Notice2022-27130
Chlorpyrifos; Notice of Intent To Cancel Pesticide Registrations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 14, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 239 (Wednesday, December 14, 2022)</title>
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[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76474-76481]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>. For the latest status
information on EPA/DC services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: (202) 566-0700; email address:
<a href="/cdn-cgi/l/email-protection#aae5fafae9c2c6c5d8dad3d8c3ccc5d9e3c4dbdfc3d8c3cfd9eacfdacb84cdc5dc"><span class="__cf_email__" data-cfemail="a7e8f7f7e4cfcbc8d5d7ded5cec1c8d4eec9d6d2ced5cec2d4e7c2d7c689c0c8d1">[email protected]</span></a>.
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.
<bullet> EPA Reg. No. 93182-3 Chlorpyrifos Technical.
<bullet> EPA Reg. No. 93182-7 Pilot 4E Chlorpyrifos Agricultural
Insecticide.
<bullet> 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:
<bullet> 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
[[Page 76475]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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
[[Page 76476]]
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).
[[Page 76477]]
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
[[Page 76478]]
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 <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969</a>; Chlorpyrifos Revocation Small Business and Employment Analysis
(August 12, 2021), available at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031">https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
[[Page 76479]]
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 <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969</a>; Chlorpyrifos
Revocation Small Business and Employment Analysis (August 12, 2021),
available at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031">https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031</a>.
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, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-channels-trade-policy-human-food-commodities">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-channels-trade-policy-human-food-commodities</a>, 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
[[Page 76480]]
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:
<bullet> 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);
<bullet> 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
<bullet> 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 <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
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 <a href="https://www.epa.gov/alj">https://www.epa.gov/alj</a>. 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 <a href="https://yosemite.epa.gov/oa/eab/EAB-ALJ_Upload.nsf">https://yosemite.epa.gov/oa/eab/EAB-ALJ_Upload.nsf</a>. 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 <a href="https://yosemite.epa.gov/oarm/alj/alj_web_docket.nsf">https://yosemite.epa.gov/oarm/alj/alj_web_docket.nsf</a>, or on the Agency's Administrative Enforcement
Dockets web page, available at <a href="https://yosemite.epa.gov/oa/rhc/epaadmin.nsf">https://yosemite.epa.gov/oa/rhc/epaadmin.nsf</a>, 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
[[Page 76481]]
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 (202) 564-6281 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 (202) 564-6281.
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 (916) 550-9639.
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 <a href="https://www.epa.gov/alj">https://www.epa.gov/alj</a>.
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
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</html>Indexed from Federal Register on December 14, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.