses that do not result in residues in or on
food would have no economic impact, beyond the impact already resulting
from the revocation of the chlorpyrifos tolerances, since these
products already cannot be used on food due to the lack of tolerances.

VI. Mandated FIFRA Reviews

A. What is required?

    When EPA intends to issue a NOIC, it must furnish a draft of that
Notice and an analysis of the impact of the proposed action on the
agricultural economy to the Secretary of the USDA for comment at least
60 days prior to sending such Notice to the registrant or making such
Notice public. 7 U.S.C. 136d(b). When a public health use is affected,
FIFRA section 6(b) also directs the Secretary of the Department of
Health and Human Services (HHS) to provide available benefits and use
information, or an analysis thereof. Within the same time period, the
Agency must also submit the proposed cancellation action to the FIFRA
Scientific Advisory Panel (SAP) for comment concerning the impact of
the proposed action on health and the environment, unless the SAP
agrees to waive its review. 7 U.S.C. 136w(d).
    In the event that written comments are received from the USDA, HHS,
or the SAP within 30 days of such referral, the Agency must publish
those comments and the Agency's response to the comments.

B. What are the results of this review?

    Because all tolerances for chlorpyrifos have already been revoked
for the reasons set forth in the Final Rule and Denial Order, this
proposed cancellation action itself is not anticipated to have any
impacts on the agricultural economy. This NOIC is purely an
administrative action to address three registrations that the
registrant is unable or unwilling to cancel or modify to comply with
the Agency's tolerance revocation. EPA provided a draft of this NOIC to
the SAP requesting a waiver due to the lack of scientific issues for
consideration by the SAP. The SAP waived its review of this NOIC on
August 19, 2022.
    This NOIC is not subject to review by HHS because there are no
public health uses affected by this NOIC.
    On August 11, 2022, EPA provided a draft of this NOIC to USDA for
review and received a response from USDA on September 11, 2022. USDA
expressed three major concerns in its comments: (1) that an economic
analysis was not provided for review in conjunction with the draft
NOIC; (2) USDA's opinion that historical precedent and procedures was
not followed; and (3) USDA's opinion that EPA could have retained some
tolerances consistent with the proposal in the Proposed Interim
Registration Review Decision for Chlorpyrifos (2020 PID) instead of
revoking all tolerances and should initiate action to reestablish
tolerances consistent with the conclusions of the 2020 PID. USDA's
comments are available at https://www.regulations.gov in the docket for
this action, docket ID EPA-HQ-OPP-2022-0417.
    The Agency has considered each of these comments prior to
finalizing this Notice. Below is a summary of these comments and the
Agency's detailed responses to these comments.
    Comment: USDA notes that FIFRA requires EPA to consider the impact
of the action proposed in the NOIC on production and prices of
agricultural commodities, retail food prices, and otherwise on the
agricultural economy and to provide that analysis to the USDA. USDA
expressed concern with statements in EPA's draft NOIC that the
cancellation of the products would produce no negative effects beyond
those that were already imposed when EPA revoked the chlorpyrifos
tolerances. Since, as USDA notes in

their comments, the FFDCA does not provide for consideration of
economic impacts in a determination of whether to retain tolerances,
the USDA had concerns about the lack of consideration to the economy.
    EPA Response: As noted in unit III, EPA revoked the chlorpyrifos
tolerances in a final rule issued in August 2021, as a result of
concluding that the chlorpyrifos tolerances were not safe. As USDA
recognizes, the FFDCA does not authorize EPA to consider economic
impacts to farmers when determining whether to retain tolerances. As
noted in the Final Rule and the Denial Order, the FFDCA permits EPA to
leave a tolerance in place only if it is safe; whether a tolerance is
important to the agricultural economy is not a permissible
consideration for EPA in determining whether to leave a tolerance in
place.
    When the tolerances were revoked, chlorpyrifos was no longer
permitted to be used on food crops. Although not a consideration under
the FFDCA, as part of its assessment of chlorpyrifos in registration
review, EPA prepared a benefits assessment and a small business
analysis of the economic benefits of chlorpyrifos for a variety of
crops as well as the potential economic impact if chlorpyrifos were not
available. See Revised Benefits of Agricultural Uses of Chlorpyrifos
(PC# 059101) (November 18, 2020), available at https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969; Chlorpyrifos
Revocation Small Business and Employment Analysis (August 12, 2021),
available at https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031.
    Although the benefits assessment and small business analysis did
indicate some economic impacts as a result of chlorpyrifos not being
available for growers, those impacts have already occurred as a result
of the revocation of the tolerances and would not be attributable to
the cancellation of these products. Even if these products were not
cancelled, the products could still not be used as a result of the
tolerance revocation; thus, the same economic impact would result with
or without this cancellation action. To the extent the products being
cancelled are registered for non-food uses, these are not the only
chlorpyrifos products registered for these non-food uses. Consequently,
EPA concluded that the cancellation action being proposed in this NOIC
itself does not actually result in any impact on agricultural
commodities, retail food prices, or the agricultural economy.
    Comment: USDA notes that it considers EPA's process for revoking
tolerances as ``harmful precedent'' that has created confusion and
concern among agricultural stakeholders and international trading
partners. USDA asserts that the lack of a phase-out period has caused a
widespread disposal problem for existing stocks of chlorpyrifos, and
that the ``divergence from normal procedures caused confusion and
concerns'' and may ``harm the economic viability of U.S. producers in
the long-term'' by undercutting U.S. credibility in future trade
negotiations.
    EPA Response: As an initial matter, EPA notes that this comment
does not appear to be directly relevant to the cancellation of the
particular products identified in this NOIC, but rather a commentary on
EPA's issuance and implementation of the final rule revoking
tolerances. Prior to the issuance of the final rule, EPA coordinated
with FDA and USDA to ensure they could develop any necessary
enforcement guidance, such as how long legally treated food and feed
commodities may be in the channels of trade, and FDA released a
document entitled Guidance for Industry: Questions and Answers
Regarding Channels of Trade Policy for Human Food Commodities with
Chlorpyrifos Residues, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-channels-trade-policy-human-food-commodities, in order to
provide guidance to stakeholders in the food industry. In addition, in
the Final Rule itself and contrary to the USDA's assertion, EPA did
provide a six-month transition period between the publication of the
final revoking tolerances and the effective date of the revocation
consistent with the Agency's obligations under the World Trade
Organization Agreement on the Application of Sanitary and Phytosanitary
Measures. Although EPA recognizes that there has been confusion in the
regulated community on what to do with registered chlorpyrifos products
that can no longer be used on food, EPA is, and has been, working with
registrants to provide for an appropriate transition. Specifically, the
Agency continues to work with the registrants in the development of
their return programs and update stakeholders and the Agency's website
with the latest information regarding chlorpyrifos.
    To the extent this comment expressed a concern about the process
EPA used for terminating use of chlorpyrifos on food, EPA fully
addressed this comment in its Denial Order. See 87 FR at 11247-49.
Objectors to EPA's Final Rule alleged that EPA was required to
negotiate with chlorpyrifos registrants and cancel food uses under
FIFRA before revoking tolerances under the FFDCA. Consistent with EPA's
position in the Denial Order, neither FIFRA nor the FFDCA direct that
the Agency proceed with cancellation under FIFRA prior to revoking
tolerances under the FFDCA. Id. Where EPA determines that tolerances
are not safe, the FFDCA requires that tolerances be revoked, regardless
of the economic impact of that revocation. In addition, in this
particular instance, the Ninth Circuit prioritized the Agency taking
action under the FFDCA over taking action under FIFRA, by ordering EPA
to take action on the tolerances within 60 days of the issuance of the
mandate in that case, i.e., August 20, 2021, and to take action to
cancel food uses ``in a timely fashion''. LULAC, 996 F.3d. at 703-04.
    Nonetheless, even with the restricted timeframe imposed by the
Ninth Circuit and the need to prioritize tolerance actions under the
FFDCA over cancellations under FIFRA, EPA did attempt to coordinate the
tolerance revocations with cancellation actions. While EPA was unable
to complete the necessary steps for that process to impact the
tolerance revocation rule for chlorpyrifos by the Court's deadline, EPA
recognizes that coordinating tolerance revocations and FIFRA
cancellations can be helpful since product cancellation orders can
provide clarity around existing stocks and disposal procedures.
    Comment: USDA's comments outline its opinion that the Agency could
have pursued a pathway on the 11 high benefit uses outlined in the 2020
PID instead of revoking all tolerances. USDA also requests Agency-
initiated action to reestablish tolerances consistent with the
conclusions of the 2020 PID.
    EPA Response: EPA notes that this comment appears to be more
appropriately directed towards the Final Rule itself rather than the
cancellation action that is the subject of this NOIC. Under FFDCA
section 408(g), 21 U.S.C. 346a, any person may file an objection to any
aspect of the 2021 final tolerance rule and may also request a hearing
on those objections. USDA did not file any such objection, although
several other parties did, asserting that EPA should have left
tolerances in place associated with 11 uses as described in the 2020
PID rather than revoking all the tolerances. EPA denied that objection
in its Denial Order. See 87 FR at 11244-47. The Denial Order fully
explained the

rationale for not adopting the proposal presented in the 2020 PID.
Briefly, in the December 2020 PID, EPA proposed that all chlorpyrifos
uses contributing aggregate exposures be cancelled except for 11
specific uses in specific geographic areas. Those 11 uses were
identified by registrants and EPA as having high benefits, although the
Agency recognized that it was just one possible subset of uses that
might be retainable. The Agency's proposed safety determination for
those uses was contingent on other uses being cancelled and additional
use restrictions being in effect. It is also important to note that the
findings in the PID were simply proposals, and those proposals, and the
underlying risk assessments on which those proposals were based, were
subject to public comment and did not represent a final safety
determination. Despite the potential for supporting a safety finding
consistent with the PID, at the time that EPA was required to
expeditiously issue a rule by the Ninth Circuit, no concrete steps had
been taken by registrants under FIFRA to implement the PID proposal: no
uses had been cancelled, no labels had been revised to geographically
limit applications or limit maximum application rates, nor had any
applications to initiate such actions been filed with the Agency.
Therefore, at the time of the Final Rule, the option to leave certain
tolerances in place was not available. Thus, EPA assessed aggregate
exposure based on all currently registered uses of chlorpyrifos as
required by the FFDCA and consistent with its guidance, finding that it
could not determine that there was a reasonable certainty of no harm
from aggregate exposure. As a result, chlorpyrifos tolerances were
revoked and expired as of February 28, 2022.
    A challenge to the Final Rule is outside the scope of this NOIC.
All the chlorpyrifos tolerances have been revoked, so the products
identified in this document must be cancelled because they bear
labeling for use on food. As noted above, the Agency views this NOIC as
an administrative action, as once tolerances were revoked, chlorpyrifos
products cannot bear labeling for use on food, since the products could
no longer be used without rendering food and feed crops adulterated.
    The request to reestablish tolerances associated with those 11 uses
is also outside the scope of this NOIC. At this time, the Agency does
not intend to initiate a rulemaking to re-establish those tolerances.
Initiating tolerance rulemaking under section 408(e) of the FFDCA is a
discretionary action, 21 U.S.C. 346a(e), and at this time, no petition
has been submitted requesting specific tolerances to be established
under section 408(d) of the FFDCA, 21 U.S.C. 346a(d). Even if EPA
initiated such a rulemaking, or if a petition were submitted, EPA would
need to follow the statutory process and make a determination that the
tolerances were safe in order to establish them. It is important to
note that the proposal in the 2020 PID was only a proposed safety
finding based on a subset of uses; it was not a final determination of
safety. Any final safety determination supporting the re-establishment
of the tolerances would need to take into consideration aggregate
exposures to chlorpyrifos.

VII. Requesting a Hearing

    This unit explains how eligible persons may request a hearing and
the consequences of requesting or failing to request such a hearing.

A. Who can request a hearing?

    A registrant or any other person who is adversely affected by a
cancellation of registration as described in this Notice may request a
hearing.

B. When must a hearing be requested?

    A request for a hearing by a registrant must be submitted in
writing within 30 days after the date of receipt of the NOIC, or within
30 days after publication of this announcement in the Federal Register,
whichever occurs later. A request for a hearing by any other person
adversely affected by the Agency's proposed action must be submitted
within 30 days after the date of publication of this Notice in the
Federal Register. See the DATES section of this document.

C. How must a hearing be requested?

    All persons who request a hearing must comply with the Agency's
Rules of Practice Governing Hearings, 40 CFR part 164. Among other
requirements, these rules include the following requirements:
     Each hearing request must specifically identify by
registration or accession number each individual pesticide product for
which a hearing is requested, 40 CFR 164.22(a);
     Each hearing request must be accompanied by a document
setting forth specific objections that respond to the Agency's reasons
for proposing cancellation as set forth in this Notice, and stating the
factual basis for each such objection, 40 CFR 164.22(a); and
     Each hearing request must be received by the OALJ within
the applicable 30-day period, 40 CFR 164.5(a).
    Failure to comply with any one of these requirements will
invalidate the request for a hearing and, in the absence of a valid
hearing request, result in final cancellation for the products in
question by operation of law.

D. Where does a person submit a hearing request?

    Requests for hearing must be submitted to the OALJ. The OALJ
strongly encourages electronic filing due to the coronavirus pandemic.
See Order Urging Electronic Service and Filing, issued by Chief ALJ
Biro (April 10, 2020), available at https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
    1. Submitting the hearing request electronically. To file a
document electronically, a party shall use a web-based tool known as
the OALJ E-Filing System by visiting the OALJ's website at https://www.epa.gov/alj. Documents filed electronically are deemed to
constitute both the original and one copy of the document.
    Any party choosing to file electronically must first register with
the OALJ E-Filing System at https://yosemite.epa.gov/oa/eab/EAB-ALJ_Upload.nsf. There may be a delay of one to two business days
between the time a party applies for registration and the time at which
the party is able to upload documents into the system.
    A document submitted to the OALJ E-Filing System is considered
``filed'' at the time and date of electronic reception, as recorded by
the OALJ E-Filing System immediately upon reception. To be considered
timely, documents submitted through the OALJ E-Filing System must be
received by 11:59 p.m. Eastern Time on the date the document is due,
unless another time is specified by the Judge. Within an hour of a
document being electronically filed, the OALJ E-Filing System will
generate an electronic receipt of the submission that will be sent by
email to both the party submitting the document and the Headquarters
Hearing Clerk. This emailed electronic receipt will be the filing
party's only proof that the OALJ received the submitted document. The
absence or presence of a document on the OALJ's E-Docket Database web
page, available at https://yosemite.epa.gov/oarm/alj/alj_web_docket.nsf, or on the Agency's Administrative Enforcement
Dockets web page, available at https://yosemite.epa.gov/oa/rhc/epaadmin.nsf, is not proof that the document was or was not received.
If the filing party does not receive an electronic receipt within one
hour after submitting the document through the OALJ E-Filing System,
the

Headquarters Hearing Clerk may be able to confirm receipt of the
document but not earlier than one hour after the document was
submitted.
    The OALJ E-Filing System will accept any type of digital file, but
the file size is limited to 70 megabytes. Electronically filed textual
documents must be in Portable Document Format (``PDF''). If a party's
multimedia file exceeds 70 megabytes, the party may save the file on a
compact disc and send it by U.S. mail to the Hearing Clerk mailing
address identified in unit VII.D.2. of this Notice, or the party may
contact the Headquarters Hearing Clerk at<PHONE_NUMBER> for
instructions on alternative electronic filing methods.
    A motion and any associated brief may be filed together through the
OALJ E-Filing System. However, any documents filed in support of a
brief, motion, or other filing, such as copies of proposed exhibits
submitted as part of party's prehearing exchange, should be filed
separately as an attachment. Where a party wishes to file multiple
documents in support of a brief, motion, or other filing, rather than
filing a separate attachment for each such document, the documents
should be compiled into a single electronic file and filed as a single
attachment, to the extent technically practicable.
    2. Submitting the hearing request by non-electronic means.
Alternatively, if a party is unable to file a document utilizing the
OALJ E-Filing System, e.g., the party lacks access to a computer, the
party may file the document by U.S. mail or facsimile, although the
OALJ's ability to receive filings via those methods is limited. U.S.
mail is currently being delivered to the OALJ at an offsite location on
a weekly basis only, and documents sent by facsimile will also be
received offsite. If a party must file documents by U.S. mail or
facsimile, the party shall notify the Headquarters Hearing Clerk each
time it files a document in such a manner by calling<PHONE_NUMBER>.
    To file a document using U.S. mail, the document shall be sent to
the following mailing address: Mary Angeles, Headquarters Hearing
Clerk, Office of Administrative Law Judges (Mail Code 1900R), U.S.
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460.
    Please note that mail deliveries to federal agencies are screened
off-site, and this security procedure can delay delivery.
    Facsimile may be used to file a document if it is fewer than 20
pages in length. To file a document using facsimile, the document shall
be sent to OALJ's offsite location at<PHONE_NUMBER>.
    A document submitted by U.S. mail or facsimile is considered
``filed'' when the Headquarters Hearing Clerk physically receives it,
as reflected by the inked date stamp physically applied by the
Headquarters Hearing Clerk to the paper copy of the document.
    At this time, the OALJ is not able to accept filings or
correspondence by courier or commercial delivery service, such as UPS,
FedEx, and DHL. Likewise, the physical office of the OALJ is not
currently accessible to the public, and the OALJ is not able to receive
documents by personal delivery. For further information on filings with
the OALJ, please see https://www.epa.gov/alj.
    3. Important reminders. Regardless of the method of filing, all
filed documents must be signed in accordance with 40 CFR part 164 and
must contain the contact name, telephone number, mailing address, and
email address of the filing party or its authorize representative. A
copy of each document filed in this proceeding shall also be ``served''
by the filing party on the presiding judge and on all other parties.

E. The Hearing

    If a hearing concerning any product affected by this Notice is
requested in a timely and effective manner, the hearing will be
governed by the Agency's Rules of Practice Governing Hearings, 40 CFR
part 164, and the procedures set forth in this unit. Any interested
person may participate in the hearing, in accordance with 40 CFR
164.31.

F. Separation of Functions

    EPA's Rules of Practice forbid anyone who may take part in deciding
this case, at any stage of the proceeding, from discussing the merits
of the proceeding ex parte with any party or with any person who has
been connected with the preparation or presentation of the proceeding
as an advocate or in any investigative or expert capacity, or with any
of their representatives. 40 CFR 164.7. To facilitate compliance with
the ex parte rule, the following are designated as adjudicatory
personnel for purposes of this proceeding: the Administrative Law
Judges and their staff and the Environmental Appeals Board and its
staff. None of the persons identified as adjudicatory personnel may
discuss the merits of the proceeding with any person with an interest
in the proceeding, or representative of such person, except in
compliance with 40 CFR 164.7.

List of Subjects

    Environmental protection, Pesticides and pests, Cancellation.

    Dated: December 9, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-27130 Filed 12-13-22; 8:45 am]
BILLING CODE 6560-50-P