[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76474-76481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
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: (202) 566-0700; 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

[[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 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

[[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 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

[[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 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

[[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:
     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

[[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 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


