Notice2024-17431
Pesticides; Emergency Order Suspending the Registrations of All Pesticide Products Containing Dimethyl Tetrachloroterephthalate (DCPA)
Primary source
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Published
August 7, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is issuing an Emergency Order directing the suspension of all registrations issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for pesticide products containing the active ingredient dimethyl tetrachloroterephthalate (DCPA), also marketed under the trade name Dacthal. EPA has determined that continued sale, distribution, or use of DCPA products during the time required to cancel such products would pose an imminent hazard and that an emergency exists that does not permit EPA to hold a hearing before suspending such products. These determinations are based primarily on a risk of thyroid hormone perturbations in the fetuses of female bystanders and workers who apply DCPA or who enter treated fields after application. EPA has concerns that pregnant individuals may be currently exposed to DCPA at levels higher than those that cause fetal thyroid hormone disruption, but at which no thyroid effects would occur in the pregnant individual. The downstream effects of such hormone perturbations in the fetus may include low birth weight and irreversible and life-long impacts to children exposed in-utero, such as impaired brain development and motor skills. While the sole registrant of DCPA products, AMVAC Chemical Corporation (AMVAC), has attempted to address these concerns, EPA has determined that there is no combination of practicable mitigations under which DCPA use can continue without presenting an imminent hazard. Set forth below are the substantive bases for these determinations and the procedures that affected registrants must follow to obtain a hearing on or otherwise challenge these determinations.
Full Text
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[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Notices]
[Pages 64445-64458]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17431]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2011-0374; FRL-12147-01-OCSPP]
Pesticides; Emergency Order Suspending the Registrations of All
Pesticide Products Containing Dimethyl Tetrachloroterephthalate (DCPA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Order.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is issuing
an Emergency Order directing the suspension of all registrations issued
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
for pesticide products containing the active ingredient dimethyl
tetrachloroterephthalate (DCPA), also marketed under the trade name
Dacthal. EPA has determined that continued sale, distribution, or use
of DCPA products during the time required to cancel such products would
pose an imminent hazard and that an emergency exists that does not
permit EPA to hold a hearing before suspending such products. These
determinations are based primarily on a risk of thyroid hormone
perturbations in the fetuses of female bystanders and workers who apply
DCPA or who enter treated fields after application. EPA has concerns
that pregnant individuals may be currently exposed to DCPA at levels
higher than those that cause fetal thyroid hormone disruption, but at
which no thyroid effects would occur in the pregnant individual. The
downstream effects of such hormone perturbations in the fetus may
include low birth weight and irreversible and life-long impacts to
children exposed in-utero, such as impaired brain development and motor
skills. While the sole registrant of DCPA products, AMVAC Chemical
Corporation (AMVAC), has attempted to address these concerns, EPA has
determined that there is no combination of practicable mitigations
under which DCPA use can continue without presenting an imminent
hazard. Set forth below are the substantive bases for these
determinations and the procedures that affected registrants must follow
to obtain a hearing on or otherwise challenge these determinations.
DATES: This Emergency Order is issued and effective immediately upon
signature. The sole affected registrant has also been notified by
certified mail. Any request by the registrant for a
[[Page 64446]]
hearing on the issue of whether an imminent hazard exists must be
received by the Clerk of the EPA Office of Administrative Law Judges
(OALJ). A copy of the Emergency Order has been filed with the OALJ
Clerk.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0374, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/">https://www.epa.gov/</a>dockets.
FOR FURTHER INFORMATION CONTACT: Jean Overstreet, Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: 202-566-2425; email address:
<a href="/cdn-cgi/l/email-protection#ee81988b9c9d9a9c8b8b9ac08f80808bae8b9e8fc0898198"><span class="__cf_email__" data-cfemail="8ee1f8ebfcfdfafcebebfaa0efe0e0ebceebfeefa0e9e1f8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action.
B. What action is the Agency taking?
EPA is issuing an Emergency Order directing the suspension of all
registrations for pesticide products containing the active ingredient
dimethyl tetrachloroterephthalate (DCPA), also marketed under the trade
name Dacthal. See Unit II.
C. What is the Agency's authority for taking this action?
The Emergency Order is issued under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., pursuant
to section 6(c)(3) (7 U.S.C. 136d(c)(3)). See Unit IV.
D. What is DCPA?
DCPA is a benzoic acid herbicide (Herbicide Resistance Action
Committee/Weed Science Society of America Group 3) which inhibits cell
division of root tips in target plants. It controls annual grasses and
broadleaf weeds before they emerge in a variety of agricultural crops.
DCPA is registered for agricultural uses, including on Allium species,
Brassica species, cucurbits, root vegetables, fruiting vegetables,
strawberry, sod and nursery ornamental production. Non-agricultural
uses of DCPA include non-residential grass/turf including golf courses
and athletic fields. While these turf uses are considered non-
residential because the treated turf is not a home lawn, there is still
the potential for residential post-application exposures as a result of
application to these use sites. The registered end-use product may be
applied by handheld, ground, aerial, and chemigation equipment.
E. Why is EPA issuing this Emergency Order?
EPA has determined that the further sale, distribution, and use of
DCPA as an herbicide would pose an imminent hazard during the period
required to conduct administrative hearings concerning cancellation.
EPA has further determined that an emergency exists with respect to all
DCPA products which does not permit it to hold a hearing concerning its
determination of imminent hazard before acting to prohibit further
sale, distribution, and use of such products.
EPA has evaluated the available information concerning the risks
and benefits associated with continued use of DCPA during the time
required for a cancellation hearing. Based on this information, EPA has
determined that the risks of continued use during this period outweigh
the benefits and that registered DCPA products therefore pose an
imminent hazard. The Agency has determined that this imminent hazard
constitutes an emergency, such that sale, distribution, and use of all
DCPA products must be suspended during the pendency of any expedited
hearing held under FIFRA section 6(c)(2).
EPA's findings concerning the existence of an imminent hazard and
an emergency are summarized in Unit V., and Unit VI. then provides in
greater detail the evidence and analyses upon which these findings are
based.
II. Emergency Order
This Emergency Order suspends the registration of all pesticide
products which contain DCPA (see Table 1). EPA has determined that
continued registration of DCPA products during the time required to
conduct a cancellation proceeding would likely result in unreasonable
adverse effects on the environment (which, according to FIFRA section
2(j), includes ``man and other animals living therein'') and therefore
poses an imminent hazard. EPA has also determined that there is a
substantial likelihood that the continued sale, distribution, or use of
DCPA products during the pendency of a suspension hearing would result
in serious harm and therefore that an emergency exists that does not
permit EPA to hold a hearing before suspending such products.
Accordingly, EPA is issuing this Emergency Order immediately suspending
all registrations of DCPA products. The substantive rationale for these
determinations is explained below.
Table 1--Pesticide Products Subject to Order
----------------------------------------------------------------------------------------------------------------
Product EPA Reg. No. Registrant Active ingredient
----------------------------------------------------------------------------------------------------------------
Dacthal Flowable Herbicide...... 5481-487.................... AMVAC Dimethyl
tetrachloroterephthala
te (DCPA).
Dacthal W-75 Herbicide.......... WI050002.................... AMVAC Dimethyl
tetrachloroterephthala
te (DCPA).
Technical Chlorthal Dimethyl.... 5481-495.................... AMVAC Dimethyl
tetrachloroterephthala
te (DCPA).
----------------------------------------------------------------------------------------------------------------
Pursuant to FIFRA section 6(c)(3), EPA hereby suspends the
registration of each pesticide product containing DCPA as identified in
Table 1. Effective immediately, no person in any state may distribute,
sell, offer for sale, hold for sale, ship, deliver for shipment, or
receive and (having so received) deliver or offer to deliver to any
person any pesticide product containing DCPA. Additionally, in
accordance with FIFRA section 6(a)(1), EPA has elected not to permit
the continued use of existing stocks, consistent with its policies
applicable to cancellations where the Agency has identified significant
risk concerns. See 56 FR 29362, 29367, June 26, 1991 (FRL-3845-4).
Generally, the Agency will not permit continued distribution, sale, or
use of a cancelled pesticide that raises risk concerns, absent a
showing that the benefits of such use exceed the risks. The same facts
supporting the imminent hazard
[[Page 64447]]
determination in this Emergency Order weigh heavily against allowing
any sale, distribution, or use of DCPA during cancellation proceedings.
Accordingly, this Emergency Order expressly prohibits any person from
using any pesticide product containing DCPA for any purpose. However,
EPA will allow continued distribution of existing stocks of DCPA for
the express purpose of returning any DCPA product to the registrant of
such products. EPA intends to issue a notice of intent to cancel the
same DCPA products (identified in Table 1) within the next 90 days,
pursuant to FIFRA section 6(c)(3).
III. Background
Based on indications that DCPA likely has effects on thyroid
function in rats, (e.g., DCPA Reregistration Eligibility Decision, 64
FR 40370, July 26, 1999 (FRL-6087-4)), EPA determined that additional
information was necessary for the Agency to complete its statutorily-
required Registration Review of DCPA under FIFRA section 3(g).
Accordingly, in 2013 EPA issued a data call-in (DCI) under FIFRA
section 3(c)(2)(B) to the sole registrant of DCPA products, AMVAC,
requiring the registrant to submit a number of studies, including a
comparative thyroid assay (CTA). The Agency required the CTA to
evaluate the potential impact (hazard) of DCPA exposure on thyroid
hormone homeostasis and thyroid function in the developing organism.
AMVAC submitted a dose range-finding report for the CTA in May 2021 as
a first step towards satisfying the DCI requirement. However, by
itself, this report was insufficient to satisfy the DCI. In April 2022,
the Agency filed a Notice of Intent to Suspend the DCPA technical
(manufacturing use) product, pursuant to FIFRA section 3(c)(2)(B). See
In re FIFRA Section 3(c)(2)(B) Notice of Intent to Suspend Dimethyl
Tetrachloroterephthalate (DCPA) Technical Registration, OALJ Docket No.
FIFRA-HQ-2022-0002 (EPA 2022).
AMVAC subsequently submitted a definitive CTA in August 2022. The
results of the CTA indicated that very low levels of DCPA cause thyroid
hormone perturbations in fetal rats. DCPA--Data Evaluation Record (DER)
of a submitted definitive study to fulfill the Comparative Thyroid
Assay (CTA) study requirement (EPA 2023), available at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0080">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0080</a>. The level of
exposure at which fetal hormone perturbations was observed (1 mg/kg/
day) is at least 10-fold lower than the dose that did not cause adverse
thyroid effects in maternal animals (10 mg/kg/day) in the CTA, and
lower than levels at which EPA estimates human users of DCPA are
currently being exposed (maximum estimated exposure of 2.42 mg/kg/day
for occupational handlers). See May 2023 ORE Assessment at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0081">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0081</a>.
In the fetus of exposed pregnant humans, thyroid hormone
perturbations, such as those observed in the CTA, can lead to
downstream health problems such as low birth weight, impaired brain
development, decreased Intelligence Quotient (IQ), impaired motor
skills, and decreased bone deposition (Chan, S; Kilby, MD. Thyroid
hormone and central nervous system development. Journal of
Endocrinology. April 1, 2000. 165:1-8; Fisher, DA. The importance of
early management in optimizing IQ in infants with congenital
hypothyroidism. The Journal of Pediatrics. March 2000. 136:274-274;
Morreale de Escobar, G; Obreg[oacute]n, MJ; Sescobar del Rey, F. Is
neuropsychological development related to maternal hypothyroidism or to
maternal hypothyroxinemia? The Journal of Clinical Endocrinology and
Metabolism. November 1, 2000. 85:3975-3987; Zoeller, RT; Rovet, J.
Timing of thyroid hormone action in the developing brain: clinical
observations and experimental findings. Journal of Neuroendocrinology.
October 20, 2004. 16:809-818). Based on the CTA data for DCPA, these
effects are not expected in exposed adults, but rather in children born
to individuals exposed to DCPA during pregnancy and might not always be
obvious in affected children at the time of birth. The health problems
associated with thyroid hormone perturbations have long-lasting
consequences for children exposed before birth that--when later
identified--would not likely be recognized as resulting from prior
pesticide exposure. Id.
In May 2023, an occupational and residential exposure (ORE)
assessment was conducted based on the two DCPA end-use products
registered at that time [EPA Reg. Nos. 5481-487 (a liquid formulation)
and 5481-490 (a wettable powder formulation)]. See 88 FR 89447,
December 27, 2023 (FRL-11590-01-OCSPP) (final cancellation order for
EPA Reg. No. 5481-490). Risks of concern were identified for multiple
scenarios, including occupational scenarios (handler and post-
application), residential post-application scenarios, and non-
occupational post-application bystander spray drift scenarios.
Occupational handler scenarios were of concern assuming label-
prescribed personal protective equipment (PPE), and even assuming
maximum PPE and/or engineering controls. Occupational post-application
scenarios were of concern on the day of application (the current label
required restricted entry interval of 12 hours) and even past 30 day
after application. It should be noted that available data for DCPA
indicates that while DCPA residues decline on treated foliage after
application, residues that are present even out 40 days post-
application can result in risks of concern. For bystander spray drift
scenarios, risks were of concern up to and greater than 300 feet from
the field edge.
These risks of concern indicate that individuals, either using DCPA
products as currently registered, working in areas/fields treated with
DCPA, or present near areas where DCPA is being used can be exposed to
DCPA at levels greater than the level at which no adverse effects were
observed in rat fetuses in the CTA. In some situations, pregnant
individuals are likely being exposed to DCPA at levels greater than the
level at which adverse effects were observed in the study. EPA is
concerned that exposure at these levels could result in adverse effects
to the fetuses of the pregnant individuals being exposed. Although the
registrant has presently unilaterally promised to halt the sale and
distribution of DCPA (until EPA approves new labels incorporating the
registrant's proposed mitigations), DCPA products that were sold or
distributed prior to this voluntary cessation remain in the hands of
growers, and the Agency has no mechanism to enforce the voluntary
cessation. DCPA is used year-round on certain crops, so EPA believes
that these exposures of concern are likely to be occurring at present.
Succinctly, EPA believes that the continued use of DCPA products will
allow for people, particularly pregnant individuals, to be unknowingly
exposed to DCPA at levels that result in a risk of concern and in some
cases, are equal to or greater than those that result in fetal thyroid
hormone perturbations in the CTA and the life-long health effects that
may result from those perturbations.
In addition to assessing the risks posed by continued registration
or use of DCPA, the Agency also assessed all currently registered uses
of the pesticide to conduct a ``rough and ready balancing'' of health
risks against economic benefits. Love v. Thomas, 858 F.2d 1347, 1361-62
(9th Cir. 1988). DCPA's main benefits are its broad spectrum of weed
control and its safety to the crop when applied as a band of spray
within rows of crops (``banded
[[Page 64448]]
within rows'') at planting in direct-seeded production of Brassicas and
registered Alliums. Weed control prior to crop emergence is important
in these crops, especially in Alliums, as these crops are slow to
emerge and vulnerable to early season weed competition.
DCPA has high benefits for growers of specialty Brassica crops
(e.g., bok choy, collards and kale), which have fewer alternative pre-
emergence herbicides than major Brassica crops (e.g., broccoli,
brussels sprouts, cabbage, cauliflower). Without DCPA, growers of
specialty Brassica crops could incur significant additional costs. DCPA
has medium benefits for growers of direct-seeded major Brassicas, who
have access to alternative herbicides and other options. DCPA provides
low benefits for growers of transplanted major Brassicas, who have
adequate alternatives available to replace DCPA. In Alliums, DCPA has
high benefits for green onions and leeks in California due to a lack of
registered preemergence herbicides for those uses. DCPA has low
benefits in dry bulb onion and shallots where growers can replace DCPA
with other alternatives. DCPA has low benefits in all other registered
uses, and data available to EPA indicate that actual herbicide
applications for these uses are limited. Though growers of Brassica and
Allium crops may be substantially impacted, these crops are
internationally traded, and the global price is unlikely to increase.
If the global price does not increase, growers will be unable to pass
cost increases on to the consumer, thus this Emergency Order is likely
to result in negligible impact at the consumer level. For more
information, see Assessment of Dimethyl Tetrachloroterephthalate (DCPA)
(PC: 078701) Use, Usage, and Benefits, available at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0088">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0088</a>.
Between EPA's issuance of the May 2023 ORE Assessment and April
2024, the Agency and AMVAC discussed how to limit exposures to DCPA.
AMVAC voluntarily cancelled all but two of its DCPA products [(EPA Reg.
Nos. 5481-495 (technical product) and 5481-487 (liquid end-use
product)] pursuant to FIFRA Section 6(f). 88 FR 89447, December 27,
2023 (FRL-11590-01-OCSPP) (final cancellation order). These product
cancellations limited registered end-use products to only one liquid
formulation (a Special Local Need (SLN) registration in Wisconsin
remains active (WI050002), but will imminently be cancelled pursuant to
FIFRA Section 4 due to AMVAC's failure to pay the required maintenance
fees). Further, in July 2023, the registrant requested to voluntarily
cancel uses on turf from its remaining product. While these voluntary
cancellations would eliminate residential post-application exposures to
DCPA from activities on and around turf (including golf courses and
athletic fields), the currently available product labels have not been
revised--due to the remaining issues not addressed by the proposed
mitigations--and still allow for these uses.
AMVAC submitted additional proposals in April 2024 and May 2024 to
address the identified risk to handlers, post-application workers and
residential bystanders that still remained even after cancelling the
products identified above and proposing cancellation of the turf uses.
These additional proposals include limiting the amount of product
individual handlers are allowed to use, only permitting banded
applications, limiting applications over the top of crops to reduce the
post-application exposure potential, and requiring buffers around
agricultural applications to address risks in residential areas from
spray drift. In April 2024, AMVAC informed EPA that the company had
voluntarily ceased sale and distribution of all Dacthal Flowable
Herbicide (the only remaining end-use product) in the company's
possession until the Agency approved product labels addressing the
risks described in the May 2023 ORE Assessment. Although the registrant
has presently unilaterally promised to halt the sale and distribution
of DCPA, DCPA products that were sold or distributed prior to this
voluntary cessation remain in the hands of growers. DCPA is used year-
round on certain crops, so EPA believes that exposures of concern
likely continue to occur.
While the voluntary steps identified above may reduce the risks of
concern identified for DCPA, according to the Agency's analysis, these
steps would not adequately address all of the identified risks of
concern, leaving the current approved product label in use. As noted in
the May 2023 ORE Assessment, use under the current approved product
label can result in pregnant individuals being unknowingly exposed to
DCPA at levels greater than the level at which adverse effects were
observed in the CTA. EPA is concerned that exposure at these levels
could result in adverse effects to the fetuses of the pregnant
individuals being exposed. There are unknown amounts of existing DCPA
product in the hands of users which may lead to the serious and
significant health outcomes described in this Emergency Order.
Additional explanation as to why the proposed mitigations do not
address the risks of concern or alleviate the imminent hazard from
continued DCPA use is provided in Unit VII., below. Due to the concerns
summarized, EPA does not believe that the risks identified in this
Emergency Order can be sufficiently mitigated through any means except
cancellation and immediate suspension of all products containing DCPA.
Accordingly, issuance of this Emergency Order is necessary.
IV. Legal Authority
A. Standards for Maintaining a Registration and Cancelation
FIFRA provides for federal regulation of pesticide distribution,
sale, and use. 7 U.S.C. 136 et seq. Subject to limited exceptions, a
pesticide may be distributed or sold in the United States only if it is
registered by the EPA under FIFRA section 3(a). A registration is a
license allowing a pesticide product to be sold and distributed for
specified uses in accordance with specified use instructions,
precautions, and other terms and conditions. Before EPA may register a
pesticide under FIFRA, an applicant must show, among other things, that
using the pesticide according to its specifications ``will not
generally cause unreasonable adverse effects on the environment.''
FIFRA section 3(c)(5)(D). ``Unreasonable adverse effects on the
environment'' is defined, in part, as ``any unreasonable risk to man or
the environment, taking into account the economic, social, and
environmental costs and benefits of the use of [the] pesticide.'' FIFRA
section 2(bb). This portion of the unreasonable adverse effects
standard creates a ``risk-benefit'' standard wherein the EPA compares
the risks presented from the use of a pesticide with the benefits from
the use of the pesticide. The burden to demonstrate that a pesticide
product satisfies the criteria for registration is at all times on the
proponents of initial or continued registration. Indus. Union Dept. v.
Am. Petroleum Inst., 448 U.S. 607, 653 n. 61 (1980); Envtl. Defense
Fund v. EPA, 510 F.2d 1292, 1297, 1302 (D.C. Cir. 1975).
Whenever the Agency determines that the product no longer satisfies
the statutory criteria for registration, it may issue a notice of
intent to cancel the registration of a pesticide product under FIFRA
section 6(b). In such notice, the Agency may specify particular
modifications in the terms and conditions of registration, such as
deletion of particular uses or revisions of labeling, as an alternative
to cancellation. If a hearing is requested by an adversely affected
person, the final
[[Page 64449]]
order concerning cancellation of the product is not issued until after
a formal administrative hearing. FIFRA section 6(d). For purposes of
this Emergency Order, and in conformity with the timetable for any
cancellation hearing held pursuant to FIFRA section 6(b), EPA has
assumed that a cancellation hearing concerning the registered DCPA
products would require at least 18 months.
B. Suspension of a Pesticide Product
The suspension provisions in FIFRA section 6(c) give EPA the
authority to take interim action until completion of the time-consuming
procedures which may be required to reach a final cancellation
decision. Under this authority, EPA may suspend the registration of a
product and prohibit its distribution, sale, or use during cancellation
proceedings upon a finding that the pesticide poses an ``imminent
hazard'' to humans or the environment. FIFRA section 6(c)(1).
Suspension is an interim remedy which enables the Agency to abate
potential unreasonable adverse effects in advance of the full analysis
of risks and benefits in a cancellation hearing. The function of
suspension ``is to make a preliminary assessment of evidence, and
probabilities, not an ultimate resolution of difficult issues.'' Envtl.
Defense Fund v. EPA, 465 F.2d 528, 537 (D.C. Cir. 1972). FIFRA section
2(1) defines ``imminent hazard'' as ``. . . a situation which exists
when the continued use of a pesticide during the time required for
cancellation proceedings would be likely to result in unreasonable
adverse effects on the environment or will involve unreasonable hazard
to the survival of a species declared endangered by the Secretary of
the Interior under Public Law 91-135.''
As noted previously, ``unreasonable adverse effects on the
environment'' means that the risks associated with use of a pesticide
outweigh the benefits of its use. Thus, in order to find an ``imminent
hazard,'' the Agency must determine that the risks appear to outweigh
the benefits associated with continued registration during the period
likely to be necessary to complete a cancellation proceeding. Courts
addressing the suspension provisions of FIFRA section 6 have held that
an imminent hazard exists if there is ``a substantial likelihood that
serious harm will be experienced during the year or two required in any
realistic projection of the administrative [cancellation] process.''
Love, 858 F.2d at 1350 (quoting Envtl. Defense Fund v. EPA, 465 F.2d at
540). Thus, courts interpreting the FIFRA section 6 suspension standard
have made clear that an imminent hazard finding requires a greater
degree of likelihood, immediacy, and severity of harm than is otherwise
required to take cancellation action under FIFRA. In evaluating the
nature and extent of information before the agency, courts have
instructed EPA to consider:
(1) The seriousness of the threatened harm;
(2) The immediacy of the threatened harm;
(3) The probability that the threatened harm will occur;
(4) The benefits to the public of the continued use of the
pesticide; and
(5) The nature and extent of the information before the Agency at
the time it makes a decision.
Dow Chem. Co. v. Blum, 469 F.Supp. 892, 902 (E.D. Mich. 1979).
C. Emergency Suspension
If the Administrator determines that: (1) A pesticide poses an
imminent hazard, and (2) An emergency exists that does not permit the
Administrator to hold a hearing before suspending the pesticide, FIFRA
section 6(c)(3) provides that the Administrator may issue an Emergency
Order immediately suspending registration of the pesticide.
The term ``emergency'' is not defined by FIFRA. In the case of
emergency suspension, one court has found by analogy that suspension is
appropriate if there is ``a substantial likelihood that serious harm
will be experienced during the three or four months required in any
realistic projection of the administrative suspension process.'' Dow
Chem. Co., 469 F.Supp. at 901. The Agency interprets FIFRA section
6(c)(3) to mean that, if the threat of harm to humans or the
environment associated with continued sale, distribution, or use of a
pesticide is sufficiently serious and immediate that the risks would be
likely to outweigh the benefits during the time required for a
suspension hearing, the registration of that pesticide may be suspended
immediately. Thus, the determination whether an emergency exists is
even more preliminary than the determination concerning the question of
imminent hazard, and an Emergency Order is analogous to a temporary
restraining order issued by a court while it is determining whether to
issue a preliminary injunction. Dow Chem. Co., 469 F.Supp. at 901.
An Emergency Order to suspend a registration may be issued without
prior notice to affected registrants and is effective immediately upon
issuance. In contrast to a notice of intent to suspend issued pursuant
to FIFRA section 6(c)(1), there is no requirement that EPA issue a
notice of intent to cancel the registration or change the
classification of that pesticide prior to or simultaneous with issuing
an Emergency Order of suspension. The Agency may issue an Emergency
Order of suspension, effective immediately, prior to issuing a notice
of intent to cancel. However, if EPA does not issue a notice of intent
to cancel within 90 days of issuing an Emergency Order of suspension,
the Emergency Order of suspension will expire.
The Agency must notify the affected registrant that an Emergency
Order of suspension has been issued and the registrant may request an
expedited hearing by submitting a valid hearing request to the OALJ
Clerk. If an expedited hearing is held concerning any product, the
hearing is confined solely to the question of imminent hazard, and the
Emergency Order of suspension remains in effect during the pendency of
the expedited hearing. Following the expedited hearing, the
Administrator issues a final order which may either retain, modify, or
rescind the suspension. FIFRA section 6(c)(2).
The Administrator's determination to issue an Emergency Order of
suspension is also subject to immediate review in an appropriate United
States district court. The only issues in any such review are whether
the Emergency Order was arbitrary, capricious, or an abuse of
discretion, and was issued in accordance with procedures established by
law. FIFRA section 6(c)(4).
If a registrant does not request an expedited hearing concerning a
particular product but does request a hearing concerning cancellation
of that product, the Emergency Order of suspension remains in effect
until the completion of the cancellation proceeding, unless the
suspension is lifted, stayed, or otherwise modified by the
Administrator or an appropriate federal court.
V. Findings Concerning Imminent Hazard and Emergency
This unit summarizes EPA's findings concerning the existence of an
imminent hazard and an emergency.
A. Findings Concerning Imminent Hazard
1. Nature and Extent of Information Before the Administrator
In evaluating the risks which DCPA would pose during the time
needed to conduct a cancellation hearing, EPA has placed the greatest
emphasis on the results of the CTA submitted to the Agency, which
indicates that very low levels of DCPA (at least 10-fold lower
[[Page 64450]]
than a dose that did not cause adverse thyroid effects in maternal
animals in the CTA) causes thyroid hormone perturbations in fetal rats.
DCPA--Data Evaluation Record (DER) of a submitted definitive study to
fulfill the Comparative Thyroid Assay (CTA) study requirement (EPA
2023), available at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0080">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0080</a>. The Agency required the CTA to evaluate the potential
impact (hazard) of DCPA exposure on thyroid hormone homeostasis and
thyroid function in the developing organism. Subsequent analysis of the
CTA data by the Agency and review of registered end-use product labels
as of May 2023, in combination with multiple other data sources,
enabled the production of DCPA Occupational and Residential Exposure
Assessment for the Registration Review of DCPA (May 18, 2023) (May 2023
ORE Assessment). This analysis indicates that current uses of DCPA may
expose pregnant individuals to levels of the pesticide sufficient to
cause adverse thyroid effects--with attendant lifelong health
problems--in the fetuses of those individuals. There are still risk
concerns even when taking into consideration the subsequent December
2023 product cancellations, the July 2023 voluntary use cancellation
requests, and the registrant's voluntary cessation of the sale and
distribution of DCPA.
EPA also took time to gather and evaluate essential and available
data on the benefits associated with DCPA use. While this benefits
assessment focused primarily on the heaviest current use patterns and
locations, EPA also assessed DCPA use on a national level for all
registered uses, to the extent that information was available to the
Agency. Accordingly, as discussed in Unit VI. of this Emergency Order,
EPA assessed DCPA's benefits as a preemergence treatment in crops with
registered uses, primarily Brassica vegetables and Alliums, based on
the observed usage of DCPA in these crops, weed control
recommendations, and other information on DCPA's benefits from
extension publications, pest management strategic plans, United States
Department of Agriculture Office of Pest Management Policy (USDA OPMP),
and a report from faculty at the University of California (UC) Davis on
DCPA's benefits in California agriculture.
2. Seriousness of the Threatened Harm
In the CTA, decreased levels of the thyroid hormones T3
(triiodothyronine) and T4 (thyroxine) were observed in rats exposed to
very low levels of DCPA (1 mg/kg/day). The level of exposure at which
fetal hormone perturbations were observed is much lower than the level
at which effects were observed in adult rats, and lower than levels at
which EPA estimates human users of DCPA are currently being exposed.
See May 2023 ORE Assessment at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0081">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0081</a>.
In the fetus of exposed pregnant humans, thyroid hormone
perturbations, such as those observed in the CTA, can lead to
downstream health problems such as low birth weight, impaired brain
development, decreased IQ, impaired motor skills, and decreased bone
deposition (Chan and Kilby, 2000; Fisher, 2000; Morreale, et al., 2000;
Zoeller and Rovet, 2004). Based on the CTA data for DCPA, these effects
are not expected in exposed adults, but rather in children born to
individuals exposed to DCPA during pregnancy and might not always be
obvious in affected children at the time of birth. Brief thyroid
hormone perturbations in fetuses during critical stages of development
may result in life-long consequences for children exposed before birth
(e.g., impaired brain development, decreased IQ, and impaired motor
skills) that--when later identified--would not likely be recognized as
resulting from prior pesticide exposure. Id.
3. Immediacy of the Threatened Harm
EPA has determined that there are likely immediate, ongoing risks
of concern presented by continued use of DCPA. Of primary concern,
based on usage data, are the risks identified in the May 2023 ORE
Assessment for occupational scenarios (handler and post-application)
and non-occupational post-application bystander spray drift scenarios.
Occupational handler scenarios were of concern assuming label-
prescribed PPE, and even assuming maximum PPE and/or engineering
controls. Occupational post-application scenarios were of concern on
the day of application (the current label required restricted entry
interval of 12 hours) and even past 30 days after application. It
should be noted that available data for DCPA indicates that while DCPA
residues decline on treated foliage after application, residues that
are present more than 40 days post-application for some uses can result
in risks of concern. For bystander spray drift scenarios, risks were of
concern up to and greater than 300 feet from the field edge.
These risks of concern indicate that individuals, either using DCPA
products as currently registered, working in areas/fields treated with
DCPA, or present near areas where DCPA is being used, can be
unknowingly exposed to DCPA at levels greater than the level at which
no adverse effects were observed in rat fetuses in the CTA, and in some
situations, can be exposed to DCPA at levels greater than the level at
which adverse effects were observed in the study. EPA is concerned that
exposure at these levels could result in adverse effects to the fetuses
of pregnant individuals being exposed. Although the registrant has
presently unilaterally promised to halt the sale and distribution of
DCPA (until EPA approves new labels incorporating the registrant's
proposed mitigations), DCPA products that were sold or distributed
prior to this voluntary cessation remain in the hands of growers and
EPA has no mechanism to enforce this voluntary cessation. DCPA is used
year-round on certain crops; EPA thus believes that these exposures of
concern are likely occurring at present. To summarize, EPA believes
that the continued use of DCPA products will allow for people,
particularly pregnant individuals, to be unknowingly exposed to DCPA at
levels that result in a risk of concern and in some cases, are equal to
or greater than those that result in fetal thyroid hormone
perturbations in the CTA and the life-long health effects that may
result from those perturbations.
4. Probability That the Threatened Harm Will Occur
Based on EPA's analysis of the available evidence, the fetuses of
pregnant individuals exposed to DCPA are at significant risk for
adverse thyroid hormone changes. Without this Emergency Order, such
exposures would continue during the time required to conduct a
cancellation hearing. If the products were not suspended, use of DCPA
could lawfully continue during the pendency of a cancellation hearing.
Although EPA considered AMVAC's statement that the company has
voluntarily temporarily ceased sale and distribution of Dacthal
Flowable Herbicide in the context of this determination, EPA still
considers the probability of the harm in this situation sufficiently
likely to justify this Emergency Order. While such voluntary steps
would likely reduce the risks of concern identified for DCPA, the
Agency has no means of assessing whether AMVAC is adhering to this
temporary cessation of sale, neither EPA nor AMVAC has information
concerning subsequent downstream distribution and use, and--in any
event--there is no
[[Page 64451]]
mechanism under FIFRA through which EPA can enforce compliance with
such voluntary measures. AMVAC could resume sale and distribution at
any time, and application of DCPA products by end users is still
allowed under current approved product labels.
EPA also considered, in the context of this determination, AMVAC's
voluntary cancellation of all but two of its DCPA products (EPA Reg.
Nos. 5481-495 and 5481-487; a SLN registration in Wisconsin remains
active (WI050002), but will imminently be cancelled pursuant to FIFRA
section 4 due to AMVAC's failure to pay the required maintenance fees)
pursuant to FIFRA section 6(f). 88 FR 89447, December 27, 2023 (FRL-
11590-01-OCSPP) (final cancellation order). Additionally, AMVAC
submitted several revised proposed product labels from approximately
July 2023 through May 2024, including its requests to cancel certain
uses of DCPA. Of particular note, in July 2023 the registrant requested
to voluntarily cancel remaining (non-residential) uses on turf from its
remaining products. Accordingly, while risks of concern arising from
turf uses are addressed in the May 2023 ORE Assessment, those risks are
not part of the basis for this Emergency Order. However, the proposed
product labels do not adequately address the risks of concern for
continued DCPA use. Following the registrant's April and May proposals,
EPA has determined that there is no combination of practicable
mitigations under which DCPA use can continue without presenting an
imminent hazard. Additional explanation as to why the proposed
mitigations do not address the risks of concern or alleviate the
imminent hazard from continued DCPA use is provided in Unit VII. of
this Emergency Order. Due to the concerns described in this unit, EPA
does not believe that the risks identified in this Emergency Order can
be mitigated through any means except cancellation and immediate
suspension of all products containing DCPA. Accordingly, issuance of
this Emergency Order is necessary.
5. Benefits to the Public of the Continued Use of DCPA
While DCPA has high benefits for the growers of certain crops, EPA
estimates that the suspension and cancellation of DCPA is likely to
have negligible impacts to consumers of those crops. DCPA is registered
for use in the production of Brassica (cole) vegetables (e.g.,
broccoli, cabbage, cauliflower, brussels sprouts), certain Alliums
(onions, including dry bulb and various green onions), certain
cucurbit, root, and fruiting vegetables, strawberries, sod, and nursery
ornamental plants. While DCPA is registered for non-agricultural turf
uses, the registrant has requested cancellation of these uses; thus,
these non-agricultural turf uses are not addressed here. DCPA is
applied preemergent to the crop, and growers use DCPA for residual
control of major broadleaf and grassy weeds, including common
chickweed, common purslane, dodder, annual bluegrass, canarygrass, and
barnyardgrass. DCPA's main benefits are its broad spectrum of weed
control and its safety to the crop at planting in direct-seeded
production of Brassicas and registered Alliums. Weed control prior to
crop emergence is important in these crops, especially in Alliums, as
these crops are slow to emerge and vulnerable to early-season weed
competition.
DCPA has high benefits for growers of specialty Brassica crops
(e.g., bok choy, collards, and kale), which have fewer alternative pre-
emergence herbicides than major Brassica crops (e.g., broccoli,
brussels sprouts, cabbage, cauliflower). In the absence of DCPA,
growers of specialty Brassica crops would need to use a combination of
alternative herbicides and hand-weeding labor to achieve the same level
of control, at an additional cost to growers. Growers of specialty
Brassica crops could lose up to 20% of gross revenue in the absence of
DCPA due to lower yield resulting from less dense planting to avoid
damage from hand-weeding, competition from uncontrolled weeds, or crop
damage and increased labor costs resulting from increased hand-weeding.
DCPA has medium benefits for growers of direct-seeded major
Brassicas who can acquire hand-weeding labor. In the absence of DCPA,
growers of direct-seeded broccoli, brussels sprouts, cabbage, and
cauliflower could replace DCPA with alternative preemergence herbicides
and increased hand-weeding, facing estimated cost increases of $40 per
acre or 1% of gross revenue. If growers are unable to acquire the labor
for increased hand-weeding, they would either have to switch to
transplanting (as opposed to direct-seeding) and using oxyfluorfen,
which is registered on Brassicas for transplanted broccoli, cabbage,
and cauliflower only (growers of brussels sprouts can use napropamide),
or else face yield loss. Both switching to transplanting with
oxyfluorfen or using bensulide without additional hand-weeding may
result in losses of over $700 per acre or 9% of gross revenue.
In Alliums, DCPA has high benefits for green onions and leeks in
California due to a lack of registered preemergence herbicides for
those uses. DCPA has low benefits in dry bulb onion and shallots where
growers can replace DCPA with pendimethalin or a combination of
bensulide and additional hand-weeding for sufficient control of early
season weeds.
DCPA has low benefits in strawberry and the remaining cucurbit,
fruiting, and root vegetables for which it is registered for use
because extension publications do not recommend DCPA and/or recommend
alternative preemergence herbicides; where surveyed, growers do not
report using DCPA extensively on these crops. DCPA also has low
benefits in sod and ornamental production as registered and recommended
alternative herbicides are available on these use sites and growers do
not report using DCPA.
In the use sites where there are high benefits from the use of
DCPA, its absence could result in growers who rely on DCPA shifting to
production of other crops. For registered Brassica and Allium crops,
use of alternatives will likely result in increased treatment costs for
growers, but these costs will have a negligible impact at the consumer
level. The shift away from production of Brassicas could decrease U.S.
production of Brassica crops; however, Brassicas are internationally
traded crops, the total supply globally is unlikely to substantially
decrease, and the global price for these commodities is unlikely to
substantially increase. If the global price for these commodities does
not increase, growers will be unable to pass cost increases from the
absence of DCPA on to consumers. Thus, this Emergency Order is likely
to result in negligible impact at the consumer level, but some growers
of Brassica and Allium crops may be substantially impacted.
For additional details on the benefits of DCPA in registered use
sites, see Assessment of Dimethyl Tetrachloroterephthalate (DCPA) (PC:
078701) Use, Usage, and Benefits, available at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0088">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0088</a>.
B. Findings Concerning Existence of an Emergency
The Agency has determined that an emergency exists such that sale,
distribution, and use of all DCPA products must be suspended during the
pendency of any expedited hearing. In order to find that an emergency
exists, EPA must determine whether the threat of harm associated with
continued sale, distribution, or use of DCPA products is sufficiently
serious and immediate that
[[Page 64452]]
the risks outweigh the benefits during the time required for a
suspension hearing. For purposes of this determination, and in
conformity with the mandatory timetable for any hearing on the question
of imminent hazard established by FIFRA section 6(c)(2) and 40 CFR part
164, subpart D, EPA assumes that a suspension hearing would require
approximately four months. Dow Chem. Co., 469 F.Supp. at 901.
Although EPA considered AMVAC's statement that the company has
voluntarily ceased sale and distribution of Dacthal Flowable Herbicide
in the context of this determination, EPA still considers the
probability of the harm in this situation sufficiently likely to
justify this Emergency Order. While such voluntary steps would likely
reduce the risks of concern identified for DCPA, the Agency has no
means of assessing whether AMVAC is adhering to this temporary
cessation of sale, neither EPA nor AMVAC has information concerning
subsequent downstream distribution and use, and--in any event--there is
no mechanism under FIFRA through which EPA can enforce compliance with
such voluntary measures. AMVAC could resume sale and distribution at
any time, and application of DCPA products by end users is still
allowed under current approved product labels.
In the absence of an emergency order, it appears that exposures to
pregnant individuals resulting in adverse fetal thyroid effects could
unknowingly occur as a result of lawful use during the time required
for a suspension hearing. DCPA is registered and is typically used for
weed control throughout the calendar year on a variety of crops,
including Allium species, Brassica species, cucurbits, root vegetables,
fruiting vegetables, and strawberry.
An immediate prohibition on use of DCPA products may cause some
disruption, as users need to identify and obtain or implement
alternatives. However, the Agency has concluded that alternative
pesticides are available for most DCPA target pests and use sites,
though there will be impacts on growers as they transition to
combinations of alternative herbicides and hand weeding at an
additional cost, and some Brassica and Allium growers that currently
use DCPA may choose to cease production of these crops. Growers who
have DCPA at the time the order is issued will not only have to obtain
other weed control products, but they will also bear the burden of
disposing of DCPA products. Based on the available evidence on risks
and benefits, EPA has determined that an emergency exists that does not
permit the Agency to hold a hearing before suspending the registration
of DCPA products. EPA has concluded that the risks of continued use are
sufficiently serious and immediate to require immediate prohibition of
all use of all pesticide products containing DCPA. EPA has also
concluded that continued distribution or sale of DCPA products would be
inconsistent with and frustrate enforcement of any prohibition on
continued use of such products.
C. Waiver of Consultation With the Secretary of Agriculture and
Submission to the FIFRA Scientific Advisory Panel
Although FIFRA section 6(b) generally requires prior review of and
comment upon proposed notices of intent to cancel by the Secretary of
Agriculture and the FIFRA Scientific Advisory Panel (SAP), FIFRA
specifically provides the Administrator with the authority to waive
such requirements and proceed in accordance with FIFRA section 6(c)
whenever it finds that suspension of a pesticide registration is
necessary to prevent an imminent hazard to human health. As described
in this unit, EPA has found that immediate suspension of the
registrations of pesticide products containing DCPA is necessary to
prevent an imminent hazard to human health, and the Administrator
hereby invokes the authority to waive the requirements for the
Secretary of Agriculture and FIFRA SAP reviews.
VI. Analysis of Risk Posed by Continued Use of DCPA
As noted previously, in May 2023, an ORE assessment was conducted
based on the two DCPA products registered at the time: EPA Reg. Nos.
5481-487 (a liquid formulation) and 5481-490 (a wettable powder
formulation). The wettable powder product has since been voluntarily
cancelled by AMVAC. Full details of inputs, assumptions and
calculations are provided in the ORE Assessment. A summary of the
exposure and risks identified in the May 2023 ORE Assessment are
presented below. This summary takes into account the product
cancellations that occurred in December 2023 (i.e., the summary is only
representative of the remaining liquid end-use product). While this
product does allow for use on non-residential turf (including golf
course and athletic fields), for which risks of concern were
identified, a summary is not included here since those uses were
requested for voluntary cancellation. The primary concern addressed by
this Emergency Order is occupational risks and non-occupational
bystander drift risks.
A. Hazard Characterization
Any risk assessment begins with an evaluation of a chemical's
properties that have the potential to cause adverse effects to humans.
In evaluating toxicity or hazard, EPA reviews toxicity data, typically
from studies with laboratory animals, to identify any adverse effects
on the test subjects leading to the establishment of a Lowest Observed
Adverse Effect Level (LOAEL) and a No Observed Adverse Effect Level
(NOAEL). A Point of Departure (POD) is the dose that serves as the
`starting point' in extrapolating a risk to the human population. PODs
are selected to be protective of the most sensitive adverse toxic
effect for each exposure scenario and are chosen from toxicity studies
that show clearly defined NOAELs or LOAELs, dose-response
relationships, and relationships between the chemical exposure and
effect. EPA will select separate PODs, as needed, for each expected
exposure duration and route of exposure.
DCPA has low acute toxicity via the oral, dermal, and inhalation
routes (Toxicity Category III-IV). DCPA is not a dermal sensitizer and
is classified as Toxicity Categories III and IV for eye and skin
irritation, respectively. Thyroid effects are the most sensitive
endpoints in the DCPA toxicity database. Thyroid histological
alterations and thyroid hormone perturbations were seen at all exposure
durations and across lifestages. The decreased fetal thyroid hormone
levels identified in the CTA are the basis for occupational and adult
bystander assessments. Toxicological PODs for adults (including
pregnant individuals) were selected for the following routes of
exposure:
<bullet> Short- and intermediate-term dermal; and
<bullet> Short- and intermediate-term inhalation.
Although no adverse effects were observed up to the highest doses
tested in the route-specific dermal and inhalation studies (1,000 mg/
kg/day and 3.11 mg/L, respectively), increased quantitative
susceptibility in the fetal life stage was observed in the definitive
CTA in rats. Thus, an oral POD was selected for dermal and inhalation
risk assessment because the dermal and inhalation toxicity studies did
not evaluate the critical endpoint (thyroid hormone levels, thyroid
weights or thyroid histopathology) or the fetal lifestage that were
identified as the most sensitive endpoint and lifestage, respectively,
in the DCPA database for
[[Page 64453]]
these exposure scenarios. The NOAEL of 0.1 mg/kg/day from the CTA
served as the POD for evaluating short-and intermediate-term adult
dermal and inhalation exposure scenarios. Although the POD for adults
is based on the disruption of the thyroid hormones in rats, the 10X
interspecies extrapolation factor is retained because the young (fetus)
has been identified as the target lifestage of concern and differences
in the toxicodynamics for the developing thyroid function between
juvenile rats and juvenile humans are not well understood. The level of
concern (LOC) for adult dermal and inhalation exposure scenarios is 100
(10X interspecies extrapolation, 10X intraspecies variation, and 1X
FQPA when applicable). For dermal exposure scenarios, a dermal
absorption factor (DAF) of 15%, based on the results of an in vivo
dermal absorption study (MRID 42651502), was applied to account for the
amount of chemical absorbed through the skin. For the inhalation
exposure scenario, toxicity via the inhalation route is assumed to be
equivalent to oral exposure.
Since decreased fetal thyroid hormone levels (a female specific
effect) is the endpoint for both the dermal and inhalation exposure
scenarios, a body weight of 69 kg (representing females) was used in
the dose calculations rather than 80 kg (representing males and
females). This body weight was used for the ORE assessment because it
accounts for the adverse effects to the fetal lifestage and is
protective of pregnant individuals.
Although a cancer assessment was also presented for DCPA in the May
2023 ORE Assessment, the concern for the Emergency Order are the non-
cancer risks, specifically for the fetuses of exposed pregnant
individuals. As such, only information related to the non-cancer risks
for adults are further summarized here.
B. Occupational Exposure and Risk Estimates
1. Occupational Post-Application Exposure/Risk Estimates
EPA uses the term post-application to describe exposures that occur
when individuals are present in an environment that has been previously
treated with a pesticide (also referred to as re-entry exposure). Such
exposures may occur when workers enter previously treated areas to
perform job functions, including activities related to crop production,
such as scouting for pests or harvesting. Post-application exposure
levels vary over time and depend on such things as the type of
activity, the nature of the crop or target that was treated, the type
of pesticide application, and the chemical's degradation properties. In
addition, the timing of pesticide applications, relative to harvest
activities for example, can greatly reduce the potential for post-
application exposure.
A series of assumptions and exposure factors served as the basis
for completing the occupational post-application risk assessments. Each
assumption and factor are detailed in the May 2023 ORE Assessment. The
algorithms used to estimate non-cancer exposure and dose for
occupational post-application scenarios can be found in Appendix A of
the May 2023 ORE Assessment. Occupational post-application non-cancer
dermal risk estimates are of concern on the day of application (i.e.,
0-DAT ``days after treatment'')) (i.e., MOEs < LOC of 100) for all
scenarios with MOEs ranging from 0.08 to 5.6. Some scenarios are no
longer of concern from 20 to 31-DAT; however, most scenarios are still
of concern greater than 30-DAT. The lowest MOEs are associated with
activities that are likely to occur later in the season, when residues
may be low but still present. These activities include scouting, hand
harvesting, and moving hand-set irrigation in crops such as broccoli,
brussels sprouts, cabbage, cauliflower, and onion. For these
activities, there are still risks of concern at greater than 30-DAT. A
full list of crops/activities and their associated risks are presented
in the May 2023 ORE assessment.
A restricted entry interval (REI) can be established based on
different sources of information considering both acute effects and
also systemic effects. EPA considers both the acute toxicity categories
for the active ingredient in a product and also the post-application
risk assessment which may incorporate systemic effects from exposure to
a pesticide product and establishes the REI based on the more
protective duration.
Although active ingredients like DCPA that are classified as
Category III or IV for acute dermal, eye irritation and primary skin
irritation are assigned under 40 CFR 156.208(c)(2) a 12-hour REI
(currently listed on registered product labels), short- and
intermediate-term post-application risk estimates were of concern on 0-
DAT (12 hours following application) for all activities with
implications for re-entry risks of concern extending past 30 days.
2. Occupational Handler Exposure/Risk Estimates
EPA uses the term handlers to describe those individuals who are
involved in the pesticide application process. EPA believes that there
are distinct job functions or tasks related to applications and
exposures can vary depending on the specifics of each task. The amount
of chemical used in each application (i.e., application rate and area
treated or amount handled for the specific task), the kinds of
equipment used, the target being treated, and the level of protection
used by a handler can cause exposure levels to differ in a manner
specific to each application event.
Based on the anticipated use patterns and current labeling, types
of equipment and techniques that can potentially be used, occupational
handler exposure is expected from the registered uses. A series of
assumptions and exposure factors served as the basis for completing the
occupational handler risk assessments. Each assumption and factor are
detailed in the May 2023 ORE Assessment. The algorithms used to
estimate non-cancer exposure and dose for occupational handlers can be
found in Appendix A of the May 2023 ORE Assessment.
Estimates of dermal and inhalation exposure were calculated for
various levels of personal protective equipment (PPE). Results are
presented for the highest level of protection available for the
particular scenario, which ranged from double layer of clothing (i.e.,
coveralls over a long-sleeved shirt and long pants) and a PF10
respirator to engineering controls (i.e., closed loading systems or
closed cab tractors or cockpits). The current DCPA product labels
direct mixers, loaders, applicators and other handlers to wear baseline
attire (i.e., long sleeve shirt, long pants, shoes and socks) as well
as PPE including chemical- or water-resistant gloves.
Dermal and inhalation risk estimates were combined in this
assessment, since the toxicological effects for these exposure routes
were similar. Occupational handler non-cancer combined (dermal and
inhalation) risk estimates are of concern (i.e., MOEs < LOC of 100)
when considering currently labelled PPE. Further, there are still risk
estimates of concern for 37 out of 39 scenarios with engineering
controls (e.g., closed loading systems for mixer/loaders, closed
cockpit or cab for aerial or groundboom applications) and/or maximum
PPE (i.e., double layer, gloves, respirators, etc.). Combined (dermal
and inhalation) MOEs range
[[Page 64454]]
from 0.065 to 150. See Table 8.1.1 of the May 2023 ORE Assessment for
the full list of occupational handler non-cancer exposure and risk
estimates for DCPA.
C. Non-Occupational Spray Drift Exposure and Risk Estimates
The spray drift risk estimates are based on an estimated deposited
residue concentration as a result of screening level agricultural
application scenarios. DCPA is used on field crops, sod farms, and
nurseries, and can be applied via groundboom and aerial equipment. The
recommended drift scenario screening level options are las follows:
<bullet> Groundboom applications are based on the AgDrift model
option for high boom height and using very fine to fine spray type
using the 90th percentile results.
<bullet> Aerial applications are based on the use of AgDrift Tier 1
aerial model option for a fine to medium spray type and a series of
other parameters which will be described in more detail below (e.g.,
wind vector assumed to be 10 mph in a downwind direction for entire
application/drift event). (AgDrift allows for consideration of even
finer spray patterns characterized as very fine to fine. However, this
spray pattern was not selected as the common screening basis since it
is used less commonly for most agriculture.)
Adult dermal exposures resulting from spray drift residues were
estimated. Exposures were considered for 50 feet wide lawns where the
nearest side of the property was directly adjoining the treated field
(at field edge) and at varied distances up to 300 feet downwind of a
treated field. The algorithms used to estimate exposure and dose for
non-occupational spray drift can be found in Appendix C of the May 2023
ORE Assessment.
Results for the screening level scenarios are presented in Table
6.1.1 (adult risk estimates) of the May 2023 ORE Assessment and
indicate that there are risks of concern at the field edge and at
distances greater than 300 feet for some adult exposure scenarios
(which includes exposures to pregnant individuals). For adults, dermal
screening-level risk estimates were of concern at the field edge with
MOEs ranging from 0.4-1 for all scenarios (dermal LOC = 100). The
distance required for exposures to reach the LOC of 100 is >300 feet
from the field edge.
VII. Analysis of Benefits Associated With Continued Use of DCPA
The Agency assessed DCPA's benefits as a preemergence treatment in
the Brassica vegetables and Alliums for which there are registered uses
based on the observed usage of DCPA in these crops, weed control
recommendations, and other information on DCPA's benefits from
extension publications, pest management strategic plans, United States
Department of Agriculture Office of Pest Management Policy (USDA OPMP),
and a report from faculty at the University of California (UC), Davis,
on DCPA's benefits in California agriculture.
EPA determined that DCPA is rarely used in registered use sites
other than Brassica vegetables and Alliums because it provides little
to no benefits to growers of those other registered use sites, it is
not recommended for weed control in those sites, and/or other
registered preemergence herbicides are preferred.
For more information on the benefits of DCPA usage (and to see
supporting references), see Assessment of Dimethyl
Tetrachloroterephthalate (DCPA) (PC: 078701) Use, Usage, and Benefits,
available at <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0088">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0088</a>.
A. Benefits in Brassicas
Growers use DCPA, as directed by the product label, when planting
seed (also referred to as direct seeding) and at transplant to provide
residual control of weeds during the period between Brassica seeding
and crop emergence, or during the establishment period for transplants.
DCPA is applied banded within rows to reduce weed emergence around
vulnerable seedlings. DCPA controls a broad range of annual broadleaf
and grassy weeds prior to emergence, including several weeds identified
by the University of California Integrated Pest Management (IPM)
Program as problem weeds in Brassica production: i.e., weeds that
compete with growing crops and reduce yield, pose a risk to workers,
are prolific seed producers (leading to weed problems in subsequent
crops), and/or for which no other herbicides are registered. Of these
identified problem weeds, DCPA controls common chickweed and common
purslane and provides partial control of little mallow, London rocket,
burning nettle, nightshades, and sowthistles. Since Brassica vegetables
can be produced year-round in California and DCPA is applied at
planting/transplanting, applications of DCPA can and do occur in all
months of the year. As noted previously, DCPA use is more prevalent for
direct-seeded production than when growers use transplants. Direct-
seeded Brassicas are more dependent on weed control than transplants
because weeds can more readily out-compete emerging seedlings than
transplants.
The cost of herbicides used in Brassicas ranges widely, even
herbicides targeting the same pests. DCPA ($113/acre) is more expensive
than other herbicides used in Brassicas ($4/acre-$90/acre) (Kynetec
USA, Inc. 2022. ``The AgroTrak[supreg] Study from Kynetec USA, Inc.''
iMap Software. Database Subset: 2017-2021. [Accessed February 2023]).
Growers' willingness to pay a premium for DCPA suggests that DCPA
cannot be easily replaced with other available herbicides in some
applications.
In production of direct-seeded broccoli, Brussels sprouts, cabbage,
and cauliflower, the most likely pre-emergent alternative to DCPA is
bensulide. Bensulide can be applied without injuring the crop (crop-
safe), and it allows for a number of rotational crops to be grown
following Brassicas, but it does not control the full spectrum of weeds
that DCPA controls. The next most likely alternative for these use
sites is trifluralin: it is cheaper and has slightly better efficacy
than bensulide, but it can be less crop-safe than bensulide, and it has
a long (12-month) plant-back interval (PBI) for spinach, a common
rotational crop. Trifluralin is not an alternative to DCPA in arid
areas or during cold, wet winters due to the likelihood of crop injury.
Neither bensulide nor trifluralin control the problem weeds little
mallow, London rocket, or sowthistles; DCPA partially controls these
weeds. If growers switch to bensulide or trifluralin to replace DCPA,
the addition of hand-weeding may be necessary to replace early-season
in-row weed control, as mechanical weeding and postemergence herbicides
can damage emerging seedlings. Growers of direct-seeded broccoli,
Brussels sprouts, cabbage, and cauliflower could also switch to
transplanting in order to avoid the critical period for weed control
between planting and emergence in direct-seeded production; this may
also reduce hand-weeding labor needs from the loss of DCPA, though
other labor costs may increase. Growers of direct-seeded broccoli,
Brussels sprouts, cabbage, and cauliflower who do not have access to
transplanting equipment and are unable to hire sufficient additional
labor for increased hand-weeding may face substantial cost increases to
either purchase or rent transplanting equipment or hire contract
transplanters, or else suffer yield loss due to uncontrolled weeds.
In the absence of DCPA, growers who transplant broccoli, cabbage,
and cauliflower could switch to oxyfluorfen
[[Page 64455]]
with few to no impacts on weed control, crop safety, or crop rotational
programs. Oxyfluorfen, however, does not control common chickweed.
Additional hand-weeding or a bensulide application may be necessary to
replace in-row control of common chickweed. Oxyfluorfen is not
registered for use on Brussels sprouts, but these growers can use
napropamide, which is also less expensive and is effective against all
problem weeds that DCPA is effective against. While napropamide has
crop safety concerns and may not be an appropriate alternative for
direct-seeded Brussels sprouts, growers who transplant Brussels sprouts
can use napropamide without significant crop injury concerns.
Napropamide also has long PBIs for several rotational crops; however,
leafy greens, the typical rotational vegetables for Brassicas, can be
planted following an early season napropamide application with little
to no estimated impact to growers.
Growers of both direct-seeded and transplanted specialty Brassica
may also replace DCPA with alternative pre-emergence herbicides such as
bensulide and increased hand-weeding but could lose up to 20% of gross
revenue in the absence of DCPA due to lower yield resulting from less
dense planting to avoid damage from hand-weeding, competition from
uncontrolled weeds, or crop damage and increased labor costs resulting
from increased hand-weeding.
B. Benefits in Alliums
DCPA is recommended for weed management throughout the season;
however, DCPA is the only herbicide that UC IPM recommends for
application at seeding or transplant in onion, indicating its specific
importance in early-season weed control in onion in California.
Herbicide extension recommendations for states other than California
generally do not recommend DCPA therefore the analysis for Alliums
focuses on California. In onion, DCPA is used at seeding to provide
residual control of weeds during the period between onion planting and
emergence; DCPA can also be used at transplant. Preemergence weed
control in onion is especially important because of the long time
between onion seeding and emergence which permits weeds to outcompete
the crop. DCPA is typically applied banded within rows to reduce weed
emergence around vulnerable seedlings, and registered postemergence
herbicides can only be applied after the crop and weeds have emerged.
In the absence of DCPA, onion growers would need to use other
preemergence herbicides combined with other weed control or avoidance
strategies, such as hand/mechanical weeding and growing onions from
transplants, where feasible.
Herbicides that can be applied before crop emergence in onions and
associated crops (shallot, leek) are bensulide, ethofumesate,
flumioxazin, and pendimethalin; however, these herbicides are
registered for different Allium crops than DCPA. Bensulide,
ethofumesate, and flumioxazin are registered only for dry bulb onions
including shallots; however, flumioxazin cannot be used in California.
Pendimethalin is registered for all Alliums, but it is not registered
at the state level for use in green onion or leek in California.
DCPA provides control or partial control for a wide spectrum of
annual weeds in Allium spp. Of these weeds, several are problem weeds
in California onion production: annual bluegrass, canarygrass, and
dodder. While bensulide, ethofumesate, and pendimethalin are
recommended for control of annual bluegrass and canarygrass in dry bulb
onion and shallots, pendimethalin is the only preemergence herbicide
besides DCPA that UC IPM recommends for control of dodder.
Pendimethalin also has the broadest weed control spectrum of the
potential alternatives, as it controls or partially controls all the
weeds DCPA controls, while ethofumesate and bensulide have narrower
control spectra. Additionally, onions are sensitive to crop injury from
ethofumesate. If unable to use DCPA, affected dry bulb onion growers
could use pendimethalin and likely face no reductions in weed control.
However, pendimethalin cannot be used on green onions or leeks in
California. Pendimethalin is already the recommended preemergence
herbicide for green onions grown outside of California as it is
cheaper, has better efficacy than DCPA, and performs better in the muck
and mineral soils where most onions outside California are grown.
In the absence of DCPA, growers could transplant green onions to
avoid the critical weed management period between onion seeding and
emergence; however, transplanting is not currently a common practice in
California onion production and may not be feasible for growers
currently using DCPA. Green onions are densely planted, so
transplanting can be infeasible for large-scale operations, and dense
plantings can also make hand-weeding and mechanical cultivation
difficult or impractical. If no preemergence herbicide options exist
and transplanting is typically infeasible for most onion growers who
use DCPA, then growers would need to rely on other cultural weed
management practices. Cultural weed management practices include using
fields with low levels of weed pressure or using pre-irrigation before
planting followed by shallow cultivation to reduce the emergence of
weeds during crop emergence. Growers can also rotate onions with crops
that have more effective registered herbicide options to reduce weed
pressure before onions are planted. In all cases, the labor needs for
green onion production would likely increase due to the lack of a
preemergence herbicide.
In the absence of DCPA, dry bulb onion growers can use
pendimethalin for early season weed control. Since pendimethalin
provides the same level of preemergence weed control as DCPA, dry bulb
onion growers will not face revenue loss from switching from DCPA to
pendimethalin for early season weed control. Like dry bulb onion
growers, shallot growers can also replace DCPA with pendimethalin for
similar weed control without revenue loss. EPA expects that green onion
and leek growers in California will face substantial impacts from the
loss of DCPA due to a lack of registered preemergence herbicides;
impacts include yield losses and increased labor for hand-weeding or
other cultural weed management practices.
VIII. Risk Mitigation Measures
EPA has explored various mitigation measures to feasibly address
the identified risks of concern to bystanders, occupational handlers,
and occupational post-application workers. EPA requested public comment
on the ORE Assessment on June 1, 2023, and received comments from
various stakeholders including AMVAC. EPA has received various
mitigation proposals from AMVAC beginning in July 2023, with each
proposal further restricting DCPA registered uses, and a proposed draft
product label submitted in April 2024. After EPA's extensive review and
analysis of AMVAC's April 2024 mitigation proposal and considering all
feasible mitigation measures, risks of concern remain for handlers and
post-application workers exposed to DCPA and are documented in a
revised ORE Assessment (DCPA. Revised Occupational and Residential
Exposure Assessment for the Registration Review of DCPA to Reflect
Proposed Mitigation, May 2, 2024) (Revised ORE Assessment). On May 7,
2024, AMVAC submitted another proposed draft product label
incorporating additional restrictions to
[[Page 64456]]
address the remaining handler and post-application worker risks of
concern. Similar to EPA's review of AMVAC's April 2024 proposal, EPA
finds remaining risks of concern after considering all feasible
mitigation measures.
A. Mitigation Proposals Prior to AMVAC's April 2024 Proposed Product
Label
Prior to AMVAC's April 2024 proposed product label, AMVAC proposed
a number of mitigation options, including restricting use patterns and
reduced application rates, for DCPA to radish, Brassica (cole) leafy
vegetables, and onions and restricting the formulation type (liquid
formulation only). Mitigation was also proposed by AMVAC that would
restrict application to groundboom and chemigation only and would
require handlers to use engineering controls with gloves for all
activities. In addition, REIs of 10 days and 21 days were proposed by
AMVAC for post-application activities such as scouting and hand-set
irrigation, respectively. For spray drift, AMVAC's proposed mitigations
initially included a label requirement for medium/coarse droplets, use
of a low boom, and a 150 ft buffer. However, risks of concern still
remained for occupational handlers, occupational post-application
workers and bystanders even after consideration of these mitigations.
B. Mitigations Proposed on AMVAC's April 2024 Product Label
In April 2024, AMVAC submitted an amended product label
significantly reducing the use pattern and incorporating additional
restrictions to address remaining risk concerns. On AMVAC's amended
product label, many of the same restrictions noted above were
incorporated, including the reduced application rate and requirement of
engineering controls plus additional PPE. The following additional
restrictions were proposed by AMVAC: applications only to radish and
Brassica (cole) leafy vegetables, limitation of usage to CA and AZ,
designation of the product as a restricted use pesticide (RUP),
inclusion of a 200-foot buffer and low boom release height, restriction
of handheld equipment applications, REIs for various activities ranging
from 10 days to 21 days, restriction to banded ground applications, and
restrictions on the amount of product handlers could use per day. These
mitigations impact the occupational handler, occupational post-
application worker, and bystander scenarios.
1. Analysis of AMVAC's Proposed Mitigations for Occupational Handlers
The restrictions of handheld equipment and the restriction to
banded ground applications would result in only groundboom applications
being allowed on the product label. Banded applications consist of a
12-inch band along a 24-inch row and would essentially reduce the
application area by 50% because only half of the row is sprayed.
Therefore, the banded groundboom scenarios assessed include a reduction
in the area treated input from the default of 80 acres to 40 acres.
This results in an increase in the combined (dermal + inhalation) MOEs,
but not enough to reach the LOC of 100. MOEs range from 32 for
applicators to 41 for mixers/loaders when considering banded
applications.
Incorporating the additional restrictions on the amount of product
that can be handled per day further reduces exposures and results in a
combined MOE (dermal plus inhalation) of 98 for both mixers/loaders and
applicators (LOC = 100). However, EPA does not typically approve
labeling that restricts the amount of product that individual handlers
are allowed to use for several reasons. First, there are various kinds
of tasks individual handlers may need to do as part of an application,
such as mixing the product, loading application equipment, using
specific equipment, cleaning, repairing, or maintaining application
equipment, and disposing of pesticides or materials with pesticide
residue. These multiple activities can all lead to exposure, and make
it difficult to adequately reduce exposure through a simple label
restriction on the amount of a pesticide handled each day.
At present, there is also no mechanism in place through which users
can track compliance with the proposed daily amount handled
limitations. While AMVAC proposed to classify end use products
containing DCPA as a RUP, which requires certain information to be
retained concerning the application of a RUP (e.g., the total amount
applied by a certified applicator and others under the certified
applicator's direct supervision), the information required to be
recorded does not include tracking the amounts of product individual
handlers may use or the identity of handlers participating in an
application.
Without a mechanism for reliably tracking the amounts of product
handled per day, across different handling tasks such as mixing,
loading and applying the pesticide, it would be very difficult to
enforce this label requirement. Without a way to provide clear limits
for all handler tasks, and ensure compliance with a limit to the amount
of product handled each day for each handler, EPA determined this
mitigation measure would not adequately address these handler risks.
2. Analysis of AMVAC's Proposed Mitigations for Occupational Post-
Application
AMVAC's April 2024 proposed product label limits use to cole crops
and radish and only allows for applications over transplants for
certain cole crops. Under AMVAC's April 2024 proposed product label,
MOEs on the day of application (12 hours after application) are still
of concern and MOEs continue to be of concern up until 28 or more days
later.
3. Analysis of AMVAC's Proposed Mitigations for Bystanders
AMVAC proposed requiring a 200-foot buffer for a low boom height
groundboom spray, which would result in no spray drift risks of concern
for adults (including pregnant individuals) (all MOEs >= LOC of 30).
Implementing this change proposed by AMVAC would address EPA's risk
concerns for bystanders.
C. Mitigations Proposed on AMVAC's May 2024 Product Label
AMVAC's May 2024 proposed product label did not include additional
mitigations to address the occupational handler nor the bystander
scenarios. The same mitigations which addressed the bystander risks
that were included on AMVAC's proposed April 2024 label were present on
AMVAC's proposed May 2024 label. The same mitigations AMVAC proposed on
the April 2024 label (i.e., restrictions on the amount of product
handled per day) to address the occupational handler risks were present
on AMVAC's proposed May 2024 label; however, as noted above, without a
way to provide clear limits for all handler tasks, and ensure
compliance with a limit to the amount of product handled each day for a
handler, EPA determined this mitigation measure would not adequately
address the handler risks.
AMVAC proposed additional mitigations to address the occupational
post-application worker risks of concern. AMVAC's May 2024 proposed
product label prohibits applications over transplanted crops, which
would address the identified post-application risk concerns.
Implementing AMVAC's proposed change would address EPA's risk concerns
for occupational post-application workers.
[[Page 64457]]
While the proposed mitigations on AMVAC's May 2024 product label
would address the risk concerns related to occupational post-
application workers and bystanders, EPA still has concerns related to
occupational handlers and does not feel that AMVAC's proposed
mitigations will adequately address all of the identified risks of
concern, leaving the current approved product label in use. As noted in
the May 2023 ORE Assessment, use under the current approved product
label can result in pregnant individuals being exposed to DCPA at
levels greater than the level at which adverse effects were observed in
the CTA. EPA has concerns that pregnant individuals may be exposed to
DCPA at levels higher than those that cause fetal thyroid hormone
disruption, but at which no thyroid effects would occur in the pregnant
individual. There are unknown amounts of existing DCPA product in the
hands of users which may lead to the serious and significant health
outcomes described in this Emergency Order.
IX. Procedural Matters
With this Emergency Order the Agency has suspended the
registrations of all pesticide products containing DCPA. The Emergency
Order expressly prohibits any further sale, distribution, or use of any
pesticide product containing DCPA, including federally registered
products and products registered pursuant to FIFRA section 24(c) and 40
CFR 162.152. The registrant of products affected by the Emergency Order
may request an expedited Agency hearing on the question of whether an
imminent hazard exists. This unit explains how to request an expedited
hearing, the consequences of requesting or not requesting an expedited
hearing, and the procedures which will govern any expedited hearing in
the event one is requested.
Alternatively, FIFRA section 6(c)(4) provides that a registrant--or
other interested person, with the concurrence of the registrant--may
seek immediate review of this Emergency Order in an appropriate
district court. Such review shall be solely to determine whether the
Emergency Order of suspension was arbitrary, capricious or an abuse of
discretion, or whether the Emergency Order was issued in accordance
with the procedures established by law. The registrant or other
interested person need not request an expedited hearing pursuant to
FIFRA section 6(c)(2) before seeking review in district court. Love,
858 F.2d at 1354.
A. Procedures for Requesting an Expedited Hearing
The registrant of a pesticide product containing DCPA may request
an expedited hearing concerning the Agency's determination that an
imminent hazard exists. Hearings must comply with the Agency's Rules of
Practice Governing Hearings, 40 CFR part 164. These procedures
establish the following requirements:
(1) Each hearing request must specifically identify by registration
or accession number each individual pesticide product concerning which
a hearing is requested, 40 CFR 164.121(a)(3) and 164.22(a);
(2) Each hearing request must be accompanied by a document setting
forth specific objections to the Agency's findings pertaining to the
question of imminent hazard and state the factual basis for each such
objection, 40 CFR 164.121(a)(3) and 164.22(a); and
(3) Each hearing request must be received by the Office of the
Hearing Clerk, FIFRA section 6(c)(2); 40 CFR 164.121(a)(2) and
164.5(a).
Failure to comply with any one of these requirements will
invalidate the request for a hearing.
Any person requesting a hearing is strongly encouraged to file such
requests electronically via the EPA OALJ's E-filing system at: <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm</a>. If a
person opts to file by US mail or commercial delivery service, said
party shall notify the OALJ Hearing Clerk every time it files a
document, which must all be submitted to the following address: Office
of Administrative Law Judges, U.S. Environmental Protection Agency,
Attn: Mary Angeles, Headquarters Hearing Clerk, Mail Code 1900R, WJC
East Mailroom 1309, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
B. Effective Date of Emergency Order
This Emergency Order is effective immediately upon signature,
regardless of whether a registrant requests an expedited hearing
concerning the question of imminent hazard. If an expedited hearing is
requested, this Emergency Order will remain in effect during any
expedited hearing and consistent with the Administrator's final order
on the issue of suspension. The final order to be issued by the
Administrator or his delegate after any expedited hearing may retain
the Emergency Order of suspension, modify it, or rescind it. Regardless
of whether a registrant requests a hearing on this Emergency Order, the
suspension shall be lifted automatically if EPA fails to issue a Notice
of Intent to Cancel for the DCPA products at issue within 90 days from
issuance of this Emergency Order.
C. Hearing Procedures
If a registrant of a DCPA product submits a valid request for an
expedited hearing, that hearing must commence within 5 days of receipt
of the hearing request unless the registrant and the Agency agree that
it will commence at a later time (FIFRA section 6(c)(2)). Valid
requests received subsequently may be consolidated with requests
received prior to commencement of the suspension hearing. Any
suspension hearing will be limited to the question of whether an
imminent hazard exists (FIFRA section 6(c)(1)) and no parties other
than affected registrants and the Agency will be permitted to
participate actively in the hearing (FIFRA section 6(c)(3)). However,
other persons adversely affected may file proposed findings and
conclusions and briefs in support thereof. 40 CFR 164.121(e)(3) and
(j).
Once the presentation of evidence has been concluded, FIFRA section
6(c)(2) provides that the Administrative Law Judge will have 10 days to
submit recommended findings and conclusions to the Administrator and
the Administrator will have 7 days to issue a final order on the issue
of suspension. Additional time requirements are set forth at 40 CFR
164.121(j).
D. 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).
Accordingly, the following EPA offices, and the staffs thereof, are
designated as the judicial staff to perform the judicial function of
EPA in any administrative hearing on the issue of imminent hazard: The
Presiding Officer, the Environmental Appeals Board, the Administrator,
the Deputy Administrator, and the members of the staff in the immediate
office of the Administrator and Deputy Administrator. None of the
persons designated as the judicial staff may have any ex parte
communication with the trial staff or any other interested person not
employed by EPA on the merits of any of the issues involved in this
proceeding, without fully complying
[[Page 64458]]
with the applicable regulations. 40 CFR 164.7.
Authority: 7 U.S.C. 136 et seq.
Dated: August 2, 2024.
Michael S. Regan,
Administrator.
[FR Doc. 2024-17431 Filed 8-6-24; 8:45 am]
BILLING CODE 6560-50-P
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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.