[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 11222-11273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04139]



[[Page 11221]]

Vol. 87

Monday,

No. 39

February 28, 2022

Part IV





Environmental Protection Agency





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40 CFR Part 180





Chlorpyrifos; Final Order Denying Objections, Requests for Hearings, 
and Requests for a Stay of the August 2021 Tolerance Final Rule; Final 
Rule

  Federal Register / Vol. 87 , No. 39 / Monday, February 28, 2022 / 
Rules and Regulations  

[[Page 11222]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0523; 5993-05-OCSPP]


Chlorpyrifos; Final Order Denying Objections, Requests for 
Hearings, and Requests for a Stay of the August 2021 Tolerance Final 
Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Order.

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SUMMARY: In response to EPA's August 2021 final rule revoking all 
tolerances for the insecticide chlorpyrifos under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), several objections, hearing requests, 
and requests for stay were filed by numerous parties representing a 
wide variety of growers and pesticide users. In this Order, EPA denies 
all objections to, requests for hearing on those objections, as well as 
requests for stay of the final rule.

DATES: The Order is effective February 28, 2022.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0523, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001.
    Due to public health concerns related to COVID-19, the EPA/DC and 
Reading Room is open to visitors by appointment only. For the latest 
status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Elissa Reaves, Pesticide Re-Evaluation 
Division (7508P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: 202-566-0700; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    In this document, EPA denies all objections to, requests for 
hearing on those objections, and requests for stay of EPA's August 2021 
final rule (Ref. 1) revoking all tolerances for the insecticide 
chlorpyrifos under section 408(d) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346(d). This action may be of interest 
to all parties filing objections, requests for hearing on those 
objections, and requests for stay. This action may also be of interest 
to agricultural producers, food manufacturers or pesticide 
manufacturers, and others interested in food safety issues generally. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    Other types of entities not listed in this unit could also be 
affected. The NAICS codes have been provided to assist you and others 
in determining whether this action might apply to certain entities. If 
you have any questions regarding the applicability of this action to a 
particular entity, consult the contact listed under FOR FURTHER 
INFORMATION CONTACT.

B. What action is the Agency taking?

    In this Order, EPA denies all objections to, requests for hearing 
on those objections, as well as requests for stay of the August 2021 
final rule (Ref. 1). This Order is issued under FFDCA section 
408(g)(2)(C), 21 U.S.C. 346a(g)(2)(C)).
    Based on information available as of August 20, 2021--the date by 
which the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) 
ordered EPA to issue a final rule concerning chlorpyrifos tolerances--
EPA was unable to conclude that the tolerances for chlorpyrifos 
residues were safe in accordance with the FFDCA safety standard. In 
other words, EPA could not determine that there was a reasonable 
certainty that no harm would result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information. The 
Agency's analysis indicated that aggregate exposures (i.e., exposures 
from food, drinking water, and residential exposures), resulting from 
currently registered uses, exceeded safe levels. This decision relied 
on the well-established 10% red blood cell acetylcholinesterase (RBC 
AChE) inhibition as an endpoint for risk assessment and included the 
default Food Quality Protection Act (FQPA) tenfold (10X) margin of 
safety to account for uncertainties related to the potential for 
neurodevelopmental effects to infants, children, and fetuses. 
Accordingly, EPA issued a final rule revoking all tolerances for 
chlorpyrifos contained in 40 CFR 180.342. (See 86 FR 48315, Aug. 30, 
2021) The prepublication of the final rule was issued on August 18, 
2021, the final rule was published in the Federal Register on August 
30, 2021, and the final rule became effective on October 29, 2021.
    Pursuant to the procedures set forth in FFDCA section 408(g)(2), 
objections to, requests for evidentiary hearings on those objections, 
and/or requests for stays of, the final rule were filed by the persons 
listed in Unit V. (each, an Objector, and collectively, the Objectors) 
on or before the close of the objections period on October 29, 2021. 
(Ref. 1) The Objectors raised challenges to the final rule, including, 
for example, objections relating to the scope of the revocations in the 
final rule, retention of the additional FQPA Safety Factor, and use of 
the 2016 drinking water assessment, as well as raising procedural or 
other irrelevant concerns that do not change the basis for the final 
rule itself.
    Four Objectors requested a hearing on their objections. The 
American Soybean Association, American Sugarbeet Growers Association 
and U.S. Beet Sugar Association (collectively, ``Sugarbeet 
Associations''), and Cherry Marketing Institute each submitted requests 
for evidentiary hearings to dispute EPA's revocation of tolerances for 
the 11 ``high-benefit'' uses identified in the ``Proposed Interim 
Decision for the Registration Review of Chlorpyrifos'' (2020 PID) (Ref. 
31)--including soybean uses, sugarbeet uses, and the Michigan tart 
cherry industry's use. Gharda also submitted a request for an 
evidentiary hearing on an issue related to the assessment of 
chlorpyrifos oxon in EPA's aggregate assessment.
    Finally, EPA received several written requests for EPA to stay the 
effective date of the final rule due to impacts on the agricultural 
industry and in order to provide more time for EPA to fully consider 
the objections filed.
    This Order denies all of the objections, requests for evidentiary 
hearings on those objections, and requests for stays of the final rule. 
EPA has undertaken a comprehensive analysis of the merits of each of 
the Objectors' objections, hearing requests, and requests for stay. 
That analysis shows, as set out in Units VI., VII., and VIII. of this 
document, respectively, that none of the Objectors' objections support 
the claims raised, none of the Objectors' requests for hearing meet the

[[Page 11223]]

regulatory standard for granting a hearing, and none of the Objectors' 
requests for stay warrant staying the effective date of the final rule. 
There are numerous reasons for EPA's conclusions, for which additional 
detail is provided in Units VI., VII., and VIII. of this document.

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

    The procedure for filing objections and requests for hearings 
thereon to EPA's final rule and EPA's authority for acting on such 
objections is contained in FFDCA section 408(g)(2) (21 U.S.C. 
346a(g)(2)) and EPA's regulations at 40 CFR part 178.

II. Statutory and Regulatory Background

    In this Unit, EPA provides background on the relevant statutes and 
regulations governing pesticides and tolerances, objections, requests 
for hearing, and requests for a stay, as well as on pertinent Agency 
policies and practices.
    Unit II.A. summarizes the requirements and procedures in FFDCA 
section 408 and applicable regulations pertaining to pesticide 
tolerances, including the procedures for objecting to EPA tolerance 
actions and the substantive standards for evaluating the safety of 
pesticide tolerances. This unit also discusses the closely-related 
statute under which EPA regulates the sale, distribution, and use of 
pesticides, the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) (7 U.S.C. 136 et seq.).
    Unit II.B. provides an overview of EPA's Office of Pesticide 
Programs (OPP) risk assessment process. It contains an explanation of 
how EPA identifies the hazards posed by pesticides, how EPA determines 
the level of exposure to pesticides that pose a concern (level of 
concern), how EPA measures human exposure to pesticides, and how 
hazard, level of concern conclusions, and human exposure estimates are 
combined to evaluate risk. Further, this unit presents background 
information on the Agency's policy on the FQPA safety factor and 
acetylcholinesterase (AChE) inhibition.

A. FFDCA/FIFRA and Applicable Regulations

1. General
    EPA establishes, modifies, or revokes tolerances for pesticide 
residues in food under FFDCA section 408. (21 U.S.C. 346a) A 
``tolerance'' represents the maximum level for residues of pesticide 
chemicals legally allowed in or on raw agricultural commodities and 
processed foods. Without a tolerance or exemption, pesticide residues 
in or on food are considered unsafe (21 U.S.C. 346a(a)(1)), and such 
food, which is then rendered ``adulterated'' under FFDCA section 402(a) 
(21 U.S.C. 342(a)), may not be distributed in interstate commerce. (21 
U.S.C. 331(a)) Monitoring and enforcement of pesticide tolerances are 
carried out by the U.S. Food and Drug Administration (FDA) and the U.S. 
Department of Agriculture (USDA). FFDCA section 408 was substantially 
rewritten by the Food Quality Protection Act of 1996 (FQPA), which 
added the provisions establishing a detailed safety standard for 
pesticides and additional protections for infants and children, among 
other things. (Pub. L. 104-170, 110 Stat. 1489 (1996))
    EPA also regulates pesticides under FIFRA. (7 U.S.C. 136 et seq.) 
While FFDCA authorizes the establishment of legal limits for pesticide 
residues in food, FIFRA requires the approval of pesticides prior to 
their sale and distribution (Id. at section 136a(a)), and establishes a 
registration regime for regulating the use of pesticides. In order for 
a pesticide to be registered, EPA must determine that a pesticide 
``will not generally cause unreasonable adverse effects on the 
environment'', among other things. (Id. at section 136a(c)(5)) The term 
``unreasonable adverse effects on the environment'' is defined to 
include ``a human dietary risk from residues that results from a use of 
a pesticide in or on any food inconsistent with the standard under 
section 346a of Title 21.'' (Id. at section 136(bb)) The FFDCA safety 
standard was integrated into the FIFRA registration standard in the 
FQPA, which also directed that EPA coordinate, to the extent 
practicable, revocations of tolerances with pesticide cancellations 
under FIFRA. (21 U.S.C. 346a(l)(1))
    Also under FIFRA, EPA is required to re-evaluate existing 
registered pesticides every 15 years in a process called ``registration 
review.'' (7 U.S.C. 136(a)(g)) The purpose of registration review is 
``to ensure that each pesticide registration continues to satisfy the 
FIFRA standard for registration,'' (40 CFR 155.40(a)(1)) taking into 
account changes that have occurred since the last registration 
decision, including any new relevant scientific information and any 
changes to risk-assessment procedures, methods, and data requirements. 
(40 CFR 155.53(a)) To ensure that a pesticide continues to meet the 
standard for registration, EPA must determine, based on the available 
data, including any additional information that has become available 
since the pesticide was originally registered or re-evaluated, that the 
pesticide does not cause ``unreasonable adverse effects on the 
environment.'' (7 U.S.C. 136a(c)(1), (5); see also 40 CFR 152.50)
2. Safety Standard for Pesticide Tolerances
    FFDCA section 408(b)(2) directs that EPA may establish or leave in 
effect a tolerance for a pesticide only if it finds that the tolerance 
is safe and that EPA must revoke or modify tolerances determined to be 
unsafe. (21 U.S.C. 346a(b)(2)(A)(i)) FFDCA section 408(b)(2)(A)(ii) 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' (Id. At section 
346a(b)(2)(A)(ii)) FFDCA section 408(b)(2)(D) directs EPA, in making a 
safety determination, to consider, among other relevant factors 
``available information concerning the aggregate exposure levels of 
consumers (and major identifiable subgroups of consumers) to the 
pesticide chemical residue and to other related substances, including 
dietary exposure under the tolerance and all other tolerances in effect 
for the pesticide chemical residue, and exposure from other non-
occupational sources.'' (Id. at section 346a(b)(2)(D)(vi)) As the 
language indicates, this includes exposure through food, drinking 
water, and all non-occupational exposures (e.g., in residential 
settings), but does not include occupational exposures to workers 
(i.e., occupational).
    Risks to infants and children are given special consideration. 
Specifically, pursuant to FFDCA section 408(b)(2)(C), EPA must assess 
the risk of the pesticide chemical based on ``available information 
concerning the special susceptibility of infants and children to the 
pesticide chemical residues, including neurological differences between 
infants and children and adults, and effects of in utero exposure to 
pesticide chemicals''; and available information concerning the 
cumulative effects on infants and children of such residues and other 
substances that have a common mechanism of toxicity. (21 U.S.C. 
346a(b)(2)(C)(i)(II) and (III))
    This provision also creates a presumption that EPA will use an 
additional safety factor for the protection of infants and children. 
Specifically, it directs that ``in the case of threshold effects, ... 
an additional

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tenfold margin of safety for the pesticide chemical residue and other 
sources of exposure shall be applied for infants and children to take 
into account potential pre- and postnatal toxicity and completeness of 
the data with respect to exposure and toxicity to infants and 
children.'' (21 U.S.C. 346a(b)(2)(C)) EPA is permitted to ``use a 
different margin of safety for the pesticide chemical residue only if, 
on the basis of reliable data, such margin will be safe for infants and 
children.'' (Id.) Due to Congress's focus on both pre- and postnatal 
toxicity, EPA has interpreted this additional safety factor as 
pertaining to risks to infants and children that arise due to prenatal 
exposure as well as to exposure during childhood years. This section 
providing for the special consideration of infants and children in 
section 408(b)(2)(C) was added to the FFDCA by the FQPA in 1996; 
therefore, this additional margin of safety is referred to throughout 
this Order as the ``FQPA safety factor (SF)''.
3. Procedures for Establishing, Amending, or Revoking Tolerances
    Tolerances are established, amended, or revoked by rulemaking under 
the unique procedural framework set forth in FFDCA. Generally, a 
tolerance rulemaking is initiated by the party seeking to establish, 
amend, or revoke a tolerance by means of filing a petition with EPA. 
(See 21 U.S.C. 346a(d)(1)) EPA publishes in the Federal Register a 
notice announcing the filing of a petition filing and requesting public 
comment. (Id. at section 346a(d)(3)) After reviewing the petition, and 
any comments received on it, EPA may issue a final rule establishing, 
amending, or revoking the tolerance; issue a proposed rule subject to 
public comments and then finalize a rule to do the same; or deny the 
petition. (Id. at section 346a(d)(4))
    Once EPA takes final action on the petition by either establishing, 
amending, or revoking the tolerance or denying the petition, any person 
may file objections with EPA and seek an evidentiary hearing on those 
objections. (21 U.S.C. 346a(g)(2)) Objections and hearing requests must 
be filed within 60 days after EPA takes that action. (Id.) The statute 
provides that EPA shall ``hold a public evidentiary hearing if and to 
the extent the Administrator determines that such a public hearing is 
necessary to receive factual evidence relevant to material issues of 
fact raised by the objections.'' (Id. at section 346a(g)(2)(B)) EPA 
regulations make clear that hearings will only be granted where it is 
shown that there is ``a genuine and substantial issue of fact,'' the 
requestor has identified evidence ``which, if established, resolve one 
or more of such issues in favor of the requestor,'' and the issue is 
``determinative'' with regard to the relief requested. (40 CFR 
178.32(b)) EPA's final Order on the objections and requests for hearing 
is subject to judicial review. (21 U.S.C. 346a(h)(1)) The statute 
directs that tolerance regulations shall take effect upon publication 
unless EPA specifies otherwise. (Id. at section 346a(g)(1)) EPA is 
authorized to stay the effectiveness of the tolerance if objections are 
filed. (Id.) Because EPA does not have its own regulations governing 
stay requests, EPA typically evaluates requests for stay under the 
criteria set out in FDA's regulations at 21 CFR 10.35(e) due to the 
fact that the FFDCA provisions governing EPA's objections and hearings 
process were adapted from the similar parallel statutory process 
governing FDA objections and hearings.

B. EPA Risk Assessment--Policy and Practice

1. The Safety Determination--Risk Assessment
    To assess risk of a pesticide tolerance, EPA combines information 
on pesticide toxicity with information regarding the route, magnitude, 
and duration of exposure to the pesticide. The risk assessment process 
involves four distinct steps, which are discussed in further detail in 
this section: (1) Identification of the toxicological hazards posed by 
a pesticide; (2) determination of the ``level of concern'' with respect 
to human exposure to the pesticide, which includes choosing a point of 
departure (PoD) that reflects the adverse health endpoint that is most 
sensitive to the pesticide and uncertainty factors; (3) estimation of 
human exposure to the pesticide through all applicable routes; and (4) 
characterization of risk posed to humans by the pesticide based on 
comparison of human exposure to the level of concern. For tolerances, 
characterization of risk involves determining whether the tolerances 
are safe; if aggregate exposure to humans is greater than the Agency's 
determined level of concern, the Agency's determination is that the 
tolerances are not safe.
a. Hazard Identification
    Any risk assessment begins with an evaluation of a chemical's 
potential to cause adverse effects, and whether those properties have 
the potential to cause adverse effects (i.e., a hazard identification). 
In evaluating toxicity or hazard, EPA reviews toxicity data, typically 
from studies with laboratory animals, to identify any adverse effects 
on the test subjects. Where available and appropriate, EPA will also 
take into account studies involving humans, including human 
epidemiological studies. For most pesticides, the animal toxicity 
database usually consists of studies investigating a broad range of 
endpoints including potential for carcinogenicity, mutagenicity, 
developmental and reproductive toxicity, and neurotoxicity. These 
studies include gross and microscopic effects on organs and tissues; 
functional effects on bodily organs and systems; effects on blood 
parameters (such as red blood cell count, hemoglobin concentration, 
hematocrit, and a measure of clotting potential); effects on the 
concentrations of normal blood chemicals (including glucose, total 
cholesterol, urea nitrogen, creatinine, total protein, total bilirubin, 
albumin, hormones, and enzymes such as alkaline phosphatase, alanine 
aminotransferase, and cholinesterases); and behavioral or other gross 
effects identified through clinical observation and measurement. EPA 
examines whether adverse effects are caused by different durations of 
exposure ranging from short-term (acute) to long-term (chronic) 
pesticide exposure and different routes of exposure (oral, dermal, 
inhalation). For chlorpyrifos, the Agency examined acute and steady-
state durations because of the potential to cause adverse effects based 
on acute (single day, 24 hours) and steady-state (21-day) exposures. 
The latter duration is based on the observation in the available 
studies for organophosphates (OPs) indicating a consistent pattern of 
AChE inhibition that reaches a steady-state (or comes to an 
equilibrium) around 2-3 weeks and does not change in studies of longer 
duration. (Ref. 2 at pg. 7) Further, EPA evaluates potential adverse 
effects in different age groups (adults as well as fetuses and 
juveniles). (Ref. 3 at pgs. 8 through 10)
    EPA also considers whether the adverse effect has a threshold--a 
level below which exposure has no appreciable chance of causing the 
adverse effect. For effects that have no threshold, EPA assumes that 
any exposure to the substance increases the risk that the adverse 
effect may occur.
b. Level of Concern/Dose-Response Analysis
    Once a pesticide's potential hazards are identified, EPA determines 
a toxicological level of concern for evaluating the risk posed by human 
exposure to the pesticide. In this step of the risk assessment process, 
EPA

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essentially evaluates the levels of exposure to the pesticide at which 
effects might occur. An important aspect of this determination is 
assessing the relationship between exposure (dose) and response (often 
referred to as the dose-response analysis). EPA follows differing 
approaches to identifying a level of concern for threshold and non-
threshold hazards.
    i. Threshold effects. In examining the dose-response relationship 
for a pesticide's threshold effects, EPA evaluates an array of toxicity 
studies on the pesticide. In each of these studies, EPA attempts to 
identify the lowest observed adverse effect level (LOAEL) and the no 
observed adverse effect level (NOAEL), which by definition is the next 
lower tested dose level below the LOAEL. Generally, EPA will use a 
NOAEL from the available studies as a starting point (called ``the 
Point of Departure'' or ``PoD'') in estimating the level of concern for 
humans. At times, however, EPA will use a LOAEL from a study as the 
Point of Departure when no NOAEL is identified in that study and the 
LOAEL is close to, or lower than, other relevant NOAELs. 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 and dose-response relationships. 
The Point of Departure is, in turn, used in choosing a level of 
concern. EPA will make separate determinations as to the Points of 
Departure, and corresponding levels of concern, for both short and long 
exposure periods as well as for the different routes of exposure (oral, 
dermal, and inhalation).
    EPA has also used other approaches for choosing the Point of 
Departure. One approach, called a benchmark dose, or BMD, estimates a 
point along a dose-response curve that corresponds to a specific 
response level. (Ref. 4) For example, a BMD10 represents a 
10% change from the background or typical value for the response of 
concern. In contrast to the NOAEL/LOAEL approach, a BMD is calculated 
using a range of dose-response data and thus better accounts for the 
variability and uncertainty in the experimental results due to 
characteristics of the study design, such as dose selection, dose 
spacing, and sample size. In addition to a BMD, EPA generally also 
calculates a ``confidence limit'' in the BMD. Confidence limits express 
the uncertainty in a BMD that may be due to sampling and/or 
experimental error. The lower confidence limit on the dose used as the 
BMD is termed the BMDL, which the Agency often uses as the PoD. Use of 
the BMDL for deriving the PoD rewards better experimental design and 
procedures that provide more precise estimates of the BMD, resulting in 
tighter confidence intervals. It also provides a health protective 
conservative estimate of the safe dose. Numerous scientific peer review 
panels have supported the Agency's application of the BMD approach as a 
scientifically supportable method for deriving PoDs in human health 
risk assessment, and as an improvement over the historically applied 
approach of using NOAELs or LOAELs. (Refs. 5 and 6)
    Another approach for deriving Points of Departure uses a 
sophisticated model called a physiologically based pharmacokinetic-
pharmacodynamic (PBPK-PD) model. PBPK models are mathematical 
descriptions of how a chemical enters the body (e.g., breathing, 
drinking, eating); the amount of chemical that gets into the blood; how 
the chemical moves between body tissues (e.g., fat, brain) and the 
blood; and how the body alters (i.e., metabolizes) and eliminates the 
chemical (e.g., via urine, feces). PBPK models incorporate information 
about the body's anatomical and physiological structure as well as 
biochemical processes into the model structure. EPA uses PBPK models to 
better translate animal toxicity data to potential human risks (i.e., 
extrapolation). A PBPK model that describes a chemical in a laboratory 
animal species can be used for humans by changing the physiological 
parameters. In the case of chlorpyrifos assessment, the PBPK-PD model 
is used to derive age-, duration-, and route-specific PoDs that would 
have resulted in a maximum RBC AChE inhibition level at 10% in humans. 
Rather than converting an animal BMDL to derive a human POD, the PBPK-
PD modeling approach accounts for human physiology, biochemistry, life-
stage, and exposure scenarios to derive human PODs based on predicted 
AChE inhibition in humans. (Ref. 7) Numerous Federal Advisory 
Committees and external review panels have encouraged the use of such a 
modeling approach to reduce inherent uncertainty in the risk assessment 
and facilitate more scientifically sound extrapolations across studies, 
species, routes, and dose levels. The PBPK-PD model for chlorpyrifos 
has undergone extensive peer review by various individual and groups, 
including the FIFRA Scientific Advisory Panel (SAP) (discussed in Unit 
III.A.3.) Significant improvements have been made to the model over the 
years in response to recommendations from the 2008, 2011, and 2012 
FIFRA SAPs and comments from both internal and external peer reviewers. 
(Ref. 2 at pg. 20)
    In estimating and describing the level of concern, the Point of 
Departure is at times used differently depending on whether the risk 
assessment addresses dietary or non-dietary exposures. For dietary 
risks, EPA uses the PoD to calculate an acceptable level of exposure or 
reference dose (RfD). The RfD is calculated by dividing the PoD by all 
applicable safety or uncertainty factors. Typically, EPA uses a 
baseline safety/uncertainty factor of 100X in assessing pesticide risk. 
That value includes a factor of 10 (10X) where EPA is using data from 
laboratory animals to account for the possibility that humans 
potentially have greater sensitivity to the pesticide than animals 
(also known as the ``inter-species factor'' or ``inter-species 
extrapolation factor'') and another factor of 10X to account for 
potential variations in sensitivity among members of the human 
population (also known as the ``intra-species factor'' or ``intra-
species extrapolation factor''). These factors may vary if data is 
available to indicate that another extrapolation factor would be 
appropriate and protective. For example, where a PBPK-PD model using 
human parameters is used for deriving Points of Departure, there is no 
need for an interspecies factor since the model directly predicts human 
Points of Departure based on human physiology and biochemistry, rather 
than animal studies. Moreover, because the PBPK-PD model used for 
assessing chlorpyrifos accounts for differences in metabolism and 
toxicity response across the human population for some age groups and 
some subpopulations, the intraspecies extrapolation factor can be 
refined in accordance with EPA's 2014 Guidance for Applying 
Quantitative Data to Develop Data-Derived Extrapolation Factors for 
Interspecies and Intraspecies Extrapolation. (Ref. 8)
    Additional safety factors may be added to address data deficiencies 
or concerns raised by the existing data. Under the FQPA, an additional 
safety factor of 10X is presumptively applied to protect infants and 
children, unless reliable data support selection of a different factor. 
This FQPA additional safety factor largely replaces EPA's pre-FQPA 
practice regarding additional safety factors (e.g., LOAEL to NOAEL 
factor or database uncertainty factor), but it might also account for 
residual concerns related to pre- and postnatal toxicity or exposure. 
(Ref. 9 at pgs. 4 through 11)

[[Page 11226]]

    In implementing FFDCA section 408, EPA's Office of Pesticide 
Programs, also calculates a variant of the RfD referred to as a 
Population Adjusted Dose (PAD). A PAD is the RfD divided by the FQPA 
safety factor. (Id. at pgs. 13 through 16) RfDs and PADs are generally 
calculated for both acute and chronic dietary risks. Throughout this 
document, general references to OPP's calculated safe dose are denoted 
as an RfD/PAD.
    For non-dietary, and combined dietary and non-dietary, risk 
assessments of threshold effects, the toxicological level of concern is 
not expressed as an RfD/PAD but rather in terms of an acceptable (or 
target) margin of exposure (MOE) between human exposure and the Point 
of Departure. The ``margin'' of interest is the ratio between human 
exposure and the Point of Departure, which is calculated by dividing 
human exposure into the Point of Departure. An acceptable MOE is 
generally considered to be a margin at least as high as the product of 
all applicable safety factors for a pesticide. For example, if a 
pesticide needs a 10X factor to account for potential inter-species 
differences, 10X factor for potential intra-species differences, and 
10X factor for the FQPA children's safety provision, the safe or target 
MOE would be an MOE of at least 1,000. What that means is that for the 
pesticide in the example to meet the safety standard, human exposure to 
the pesticide would generally have to be at least 1,000 times smaller 
than the Point of Departure. Like RfD/PADs, specific target MOEs are 
selected for exposures of different durations. For non-dietary 
exposures, EPA typically examines short-term, intermediate-term, and 
long-term exposures. Additionally, target MOEs may be selected based on 
both the duration of exposure and the various routes of non-dietary 
exposure--dermal, inhalation, and oral.
    ii. Non-threshold effects. For risk assessments for non-threshold 
effects, EPA does not use the RfD/PAD or MOE approach to choose a level 
of concern if quantification of the risk is deemed appropriate. Rather, 
EPA calculates the slope of the dose-response curve for the non-
threshold effects from relevant studies frequently using a linear, low-
dose extrapolation model that assumes that any amount of exposure will 
lead to some degree of risk. This dose-response analysis will be used 
in the risk characterization stage to estimate the risk to humans of 
the non-threshold effect.
c. Estimating Human Exposure
    Risk is a function of both hazard and exposure. Thus, equally 
important to the risk assessment process as determining the hazards 
posed by a pesticide and the toxicological level of concern for those 
hazards is estimating human exposure. Under FFDCA section 408, EPA must 
evaluate the aggregate exposure to a pesticide chemical residue. This 
means that EPA is concerned not only with exposure to pesticide 
residues in food but also exposure resulting from pesticide 
contamination of drinking water supplies and from use of pesticides in 
the home or other non-occupational settings. (See 21 U.S.C. 
346a(b)(2)(D)(vi)) This statutory requirement specifically clarifies 
that the assessment of dietary exposures includes exposure under the 
tolerances at issue, as well as ``all other tolerances in effect for 
the pesticide chemical residue''. (Id.) Additionally, EPA must take 
into account exposure from ``other related substances.'' (Id.)
    i. Exposure from food. There are two critical variables in 
estimating exposure in food: (1) The types and amount of food that is 
consumed and (2) the residue level in that food. Consumption is 
estimated by EPA based on scientific surveys of individuals' food 
consumption in the United States conducted by the USDA. (Ref. 3 at pg. 
12) Information on residue values comes from a range of sources 
including crop field trials, data on pesticide reduction (or 
concentration) due to processing, cooking, and other practices, 
information on the extent of usage of the pesticide, and monitoring of 
the food supply. (Ref. 3 at pg. 17)
    In assessing exposure from pesticide residues in food, EPA, for 
efficiency's sake, follows a tiered approach in which it, in the first 
instance, assesses exposure using the worst-case assumptions that 100% 
of the crop or commodity in question is treated with, or exposed to, 
the pesticide and 100% of the food from that crop or commodity contains 
pesticide residues at the tolerance level. (Ref. 3 at pg. 11) When such 
an assessment shows no risks of concern, a more refined risk assessment 
is unnecessary. By using worst-case assumptions as a starting point for 
risk assessment, EPA's resources are conserved, and regulated parties 
are spared the cost of any additional studies that may be needed. The 
risk assessments produced using the worst-case assumptions yield 
conservative and health-protective outcomes; however, if a first-tier 
assessment suggests there could be a risk of concern, EPA then attempts 
to refine its exposure assumptions to yield a more realistic picture of 
residue values through use of data on the percent of the crop or 
commodity actually treated with, or exposed to, the pesticide and data 
on the level of residues that may be present on the treated crop or 
commodity. These latter data are used to estimate what has been 
traditionally referred to by EPA as ``anticipated residues''.
    Use of percent crop/commodity treated data and anticipated residue 
information is appropriate because EPA's worst-case assumptions of 100% 
treatment and residues at tolerance value significantly overstate 
residue values. There are several reasons why this is true. First, all 
growers of a particular crop would rarely choose to apply the same 
pesticide to that crop (some may apply no pesticide; some may apply an 
alternative pesticide); generally, the proportion of the crop treated 
with a particular pesticide is significantly below 100%. (70 FR 46706, 
46731, August 10, 2005) (FRL-7727-4) Second, the tolerance value 
represents a high-end or worst-case value. Tolerance values are chosen 
only after EPA has evaluated data from experimental trials in which the 
pesticide has been used in a manner, consistent with the draft FIFRA 
label, that is likely to produce the highest residue in the crop or 
food in question (e.g., maximum application rate, maximum number of 
applications, minimum pre-harvest interval between last pesticide 
application and harvest). (Refs. 3 and 10) These experimental trials 
are generally conducted in several locations and involve multiple 
samples. (Ref. 10 at pgs. 5 and 7 and Tables 1 and 5) The results from 
such experimental trials invariably show that the residue levels for a 
given pesticide use will vary from as low as non-detectable to 
measurable values in the parts per million (ppm) range with the 
majority of the values falling at the lower part of the range. (70 FR 
46706 at 46731) EPA uses a statistical procedure to analyze the 
experimental trial results and identify the upper bound of expected 
residue values. This upper bound value is typically used as the 
tolerance value. There may be some commodities for which pesticide 
residues come close to the tolerance value where the maximum label 
rates are followed, but most generally fall significantly below the 
tolerance value. If less than the maximum legal rate is applied, 
residues will be even lower. Third, residue values measured at the time 
of treatment do not take into account the lowering of residue values 
that frequently occurs as a result of degradation over time and through 
food processing and cooking.
    EPA uses several techniques to refine residue value estimates. 
(Ref. 3 at pgs. 17 through 28) First, where appropriate, EPA will take 
into account all the

[[Page 11227]]

residue values reported in the experimental trials, either through an 
average of all the field trials or consideration of individual field 
trials. Second, EPA will consider data showing what portion of the crop 
or commodity is not treated with, or exposed to, the pesticide. Third, 
data can be produced showing pesticide degradation and decline over 
time, and the effect of commercial and consumer food handling and 
processing practices. Finally, EPA can consult monitoring data gathered 
by the FDA, the USDA, or pesticide registrants, on pesticide levels in 
food at points in the food distribution chain distant from the farm, 
including retail food establishments. Monitoring data, including data 
gathered by USDA's Pesticide Data Program (PDP), generally provide a 
characterization of pesticide residues in or on foods consumed by the 
U.S. population that closely approximates real-world exposures because 
they are sampled closer to the point of consumption in the chain of 
commerce than field trial data, which are generated to establish the 
maximum level of legal residues that could result from maximum 
permissible use of the pesticide immediately after harvest.
    Another critical component of the exposure assessment is how data 
on consumption patterns are combined with data on pesticide residue 
levels in food. Traditionally, EPA has calculated exposure by simply 
multiplying average consumption by average residue values for 
estimating chronic risks and high-end consumption by maximum residue 
values for estimating acute risks. Using average residues is a 
realistic approach for chronic risk assessment due to the fact that 
variations in residue levels and consumption amounts average out over 
time, especially given the nationwide market for food in the United 
States. Using average values is inappropriate for acute risk 
assessments, however, because in assessing acute exposure situations it 
matters how much of each treated food a given consumer eats in the 
short-term and what the residue levels are in the particular foods 
consumed. Yet, using maximum residue values for acute risk assessment 
tends to greatly overstate exposure because it is unlikely that a 
person would consume at a single meal multiple food components bearing 
high-end residues. To take into account the variations in short-term 
consumption patterns and food residue values for acute risk 
assessments, EPA uses probabilistic modeling techniques for estimating 
exposure when more simplistic models appear to show risks of concerns.
    In practice, EPA uses a computer program known as the Dietary 
Exposure Evaluation Model and Calendex software with the Food Commodity 
Intake Database (DEEM-FCID version 3.16/Calendex) to estimate dietary 
exposure from pesticide residues in food by combining data on human 
consumption amounts with residue values in food commodities. The model 
used for assessment of chlorpyrifos in the 2020 human health risk 
assessment (HHRA) incorporated 2003-2008 consumption data from USDA's 
National Health and Nutrition Examination Survey/What We Eat in America 
database (NHANES/WWEIA). The data are based on the reported consumption 
of more than 20,000 individuals over two non-consecutive survey days. 
Foods ``as consumed'' (e.g., apple pie) are linked to EPA-defined food 
commodities (e.g., apples, peeled fruit--cooked; fresh or N/S (Not 
Specified); baked; or wheat flour--cooked; fresh or N/S, baked) using 
publicly available recipe translation files developed jointly by USDA 
Agricultural Research Service (ARS) and EPA. For chronic exposure 
assessment (or in the case of chlorpyrifos, for steady-state exposure 
assessment), consumption data are averaged for the entire U.S. 
population and within population subgroups; however, for acute exposure 
assessment, consumption data are retained as individual consumption 
events. Using this consumption information and residue data, the 
exposure estimates are calculated for the general U.S. population and 
specific subgroups based on age, sex, ethnicity, and region.
    All of these refinements to the exposure assessment process, from 
use of food monitoring data through probabilistic modeling, can have 
dramatic effects on the level of exposure predicted, typically reducing 
worst-case estimates by at least 1 or 2 orders of magnitude. (Ref. 11 
at pgs. 16 through 17; 70 FR 46706 at 46732)
    For chlorpyrifos, EPA has calculated potential risk by using 
probabilistic techniques to combine distributions of potential 
exposures in sentinel populations. The resulting probabilistic 
assessments present a range of dietary exposure/risk estimates. Because 
probabilistic assessments generally present a realistic range of 
residue values to which the population may be exposed, EPA's starting 
point for estimating exposure and risk for such assessments is the 
99.9th percentile of the population under evaluation. When using a 
probabilistic method of estimating acute dietary exposure, EPA 
typically assumes that, when the 99.9th percentile of acute exposure is 
equal to or less than the acute PAD (aPAD), the level of concern for 
acute risk has not been exceeded. By contrast, where the analysis 
indicates that estimated exposure at the 99.9th percentile exceeds the 
aPAD, EPA would generally conduct one or more sensitivity analyses to 
determine the extent to which the estimated exposures at the high-end 
percentiles may be affected by unusually high food consumption or 
residue values. (The same assumptions apply to estimates for steady-
state dietary exposure and the steady-state PAD (ssPAD).) To the extent 
that one or a few values seem to ``drive'' the exposure estimates at 
the high-end of exposure, EPA would consider whether these values are 
reasonable and should be used as the primary basis for regulatory 
decision making. (Ref. 11)
    ii. Exposure from water. (a) Modeling and monitoring data. EPA may 
use either or both field monitoring data and mathematical water 
exposure models to generate pesticide exposure estimates in drinking 
water. Monitoring and modeling are both important tools for estimating 
pesticide concentrations in water and can provide different types of 
information. Monitoring data can provide estimates of pesticide 
concentrations in water that are representative of specific 
agricultural or residential pesticide practices and under environmental 
conditions associated with a sampling design. Although monitoring data 
can provide a direct measure of the concentration of a pesticide in 
water, it does not always provide a reliable estimate of exposure 
because sampling may not occur in areas with the highest pesticide use, 
and/or the sampling may not occur when the pesticides are being used. 
When monitoring data meet certain data quantity criteria, EPA has tools 
available to quantify the uncertainty in available monitoring data such 
that it can be used quantitively to estimate pesticide concentrations 
in drinking water. (Ref. 12) Furthermore, monitoring data can be used 
in a weight of evidence (WOE) approach with model estimated 
concentrations to increase confidence in the conclusions of a drinking 
water assessment.
    Due often to the limitations in many monitoring studies, EPA uses 
mathematical water exposure models to estimate pesticide exposure 
levels in drinking water. EPA's models are based on extensive 
monitoring data and detailed information on soil properties, crop 
characteristics, and weather patterns to estimate water concentrations 
in vulnerable locations where the pesticide could be used according to 
its label. (Ref. 13 at pgs. 27 and 28) (See also 69 FR 30042, 30058

[[Page 11228]]

through 30065, May 26, 2004) (FRL-7355-7) These models calculate 
estimated environmental concentrations of pesticides using laboratory 
data that describe how fast the pesticide breaks down to other 
chemicals and how it moves in the environment. The modeling provides an 
estimate of pesticide concentrations in ground water and surface water. 
Depending on the modeling algorithm (e.g., surface water modeling 
scenarios), daily concentrations can be estimated continuously over 
long periods of time, and for places that are of most interest for any 
particular pesticide. Modeling is a useful tool for characterizing 
vulnerable sites and can be used to estimate peak concentrations from 
infrequent, large rain events.
    EPA relies on models it has developed for estimating pesticide 
concentrations in both surface water and groundwater. The most common 
model used to conduct drinking water assessments is the Pesticide in 
Water Calculator (PWC). PWC couples the Pesticide Root Zone Model 
(PRZM) and Variable Volume Water Model (VVWM) together to simulate 
pesticide fate and transport from the field of application to an 
adjacent reservoir. (Ref. 13 at pgs. 27 and 28) The PWC estimates 
pesticide concentrations for an index reservoir that is modeled for 
site-specific scenarios (i.e., weather and soil data) in different 
areas of the country. A detailed description of the models routinely 
used for exposure assessment is available from the EPA OPP Aquatic 
Models website: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment#aquatic.
    In modeling potential surface water concentrations, EPA attempts to 
model areas of the country that are vulnerable to surface water 
contamination rather than simply model ``typical'' concentrations 
occurring across the nation. EPA models exposures occurring in small 
highly agricultural watersheds in different growing areas throughout 
the country, over a 30-year period. The scenarios are designed to 
capture residue levels in drinking water from reservoirs with small 
watersheds with a large percentage of land use in agricultural 
production. EPA believes these assessments are likely reflective of a 
small subset of the watersheds across the country that maintain 
drinking water reservoirs, representing a drinking water source 
generally considered to be more vulnerable to frequent high 
concentrations of pesticides than most locations that could be used for 
crop production.
    (b) Drinking Water Level of Comparison (DWLOC). The drinking water 
level of comparison (DWLOC) is an estimate of the maximum concentration 
of the pesticide (and other residues of concern) that may be in 
drinking water without triggering a risk concern for human health. 
(Ref. 13 at pg. 10) The DWLOC is a benchmark that can be used to guide 
refinements of the drinking water assessment (DWA). This value relates 
to the concept of the ``risk cup,'' which EPA developed to facilitate 
risk refinement when considering aggregate human health risk to a 
pesticide. (Ref. 14) The risk cup is the total exposure allowed for a 
pesticide considering its toxicity and required safety factors. The 
risk cup is equal to the maximum safe exposure for the duration and 
population being considered. Exposures exceeding the risk cup are of 
potential concern. There are risk cups for each pertinent duration of 
exposure (e.g., acute, short-term, chronic). The exposure durations 
most commonly of interest for acute or short-term pesticide exposure 
risk assessments are 1-day, 4-day, and 21-day averages. For example, 
the relevant exposure duration for AChE reversible inhibition from 
exposure to N-methyl carbamate insecticides is 1-day, while AChE 
irreversible inhibition resulting from exposure to OP insecticides is 
usually 21-days based on steady-state kinetics. (Ref. 5)
    When using the DWLOC approach, EPA calculates the total exposure 
from food consumption and residential (or other non-occupational) 
exposures and subtracts this value from the maximum safe exposure 
level. The resulting value is the allowable remaining exposure without 
the potential for adverse health effect, and this allowable remaining 
exposure becomes the remaining space in the ``risk cup'' for pesticide 
exposures in drinking water. Knowing this allowable remaining exposure 
and the water consumption for each population subgroup (e.g., infants), 
the Agency can calculate the DWLOC, which is the estimate of safe 
concentrations of pesticides in drinking water. Using this process of 
DWLOC calculation allows EPA to determine a target maximum safe 
drinking water concentration, which makes it easier to identify 
instances where drinking water estimates require refinement. (Ref. 13 
at pgs. 19 and 20)
    (c) Scale of drinking water assessment. Although food is 
distributed nationally, and residue values are therefore not expected 
to vary substantially throughout the country, drinking water is locally 
derived and concentrations of pesticides in source water fluctuate over 
time and location for a variety of reasons. Pesticide residues in water 
fluctuate daily, seasonally, and yearly because of the timing of the 
pesticide application, the vulnerability of the water supply to 
pesticide loading through runoff, spray drift and/or leaching, and 
changes in the weather. Concentrations are also affected by the method 
of application, the location, characteristics of the sites where a 
pesticide is used, the climate, and the type and degree of pest 
pressure, which influences the application timing, rate used, and 
number of treatments in a crop production cycle.
    EPA may conduct a drinking water assessment (DWA) for a national 
scale depending on the pesticide use under evaluation. A national-scale 
DWA may use a single upper-end pesticide concentration as a starting 
point for assessing whether additional refinements are needed or 
estimated pesticide concentrations for certain site-specific scenarios 
that are associated with locations in the United States vulnerable to 
pesticide contamination based on pesticide use patterns. (Ref. 13 at 
pg. 22)
    EPA may also conduct a regional-scale DWA to focus on areas where 
pesticide concentrations may be higher than the DWLOC. Under this type 
of assessment, EPA estimates pesticide concentrations across different 
regions in the United States that correspond with specific hydrologic 
units identified by a unique hydrologic unit code (HUC). For purposes 
of assessing chlorpyrifos, EPA evaluated concentrations in the 21 major 
geographic areas (or regions) used that comprise the United States. 
These areas contain either the drainage area of a major river or a 
combined drainage of a series of rivers. This information can be found 
at: https://water.usgs.gov/GIS/huc.html. Estimated pesticide 
concentrations under this approach would be associated with a 
vulnerable pesticide use area somewhere within the evaluated region. 
(Ref. 13 at pg. 23)
    (d) Refinements to drinking water assessments. Much like the tiered 
approach used for assessing exposures of pesticides in food, EPA has 
defined four tiers for drinking water assessments. Lower-tiered 
assessments are more conservative based on the defaults or upper bound 
assumptions and may compound conservatisms, while higher tiers 
integrate more available data and provide more realistic estimates of 
environmental pesticide concentrations.
    These four tiers are generally based on the level of effort, the 
amount of data considered, the spatial scale, and the

[[Page 11229]]

certainty in the estimated pesticide concentration. Each successive 
tier integrates more focused pesticide, spatial, temporal, agronomic, 
and crop-specific information. Tier 1 requires the least amount of 
effort and the least amount of data, whereas Tier 4 is resource 
intensive, considers a wide range of sources and types of data, and is 
spatially explicit. The order in which refinements are considered 
(i.e., the order in which the assessment is refined) is pesticide-
specific and depends on the nature and quality of the available data 
used to support the refinement. Additional information on the conduct 
of drinking water assessments can be found in EPA's ``Framework for 
Conducting Pesticide Drinking Water Assessment for Surface Water'' 
(Drinking Water Framework) (Ref. 13).
    As discussed in the Drinking Water Framework, EPA can incorporate 
several refinements in higher tiered modeling. Two such refinements are 
the percent cropped area (PCA) and the percent crop treated (PCT). The 
PCA refers to the amount of area in a particular community water system 
that is planted with the crop of interest (e.g., the default assumption 
is that the entire watershed is planted with a crop of interest). The 
PCT refers to the amount of the cropped area that is treated with the 
pesticide of interest (e.g., the default is that the entire cropped 
area is treated with the pesticide of interest). With additional use 
and usage data, EPA can refine assumptions about the application rate 
and PCT for use in modeling to generate estimated drinking water 
concentrations (EDWCs) that are appropriate for human health risk 
assessment and more accurately account for the contribution from 
individual use patterns in the estimation of drinking water 
concentrations. The goal of the PCA and PCT refinements are to generate 
EDWCs that are appropriate for human health risk assessment that reduce 
the magnitude of overestimation due to variability in crops and actual 
pesticide usage. (Ref. 15)
    iii. Non-occupational (Residential) exposures. Residential 
assessments examine exposure to pesticides in non-occupational or 
residential settings (e.g., homes, parks, schools, athletic fields, or 
any other areas frequented by the general public), based on registered 
uses of the pesticide. Exposures to pesticides may occur to persons who 
apply pesticides (which is referred to as residential handler exposure) 
or to persons who enter areas previously treated with pesticides (which 
is referred to as post-application exposure). Such exposures may occur 
through oral, inhalation, or dermal routes and may occur over different 
exposure durations (e.g., short-term, intermediate-term, long-term), 
depending on the type of pesticide and particular use pattern.
    Residential assessments are conducted through examination of 
significant exposure scenarios (e.g., children playing on treated lawns 
or homeowners spraying their gardens) using a combination of generic 
and pesticide-specific data. To standardize this process, EPA has 
prepared Standard Operating Procedures (SOPs) for conducting 
residential assessments on a wide array of scenarios that are intended 
to address all major possible means by which individuals could be 
exposed to pesticides in a non-occupational environment. (Ref. 16) SOPs 
have been developed for many common exposure scenarios including 
pesticide treatment of lawns, garden plants, trees, swimming pools, 
pets, and indoor surfaces including crack-and-crevice treatments.
    The SOPs identify relevant generic data and construct algorithms 
for calculating application and post-application exposures in a 
residential or non-occupational setting using these generic data in 
combination with pesticide-specific information. The generic data 
typically involve survey data on behavior patterns (e.g., activities 
conducted on turf and time spent on these activities) and transfer 
coefficient data (i.e., data measuring the amount of pesticide that 
transfers from the environment to humans during some activity). 
Specific information on pesticides can include information on residue 
levels as well as information on environmental fate such as degradation 
data.
    Once EPA assesses all the potential exposures from all applicable 
residential exposure scenarios, EPA selects the highest exposure 
scenario for each exposed population to calculate representative risk 
estimates for use in the aggregate exposure assessment. Those specific 
exposure values are then combined with the life-stage appropriate 
exposure values provided for food and drinking water to determine 
whether a safety finding can be made.
    iv. Aggregate exposures. The aggregate exposure assessment process 
considers exposure through multiple pathways or routes of exposure 
(e.g., food, water, and residential) for different sub-populations 
(e.g., infants, children ages 1 through 6) and exposure duration or 
types of effects (e.g., acute noncancer effects (single dose), chronic 
noncancer effects, and cancer). The aggregated exposure assessments can 
be deterministic (levels of exposure for each pathway are point 
estimates), probabilistic (levels of exposure are a distribution for a 
given population), or a combination of the two and are dependent on the 
level of refinement or assessment tier.
    EPA evaluates aggregate exposure by comparing combined exposure 
from all relevant sources to the safe level. Where exposures exceed the 
safe level, those levels exceed the risk cup and are of potential 
concern. There are risk cups for each pertinent duration of exposure 
for a pesticide because the amount of exposure that can be incurred 
without adverse health effects will vary by duration (e.g., acute, 
short-term, chronic, steady-state). The size of the risk cup is 
dependent on the maximum safe exposure for the different relevant 
durations (e.g., acute, short-term, intermediate-term, long-term, 
steady-state).
d. Risk Characterization
    The final step in the risk assessment is risk characterization. In 
this step, EPA combines information from the first three steps (hazard 
identification, level of concern/dose-response analysis, and human 
exposure assessment) to quantitatively estimate the risks posed by a 
pesticide. Separate characterizations of risk are conducted for 
different durations of exposure. Additionally, separate and, where 
appropriate, aggregate characterizations of risk are conducted for the 
different routes of exposure (dietary and non-dietary).
    Whether exposures will exceed the available space in the risk cup 
(i.e., whether exposures are expected to exceed safe levels) is 
expressed differently, depending on the type of level of concern (i.e., 
RfD/PAD or MOE) the Agency has identified. For dietary assessments for 
which EPA calculates an RfD/PAD, the risk is expressed as a percentage 
of the acceptable dose (i.e., the dose which EPA has concluded will be 
``safe''). Dietary exposures greater than 100% of the percentage of the 
acceptable dose are generally cause for concern and would be considered 
``unsafe'' within the meaning of FFDCA section 408(b)(2)(B). For non-
dietary (and combined dietary and non-dietary) risk assessments of 
threshold effects, the toxicological level of concern is typically not 
expressed as an RfD/PAD, but rather in terms of an acceptable (or 
target) Margin of Exposure (MOE) between human exposure and the PoD. 
Non-dietary (and combined) exposures that result in an MOE equal to or 
exceeding the product of all applicable

[[Page 11230]]

safety factors would not generally be of concern.
    As a conceptual matter, the RfD/PAD and MOE approaches are 
fundamentally equivalent. For a given risk and given exposure of a 
pesticide, if exposure to a pesticide were found to be acceptable under 
an RfD/PAD analysis it would also pass under the MOE approach, and 
vice-versa. However, for any specific pesticide, risk assessments for 
different exposure durations or routes may yield different results. 
This is a function not of the choice of the RfD/PAD or MOE approach but 
of the fact that the levels of concern and the levels of exposure may 
differ depending on the duration and route of exposure.
    Where EPA has calculated a DWLOC, the Agency can assess risk by 
comparing estimated pesticide concentrations in drinking water to the 
DWLOC. As noted previously, an aggregate DWLOC represents the amount of 
maximum safe residues of pesticide in drinking water because it 
represents the room remaining in the risk cup for drinking water 
exposures, after accounting for the food and residential exposures. 
When the EDWC is less than the DWLOC, there are no risk concerns for 
aggregate exposures because the Agency can conclude that the 
contribution from drinking water, when aggregated with food and non-
occupational exposures, will not exceed safe levels of exposure. 
Conversely, an EDWC at or exceeding the DWLOC would indicate a risk of 
concern, as pesticide exposures in drinking water, when aggregated with 
exposures from food and residential exposures, would exceed safe levels 
of exposure. (Ref. 14)
    For non-threshold risks (generally, cancer risks), EPA uses the 
slope of the dose-response curve for a pesticide in conjunction with an 
estimation of human exposure to that pesticide to estimate the 
probability of occurrence of additional adverse effects. Under FFDCA 
section 408, for non-threshold cancer risks, EPA generally considers 
cancer risk to be negligible if the probability of increased cancer 
cases falls within the range of 1 in 1 million. EPA describes this 
quantitative standard as a ``range'' because it does not want to impart 
a false precision to numerical cancer risk estimates. EPA seeks to 
identify risks differing significantly from a 1 in 1 million risk, and 
that involves both a quantitative as well as qualitative assessment of 
what a risk estimate represents.
2. EPA Policy on the FQPA Children's Safety Factor
    As the summary of EPA's risk assessment practice indicates, the use 
of safety factors plays a critical role in the process. This is true 
for traditional safety factors to account for potential differences 
between animals and humans when relying on studies in animals (inter-
species factor) and potential differences among humans (intra-species 
factor), as well as the FQPA's additional 10X children's safety factor.
    In implementing the children's safety factor provision, EPA has 
interpreted it as imposing a presumption in favor of applying a 10X 
safety factor, in addition to the traditional safety factors for inter- 
and intra-species extrapolation. (Ref. 9 at pgs. 4 and 11) Thus, EPA 
generally refers to the FQPA 10X factor as a presumptive or default 10X 
factor. EPA has also made clear, however, that this presumption or 
default in favor of the FQPA 10X safety factor is only a presumption. 
The presumption can be overcome if reliable data demonstrate that a 
different factor is safe for children. (Id.) In determining whether a 
different factor is safe for children, EPA focuses on the three factors 
listed in section 408(b)(2)(C) of the FFDCA--the completeness of the 
toxicity database, the completeness of the exposure database, and 
potential pre- and postnatal toxicity. In examining these factors, EPA 
strives to make sure that its choice of a safety factor, based on a WOE 
evaluation, does not understate the risk to children. (Id. at pgs. 24 
through 25 and 35)
3. Acetylcholinesterase Inhibition
    Acetylcholinesterase (AChE) inhibition is a disruption of the 
normal process in the body by which the nervous system chemically 
communicates with muscles and glands. Communication between nerve cells 
and a target cell (i.e., another nerve cell, a muscle fiber, or a 
gland) is facilitated by the chemical, acetylcholine. When a nerve cell 
is stimulated, it releases acetylcholine into the synapse (or space) 
between the nerve cell and the target cell. The released acetylcholine 
binds to receptors in the target cell, stimulating the target cell in 
turn. As EPA has explained, ``the end result of the stimulation of 
cholinergic pathway(s) includes, for example, the contraction of smooth 
(e.g., in the gastrointestinal tract) or skeletal muscle, changes in 
heart rate or glandular secretion (e.g., sweat glands) or communication 
between nerve cells in the brain or in the autonomic ganglia of the 
peripheral nervous system.'' (Ref. 17 at pg. 10)
    AChE is an enzyme that breaks down acetylcholine and terminates its 
stimulating action in the synapse between nerve cells and target cells. 
When AChE is inhibited, acetylcholine builds up prolonging the 
stimulation of the target cell. This excessive stimulation potentially 
results in a broad range of adverse effects on many bodily functions 
including muscle cramping or paralysis, excessive glandular secretions, 
or effects on learning, memory, or other behavioral parameters. 
Depending on the degree of inhibition, these effects can be serious or 
even fatal.
    EPA's cholinesterase inhibition policy statement explains EPA's 
approach to evaluating the risks posed by AChE-inhibiting pesticides 
such as chlorpyrifos. (Id.) The policy focuses on three types of 
effects associated with AChE-inhibiting pesticides that may be assessed 
in animal and human toxicological studies: (1) Physiological and 
behavioral/functional effects; (2) AChE inhibition in the central and 
peripheral nervous system; and (3) AChE inhibition in red blood cells 
and blood plasma. The policy discusses how such data should be 
integrated in deriving an acceptable dose (e.g., RfD/PAD) for an AChE-
inhibiting pesticide.
    After clinical signs or symptoms, AChE inhibition in the nervous 
system provides the next most important endpoint for evaluating AChE-
inhibiting pesticides. Although AChE inhibition in the nervous system 
is not itself regarded as a direct adverse effect, it is ``generally 
accepted as a key component of the mechanism of toxicity leading to 
adverse cholinergic effects.'' (Id. at pg. 25) As such, the policy 
states that it should be treated as ``direct evidence of potential 
adverse effects'' and ``data showing this response provide valuable 
information in assessing potential hazards posed by anticholinesterase 
pesticides.'' (Id.) Unfortunately, useful data measuring AChE 
inhibition in the peripheral nervous system tissues has only been 
relatively rarely captured by standard toxicology testing. For central 
nervous system effects, however, more recent neurotoxicity studies 
``have sought to characterize the time course of inhibition in * * * 
[the] brain, including brain regions, after acute and 90-day 
exposures.'' (Id. at pg. 27)
    AChE inhibition in the blood is one step further removed from the 
direct harmful consequences of AChE-inhibiting pesticides. According to 
the policy, inhibition of blood AChEs ``is not an adverse effect, but 
may indicate a potential for adverse effects on the nervous system.'' 
(Id. at pg. 28) The policy states that ``[a]s a matter of science 
policy, blood cholinesterase data are considered appropriate surrogate 
measures of potential effects on peripheral nervous system

[[Page 11231]]

acetylcholinesterase activity in animals, for CNS [central nervous 
system] acetylcholinesterase activity in animals when CNS data are 
lacking and for both peripheral and central nervous system 
acetylcholinesterase in humans.'' (Id. at pg. 29) The policy notes that 
``there is often a direct relationship between a greater magnitude of 
exposure [to an AChE-inhibiting pesticide] and an increase in incidence 
and severity of clinical signs and symptoms as well as blood 
cholinesterase inhibition.'' (Id. at pg. 30) Thus, the policy regards 
blood AChE data as ``appropriate endpoints for derivation of reference 
doses or concentrations when considered in a weight-of-the-evidence 
analysis of the entire database * * *.'' (Id. at pg. 29) Between AChE 
inhibition measured in red blood cell (``RBC'') or blood plasma, the 
policy states a preference for reliance on RBC AChE measurements 
because plasma cholinesterase is composed of a mixture of 
acetylcholinesterase and butyrylcholinesterase, and inhibition of the 
latter is less clearly tied to inhibition of acetylcholinesterase in 
the nervous system. (Id. at pgs. 29 and 32)
    In the Agency's analysis for chlorpyrifos, EPA used a response 
level of 10% RBC AChE inhibition; this value represents the estimated 
dose where AChE is inhibited by 10%, compared to untreated animals. For 
the last several years EPA has used the 10% value to regulate AChE-
inhibiting pesticides, including other organophosphorous pesticides. 
For a variety of toxicological and statistical reasons, EPA chose 10% 
RBC AChE inhibition as the response level for use in its PBPK-PD 
modeling. (Ref. 2 at pg. 7) EPA analyses have demonstrated that 10% is 
a level that can be reliably measured in the majority of rat toxicity 
studies; is generally at or near the limit of sensitivity for 
discerning a statistically significant decrease in AChE activity across 
the brain compartment; and is a response level close to the background.

III. Chlorpyrifos Background

A. Regulatory Background

1. General
a. Chlorpyrifos Uses
    Chlorpyrifos (0,0-diethyl-0-3,5,6-trichloro-2-pyridyl 
phosphorothioate) is a broad-spectrum, chlorinated organophosphate (OP) 
insecticide that has been registered for use in the United States since 
1965. (The OPs are a group of closely related pesticides that affect 
functioning of the nervous system.) Pesticide products containing 
chlorpyrifos are registered for use on many agricultural crops, 
including, but not limited to, corn, soybeans, alfalfa, oranges, wheat, 
and walnuts. Additionally, chlorpyrifos products are registered for use 
on nonfood sites such as ornamental plants in nurseries, golf course 
turf, and as wood treatment. There are also public health uses 
including aerial and ground-based mosquito adulticide fogger 
treatments, use as fire ant control in nursery stock grown in USDA-
designated quarantine areas, and for some tick species that may 
transmit diseases such as Lyme disease. The majority of uses in 
residential settings were voluntarily canceled over two decades ago 
(e.g., 65 FR 76233, December 6, 2000 (FRL-6758-2); 66 FR 47481, 
September 12, 2001 (FRL-6799-7)).
b. Chlorpyrifos Risks
    i. Acetylcholinesterase (AChE) inhibition. Chlorpyrifos, like other 
OP pesticides, affects the nervous system by inhibiting AChE, an enzyme 
necessary for the proper functioning of the nervous system, and 
ultimately leading to signs of neurotoxicity. This mode of action, in 
which AChE inhibition leads to neurotoxicity, is well-established, and 
thus has been used as basis for the PoD for OP human health risk 
assessments, including chlorpyrifos. This science policy is based on 
decades of work, which shows that AChE inhibition is the initial event 
in the pathway to acute cholinergic neurotoxicity. (Ref. 17 at pg. 14)
    The Agency has conducted a comprehensive review of the available 
data and public literature regarding this adverse effect from 
chlorpyrifos. (Ref. 18 at pgs. 25 through 27) There are many 
chlorpyrifos studies evaluating RBC AChE inhibition or the brain in 
multiple lifestages (gestational, fetal, postnatal, and non-pregnant 
adult); multiple species (rat, mouse, rabbit, dog, human); methods of 
oral administration (oral gavage with corn oil, dietary, gavage via 
milk); and routes of exposure (oral, dermal, inhalation via vapor and 
via aerosol). In addition, chlorpyrifos is unique in the availability 
of AChE data from peripheral tissues in some studies (e.g., heart, 
lung, liver). There are also literature studies comparing the in vitro 
AChE response to a variety of tissues that show similar sensitivity and 
intrinsic activity. Across the database, brain AChE tends to be less 
sensitive than RBC AChE or peripheral AChE. In oral studies, RBC AChE 
inhibition is generally similar in response to peripheral tissues. 
Thus, the in vitro data and oral studies combined support the continued 
use of RBC AChE inhibition as the critical effect for quantitative 
dose-response assessment.
    Female rats tend to be more sensitive than males to these AChE 
effects. For chlorpyrifos, there are data from multiple studies which 
provide robust RBC AChE data in pregnant, lactating, and non-pregnant 
female rats from oral exposure (e.g., developmental neurotoxicity 
(DNT), reproductive, and subchronic data).
    In addition, studies are available in juvenile pups that show age-
dependent differences, particularly following acute exposures, in 
sensitivity to chlorpyrifos and its oxon metabolite. This sensitivity 
is not derived from differences in the AChE enzyme itself but instead 
are derived largely from the immature metabolic clearance capacity in 
the juveniles.
    ii. Neurodevelopmental toxicity. In addition to information on the 
effects of chlorpyrifos on AChE, there is an extensive body of 
information (in the form of laboratory animal studies, epidemiological 
studies, and mechanistic studies) studying the potential effects on 
neurodevelopment in infants and children following exposure to OPs, 
including chlorpyrifos.
    There are numerous laboratory animal studies on chlorpyrifos in the 
literature that have evaluated the impact of chlorpyrifos exposure in 
pre- and postnatal dosing on the developing brain. These studies vary 
substantially in their study design, but all involve gestational and/or 
early postnatal dosing with behavioral evaluation from adolescence to 
adulthood. The data provide qualitative support for chlorpyrifos to 
potentially impact the developing mammalian brain with adverse outcomes 
in several neurological domains including cognitive, anxiety and 
emotion, social interactions, and neuromotor function. It is, however, 
important to note that there is little consistency in patterns of 
effects across studies. In addition, most of these studies use doses 
that far exceed EPA's 10% benchmark response level for RBC AChE 
inhibition. There are only a few studies with doses at or near the 10% 
brain or RBC AChE inhibition levels; among these only studies from Carr 
laboratory at Mississippi State University are considered by EPA to be 
high quality. EPA has concluded that the laboratory animal studies on 
neurodevelopmental outcomes are not sufficient for quantitatively 
establishing a PoD. (Ref. 2 at pgs. 88 and 89)
    EPA evaluated numerous epidemiological studies on chlorpyrifos and 
other OP pesticides in accordance with the Agency's ``Framework for

[[Page 11232]]

Incorporating Human Epidemiologic & Incident Data in Health Risk 
Assessment'' (``Epidemiologic Framework''). (Ref. 19) The most robust 
epidemiologic research comes from three prospective birth cohort 
studies. These include: (1) The Mothers and Newborn Study of North 
Manhattan and South Bronx performed by the Columbia Children's Center 
for Environmental Health (CCCEH) at Columbia University (``CCCEH 
study''); (2) the Mount Sinai Inner-City Toxicants, Child Growth and 
Development Study (``Mt. Sinai study''); and (3) the Center for Health 
Assessment of Mothers and Children of Salinas Valley (CHAMACOS) 
conducted by researchers at University of California Berkeley 
(``CHAMACOS study''). (Ref. 20 at pgs. 32 through 43)
    In the case of the CCCEH study, which specifically evaluated the 
possible connections between chlorpyrifos levels in cord blood and 
neurodevelopmental outcomes on a specific cohort, there are a number of 
notable associations. (Id. at pgs. 35 through 38) Regarding infant and 
toddler neurodevelopment, the CCCEH study authors reported 
statistically significant deficits of 6.5 points on the Psychomotor 
Development Index at three years of age when comparing high to low 
exposure groups. Notably, these decrements persist even after 
adjustment for group and individual level socioeconomic variables. 
These investigators also observed increased odds of mental delay and 
psychomotor delay at age three when comparing high to low exposure 
groups. The CCCEH study authors also report strong, consistent evidence 
of a positive association for attention disorders, attention deficit 
hyperactivity disorder (ADHD), and pervasive development disorder (PDD) 
when comparing high to low chlorpyrifos exposure groups. Moreover, it 
was reported that for children in the CCCEH study cohort at age seven 
for each standard deviation increase in chlorpyrifos cord blood 
exposure, there is a 1.4% reduction in Full-Scale IQ and a 2.8% 
reduction in Working Memory. In addition, the CCCEH study authors 
evaluated the relationship between prenatal chlorpyrifos exposure and 
motor development/movement and reported elevated risks of arm tremor in 
children around 11 years of age in the CCCEH cohort.
    Notwithstanding the observed associations, EPA and the 2012 and 
2016 FIFRA SAPs identified multiple uncertainties in the CCCEH 
epidemiology studies. (Refs. 21 and 22) Some of these include the 
relatively modest sample sizes, which limited the statistical power; 
exposure at one point in prenatal time with no additional information 
regarding postnatal exposures; representativeness of a single-point 
exposure where time-varying exposures or the ability to define 
cumulative exposures would be preferable; lack of specificity of a 
critical window of effect and the potential for misclassification of 
individual exposure measures; and lack of availability of the raw data 
from the studies that would allow verification of study conclusions.
    One of the notable uncertainties in the CCCEH epidemiology studies 
identified by EPA and the 2016 FIFRA SAP is the lack of specific 
exposure information on the timing, frequency, and magnitude of 
chlorpyrifos application(s) in the apartments of the women in the 
study. Despite extensive effort by EPA to obtain or infer this exposure 
information from various sources, the lack of specific exposure data 
remains a critical uncertainty. EPA made efforts in 2014 and 2016 to 
develop dose reconstruction of the exposures to these women. These dose 
reconstruction activities represent the best available information and 
tools but are highly uncertain. In addition, the pregnant women and 
children in the CCCEH studies were exposed to multiple chemicals, 
including multiple potent AChE inhibiting OPs and N-methyl carbamates. 
Moreover, using EPA's dose reconstruction methods from 2014 suggest 
that the pregnant women likely did not exhibit RBC AChE inhibition 
above 10%. The 2012 and 2016 FIFRA SAP reports expressed concern that 
it is likely that the CCCEH findings occurred at exposure levels below 
those that result in 10% RBC AChE inhibition. (Refs. 21 and 22) 
However, given the available CCCEH exposure information and the 
exposures to multiple potent AChE inhibiting pesticides, EPA cannot 
definitively attribute all AChE inhibition to chlorpyrifos. EPA remains 
unable to make a causal linkage between chlorpyrifos exposure and the 
outcomes reported by CCCEH investigators. (Ref. 20 at pg. 43) Moreover, 
given the uncertainties, particularly in the exposure information 
available from CCCEH (single timepoints, lack of time varying exposure, 
lack of knowledge about application timing), uncertainties remain about 
the dose-response relationships from the epidemiology studies.
    Finally, there are several lines of evidence for actions of 
chlorpyrifos distinct from the classical mode of action of AChE 
inhibition. This information has been generated from model systems 
representing different levels of biological organization and provide 
support for molecular initiating events (binding to the morphogenic 
site of AChE, muscarinic receptors, or tubulin), cellular responses 
(alterations in neuronal proliferation, differentiation, neurite 
growth, or intracellular signaling), and responses at the level of the 
intact nervous system (serotonergic tone, axonal transport). Among the 
many in vitro studies on endpoints relevant to the developing brain 
available for chlorpyrifos, only three have identified outcomes in 
picomole concentrations, including concentrations lower than those that 
elicit AChE inhibition in vitro. However, as is the case for many other 
developmental neurotoxicants, most of these studies have not been 
designed with the specific goal of construction or testing an adverse 
outcome pathway. Thus, there are not sufficient data available to test 
rigorously the causal relationship between effects of chlorpyrifos at 
the different levels of biological organization in the nervous system. 
(Id. at pgs. 27 through 31)
    Due to the complexity of nervous system development involving the 
interplay of many different cell types and developmental timelines, it 
is generally accepted that no single in vitro screening assay can 
recapitulate all the critical processes of neurodevelopment. As a 
result, there has been an international effort to develop a battery of 
new approach methodologies (NAMs) to inform the DNT potential for 
individual chemicals. This DNT NAM battery is comprised of in vitro 
assays that assess critical processes of neurodevelopment, including 
neural network formation and function, cell proliferation, apoptosis, 
neurite outgrowth, synaptogenesis, migration, and differentiation. In 
combination the assays in this battery provide a mechanistic 
understanding of the underlying biological processes that may be 
vulnerable to chemically-induced disruption. It is noteworthy, however, 
that the quantitative relationship between alterations in these 
neurodevelopmental processes and adverse health outcomes has, to date, 
not been fully elucidated. Moreover, additional assays evaluating other 
critical neurodevelopmental processes such as myelination are still 
being developed. (Ref. 23)
    In September 2020, EPA convened a FIFRA SAP on developing and 
implementing NAMs using methods such as in vitro techniques and 
computational approaches. Included in that consideration was use of the 
DNT NAM battery to evaluate OP compounds as a case study. These methods

[[Page 11233]]

presented to the 2020 FIFRA SAP provide a more systematic approach to 
evaluating pharmacodynamic effects on the developing brain compared to 
the existing literature studies. Initial data from the NAM battery were 
presented to the SAP for 27 OP compounds, including chlorpyrifos and 
its metabolite, chlorpyrifos-oxon, and, when possible, compared to in 
vivo results (by using in vitro to in vivo extrapolation). On December 
21, 2020, the SAP released its final report and recommendations on 
EPA's proposed use of the NAMs data. (Ref. 24) The advice of the SAP is 
currently being taken into consideration as EPA develops a path forward 
on NAMs. The Agency is continuing to explore the use of NAMs for the 
OPs, including chlorpyrifos, and intends to make its findings available 
as soon as it completes this work.
2. Reregistration and Registration Review
    In 2006, EPA completed FIFRA section 4 (7 U.S.C. 136a-1) 
reregistration (a program under which EPA reregisters older pesticides 
that continue to meet the standard for registration) and FFDCA 
tolerance reassessment (21 U.S.C. 346a(q)) for chlorpyrifos and the OP 
class of pesticides. EPA concluded that process by determining that 
those tolerances were safe and should be left in effect. That decision 
relied on an endpoint based on 10% RBC AChE inhibition. (Ref. 25)
    Given ongoing scientific developments in the study of the OPs 
generally, in March 2009 EPA announced its decision to prioritize the 
FIFRA section 3(g) (7 U.S.C. 136a(g)) registration review of 
chlorpyrifos by opening a public docket and releasing a preliminary 
work plan to complete the chlorpyrifos registration review by 2015. 
Despite the ambitions of that original work plan, the registration 
review of chlorpyrifos has proven to be far more complex than 
originally anticipated, and thus, chlorpyrifos is currently still 
undergoing registration review, which must be completed by October 1, 
2022. (7 U.S.C. 136a(g)(1)(A)(iv)) For information about the ongoing 
registration review process for chlorpyrifos, see https://www.regulations.gov/docket/EPA-HQ-OPP-2008-0850.
    Reflecting that complexity, the Agency has engaged in extensive and 
ongoing analyses of the available science since initiating registration 
review in 2009, including multiple human health risk assessments and 
drinking water assessments, development of a new model for deriving 
points of departure to assess risks of chlorpyrifos, development of a 
framework for incorporating human epidemiology information into risk 
assessments as well as conducting an in-depth epidemiology and 
literature review, and in the process convening the FIFRA SAP at least 
six times. The following lays out the major milestones of the 
chlorpyrifos registration review process.
    In 2011, EPA released its preliminary human health risk assessment 
(2011 HHRA) for the registration review of chlorpyrifos. (Ref. 18) The 
2011 HHRA used 10% RBC AChE inhibition from laboratory rats as the 
critical effect (or PoD) for extrapolating risk. It also used the 
default 10X uncertainty factors for inter- and intra-species 
extrapolation. The 10X FQPA safety factor was reduced to 1X with a note 
to the public that a WOE analysis evaluating available epidemiological 
studies would be forthcoming. Also, in 2011, EPA released its Revised 
Chlorpyrifos Preliminary Registration Review Drinking Water Assessment. 
(Ref. 26) This assessment provided estimated drinking water 
concentrations (EDWCs) based on Tier I groundwater and Tier II surface 
water model simulations for registered uses of chlorpyrifos and 
considered monitoring data from several different programs. Based on 
data demonstrating the impacts of drinking water treatment on 
chlorpyrifos, EPA concluded that chlorpyrifos in drinking water would 
convert to chlorpyrifos-oxon, a metabolite, when going through 
chlorinated drinking water treatment systems. Based on modeling 
results, EDWCs for chlorpyrifos and chlorpyrifos-oxon generated from 
surface water sources provided higher estimates of the potential 
exposure to either of these chemicals in drinking water than those from 
groundwater.
    In 2014, following the development of the PBPK-PD model and 2012 
SAP's review of EPA's epidemiology review, EPA released a revised human 
health risk assessment (2014 HHRA). (Ref. 20) Using the chlorpyrifos 
PBPK-PD model for deriving human PoDs for RBC AChE inhibition, which 
obviated the need for the inter-species extrapolation factor and 
allowed for data-derived intra-species extrapolation factors (as 
described in Unit II.B.1.b.i.), the revised risk assessment identified 
highly refined PoDs that accounted for gender, age, duration and route-
specific exposure considerations. In addition, the revised risk 
assessment retained the 10X FQPA SF, based on EPA's WOE analysis 
concerning the potential for neurodevelopmental outcomes that followed 
a draft of EPA's Epidemiologic Framework (Ref. 19), and incorporated 
recommendations from the 2012 SAP. Also in 2014, EPA released its 
Updated Drinking Water Assessment for Registration Review (``2014 
DWA''). (Ref. 27) As an update to the 2011 DWA, the 2014 DWA included 
several additional analyses focusing on: (1) Clarifying labeled uses, 
(2) evaluating volatility and spray drift, (3) revising aquatic 
modeling input values, (4) comparing aquatic modeling and monitoring 
data, (5) summarizing the effects of drinking water treatment, and (6) 
updating model simulations using current exposure tools. The additional 
analyses did not change the exposure assessment conclusions reported in 
the preliminary DWA. The 2014 HHRA, taken together with the Agency's 
drinking water assessment, identified estimated aggregate risks 
exceeding the level of concern for chlorpyrifos.
    In 2016 EPA issued a revised human health risk assessment using a 
dose-reconstruction approach to derive the PoD based on the 
neurodevelopmental effects observed in the CCCEH study based on advice 
from the 2016 SAP. (Ref. 28) Although the 2016 HHRA found that risks 
from food alone exceeded the safe level for chlorpyrifos, EPA also 
issued a revised drinking water assessment (2016 DWA). (Ref. 29) This 
refined drinking water assessment served to combine, update, and 
complete the work presented in the 2011 and 2014 drinking water 
assessments for chlorpyrifos as part of the registration review 
process. Even with the additional refinements, the results were 
consistent and suggested potential exposure to chlorpyrifos or 
chlorpyrifos[hyphen]oxon in finished drinking water based on labeled 
uses. The assessment noted that depending on the drinking water level 
of concern, measured concentrations of chlorpyrifos and 
chlorpyrifos[hyphen]oxon may exceed the level of concern in some 
locations across the country, which warranted comparison of EDWCs to 
the established drinking water level of concern. EPA issued a Notice of 
Data Availability seeking public comment on the 2016 HHRA and 2016 DWA. 
(81 FR 81049, November 17, 2016) (FRL-9954-65)
    In September 2020, EPA issued the ``Chlorpyrifos: Third Revised 
Human Health Risk Assessment for Registration Review'' (2020 HHRA) 
(Ref. 2) and the ``Updated Chlorpyrifos Refined Drinking Water 
Assessment for Registration Review'' (2020 DWA) (Ref. 30). In the 2020 
HHRA, EPA utilizes the same endpoint and PoDs as those used in the 2014 
HHRA. This was done because the Agency concluded that the

[[Page 11234]]

unresolved nature of the science addressing neurodevelopmental effects 
warranted further evaluation of the science during the remaining time 
for completion of registration review. Due to the uncertainties 
concerning neurodevelopmental effects, the 2020 HHRA retained the 
default 10X FQPA safety factor; the 2020 HHRA also presented potential 
risk estimates at a reduced 1X FQPA safety factor to reflect the range 
of estimates possible, although it did not adopt or explain why the 1X 
FQPA safety factor would be safe for infants and children. While in the 
2020 HHRA the Agency determined that risks from exposures to 
chlorpyrifos residues in food combined with residential exposures were 
not of concern, drinking water exposures significantly add to those 
risks. The 2020 DWA built upon the analysis in the 2016 DWA but focused 
on a subset of currently registered chlorpyrifos uses for high benefit 
crops to growers in specific areas of the country, i.e., alfalfa, 
apple, asparagus, cherry, citrus, cotton, peach, soybean, sugar beet, 
strawberry, and wheat. This assessment utilized new surface water model 
scenarios (i.e., soil, weather, and crop data), integrated the entire 
distribution of community water system percent cropped area (PCA) 
adjustment factors and state[hyphen]level percent crop treated (PCT) 
data, and considered the quantitative use of available surface water 
monitoring data. The 2020 DWA noted that concentrations of chlorpyrifos 
and chlorpyrifos[hyphen]oxon in drinking water were not likely to 
exceed the drinking water level of comparison (DWLOC) even with the 
retention of the 10X FQPA safety factor for the subset of uses 
considered; however, that assessment noted that adding additional uses 
could change estimated drinking water concentrations, which could 
ultimately result in changes to the risk conclusion relative to the 
drinking water level of comparison(s).
    In December 2020, EPA released the ``Proposed Interim Decision for 
the Registration Review of Chlorpyrifos'' (2020 PID) for a 60-day 
public comment period (85 FR 78849, December 7, 2020) (FRL-10017-1). 
The 2020 PID concluded that ``[w]hen considering all currently 
registered agricultural and non-agricultural uses of chlorpyrifos, 
aggregate exposures are of concern.'' (Ref. 31 at pg. 19) However, the 
2020 PID also noted that if one considered only the uses that result in 
EDWCs below the DWLOC, then aggregate exposures would not be of 
concern. (Id.) Accordingly, the 2020 PID proposed to limit applications 
of chlorpyrifos in this country to only 11 uses in certain regions of 
the United States; EPA had focused its review on those 11 
geographically limited uses due to potential benefits from those uses 
and concluded that the EDWCs for those uses alone were below the DWLOC. 
This proposed path forward was intended to offer to stakeholders a way 
to mitigate the aggregate risk from chlorpyrifos, although as a 
proposal, it was not a final Agency determination and could be subject 
to change following public comment and stakeholder interest, perhaps in 
an Agency determination on a different subset of uses. Along with 
comments on the 2020 PID, EPA invited comments on the benefits 
assessments, the 2020 HHRA, draft ecological risk assessment, and 2020 
DWA. EPA extended the 60-day comment period by 30 days, which then 
closed on March 7, 2021. EPA is currently reviewing public input and 
will respond to comments prior to issuing an interim decision.
3. Scientific Issues and SAPs
    As noted previously, the registration review of chlorpyrifos has 
proven to be far more complex than originally anticipated. The OPs have 
presented EPA with numerous novel scientific issues that the Agency has 
taken to multiple FIFRA Scientific Advisory Panel (SAP) meetings since 
the completion of reregistration in 2006. (Note: The SAP is a federal 
advisory committee created by FIFRA section 25(d), 7 U.S.C. 136w(d), 
and serves as EPA's primary source of peer review for significant 
regulatory and policy matters involving pesticides. EPA may convene an 
SAP meeting to present significant regulatory, science, or policy 
matters involving pesticides and request that the SAP provide comments, 
evaluations, and recommendations on the matters submitted for its 
review.)
    These FIFRA SAP meetings, which have included the review of new 
worker and non-occupational exposure methods, experimental toxicology 
and epidemiology, and the evaluation of a chlorpyrifos-specific PBPK-PD 
model, have resulted in significant developments in EPA's risk 
assessments generally, and, more specifically, in the study of 
chlorpyrifos's effects. In particular, and partly in response to issues 
raised in the 2007 Petition (discussed in Unit III.B. of this 
document), EPA has conducted extensive reviews of available data to 
evaluate the possible connection between chlorpyrifos and adverse 
neurodevelopmental effects and to assess whether the neurodevelopmental 
effects could be used to determine PoDs for assessing chlorpyrifos. On 
this particular topic, EPA has convened multiple FIFRA SAP meetings.
    In 2008, the Agency presented to the FIFRA SAP a preliminary review 
of available literature and research on epidemiology in mothers and 
children following exposures to chlorpyrifos and other OPs, laboratory 
studies on animal behavior and cognition, AChE inhibition, and 
mechanisms of action. (Ref. 32) The 2008 FIFRA SAP recommended that 
AChE inhibition remain as the source of data for the PoDs but noted 
that despite some uncertainties, the CCCEH epidemiologic studies ``is 
epidemiologically sound'' and ``provided extremely valuable 
information'' for evaluating the potential neurodevelopmental effects 
of chlorpyrifos.
    The 2010 FIFRA SAP favorably reviewed EPA's 2010 draft epidemiology 
framework. (Ref. 33) This draft framework, titled ``Framework for 
Incorporating Human Epidemiologic & Incident Data in Risk Assessments 
in Pesticides,'' (``Epidemiologic Framework'') described the use of the 
Bradford Hill Criteria as modified in the Mode of Action Framework to 
integrate epidemiology information with other lines of evidence. As 
suggested by the 2010 FIFRA SAP, EPA did not immediately finalize the 
draft framework but instead used it in several pesticide evaluations 
prior to making revisions and finalizing it. EPA's Office of Pesticide 
Program's (OPP) finalized this Epidemiologic Framework in December 
2016. (Ref. 19)
    In 2012, the Agency convened another meeting of the FIFRA SAP to 
review the latest experimental data related to RBC AChE inhibition, 
cholinergic and non-cholinergic adverse outcomes, including 
neurodevelopmental studies on behavior and cognition effects. The 
Agency also performed an in-depth analysis of the available 
chlorpyrifos biomonitoring data and of the available epidemiologic 
studies from three major children's health cohort studies in the United 
States, including those from the CCCEH, Mount Sinai, and University of 
California, Berkeley. The Agency explored plausible hypotheses on mode 
of actions/adverse outcome pathways (MOAs/AOPs) leading to 
neurodevelopmental outcomes seen in the biomonitoring and epidemiology 
studies.
    The 2012 FIFRA SAP described the Agency's epidemiology review as 
``very clearly written, accurate'' and a ``very thorough review.'' 
(Ref. 21 at pgs. 50-52, 53) It went further to note that it ``believes 
that the [Agency's] epidemiology review appropriately

[[Page 11235]]

concludes that the studies show some consistent associations relating 
exposure measures to abnormal reflexes in the newborn, pervasive 
development disorder at 24 or 36 months, mental development at 7 
through 9 years, and attention and behavior problems at 3 and 5 years 
of age. . . .'' The 2012 FIFRA SAP concluded that the RBC AChE 
inhibition remained the most robust dose-response data, though 
expressed concerns about the degree to which 10% RBC AChE inhibition is 
protective for neurodevelopmental effects, pointing to evidence from 
epidemiology, in vivo animal studies, and in vitro mechanistic studies, 
and urged the EPA to find ways to use the CCCEH data.
    Taking that recommendation into consideration, the Agency prepared 
a proposal for using cord blood data from the CCCEH epidemiology 
studies as the source of data for the PoDs, which it presented to the 
FIFRA SAP in April 2016. The 2016 SAP did not support the ``direct 
use'' of the cord blood and working memory data for deriving the 
regulatory endpoint, due in part to insufficient information about 
timing and magnitude of chlorpyrifos applications in relation to cord 
blood concentrations at the time of birth, uncertainties about the 
prenatal window(s) of exposure linked to reported effects, lack of a 
second laboratory to reproduce the analytical blood concentrations, and 
lack of raw data from the epidemiology study. (Ref. 22) Despite its 
critiques of uncertainties in the CCCEH studies, the 2016 FIFRA SAP 
stated that it ``agrees that both epidemiology and toxicology studies 
suggest there is evidence for adverse health outcomes associated with 
chlorpyrifos exposures below levels that result in 10% RBC AChE 
inhibition (i.e., toxicity at lower doses).'' (Id. at pg. 18)

B. FFDCA Petition and Associated Litigation

1. 2007 Petition Seeking Revocation of Chlorpyrifos Tolerances
    As described previously, in 2006, EPA issued the Reregistration 
Eligibility Decision (RED) for chlorpyrifos, which concluded that 
chlorpyrifos was eligible for reregistration as it continued to meet 
the FIFRA standard for registration. In September 2007, Pesticide 
Action Network North America (PANNA) and Natural Resources Defense 
Council (NRDC) (collectively, the Petitioners) submitted to EPA a 
petition (the Petition) seeking revocation of all chlorpyrifos 
tolerances under FFDCA section 408 and cancellation of all chlorpyrifos 
pesticide product registrations under FIFRA. (Ref. 34) That Petition 
raised several claims regarding EPA's 2006 FIFRA reregistration 
decision for chlorpyrifos and the active registrations in support of 
the request for tolerance revocations and product cancellations. Those 
claims are described in detail in EPA's earlier Order denying the 
Petition (82 FR 16581, April 5, 2017) (FRL-9960-77).
2. Agency Responses and 2017 Order Denying Petition
    Ultimately, EPA denied the Petition in full on March 29, 2017 (82 
FR 16581, April 5, 2017) (FRL-9960-77). Prior to issuing that Order, 
however, EPA issued two interim responses and a proposed rule in 
response to the Petition.
    EPA provided the Petitioners with two interim responses on July 16, 
2012, and July 15, 2014, which denied six of the Petition's claims. EPA 
made clear in both the 2012 and 2014 responses that, absent a request 
from Petitioners, EPA's denial of those six claims would not be made 
final until EPA finalized its response to the entire Petition. 
Petitioners made no such request, and EPA therefore finalized its 
response to those claims in the March 29, 2017 Order Denying Petition.
    As background, three of the Petition's claims all related to the 
same issue: Whether the potential exists for chlorpyrifos to cause 
neurodevelopmental effects in children at exposure levels below EPA's 
existing regulatory standard (10% RBC AChE inhibition). Because the 
claims relating to the potential for neurodevelopmental effects in 
children raised novel, highly complex scientific issues, EPA originally 
decided it would be appropriate to address these issues in connection 
with the registration review of chlorpyrifos under FIFRA section 3(g) 
and decided to expedite that review, intending to finalize it in 2015, 
well in advance of the October 1, 2022 registration review deadline. 
(Ref. 35) EPA decided as a policy matter that it would address the 
Petition claims regarding these matters on a similar timeframe. (82 FR 
16581 at 16583)
    As noted earlier in this Unit, the complexity of these scientific 
issues precluded EPA from finishing its review according to EPA's 
original timeline, and the Petitioners brought legal action in the 
Ninth Circuit Court of Appeals to compel EPA to either issue an Order 
denying the Petition or to grant the Petition by initiating the 
tolerance revocation process. The result of that litigation was that on 
August 10, 2015, the Court ordered EPA to ``issue either a proposed or 
final revocation rule or a full and final response to the 
administrative [P]etition by October 31, 2015.'' (In re Pesticide 
Action Network N. Am., 798 F.3d 809, 815 (9th Cir. 2015))
    In response to that Court's order, EPA issued a proposed rule in 
2015 to revoke all tolerances for chlorpyrifos (80 FR 69080, November 
6, 2015) (FRL-9935-92) (2015 proposed rule), based on its unfinished 
registration review risk assessment. EPA acknowledged that it had had 
insufficient time to complete its drinking water assessment and its 
review of data addressing the potential for neurodevelopmental effects. 
Although EPA noted that further evaluation might enable more tailored 
risk mitigation, EPA was unable to conclude, based on the information 
before EPA at the time, that the tolerances were safe, since the 
aggregate exposure to chlorpyrifos exceeded safe levels.
    On December 10, 2015, the Ninth Circuit issued a further order, in 
response to additional legal challenge by Petitioners, requiring EPA to 
take final action on its proposed revocation rule and issue its final 
response to the Petition by December 30, 2016. In re Pesticide Action 
Network N. Am., 808 F.3d 402 (9th Cir. 2015). In response to EPA's 
request for an extension of the deadline in order to be able to fully 
consider the July 2016 FIFRA SAP report regarding chlorpyrifos 
toxicology, the Ninth Circuit ordered EPA to complete its final action 
by March 31, 2017. In re Pesticide Action Network of North America v. 
EPA, 840 F.3d 1014 (9th Cir. 2016). Following that Court's order, EPA 
published a Notice of Data Availability (NODA), seeking comment on 
EPA's revised risk assessment and water assessment and reopening the 
comment period on the proposal to revoke tolerances. (81 FR 81049, 
November 17, 2016) (FRL-9954-65)
    On March 29, 2017, the EPA issued the 2017 Order Denying Petition. 
(82 FR 16581, April 5, 2017) (FRL-9960-77) The specific responses are 
described in full in that 2017 Order Denying Petition (and summarized 
again in the Agency's denial of objections. (84 FR 35555, July 24, 
2019) (FRL-9997-06) EPA's 2017 Order Denying Petition did not contain a 
determination concerning the safety of chlorpyrifos. Rather, EPA 
concluded that, despite several years of study, the science addressing 
neurodevelopmental effects remained unresolved and that further 
evaluation of the science on this issue during the remaining time for 
completion of registration review was warranted. EPA therefore denied 
the remaining Petition claims, concluding that it was not required to 
complete--and would not complete--the human

[[Page 11236]]

health portion of the registration review or any associated tolerance 
revocation of chlorpyrifos without resolution of those issues during 
the ongoing FIFRA registration review of chlorpyrifos.
3. Objections and EPA's Denial of Objections
    In June 2017, several public interest groups and states filed 
objections to the 2017 Order Denying Petition pursuant to the 
procedures in FFDCA section 408(g)(2). Specifically, Earthjustice 
submitted objections on behalf of the following 12 public interest 
groups: Petitioners PANNA and NRDC, United Farm Workers, California 
Rural Legal Assistance Foundation, Farmworker Association of Florida, 
Farmworker Justice, GreenLatinos, Labor Council for Latin American 
Advancement, League of United Latin American Citizens (LULAC), Learning 
Disabilities Association of America, National Hispanic Medical 
Association and Pineros y Campesinos Unidos del Noroeste. Another 
public interest group, the North Coast River Alliance, submitted 
separate objections. With respect to the states, New York, Washington, 
California, Massachusetts, Maine, Maryland, and Vermont submitted a 
joint set of objections. (Ref. 34), These objectors asserted that EPA 
erred in not making the requisite safety finding in denying the 
Petition and that EPA should revoke all tolerances because the 
available record supported a conclusion that the tolerances were 
unsafe.
    On July 18, 2019, EPA issued a final Order denying all objections 
to the 2017 Order Denying Petition and thereby completing EPA's 
administrative denial of the petition (2019 Order Denying Objections to 
Petition Denial) (84 FR 35555, July 27, 2019) (FRL-9997-06). Again, the 
2019 Order Denying Objections to Petition Denial did not issue a 
determination concerning the safety of chlorpyrifos. Rather, EPA denied 
the objections on the grounds that the data concerning 
neurodevelopmental toxicity were not sufficiently valid, complete, and 
reliable to meet the Petitioners' burden to present evidence supporting 
the request for revocation.
4. Judicial Challenge to 2019 Order Denying Objections To Petition 
Denial and 2021 Ninth Circuit Order
    On August 7, 2019, the objectors (LULAC Petitioners) and States 
petitioned the Ninth Circuit for review of the 2017 Order Denying 
Petition and the 2019 Order Denying Objections to Petition Denial. The 
LULAC Petitioners and States argued that EPA was compelled to grant the 
2007 Petition and revoke chlorpyrifos tolerances because: (1) EPA 
lacked authority to maintain chlorpyrifos tolerances without an 
affirmative finding that chlorpyrifos is safe; (2) EPA's findings that 
chlorpyrifos is unsafe in the Agency's 2014 and 2016 risk assessments 
compel revocation of the chlorpyrifos tolerances; and (3) The Petition 
provided a sufficient basis for EPA to reconsider the question of 
chlorpyrifos's safety and was not required to prove that a pesticide is 
unsafe.
    On April 29, 2021, the Ninth Circuit issued its decision, finding 
that when EPA denied the 2007 Petition to revoke chlorpyrifos 
tolerances, it was essentially leaving those chlorpyrifos tolerances in 
effect, which, the Court noted, the FFDCA only permits if EPA has made 
an affirmative determination that such tolerances were safe. (League of 
United Latin Am. Citizens (LULAC) v. Regan, 996 F.3d. 673 (9th Cir. 
2021)) Although EPA argued that it was not compelled to reconsider its 
safety determination because the 2007 Petition had failed to meet the 
threshold requirement of providing reliable evidence that the 
tolerances were unsafe, the Court found that the Petition provided the 
necessary ``reasonable grounds,'' which triggered EPA's duty to ensure 
the tolerances were safe. (Id. at pg. 695) Since the 2017 Order Denying 
Petition and 2019 Order Denying Objections to Petition Denial failed to 
make any safety determinations for chlorpyrifos, the Court concluded 
that EPA violated the FFDCA by leaving those tolerances in place 
without the requisite safety findings. (Id. at pgs. 678, 695 and 696 
(declaring that EPA's action was a ``total abdication of EPA's 
statutory duty under the FFDCA'')) Moreover, in light of the record 
before the Court, including the 2016 HHRA indicating that the current 
chlorpyrifos tolerances were not safe, the Court found EPA's denial of 
the 2007 Petition to be arbitrary and capricious. (Id. at pg. 697) 
Based on the available record, the Court concluded that EPA must grant 
the Petition and issue a final rule modifying or revoking the 
tolerances under FFDCA section 408(d)(4)(A)(i). (Id. at pg.701)
    The Court recognized that, since the litigation had commenced, EPA 
had been continuing to evaluate chlorpyrifos in registration review and 
had issued the 2020 PID and convened another FIFRA SAP; the Court noted 
that such information could be relevant to a safety determination. (Id. 
at pg. 703) The Court allowed that if the new information could support 
a safety determination, EPA might issue a final rule modifying 
chlorpyrifos tolerances rather than revoking them. But the Court warned 
that EPA was to act ``immediately'' and not engage in ``further 
factfinding.'' (Id.) The Court chided that taking ``nearly 14 years to 
publish a legally sufficient response to the 2007 Petition'' was an 
``egregious delay'' and ``EPA's time is [ ] up.'' (Id.) As a result, 
the Court ordered EPA to: (1) Grant the 2007 Petition; (2) Issue a 
final rule within 60 days of the issuance of the mandate that either 
revokes all chlorpyrifos tolerances or modifies chlorpyrifos 
tolerances, provided that such modification is supported by a safety 
finding, and (3) Modify or cancel related FIFRA registrations for food 
use in a timely fashion. (Id. at 703 and 704) Since the mandate was 
issued on June 21, 2021, the deadline for issuing the final rule was 
August 20, 2021, less than four months from the date the Court issued 
its decision.

IV. The Final Rule

    As noted in the previous Unit, the Ninth Circuit directed EPA to 
act on the 2007 Petition by granting it and issuing a final rule 
concerning the chlorpyrifos tolerances. The Court allowed that that 
rule could either revoke all tolerances or modify tolerances, as long 
as EPA issued, concurrently with such modification, a determination 
that such modified tolerances were safe. The Court, impatient with 
EPA's failure to comply with the FFDCA when it left chlorpyrifos 
tolerances in place without the requisite safety finding, directed EPA 
to issue that final rule very quickly, i.e., 60 days after the issuance 
of the mandate.
    Given the limited window for issuing the rule and the Court's 
directive not to engage in additional fact-finding or further delay, 
the Agency focused in its rulemaking on the data and completed 
assessments available at the time and whether they were adequate to 
support a safety finding for the chlorpyrifos tolerances. EPA did not 
conduct additional analyses or engage in any additional fact-finding or 
scientific review, due to the limited time. Thus, the rule was based on 
available information that EPA had already reviewed and incorporated 
into risk assessments and/or regulatory documents.
    The most recent risk assessments and regulatory documents were the 
2020 HHRA (Ref. 2), 2020 DWA (Ref. 30), and the 2020 PID (Ref. 31). 
These documents were not in the record before the Ninth Circuit, 
although as noted previously, the Court allowed that the new 
information could be used in support of

[[Page 11237]]

a safety finding as appropriate. Thus, the Agency considered, in 
addition to other previously developed documents on chlorpyrifos as 
cited in the final rule (Ref. 1), whether the 2020 documents would 
support a safety finding for the chlorpyrifos tolerances.
    EPA's final rule follows the Agency's practice of assessing risk 
described in Unit II.B. of this document. Relying on the Agency's 
existing analyses on chlorpyrifos, EPA examined the toxicological 
profile of chlorpyrifos to identify potential hazards and identify PoDs 
for assessing risk. The Agency considered the appropriate uncertainty 
factors, including the appropriate FQPA safety factor, for setting the 
level of concern. EPA also examined potential exposures of chlorpyrifos 
in food and drinking water, as well as from uses that might result in 
exposure to residues in residential settings. Finally, EPA aggregated 
all anticipated exposures to determine if the existing tolerances would 
meet the safety standard of the FFDCA. The rest of this Unit summarizes 
the analysis and conclusions of the 2021 final rule. For further 
detail, see Ref. 1.
    In the 2021 final rule, EPA described the two primary toxicological 
effects associated with chlorpyrifos: Acetylcholinesterase inhibition 
and neurodevelopmental effects. These effects are discussed in greater 
detail in Unit III.A.1.b. of this document. As EPA noted, the mode of 
action of chlorpyrifos of affecting the nervous system through 
inhibition of AChE is well-established, as well as its use as the basis 
for PoD for assessing risks from chlorpyrifos as well as other OPs. In 
addition, EPA acknowledged and addressed the extensive body of 
information studying the potential effects on neurodevelopment in 
infants and children following exposure to OPs, including chlorpyrifos. 
EPA recognized that available data provide qualitative support for 
chlorpyrifos to potentially impact the developing mammalian brain and 
acknowledged the observed associations between prenatal chlorpyrifos 
exposure and neurodevelopmental outcomes in the epidemiological data. 
But EPA also noted that due to uncertainties in the data, including the 
lack of specific exposure information, EPA was precluded from being 
able to make a causal linkage between chlorpyrifos exposure and the 
outcomes found in the epidemiological studies. As a result, while there 
is a lot of information about the potential association between 
chlorpyrifos and neurodevelopmental outcomes in infants and children, 
there was insufficient information at the time of the final rule to 
draw conclusions about the dose-response relationship between 
chlorpyrifos and those outcomes.
    As a result, EPA relied on the RBC AChE inhibition results from 
laboratory animals to derive PoD, consistent with the 2006 chlorpyrifos 
RED, the 2006 OP cumulative risk assessment, and other single chemical 
OP risk assessments. To account for the unresolved scientific 
uncertainties associated with the potential for neurodevelopmental 
effects--and to be protective of those effects--the Agency retained the 
default 10X FQPA safety factor. As noted earlier, EPA is required to 
apply this tenfold margin of safety to account for potential pre- and 
postnatal toxicity, unless it has reliable data to support a 
determination that a different margin of safety would be protective. 
(21 U.S.C. 346a(b)(2)(C)) EPA explained that the Agency's WOE analysis 
indicates there is qualitative evidence of a potential effect on the 
developing brain associated with chlorpyrifos exposures; however, 
uncertainties remain about the levels at which those neurodevelopmental 
outcomes may occur. Therefore, EPA retained the 10X FQPA safety factor 
in recognition of the fact that despite extensive analysis of the 
available data, the science concerning neurodevelopmental effects 
remains unresolved and thus presents an uncertainty concerning the 
potential pre- and postnatal toxicity. EPA did not believe it had 
sufficient reliable data to determine that a lower safety factor would 
be protective of infants and children.
    To assess risk, EPA estimated exposures to chlorpyrifos from 
approved uses. As the FFDCA requires, EPA examined exposures for 
chlorpyrifos uses that resulted in residues of chlorpyrifos in or on 
food, in drinking water, and in residential (or non-occupational) 
settings. EPA's assessment of dietary (food only) exposures relied on 
the Agency's Dietary Exposure Evaluation Model and Calendex software 
with the Food Commodity Intake Database (DEEM-FCID version 3.16/
Calendex) to estimate exposure by combining data on human consumption 
amounts with residue values in food commodities. These food-only 
exposure assessments were highly refined, based both on field trial 
data and monitoring data.
    In drinking water, EPA estimated exposures of chlorpyrifos and 
chlorpyrifos-oxon, a metabolite of chlorpyrifos. The most recent 
drinking water assessment that examined all approved uses of 
chlorpyrifos was conducted in 2016; thus, the Agency relied on that 
assessment in evaluating the safety of the chlorpyrifos tolerances. 
While a more recent drinking water assessment had been conducted in 
2020, that newer assessment only evaluated a subset of the approved 
uses and thus was incomplete for purposes of assessing the aggregate 
exposures of chlorpyrifos. Based on the 2016 drinking water assessment 
then, EPA evaluated estimated concentrations of chlorpyrifos and 
chlorpyrifos-oxon in drinking water resulting from approved uses of 
chlorpyrifos.
    There are few remaining uses of chlorpyrifos that result in 
residential or non-occupational exposures. EPA evaluated those uses and 
used estimated exposures from use on golf courses in the overall 
aggregate risk assessment since golf course uses result in the highest 
estimated exposures among remaining residential (non-occupational) 
uses.
    In accordance with the requirements of the FFDCA, EPA considered 
aggregate exposures of chlorpyrifos in all food, drinking water, and 
residential settings. EPA used a DWLOC approach, in which EPA compared 
estimated drinking water exposures to a DWLOC, i.e., a value 
corresponding to the maximum amount of chlorpyrifos exposures that may 
be present in drinking water without resulting in aggregate exposures 
of chlorpyrifos that would result in unsafe exposures. Where the 
estimated drinking water concentrations for chlorpyrifos exceed the 
DWLOC, the Agency concluded that aggregate exposures would be unsafe 
because the chlorpyrifos residues in drinking water, when combined with 
food and residential exposures, would exceed safe levels of 
chlorpyrifos exposure. For chlorpyrifos and chlorpyrifos-oxon, the 
Agency calculated DWLOCs for acute and steady-state exposures for 
several population subgroups. (Ref. 2 at pgs. 15, and 44 through 47)
    As noted in the final rule, EPA's assessment concluded that 
exposures to chlorpyrifos from food and residential exposures 
individually or together did not exceed EPA's levels of concern. 
However, the Agency found that when combined with the exposures in 
drinking water from all registered uses of chlorpyrifos, the aggregate 
exposure to chlorpyrifos exceeded safe levels. The estimated drinking 
water concentrations calculated in the 2016 drinking water assessment 
exceeded the DWLOC. The Agency recognized that the 2020 PID proposed a 
subset of uses that might result in exposures below the Agency's level 
of concern if uses were eliminated and significant changes to the 
labels were made, including use cancellations

[[Page 11238]]

and geographic limitations, among others. However, as no registration 
or label changes had been effectuated such that EPA could rely on them 
at the time of the final rule, EPA assessed aggregate exposures 
expected from all registered uses.
    Ultimately, EPA concluded that, based on the information before the 
Agency and taking into consideration all the registered uses for 
chlorpyrifos at the time, it was unable to determine that the 
chlorpyrifos tolerances were safe, since aggregate exposures to 
chlorpyrifos exceeded safe levels. Therefore, EPA issued a final rule 
revoking all tolerances for chlorpyrifos contained in 40 CFR 180.342. 
The prepublication copy of the final rule was posted on the EPA website 
on August 18, 2021, and the final rule published in the Federal 
Register on August 30, 2021 (Ref. 1). The final rule became effective 
on October 29, 2021. EPA provided a grace period of six months to ease 
the transition for growers and accommodate international trade 
considerations, by setting an expiration date for the chlorpyrifos 
tolerances of February 28, 2022.
    The final rule provided that, pursuant to FFDCA section 408(g), 21 
U.S.C. 346a, any person could file an objection to any aspect of the 
regulation, request a hearing on those objections, and requests for 
stay of the final rule. The objections, requests for hearing, and 
requests for stay received are summarized in Units V. and VI. of this 
document.

V. Objections, Requests for Hearing, and Requests for Stay

    The Agency received several filings of objections, four requests 
for hearing on those objections, and several requests seeking a stay or 
extension of the rule. EPA briefly summarizes the objections, hearing 
requests, and stay requests, and responds to them in the next three 
units of this document.
    Individual objections were filed by the following: The Amalgamated 
Sugar Company; the American Crystal Sugar Company; the American Farm 
Bureau Federation; the American Soybean Association; the California 
Citrus Quality Council; the Cherry Marketing Institute; the Coalition 
of Organophosphate (OP) Registrants; Gharda Chemicals International, 
Inc.; the Michigan Vegetable Council. Inc.; the Minor Crop Farmer 
Alliance; the Republic of Colombia; the Southern Minnesota Beet Sugar 
Cooperative; and 99 independent growers of soybean, corn, wheat, 
cotton, rice, alfalfa, and sugarbeet. Several entities also filed 
objections jointly in response to the final rule as follows: American 
Sugarbeet Growers Association and U.S. Beet Sugar Association 
(collectively, Sugarbeet Associations) CropLife America (CLA) and 
Responsible Industry for a Sound Environment (RISE) (collectively, CLA/
RISE); two sugarbeet farmers filed a joint objection; numerous growers, 
retailers, co-ops, applicators, refiners, crop consultants, and other 
agricultural stakeholders signed on to a set of objections 
(collectively, the Agricultural Retailers Association, et al.).
    The Agency has grouped the objections submitted into the following 
five categories:
    (i) Objections to the scope of EPA's final rule revoking 
tolerances. Several Objectors objected to the final rule revoking all 
chlorpyrifos tolerances. Rather than revoke all tolerances, the 
Objectors assert that EPA should have modified tolerances by retaining 
the tolerances for those 11 high-benefit crops identified in the 2020 
PID. Some of those objectors also argued that EPA had an obligation to 
harmonize its tolerance revocations with action under FIFRA (e.g., 
canceling uses) in order to allow for the retention of the 11 
tolerances identified in the PID. Finally, a number of Objectors 
requested that EPA retain ``import tolerances'' for chlorpyrifos 
commodities, on the grounds that those tolerances would not contribute 
to drinking water exposures, which are driving risks.
    (ii) Retention of the 10X FQPA safety factor. Several objectors 
assert that EPA should not have retained the 10X FQPA safety factor due 
to scientific uncertainties tied to epidemiological data that objectors 
believe is invalid, incomplete, and unreliable. Objectors argue that 
EPA should have reduced the FQPA safety factor to 1X based on the rest 
of the available data for assessing the toxicity of chlorpyrifos.
    (iii) Objections related to drinking water. Several objectors 
assert that EPA erred in relying on the 2016 Drinking Water Assessment 
(DWA), instead of the more refined 2020 DWA for assessing drinking 
water exposures. Objectors believe the Agency's approach is highly 
conservative and inaccurate. In addition, Gharda asserts that the 
Agency erred in assessing chlorpyrifos-oxon in the aggregate assessment 
of chlorpyrifos.
    (iv) Procedural considerations. A number of objectors argue that 
EPA has failed to provide adequate due process by not addressing 
comments submitted on the 2015 proposed rule to revoke chlorpyrifos 
tolerances, and in the chlorpyrifos registration review process. 
Moreover, an objector raised due process concerns with the delayed 
opening of the Agency's Federal eRulemaking Portal for submitting 
objections electronically. Finally, some objectors argued that the 
Agency failed to provide meaningful opportunity for interagency input 
under Executive Order 12866.
    (v) Objections that, as a matter of law, do not provide a basis for 
leaving the tolerances in place. Several Objectors requested that EPA 
rescind the final rule due to the impacts on growers and the 
environment from the loss of the pesticide. One objector believes that 
EPA improperly considered occupational exposure in the final rule based 
on an Agency press statement. Other objectors assert that the final 
rule is improper because it deviates from an unspecified Codex 
Alimentarius international standard of 0.05 mg/kg for chlorpyrifos. 
Some objectors assert that the implementation timeline specified by EPA 
was too short and that the final rule should have provided guidance for 
chlorpyrifos products in the channels of trade and considered the 
implications for existing stocks of chlorpyrifos. Finally, Gharda 
objects that the final rule violates their substantive due process 
rights.
    Four objectors also included requests for evidentiary hearings. 
Three of these requesters--the American Soybean Association, the 
Sugarbeet Associations, and the Cherry Marketing Institute--each 
request evidentiary hearings to demonstrate that the best available 
science, including the 2020 PID, supports a finding that chlorpyrifos 
tolerances can remain in effect for soybeans, sugarbeets, and Michigan 
tart cherries, respectively. Gharda submitted the fourth request for an 
evidentiary hearing on its objection that the chlorpyrifos-oxon was not 
relevant to the Agency's aggregate risk assessment. While Gharda 
believes the Agency has all the evidence necessary to make this 
determination, it still requests a hearing ``[t]o the extent that EPA 
believes that a fact issue is presented by this data.''
    Finally, EPA received written requests to stay the effective date 
of the final rule from several objectors. The Sugarbeet Associations 
and Gharda both argue that the criteria set out in the FDA's 
regulations regarding stays of administrative proceedings at 21 CFR 
10.35 require that EPA stay the effectiveness of the final rule. 
Specifically, these Objectors argue that they will suffer irreparable 
injury absent a stay, that their objections are not frivolous and are 
undertaken in good faith, that the public interest favors a stay, and 
the delay caused by a stay is not outweighed by the public health or 
public interest. Several other Objectors

[[Page 11239]]

do not specifically address the regulatory criteria set forth at 21 CFR 
10.35, but request that EPA stay the effectiveness of the final rule 
until EPA can address the issues raised in their various objections. 
Some objectors simply request an extension of the timeframe for 
implementation of the rule.

VI. Response to Requests for Hearing

    EPA denies each of the four requests for evidentiary hearing on 
objections. Three objectors requested an evidentiary hearing on their 
objection that EPA should have retained tolerances for certain crops 
based on the conclusions of the 2020 PID; these requests are denied for 
failure to make a sufficient evidentiary proffer. Gharda also requested 
a hearing on its objection to EPA's assessment of chlorpyrifos-oxon 
exposures in drinking water; this request is denied as unnecessary for 
the purpose of receiving evidence and because the likely factual issue 
has no material impact on Agency's decision to revoke tolerances. EPA's 
substantive responses to the underlying objections follow in the next 
Unit, i.e., Unit VII.C.1. and VII.C.3.b., respectively. Under EPA's 
regulations, EPA may treat these objections as a group and rule on them 
only after ruling on the request for an evidentiary hearing on that 
objection. 40 CFR 178.30(c)(2) Therefore, EPA is addressing these 
hearing requests before responding to objections in the next Unit.

A. The Standard for Granting an Evidentiary Hearing

    EPA has established regulations governing objections to tolerance 
rulemakings and tolerance petition denials and requests for hearings on 
those objections. (40 CFR part 178; 55 FR 50282, December 5, 1990) 
(FRL-3688-4)) Those regulations prescribe both the form and content of 
hearing requests and the standard under which EPA is to evaluate 
requests for an evidentiary hearing.
    As to the form and content of a hearing request, the regulations 
specify that a hearing request must include: (1) A statement of the 
factual issues on which a hearing is requested and the requestor's 
contentions on those issues; (2) A copy of any report, article, or 
other written document ``upon which the objector relies to justify an 
evidentiary hearing;'' (3) A summary of any other evidence relied upon 
to justify a hearing; and (4) A discussion of the relationship between 
the factual issues and the relief requested by the objection. (40 CFR 
178.27)
    The standard for granting a hearing request is set forth in 40 CFR 
178.32. That section provides that a hearing will be granted if EPA 
determines that the ``material submitted'' shows all of the following:
    (1) There is a genuine and substantial issue of fact for resolution 
at a hearing. An evidentiary hearing will not be granted on issues of 
policy or law.
    (2) There is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary. An evidentiary hearing 
will not be granted on the basis of mere allegations, denials, or 
general descriptions of positions and contentions, nor if the 
Administrator concludes that the data and information submitted, even 
if accurate, would be insufficient to justify the factual determination 
urged.
    (3) Resolution of the factual issue(s) in the manner sought by the 
person requesting the hearing would be adequate to justify the action 
requested. An evidentiary hearing will not be granted on factual issues 
that are not determinative with respect to the action requested. For 
example, a hearing will not be granted if the Administrator concludes 
that the action would be the same even if the factual issue were 
resolved in the manner sought. (40 CFR 178.32(b))
    This provision essentially imposes four requirements upon a hearing 
requestor. First, the requestor must show it is raising a question of 
fact, not one of law or policy. Hearings are for resolving factual 
issues, not for debating law or policy questions. Second, the requestor 
must demonstrate that there is a genuine dispute as to the issue of 
fact. If the facts are undisputed or the record is clear that no 
genuine dispute exists, there is no need for a hearing. Third, the 
requestor must show that the disputed factual question is material, 
i.e., that it is outcome determinative with regard to the relief 
requested in the objections. Finally, the requestor must make a 
sufficient evidentiary proffer to demonstrate that there is a 
reasonable possibility that the issue could be resolved in favor of the 
requestor. Hearings are for the purpose of providing objectors with an 
opportunity to present evidence supporting their objections as the 
regulation states, hearings will not be granted on the basis of ``mere 
allegations, denials, or general descriptions of positions or 
contentions.'' (40 CFR 178.32(b)(2))
    The Court in National Corn Growers Ass'n v. EPA noted that the 
FFDCA and EPA's regulations ``establish a `summary-judgment type' 
standard for determining whether to hold a hearing: The EPA must hold a 
hearing if it determines an objection raises a material issue of 
fact.'' (613 F.2d 266, 271 (DC Cir. 2010)) In addition, the Court 
applied a ``necessarily deferential'' standard of review in determining 
whether an issue was material, looking to whether the agency ``has 
given adequate consideration to all relevant evidence in the record.'' 
(Id. at pgs. 271 and 272) ``Mere difference in the weight or credence 
given to particular scientific studies . . . are insufficient'' to 
overturn an agency conclusion regarding whether an objection raises a 
material issue of fact. (Id. at pg. 271)
    EPA's hearing request requirements are based heavily on FDA 
regulations establishing similar requirements for hearing requests 
filed under other provisions of the FFDCA (53 FR 41126, 41129, October 
19, 1988) (FRL-8372-5). FDA pioneered the use of summary judgment-type 
procedures to limit hearings to disputed material factual issues and 
thereby conserve agency resources. FDA's use of such procedures was 
upheld by the Supreme Court in 1972, (Weinberger v. Hynson, Westcott & 
Dunning, Inc., 412 U.S. 609 (1973)), and, in 1975, FDA promulgated 
generic regulations establishing the standard for evaluating hearing 
requests (40 FR 22950, May 27, 1975). It is these regulations upon 
which EPA relied in promulgating its hearing regulations in 1990.
    Unlike EPA, FDA has had numerous occasions to apply its regulations 
on hearing requests. FDA's summary of the thrust of its regulations, 
which has been repeatedly published in the Federal Register in Orders 
ruling on hearing requests over the last 24 years, is instructive on 
the proper interpretation of the regulatory requirements. That summary 
states:

    A party seeking a hearing is required to meet a threshold burden 
of tendering evidence suggesting the need for a hearing.' [ ] An 
allegation that a hearing is necessary to sharpen the issues' or 
fully develop the facts' does not meet this test. If a hearing 
request fails to identify any evidence that would be the subject of 
a hearing, there is no point in holding one.
    A hearing request must not only contain evidence, but that 
evidence should raise a material issue of fact concerning which a 
meaningful hearing might be held. [ ] FDA need not grant a hearing 
in each case where an objection submits additional information or 
posits a novel interpretation of existing information. [ ] Stated 
another way, a hearing is justified only if the objections are made 
in good faith and if they `draw in question in

[[Page 11240]]

a material way the underpinnings of the regulation at issue.' 
Finally, courts have uniformly recognized that a hearing need not be 
held to resolve questions of law or policy.

(49 FR 6672 at 6673, February 22, 1984; 72 FR 39557 at 39558, July 19, 
2007 (citations omitted) EPA has been guided by FDA's application of 
its regulations in this proceeding.
    Congress confirmed EPA's authority to use summary judgment-type 
procedures with hearing requests when it amended FFDCA section 408 in 
1996. Although the statute had been silent on this issue previously, 
the FQPA added language specifying that when a hearing is requested, 
EPA ``shall . . . hold a public evidentiary hearing if and to the 
extent the Administrator determines that such a public hearing is 
necessary to receive factual evidence relevant to material issues of 
fact raised by the objections'' (21 U.S.C. 346a(g)(2)(B)). This 
language grants EPA broad discretion to determine whether a hearing is 
``necessary to receive factual evidence'' to objections (H.R. Rep. No. 
104-669, at pg. 49 (1996)).

B. American Soybean Association, Sugarbeet Associations, and Cherry 
Marketing Institute Hearing Requests

1. Summary of Hearing Request
    Three Objectors--the American Soybean Association, the Sugarbeet 
Associations, and the Cherry Marketing Institute--requested evidentiary 
hearings based on their objections that EPA erred in revoking 
tolerances covering chlorpyrifos residues for their particular 
commodity, i.e., soybean, sugarbeet, and cherry, respectively. (Refs. 
36 through 38) These Objectors root this claim in statements made in 
the 2020 PID, in which EPA proposed a subset of 11 registered uses for 
retention as an option to mitigate dietary risks from uses of 
chlorpyrifos. The 2020 PID noted that if uses were limited in 
accordance with that proposal, EPA would be able to determine that such 
uses would ``not pose potential risks of concern.'' Because, at the 
time of the final rule, uses were not so limited, EPA revoked all 
tolerances. These Objectors assert that such a conclusion was 
inconsistent with the conclusions in the 2020 PID and thus not 
supported by factual evidence. As a result, these Objectors request a 
hearing on that objection to dispute the underlying factual basis for 
EPA's decision to revoke all tolerances and, in particular, for their 
tolerance of interest.
    Specifically, the American Soybean Association notes that soybeans 
were included among the 11 high-benefit crop uses of chlorpyrifos that 
the 2020 PID described as ``not pos[ing] potential risks of concern 
with a Food Quality Protection Act (FQPA) safety factor of 10X.'' (Ref. 
36 at pg. 4) In addition, the American Soybean Association asserts that 
EPA has determined ``elsewhere in its administrative record'' that it 
is reasonably certain soybean uses will not pose harm from aggregate 
dietary exposures. (Id.) Therefore, the American Soybean Association 
challenges EPA's determination in the final rule that soybean uses of 
chlorpyrifos might pose dietary risks of concern as factually 
inaccurate and contrary to the finding in the 2020 PID, and requests an 
evidentiary hearing ``to dispute this underlying factual inaccuracy.'' 
(Id.) Similarly, the Sugarbeet Associations argue that EPA's decision 
to revoke tolerances for the 11 high-benefit crop uses of chlorpyrifos 
identified in the 2020 PID is arbitrary and capricious and request an 
evidentiary hearing ``to demonstrate that the best available science, 
including the 2020 PID, supports a finding that tolerances for 
sugarbeets can remain in effect.'' (Ref. 37 at pg. 6) Lastly, the 
Cherry Marketing Institute argues that EPA's decision to revoke 
tolerances for chlorpyrifos in the Michigan tart cherry industry due to 
dietary risks is factually inaccurate, in light of EPA's identification 
of tart cherries among the 11 high-benefit crop uses of chlorpyrifos 
identified in the 2020 PID. (Ref. 38 at pg. 2) The Cherry Marketing 
Institute allege that an unspecified ``drinking water assessment and a 
dietary assessment'' provide that the Michigan tart cherry industry's 
use of chlorpyrifos meets FFDCA safety standards. (Id. at pg. 1) The 
Cherry Marketing Institute therefore requests an evidentiary hearing 
``to further convey [its] concerns with EPA's determination'' to revoke 
chlorpyrifos tolerances. (Id. at pg. 2)
2. Denial of Hearing Request
    The evidentiary hearing requests submitted by the American Soybean 
Association, the Sugarbeet Associations, and the Cherry Marketing 
Institute do not meet the regulatory standard for granting an 
evidentiary hearing request set forth in 40 CFR 178.32 and are 
therefore denied.
    As noted previously, the purpose for holding hearings is ``to 
receive factual evidence.'' (21 U.S.C. 346a(g)(2)(B); 53 FR 41126 at 
41129 (``Hearings are for the purpose of gathering evidence on disputed 
factual issues . . . .'')) Therefore, at a bare minimum, a requestor 
must identify evidence relied upon to justify a hearing and either 
submit copies of that evidence or summarize it. (40 CFR 178.27)
    None of these Objectors proffers any factual evidence to support 
their request for an evidentiary hearing. Other than offering that the 
Agency's determinations in the final rule were inconsistent with the 
2020 PID, these Objectors refer to a hearing as an opportunity to 
dispute the Agency's factual conclusions regarding the risks posed by 
the use of chlorpyrifos on their particular commodity. As noted 
previously, ``[a]n allegation that a hearing is necessary to sharpen 
the issues' or fully develop the facts' does not meet this test. If a 
hearing request fails to identify any evidence that would be the 
subject of a hearing, there is no point in holding one.'' (49 FR 6672 
at 6673, February 22, 1984; 72 FR 39557 at 39558, July 19, 2007) 
(citing Georgia Pacific Corp v. EPA, 671 F.2d 1235, 1241 (9th Cir. 
1982)) The statute requires that the objector identify actual evidence; 
however, the Objectors point to no additional factual evidence that 
they would offer for review in this evidentiary hearing. Failing to 
identify any factual evidence that the Objectors would like to be 
considered in a hearing, the Objectors' hearing request fails to 
proffer the requisite evidence.
    Even viewed in the most favorable light, these Objectors merely 
proffer the Agency's own statements in its risk assessments and the 
2020 PID and unspecified references to statements ``elsewhere in the 
administrative record.'' As a result, EPA concludes that this 
submission is sufficiently lacking to be considered an evidentiary 
proffer. Given that the purpose of a hearing is to gather or receive 
evidence, proffering evidence already considered and relied upon by EPA 
is not grounds for holding a hearing. Furthermore, EPA has already 
considered and found inadequate the evidence in the record to support 
retaining individual tolerances without a change in registrations, and 
it is difficult to understand, how, as a matter of law, this same 
evidence would justify the opposite conclusion, given the same 
underlying facts. At bottom, these objectors' proffer fails to 
``identify'' evidence which would, if established, resolve an issue in 
the objectors' favor.
    Moreover, the American Soybean Association, the Sugarbeet 
Associations, and the Cherry Marketing Institute have all failed to 
demonstrate that there is a ``genuine and substantial issue of fact for 
resolution at a hearing.'' (40 CFR 178.32(b)(1)) Whether EPA was 
arbitrary and capricious in revoking the soybean, sugarbeet, and cherry 
tolerances is a question of law, not of fact. Contrary to what these 
objectors assert, EPA does

[[Page 11241]]

not assess safety of tolerances based upon the risks posed by use on a 
single commodity. Under the FFDCA, EPA is required to assess aggregate 
exposures, i.e., exposure to the pesticide from use on that particular 
commodity, as well as use on all other commodities, contributions to 
drinking water from all registered uses, and exposures in non-
occupational settings. Furthermore, to the extent there is a factual 
question here, it is not in dispute. EPA does not dispute its own 
scientific conclusions and findings in the 2020 PID that the Agency 
could support a safety determination for the very limited and specific 
subset of uses identified in that document. The problem is that at the 
time of the final rule, the Agency did not have a basis for assuming 
that uses would be limited in accordance with the 2020 PID mitigation 
proposal. Thus, as a legal matter, EPA could not rely on those 
scientific findings to support leaving the tolerances in place at the 
time of the final rule. Ultimately, this issue comes down to whether 
EPA properly interpreted its obligation under the FFDCA in assessing 
aggregate exposure to chlorpyrifos, and that is ultimately a question 
of law and not one of fact. Hearings are not granted on legal 
questions. (40 CFR 178.32(b)(1)) Accordingly, the hearing requests of 
the American Soybean Association, the Sugarbeet Associations, and the 
Cherry Marketing Institute are denied.
    EPA responds to the objection concerning whether EPA was justified 
in revoking all chlorpyrifos tolerances in Unit VII.C.1.a. of this 
document.

C. Gharda Chemicals International, Inc. Hearing Request

1. Summary of Hearing Request
    In a footnote in a section of its objections alleging that EPA 
failed to adequately consider certain relevant scientific information, 
Gharda says, ``Gharda respectfully submits that EPA has all of the 
scientific data at its disposal to find that chlorpyrifos oxon is not 
relevant to EPA's aggregate exposure assessment under the FFDCA. To the 
extent that EPA believes that a fact issue is presented by this data, 
Gharda respectfully requests a hearing.'' (Ref. 39 at pg. 34) Although 
the first sentence of Gharda's footnote indicates that Gharda does not 
believe that a hearing is necessary, which should settle the matter, 
the second sentence introduces some ambiguity that compels a response 
as a matter of completeness. So, as discussed later in this document, 
EPA considers whether an evidentiary hearing on Gharda's objection to 
EPA's assessment of chlorpyrifos-oxon is warranted and determines that 
it is not.
    On its face, Gharda's request for a hearing fails to proffer any 
evidence that Gharda believes warrants an evidentiary hearing. The 
specific request refers simply to ``scientific data'', which is so 
vague as to not be an evidentiary proffer at all. Nevertheless, taking 
into consideration the whole of Gharda's objection concerning the 
assessment of chlorpyrifos-oxon, EPA notes that Gharda references two 
documents: (i) A drinking water study submitted to EPA by Corteva in 
December 2020 (Study of Cholinesterase Inhibition in Peripheral Tissues 
in Sprague Dawley Rats Following Exposure to Chlorpyrifos Oxon in 
Drinking Water for 21 Days (MRID 51392601) (``Corteva Oxon Study'')) 
and (ii) A Declaration of Dr. Richard Reiss, dated October 21, 2021 and 
included as an exhibit attached to Gharda's Objections to the final 
rule, offering opinions on the meaning of the Corteva Oxon Study 
(``Reiss Declaration''). (Id. at pg. 32) Also mentioned within the same 
section of Gharda's submission as its objection relating to 
chlorpyrifos-oxon are two other documents: (i) Comments filed by Dow 
AgroSciences LLC (DAS) (now doing business as Corteva Agriscience) on 
January 17, 2017 on the Chlorpyrifos: Tolerance Revocations; Notice of 
Data Availability and Request for Comment (81 FR 81049) and its 
accompanying assessments, including the 2016 DWA; and (ii) A Response 
to Objections document filed by DAS on April 18, 2019 regarding 
objections submitted by PANNA, NRDC, and others to EPA's March 29, 2017 
Order denying the 2007 Petition. (Id. at 31) Because Gharda refers to 
these documents only in the context of challenging the Agency's use of 
the 2016 DWA in general and not with regard to the chlorpyrifos-oxon 
objection specifically, EPA concludes that Gharda is not proffering 
those documents in support of its objection on the assessment of 
chlorpyrifos-oxon.
    Gharda points to the Corteva Oxon Study as support for its 
objection that the chlorpyrifos-oxon was not relevant to, and should 
not have been included in, EPA's aggregate risk assessment. Gharda 
asserts, quoting from the Reiss Declaration, that the Corteva Oxon 
Study found ``(a) no detectable circulating chlorpyrifos oxon in blood, 
(b) no statistically significant AChE inhibition in either RBC or 
brain, and (c) an absence of clinical signs of toxicity or markers of 
exposure,'' and therefore nullified EPA's assumption in the 2020 DWA 
``that chlorpyrifos oxon is more toxic that the parent chlorpyrifos for 
drinking water exposure purposes.'' (Id. at pg. 32) As a result, Gharda 
argues that this study shows that ``drinking water risks associated 
with the oxon are not a risk concern for any agricultural uses of 
chlorpyrifos and should not be part of the EPA's aggregate risk 
assessment or serve as a basis for limiting uses of chlorpyrifos.'' 
(Id. at pgs. 32 and 33) According to Gharda, EPA has received this 
study but has failed to review it. Gharda argues that EPA's failure to 
consider this study means that the final rule rests on incomplete 
information and is arbitrary and capricious. (Id. at pgs. 33 through 
34) Therefore, giving Gharda the benefit of the doubt, EPA finds that 
the Corteva Oxon Study is being proffered by Gharda for the Agency's 
consideration in determining whether a factual issue is raised that 
warrants an evidentiary hearing. Similarly, because Gharda relies 
heavily on the Reiss Declaration for its allegations concerning the 
Corteva Oxon Study, EPA finds that Gharda is proffering that 
declaration as evidence as well.
2. Denial of Hearing Request
    EPA denies Gharda's hearing request under both its broad 
discretionary authority found in FFDCA section 408(g)(2) and under the 
regulatory standard in 40 CFR 178.32. As an initial matter, the 
equivocating and vague nature of Gharda's hearing request makes it 
difficult to discern whether Gharda has submitted a request for an 
evidentiary hearing that meets even the basic form and content criteria 
of EPA's regulations. (40 CFR 178.27) First, EPA's regulations require 
a specific request for an evidentiary hearing and a statement of the 
factual issue on which the hearing is requested. (40 CFR 178.27(a) and 
(b)) While Gharda ``respectfully requests a hearing,'' it is only to 
the extent EPA finds a factual issue warranting one. (Ref. 39 at pg. 
34) Gharda asserts many things in this particular objection concerning 
what Gharda believes is EPA's failure to consider relevant scientific 
data, including failure to consider the Corteva Oxon Study, which 
Gharda asserts would support a conclusion that chlorpyrifos-oxon in 
drinking water is not relevant for chlorpyrifos risk assessment 
purposes. That is not a clear statement of the factual issue on which 
EPA should evaluate the request for a hearing. (40 CFR 178.27(b)) 
Moreover, as discussed previously, it is difficult to discern exactly 
what evidence Gharda is proffering--``all scientific data'' in EPA's 
files or just the Corteva Oxon Study. (40 CFR 178.27(c)) Finally, 
Gharda makes no attempt to ``include a discussion of the relationship 
between

[[Page 11242]]

the factual issues and the relief requested by the objection.'' (40 CFR 
178.27(e)) Gharda seems to be arguing that if the chlorpyrifos-oxon was 
not relevant to the Agency's assessment, it would somehow change the 
outcome of the final rule, but Gharda fails to explain how 
consideration of that study would ultimately impact the Agency's 
conclusions concerning the safety of chlorpyrifos. In order to evaluate 
this ``hearing request'', EPA has had to discern from context what the 
factual issue is and what Gharda specifically hopes to accomplish with 
this evidence. This is contrary to EPA's regulations, which place the 
burden of presenting evidence upon which the objector relies to justify 
an evidentiary hearing on the objector, not on EPA. (40 CFR 178.27(c) 
and (d)) It appears that Gharda in its comment is trying to flip the 
burden for demonstrating whether an evidentiary hearing is necessary 
onto EPA; as such EPA believes that Gharda has failed to meet a 
threshold burden of submitting a hearing request that meets the basic 
criteria for such submissions under 40 CFR 178.27.
    Significantly, by its own terms, Gharda does not believe that a 
hearing is necessary for the Agency to receive factual evidence, since 
the Agency already ``has all of the scientific data at its disposal'' 
to evaluate this objection. (Ref. 39 at pg. 34) As noted previously, 
FFDCA directs EPA to ``hold a public evidentiary hearing if and to the 
extent the Administrator determines that such a public hearing is 
necessary to receive factual evidence relevant to material issues of 
fact raised by the objections'' (21 U.S.C. 346a(g)(2)(B)) This language 
was added to the FFDCA by the FQPA in 1996, after EPA promulgated its 
evidentiary hearing regulations, and EPA views it as providing broad 
discretion to evaluate whether a hearing is necessary, even if the 
requirements in 40 CFR 178.32 are met. EPA does not interpret this 
language as requiring it to hold a hearing in any instance where 
factual evidence relevant to a material issue of fact is proffered 
(essentially the standard set forth in 40 CFR 178.32); rather, EPA 
construes the statutory language as requiring it to hold a hearing only 
where it determines a hearing is necessary to receive such proffered 
evidence. In other words, a party wishing to obtain a hearing must not 
only satisfy the requirements of 40 CFR 178.32, it must also show that 
an evidentiary hearing is necessary for the presentation of proffered 
evidence to the Agency.
    In this particular instance, Gharda states that EPA already has all 
the scientific data necessary to evaluate this issue and thus does not 
believe that a hearing is necessary to address the relevance of the 
oxon issue. EPA agrees. Because EPA already has the Corteva Oxon Study 
in its files, EPA has determined that a hearing is not necessary to 
receive that evidence. This conclusion is bolstered by EPA's 
determination that ultimately, consideration of this study would not 
materially impact EPA's conclusions regarding the safety of 
chlorpyrifos, since (as discussed later in this unit) EPA could not 
support a safety finding for chlorpyrifos based on consideration of 
only the chlorpyrifos (and not the oxon) concentrations in drinking 
water.
    Moreover, in examining the evidentiary proffer of the Reiss 
Declaration, EPA concludes that a hearing would not be appropriate for 
receiving that evidence. ``An evidentiary hearing will not be granted 
on the basis of mere allegations . . . or general descriptions of 
positions and contentions. . . .'' (40 CFR 178.32(b)(2)) The Reiss 
Declaration contains a composite of conclusory statements of 
interpretation of the Corteva Oxon Study, with no elucidation of how 
Dr. Reiss arrived at those conclusions. (Ref. 39 at pgs. 113 through 
132) One paragraph simply refers to a ``prior study'' to illustrate an 
example of the oxon causing lower levels of brain AChE inhibition than 
chlorpyrifos, but no citation to that study is provided. (Id. at pg. 
120, paragraph 26) Paragraph 27, which Gharda quotes for its 
objections, concludes that the Corteva Oxon Study ``found (a) no 
detectable circulating chlorpyrifos oxon in blood, (b) no statistically 
significant AChE inhibition in either RBC or brain, and (c) an absence 
of clinical signs of toxicity or markers of exposure.'' (Id. at pg. 
121, paragraph 27) But that is it. There is no explanation of how Dr. 
Reiss came to those conclusions based on the study or what information 
provided in the study that supports these conclusions. Therefore, with 
regard to the Corteva Oxon Study, EPA finds that a hearing is not 
warranted to receive the Reiss Declaration, since the statements 
contained therein appear to contain mere allegations and conclusions.
    In applying the criteria for granting a hearing, EPA looks first to 
the question of whether there is a genuine and substantial issue of 
fact. (40 CFR 178.32(b)(1)) As noted previously, Gharda has failed to 
provide a clear statement of the factual issue to be resolved at an 
evidentiary hearing. However, EPA recognizes Gharda's assertion that 
chlorpyrifos-oxon is not relevant for risk assessment purposes due to 
the lack of toxicity allegedly demonstrated in the Corteva Oxon Study 
is at odds with EPA's assessment of chlorpyrifos-oxon residues in 
drinking water and in the aggregate risk assessment. Whether there is 
valid scientific data supporting a different conclusion about the 
toxicity of chlorpyrifos-oxon is likely to be a factual question, 
rather than one of law or policy.
    Nevertheless, EPA's hearing regulations also require that the 
``[r]esolution of the factual issue(s) in the manner sought by the 
person requesting the hearing would be adequate to justify the action 
request.'' (40 CFR 178.32(b)(3)) Under this prong, Gharda's request for 
a hearing fails. As noted previously, Gharda has failed to provide a 
discussion of how resolution of this factual issue would assist in 
granting the relief of their objection. For that matter, Gharda has not 
even clarified how their objection (i.e., failure to consider relevant 
scientific information) supports a change to the Agency's safety 
determination in the final rule.
    Assuming arguendo that Gharda (and Dr. Reiss) has correctly 
interpreted the Corteva Oxon Study and assuming also that chlorpyrifos-
oxon is less toxic than chlorpyrifos and is not therefore the relevant 
exposure measurement for assessing risks of chlorpyrifos in drinking 
water as EPA had assumed, Gharda's request for an evidentiary hearing 
still fails. This is because this assumption would not ultimately 
change the outcome of the final rule; EPA would still be unable to 
conclude that the chlorpyrifos tolerances were safe because the 
estimated concentrations of chlorpyrifos itself (rather than 
chlorpyrifos-oxon) in drinking water still exceed the relevant DWLOC.
    In the 2020 PID, EPA calculated a DWLOC for both chlorpyrifos and 
chlorpyrifos-oxon. The DWLOCs used for comparison to residues of 
chlorpyrifos in drinking water in the final rule were associated with 
chlorpyrifos-oxon, as that was considered the residue of concern: 4.0 
ppb for steady-state exposures and 23 ppb for acute exposures. Based on 
the 2016 DWA, EPA determined that there were likely to be estimated 
concentrations of chlorpyrifos-oxon in drinking water that exceeded 
those DWLOCs. As indicated in Unit II.B.1.d., where the concentrations 
of pesticide in drinking water exceed the DWLOC, the Agency concludes 
that the aggregate exposures are not safe. If, as Gharda asserts, the 
chlorpyrifos-oxon residues are not relevant, there would still be 
exposures to chlorpyrifos in drinking

[[Page 11243]]

water, and EPA would need to consider whether those exposures to 
chlorpyrifos would be safe. The DWLOCs calculated for chlorpyrifos were 
17 ppb for steady-state exposures and 100 ppb for acute exposures. 
(Ref. 31 at pg. 15) Relative to the DWLOCs for chlorpyrifos-oxon, the 
DWLOCs for chlorpyrifos are larger, providing slightly more room in the 
risk cup for residues of chlorpyrifos, relative to chlorpyrifos-oxon. 
Nevertheless, the 2016 DWA indicates that for the majority of HUC 
regions assessed, the estimated concentrations of chlorpyrifos alone in 
drinking water still exceed the higher DWLOC of 17 ppb, i.e., Table 25 
of the 2016 DWA indicates that the range of chlorpyrifos concentrations 
in drinking water have the potential to exceed the DWLOC for all HUC 
regions except one (HUC 16b). (Ref. 29 at pgs. 73-74) As long as there 
are certain vulnerable watersheds where the concentrations of 
chlorpyrifos exceed the maximum amount allowed for residues in drinking 
water to ensure that aggregate chlorpyrifos exposures stay below safe 
levels, the Agency cannot make a safety finding to support the 
chlorpyrifos tolerances. Thus, Gharda has failed to raise a material 
factual issue for which an evidentiary hearing would be appropriate. 
``An evidentiary hearing will not be granted on factual issues that are 
not determinative with respect to the action requested. For example, a 
hearing will not be granted if the Administrator concludes that the 
action would be the same even if the factual issue were resolved in the 
manner sought.'' (40 CFR 178.32(b)(3))
    The absence of a material issue of fact here is fatal to Gharda's 
request for a hearing. As noted previously, the Corteva Oxon Study, 
even if it supported Gharda's assertion that chlorpyrifos-oxon residues 
were not relevant for EPA's risk assessment, does not ultimately 
support a finding that the chlorpyrifos tolerances are safe. Therefore, 
EPA concludes that a hearing is not justified to receive that evidence 
for the purposes of evaluating Gharda's claim concerning the 
consideration of chlorpyrifos-oxon in the Agency's risk assessment. 
This conclusion also reinforces EPA's earlier determination that a 
hearing is not necessary to receive the evidence since the study is 
already in the Agency's files. Furthermore, because the Reiss 
Declaration offers nothing more than conclusory statements about how to 
interpret the Corteva Oxon Study, it also fails to provide a basis for 
determining that the chlorpyrifos tolerances are safe and changing the 
final rule. Conclusory statements indicating a potential difference of 
scientific interpretation of a study that, even in the most favorable 
light, is not outcome determinative, does not create a material issue 
of fact. (See National Corn Growers Ass'n, 613 F.3d at 274 (finding 
that ``[m]ere differences in the weight or credence given to particular 
scientific studies'' would not be a sufficient basis to overturn an 
Agency conclusion that there is no material issue of fact)) Therefore, 
EPA has determined that Gharda has failed to proffer evidence 
warranting an evidentiary hearing on its objection concerning the 
Agency's assessment of chlorpyrifos-oxon.

D. Summary of Reasons for Denial of Hearing Requests

    EPA is denying the requests for evidentiary hearing submitted by 
the American Soybean Association, the Sugarbeet Associations, and the 
Cherry Marketing Institute because those entities failed to proffer any 
evidence for which a hearing would be appropriate. The statute clearly 
states that a hearing is appropriate when ``necessary to receive 
material evidence.'' (21 U.S.C. 346a(g)(2)(B)) Moreover, these 
Objectors ultimately disagree with EPA's application of the FFDCA 
statutory standard for assessing exposures, which is a legal question, 
rather than a factual one, and thus not appropriate for a hearing. (40 
CFR 178.32(b)(1))
    EPA is denying Gharda's request for an evidentiary hearing for lack 
of necessity since, as Gharda concedes, EPA already has the evidence 
proffered and for lack of materiality, since even if Gharda's factual 
assertions are correct and supported by the evidence proffered, those 
issues are not determinative with regard to the Agency's conclusions in 
the final rule, i.e., they would not provide a basis for leaving the 
chlorpyrifos tolerances in place at this time.

VII. Response to Objections

A. Overview

    EPA denies each of the objections to the final rule. As noted in 
Unit V. of this document, EPA received several objections from many 
different entities, including trade associations, farm bureaus, 
individual growers, and registrants. EPA has grouped these objections 
into five different categories, which are described later in this unit. 
After a brief description of each objection or objection subissue, EPA 
responds to each in this unit.

B. Denial of Objections Not Properly Filed

    As a preliminary matter, EPA notes that several parties submitted 
documents to the Federal eRulemaking Portal that are styled as 
objections but that do not comply with the requirements of 40 CFR 
178.25. As EPA noted in the final rule--and as required in EPA's 
regulations--objections must be submitted in writing and filed with the 
Office of the Hearing Clerk in accordance with the procedures in 40 CFR 
178.25. While the regulations specify that objections are to be mailed 
or hand-delivered to the Hearing Clerk, due to the pandemic the Office 
of Administrative Law Judges (OALJ), where the Office of the Hearing 
Clerk is housed, is directing parties to file electronically. (Ref. 40) 
The final rule provided instructions for filing online as well as what 
to do in the event that online filing was not available. (Ref. 1 at 
pgs. 48315-16)
    The following parties did not submit their objections to the Office 
of the Hearing Clerk either through the OALJ e-filing system or through 
mail or hand delivery as required by 40 CFR 178.25(b): The Colombia 
Ministry of Trade, Industry and Tourism; Drexel Chemical Company; the 
International Pepper Community; Oregonians for Food and Shelter; and 
the Republic of Ecuador. (Refs. 41 through 45) EPA also notes that the 
National Association of Wheat Growers submitted two sets of objections: 
One as a standalone document, which was not properly filed with the 
Office of the Hearing Clerk (Ref. 46), and one as a signatory to 
objections submitted by numerous growers, retailers, co-ops, 
applicators, refiners, crop consultants, and other agricultural 
stakeholders (which EPA is referring to as the Agricultural Retailers 
Association, et al. objections (Ref. 47)), which was properly filed 
with the Office of the Hearing Clerk. EPA's regulations require EPA to 
deny each objection that is found not to conform with 40 CFR 178.25. 
(40 CFR 178.30(a)(1)) As a result, EPA denies the previously-described 
objections that were not submitted to the Office of the Hearing Clerk 
and will not be considering them in this Order.

C. Responses to Specific Issues Raised in Objections

1. Objections to the Scope of EPA's Final Rule Revoking Tolerances
    One theme running through several objections was an assertion that 
EPA's revocation of all chlorpyrifos tolerances was unlawful and 
unnecessary. Some Objectors argued that EPA should have

[[Page 11244]]

retained some of the chlorpyrifos tolerances, rather than revoking them 
all, based on EPA's mitigation proposal in the 2020 PID to limit uses 
to 11 high-benefit crops in certain geographic locations. Relatedly, 
some Objectors believed that EPA should have coordinated the tolerance 
revocations with actions under FIFRA to cancel uses in order to avoid 
revoking all tolerances. Finally, some Objectors asserted that EPA 
should have retained import tolerances since imported commodities would 
not contribute to drinking water exposures, which were driving risk 
concerns. These objections and EPA's responses are discussed in further 
detail in this sub-unit.
a. EPA's Proposal for Limiting Uses to 11 High-Benefit Crops in the 
2020 Proposed Interim Decision (PID) for Chlorpyrifos
    i. Objection. Nearly all Objectors assert that revoking all 
chlorpyrifos tolerances was unlawful and unnecessary based on 
statements in the 2020 PID where EPA proposed a subset of chlorpyrifos 
tolerances for retention, provided certain restrictions were 
implemented. (The objections, requests for hearing on objections, and 
stay requests submitted in response to the final rule are available at 
https://www.regulations.gov in docket ID number EPA-HQ-OPP-2021-0523.) 
Some Objectors' claims are general, asserting that EPA should have 
retained all 11 tolerances, and some are specific to their own 
commodity of interest (e.g., the American Soybean Association focuses 
on EPA's determination in the 2020 PID as it relates to soybeans, 
specifically). (Ref. 36 at pg. 4) In each case, however, these 
Objectors rely on EPA's proposed finding in the 2020 PID to demonstrate 
that EPA's record contains sufficient information to determine that at 
least some tolerances and uses satisfy the FFDCA safety standard. The 
objectors conclude that, therefore, revocation of all tolerances was 
inconsistent with the FFDCA requirement to consider aggregate exposure 
from all ``anticipated dietary exposures''.
    The Objectors point to the Ninth Circuit's April 29, 2021, decision 
for support that EPA was not required to revoke all chlorpyrifos 
tolerances. The Objectors note that the Court gave EPA the option to 
``either revoke all chlorpyrifos tolerances or modify chlorpyrifos 
tolerances,'' as long as the modification was supported by a safety 
determination, as well as a direction to ``modify or cancel related 
FIFRA registrations for food use in a timely fashion consistent with 
the requirements of [FFDCA 408(a)].'' (LULAC, 996 F.3d at 703-04) 
Consequently, the Objectors assert that EPA should have modified 
tolerances by retaining the 11 uses rather than revoking all.
    ii. Denial of objection. EPA denies this objection. The Objectors' 
claim is primarily based on a misunderstanding of the FFDCA's 
requirement to consider aggregate exposure, a misreading of the 2020 
PID, and a disregard of the facts at the time of the final rule. When 
one corrects for each of those factors, it is clear that EPA's 
revocation of all chlorpyrifos tolerances was entirely consistent with 
the Agency's obligations under the FFDCA.
    Before diving into the rationale for why the Objectors' argument is 
legally flawed, it is worth providing context for the PID, or proposed 
registration review decision. Under EPA's regulations, a proposed 
(interim) registration review decision lays out the Agency's proposed 
findings, identifies proposed risk mitigation measures or other 
remedies as needed, identifies any missing or needed data, specifies 
proposed labeling changes, and identifies any anticipated deadlines. 
(See 40 CFR 155.58(b)) EPA publishes notice of the availability of this 
proposed decision and provides for at least a 60-day comment period. 
(40 CFR 155.58(a)) After consideration of those comments, EPA will 
issue an interim or final registration review decision, which can be 
very similar to the proposed decision or incorporates changes based on 
those comments. (40 CFR 155.58(c)) As noted in Unit II.A., the purpose 
of registration review is to determine whether the registered pesticide 
continues to meet the standard for registration. Where EPA identifies 
potential unreasonable risks from use of a pesticide, EPA considers 
whether there are any options or measures for reducing or mitigating 
those risks that would enable the pesticide to meet the standard for 
registration. Where such mitigation measures are available, EPA will 
propose those in the proposed registration review decision in 
conformance with its regulations. But consistent with the nature of any 
proposal, the findings in the proposed decision are just proposals and 
subject to change based upon public comment or other developments that 
may occur before the final decision is issued.
    For the 2020 PID for chlorpyrifos, EPA followed the process laid 
out in its regulations. EPA summarized the findings of its aggregate 
risk assessment and concluded that ``[w]hen considering all currently 
registered agricultural and non-agricultural uses of chlorpyrifos, 
aggregate exposures are of concern. If considering only the uses that 
results in DWLOCs below the EDWCs, aggregate exposures are not of 
concern.'' (Ref. 31 at pg. 19 (emphases added)) In other words, EPA 
found that the universe of currently registered chlorpyrifos uses 
presented aggregate exposures that exceeded the Agency's determined 
safe level of exposure. As a result, EPA proposed mitigation to address 
the dietary and aggregate risks of concern that were posed by use of 
chlorpyrifos as currently registered. (Id. at pg. 40)
    To mitigate these risks, EPA proposed that chlorpyrifos 
applications be limited to the following 11 specific uses in only those 
specific geographic areas where the estimated concentrations of 
chlorpyrifos in drinking water from those uses were lower than the 
DWLOC, i.e., the maximum amount of chlorpyrifos residues that could be 
present in water and still ensure that aggregate exposures would be 
safe: Alfalfa, apple, asparagus, tart cherry, citrus, cotton, peach, 
soybean, strawberry, sugar beet, and spring and winter wheat. (Id. at 
pgs. 40 and 41) For this mitigation proposal to reduce aggregate 
exposures to safe levels, all other existing uses of chlorpyrifos that 
contribute to aggregate exposures (i.e., food, drinking water, and 
residential exposures) would need to be cancelled and the labels for 
products containing the identified subset of uses would need to be 
amended to ensure that applications would be limited to those 
specifically identified geographic areas. Moreover, some revisions to 
labeled application rates would also be required since the conclusions 
in the 2020 PID that drinking water contributions were safe in these 
areas from these uses was based on usage data rather than maximum 
labeled application rates. It is also important to emphasize that the 
act of proposing to limit chlorpyrifos applications to this subset of 
uses did not, in fact, automatically result in the elimination of all 
uses beyond those identified uses; that would require separate actions 
under FIFRA to cancel uses and to amend labels, which has not occurred.
    EPA proposed this particular list of uses as critical and high-
benefit uses of those uses currently registered for chlorpyrifos. (Ref. 
30, Attachment 2) Although the ``reasonable certainty of no harm'' 
standard in the FFDCA, which is strictly a risk-based standard, allows 
no consideration of benefits, except in one very limited circumstance 
not relevant here (see 21 U.S.C. 346a(b)(2)(B)), FIFRA's ``unreasonable 
adverse effects'' standard incorporates a consideration of economic 
costs or benefits, which EPA took into

[[Page 11245]]

consideration when identifying this proposed list of retainable uses as 
part of the FIFRA registration review process. But this is likely not 
the only combination of uses that could have resulted in safe levels of 
aggregate exposure. To conserve resources (and because previous 
analyses had indicated risks of concern when considering all 
chlorpyrifos uses), EPA's 2020 DWA focused solely on the areas where 
these particular crops were grown that had the highest benefit to 
growers to determine if there were areas where the EDWCs were below the 
DWLOC; it is possible that a different set of crops and a different 
range of geographic areas could also result in safe aggregate 
exposures. The Agency expressly noted that it would ``consider 
registrant and stakeholder input on the subset of crops and regions 
from the public comment period and may conduct further analysis to 
determine if any other limited uses may be retained.'' (Ref. 31 at pg. 
40) The 2020 PID was made available for public comment, and the Agency 
did, in fact, receive hundreds of comments, although none committed to 
making changes to the chlorpyrifos registrations necessary to implement 
the 2020 PID as proposed, nor were any requests for voluntary 
cancellation of registered uses submitted under FIFRA in response to 
the 2020 PID.
    Turning now to the legal standard, as noted in Unit II.A., FFDCA 
section 408(b)(2)(A)(i) permits EPA to leave tolerances in place only 
if the Agency can determine that the tolerance is safe. If the Agency 
determines that the tolerances, which must be based on aggregate 
exposures, are not safe (or cannot determine that tolerances are safe), 
the Agency must modify or revoke them. (21 U.S.C. 346a(b)(2)(A)(i); see 
also LULAC, 996 F.3d at pgs. 693-94 (concluding that when EPA receives 
a petition raising substantive questions concerning safety, FFDCA 
provides no middle ground in which EPA can leave tolerances in place if 
EPA is unwilling or unable to make a safety finding)) The FFDCA also 
defines safe as requiring EPA to determine that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' (21 
U.S.C. 346a(b)(2)(A)(ii) (emphases added)) Congress understood the 
phrase ``aggregate exposure'' to include dietary exposures under all 
tolerances for the pesticide chemical residue, H.R. Rep. 104-669(II) at 
1279, and codified that understanding among the factors EPA must 
consider when establishing, modifying, leaving in effect, or revoking 
tolerances. (21 U.S.C. 346a(b)(2)(D)(vi)) In FFDCA section 
408(b)(2)(D)(vi), EPA must consider ``available information concerning 
the aggregate exposure levels of consumers (and major identifiable 
subgroups of consumers) to the pesticide chemical residue and to other 
related substances, including dietary exposure under the tolerance and 
all other tolerances in effect for the pesticide chemical residue, and 
exposure from other non-occupational sources.'' (Id. (emphasis added))
    The requirement to consider ``aggregate exposure'' was added to the 
FFDCA through the FQPA amendments in 1996. (Food Quality Protection Act 
of 1996, Pub. L. 104-170) Prior to the enactment of the FQPA, when 
assessing risk, EPA treated exposures from different pathways as 
independent events and made no concerted effort to evaluate potential 
exposures simultaneously. In reality, however, exposures to pesticides 
do not occur as single, isolated events, but rather as a series of 
sequential or concurrent events that may overlap or be linked in time 
and space. Congress, in enacting the FQPA, was concerned with ensuring 
that the Agency's assessments under the FFDCA would be strictly health-
protective and risk-based, and as a result, made a number of 
significant amendments to the FFDCA, including the new risk-only safety 
standard, the FQPA children's safety factor, and, of most relevance 
here, a new requirement for EPA to consider exposures in the aggregate 
rather than independently.
    Following the enactment of the FQPA, EPA developed guidance on how 
to conduct aggregate exposure and risk assessment. (Ref. 14) That 
guidance describes the aggregate exposure and risk assessment as 
involving ``the analysis of exposure to a single chemical by multiple 
pathways [food, drinking water, residential] and routes of exposure 
[oral, dermal, inhalation] . . . . All potential, relevant routes of 
exposure are analyzed with an aggregate exposure assessment.'' (Id. at 
pg. 4) That guidance also defines aggregate risk as ``[t]he likelihood 
of the occurrence of an adverse health effect resulting from all routes 
of exposure to a single substance.'' (Id. at pg. 72) In describing how 
EPA intends to conduct such aggregate risk assessments, EPA states that 
``[t]he starting point for identifying the exposure scenarios for 
inclusion in an aggregate exposure assessment is the universe of 
proposed and approved uses for the pesticide,'' which are determined by 
looking to labeled allowable use patterns. (Id. at pgs. 24, 44 and 45) 
Moreover, the guidance directs that aggregate exposure and risk should 
be estimated for major identifiable subgroups of the population, which 
the Agency typically does through considerations of demographics (e.g., 
age, gender, racial/ethnic background) and temporal (season) and 
spatial (geographics) characteristics of potentially exposed 
individuals. (Id. at pgs. 12, 24)
    The Aggregate Exposure Guidance describes an approach for assessing 
aggregate exposures that recognizes such exposures to hypothetical 
individuals in the population: ``(1) may occur by more than one route 
(i.e., oral, dermal and/or inhalation); (2) may originate from more 
than one source and/or pathway (i.e., food, drinking water, and 
residential); (3) may occur within a time-frame that corresponds to the 
period of exposure required in an appropriately designed toxicity study 
to elicit an adverse toxicological effect; (4) should occur at a 
spatially relevant set of locations that correspond to an individual's 
potential exposure; and (5) should be consistent with the individual's 
demographic and behavioral attributes.'' (Id. at pg. 26) In practice, 
this means that the Agency might consider whether different populations 
of individuals are more or less likely to eat different kinds of food 
over different time periods; whether pesticide concentrations in 
drinking water vary temporally due to the growing season calendar or 
spatially due to the nature of applications generally being localized 
or regional; and/or whether different populations are likely to use or 
be exposed to pesticides in non-occupational settings. Generally, EPA 
would utilize upper-end estimates to ensure protection for the most 
vulnerable populations, unless other factors warranted a different 
approach.
    From there, the Agency assesses the aggregate exposure through 
relevant routes of exposure for hypothetical individuals among these 
major identifiable subgroups (including food, drinking water, and 
residential exposures to which that individual is likely exposed), 
taking into consideration the various factors for co-occurrence of 
exposures in the various exposure pathways. (Id. at pg. 26) Where risks 
from aggregate exposures exceed safe levels, EPA will examine whether 
refinements can be made to the assessment. (Id. at pg. 13)
    In the final rule, EPA assessed aggregate exposure based on all 
currently registered uses of chlorpyrifos as required by the FFDCA and 
consistent with its guidance. That

[[Page 11246]]

assessment considered exposure through oral, dermal, and inhalation 
routes of exposure that could result from exposures in food, drinking 
water, and residential uses. Taking into consideration the registered 
use patterns for chlorpyrifos, EPA assessed the universe of potential 
exposures from all currently approved uses of chlorpyrifos because no 
formal steps had been taken to limit those uses.
    In demanding that EPA retain tolerances for the 11 uses, the 
Objectors essentially argue that EPA should have presumed that 
individuals would only be exposed to chlorpyrifos from the 11 uses 
because EPA proposed those 11 uses as an option for mitigation in the 
2020 PID proposal. However, that argument ignores the premise in the 
PID that the safety finding for those uses is contingent on all other 
uses being cancelled and the remaining 11 uses being restricted both 
geographically and with lowered use rates. Exposures from those uses 
alone could not reasonably be considered as ``anticipated'' since they 
did not yet (nor did EPA have reason to believe that they would) 
reflect the exposures people would be exposed to in the real world. The 
FFDCA requires EPA to determine whether tolerances are safe, requiring 
consideration of aggregate exposures, including ``anticipated dietary 
exposures''; it does not allow EPA to leave tolerances in place if they 
would be safe at some unspecified time in the future based on certain 
mitigation that may not be implemented.
    At the time of the final rule, no concrete steps had been taken by 
registrants under FIFRA to implement the PID proposal: No uses had been 
cancelled, nor had any labels been revised to geographically limit 
applications or limit maximum application rates. Although there were 
discussions with registrants and indications of a willingness to 
mitigate uses (see discussion in next sub-unit), the Agency had not 
received prior to the issuance of the final rule from registrants any 
formal requests under FIFRA for voluntary cancellation or applications 
to amend labels, to which the Agency could point as directionally 
supportive for a conclusion that exposures would at some future time be 
limited to that subset of chlorpyrifos applications. Until such uses 
cease--or at least until EPA has a reasonable basis to believe that 
they will cease--the Agency could not ignore the exposures from those 
uses. In sum, the 2020 PID proposal, without more, is just a proposal; 
it does not support an EPA assumption that aggregate exposures would be 
limited to that subset of uses instead of an assessment based on the 
actual registered uses and ongoing real-world applications of 
chlorpyrifos.
    While the Objectors claim that EPA could have modified tolerances, 
as per the Court's order, by leaving in place only those identified in 
the 2020 PID, doing so, without accompanying registration actions under 
FIFRA, would have put EPA in the position of picking ``winners and 
losers'' among the tolerances. While, under FIFRA, EPA might be able to 
make an argument that some uses contribute relatively lower risks or 
higher benefits than other uses and thus meet the FIFRA standard of no 
unreasonable adverse effects on the environment whereas others may not, 
considerations of those relative benefits is not a factor for 
consideration under the FFDCA when determining which tolerances are 
safe or not. As noted previously, the 2020 PID proposal reflected one 
possible subset of uses that might warrant retention based on economic 
considerations. In circumstances where aggregate exposures exceed safe 
levels, there are potentially multiple variations of the potential 
subset of tolerances that might meet the safety standard and that EPA 
did not analyze. As such, EPA's general policy is to defer to the 
pesticide registrant and the public to determine which of the various 
subsets of tolerances are of sufficient importance to warrant 
retentions since not all parties might agree on the particular 
combination that should be retained. For example, one comment submitted 
on the 2020 PID requested that EPA retain tolerances on cranberries 
(Ref. 48), which was not listed among the 11 uses in the PID. Without 
some reasonable basis to believe that the uses would be limited as had 
been proposed, EPA did not have a basis to assume anticipated exposures 
would be limited to that particular subset of uses for purposes of 
modifying the tolerances.
    Some Objectors made this same argument but focused more 
specifically on their crop of interest (e.g., cherry, citrus, soybean, 
sugarbeet). These objectors assert that EPA could not have revoked the 
specific commodity tolerance because that crop was included in the list 
of crops EPA proposed to retain and thus EPA did not have a basis for 
concluding that those tolerances themselves were unsafe. However, the 
Agency does not assess tolerances for each crop in a vacuum; whether 
one tolerance is safe depends on whether aggregate exposure from that 
tolerance and all other tolerances in effect are safe. (21 U.S.C. 
346a(b)(2)(D)(vi)) The consequence of the FFDCA requirement for EPA to 
assess the safety of tolerances as an aggregate is that, when one 
tolerance is unsafe, all tolerances are equally unsafe until aggregate 
exposures have been reduced to acceptable levels. At the time the final 
rule was issued, there were over 80 tolerances in effect, which the 
Agency was required to consider in its aggregate exposure assessment, 
unless there had been a reasonable basis to exclude exposures from 
those tolerances. The list in the 2020 PID was only a proposed 
mitigation measure, necessary because the aggregate exposures from 
chlorpyrifos, which included exposures from use of chlorpyrifos on 
these three commodities, exceeded safe levels.
    It is also worth noting that tolerances themselves are broadly 
applicable rules that regulate the amount of pesticide residues on a 
food commodity. As such, they are not limited in geographic scope, and 
the Agency must be able to determine that all aggregate exposures from 
any registered uses (including all relevant geographic areas) that 
would be covered by a particular tolerance would be safe. For example, 
the tolerance covering residues of chlorpyrifos on cherry applies to 
the pesticide residues on the crop regardless of the location of 
application. In practice, this means that EPA needs to be able to 
determine that use of chlorpyrifos in any place permitted by the FIFRA 
label would be safe. For cherries, EPA's 2020 PID proposal only 
concluded that use on cherry could be safe in Michigan, if the other 
aforementioned mitigation measures were implemented; whether cherry use 
could be safe in other areas was not assessed. In order to conclude 
that cherry use was safe based on the 2020 PID proposal, the labels 
would need to restrict chlorpyrifos use to cherries only in Michigan. 
Since the uses on cherry were not so restricted under FIFRA at the time 
of the final rule, EPA could not assume that chlorpyrifos would be used 
only in the limited geographical regions without some progress being 
made on the label revisions.
    In conclusion, while the 2020 PID proposed that there is at least 
one subset of chlorpyrifos uses that could be safe if additional 
restrictions were adopted and all other uses contributing to aggregate 
exposures were cancelled under FIFRA, that is not a basis for 
maintaining tolerances when the Agency does not have a reasonable basis 
to believe that the registrations would be so amended. Based on the 
factual realities at the time of the final rule, EPA was required to 
consider aggregate exposures resulting from approved labelling and all 
currently registered

[[Page 11247]]

uses. The Objectors' claim incorrectly relies on the proposal in the 
2020 PID as a basis for limiting the aggregate exposure assessment, and 
the request to limit EPA's safety assessment to a subset of actual 
exposures based on a proposal would reflect an incorrect application of 
the statutory standard under the FFDCA. EPA recognizes that the 
practice of identifying mitigation measures to address risks of concern 
in the proposed or interim decisions in registration review is common, 
and the expectation is that registrants will make adjustments to retain 
registrations. However, this is not always the case; some registrants 
may suggest alternative means of mitigating risks, which the Agency 
then needs to evaluate, or may refuse due to a disagreement with the 
Agency's underlying rationale for its decision. When mitigation 
measures are not implemented (or it is unclear that such risks will be 
mitigated), the risks that EPA initially identified remain. Therefore, 
the objection is denied.
b. Coordination With FIFRA Under FFDCA Section 408(l)(1)
    i. Objection. Objectors assert that the revocation of tolerances 
should not have been undertaken without coordination of use 
cancellations under FIFRA. The Sugarbeet Associations and Gharda argue 
that EPA had a statutory duty under section 408(l)(1) of the FFDCA to 
harmonize the chlorpyrifos tolerance revocation with necessary actions 
under FIFRA. (Refs. 37 and 39) They argue that EPA offers no 
explanation for why it was not practicable for EPA to cancel the FIFRA 
registrations and revoke tolerances for the food uses for which EPA 
would be unable to make a safety finding while maintaining the 
registrations and tolerances that the 2020 PID proposed for retention. 
The Sugarbeet Associations also argue that because the Ninth Circuit 
also ordered EPA to ``correspondingly modify or cancel related FIFRA 
registrations for food use in a timely fashion,'' EPA's failure to 
harmonize its revocations with FIFRA actions is therefore also 
inconsistent with the Court's order. (Ref. 37 at pg. 7) Gharda 
acknowledges that EPA did engage in negotiations with registrants to 
attempt this harmonization but alleges that EPA was acting in bad faith 
in those negotiations and disregarded Gharda's commitment to modify its 
registration. (Ref. 39 at pgs. 28 through 31) The Minor Crop Farmers 
Alliance notes that EPA did not follow ``its traditional FIFRA/FQPA 
sequencing of taking the necessary tolerance actions only after first 
finalizing its decision in a cancellation action under Section 6 of 
FIFRA.'' (Ref. 49 at pg. 4) Finally, CLA/RISE requests guidance on how 
EPA intends to harmonize the tolerance revocation under FIFRA to reduce 
confusion among growers and industry. (Ref. 50)
    ii. Denial of objection. EPA denies this objection on the following 
legal and factual grounds. FFDCA 408(l)(1) states that ``[t]o the 
extent practicable . . . , in issuing a final rule under this 
subsection that suspends or revokes a tolerance or exemption for a 
pesticide chemical residue in or on food, the Administrator shall 
coordinate such action with any related necessary action under 
[FIFRA].'' (21 U.S.C. 346a(l)(1)) While the statutory language includes 
the word ``shall,'' this provision clearly contemplates that there may 
be circumstances in which coordination is not practicable and thus such 
coordination is not required. Even when such coordination would be 
practicable, the statute does not require that this coordination be 
concurrent or occur in any predetermined order.
    EPA has previously opined on this provision in a final rule 
revoking carbofuran tolerances in which this same comment was raised. 
(See 74 FR 23046, 23069-70, May 15, 2009 (FRL-8413-3)) In that rule, 
EPA found that the requirement to ``coordinate'' is a direction to 
ensure that the substance of actions taken under FIFRA and the FFDCA 
are consistent, and that the Agency make a determination as to the 
proper order of action under the two statutes. It cannot be read as a 
requirement that actions under FIFRA precede actions under the FFDCA, 
or that any particular order for EPA actions is necessarily required. 
Accordingly, there is no support for the notion that, as a matter of 
law, the Agency lacks the legal authority to revoke pesticide 
tolerances under the FFDCA that do not meet the safety standard of that 
statute unless the Agency has first canceled--or simultaneously 
cancels--associated pesticide registrations under FIFRA.
    In this instance, the Ninth Circuit itself prioritized EPA's taking 
action on the chlorpyrifos tolerances above the action necessary under 
FIFRA, when it set a very short and specific deadline for addressing 
pesticide tolerances (i.e., within 60 days of the issuance of the 
mandate) and allowed flexibility for EPA to ``modify or cancel related 
FIFRA registrations for food use in a timely fashion.'' (LULAC, 996 
F.3d at 703-04) Under the Court's timeframe, it was not practicable for 
EPA to take action under FIFRA to cancel registered food uses of 
chlorpyrifos concurrently with the final rule. Cancellation of uses 
under FIFRA section 6(b) requires several steps, including drafting a 
notice of intent to cancel, interagency coordination and SAP review, as 
well as possible administrative hearings, and can take several years to 
complete. (See 7 U.S.C. 136d(b)) Even the process to obtain and act on 
voluntary cancellation requests can be a time-consuming process with 
statutorily set comment periods before a cancellation can be ordered. 
(7 U.S.C. 136d(f))
    In any event, in this particular instance, EPA did attempt to 
harmonize its tolerance revocation actions with cancellation actions 
under FIFRA. As the Minor Crop Farmer Alliance pointed out, EPA 
traditionally, as part of the registration review process, identifies 
the relative risks and benefits of particular uses and works with 
registrants to eliminate uses that no longer meet the FIFRA standard, 
including for safety risks. Under that approach, EPA and the 
registrant(s) can mutually agree on terms for the smooth phase-out of 
the product, and the product or use cancellations can be coordinated 
with tolerance revocations under the FFDCA. After the Ninth Circuit's 
decision was issued, EPA engaged in discussions with the four 
registrants of technical chlorpyrifos products (i.e., those that are 
used to manufacture the chlorpyrifos pesticide products sold to end 
users) to discuss possible voluntary use cancellations and label 
restrictions, although EPA did not initiate any discussions with the 
dozens of registrants of end-use products. (Ref. 51) Despite the 
progress made in those discussions, no registrant submitted under FIFRA 
a request for voluntary cancellation of any uses or application to 
amend existing chlorpyrifos labels to reduce application rates and 
geographically limit uses. One of those registrants, Gharda, asserts 
that EPA acted in bad faith in the negotiations with Gharda and 
disregarded a commitment from Gharda to modify its registration. EPA 
disagrees with Gharda's characterization of the negotiations.
    Prior to the issuance of the final rule, EPA entered into 
discussions with Gharda, as well as several other registrants, in a 
good-faith effort to determine if the safety issues identified in EPA's 
record on chlorpyrifos by the Ninth Circuit could be resolved in a 
sufficient and timely manner to allow for the modification of 
tolerances by the Court's imposed timeline. EPA held several meetings 
with each of the technical registrants, including Gharda, to discuss 
their interests and concerns as EPA considered its response to the 
Court's directive to issue a final rule. (Id.) The meetings with Gharda 
occurred on May 27, June 3, June 17, June 24, July

[[Page 11248]]

14, and August 16, 2021. As Gharda's objection filing indicates, there 
was an extensive amount of back-and-forth between EPA and Gharda 
concerning restrictions to the current registrations and an attempt to 
work out mutually agreeable terms (e.g., uses to be retained, 
geographic limitations on uses, retention of import tolerances, timing 
for phase-out of existing uses) to provide a reasonable basis for 
assuming aggregate exposures could be limited to the 11 uses proposed 
for retention in the 2020 PID.
    Gharda asserts, in its objection, that EPA disregarded a written 
commitment to voluntarily cancel uses and therefore, the Agency's 
decision to revoke all tolerances was arbitrary and capricious. (Ref. 
39 at pgs. 28 and 29) EPA acknowledges that Gharda submitted two such 
letters to the Agency; however, the question is whether those letters 
provided a legal basis for any EPA regulatory determination, e.g., 
whether to retain tolerances for the 11 uses assessed in the PID. EPA 
concludes that they did not.
    On their face, Gharda's letters fall far short of actually 
requesting voluntary cancellation of their registered uses. Gharda's 
first letter says that it is ``willing to work with EPA to negotiate 
the voluntary cancellation of many currently approved uses of 
chlorpyrifos on mutually acceptable terms and in a manner that 
minimizes disruption on growers and other users.'' Gharda requests that 
any agreement with EPA to voluntarily cancel uses include several key 
terms, including further discussion of the geographic restrictions set 
forth in the PID as to the 11 crops, allowing use on crops in addition 
to the 11 uses in the PID, phase-out schedules that would allow some 
uses to continue until 2026 (5 years after the Court ordered EPA to 
issue a final rule revoking or modifying tolerances), additional 
existing stocks orders that would allow additional time for phase-out, 
retention of all import tolerances, etc. (Ref. 39 at Exhibit B to 
Gharda's objection, Letter from Gharda to EPA (May 12, 2021)) Gharda's 
second letter states that ``Gharda commits to voluntarily cancel all 
currently approved agricultural uses of chlorpyrifos other than uses 
for the 11 high-benefit agricultural crops in select regions that the 
Agency has identified [in the PID] . . . . subject to [several] 
conditions.'' Those conditions included allowing use on cotton in Texas 
(which the Agency had not determined would be safe under the limited 
conditions presented in the 2020 PID), existing stocks terms that 
allowed for sale of all finished Gharda technical product in the United 
States and overseas to be processed and sold until stocks were 
exhausted, retention of all ``import tolerances,'' and allowing food 
treated with chlorpyrifos to clear the channels of trade. (Id. at 
Exhibit C, Letter from Gharda to EPA (June 7, 2021)) As Gharda's 
objection filing indicates, there were several other emails exchanged 
in which terms continued to be negotiated, and Gharda continued to seek 
agreement on various terms prior to submission of a voluntary 
cancellation request. (Id. at Exhibits D through J)
    Contrary to Gharda's assertions, a conditional proposal does not 
provide a sufficient basis for EPA to conclude that uses will be 
cancelled and exposures will be reduced. By their terms the letters 
simply indicate an intent to keep discussing the issue and a 
willingness to initiate the process to cancel uses provided other 
conditions can be agreed upon. The implication in Gharda's letter was 
that if agreement could not be reached on the other conditions, then no 
such voluntary cancelation request would be forthcoming. And as 
indicated previously, Gharda's proposal was initially contingent upon 
EPA allowing use on crops beyond the 11 identified in the PID, which 
EPA had not assessed and proposed to find safe if other conditions were 
met. Although Gharda's subsequent email traffic indicated a willingness 
to drop those additional uses, given the Agency's safety concerns with 
the tolerances, EPA continued to express a concern about whether an 
extended existing stocks period would be considered consistent with the 
Ninth Circuit's order.
    Typically, a formal request for voluntary cancellation of a 
pesticide registration or registered uses would involve the submission 
of a letter requesting cancelation of a product or uses and would also, 
in the case of deletions of certain uses, need to be accompanied with 
applications to amend relevant labels. (See https://www.epa.gov/pesticide-registration/voluntary-cancellation-pesticide-product-or-use) 
While Gharda's letters indicate a willingness to continue negotiations 
with EPA, they do not constitute an actual request to cancel uses and 
thus do not provide a sufficient basis for EPA to conclude that 
aggregate exposures to chlorpyrifos would be limited to the 11 
geographically limited uses identified in the 2020 PID proposal.
    It should also be noted that Gharda's voluntary cancellation 
request alone would not be sufficient to support a conclusion that all 
registered uses would be cancelled since other products are registered 
for those uses as well. Other registrants would have also needed to 
submit voluntary cancellation requests and label amendments, and as 
indicated previously, that has not happened.
    Unlike negotiations that are typically conducted as part of 
registration review, this situation involved a tight deadline for a 
final Agency rulemaking and thus a very short period of time to resolve 
differences and allow EPA to develop a final rule that incorporated any 
such resolution. In light of the Ninth Circuit's impending deadline for 
issuing a final rule and the lack of a mutually agreeable resolution to 
the remaining issues in a timely manner, it simply was not practicable 
for EPA to continue negotiating these terms.
    While it is understandable for Gharda to be disappointed, Gharda 
erroneously asserts now, based on the lack of resolution in time for 
the final rule to be completed by the Court's deadline, that EPA's rule 
is arbitrary and capricious. This simply is not true. Whether a rule 
revoking tolerances is legally valid is strictly dependent on whether 
EPA had substantial evidence to support its conclusion that the 
tolerances were not safe; how negotiations proceed regarding use 
cancellations and label amendments under FIFRA is irrelevant to that 
safety question. As noted in the denial of the previous objection, EPA 
determined that the tolerances were not safe, based on the assessments 
EPA had completed at the time and aggregate exposures resulting from 
the uses in place at the time of the final rule.
    It is worth noting that, although the Agency/registrant 
negotiations prior to the final rule ended without resulting in use 
cancellations or label amendments under FIFRA, any registrant is 
authorized at any time, without prior EPA consent, to take initiative 
and submit a request to voluntarily cancel uses on its registration or 
to submit an application seeking amendments to its label to restrict 
uses. Upon submission of such a request, EPA would consider that 
request and publish a notice of receipt of a voluntary cancellation 
request, and for situations like chlorpyrifos, take into consideration 
whether that request would have an impact on the Agency's ability to 
support a safety finding, in light of uses remaining on other 
registered products. For chlorpyrifos, however, no such submissions 
were submitted to with the Agency prior to the issuance of the final 
rule. While there were communications from Gharda indicating an intent 
to amend registrations and cancel uses, with an extended existing 
stocks period to allow for continued sale and distribution of their 
chlorpyrifos inventory, no formal steps were taken

[[Page 11249]]

under FIFRA to put those processes in action.
c. Import Tolerances
    i. Objection. Gharda, the Agricultural Retailers Association, et 
al., and CLA/RISE argue that EPA should have retained import tolerances 
(i.e., tolerances covering pesticide residues for commodities that are 
imported into the United States) for chlorpyrifos commodities. (Refs. 
39, 47 and 50) These Objectors assert that because EPA's final rule 
noted that food exposures and non-occupational exposures do not exceed 
levels of concern--rather, risks are driven by exposures to 
chlorpyrifos in drinking water--EPA could conclude that import 
tolerances, which would not contribute to drinking water exposures, 
would be safe. The Objectors assert that there is no science-based 
reason to revoke tolerances as they apply to food imported with 
chlorpyrifos residues. CLA/RISE cites to EPA's guidance entitled, 
``Pesticides; Guidance on Import Tolerances & Residue Data for Imported 
Food'' ((65 FR 35069, June 1, 2000) (FRL-6559-3)), and legal precedent 
for support for the retention of import tolerances. (Ref. 50)
    ii. Denial of objection. This objection is denied because, as a 
matter of law, where aggregate exposures from pesticide use exceed safe 
levels, EPA cannot leave tolerances in place, even if those tolerances 
just cover residues in imported foods.
    As a legal matter, tolerances established under the FFDCA apply to 
pesticide residues in or on food moving through interstate commerce, 
regardless of whether those residues came from use of a domestically 
registered pesticide or from application of a pesticide overseas to a 
food that is then imported into the United States. As a matter of law, 
EPA does not separately establish ``import tolerances'' that apply 
exclusively to imported commodities. The term ``import tolerance'' is a 
term of convenience that refers to tolerances for pesticide residues in 
an imported food where there is no corresponding U.S. registration for 
that pesticide on that particular commodity; however, there is no 
statutory or regulatory distinction between a tolerance covering 
pesticide residues in imported commodities and tolerances covering 
pesticide residues from use of a pesticide product registered in the 
United States. Once established, that tolerance would cover pesticide 
residues in that particular commodity, regardless of how residues came 
to be present in the food.
    It is correct that imported food treated with a pesticide would 
only contribute to aggregate exposures through the residues that are 
present on the imported commodity. Imported foods do not result in 
additional drinking water and residential contributions to exposure 
because the pesticides are used overseas, not domestically. 
Nevertheless, the pesticide residues on the imported food must be 
aggregated with all the other food, drinking water, and residential 
exposures to that pesticide that occur in the United States, as part of 
the safety determination and consideration of aggregate exposures for 
that pesticide. If the domestic uses of that particular pesticide 
already exceed safe levels, EPA would not be able to approve the new 
import tolerance, even if the relative contributions from the imported 
commodities was very minor because the safety assessment of that 
tolerance requires a consideration of ``aggregate exposures'' from all 
other tolerances in effect.
    For chlorpyrifos, since domestic use of chlorpyrifos in accordance 
with currently approved labeling results in aggregate exposures that 
exceed safe levels, due to drinking water concerns, all tolerances, 
including those covering imported commodities, are unsafe and must be 
revoked. Until domestic use ceases--or EPA has a reasonable basis to 
believe that it will cease--the risks from drinking water need to be 
assessed in EPA's risk assessment. Once domestic uses are cancelled and 
aggregate exposures are reduced below the Agency's levels of concern 
for safety, EPA could consider whether risks from exposures in or on 
imported food would be safe. Again, this is a consequence of the 
requirement under the FFDCA to consider aggregate exposures from all 
uses; when one tolerance is unsafe, all are equally unsafe until 
aggregate exposures have been reduced to levels that are below the 
Agency's level of concern.
    CLA/RISE cite EPA's Guidance on Import Tolerances to encourage EPA 
to consider and approve requests to retain import tolerances. This 
guidance, however, does not provide a legal basis for retaining import 
tolerances under the current circumstances. Rather the guidance 
document describes how EPA may consider requests for modifying or 
maintaining tolerances to allow the continue import of food treated 
with a pesticide, where ``domestic uses are canceled . . . for any 
other reason (other than dietary risk)'' as long as EPA can make the 
required safety finding. (65 FR at 35072) For chlorpyrifos, no domestic 
uses have been cancelled to date, which precludes EPA from making the 
required safety finding.
    CLA/RISE also point to the D.C. Circuit Court's decision in 
National Corn Growers Ass'n v. EPA, 613 F.3d 266, as instructive here. 
In that case, the Court ordered EPA to reinstate import tolerances for 
the pesticide carbofuran because the Agency had received requests for 
retaining those tolerances and because EPA had concluded that exposure 
from imported foods alone was safe. (Id. at pg. 275)
    This present case is distinguishable in that for the carbofuran 
situation, the import tolerances at issue had no domestic registrations 
for the commodities covered by those tolerances. This fact was 
specifically identified by footnotes to the tolerances for those 
commodities. For chlorpyrifos, there are no specifically designated 
import tolerances, although the Agency notes that there is a tolerance 
for chlorpyrifos on banana, for which there are no U.S. registrations. 
To the extent there were requests for retention of import tolerances 
prior to the issuance of the final rule, such requests were to leave 
all current tolerances in place, in order to accommodate chlorpyrifos 
use in other countries on any of the commodities for which tolerances 
were set. Because those uses would overlap with domestic uses, the 
Agency could not exclude other non-food exposures associated with those 
uses until those domestic uses were cancelled.
    EPA recognizes that the Republic of Colombia, in its objections, 
requested the retention of the banana tolerance; however, EPA denies 
that request since EPA is unable, at this time with the existing 
domestic uses still being registered, to make a safety finding for the 
banana tolerance. While after National Corn Growers Ass'n was decided, 
the import tolerances were reinstated for commodities that had no 
domestic uses, that reinstatement occurred after the other domestic 
uses that had resulted in unsafe aggregate exposure levels had been 
cancelled, thus obviating the need to tackle a potential aggregate 
exposure issue involving residues from both domestic and imported food. 
(See Carbofuran; Product Cancellation Order ((74 FR 11551, March 18, 
2009) (FRL-8403-6)) (announcing FMC Corporation's voluntary cancelation 
of its carbofuran registrations for all but six crops); Carbofuran; 
Reinstatement of Specific Tolerances and Removal of Expired Tolerances 
((80 FR 21187, Apr. 17, 2015) (FRL-9925-70)) (EPA reinstatement of 
import tolerances for carbofuran for banana; coffee, bean, green; rice, 
grain; and sugarcane, cane))

[[Page 11250]]

Here, all registrations of chlorpyrifos remain intact and uses in 
accordance with the labels are still contributing to drinking water 
concentrations that result in aggregate exposures exceeding safe 
levels. Therefore, for chlorpyrifos, the Agency cannot make the safety 
finding for leaving tolerances in place to accommodate imports until 
sufficient uses are cancelled that reduce aggregate exposures to 
acceptable levels.
2. Retention of the 10X Food Quality Protection Act (FQPA) Safety 
Factor
a. Objection
    Several Objectors (Sugarbeet Associations, Gharda, the Agricultural 
Retailers Association, et al., Minor Crop Farmer Alliance, California 
Citrus Quality Council, and Coalition of OP Registrants) claim that EPA 
acted unlawfully in retaining the 10X FQPA safety factor based on the 
epidemiology data. (Refs. 37, 39, 47, 49, 52 and 53) Objectors assert 
that the epidemiological data was invalid and unreliable and should not 
been considered nor should it have been relied upon to introduce 
``scientific uncertainties'' into the Agency's assessment of 
chlorpyrifos. In light of the alleged defects with the epidemiological 
studies, the Objectors assert EPA had no basis to retain the 10X FQPA 
safety factor, given the balance of toxicity data on chlorpyrifos.
b. Denial of Objection
    As an initial matter, EPA points out that the Objectors have failed 
to identify an issue that supports a retention of the chlorpyrifos 
tolerances or changing the EPA's final rule, even if what the objectors 
assert is correct. Even if the Agency agreed that the epidemiological 
data should not have been considered by the Agency or that available 
data support a reduction of the FQPA safety factor to 1X, as indicated 
in the 2020 PID, EPA would not have been able to determine that 
chlorpyrifos tolerances were safe without some uses being cancelled and 
other uses being modified.
    The 2020 PID provided estimates of potential risks based on 
retention of the 10X FQPA safety factor and on a reduced FQPA safety 
factor of 1X. The previous sub-unit discussed the need to cancel all 
uses besides the 11 uses identified for retention and the need for 
label amendments to geographically restrict applications and to reduce 
maximum application rates, if EPA retained the 10X FQPA safety factor. 
For the 1X scenario, EPA concluded that ``the majority of labeled 
chlorpyrifos uses result in drinking water concentrations below the 
DWLOC.'' (Ref. 31 at pg. 41) The ``majority,'' however, is not all, and 
thus, EPA noted that three uses still resulted in EDWCs above the DWLOC 
(peppers, trash storage bins, and wood treatment), and six uses would 
need to be restricted to certain states and application rates adjusted 
consistent with assessed usage data in order to ensure that 
concentrations of chlorpyrifos in drinking water did not exceed safe 
levels. (Id.) In other words, uses as registered at the time EPA issued 
the 2020 PID--and at the time of the final rule--still resulted in 
aggregate exposures that were not safe under a scenario in which EPA 
applied a 1X FQPA safety factor. Since some uses would result in 
exposures of chlorpyrifos that exceeded the Agency's safe levels, EPA 
would not have been able to determine that the tolerances were safe, 
even with the FQPA safety factor being reduced to 1X. If EPA had had a 
reasonable basis to assume that such uses resulting in exceedances 
would cease, EPA may have been able to aggregate only those uses that 
were expected to continue. As there was no such basis at the time the 
final rule was issued--and, indeed at this time, there is still no such 
basis, EPA was required to look at aggregate exposures from all 
currently registered uses, as those exposures were anticipated to 
continue. Therefore, since the Objectors have failed to state a claim 
upon which the relief they seek (leaving the tolerances in place) can 
be granted, this objection is denied.
    Notwithstanding this denial, EPA disagrees with the assertions made 
by Objectors with regard to the Agency's decisions to rely on the 
epidemiological data and retain the 10X FQPA safety factor as discussed 
in this unit. For ease of addressing this claim, EPA is breaking this 
objection into two subissues: (1) Whether it was reasonable for EPA to 
use the epidemiology data as part of its weight-of-the evidence 
analysis for assessing the potential pre- and postnatal toxicity 
relating to neurodevelopmental effects and (2) Whether EPA had 
``reliable data'' to support a different margin of safety to protect 
infants and children based on the available record.
c. Background
    Before responding to these objections, it is helpful to provide 
some background on the FQPA safety factor EPA used in the final rule to 
clarify the statutory standard, and to provide some background on EPA's 
FQPA safety factor policy.
    i. Final rule. In the final rule, EPA retained the 10X FQPA safety 
factor due to uncertainty around the levels at which potential 
neurodevelopmental outcomes may occur in infants and children exposed 
to chlorpyrifos. The decision was based on the Agency's weight-of-
evidence (WOE) analysis, which took into consideration the totality of 
available information on the toxicity of chlorpyrifos and the potential 
for neurodevelopmental outcomes associated with chlorpyrifos exposure. 
That information included laboratory animal studies, epidemiological 
studies, and available mechanistic data, as described in Unit 
III.A.1.b. of this document.
    In essence, the WOE analysis concluded that there was qualitative 
evidence of a potential effect on the developing brain; however, due to 
insufficient clarity on the levels at which these neurodevelopmental 
outcomes occur relative to levels at which cholinesterase inhibition 
occurs, the science addressing neurodevelopmental outcomes remained 
unresolved in a manner sufficient to quantify these effects. Due to the 
remaining uncertainties, EPA was unable to conclude at the time of the 
final rule that a different safety factor would be sufficient to 
protect infants and children from potential pre- and postnatal toxicity 
related to neurodevelopmental effects. (Ref. 1 at pg. 48327)
    ii. FFDCA section 408(b)(2)(C) and EPA's FQPA safety factor policy. 
Through the FQPA, Congress significantly amended the FFDCA, to 
establish a new stringent health-based standard (``reasonable certainty 
of no harm'') and add a new provision providing heightened protections 
for infants and children. (21 U.S.C. 346a(b)(2)(C)) That provision 
directs EPA to consider available data on, among other things, the 
``special susceptibility of infants and children to the pesticide 
chemical residues, including neurological differences between infants 
and children and adults, and effects of in utero exposure to pesticide 
chemicals.'' (21 U.S.C. 346a(b)(2)(C)(i)(II)) Moreover, EPA is required 
to ensure that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to the pesticide. (21 
U.S.C. 346a(b)(2)(C)(ii)(I)) When making that safety determination for 
infants and children, EPA is required to apply, in the case of 
threshold effects, an additional tenfold margin of safety ``to take 
into account potential pre- and post-natal toxicity and completeness of 
the data with respect to exposure and toxicity to infants and 
children.'' (21 U.S.C. 346a(b)(2)(C)) This provision

[[Page 11251]]

permits a different margin of safety ``only if, on the basis of 
reliable data, such margin will be safe for infants and children.'' 
(Id.) Thus, EPA interprets this provision as establishing a presumption 
in favor of applying the default 10X safety factor, which can be 
departed from only if reliable evidence show that a different factor 
would be protective of infants and children.
    In 2002, EPA issued guidance on how OPP intends to make 
determinations regarding the FQPA safety factor when developing risk 
assessments for pesticides (``FQPA Policy Paper'') (Ref. 9) While not 
binding, that document provides helpful background and clarification on 
the process for determining the appropriate FQPA safety factor. 
Ultimately, the decision to retain the default 10X FQPA safety factor 
or use a different factor depends on level of confidence in the risk 
assessment and the degree of concern for any susceptibility or residual 
uncertainties in the toxicity and exposure databases. (Id. at 50) A 
lower level of confidence and a higher degree of concern will support 
retention of the default 10X FQPA safety factor. Because the 
chlorpyrifos 10X FQPA safety factor decision relates primarily to the 
concern for potential pre- and postnatal toxicity, this discussion 
focuses on those aspects of the guidance, although it also covers 
concerns related to the completeness of the toxicity and exposure 
databases.
    Before making any determination on the FQPA safety factor, OPP will 
review all available and relevant toxicological data and determine 
whether the chemical has any potential to cause adverse effects in 
infants and children, i.e., potential pre- and postnatal toxicity or 
special susceptibility. (Id. at pg. 8) The FQPA Policy Paper states, 
``In general terms, there is increased susceptibility or sensitivity 
when data demonstrate unique effects (e.g., a different pattern of 
effects of concern) or adverse effects in the young that are of a type 
similar to those seen in adults, but occur either at doses lower than 
those causing effects in adults, occur more quickly, or occur with 
greater severity or duration than in adults.'' (Id. at pg. 30) If the 
toxicity data indicate no concern for pre- and postnatal toxicity or 
special susceptibility, then the presumption for the 10X factor should 
be treated as obviated with respect to the potential for pre- and 
postnatal toxicity. In contrast, if the toxicity data indicate pre- and 
postnatal toxicity, then OPP will assess the level or degree of concern 
for the potential for those effects, taking into consideration the 
degree to which the traditional uncertainty factors provide protection 
for infants and children. (Id. at pg. 29)
    EPA typically uses a WOE approach for making judgments about the 
degree of concern for potential pre- and postnatal toxicity, in the 
context of the entire database, taking into consideration the quality 
and adequacy of the data, and the consistency of responses induced by 
the chemical across different studies. (Id. at pg. 30) The FQPA Policy 
Paper notes that this integrative approach is important because ``for 
example, positive animal findings may be diminished by other key data 
(e.g., toxicokinetic or mechanism of toxicity information), or 
likewise, a weak association found in epidemiological studies may be 
bolstered by experimental findings in animal studies.'' (Id. at pg. 31) 
Moreover, it is important to consider other factors concerning the 
biological responses observed in the young relative to the adult 
effects, such as ``progression, severity, recovery time or persistence, 
and dose-response . . . . For example, there would be greater concern 
for effects that were irreversible and of a greater potential 
consequence to the young compared to observed effects in adults that 
are of a transient and minimal nature, even when they occur at the same 
dose.'' (Id. at pg. 33) The FQPA Policy Paper notes that ``[w]hen 
sufficient human data are available to judge that an adverse 
developmental outcome is related to exposure, the degree of concern 
increases,'' although ``sufficient human evidence is very difficult to 
obtain.'' (Id.) Another factor influencing the degree of concern is the 
relationship between dose and response. Where the dose-response 
relationship is well-characterized, there is a lower degree of concern, 
whereas in cases where the opposite is the case, the degree of concern 
may increase. (Id. at pg. 34) Finally, mechanistic data can be helpful 
in evaluating the degree of concern. (Id.)
    In some cases, concerns regarding pre- and postnatal toxicity can 
be addressed by calculating a protective reference dose or margin of 
exposure based on relevant endpoints in the offspring or through the 
use of traditional uncertainty factors. (Id. at pg. 35) OPP risk 
assessors will consider whether the developmental and offspring effects 
are well-characterized in the toxicity database and if other 
appropriate uncertainty factors are already applied for calculating a 
protective RfD; if so, then ``there would normally be no need for an 
additional FQPA safety factor to address potential pre- and postnatal 
toxicity.'' (Id.) However, in some instances, ``data may raise 
uncertainties or a high concern for infants or children which cannot be 
addressed in the derivation of an RfD or MOE''. (Id. at pg. iv) If so, 
``those residual concerns or uncertainties should be addressed through 
retention of the default FQPA safety factor . . . .'' (Id. at pg. 35)
    If there is a high level of confidence that the combination of the 
hazard and exposure assessments is adequately protective of infants and 
children, then the presumption in favor of the additional 10X default 
FQPA safety factor would be obviated and the risk assessor should 
recommend that a different FQPA safety factor be applied . . . . 
Conversely, if the risk assessor finds evidence of pre- or postnatal 
toxicity or problems with the completeness of the toxicity or exposure 
databases and these uncertainties have not been adequately dealt with 
in the toxicity and/or exposure assessments (through use of traditional 
uncertainty factors or conservative exposure assumptions), then the 
default additional 10X safety factor should be retained.'' (Id. at pgs. 
51 and 52)
    If the degree of concern for the potential pre- or postnatal 
uncertainty is high, the default 10X FQPA safety factor will typically 
be retained, unless there is ``reliable data'' to account for and 
describe the level of uncertainty regarding the potential for pre- or 
postnatal toxicity. (Id. at pg. 30) ``If the uncertainty can be 
addressed by reliable data, the risk assessor should recommend use of a 
different FQPA safety factor . . . to protect the safety of infants and 
children.'' (Id.) In the FQPA Policy Paper, EPA explains that 
``reliable data'' must ``be sufficiently sound such that OPP could 
routinely rely on such information in taking regulatory action.'' (Id. 
at pg. A-5) As part of determining whether a different margin of safety 
would be safe, the paper indicates that the risk assessment should 
focus on whether the ``combination of data and reasonable scientific 
judgment,'' taking into account relevant information and data, would 
lead to a conclusion that the ``hazard or exposure . . . will not be 
underestimated.'' (Id. at pg. A-8)
d. Reliance on Epidemiological Data
    i. Objection subissue. The Objectors assert that EPA's retention of 
the 10X FQPA safety factor to account for scientific uncertainties in 
the epidemiological data was unlawful. Citing the lack of underlying 
data and EPA's inability to reproduce or verify the conclusions of the 
studies, the Objectors claim that the epidemiological data are 
incomplete, invalid, and unreliable. As a result, Objectors argue

[[Page 11252]]

that the ``scientific uncertainties'' in those epidemiological data 
cannot be used to justify retention of the 10X FQPA safety factor. 
Gharda also asserts that the FFDCA does not allow application of the 
10X FQPA safety factor based on unreliable epidemiological studies, 
``particularly where a 10X safety factor results in the elimination of 
many important crop uses.'' (Ref. 39 at pg. 48) In essence, the 
Objectors are arguing that EPA acted arbitrarily and capriciously in 
considering the epidemiological studies in its WOE analysis.
    ii. Denial of objection subissue. To the extent the Objectors are 
arguing that EPA cannot, as a matter of law, rely on epidemiological 
studies where the underlying raw data is unavailable or EPA cannot 
independently verify or reproduce the studies' conclusions, that 
objection is denied. There is no requirement for epidemiological 
studies to be supported by the raw data before the Agency can rely on 
them. On the contrary, a rule promulgated in January 2021, which would 
have required EPA to give heightened consideration to studies for which 
underlying data were publicly available, was judicially vacated one 
month after its issuance. (EDF v. EPA, 515 F. Supp. 3d 1135 (D. Mt. 
Jan. 27, 2021); 86 FR 29515, June 2, 2021 (FRL-10024-32-ORD) (removal 
of regulatory provisions from Code of Federal Regulations))
    Significantly, the idea that these epidemiological studies are 
unreliable without the raw data was soundly rejected by the Ninth 
Circuit as applied to the chlorpyrifos studies. In a departure from its 
previous statements about the epidemiological studies, in the 2019 
Denial Order and in the attendant litigation, EPA argued that the 
epidemiological data was invalid, incomplete, and unreliable due to the 
lack of underlying data and thus should not be considered by the Agency 
in assessing chlorpyrifos. The Ninth Circuit rejected EPA's reasoning 
as follows:
    ``[W]hile the EPA might reasonably conclude that divergences from 
international protocols and lack of access to raw data might affect the 
weight the EPA accords to these studies, they are nowhere near enough 
to show that the studies are entirely unreliable. The FFDCA requires 
the EPA to consider the ``information'' that is ``available'' and to 
make a safety determination based on that information. In this case, 
live animal studies showing sex-linked, neurotoxic harms from in utero 
chlorpyrifos exposure are available--even if such studies are 
supposedly not perfectly aligned with (unspecified) international 
standards. And peer-reviewed cohort studies showing harms to infants' 
neurological development following their mothers' exposure to 
chlorpyrifos are available--even if the underlying data is not. The EPA 
speculates that it might find an error if the unspecified international 
standards were applied to the animal studies or if the data from the 
Human Cohort Studies were available. But that is all it is: 
Speculation. Such speculation ``runs counter to the evidence before the 
agency,'' so it cannot form the basis for denying the 2007 Petition.'' 
(Id. pgs. 699 and 700 (citations excluded))
    Moreover, in its recent framework document concerning the use of 
epidemiology studies, EPA recognizes that it is quite common and 
understood that certain information may be unavailable in epidemiology 
studies or suffer some limitations that may impede their use in 
quantitative risk assessment. (Ref. 19 at pgs. 10 and 16) That does not 
mean EPA cannot rely on these studies or use them to inform risk 
assessment. Often, such studies can ``provide insight into the effects 
cause by actual chemical exposures in humans and thus can contribute to 
problem formulation and hazard/risk characterization.'' In addition, 
epidemiological data ``can guide additional analyses or data 
generations . . . , identify potentially susceptible populations, 
identify new health effects, or confirm the existing toxicological 
observations.'' (Id. at pg. 4) Epidemiology studies ``have the 
potential to help inform multiple components of the risk assessment'', 
e.g., qualitative comparisons between outcomes in epidemiologic studies 
to those in in vitro and animal studies to evaluate the human relevance 
of animal findings or assessing the biological plausibility of 
epidemiologic outcomes. (Id. at pg. 16)
    Turning to the epidemiology studies themselves, there is extensive 
evidence in the record to support EPA's scientific decision to include 
those studies as part of its WOE analysis. Until its statements in the 
2019 Denial Order and attendant litigation, which was rejected by the 
Ninth Circuit, EPA had concluded that the three prospective cohort 
studies (CCCEH, Mt. Sinai, and CHAMACOS, as described in Unit 
III.A.1.b.ii. of this document) were ``strong studies which support a 
conclusion that chlorpyrifos likely played a role in these 
[neurodevelopmental] outcomes.'' (Ref. 20 at pg. 33) Having considered 
the strengths and limitations of the studies, EPA concluded that the 
observed positive associations between in utero chlorpyrifos exposures 
and adverse neurodevelopmental effects were unlikely the result of 
errors in the design of the study. (Id.) While EPA did identify 
limitations in the studies, overall, EPA found the studies to be sound 
and worthy of consideration as part of a WOE analysis of available data 
concerning the potential pre- and postnatal toxicity of chlorpyrifos.
    Under EPA's Epidemiologic Framework, ``human health 
characterizations involve the consideration of all available and 
relevant data, including but not limited to human studies/epidemiology 
. . . .'' (Ref. 19 at pg. 12) In evaluating epidemiology studies for 
use in pesticide risk assessment, EPA considers the ``quality of 
epidemiologic research, sufficiency of documentation of the study 
(study design and results), and relevance to risk assessment.'' (Id. at 
pg. 21) EPA will take into consideration various aspects of the study, 
including, but not limited to, adequacy of the exposure assessment, 
sample population and statistical power of the study, reliability of 
identifying affected individuals, adequacy of method for identifying 
confounding variables, characterization of systematic biases, among 
others. (Id. at pgs. 22 through 36)
    For the epidemiology studies incorporated into EPA's WOE analysis, 
EPA fully evaluated and characterized the strengths and limitations of 
those studies consistent with its Framework Document. (Ref. 20 at pgs. 
32-49) Despite limitations in the studies, EPA found ``considerable 
strengths in study design, conduct, and analyses demonstrated'' in the 
three cohort studies, including using prospective birth cohorts as a 
strong study design; using several methods for measuring pesticide 
exposure; using well-established, validated analytical tools for 
ascertaining developmental outcomes; measuring, analyzing, and 
adjusting for potentially confounding variables. Balancing those 
strengths against the limitations (one-time measure of exposure to 
assess prenatal exposure, lack of assessment of influence of mixtures, 
and small sample size, as well as lack of understanding of a critical 
window of exposure), EPA concluded that ``these data present an 
informative body of evidence with some notable consistencies across 
studies.'' (Id. at pg. 34)
    Therefore, there is no merit to the Objectors' claim that it was 
unlawful for EPA to rely on the epidemiological studies in its 
assessment of chlorpyrifos. There is no requirement for the underlying 
data to be made available before EPA can rely on these studies,

[[Page 11253]]

and EPA had a rational scientific basis for including such data in its 
review in order to satisfy its statutory obligation to consider all 
data concerning the special susceptibility of infants and children.
e. Whether There Are ``reliable data'' Supporting a Different FQPA 
Safety Factor
    i. Objection subissue. By objecting to the retention of the 10X 
FQPA safety factor, the Objectors appear to assert that EPA had 
``reliable data'' to support a different margin of safety than the 
default 10X FQPA safety factor. However, most Objectors (Sugarbeet 
Associations, Gharda, Minor Crop Farmer Alliance) argue that because 
the epidemiological data is allegedly unreliable, the data should not 
be utilized. (Refs. 37, 39, and 49) Thus, removing the epidemiological 
data from consideration erases ``uncertainties'' and removes the need 
to retain the default safety factor. As EPA has demonstrated, the 
epidemiological studies have been evaluated and have been determined to 
support the conclusion of a potential effect on the developing brain 
associated with chlorpyrifos exposure.
    The Coalition of OP Registrants assert that the toxicological 
profile of chlorpyrifos and other OPs indicates that the 
acetylcholinesterase inhibition endpoint is protective of the 
neurodevelopmental effects and thus the 10X FQPA safety factor was 
unnecessary to protect infants and children. (Ref. 53) Moreover, 
although noting that work concerning the New Approach Methodologies 
(NAMs) is ongoing, the Coalition of OP Registrants and the Agricultural 
Retailers Association, et al., assert that NAMs would also support the 
position that the acetylcholinesterase inhibition endpoint would be 
protective of adverse neurodevelopmental effects. (Refs. 47 and 53)
    ii. Denial of objection subissue. As noted previously, the FQPA 
amended the FFDCA to include an additional tenfold margin of safety to 
ensure the protection of infants and children. EPA may use a different 
margin of safety ``only if, on the basis of reliable data, such margin 
will be safe for infants and children.'' (21 U.S.C. 346a(b)(2)(C)) 
Thus, the presumption is to retain the 10X FQPA safety factor, unless 
there are reliable data to support a conclusion that a different safety 
factor will protect infants and children, taking into consideration 
potential pre- and postnatal toxicity and any residual uncertainties in 
the toxicity and exposure databases. Rather than requiring EPA to 
justify why the default factor is retained, the statute puts the burden 
on EPA to ensure that there are ``reliable data'' supporting a 
conclusion that a different safety margin would be protective for 
infants and children. Contrary to Gharda's implication, the FFDCA 
provides no flexibility for EPA to consider impacts on registrants or 
users of a pesticide when determining whether the available data is 
sufficiently reliable; this determination, much like the ``reasonable 
certainty of no harm'' standard is a purely risk-only standard, 
intended to ensure protection of infants and children from the harmful 
impacts of a pesticide.
    As discussed in the FQPA Policy Paper, where there is a high degree 
of concern for potential pre- and postnatal toxicity, where data raise 
uncertainties or a high concern for infants or children that cannot be 
addressed through traditional uncertainty factors or other tools, those 
residual concerns or uncertainties should be addressed through 
retention of the default FQPA safety factor. (Ref. 9 at pg. 35) If 
there are ``reliable data'' that can account for the uncertainty 
regarding the potential for pre- or postnatal toxicity, a different 
FQPA safety factor may be appropriate. (Id. at pg. 30) As noted 
previously, ``reliable data'' must ``be sufficiently sound such that 
OPP could routinely rely on such information in taking regulatory 
action'' and would lead to a conclusion that the ``hazard or exposure . 
. . will not be underestimated.'' (Id. at pgs. A-5 and A-8)
    As noted previously and in the final rule, acetylcholinesterase 
inhibition remains the most robust quantitative dose-response data in 
the chlorpyrifos toxicity database and thus, has been and continues to 
be the critical effect for quantitative risk assessment. Based on its 
historic experience and confirmation from the 2008 and 2012 SAPs, EPA 
used acetylcholinesterase inhibition as the endpoint for assessing 
chlorpyrifos risks. Despite the robustness of that dataset, the 
Agency's WOE analysis indicates that there is qualitative evidence of 
an association with potential effects on the developing brain and 
chlorpyrifos exposure. As EPA noted in the final rule and in the 2020 
PID, despite several years of study, the science addressing 
neurodevelopmental effects remained unresolved. In the face of that 
uncertainty, and given the potential concerns for neurodevelopmental 
effects in infants and children, the Agency could not conclude that a 
different margin of safety would be safe to infants and children. The 
data considered at the time of the final rule did not resolve the 
uncertainty about the levels at which these effects may occur.
    The purpose of the FQPA safety factor is to ensure the protection 
of infants and children against special susceptibilities identified in 
the toxicological database, including the potential for 
neurodevelopmental effects and effects occurring in utero. While the 
Agency's extensive database on the impacts of chlorpyrifos on 
acetylcholinesterase is well-established, the additional data--
including animal studies, mechanistic studies, as well as 
epidemiological studies--concerning the special susceptibility of 
infants and children and the potential for neurodevelopmental effects 
raised additional questions, and residual uncertainties remain about 
the levels at which those effects may occur. Those uncertainties could 
not be ignored. In the face of unresolved uncertainties, EPA cannot 
determine that a different safety factor would ensure the safety of 
infants and children with regard to these effects. At the time of the 
final rule, EPA did not have sufficient ``reliable data'' to identify a 
different safety factor that would assure protection of infants and 
children.
    At the time of the final rule, EPA acknowledged that ongoing work 
to develop NAMs may inform the assessment of the developmental 
neurotoxicity potential for chemicals, including chlorpyrifos and other 
OPs. EPA noted that it had convened a FIFRA SAP in September 2020 
regarding the use of NAMs, and the SAP released its report and 
recommendations on EPA's proposed use of the NAMs data in December 
2020. (Refs. 23 and 24) In the final rule, EPA stated that the advice 
of the SAP was being taken into consideration and thus ``analysis and 
implementation of NAMs for risk assessment of chlorpyrifos is in 
progress and was unable to be completed in time for use in this 
rulemaking.'' (Ref. 1 at pg. 48325) For purposes of the final rule 
then, EPA did not consider the NAMs data among the information 
available to inform its decision on the safety of chlorpyrifos.
    As noted previously, the FFDCA permits the use of a different 
safety factor only if EPA has ``reliable data'' to support a 
determination that a different factor would be safe for infants and 
children. (21 U.S.C. 346a(b)(2)(C)) At the time of the final rule, 
under pressure to finalize a rule by a tight court-ordered deadline 
from a court that found EPA's delays to be ``egregious'' and a ``total 
abdication'' of its statutory duty, EPA relied heavily on data already 
reviewed. EPA did not conduct any new risk assessments for chlorpyrifos 
or

[[Page 11254]]

incorporate any new data after the Court's decision was issued.
    Courts have recognized that court-imposed deadlines can become a 
``substantive constraint on what an agency can reasonably do.'' (San 
Luis & Delta-Mendota Water Authority v. Jewell, 747 F.3d 581, 606 (9th 
Cir. 2014); see also Am. Iron and Steel Inst. v. EPA, 115 F.3d 979, 
1006-07 (D.C. Cir. 1997) (recognizing that EPA was not required to stop 
process due to new evidence; ``mentioning the new evidence'' in the 
guidance and subsequently announcing use of that new evidence satisfied 
the requirement to deal with the new evidence ``in some reasonable 
fashion'')) In this case, EPA did recognize the NAMs data and its 
relevance, but because the Agency's path for incorporating NAMs into 
risk assessments was not finalized by the Court's deadline, EPA did not 
consider the NAMs data in the context of chlorpyrifos nor incorporate 
that data into any of its risk assessments or risk management 
decisions.
    Although the Objectors suggest that the NAMs data may support the 
conclusion that the AChE endpoint is protective of the potential for 
neurodevelopmental effects in infants and children and thus obviate the 
need to retain the 10X FQPA safety factor, at this time, such 
conclusions are merely speculative. EPA's work on responding to the SAP 
report and developing a path forward for incorporation of the NAMs data 
into risk assessment is ongoing; EPA has not yet finalized its 
approach. When EPA's analysis is complete, EPA will proceed, as 
appropriate, with its use of the NAMs data in accordance with that 
evaluation.
f. Conclusion
    In summary, EPA's inclusion of the epidemiological studies in its 
WOE was reasonable and consistent with sound science and its FQPA 
Policy Paper and Epidemiological Framework. Moreover, given the 
uncertainties surrounding the potential for neurodevelopmental effects, 
EPA's retention of the default 10X FQPA safety factor was consistent 
with the standard to apply the 10X margin of safety unless there is 
reliable data demonstrating that a different margin would be safe for 
infants and children. In any event, as EPA explained at the beginning 
of this section addressing the objection concerning the retention of 
the 10X FQPA safety factor, the question of what FQPA safety factor to 
apply is ultimately not outcome determinative in light of aggregate 
chlorpyrifos exposures resulting from registered uses. Even if EPA were 
to reduce the FQPA safety factor to 1X, the currently registered uses 
still result in aggregate risks of concern, and thus would not change 
the Agency's determination that the tolerances were unsafe and needed 
to be revoked. Therefore, this objection is denied.
3. Objections Related to EPA's Assessment of Drinking Water Exposures
    The Sugarbeet Associations, Gharda, and the Agricultural Retailers 
Association, et al., submitted objections concerning EPA's assessment 
of drinking water exposures. (Refs. 37, 39, and 47) Essentially, there 
were two objections related to drinking water: (1) Whether EPA had a 
rational basis for relying on the April 14, 2016, Chlorpyrifos Refined 
Drinking Water Assessment for Registration Review (2016 DWA) (Ref. 29) 
in the final rule instead of the September 15, 2020 Updated 
Chlorpyrifos Refined Drinking Water Assessment for Registration Review 
(2020 DWA) (Ref. 30) and (2) whether it was reasonable for EPA to 
assess exposures to chlorpyrifos-oxon, a metabolite of chlorpyrifos 
that forms in drinking water, in its drinking water assessment. Both of 
these objections are denied for the reasons discussed in the following 
unit.
a. Reliance on 2016 DWA
    i. Objection. For the objection concerning reliance on the 2016 
DWA, the Objectors claim that because EPA had conducted a more updated 
and refined drinking water assessment in 2020, the Agency could no 
longer rely on the 2016 DWA, which the Objectors allege no longer 
reflected the ``best available science.'' (Ref. 37 at pg. 10) The 
Objectors identify no substantive problems with the analysis of the 
2016 DWA itself but believe that it fails solely because it did not 
incorporate the following refinements that were used in the 2020 DWA: 
(a) New surface water modeling scenarios, (b) Presentation of the 
entire distribution of community water systems percent cropped area 
(PCA) adjustment factors and integration of state-level crop-treated 
data using percent crop treated (PCT) factors, and (c) Quantitative use 
of surface water monitoring data. (Ref. 47 at pg. 7) Gharda further 
claims that EPA could not rely on the 2016 DWA because EPA has failed 
to take into consideration comments submitted in response to the 2016 
DWA. (Ref. 39 at pgs. 31 and 32) Gharda cites Dow AgroSciences LLC's 
Comments on the 2016 Notice of Data Availability, Revised Human Health 
Risk assessment and Refined Drinking Water Assessment for Chlorpyrifos 
and Dow AgroSciences LLC's Response to Objections to EPA's Denial of 
Petition to Revoke All Tolerances and Cancel All Registrations for 
Chlorpyrifos (Ref. 39). Again, Gharda points to no specific 
deficiencies about the 2016 DWA identified in the Dow comments on the 
2016 DWA and Dow Response to Objections; rather, Gharda simply 
summarizes the Dow submissions as commenting that the 2016 DWA is ``an 
overly conservative, screening-level estimate that far over-estimates 
real world exposures and ignores science-based refinements submitted 
by'' Dow (now Corteva) and asserting that the 2016 DWA was ``incomplete 
and unrefined.'' (Id. at pgs. 31 and 32) In addition, Gharda states 
that there were ``significant limitations'' in the 2016 DWA, although 
those limitations seem, again, tied to the absence of the refinements 
in the 2020 DWA. (Id. at pg. 32)
    ii. Background. As described in Unit II.B.1.c.ii.(d), EPA takes a 
tiered approach to assessing drinking water. Lower tiered assessments 
are more conservative based on the defaults or upper-bound assumptions 
and may compound conservatisms, while higher tiers integrate more 
available data and provide more realistic estimates of environmental 
pesticide concentrations. (Ref. 13)
    Over the years, EPA has conducted several drinking water 
assessments for chlorpyrifos and refined those assessments as new 
information and tools became available. In 2011, EPA completed a 
preliminary DWA. (Ref. 26) That assessment recommended use of surface 
water estimated drinking water concentrations (EDWCs) derived from 
modeling and concluded that a range of agricultural uses could lead to 
high levels of chlorpyrifos in surface water that could potentially be 
used by community water systems to supply drinking water. That 
assessment discussed the effects of drinking water treatment on 
chlorpyrifos and concluded that during the chlorination disinfection 
processes, chlorpyrifos can be readily converted to chlorpyrifos-oxon. 
Therefore, chlorpyrifos and its oxon were considered residues of 
concern in the preliminary assessment.
    Taking into consideration public comments on the 2011 preliminary 
DWA, EPA updated that assessment in a 2014 DWA to include additional 
analyses focused on clarifying labeled uses, evaluating volatility and 
spray drift, revising aquatic modeling input values, comparing aquatic 
modeling and monitoring data, summarizing effects of drinking water 
treatment, updating model simulations, and proposing a

[[Page 11255]]

strategy to refine the assessment using community water system-specific 
drinking water intake percent cropped area (PCA) adjustment factors. 
(Ref. 27) This 2014 DWA confirmed the findings of the 2011 preliminary 
DWA, concluding that there were a number of uses that may result in 
exposures to chlorpyrifos-oxon in drinking water at unsafe levels, 
although the 2014 DWA also noted that additional analyses would be 
needed in order to finish identifying specific geographical areas where 
exposures may be of concern. (Id. at pgs. 8 and 9)
    In 2016, EPA conducted a refined drinking water assessment that 
estimated drinking water concentrations based on modeling of all 
registered uses, as well as all available surface water monitoring 
data. That assessment considered several refinement strategies in a 
two-step process to derive exposure estimates for chlorpyrifos and 
chlorpyrifos oxon across the country. The first step was an assessment 
of potential exposure based on the current maximum label rates at a 
national level. This indicated that the EDWCs could be above the DWLOC. 
The second step considered model estimates, as well as measured 
concentrations, at a more localized level and more typical use 
scenarios. This built on the approach presented in the 2014 DWA for 
deriving more regionally specific estimated drinking water exposure 
concentrations for chlorpyrifos and chlorpyrifos-oxon. The results of 
this second-step analysis also concluded that there were high levels of 
chlorpyrifos and chlorpyrifos-oxon in drinking water. (Ref. 29)
    Following the completion of the 2016 DWA, EPA developed refinement 
strategies to examine those estimated regional/watershed drinking water 
concentrations to pinpoint community drinking water systems where 
exposure to chlorpyrifos oxon as a result of chlorpyrifos applications 
may pose an exposure concern. At that time, EPA was anticipating that a 
more refined drinking water assessment might allow EPA to better 
identify where at-risk watersheds are located throughout the country 
for the purpose of supporting more targeted risk mitigation through the 
registration review process. The refinements better account for 
variability in the use area treated within a watershed that may 
contribute to a drinking water intake (referred to as PCA or percent 
use area when considering non-agricultural uses) and incorporate data 
on the amount of a pesticide that is historically applied based on user 
surveys within a watershed for agricultural uses (referred to as PCT). 
These refinement approaches underwent external peer review and were 
issued for public comment in January 2020. (Ref. 54) In addition, EPA 
used average application rates, average numbers of annual applications 
for specific crops, and estimated typical application timing at the 
state-level based on pesticide usage data derived from Kynetec, a 
statistically reliable private market survey database; publicly 
available survey data collected by the USDA; and state-specific 
scientific literature from crop extension experts.
    The recently developed refinements were integrated into the 2020 
DWA. (Ref. 30) Because of how high the estimated drinking water 
concentrations were in the 2016 DWA, it was not expected that the 
exposures for all uses could be refined to a safe level; therefore, the 
Agency decided to focus its refinements for the 2020 updated drinking 
water assessment on a subset of uses in specific regions of the United 
States. The purpose of the focus on this subset of uses was to 
determine whether, if these were the only uses permitted on the label, 
the resulting estimated drinking water concentrations would be below 
the DWLOC. The subset of uses assessed were selected because they were 
identified as critical uses by a registrant or high-benefit uses to 
growers by EPA. That subset of currently registered uses included 
alfalfa, apple, asparagus, cherry, citrus, cotton, peach, soybean, 
sugar beet, strawberry, and wheat, confined to specific areas of the 
country. (Id. at Appendix A) The updated assessment applied the new 
methods for considering the entire distribution of community water 
systems PCA adjustment factors, integrated state level PCT data, and 
included quantitative use of surface water monitoring data in addition 
to considering state level usage rate and data information. The results 
of this analysis indicated that the EDWCs from this subset of uses 
limited to certain regions would be below the DWLOC. (Id. at pgs. 16 
and 17)
    It is important to emphasize that the 2020 DWA ``focuse[d] on a 
subset of currently registered chlorpyrifos uses. . . . The exposure 
estimates reported in [the 2020 DWA] and associated conclusions drawn 
are solely for those uses. . . . Adding additional uses would require 
reassessment and could change estimated drinking water concentrations 
and thus, exposure conclusions, and ultimately the risk conclusion 
relative to the drinking water level of comparison(s).'' (Id. at cover 
memo) In other words, EPA recognized that the subset of assessed uses 
was only one combination of possible subsets that might be safe. 
Recognizing that in response to the Agency's proposal in the 2020 PID, 
registrants or growers could have advocated for a different subset of 
uses or to add different uses or geographic regions, EPA noted that 
additional analyses would need to be completed to determine the 
contributions to drinking water in those impacted regions and whether 
such uses would be safe.
    iii. Denial of objection. The Objectors' primary argument is that 
EPA could not rely on the 2016 DWA (Ref. 29) because the subsequently 
developed refinements used in the 2020 DWA (Ref. 30) meant that the 
2016 DWA, having been conducted without those refinements, did not 
represent the best available science. As EPA acknowledges in the 
background discussion, the 2020 DWA incorporated several refinements, 
including updated surface water scenarios, new methods for considering 
the entire distribution of community water systems PCA adjustment 
factors, integrated state-level PCT data, and a quantitative use of 
surface water monitoring data. (Ref. 30) The 2020 DWA represents one 
of, if not, the highest tiered, most refined drinking water assessment 
EPA has conducted to date. Nevertheless, the availability of the more 
refined 2020 DWA does not make it unlawful for EPA to rely on the 2016 
DWA in the final rule, particularly where the 2020 DWA was confined to 
a scenario that did not exist at the time of the final rule.
    In denying this objection, EPA finds the scope of the 2020 DWA to 
be determinative. As noted previously and in the final rule, the 2020 
DWA evaluated only a subset of the currently registered uses. 
Specifically, the 2020 DWA evaluated only 11 of the over 50 
agricultural use sites and non-agricultural use sites currently 
registered for chlorpyrifos. Moreover, those 11 uses were assessed only 
in specific geographic regions (not all geographic regions in which the 
pesticide is currently being used) based on typical use rates rather 
than maximum labeled application rates. The underlying presumption of 
the 2020 DWA was that chlorpyrifos would not be labeled for any other 
uses, including non-food uses, besides that limited subset. As such, it 
presented a highly refined evaluation of a particular subset of 
predicted uses only; it was not a complete and full assessment of the 
approved uses of chlorpyrifos and thus did not provide an accurate 
picture of aggregate exposures from all currently registered use 
patterns. Although the Sugarbeet Associations assert that EPA could 
have relied on the 2020 DWA

[[Page 11256]]

since it tracks the proposal in the 2020 PID, that argument fails for 
all the same reasons why EPA could not rely on the conclusions in the 
2020 PID to retain the 11 uses, as explained in Unit VIII.C.1. Since 
the FFDCA, in requiring consideration of aggregate exposure, required 
EPA to evaluate food, drinking water, and residential exposures from 
all registered uses, EPA could not rely on the partial assessment of 
registered chlorpyrifos uses for estimated drinking water 
concentrations, unless all other uses were canceled. Doing so would 
have presented an incomplete picture of potential drinking water 
contributions from currently registered uses. Thus, the 2016 DWA, which 
is the most recent EPA assessment of contributions to drinking water 
from all registered uses of chlorpyrifos--and not the 2020 DWA--
represented the most recent, most robust ``best available science'' for 
use by the Agency for the uses on current labels.
    EPA also disagrees with the Objectors' implication that the mere 
existence of new refinement methodologies somehow impacts the 
reliability of the 2016 DWA. At the time the 2016 DWA was issued, it 
represented the most refined drinking water assessment EPA's OPP had 
conducted. It applied all available refinement techniques available at 
that time, including, as discussed previously, using modeled estimates 
and measured concentrations to drill down to drinking water 
contributions on a regionally specific level. The subsequent 
development of additional tools to refine drinking water assessments 
that show risks of concern does not render the 2016 DWA overly 
conservative or otherwise scientifically invalid and unreliable. The 
Agency simply has additional tools and methods that can be applied to 
refine drinking water assessments where appropriate. The Agency's 
Drinking Water Framework notes that moving to the higher tiers that 
were used in the 2020 DWA ``requires a large amount of resources and 
adds a great amount of complexity to the assessment.'' Therefore, 
rather than moving to the higher tiers automatically, ``advancement to 
Tier 4 should be done in consultation with the interdivisional chemical 
team.'' (Ref. 13 at pg. 51)
    The question then is whether it was reasonable for EPA not to apply 
the 2020 refinements to all the uses assessed in the 2016 DWA; EPA 
concludes that it was. Following the issuance of the 2016 DWA, in which 
EPA identified EDWCs from registered chlorpyrifos uses that exceeded 
safe levels, EPA met with representatives of Corteva, a chlorpyrifos 
registrant, about whether additional information about critical uses to 
growers could be used to refine the 2016 DWA as part of the ongoing 
work in registration review to assess uses of chlorpyrifos. (Ref. 51) 
Given the large number of uses and high estimates across various 
vulnerable watersheds throughout the country, EPA focused its resources 
to apply the refinement strategies on assessing whether a subset of 
uses that were identified by Corteva as critical and considered by EPA 
to present high benefits to chlorpyrifos users could result in EDWCs 
lower than the DWLOC.
    Once EPA determined the appropriate subset of uses to evaluate, EPA 
dedicated extensive resources to apply the newly developed 
methodologies, including gathering PCT data from states in which the 
specific crops to be retained were grown, to those uses to determine if 
the resulting uses would result in estimated drinking water 
concentrations of chlorpyrifos below the Agency's relevant level of 
concern, i.e., the DWLOC. This approach is consistent with the Agency's 
standard practice during registration review; for pesticides that pose 
risks of concern, EPA will typically consider whether any mitigation is 
available that would allow the pesticide to meet the registration 
standard, including the FFDCA safety standard. (See 40 CFR 155.53 and 
155.56) For chlorpyrifos, for which the Agency had identified high 
levels of risk in 2016, EPA decided to focus on whether there was a 
mitigation package that would allow some uses of chlorpyrifos to be 
considered safe.
    Starting with a hypothetical ``blank label'' with no registered 
uses and adding back just the 11 geographically and application rate 
limited uses, i.e., assuming all other current uses did not exist, EPA 
assessed the subset of aforementioned uses applying the new refinement 
techniques. That analysis resulted in estimates of chlorpyrifos 
concentrations in drinking water below the DWLOC, which provided a 
basis for EPA to propose that subset of uses for mitigation of risk in 
the 2020 PID. For some areas, the estimated drinking water 
concentrations from combinations of those 11 uses were close to the 
DWLOC, so there was not much room in the risk cup for adding more uses. 
For example, EPA concluded that use of chlorpyrifos on alfalfa, 
sugarbeet, and soybean in the Upper Mississippi region (HUC-07) or on 
alfalfa, sugar beet, soybean, and spring and winter wheat in the 
Souris-Red-Rainy region (HUC-09), the estimated drinking water 
concentrations were 3.2 ppb and 3.3 ppb, respectively; for comparison, 
a concentration of 4.0 ppb or above would exceed safe levels of 
chlorpyrifos in those areas. (Ref. 31 at pg. 16) Because EPA was trying 
to evaluate a specific subset of uses for purposes of providing a 
mitigation option in the proposed registration review decision and 
because that evaluation indicated that that subset alone would not pose 
risks of concern, EPA did not engage in further refinements of other 
uses from the 2016 DWA to determine if other hypothetical uses could be 
safe. EPA, however, recognized the possibility that additional or 
different uses might be requested following that proposal and cautioned 
that, if so, additional assessment would need to be conducted to 
support risk management decisions for those other uses.
    Thus, at the time the 2020 DWA was conducted, it was reasonable 
that EPA did not expand the application of refinements beyond the 11 
uses assessed. It was also reasonable that EPA did not engage in 
refinements of the rest of the uses in the 2016 DWA in preparation of 
the final rule. As EPA has indicated throughout this Order, given the 
time constraints imposed on the Agency by the court-ordered deadline, 
EPA did not conduct any new risk assessments, including any new 
drinking water assessments to further refine the 2016 DWA for all 
registered uses. To apply the refinements to all currently registered 
uses would have required an extraordinary investment of resources and 
time, which EPA did not have in light of the Court's deadline. 
Consequently, EPA relied on the best available science it had available 
to assess the currently registered uses as required at the time of the 
final rule--the 2016 DWA. This objection is denied.
b. Assessing Chlorpyrifos-Oxon
    In addition to opposing the use of the 2016 DWA in the final rule, 
the Agricultural Retailers Association, et al., and Gharda assert that 
EPA's assessment of aggregate exposure should not have considered 
chlorpyrifos-oxon, a metabolite of chlorpyrifos.
    i. Objection regarding lack of exposure. (A) Objection. The 
Agricultural Retailers Association, et al. note that the 2016 DWA 
stated that there were ``no detections of chlorpyrifos-oxon degradates 
in any finished drinking water samples that people actually consume.'' 
(Ref. 47 at pg. 7) Thus, the Agricultural Retailers Association, et al. 
argue that it was arbitrary and capricious for EPA to assess the 
exposures of chlorpyrifos oxon in drinking water.
    (B) Denial of objection. EPA has extensive reliable data supporting 
its

[[Page 11257]]

conclusion that chlorpyrifos-oxon will be present in at least some 
drinking water. It is well understood that chlorpyrifos rapidly 
oxidizes to form chlorpyrifos-oxon almost quantitatively (i.e., nearly 
100% conversion of chlorpyrifos into equal quantities of chlorpyrifos-
oxon) during drinking water treatment with chlorination. While 
chlorination is the most common drinking water treatment, there are 
some areas that use different disinfection processes, such as those 
using chloramines, which are less effective at converting chlorpyrifos 
to its oxon, so, the resulting drinking water may contain combination 
of residues of chlorpyrifos and its oxon.
    Currently, there are no data available on the removal efficiency of 
chlorpyrifos prior to chlorination or the removal efficiency of 
chlorpyrifos-oxon after formation. Stability studies indicate that once 
chlorpyrifos-oxon forms, little transformation is likely to occur 
between water treatment and consumption of the drinking water; the 
chlorpyrifos-oxon has been shown to be relatively stable following 
drinking water treatment (i.e., with a half-life of 12 days). While 
some drinking water treatment procedures, such as granular activated 
carbon filtration and water softening, may reduce the amount of 
chlorpyrifos-oxon in drinking water, it is unlikely that these 
treatment processes completely remove chlorpyrifos-oxon from drinking 
water. In addition, these treatment methods are not typical practices 
across the country for surface water. For these reasons, it is 
reasonable for EPA to assume that drinking water will contain 
chlorpyrifos-oxon residues as a result of water treatment systems. 
(Ref. 26 at pgs. 2, 22 and 23)
    The Agricultural Retailers Association, et al. point out that the 
2016 DWA states that there have been no detections of chlorpyrifos oxon 
in finished water samples. (Ref. 47 at pg. 7; Ref. 29 at pg. 111) While 
it is correct that the 2016 DWA contains this statement, the lack of 
detections in finished water does not mean that chlorpyrifos-oxon is 
not present in some drinking water. There were several detections in 
the monitoring data of both chlorpyrifos and oxon in filtered and 
unfiltered surface water, and in surface water with known particulates 
(Ref. 29 at pgs. 97 through 113), so it is clear that chlorpyrifos and 
its oxon are present in at least some drinking water. Chlorpyrifos 
found in surface water that enters a drinking water treatment plant 
will be converted in most instances, as indicated previously, into 
chlorpyrifos-oxon before it leaves the plant and travels to consumers. 
There are several reasons why chlorpyrifos and chlorpyrifos[hyphen]oxon 
may not have been detected in finished drinking water, including sample 
site location, sampling frequency, as well as drinking water treatment 
not involving chlorination that may lead to less oxon formation. There 
is insufficient data available to determine if the community water 
systems sampled for chlorpyrifos to date are located in watersheds 
vulnerable to chlorpyrifos contamination. (Ref. 29 at pg. 10) Due to 
the limitations of monitoring data, EPA cannot conclusively determine 
that chlorpyrifos-oxon will not be present in some drinking water, in 
light of the available science demonstrating conversion of chlorpyrifos 
to its oxon during chlorination, which occurs in the vast majority of 
major drinking water treatment systems throughout this country.
    ii. Objection regarding lack of toxicity. (A) Objection. Gharda 
objects to EPA's assessment of chlorpyrifos-oxon residues in drinking 
water because Gharda believes that the ``drinking water risks 
associated with the oxon are not a risk concern for any agricultural 
uses of chlorpyrifos and should not be part of the EPA's aggregate risk 
assessment or serve as a basis for limiting uses of chlorpyrifos.'' 
(Ref. 39 at pgs. 32 and 33) Gharda bases this conclusion on its 
interpretation of the Corteva Oxon Study, which Gharda asserts found 
``(a) no detectable circulating chlorpyrifos oxon in blood, (b) no 
statistically significant AChE inhibition in either RBC or brain, and 
(c) an absence of clinical signs of toxicity or markers of exposure,'' 
and therefore nullified EPA's assumption in the 2020 DWA ``that 
chlorpyrifos oxon is more toxic than the parent chlorpyrifos for 
drinking water exposure purposes.'' (Id. at pg. 32) Gharda argues that 
EPA's failure to consider this study makes EPA's final rule arbitrary 
and capricious.
    (B) Denial of objection. As noted throughout this document, in 
light of the time constraints imposed on EPA by the Court and the 
direction to avoid further delay and fact-finding 14 years after the 
petition to revoke the tolerances had been filed, EPA focused on 
information already assessed to determine whether the chlorpyrifos 
tolerances were safe. The Agency did not conduct any additional 
analyses of other data, including review of the Corteva Oxon Study, due 
to the time constraints that were imposed on the Agency by the Ninth 
Circuit's deadline. That study had not been incorporated into any 
Agency's risk assessments at the time of the final rule, given that 
this study was submitted to EPA in December 2020, after the Agency's 
risk assessments on chlorpyrifos had been finalized (in September 
2020). Due to the ongoing status of registration review, the Agency has 
not yet determined whether--and if so, how--to integrate this study 
into any risk assessment. Therefore, the final rule was not arbitrary 
and capricious for failure to incorporate this study into the completed 
risk assessments.
    In any event, as EPA indicated in Unit VII.C.2., Gharda has failed 
to demonstrate how EPA could conclude that the tolerances are safe, 
even if EPA were able to incorporate this study into its assessment and 
agreed that the oxon was not relevant for risk assessment purposes. 
Also as discussed in Unit VII.C.2., EPA has concluded that even 
assuming that chlorpyrifos-oxon is not more toxic than chlorpyrifos and 
thus should not be the residue of concern for evaluating exposures in 
drinking water, the concentrations of the parent compound, 
chlorpyrifos, in drinking water would still result in exposures that 
were unsafe. Based on a comparison of 2016 DWA estimates of 
chlorpyrifos residues in drinking water to the chlorpyrifos DWLOC, 
registered uses of chlorpyrifos result in levels of chlorpyrifos in 
drinking water that would exceed safe levels of chlorpyrifos exposure. 
Therefore, this objection is denied for failure to demonstrate that 
using the Corteva Oxon Study would have a material impact on the 
Agency's safety finding.
4. Procedural Considerations
    A number of objections were filed raising a variety of process 
claims: Failure to consider public comments on the Agency's 2015 
proposal to revoke chlorpyrifos tolerances in response to the 2007 
Petition and on the 2020 PID; delayed opening of the portal for 
submission of objections; and failure to comply with requirements for 
interagency coordination under Executive Order 12866. These objections 
are denied for the reasons discussed in this unit.
a. Prior Comments
    i. Objection. The Sugarbeet Associations and CLA/RISE assert that 
the failure to consider and respond to the more than 90,000 comments on 
the 2015 proposed rule and the comments submitted in response to the 
2020 PID is inconsistent with the principles of due process and 
transparency. (Refs. 37 and 50)
    ii. Denial of objection. EPA denies this objection for lack of 
specificity and

[[Page 11258]]

relevance. EPA's regulations require that an objection ``[s]pecify with 
particularity the provision(s) of the . . . regulation . . . objected 
to, the basis for the objection(s), and the relief sought.'' (40 CFR 
178.25(a)(2)) The objection claiming that EPA must consider the 90,000 
comments on a prior proposed rule fails to meet this test. Other than 
objecting to EPA's not having considered those prior comments, the 
objections do not specify a particular aspect of the final rule that is 
problematic. Neither do the objectors point to anything specifically 
raised in the comments on the 2015 proposed rule that would support a 
particular objection they have to the rule. Without something specific 
to address, these comments as a general matter are not relevant to the 
Agency's final rule, for the reasons articulated directly following 
this discussion in this document. For this reason, this objection is 
denied as not conforming to the required form of objections. (40 CFR 
178.30(a)(1))
    Moreover, EPA does not believe that responses to the comments 
submitted on the 2015 proposed rule are required before proceeding with 
this final action, due to the unique regulatory structure provided 
under the FFDCA. The FFDCA sets up three options for EPA in responding 
to a petition seeking revocation of tolerances: (1) To issue a final 
rule establishing, modifying or revoking a tolerance; (2) to issue a 
proposed rule subject to public comment and thereafter issue a final 
rule; or (3) to issue an Order denying the petition. (21 U.S.C. 
346a(d)(4)(A)(i), (ii), (iii)) The 2015 proposed rule was issued in 
response to the 2007 Petition under the second option provided in the 
statute. (21 U.S.C. 346a(d)(4)(A)(ii)) Based on comments submitted in 
response to that proposed rule, EPA conducted additional risk 
assessments, which were also released for public comment. (See 
Chlorpyrifos; Tolerance Revocations; Notice of Data Availability and 
Request for Comment (81 FR 81049, November 17, 2016) (FRL-9954-65)) No 
formal responses to those comments were ever finalized, as soon 
thereafter, EPA abandoned the proposed rule and issued the 2017 Order 
Denying Petition under the third option provided in the statute. (21 
U.S.C. 346a(d)(4)(A)(iii)) EPA's final rule was issued under the first 
option provided by the statute--to issue a final rule establishing, 
modifying, or revoking a tolerance without public comment. In sum, the 
statute provides EPA with choices on how to act and does not constrain 
EPA's ability to follow any of the statutory paths.
    After EPA denied objections to the 2017 Order Denying Petition in 
2019, a lawsuit was filed, and the Ninth Circuit vacated the 2017 and 
2019 Orders and directed EPA to ``publish a legally sufficient final 
response to the 2007 Petition within 60 days of the issuance of the 
mandate.'' (LULAC, 996 F.3d at pg. 703) Notably, the court also 
specifically ordered EPA to issue a final rule either revoking or 
modifying chlorpyrifos tolerances under the first option provided in 
the statute, which provides for the issuance of a final rule ``without 
further notice and without further period for public comment.'' (21 
U.S.C. 346a(d)(4)(A)(i)) Since the Court directed EPA to proceed with a 
final rule without directing EPA to finalize the 2015 proposed rule, 
EPA interpreted the Court's mandate as requiring an independent final 
rule based on available information, not a finalization of the prior 
rule. The Court's strict deadline for finalizing the rule further 
suggests that the Court did not expect EPA to formalize responses to a 
large number of potentially stale comments. As such, EPA is not 
obligated to respond to comments on a rule that was never finalized.
    With regard to the comments submitted in response to the 2020 PID, 
those comments were submitted in response to the separate registration 
review action. As a separate action, EPA is also not obligated to 
respond to those comments as part of its final rule. That registration 
review process for chlorpyrifos is ongoing, and EPA is still reviewing 
the comments received in connection with that process and was not in a 
position at the time of the final rule to have finalized its responses 
to those comments. It is also worth noting that, as alluded to earlier 
in Unit VIII.C.1.a. of this document, the scope of the registration 
review differs from that of the final rule, i.e., registration review 
under FIFRA also includes consideration of environmental risks and 
benefits information that are not relevant to the Agency's final rule 
decision. As a result, several of the comments are not likely to be 
relevant to the final rule.
    Finally, to the extent any objector believes that a comment on the 
2015 proposed rule or the 2020 PID raises specific substantive 
challenges that should have been considered in the final rule, the 
FFDCA affords the exact due process they seek. Under the special 
administrative procedures provided in FFDCA section 408(g), ``any 
person may file objections thereto with the Administrator, specifying 
with particularity the provisions of the regulation or Order deemed 
objectionable and stating reasonable grounds therefor.'' (21 U.S.C. 
346a(g)(1)) Any objector can take advantage of the due process allowed 
by the FFDCA and submit any specific comments for Agency consideration 
as an objection to the final rule. Because of the opportunity to 
provide such objections directly to EPA as part of the objections 
process, there is no due process violation for not responding to 
comments on a proposed rule that was never finalized or to comments 
submitted on a separate regulatory action that remains ongoing.
b. Objections Portal
    i. Objection. The American Soybean Association argues that the 
final rule failed to provide adequate procedural due process as a 
result of technical delays in opening the Federal eRulemaking Portal 
for submission of objections. (Ref. 36 at pgs. 3 and 4) The American 
Soybean Association states that on October 12, 2021, its staff 
discovered that the docket for the final rule was not open to accepting 
comments. The American Soybean Association speculates that having the 
objections portal disabled for any portion of the objections period 
could have prevented individual growers from being able to submit 
objections, thus denying them the right to object to the final rule.
    ii. Denial of objection. EPA denies this objection. EPA's 
regulations require that objections be filed with the Hearing Clerk no 
later than 60 days following publication of the final rule in the 
Federal Register in accordance with EPA's regulations in 40 CFR part 
178. (See 40 CFR 178.25(a)(6) and (7)) This mandatory requirement, 
including the direction to submit filings through the Office of 
Administrative Law Judges' electronic filing system, was clearly laid 
out in EPA's final rule, as the American Soybean Association notes. In 
addition to the mandatory filing of objections with the Hearing Clerk, 
EPA also requests that objectors submit their filed objections online 
(redacting any Confidential Business Information (CBI)) ``for inclusion 
in the public docket''. This additional step allows submitters to 
ensure the protection of any sensitive information in what is uploaded 
as part of the public docket for the action. This additional request 
does not include a deadline for submissions. The American Soybean 
Association objects only to the delayed opening of this latter online 
public docket.
    While EPA concedes that there were technical issues with the 
opening of the

[[Page 11259]]

Federal eRulemaking Portal, this appears to be a harmless error as 
there is no legal consequence from the delay, and there is no 
indication that anyone was deprived of the opportunity to submit 
objections. Promptly upon receiving notice that the docket for the 
final rule was not open to accepting comments, and well before the 
close of the objection period on October 15, 2021, this issue was 
resolved by EPA. The American Soybean Association and over 100 other 
Objectors were able to submit their objections, hearing requests, and 
requests for stay without issue. While the American Soybean Association 
speculates that individual growers seeking to object might not have had 
the opportunity to do so, EPA did not receive any information 
suggesting that might be the case. On the contrary, EPA received dozens 
of submissions to the Federal eRulemaking Portal from individual 
growers, which were filed as both standalone objections (see the 
objections filed by individual growers Chris Hill, Willard Jack, Steve 
Kelley, Andrew Lance, Alan Meadows, and Joel Schreuers, Ref. 1) and 
included in a transmittal of 93 independent comment letters submitted 
by the Sugarbeet Associations (Ref. 37, Attachment 4).
c. Interagency Review Process
    i. Objection. The Sugarbeet Associations, Gharda, and the 
Agricultural Retailers Association argue that EPA failed to comply with 
Executive Order 12866, Regulatory Planning and Review (58 FR 51735, 
October 4, 1993), and thus deprived other federal agencies an 
opportunity to provide feedback on the final rule. (Refs. 37, 39, and 
47) The Objectors argue that the final rule is a ``significant 
regulatory action'' as defined in the Executive order, noting that EPA 
estimated a high-end annual economic benefit of chlorpyrifos of $130 
million, based on higher-cost alternatives and pest damage. (Ref. 56 at 
pg. 39) The Agricultural Retailers Association, et al. and Gharda both 
argue in the alternative that the final rule meets the definition of a 
significant regulatory action in that it is ``likely to adversely 
affect the entire agricultural economy, jobs, productivity, and our 
environment.'' (Ref. 39 at pgs. 47 and 48; Ref. 47 at pg. 4) In 
addition, Gharda and the Sugarbeet Associations assert that tolerance 
revocations are not covered by Office of Management and Budget's (OMB) 
guidance on Executive Order 12866, which excepts tolerance actions from 
OMB review, because that guidance excludes from the exemption only 
``those [tolerance actions] that make an existing tolerance more 
stringent.'' (Ref. 39 at pg. 47; Ref. 47 at pg. 12)
    ii. Background. Executive Order 12866 provides that ``significant 
regulatory actions'' must be submitted for review to the Office of 
Information and Regulatory Affairs in OMB. A significant regulatory 
action is generally any regulatory action that is likely to result in a 
rule that might, among other things, have an annual effect on the 
economy of $100 million or more or adversely affect in a material way 
the economy, a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or State, local, or tribal 
governments or communities. After the issuance of Executive Order 
12866, OMB issued Guidance for Implementing E.O. 12866, which exempted 
tolerance actions under the FFDCA from Executive Order 12866 review, 
``except those that make an existing tolerance more stringent.'' (Ref. 
55)
    iii. Denial of Objection. As an initial matter, EPA notes that 
Executive Order 12866--like most, if not all, executive orders--
explicitly says that it ``does not create any right or benefit, 
substantive or procedural, enforceable at law or equity by a party 
against the United States, its agencies or instrumentalities, its 
officers or employees, or any other person.'' (58 FR 51744) Thus, not 
submitting the final rule to OMB cannot constitute a violation of any 
law, such that a reviewing court could reasonably be expected to find 
that EPA's action was ``not in accordance with law'' under 5 U.S.C. 
706(2)(A) or ``without observance of procedure required by law'' under 
5 U.S.C. 706(2)(D). Therefore, this is not a judicially reviewable 
issue. Moreover, EPA notes that resolution of this particular objection 
has no bearing on any substantive issues with the final rule that are 
raised separately in other objections. Thus, this objection is denied.
    In any event, EPA disagrees that the final rule revoking 
chlorpyrifos tolerances triggers the Executive Order 12866 interagency 
review requirements. EPA believes the OMB guidance regarding Executive 
Order 12866 and its application to pesticide tolerance actions can be 
interpreted to mean that a pesticide tolerance is made ``more 
stringent,'' and thus subject to Executive Order 12866 requirements, 
when EPA does not make accommodations for affected parties to adjust to 
the impacts of the rule. With respect to the revocation of tolerances 
for chlorpyrifos, however, the final rule provided a meaningful period 
of time for affected parties to adjust to the rule's impact, in light 
of the identified safety concerns. Specifically, EPA provided six 
months between the publication of the final rule and its effective 
date, which far exceeds the 30-day effective date requirement contained 
in the Administrative Procedure Act. In addition, this approach is both 
consistent with the Agency's obligations under the World Trade 
Organization Agreement on the Application of Sanitary and Phytosanitary 
Measures and, in the Agency's view, generous in light of the Agency's 
conclusion that chlorpyrifos tolerances were not safe. Finally, this 
approach is consistent with the Agency's approach for other pesticide 
tolerance revocations that EPA determined were not subject to Executive 
Order 12866; see, e.g., EPA's revocations of tolerances for carbofuran 
in 2009 (74 FR 23045), butylate, clethodim, dichlorvos, dicofol, and 
isopropyl carbanilate, et al. in 2012 (77 FR 59120), and tebufenozide 
in 2017 (82 FR 53423).
    For all the foregoing reasons, the objection regarding Executive 
Order 12866 and interagency review is denied.
5. Objections That, As a Matter of Law, Do Not Provide a Basis for 
Leaving Tolerances in Place
    Many Objectors suggested that EPA's final rule was inappropriate on 
grounds that are immaterial to the question of whether tolerances can 
be maintained under the FFDCA. The FFDCA and EPA's regulations require 
that objections identify a particular aspect of the final rule deemed 
objectionable and specify with particularity the provision of the 
regulation objected to and the relief sought. (21 U.S.C. 346a(g)(2), 40 
CFR 178.25(a)(2)) In addition, the objection must seek relief that is 
consistent with the FFDCA. (40 CFR 178.30(a)(2)) Objections that do not 
meet these conditions will be denied. The objections discussed in this 
sub-unit provide no reliable information pertaining to the FFDCA safety 
standard in section 408(b)(2) that could support leaving the tolerances 
in place. Because these complaints are meritless on their face, these 
objections are denied. EPA provides further discussion in this unit.
a. Economic and Environmental Impacts
    i. Objection. A majority of Objectors, including the Agricultural 
Retailers Association, et al., the Sugarbeet Associations, American 
Soybean Association, Cherry Marketing Institute, and 93 sugarbeet 
growers as part of a mass mailer, allege that the revocation of 
chlorpyrifos tolerances will have detrimental impacts on their crops 
due to increased pest pressure, force growers

[[Page 11260]]

to use more expensive and less efficacious alternatives, and result in 
harmful effects on the environment. (Ref. 1)
    ii. Denial of objection. EPA appreciates that the revocation of 
chlorpyrifos tolerances will have an impact on growers who use the 
pesticide and the agricultural industry. Chlorpyrifos is a widely used 
pesticide that has been registered for many uses since 1965. As part of 
the registration review process under FIFRA, the Agency did evaluate 
the benefits of chlorpyrifos to growers by crop. (Ref. 56) EPA is aware 
that IPM and resistance management are critical pest management 
benefits of many pesticides, and where benefits considerations are 
permitted by law, the Agency takes these aspects into serious 
consideration. However, consideration of information on pesticidal 
benefits to growers or impacts on the environment from loss of a 
pesticide, while relevant considerations under FIFRA (see 7 U.S.C. 
136(bb)), are not factors for consideration under the FFDCA, with one 
exception not applicable here. (See 21 U.S.C. 346a(b)(2)(B))
    The safety standard under the FFDCA is strictly a human-health 
risk-based standard, which does not permit consideration of benefits or 
environmental information, in determining whether a tolerance is safe. 
Invariably, FFDCA section 408 directs EPA to consider factors relevant 
to the safety of the pesticide residue in food (aggregated with other 
sources of exposure to the pesticide residue), placing particular 
emphasis on human dietary risk. (See, e.g., 21 U.S.C. 346a(b)(2)(B) 
(addressing an exception to the safety standard for pesticide residues 
as to which EPA ``is not able to identify a level of exposure to the 
residue at which the residue will not cause or contribute to a known or 
anticipated harm to human health''); 21 U.S.C. 346a(b)(2)(C) (requiring 
special safety findings as to ``infants and children'' regarding their 
``disproportionately high consumption of foods'' and their ``special 
susceptibility * * * to pesticide chemical residues''); 21 U.S.C. 
346a(b)(2)(D)(iii) (requiring consideration of the relationship between 
toxic effects found in pesticide studies and human risk); 21 U.S.C. 
346a(b)(2)(D)(iv), (vi), and (vii) (requiring consideration of 
available information on ``dietary consumption patterns of consumers,'' 
``aggregate exposure levels of consumers,'' and the ``variability of 
the sensitivities of major identifiable subgroups of consumers''); 21 
U.S.C. 346a(b)(2)(D)(vi) (requiring consideration of ``non-
occupational'' sources of exposure); 21 U.S.C. 346a(b)(2)(D)(viii) 
(requiring consideration of information bearing on whether a pesticide 
``may have an effect in humans that is similar to an effect produced by 
a naturally occurring estrogen or other endocrine effects''); 21 U.S.C. 
346a(l)(2) and (3) (requiring revocation or suspension of tolerances 
where associated FIFRA registration is canceled or suspended ``due in 
whole or in part to dietary risks to humans posed by residues of that 
pesticide chemical on that food'')) Thus, under section 408, EPA has no 
discretion to insert economic or environmental considerations into its 
decisions on the chlorpyrifos tolerances.
    Therefore, objections that EPA should have taken economic and 
environmental impacts into consideration in issuing the final rule are 
denied, as EPA has no authority to do so as part of its safety 
evaluation under the FFDCA.
b. Consideration of Occupational Exposure by EPA
    i. Objection. Gharda and the Sugarbeet Associations assert that EPA 
unlawfully considered occupational exposures as a reason for revoking 
the tolerances. In support of this objection, they point to an EPA 
press release regarding the final rule dated August 18, 2021, which 
mentioned that the tolerance revocation will result in protections for 
farmworkers. (Ref. 37 at 13; Ref. 39 at 33)
    ii. Denial of Objection. The August 18, 2021 press release 
announcing the publication of the final rule included statements that 
EPA was stopping the use of chlorpyrifos on food ``to better protect 
human health, particularly that of children and farmworkers,'' and that 
ending the use of chlorpyrifos on food ``will help to ensure children, 
farmworkers, and all people are protected'' from potentially dangerous 
consequences of chlorpyrifos. (Ref. 57) Based on these statements 
alone, the Objectors argue that these references to farmworkers suggest 
that EPA impermissibly considered occupational exposures in its 
decision to revoke chlorpyrifos tolerances. However, the Objectors' 
arguments are not supported by the final rule itself, which 
specifically affirms that the FFDCA standard does not include 
occupational exposures to workers and which explicitly and repeatedly 
emphasizes that EPA's review included food, drinking water, and all 
non-occupational exposures (e.g., in residential settings), but did not 
include occupational exposures to workers. (See, e.g., Ref. 1 at pgs. 
48318, 48332 through 48333) The fact that the press release cited by 
the Sugarbeet Associations discusses the potential for incidental 
benefits to farmworkers from the final rule does not mean that such 
potential benefits were considered by EPA in the final rule. The 
Objectors' claim is meritless and is denied.
c. Compliance With Relevant International Standards
    i. Objection. The Republic of Colombia objects to the final rule on 
the basis that the final rule's revocation of chlorpyrifos tolerances 
deviates from the Codex Alimentarius (Codex) international standard of 
0.05 mg/kg for chlorpyrifos. (Ref. 58) Colombia requests that EPA 
reconsider the final rule's revocation of chlorpyrifos tolerances in 
light of the Codex MRL for chlorpyrifos, which it alleges is based on 
conclusive scientific evidence, although Columbia does not provide that 
scientific evidence with its objection for EPA to consider. In 
addition, Colombia requests that EPA consider, in its assessment of 
chlorpyrifos tolerances, the factors identified for consideration under 
Article 5, paragraphs 2 and 3 of the World Trade Organization Agreement 
on the Application of Sanitary and Phytosanitary Measures (SPS 
Agreement). Those paragraphs require Members to the SPS Agreement to 
``take into account available scientific evidence; relevant processes 
and production methods; relevant inspection, sampling and testing 
methods; prevalence of specific diseases or pests; existence of pest--
or disease--free areas; relevant ecological and environmental 
conditions; and quarantine or other treatment'' and ``relevant economic 
factors.'' (Ref. 59 at art. 5, paragraphs 2, 3)
    ii. Denial of objection. The Codex is a collection of 
internationally adopted food standards and related texts published by 
the Codex Alimentarius Commission, an international organization formed 
to promote the coordination of international food standards. (See 
https://www.fao.org/fao-who-codexalimentarius/en/) The Codex Committee 
on Pesticide Residues, a committee within the Codex Alimentarius 
Commission, establishes Codex Maximum Residue Limits (MRLs) for 
pesticide products, which are similar to tolerances in that they set 
the limit for allowable pesticide residues in food. Although the 
Objector seems to be referring to a single universal Codex MRL of 0.05 
mg/kg for chlorpyrifos residues, in actuality, Codex has promulgated 
several MRLs ranging from 0.01 mg/kg to 20 mg/kg for chlorpyrifos

[[Page 11261]]

residues on a variety of commodities. (Ref. 60) It is unclear why 
Colombia is pointing the Agency to a generic MRL of 0.05 mg/kg.
    The FFDCA requires consideration of Codex MRLs when EPA is making a 
decision to establish a tolerance. (21 U.S.C. 346a(b)(4)) Notably, the 
statute does not require the same consideration in revoking tolerances. 
That is because revocation is required when a tolerance is unsafe, (21 
U.S.C. 346a(b)(2)(A)(i)), regardless of whether another international 
body, including Codex, is maintaining the same determination. In the 
final rule, EPA determined that current tolerances for chlorpyrifos are 
not safe under FFDCA and must therefore be revoked. Columbia has not 
provided any reliable information to support a reconsideration of that 
conclusion.
    As far as the request to consider the factors under Article 5, 
paragraph 2 of the SPS Agreement is concerned, EPA reiterates its 
earlier arguments, that it is bound by its domestic statute, which 
requires that unsafe tolerances be revoked (21 U.S.C. 346a(b)(2)(A)(i)) 
and which does not permit consideration of environmental or economic 
factors. (See Unit VIII.C.5.a.) EPA does not have discretion to retain 
tolerances, based on consideration of the factors listed in SPS 
Agreement, where the Agency has determined those tolerances do not meet 
the FFDCA safety standard. For these reasons, the Republic of 
Colombia's objection with respect to the Codex MRLs and the SPS 
Agreement is denied.
d. Implementation Timeframe
    i. Objection. While EPA received many requests for an extension of 
the phase-out period, this section address the single objection 
asserting that the Agency's six-month expiration date for the 
tolerances was unlawful. The requests EPA received for extensions of 
the tolerance expiration date are addressed in Unit IX, along with 
other requests seeking a stay of the final rule.
    Seeking a ``gradual, multi-year phase-out of crop uses'' to 
mitigate economic injury to itself and growers, Gharda argues that 
EPA's selection of a six-month grace period was arbitrary and 
capricious because it did not provide for use in another growing season 
nor sufficient time for Gharda, distributors, or growers to phase out 
their inventories and exhaust existing stocks of chlorpyrifos. (Ref. 39 
at 40) Nor, Gharda alleges, does the SPS Agreement requirement for a 
``reasonable interval between the publication of a sanitary or 
phytosanitary regulation and its entry into force'' mandate that EPA 
select six months as the reasonable interval. (Id. at 38)
    ii. Denial of objection. Section 408(g)(1) of the FFDCA states that 
a rule issued under section 408(d)(4) of the FFDCA, which the final 
rule revoking chlorpyrifos tolerances was, ``shall take effect upon 
publication'', unless otherwise specified in the rule. (21 U.S.C. 
346a(g)(1)) The Agency's authority to specify a different effective 
date or to set an expiration date for the tolerances is entirely 
discretionary. Moreover, there is no requirement in the FFDCA for EPA 
to accommodate, through delays in the effective date or any other way, 
economic hardships and transitions away from a pesticide that the 
Agency has found to be unsafe and for which tolerances must be revoked. 
Indeed, the FFDCA is entirely focused on whether the tolerance is safe, 
and so it would subvert the intent of the statute to allow all 
tolerances the Agency has deemed unsafe to remain effective for 
significant periods of time.
    As stated in the final rule, EPA set a six-month expiration date 
for the chlorpyrifos tolerances, rather than requiring revocation 
immediately, to accommodate the SPS Agreement requirement to ``allow a 
reasonable interval between the publication of a sanitary or 
phytosanitary regulation and its entry into force.'' (Ref. 59 at Annex 
B, paragraph 2) The World Trade Organization (WTO) has interpreted the 
phrase ``reasonable interval'' to mean normally a period of not less 
than six months, although shorter durations could be justified under 
``urgent circumstances.'' (Ref. 61 at paragraph 3.2) In the SPS 
Agreement, there are some procedural exceptions allow for urgent health 
concerns. (Ref. 59 at Annex B, paragraph 5; see also Appellate Body 
Report, United States--Measures Affecting the Production and Sale of 
Clove Cigarettes, WTO Doc, WT/DS406/AB/R (April 4, 2012) (finding that 
deviations from the TBT Agreement requirement to provide ``reasonable 
interval'' may be justified in cases of urgent safety or health 
concerns))
    In light of EPA's inability to conclude that chlorpyrifos 
tolerances meet the FFDCA safety standard, the Agency determined that a 
six-month expiration date for the chlorpyrifos tolerances would provide 
a reasonable interval for importers and growers to adapt to the change 
in regulation. EPA also notes that the Ninth Circuit's decision 
directed EPA to act ``immediately,'' and chastised EPA for its 
``egregious delay'' in publishing a sufficient response to the 2007 
Petition, which ``exposed a generation of American children to unsafe 
levels of chlorpyrifos.'' (LULAC, 996 F.3d. at 703) It simply was not 
tenuous to leave tolerances in place to allow for additional growing 
season(s), given the Agency's lack of a safety finding for the 
chlorpyrifos tolerances in light of the Ninth Circuit's expressed 
impatience with EPA's delay in acting on the 2007 Petition and the 
accelerated timeframe provided by the Ninth Circuit for the issuance of 
the final rule. Consequently, EPA determined that six months was a 
reasonable period to accommodate growers and importers while minimizing 
any continued harm.
    For these reasons, Gharda's objection with respect to the 
implementation timeframe of the final rule is denied.
e. Existing Stocks
    i. Objection. The following Objectors argue that the final rule 
should have addressed the treatment of existing stocks of chlorpyrifos 
products and seek additional clarification on how existing stocks will 
be addressed: The Sugarbeet Associations, Gharda, the Agricultural 
Retailers Association, et al., CLA/RISE, and the Michigan Vegetable 
Council. (Refs. 37, 39, 47, 50, and 62) These Objectors allege that the 
revocation of the tolerances is likely to leave millions of gallons of 
chlorpyrifos in the hands of growers or in storage in the United States 
and that the lack of clarity from EPA regarding the use and/or disposal 
of these existing stocks of chlorpyrifos places a financial and 
logistical burden on users and retailers and could inadvertently lead 
to inappropriate disposal of chlorpyrifos products. Several Objectors 
argue that guidance published by EPA on its website after publication 
of the final rule titled ``Frequent Questions about the Chlorpyrifos 
2021 Final Rule'' (Ref. 63), fails to clarify this issue, and that the 
legal status of products with labels and registrations that contain 
both food and non-food uses remains unclear.
    Gharda also argues that EPA, in issuing the final rule without 
concurrently addressing existing stocks in the final rule or issuing an 
existing stocks order pursuant to FIFRA section 6(a)(1) (7 U.S.C. 
136d(a)(1)), has abdicated its responsibility under FIFRA to ensure the 
safe, lawful, and orderly phase-out and disposal of chlorpyrifos 
products. (Refs. 39 at 41 through 45) Gharda asserts that an existing 
stocks order is necessary to allow end users and others wishing to 
return existing stocks to the manufacturers or pursue other safe 
disposal options to avoid violating FIFRA. Gharda also asserts that 
because the practical effect of the final rule is to render previously 
registered products unregistered, EPA would have no

[[Page 11262]]

enforcement authority over misuse of those pesticides.
    ii. Denial of objection. As an initial matter, EPA notes that while 
the Objectors use the term ``existing stocks,'' existing stocks is a 
FIFRA term that applies to products that have been released for 
shipment upon cancellation of a registered pesticide. (See Existing 
Stocks of Pesticide Products; Statement of Policy, 56 FR 29362, June 
26, 1991 (FRL-3846-4)) Since the final rule does not cancel any 
pesticide registrations, it has not created any ``existing stocks'' 
under FIFRA.
    Nevertheless, EPA reads the majority of objections on this 
particular issue to be seeking clarity and guidance for users of 
chlorpyrifos on what to do with chlorpyrifos products that have been 
purchased but cannot be used on food crops following the expiration of 
the tolerances. As such, these objections are more akin to comments and 
requests concerning implementation of the final rule, than objections 
to the final rule itself; thus, they are denied as objections for 
failure to raise particular concerns with the final rule that can be 
resolved under the FFDCA. Nevertheless, EPA recognizes the confusion 
among the agricultural industry as a result of the final rule and the 
fact that tolerances will be revoked before any registrations for 
chlorpyrifos products are cancelled under FIFRA. Consequently, EPA will 
continue to update the FAQ page to provide guidance to assist growers 
and the agricultural industry with the implementation of this final 
rule.
    Turning to Gharda's objection next, EPA denies that it has somehow 
abdicated its responsibilities under FIFRA by taking action to revoke 
unsafe tolerances under the FFDCA. EPA finds that Gharda is essentially 
making the same argument that EPA rejected in Unit VIII.C.1.b. Gharda's 
argument boils down to an assertion that EPA was required to take 
action concurrent with the final rule to cancel chlorpyrifos 
registrations under FIFRA, to provide for the use and disposition of 
existing stocks in that cancellation order, and then to revoke 
tolerances consistent with the existing stocks provisions of that 
cancellation order; thus, for the same reasons articulated in that 
previous Unit, Gharda's objection is denied. As noted previously, 
nothing in the FFDCA compels EPA to take action under FIFRA to cancel 
pesticide registrations and provide for existing stocks concurrently 
with or prior to revoking tolerances for that same chemical. Moreover, 
there is no requirement in the FFDCA, when revoking a tolerance, to 
resolve questions regarding existing stocks in the final rule itself.
    Gharda appears to conflate the EPA's issuance of a rule revoking 
tolerances under the FFDCA with EPA's cancellation of registered 
pesticides under FIFRA. Gharda argues that because EPA's revocation of 
the tolerances under the FFDCA essentially renders the product 
unregistered, EPA was obligated to address the issue of existing stocks 
under FIFRA. However, Gharda misstates the effect of the final rule. 
The revocation of tolerances does not have the effect of rendering the 
chlorpyrifos products unregistered. Registered products only become 
unregistered once they are cancelled under FIFRA section 6. (7 U.S.C. 
136d) EPA has no authority to issue a cancellation order under the 
FFDCA, only under FIFRA, and as discussed in Unit VIII.C.1.b., EPA is 
not required to cancel pesticides under FIFRA prior to taking action to 
revoke tolerances under the FFDCA. Because the actual remedy Gharda is 
seeking with this objection--a cancellation order with instructions on 
how to handle existing stocks--is only available under FIFRA, this is 
not a proper objection to the final rule.
f. Channels of Trade
    i. Objection. The American Soybean Association and Willard Jack (an 
individual grower) submitted objections arguing that the final rule 
fails to provide adequate guidance for food or feed treated with 
chlorpyrifos that is or will be in the channels of trade when the 
tolerances are set to expire on February 28, 2022. (Refs. 36 and 64) 
The Objectors express concern that growers will be adversely impacted 
by this rule due to a lack of guidance and the potential of having 
adulterated food seized by the FDA.
    ii. Denial of objection. To the extent this objection asserts that 
lack of guidance is a fatal flaw with the final rule, this objection is 
denied. This issue does not provide a basis for reversing the Agency's 
position on the safety of chlorpyrifos and changing the final rule. 
Nevertheless, EPA recognizes the need for guidance for farmers and food 
processors following the revocation of the chlorpyrifos tolerances. As 
EPA indicated in the final rule, section 408(l)(5) of the FFDCA governs 
commodities treated with pesticides and in the channels of trade 
following the tolerance revocations. Under that provision, chlorpyrifos 
residues in or on food in the absence of a tolerance will not render 
that food adulterated, as long as it is shown to the satisfaction of 
the U.S. Food and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA, 
and
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance or exemption from tolerance that was in effect at the time of 
the application. (21 U.S.C. 346a(l)(5))
    The FDA, which is responsible for enforcing tolerances and 
implementing this provision, has developed guidance for growers and 
food processors for foods treated with chlorpyrifos. (Ref. 65) That 
guidance, which covers residues of chlorpyrifos in human food 
commodities, clarifies the FDA's planned enforcement concerning those 
foods containing chlorpyrifos residues after the tolerances expire. 
Animal feed items, which are regulated by FDA's Center for Veterinary 
Medicine, and various livestock commodities, which are regulated by 
USDA, are not covered by this guidance. EPA intends to work with those 
other agencies to assist with questions of compliance as they arise.
g. Substantive Due Process Concerns
    i. Objection. Gharda argues that it and other registrants have a 
fundamental property right in their chlorpyrifos registrations, which 
is protected by the substantive due process doctrine provided for under 
the U.S. Constitution. (Ref. 39 at 36 through 37) Gharda claims that 
the economic value of its chlorpyrifos registration for food use crops 
is dependent on having tolerances for chlorpyrifos in place. Gharda 
argues that because the Agency revoked those tolerances ``without a 
reasoned explanation or valid scientific basis, and in disregard of 
scientific data,'' the Agency improperly deprived Gharda of economic 
value of its registration and violated its substantive due process 
rights.
    ii. Denial of objection. Whether Gharda has a substantive due 
process right to its registrations and the revocation of tolerances 
somehow infringes that right is immaterial to the question EPA must 
answer when leaving a tolerance in place--whether the tolerance is 
safe. The FFDCA is clear: When a tolerance is not safe, it must be 
modified or revoked. Whether the revocation of that rule has 
implications for registrants of products or growers of crops is outside 
the scope of considerations in the FFDCA. Since nothing about this 
objection provides information bearing on the safety of chlorpyrifos, 
this objection is denied.

[[Page 11263]]

    In any event, EPA disagrees with Gharda's claim that the final rule 
has infringed substantive due process rights.
    ``To state a substantive due process claim, a plaintiff must 
allege: (1) That it had property or a property interest; (2) the 
government deprived it of that property interest; and (3) the 
government's actions fall so far beyond the outer limits of legitimate 
governmental action that no process could cure the deficiency. . . . 
[S]ubstantive due process concerns governmental action which is so 
arbitrary and irrational, so unjustified by any circumstance or 
governmental interest, as to be literally incapable of avoidance by any 
pre-deprivation procedural protections or of adequate rectification by 
any post-deprivation . . . remedies. . . . Thus, a substantive due 
process claim is warranted only where no process could cure the 
deficiencies in the governmental action.'' (Syngenta Crop Protection, 
Inc. v. EPA, 444 F.Supp.2d 435, 447 (M.D.N.C. 2006) (internal citations 
and quotations omitted)) EPA disagrees that Gharda has a property 
interest in the food uses here since ``there is no property interest in 
using property in a manner that is harmful to the general public.'' 
(American Vanguard Corp. v. United States, 142 Fed. Cl. 320, 328 (Jan. 
28, 2019) (citing Mitchell Arms, Inc. v. United States, 7 F.3d 212 
(Fed. Cir. 1993))) Moreover, Gharda has failed to allege any activity 
by EPA that would implicate the ``outer limits of legitimate 
governmental action'' or that is ``so arbitrary and irrational, so 
unjustified by any circumstance or governmental interest,'' as to be 
incapable of remedy. Gharda alleges no activity that is ``so arbitrary 
or irrational'' other than a general claim that the final rule is 
``without a reasoned explanation or valid scientific basis, and in 
disregard of scientific data.''
    EPA notes that the final rule includes significant explanation for 
its finding that EPA is unable to determine that there is a reasonable 
certainty that no harm will result from aggregate exposures to 
chlorpyrifos residues for which there is reliable information. For 
example, the final rule includes, among other key information, an 
overview of the numerous human health risk assessments EPA has 
conducted and FIFRA SAPs that were convened to discuss chlorpyrifos, a 
detailed summary of EPA's risk assessment for chlorpyrifos, EPA's 
hazard assessment of chlorpyrifos, EPA's exposure assessment for 
chlorpyrifos, and EPA's process for assessing aggregate risk based on 
the aforementioned assessments. To the extent that this assertion is 
intended to refer to or incorporate Gharda's other objections--such as 
Gharda's argument that EPA's explanation for not retaining the eleven 
uses proposed for retention in the 2020 PID or fails to consider the 
Corteva oxon study--EPA has already provided responses to those more 
detailed objections elsewhere in this Order.
    In any event, it cannot be said that EPA taking action to revoke an 
unsafe tolerance under its statutory mandate to ensure that pesticide 
residues in food are safe for public consumption is outside the bounds 
of a legitimate governmental action. Congress tasked EPA specifically 
with the responsibility to ensure that tolerances are only left in 
place if they are safe and to revoke or modify tolerances if they are 
not. (See 21 U.S.C. 346a(b)(2)(A)) Upon concluding that aggregate 
exposures were not safe, EPA revoked the tolerances in accordance with 
the statutory mandate, which is clearly within the bounds of a 
legitimate government action to ensure that residues of pesticides in 
or on food are safe for consumption. It is necessarily the case that 
when EPA revokes a tolerance on the basis of dietary risks for 
pesticides that are registered under FIFRA, there are going to be 
impacts to the registrants of those pesticides. Leaving tolerances in 
place to avoid impacts to pesticide registrants would be inconsistent 
with the FFDCA. Finally, Gharda is not without process for curing any 
deficiencies in EPA's actions, including procedures afforded by FIFRA, 
the APA, and judicial review. Therefore, Gharda's claim that its 
substantive due process rights have been infringed by EPA's final rule 
fails.

D. Summary of Reasons for Denying Objections

    EPA is denying the objections submitted by the Objectors for 
several reasons. EPA is denying the objections of the Colombia Ministry 
of Trade, Industry and Tourism; Drexel Chemical Company; the 
International Pepper Community; Oregonians for Food and Shelter; and 
the Republic of Ecuador, because these parties did not submit their 
objections to the Office of the Hearing Clerk, as required by 40 CFR 
178.25(b). As discussed in Unit VIII.A. of this document, EPA grouped 
the other Objectors' objections into five different substantive 
categories and addressed each in turn.
    Regarding the first category--objections to the scope of the final 
rule--EPA is denying the objections asserting that revoking all 
chlorpyrifos tolerances was unlawful and unnecessary in light of the 
proposal in the 2020 PID for limiting uses to 11 high-benefit crops, 
because the FFDCA requires that EPA assess aggregate exposure based on 
all currently registered uses of chlorpyrifos, not on a hypothetical 
subset of those uses. EPA also denies the objections arguing that the 
revocation of tolerances should not have been undertaken without 
coordination of use cancellations under FIFRA, because FFDCA 408(l)(1) 
does not require that actions under FIFRA precede or occur concurrently 
with actions under the FFDCA, and because in any event it was not 
practicable for EPA to first modify of cancel any registrations in 
light of the Ninth Circuit's deadline for issuing a final rule. Lastly, 
EPA denies the objections arguing that EPA should retain import 
tolerances for chlorpyrifos commodities, because EPA is unable to make 
the safety finding for leaving in place tolerances for imports until 
enough uses are canceled to reduce aggregate exposures to acceptable 
levels.
    Regarding the second category--objections to the retention of the 
10X FQPA safety factor--EPA is denying the objections that EPA's final 
rule was arbitrary and capricious for retaining the 10X FQPA safety 
factor. As an initial matter, EPA has determined that whether the 
Agency retains the 10X FQPA safety factor or uses a different margin of 
safety does not ultimately have a determinative impact on the Agency's 
conclusions regarding the safety of chlorpyrifos in the final rule; 
therefore, this objection is denied for lack of materiality. 
Nonetheless, EPA concludes that its consideration of the 
epidemiological studies was reasonable and consistent with EPA's policy 
for consideration of all available data. EPA notes there is no 
requirement that the underlying data must be made available before EPA 
can rely on these studies, and EPA had a rational scientific basis for 
including such data in its review in order to satisfy its statutory 
obligation to consider all data concerning the special susceptibility 
of infants and children. Furthermore, given the uncertainties 
surrounding the potential for neurodevelopmental effects at the time of 
the final rule, EPA's retention of the default 10X FQPA safety factor 
was consistent with the statutory standard to apply the 10X margin of 
safety unless there is reliable data demonstrating that a different 
margin would be safe for infants and children.
    Regarding the third category--objections relating to EPA's 
assessment of drinking water exposures--EPA is denying the objections 
that EPA did not have a rational basis for relying on the 2016 DWA, 
because, unlike the 2020

[[Page 11264]]

DWA, the 2016 DWA considered contributions from all registered uses of 
chlorpyrifos, and so represented the most recent and robust ``best 
available science'' for use by the Agency in its final rule. EPA is 
also denying the objections that it was unreasonable for EPA to assess 
exposures to chlorpyrifos-oxon in its drinking water assessment, 
because EPA has reliable data that chlorpyrifos-oxon will be present in 
at least some drinking water, and because EPA concluded that even 
assuming chlorpyrifos-oxon is not more toxic and should not be the 
residue of concern for evaluating exposures in drinking water, the 
concentrations of the parent compound, chlorpyrifos, in drinking water 
would still result in exposures that were unsafe.
    Regarding the fourth category--objections relating to procedural 
matters--EPA is denying the objections that EPA acted inconsistently 
with the principles of due process and transparency in failing to 
consider and respond to comments previously submitted on the 2015 
proposed rule and in response to the 2020 PID. EPA notes that these 
objections do not identify a specific element of the final rule that is 
problematic, and so do not conform to the required form of an objection 
per 40 CFR 178.30(a)(1). EPA also notes that EPA is not obligated to 
respond to comments on a rule that was never finalized (i.e., the 2015 
proposed rule), or on separate albeit parallel regulatory activities 
(i.e., the 2020 PID). EPA is also denying the American Soybean 
Association's objection that the final rule failed to provide adequate 
procedural due process due to technical delays in opening the Federal 
eRulemaking Portal, because EPA's regulations only require that 
objections be filed with the Hearing Clerk, with the Portal serving as 
an additional means of protecting any CBI, and because the delayed 
opening of the Portal is harmless error. Lastly, EPA is denying the 
objections that EPA failed to comply with Executive Order 12866, 
because this is not a judicially reviewable issue and resolution of 
these objections has no bearing on any substantive issues with the 
final rule that could be raised separately.
    Regarding the fifth and final category--objections that, as a 
matter of law, do not provide a basis for leaving tolerances in place--
EPA is denying these assorted objections because they provide no 
reliable information pertaining to the FFDCA safety standard that could 
support leaving chlorpyrifos tolerances in place.

VIII. Response to Requests for Stay

A. The Standard for Granting a Stay

    FFDCA section 408 provides that a regulation issued under 
subsection 408(d)(4) shall take effect upon publication in the Federal 
Register unless the regulation specifies otherwise. (21 U.S.C. 
346(g)(1)) The effective date of the final rule was October 29, 2021, 
and tolerances for residues of chlorpyrifos on all commodities expire 
on February 28, 2022. However, section 408 also grants the 
Administrator the discretion to stay the effectiveness of a regulation 
if objections are filed. (21 U.S.C. 346a(g)(1))
    The statute is silent on the standard to apply in granting a stay. 
The FFDCA gives EPA unlimited discretion to determine when it might be 
appropriate to issue a stay, requiring only that objections be filed 
before EPA may exercise that authority. EPA believes the discretionary 
nature of this authority gives EPA flexibility in any given case to 
determine whether and how to stay a rule or order issued under FFDCA 
section 408(d). EPA has indicated that it will consider the criteria 
set out in FDA's regulations regarding stays of administrative 
proceedings at 21 CFR 10.35, in determining whether to grant a stay. 
(See, e.g., Carbofuran; Final Tolerance Revocations, 74 FR 23045, May 
15, 2009; cf. Sulfuryl Fluoride; Proposed Order Granting Objections to 
Tolerances and Denying Request for a Stay, 76 FR 3422, Jan. 19, 2011 
(evaluating stay request based on an amalgam of the 21 CFR 10.35 
factors and a judicial stay factors)) Under 21 CFR 10.35, a stay shall 
be granted if all of the following apply: (1) The petitioner will 
otherwise suffer irreparable injury; (2) the petitioner's case is not 
frivolous and is being pursued in good faith; (3) the petitioner has 
demonstrated sound public policy grounds supporting the stay; and (4) 
the delay resulting from the stay is not outweighed by public health or 
other public interests. (21 CFR 10.35(e))

B. Requests for Stay and EPA Responses

1. Summary of Requests for Stay
    EPA received written requests for EPA to either stay the effective 
date of the final rule or allow for a longer phase-out period from the 
following objectors: Amalgamated Sugar Company, American Crystal Sugar 
Company, the American Soybean Association, the Sugarbeet Associations, 
the California Citrus Quality Council, the Cherry Marketing Institute, 
CLA/RISE, Gharda, the Minor Crop Farmer Alliance, the Agricultural 
Retailers Association, et al., the Republic of Colombia, and several 
independent sugarbeet growers. (These written requests are available in 
the final rule docket at https://www.regulations.gov in docket ID 
number EPA-HQ-OPP-2021-0523.)
    The requests for stay of the final rule can be sorted into three 
groups based on the form of the requests and the duration of the stay 
requested. The first group consists of the requests submitted by the 
Sugarbeet Associations and Gharda, both of which apply the criteria set 
out in 21 CFR 10.35 to argue that EPA is required to stay the 
effectiveness of the final rule. Specifically, these Objectors argue 
that they will suffer irreparable injury absent a stay, that their 
objections are not frivolous and are undertaken in good faith, that the 
public interest favors a stay, and the delay caused by a stay is not 
outweighed by the public health or public interest. The Sugarbeet 
Associations and Gharda also request a stay ``until a final resolution, 
including potential judicial review, is reached on all of the . . . 
issues raised in [our] objections.'' (Refs. 66 and 67) The second group 
consists solely of the Republic of Colombia. Colombia requests a period 
of at least 12 months before chlorpyrifos tolerances expire so that it 
can ``make the necessary adjustments in the production of [its] crops 
to ensure compliance.'' (Ref. 58) While Colombia does not explicitly 
frame its request as a request for a stay of the final rule, and does 
not reference the criteria at 21 CFR 10.35, EPA's interpretation is 
that this is best understood and assessed by EPA as a request for stay. 
Finally, the third group consists of the remaining stay requests. These 
Objectors do not specifically address the regulatory criteria set forth 
at 21 CFR 10.35; they simply request that EPA stay the final rule until 
EPA can address the issues raised in their various objections.
2. Denial of Requests for Stay
    As noted previously, only the Sugarbeet Associations and Gharda 
frame their requests for stay by reference to the regulatory criteria 
at 21 CFR 10.35, and until ``a final resolution'' can be obtained with 
respect to the issues raised in their objections. The other stay 
requests do not reference the regulatory criteria. The sole rationale 
provided by Colombia for its request for an additional 12-month period 
before tolerances expire is to enable unspecified parties to ``make the 
necessary adjustments'' to ensure compliance. Colombia does not include 
any information regarding any potential injury (irreparable or 
otherwise) that

[[Page 11265]]

might otherwise be suffered, showing that their case is not frivolous 
and is being made in good faith, demonstrating sound public policy 
supporting a 12-month delay, or arguing that their desired 12-month 
delay is not outweighed by public health or other interests. EPA 
declines to speculate as to the bases for Colombia's request and denies 
Colombia's stay request due to the lack of supporting information. The 
other stay requests simply ask EPA to stay the effectiveness of the 
final rule until EPA can address the issues raised in their various 
objections. These Objectors appear to contemplate a scenario in which 
EPA delays addressing their objections until well after the February 
28, 2022, expiration date for chlorpyrifos tolerances specified in the 
final rule. Because EPA has addressed these objections via this Order, 
by the plain meaning of these stay requests, there is no longer any 
need to stay the final rule. As a result, EPA denies those requests for 
stay submitted by Objectors other than the Sugarbeet Associations and 
Gharda.
    With respect to the requests for stay submitted by the Sugarbeet 
Associations and Gharda, EPA examines these parties' arguments in light 
of the four factors set forth in at 21 CFR 10.35.
a. Will the Sugarbeet Associations and Gharda suffer irreparable injury 
without the stay?
    i. Summary of arguments concerning injury. The Sugarbeet 
Associations and Gharda each argue that they will suffer irreparable 
injury in the form of economic losses and reputational impacts due to 
the final rule, and Gharda also argues that the deprivation of its 
chlorpyrifos registration under FIFRA is a due process violation that 
constitutes irreparable harm. (Refs. 66 and 67) With respect to 
economic losses, the Sugarbeet Associations argue that due to the lack 
of similarly effective alternatives to chlorpyrifos, reduced crop 
yields could cause the sugarbeet industry significant economic harm. 
(Ref. 66 at pgs. 2 through 4) Similarly, Gharda claims that it could 
face significant economic losses if, due to the final rule, it is 
unable to formulate, distribute, and sell the significant volume of raw 
materials and U.S.-labeled product it has in inventory. (Ref. 67 at 
pgs. 6 and 7) With respect to reputational impacts, the Sugarbeet 
Associations argue that the sugarbeet industry is likely to suffer 
reputational harm as a result of the final rule and the August 18, 
2021, press release announcing the final rule, including the potential 
for ill will against the sugarbeet industry from customers and the 
public that could affect the industry's ability to sell its products. 
(Ref. 66 at pgs. 4 and 5) Similarly, Gharda argues that it has suffered 
and will continue to suffer reputational harm, and that the final rule 
has strained and will continue to strain Gharda's relationships with 
its customers, who might not use Gharda products moving forward. (Ref. 
67 at pgs. 6 through 8)
    As described in more detail in this unit, EPA disagrees that any 
injuries to the Sugarbeet Associations and/or Gharda are in fact 
irreparable.
    ii. Response to the Sugarbeet Associations' and Gharda's economic 
injury arguments. EPA disagrees that the Sugarbeet Associations and 
Gharda have established that they--or, in the case of the Sugarbeet 
Associations, the farmer-owners and beet sugar manufacturers they 
represent--will be irreparably harmed without a stay. As Gharda 
correctly notes, to establish irreparable harm, ``injury must be both 
certain and great; it must be actual and not theoretical and of such 
imminence that there is clear and present need for equitable relief.'' 
(Olu-Cole v. E.L. Haynes Pub. Charter Sch., 930 F.3d 519, 529 (D.C. 
Cir. 2019) (internal quotation marks and citations omitted)) However, 
this already high ``barrier to proving irreparable injury is higher 
still'' for the economic losses asserted by the Sugarbeet Associations 
and Gharda, ``for it is well settled that economic loss does not, in 
and of itself, constitute irreparable harm.'' (Mexichem Specialty 
Resins, Inc. v. EPA, 787 F.3d 544, 555 (D.C. Cir. 2015)) ``Mere 
injuries, however substantial, in terms of money, time, and energy 
necessarily expended in the absence of a stay are not enough.'' 
(Wisconsin Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985)) 
Instead, ``recoverable monetary loss may constitute irreparable harm 
only where the loss threatens the very existence'' of a company. (Id.)
    The Sugarbeet Associations and Gharda include identical statements 
arguing that ``[l]osses for which an aggrieved party has no recourse, 
such as those caused by a governmental entity immune from suit for 
monetary relief, are `irreparable per se.' '' (Ref. 66 at pg. 3 and 
Ref. 67 at pgs. 5 and 6, respectively (each citing Feinerman v. 
Bernardi, 558 F. Supp. 2d 36, 51 (D.D.C. 2008))) However, the Sugarbeet 
Associations and Gharda fail to note that subsequent caselaw expressly 
disagrees with that principle. In ConverDyn v. Moniz, the District 
Court for the District of Columbia acknowledges that while in Feinerman 
it ``characterized economic damages that are unrecoverable due to 
sovereign immunity as `irreparable per se' . . . that characterization 
goes too far and the inability to recover economic losses can more 
accurately be considered as a factor in determining whether the movant 
has shown irreparable harm.'' (68 F. Supp. 3d 34, 49 (D.D.C. 2014) 
(internal citations omitted)) The Court observed that ``[o]therwise, a 
litigant seeking injunctive relief against the government would always 
satisfy the irreparable injury prong, nullifying that requirement in 
such cases.'' (Id.; see also N. Air Cargo v. U.S. Postal Serv., 756 F. 
Supp. 2d 116, 125 (D.D.C. 2010) (``this Court is of the opinion that a 
party asserting such a loss is not relieved of its obligation to 
demonstrate that its harm will be great . . . [otherwise] prospective 
injunctive relief would often cease to be an extraordinary remedy in 
cases involving government defendants'') (internal quotation marks and 
citations omitted))
    EPA finds that neither the Sugarbeet Associations nor Gharda have 
demonstrated that they or their member entities will suffer irreparable 
economic harm in the absence of a stay of the final rule. The Sugarbeet 
Associations provide a handful of statistics regarding the estimated 
financial impacts that they allege will result from the revocation of 
chlorpyrifos tolerances, and argue that because EPA estimated in the 
2020 PID that the benefits of chlorpyrifos for sugarbeets in North 
Dakota and Minnesota could be up to $500 per acre, and there are over 
140,000 acres of sugarbeets at risk from sugarbeet root maggots, the 
sugarbeet industry ``would face tens of millions of dollars in 
irreparable damages annually'' absent a stay. (Ref. 66 at pg. 4) EPA 
notes, however, that the Sugarbeet Associations omit key details, and 
that their conclusion is highly speculative.
    The Agency included sugarbeets in its detailed economic analysis of 
agricultural uses of chlorpyrifos, which was conducted in 2020 to 
support the preliminary interim registration review decision. The 
analysis utilized proprietary pesticide usage surveys as well as 
publicly available pest management recommendations from extension crop 
experts. (Ref. 56) This analysis indicated that for most sugarbeet 
pests targeted with chlorpyrifos, several effective alternatives are 
available. The Agency found that for regions in the upper Midwest where 
populations of sugarbeet root maggot are very high, yield losses of up 
to 45% could occur without chlorpyrifos. The impacts of such yield 
losses are estimated at $498 per acre in

[[Page 11266]]

North Dakota and Minnesota, where an average of 61,200 acres were 
estimated to be affected. While EPA acknowledges that growers in these 
areas will be impacted, these areas represent about 20% of the 
sugarbeet acreage in Minnesota and 10% of the acreage in North Dakota. 
For purposes of comparison, the total national harvested sugarbeet 
acreage is approximately 1.1 million acres. Furthermore, effective 
alternatives to chlorpyrifos are available in other areas of the 
country. Thus, while there are likely to be impacts to some growers, 
EPA does not agree that the loss of chlorpyrifos will cause an 
irreparable injury to the sugarbeet industry overall.
    EPA also notes that the Sugarbeet Associations fail to provide any 
context for the economic injuries they claim that they and their 
members will incur as a result of the final rule. As discussed 
previously, EPA acknowledges that sugarbeet yields in certain 
production areas could be reduced, and that some sugarbeet growers and/
or beet sugar manufacturers may lose some portion of their revenue due 
to the final rule. However, even assuming that the figures provided by 
the Sugarbeet Associations are accurate, it is not clear to EPA what 
the specific implications of these figures might be for the Sugarbeet 
Associations or the growers and/or manufacturers they represent, and 
nowhere in their stay request do the Sugarbeet Associations assert that 
the failure to stay the final rule will threaten their or their member 
entities' very existence.
    Finally, EPA notes that for many crops--including sugarbeets, as 
the Sugarbeet Associations acknowledge in their request for stay--
alternatives to pesticides are readily available. While these 
alternatives may be more expensive than chlorpyrifos, or perhaps less 
effective than chlorpyrifos, the availability of alternatives to 
chlorpyrifos indicates that it is unlikely that sugarbeets will be left 
completely unprotected. This in turn suggests that any injury is likely 
to be temporary and reparable.
    EPA also disagrees with Gharda's arguments regarding irreparable 
economic injury. Although EPA acknowledges that the revocation of 
tolerances will necessarily impact any registrant of chlorpyrifos 
products, EPA is not convinced that the economic injuries alleged by 
Gharda are in fact irreparable. Gharda argues that it will suffer 
certain economic losses due to the inability to formulate, distribute, 
and sell chlorpyrifos products, including a loss of future sales of 
chlorpyrifos products, and that Gharda and its customers will face a 
loss of their investments in chlorpyrifos. EPA finds that Gharda's 
claims regarding the loss of future sales of chlorpyrifos products are 
too speculative to satisfy the requirement that injury ``must be actual 
and not theoretical.'' (Olu-Cole, 930 F.3d at 529) Gharda does not 
provide any basis for its assumptions regarding future revenues from 
chlorpyrifos other than a declaration from its president that contains 
an identical assertion as in the stay request and offers no further 
evidence. To provide but a few examples, these assumptions regarding 
future revenues could be undercut by changes in customer preferences, 
supply chain complications, and/or price fluctuations. Crucially, and 
in any event, Gharda does not claim that a failure to stay the final 
rule will threaten either its or its customers' very existences.
    EPA notes that the 2020 PID proposed a subset of chlorpyrifos uses 
that might result in exposures below the Agency's level of concern if 
significant changes to the labels were made, including use 
cancellations and geographic limitations, among others. EPA also notes 
that the final rule does not foreclose Gharda's ability to sell or 
distribute its products outside of the United States for food 
applications in other jurisdictions, provided any such treated products 
are not imported into the United States in a manner inconsistent with 
FDA's channels of trade guidance. These possibilities undermine 
Gharda's assertion that any and all economic harms it has suffered or 
might suffer are irreparable.
    EPA also notes that any potential economic injury suffered by 
Gharda has been significantly exacerbated by Gharda's independent 
business decisions. Gharda notes that in 2021 it increased production 
to meet demand for chlorpyrifos after Corteva exited the market, and 
that it now stands to incur certain losses due to its inability to 
formulate, distribute, and sell chlorpyrifos products. However, Gharda 
should have recognized that there was some risk to expanding production 
in light of the Agency's proposed findings in the 2020 PID (which 
indicated that some changes to existing registered products would 
likely be required, including some potentially significant changes), 
and following the issuance of the Ninth Circuit's decision in April of 
2021.
    More generally, pursuant to the Regulatory Flexibility Act (RFA), 5 
U.S.C. 601 et seq., EPA conducted a small business analysis to assess 
the economic impact of the final rule on small entities. (Ref. 68) That 
analysis was prepared consistent with other analyses that are prepared 
for rules subject to notice and comment pursuant to the RFA, which 
requires an agency to consider the economic impacts that rules subject 
to notice and comment rulemaking will have on small entities. Since the 
final rule was not subject to notice and comment, the analysis was not 
required, but it was prepared to present information on the potential 
impact to small farms and possible job losses for industry as a result 
of the revocation of chlorpyrifos tolerances. Based on the analysis in 
the 2021 SBA memo, EPA concluded that there was not likely to be a 
significant impact on a substantial number of small entities and that 
there are unlikely to be significant job losses as a result of the 
revocation of the rule. Of the approximately 2 million farms currently 
in the United States, only an estimated 43,430 farms are using 
chlorpyrifos each year. For about 25,100 affected farms, the impacts of 
tolerance revocation are less than 1% of gross revenue. Up to 10,500 
small farms could see impacts of between 1 and 3% of gross revenue per 
acre for affected crops. This is less than 1% of all small crop farms. 
An estimated 1,900 farms would see per-acre impacts of greater than 3%, 
about 0.13% of small farms producing crops. (Ref. 68 at pg. 2)
    iii. Response to the Sugarbeet Associations' and Gharda's 
reputational arguments. EPA also disagrees with the Sugarbeet 
Associations' and Gharda's arguments regarding irreparable reputational 
injury. With respect to Gharda's arguments, EPA notes as a preliminary 
matter that Gharda claims that it ``has suffered'' reputational harm as 
a result of the final rule, and that EPA's revocation of the 
chlorpyrifos tolerances ``has . . . strain[ed]'' Gharda's customer 
relationships. (Ref. 67 at pg. 7) Even if EPA were to concede that 
Gharda has incurred such reputational injuries, staying the final rule 
would not resolve injuries that have allegedly already occurred. As a 
result, EPA will not further evaluate any reputational injuries Gharda 
alleges that it has already incurred for purposes of this first factor.
    EPA will take the Sugarbeet Associations' and Gharda's remaining 
reputational arguments in turn. First, Gharda argues that by revoking 
chlorpyrifos tolerances, ``EPA has directly attacked the safety of 
chlorpyrifos . . . and the credibility of Gharda in selling and 
distributing chlorpyrifos products.'' (Id.) While EPA has determined 
that aggregate exposures to chlorpyrifos from currently registered uses 
are not safe, EPA categorically rejects Gharda's claim that EPA 
directly

[[Page 11267]]

attacked Gharda's credibility. EPA finds it noteworthy that Gharda is 
unable to cite to a single source for this claim, other than a 
declaration from its president that simply contains a verbatim 
assertion as in the stay request and offers no further evidence. EPA 
also notes that the final rule did not single out Gharda's registered 
chlorpyrifos products. The final rule itself did not address any 
specific chlorpyrifos registered products or registrants; rather, the 
final rule revoked chlorpyrifos tolerances due to safety concerns with 
the chemical, not concerns with any specific registered product or 
individual company. Therefore, EPA finds no basis whatsoever for 
Gharda's claim that EPA attacked its credibility and thereby injured 
Gharda's reputation.
    Second, Gharda asserts that because the final rule disregarded 
written commitments by Gharda prior to the final rule to modify 
Gharda's label consistent with EPA's proposal in the 2020 PID, and 
because ``Gharda assured its customers that it was working 
cooperatively with EPA to reach agreement that would allow for many 
continued agricultural uses,'' Gharda suffered reputational injury and 
a loss of customer goodwill. (Id. at pgs. 7 and 8) As already discussed 
in Unit VII.C.1.b.ii. of this Order, EPA entered into such discussions 
with Gharda in a good-faith effort to determine if the safety issues 
identified in EPA's record on chlorpyrifos by the Ninth Circuit could 
be resolved in a sufficient and timely manner to allow for the 
modification of tolerances by the Court's imposed timeline. However, it 
simply was not practicable for EPA to complete any modifications or 
voluntary cancelations in time to inform the final rule and meet the 
Ninth Circuit's deadline. Furthermore, at no point during its 
discussions with Gharda did EPA make a binding commitment to modify 
chlorpyrifos tolerances instead of revoking them altogether. To the 
extent that Gharda informed its customers that EPA would modify 
chlorpyrifos tolerances instead of revoking them, that was an 
independent business decision made entirely by Gharda, and EPA cannot 
be held accountable for any consequences of that decision. Any 
reputational injuries suffered by Gharda as a result of assurances they 
provided their customers that EPA would modify chlorpyrifos tolerances 
are wholly attributable to Gharda.
    Third, Gharda argues that in light of the scientific record for 
chlorpyrifos, neither Gharda nor its customers expected EPA to revoke 
all tolerances, and that EPA's decision to do so ``has cast doubt on 
Gharda's credibility and resulted in a loss of customer goodwill.'' 
(Id.) EPA's review of the scientific record is already extensively 
detailed in the final rule and elsewhere in this Order, and EPA has 
made clear that based on its review of that record, it is unable to 
conclude that chlorpyrifos tolerances are safe due to the extent of 
currently registered uses. EPA also notes that chlorpyrifos has been 
subject to regulatory scrutiny since at least the 2007 Petition, and 
that on October 28, 2015 ((80 FR 69080, November 6, 2015) (FRL-9954-
65)), EPA issued a proposed rule to revoke all tolerances for 
chlorpyrifos. EPA also reiterates that the 2020 PID made clear that 
while chlorpyrifos applications could potentially be limited to 11 
specific uses in specific geographic areas to reduce aggregate 
exposures to safe levels, all other existing uses of chlorpyrifos would 
need to be cancelled under that proposed scenario. Finally, EPA notes 
that the Ninth Circuit rejected EPA's previous attempt to leave 
tolerances in place based on an argument that the petitioners had 
failed to provide sufficient data to support revoking the tolerances 
and found that the burden was on EPA to demonstrate that the tolerances 
were safe in order to leave them in place. The Court ordered EPA to act 
on the 2007 Petition by granting it and issuing a final rule concerning 
chlorpyrifos tolerances, and therefore, a realistic potential outcome 
of this order was that EPA might revoke some or all of the chlorpyrifos 
tolerances. As a result, Gharda had fair warning that EPA might revoke 
tolerances for chlorpyrifos via the final rule. Also, as noted in the 
preceding paragraph, any injury arising from Gharda's speculative 
discussions with its customers is an injury of Gharda's own making and 
not EPA's rule.
    Fourth, Gharda argues that the final rule could result in long-term 
harm to Gharda due to ``the stigma attached to the unfounded public 
statements by EPA that its action was taken `to ensure children, 
farmworkers, and all people are protected from the potentially 
dangerous consequences of [chlorpyrifos],' and `follow[s] the science 
and put[s] health and safety first.' '' (Id. at pg. 8, citing Ref. 57) 
The Sugarbeet Associations make a similar argument, claiming that 
because the final rule revoked chlorpyrifos tolerances despite the 
proposal in the 2020 PID concerning the 11 uses of chlorpyrifos 
identified by EPA, the sugarbeet industry is likely to suffer 
reputational harm in the form of ``ill-will . . . from customers and 
the public.'' It is not clear to EPA why that would be the case. The 
final rule makes no mention of Gharda or the Sugarbeet Associations at 
all and includes only a single reference to sugarbeets in its 
discussion of the 2020 DWA. (See Ref. 1 at pg. 48331) Nowhere in the 
final rule does EPA disparage sugarbeets, or single out chlorpyrifos 
applications on sugarbeets as presenting a unique risk to the public. 
Quite the opposite: EPA revoked all chlorpyrifos tolerances due to its 
inability to conclude that aggregate exposures from all chlorpyrifos 
uses would be safe. Additionally, while it is not established that 
Gharda's, the Sugarbeet Associations' or the sugarbeet industry's 
reputations will suffer as a result of the final rule, EPA's view is 
that a stay might in fact lead to the reputational harm the Sugarbeet 
Associations and Gharda are seeking to avoid. As described in the final 
rule and reiterated throughout this Order, EPA is unable to conclude 
that chlorpyrifos tolerances are safe for purposes of the FFDCA, and as 
of February 28, 2022, those tolerances will no longer be in effect. 
Assuming the Sugarbeet Associations and their member entities and 
Gharda comply with the revocation and abide by the guidance issued by 
the FDA and USDA, EPA sees no reason why customers or the public should 
have any ill will toward these entities for simply complying with the 
FFDCA. On the other hand, if EPA were to stay the final rule after 
concluding that tolerances are unsafe, customers and the public might 
have concerns about the safety of chlorpyrifos residues on food 
products, and Gharda's and the Sugarbeet Associations' members' roles 
in making these products available to the public. Therefore, EPA 
disagrees with Gharda and the Sugarbeet Associations that they and/or 
the sugarbeet industry will suffer irreparable reputational injury due 
to the final rule.
    iv. Response to Gharda's due process argument. Finally, EPA 
disagrees with Gharda that EPA has infringed its due process rights via 
the final rule. As a preliminary matter, EPA notes that Gharda's stay 
request omits a key element of the due process analysis. Gharda's 
request characterizes ``the deprivation of a legally protectable 
property right (i.e., pesticide registration)'' as a due process 
violation. However, as Gharda itself makes clear in its Objections to 
the final rule, any such deprivation must also be ``unreasonable, 
arbitrary or capricious.'' (Ref. 67 at pg. 37 (citing Nebbia v. New 
York, 291 U.S. 502, 525 (1934))) As EPA explains in more detail in Unit 
VII.C.5.g. of this

[[Page 11268]]

Order, Gharda has failed to provide information sufficient to establish 
that the final rule unfairly or arbitrarily revoked chlorpyrifos 
tolerances. EPA also notes that as a legal matter, the final rule does 
not in fact effectuate a cancellation of Gharda's registrations. 
Instead, the final rule simply revokes chlorpyrifos tolerances. As a 
result, it cannot be said that the final rule infringed Gharda's 
substantive due process rights and thereby caused Gharda irreparable 
harm.
b. Were the Sugarbeet Associations' and Gharda's cases for a stay 
frivolous, and not pursued in good faith?
    EPA generally believes that the Sugarbeet Associations' and 
Gharda's requests for a stay were made in good faith and reflect their 
concern about the potential implications of the final rule for their 
and their represented entities' business interests and/or ability to 
produce food (as the case may be). Chlorpyrifos has been an available 
insecticide for decades, and EPA recognizes that many growers have come 
to rely on it as a tool for controlling insect pests. Nor is there any 
indication in their requests for stay that the Sugarbeet Associations 
or Gharda are making frivolous arguments; EPA's impression is that the 
Sugarbeet Associations' and Gharda's requests for stay appear to 
reflect their good-faith interpretation of 21 CFR 10.35. As discussed 
in Unit VIII.B.2.a.iii., EPA note that chlorpyrifos has been subject to 
regulatory scrutiny since at least the 2007 Petition, and that in 2015 
EPA issued a proposed rule to revoke all tolerances for chlorpyrifos. 
The 2020 PID also made clear that while chlorpyrifos applications could 
potentially be limited to 11 specific uses in specific geographic areas 
to reduce aggregate exposures to safe levels, all other existing uses 
of chlorpyrifos would need to be cancelled. Finally, the Ninth Circuit 
ordered EPA to act on the 2007 Petition by granting it and issuing a 
final rule concerning chlorpyrifos tolerances, and that a realistic 
potential outcome of this order was that EPA might revoke some or all 
of the chlorpyrifos tolerances. As a result, the Sugarbeet Associations 
and Gharda had fair warning that EPA might revoke tolerances for 
chlorpyrifos via the final rule. Notwithstanding this fair warning, 
however, EPA generally agrees with these Objectors that their cases for 
a stay are not frivolous and are being pursued in good faith.
c. Have the Sugarbeet Associations and Gharda demonstrated sound public 
policy grounds supporting a stay?
    The Sugarbeet Associations and Gharda each argue that public policy 
grounds support their stay requests, though EPA notes that the 
Sugarbeet Associations combined this factor and the fourth factor into 
a single discussion. Both of these Objectors' arguments on this point 
incorporate several of the arguments raised in their objections, which 
were submitted under separate cover: That good public policy does not 
support regulatory decisions that are at odds with EPA's ``best 
available science'' and the 2020 PID; that EPA issued the final rule in 
a process that was fundamentally unfair and marked by bad faith; that 
EPA disregarded cancelation procedures, prior public comments, and 
interagency review processes, and abdicated its responsibility to 
oversee a lawful and orderly phase-out of chlorpyrifos products; and 
that the final rule will result in economic harms to U.S. growers and 
environmental harms from increased application of chlorpyrifos 
alternatives. Gharda also argues that the timeframe imposed by the 
final rule ``will result [in] the needless waste of safe and wholesome 
food,'' (Ref. 67 at pg. 11) and the Sugarbeet Associations include a 
general assertion that chlorpyrifos ``is used only when and only as 
much as necessary.'' (Ref. 66 at pg. 9)
    EPA finds that the Sugarbeet Associations and Gharda have failed to 
demonstrate sound public policy grounds supporting a stay of the final 
rule. First, EPA notes that most of the arguments marshaled by the 
Sugarbeet Associations and Gharda on this point are simply restatements 
of their objections to the final rule, and that these Objectors 
frequently fail to explain how exactly any particular public policy is 
furthered by these objections. For example, the Sugarbeet Associations 
argue that EPA's alleged failure to consider relevant scientific 
information, as indicated by its decision to revoke chlorpyrifos 
despite the 2020 PID, is itself a reason that the public interest 
supports a stay. However, the Sugarbeet Associations do not elaborate 
on how or why that alleged failure relates to sound public policy or 
furthers the public interest or in this particular case, supports a 
conclusion that EPA erred in concluding that chlorpyrifos tolerances 
were unsafe. Similarly, Gharda argues that the final rule will cause 
significant hardship to U.S. growers who might need to rely on more 
expensive and/or less effective alternatives to chlorpyrifos but does 
not explain in its stay request why that is a matter of public 
interest, rather than an issue of concern particular to those growers.
    Second, EPA notes by requesting a stay ``until a final resolution, 
including potential judicial review, is reached on all of the . . . 
issues raised in [our] objections,'' while failing to define what 
exactly constitutes a ``final resolution,'' the Sugarbeet Associations 
and Gharda are essentially asking for the final rule to be stayed 
indefinitely. Even if EPA interprets ``final resolution'' as being 
limited to the conclusion of judicial review of the final rule--which 
EPA notes is a much narrower interpretation than the plain language of 
these Objectors' request--it is extremely unlikely that this matter 
would be fully and finally resolved by the courts for at least two or 
three years. FFDCA section 408(h)(1) provides that any person who will 
be adversely affected by the final rule may obtain judicial review in 
the relevant U.S. Court of Appeals. Review in the Court of Appeals may, 
by itself, take several years; for example, over a year and a half 
elapsed between the LULAC Petitioners' and States' August 7, 2019, 
petition in the Ninth Circuit for review of the Denial Order and Final 
Order and the Ninth Circuit's decision on April 29, 2021. However, the 
process could take still longer, since FFDCA section 408(h)(4) provides 
that the judgment of the court affirming or setting aside the final 
rule is subject to review by the Supreme Court of the United States. 
Even if the Supreme Court denies certiorari, significant time will have 
elapsed before it could reasonably be said that there has been a 
``final resolution'' in terms of judicial review of the final rule. 
Furthermore, EPA is confident in its legal and scientific analyses, and 
sees no compelling policy rationale for staying the final rule and 
leaving chlorpyrifos tolerances in place pending judicial review. Doing 
so would only perpetuate the public's exposure to the unsafe levels of 
chlorpyrifos that the Agency identified based on its review of the 
science and the aggregation of relevant exposures from all currently 
registered uses, all to mitigate the potential for impacts to Gharda 
and/or the sugarbeet industry. EPA's position is that there are no 
sound public policy grounds supporting such a course of action.
    It is also clear to EPA that the Sugarbeet Associations' and 
Gharda's ultimate goal with respect to their stay requests is the 
rescission or revocation of the final rule. This is evident from the 
fact that the Sugarbeet Associations and Gharda incorporate many of the 
arguments made in their objections,

[[Page 11269]]

which request that the final rule be immediately or summarily reversed, 
and from Gharda's stay request, which discusses the economic losses 
Gharda will allegedly face if the final rule is not ``reversed or 
rescinded.'' To the extent the Sugarbeet Associations and Gharda are 
seeking to utilize the stay process to rescind the final rule, EPA 
notes that there is no need for EPA to stay the final rule simply to 
give the Sugarbeet Associations and Gharda more time to file litigation 
seeking rescission. EPA has outlined the relevant judicial review 
process in the preceding paragraph, and notes that there is no barrier 
to the Sugarbeet Associations and Gharda deciding to pursue judicial 
review of the final rule through a challenge to this Order. Nor does 
EPA believe that any public policy interest is furthered by such a 
course of action.
    In light of the foregoing, EPA has significant concerns that the 
Sugarbeet Associations and Gharda are seeking to use the stay process 
to compel the consideration of factors not permitted by the FFDCA, 
thereby keeping chlorpyrifos tolerances in place despite EPA's 
inability to make the safety finding required by the FFDCA and the 
Ninth Circuit. By arguing that public policy grounds favor an 
effectively indefinite stay of the final rule due to the potential for 
economic harm, the Sugarbeet Associations and Gharda are asking EPA to 
keep chlorpyrifos tolerances in place despite EPA's inability to make a 
statutorily required safety finding for these tolerances and despite 
the fact that the FFDCA safety standard does not permit consideration 
of economic costs or benefits. This is a significant request, and EPA 
expects any party making such a request to demonstrate in detail how it 
furthers the public interest. However, as noted in the preceding 
paragraph, the Sugarbeet Associations and Gharda fail to sufficiently 
explain how the stay request is in the public interest at all, much 
less how any such public interest warrants deviating from the plain 
language of the FFDCA. EPA's position is that there are in fact 
overwhelming public policy grounds supporting EPA's reliance on the 
plain language of the FFDCA, particularly given the public health 
concerns underlying that statute.
    Specifically, there is a significant public policy argument in 
favor of the Agency fulfilling its statutory obligation to follow the 
law as it was enacted by Congress. As enacted by Congress, section 408 
of the FFDCA is clear that in order to leave tolerances in place, EPA 
must determine that there is a reasonable certainty that no harm will 
result from aggregate exposures to chlorpyrifos, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. If the tolerances are not safe, EPA must 
modify or revoke them; any tolerances so modified, however, must also 
be safe. As discussed throughout this document, the FFDCA does not 
permit consideration of economic factors in the Agency's determination 
of safety. There is a compelling public policy argument that EPA must 
act in accordance with Congress' intent, as evidenced by the plain 
language of the statute. As a result, EPA's analysis in the final rule 
was necessarily limited to an assessment of aggregate exposures, 
including dietary, residential, and drinking water exposures, as 
instructed by the statute. Because EPA could not determine that such 
aggregate exposures were safe, EPA revoked tolerances for chlorpyrifos. 
Furthermore, EPA notes that to disregard the clear statutory language 
would also entail turning a blind eye to EPA's inability to find that 
chlorpyrifos tolerances are safe. That is, EPA taking action in direct 
contravention of the FFDCA is not only poor public policy from an 
administrative law standpoint, but also from a public health 
perspective. EPA considers the protection of public health to be a 
matter of overwhelming importance and is not inclined to so readily 
disregard its own inability to conclude that chlorpyrifos tolerances 
are safe.
    Notwithstanding, EPA is not saying that it is precluded from ever 
delaying an effective date of a tolerance revocation rule. In a 
proposed order granting objections to revoke sulfuryl fluoride 
tolerances, EPA proposed to phase-out tolerances over varying periods 
of time due to lack of alternatives and the relatively low contribution 
of harm coming directly from the use of the pesticide itself as opposed 
to naturally occurring fluoride. (See Sulfuryl Fluoride; Proposed Order 
Granting Objections to Tolerances and Denying Request for a Stay (76 FR 
3422, January 19, 2011 (FRL-8867-9))) But that is not the case here: 
For chlorpyrifos, the use of the pesticide itself is directly 
contributing to harmful aggregate exposures, there are some 
alternatives, and EPA has already delayed the expiration of the revoked 
tolerances. Therefore, EPA concludes that there are not compelling 
public policy grounds to further delay in light of the Agency's finding 
that the chlorpyrifos tolerances are not safe.
    With respect to Gharda's argument that the final rule will ``result 
[in] the needless waste of safe and wholesome food,'' EPA notes that 
Gharda is incorrect. FFDCA section 408(l)(5) provides for the continued 
distribution of food treated with chlorpyrifos as long as the 
conditions in that provision are met. Moreover, FDA has developed 
guidance describing how FDA intends to monitor any foods containing 
chlorpyrifos residues and detailing intentions concerning enforcement. 
(Ref. 65) As a general matter, implementation of the FDA guidance will 
not result in the ``needless waste'' of food since foods treated with 
chlorpyrifos prior to the expiration of the tolerances on February 28, 
2022, will continue to move through the channels of trade for the next 
few years consistent with the terms of section 408(l)(5) and the 
guidance. Therefore, as implemented, EPA does not anticipate that the 
final rule will result in the disposal of massive amounts of foods 
treated with chlorpyrifos, or in any ``needless waste.''
    Finally, while the Sugarbeet Associations include a general 
assertion that chlorpyrifos ``is used only when and only as much as 
necessary,'' EPA again notes that the Sugarbeet Associations fail to 
demonstrate how that assertion supports a determination that sound 
public policy grounds support a stay of the final rule. EPA has 
provided significant detail in the final rule and in this Order 
describing the analysis supporting its revocation of revoking 
chlorpyrifos tolerances, which analysis included consideration of 
estimated exposures from all approved uses of chlorpyrifos.
d. Is the delay resulting from the stay outweighed by public health 
concerns or other public interests?
    The Sugarbeet Associations and Gharda each argue that the delay 
resulting from a stay is not outweighed by public health concerns or 
other public interests, though as noted the Sugarbeet Associations 
combined this factor and the third factor into a single discussion. 
Gharda's arguments in support of this factor are brief and conclusory. 
Gharda argues that ``[t]here are no public health or other public 
interests that will be adversely impacted by granting a stay,'' 
referencing back to its arguments that the final rule is at odds with 
the 2020 PID, that EPA incorrectly applied the 10X FQPA safety factor, 
and that the final rule will result in economic and environmental 
harms. (Ref. 67 at pg. 11) Similarly, the Sugarbeet Associations state 
that the ``weighing of the public interest supports a stay'' based on 
the potential economic harm to growers if no stay is granted, as well 
as ``the corresponding lack of public health or public interest

[[Page 11270]]

counseling against a stay.'' (Ref. 66 at pg. 9)
    EPA disagrees with the Sugarbeet Associations and Gharda and finds 
that the delay resulting from an effectively indefinite stay of the 
final rule is outweighed by public health concerns and other public 
interests. First, EPA strongly disagrees with the Sugarbeet 
Associations and Gharda that there are no public health concerns or 
other public interests counseling against a stay. Most obviously, EPA 
is unable to conclude that chlorpyrifos tolerances are safe for 
purposes of the FFDCA. Continued use of chlorpyrifos on food in 
accordance with the current labels will continue to cause aggregate 
exposures that are not safe. While FFDCA section 408(l)(5) and the 
FDA's Channels of Trade guidance will continue to allow some foods 
treated with chlorpyrifos to move through the channels of trade, the 
revocation and expiration of the tolerances will ensure that no 
chlorpyrifos is used on food after the expiration, thus, limiting the 
ultimate universe of foods that may contain chlorpyrifos residues to 
less than what would be available if EPA stayed the rule. Moreover, the 
final rule's revocation of chlorpyrifos tolerances, which precludes 
continued application to food crops, would also prevent additional 
contributions of chlorpyrifos from ending up in drinking water due to 
its use on food. EPA does not take lightly the FFDCA's clear mandate 
that tolerances may only be left in place if they are safe and views 
the safety of pesticide chemical residues on food as a significant 
public health concern and a matter of overwhelming public interest.
    Nor have the Sugarbeet Associations or Gharda presented any 
persuasive evidence in support of this position. The Sugarbeet 
Associations simply state that there is a ``lack of public health or 
public interest counseling against a stay,'' and provide no support 
whatsoever for this proposition. Gharda makes a similar assertion, and 
then includes a few sentences briefly referencing arguments made in its 
objections. However, Gharda does not identify how these points, which 
appear to be made almost in passing, support their argument that there 
is a complete absence of public health or other public interests that 
will be adversely impacted by granting a stay.
    Second, EPA is unsettled by the open-ended nature of the Sugarbeet 
Associations' and Gharda's stay requests, which ask EPA to stay the 
final rule ``until a final resolution, including potential judicial 
review, is reached on all of the . . . issues raised in [our] 
objections.'' EPA notes that neither Objector defines or otherwise 
limits what exactly might constitute such a ``final resolution,'' 
particularly since their requests include, but are not limited to, 
potential judicial review. As a result, EPA views Objectors' request as 
at best an indefinite stay of the final rule, and at worst as an 
attempt to effectively rescind the final rule via the stay process--all 
in direct contravention of a statutory mandate that requires EPA to 
determine that tolerances are safe in order to leave them in place. 
While EPA does not necessarily require requests for stays to include a 
specific timeframe for the duration of the requested stay, EPA does not 
believe that the public interest is served by granting a stay with such 
ill-defined parameters. This is particularly true where, as is the case 
here, the subject matter bears directly on public health concerns. If 
EPA were to indulge Objectors' requests and stay the final rule on this 
basis, and after several years Objectors exhaust their judicial avenues 
for challenging the final rule, Objectors could nonetheless continue to 
assert that any or all of the specific issues raised in their 
objections have not been fully resolved and that the stay should 
continue. As a result, EPA would necessarily have to agree to a 
definable endpoint for the stay. EPA cannot agree to this indefinite 
postponement, particularly in light of its inability to conclude that 
chlorpyrifos tolerances are safe.
    Finally, EPA recognizes that the Sugarbeet Associations' and 
Gharda's requests ask EPA to continue relying on the precise approach 
for which EPA was so recently and explicitly chastised by the Ninth 
Circuit. That is, EPA is asked to set aside the final rule in order to 
engage in ``further factfinding after thirteen years of interminable 
delay,'' which the Ninth Circuit stated, ``would make a mockery, not 
just of this Court's prior rulings and determinations, but of the rule 
of law itself.'' (LULAC, 996 F.3d at pg. 702) In light of the Ninth 
Circuit's clear frustration with EPA for its long delay, EPA is 
unwilling to return to an approach that would result in further delay 
for more study of chlorpyrifos tolerances, all in pursuit of an 
amorphous ``final resolution'' of the Sugarbeet Associations' and 
Gharda's various concerns. As reiterated several times herein, EPA is 
unable to conclude that chlorpyrifos tolerances are safe. The statute 
does not permit EPA to leave tolerances in place when it cannot 
conclude that they are safe. As a result, EPA refuses to further delay 
revoking chlorpyrifos tolerances.
e. Denial of the Sugarbeet Associations' and Gharda's Stay Requests
    As stated in the regulation, the Agency shall grant a stay if all 
four of the criteria in 21 CFR 10.35(e) are satisfied. As explained 
previously, EPA find that the Sugarbeet Associations and Gharda have 
failed to satisfy three of the four criteria in 21 CFR 10.35(e). 
Consequently, EPA denies the Sugarbeet Associations' and Gharda's 
requests for a stay of the final rule.

IX. Earthjustice Feedback and Comments

A. Overview

    On October 28, 2021, prior to the close of the objections period, 
Earthjustice submitted a document titled LULAC Petitioners' Feedback on 
the Environmental Protection Agency's Chlorpyrifos Tolerance Revocation 
Rule and Comments on Growers' Objections on behalf of the following 12 
public interest groups: League of United Latin American Citizens, NRDC, 
PANNA, California Rural Legal Assistance Foundation, Farmworker 
Association of Florida, Farmworker Justice, GreenLatinos, Labor Council 
for Latin American Advancement, Learning Disabilities Association of 
America, National Hispanic Medical Association, Pineros y Campesinos 
Unidos del Noroeste, and United Farm Workers. (Ref. 69) Earthjustice 
previously submitted objections to the 2017 Order Denying Petition on 
behalf of these same 12 public interest groups in June 2017. 
Earthjustice also represented these 12 public interest groups in their 
lawsuit challenging the 2017 Order Denying Petition and the 2019 Order 
Denying Objections to Petition Denial before the Ninth Circuit Court of 
Appeals, in which they sought to have the chlorpyrifos tolerances 
revoked.
    Notably, Earthjustice does not object to the final rule's 
revocation of tolerances for chlorpyrifos. On the contrary 
Earthjustice's submission says that ``[t]he LULAC petitioners . . . 
celebrate EPA's action.'' (Id. at pg. 1) Rather, these comments are 
primarily focused on arguments that Earthjustice (on behalf of the 
advocacy groups) believes the Agency must consider and address in the 
event that chlorpyrifos tolerances would be retained or reinstated at a 
future time. For the most part, Earthjustice reiterates arguments that 
it has made previously in its objections to the 2017 Order Denying 
Petition, including that use of 10% cholinesterase inhibition as the 
regulatory endpoint, which EPA used in the final rule, is 
underprotective, even with the retention of the 10X FQPA

[[Page 11271]]

safety factor, and should not be used as precedent in future 
registration review actions for non-food uses of chlorpyrifos or for 
other organophosphate pesticides.
    Earthjustice asserts that, as a scientific and legal matter, EPA is 
unable to make a finding of reasonable certainty of no harm using 10% 
cholinesterase inhibition as the regulatory endpoint. Earthjustice 
alleges that not only does the science support the conclusion that 
neurodevelopmental harms occur below levels of this regulatory 
endpoint, but the record and the Ninth Circuit's decision in LULAC 
foreclosed EPA from making such a finding. Earthjustice also takes 
issues with certain EPA statements in the final rule, which 
Earthjustice argues are intended to ``disparage'' the causal link 
between chlorpyrifos exposure and neurodevelopmental harm to children. 
Earthjustice believes that these statements are at odds with the record 
and unsupported. Finally, Earthjustice reiterates arguments made 
previously in response to EPA's 2017 Order Denying Petition that the 
final rule's retention of the 10X FQPA safety factor is not sufficient 
to ensure reasonable certainty of no harm to children.

B. Response to Earthjustice's Feedback and Comments

    Because EPA is leaving the final rule in place as promulgated in 
August 2021 and not leaving any tolerances in place, EPA does not 
believe the Earthjustice comments necessitate a response at this time. 
While the comments might be relevant in the event that tolerances were 
retained or in any future action in which EPA considers petitions to 
establish chlorpyrifos tolerances, they are not relevant to a final 
rule that revokes tolerances. EPA does not need to address any of these 
comments as part of this Order, as they are not ripe for consideration 
at this time.

X. Conclusion

    For all of the reasons specified in Unit VI., VII., and VIII. of 
this document, EPA denies, in full, the objections and requests for 
hearing on those objections and requests for stay, respectively.

XI. Regulatory Assessment Requirements

    As indicated previously, this action announces the Agency's order 
denying objections filed under the FFDCA section 408. As such, this 
action is an adjudication and not a rule. The regulatory assessment 
requirements imposed on rulemaking do not, therefore, apply to this 
action.

XII. Congressional Review Act (CRA)

    The CRA, 5 U.S.C. 801 et seq., does not apply to this Order because 
this action is not a rule for purposes of 5 U.S.C. 804(3).

XIII. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. U.S. EPA. Chlorpyrifos; Tolerance Revocations; Final Rule. 
Federal Register. 86 FR 48315, August 30, 2021 (FRL-5993-04-OSCPP).
2. U.S. EPA (2020). Chlorpyrifos: Third Revised Human Health Risk 
Assessment for Registration Review. September 22, 2020. Available at 
https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0944.
3. U.S. EPA (2000). Available Information on Assessing Exposure From 
Pesticides In Food: A User's Guide. June 21, 2000. Available at 
https://www.doh.wa.gov/Portals/1/Documents/4000/PASW_exposurefood.pdf.
4. U.S. EPA, Office of Research and Development (2000). Benchmark 
Dose Technical Guidance Document. External Review Draft. October 
2000. EPA Document ID. No. EPA/630/R-00/001.
5. FIFRA Science Advisory Panel (2002). Methods Used to Conduct a 
Preliminary Cumulative Risk Assessment for Organophosphate 
Pesticides. Final Report from the FIFRA Scientific Advisory Panel 
Meeting of February 5-7, 2002. Report dated March 19, 2002. 
Available at https://archive.epa.gov/scipoly/sap/meetings/web/pdf/final-4.pdf.
6. FIFRA Science Advisory Panel (2005). Final Report on Preliminary 
N-Methyl Carbamate Cumulative Risk Assessment. Final Report from the 
FIFRA Scientific Advisory Panel Meeting of August 23-25, 2005. 
Report dated October 13, 2005. Available at: http://www.epa.gov/scipoly/sap/2005/august/minutes.pdf.
7. U.S. EPA (2018). Science in Action: Physiologically-Based 
Pharmacokinetic (PBPK) Models. February 2018. Available at https://www.epa.gov/sites/default/files/2018-02/documents/pbpk_factsheet_feb2018_0.pdf.
8. U.S. EPA (2014). Guidance for Applying Quantitative Data to 
Develop Data-Derived Extrapolation Factors for Interspecies and 
Intraspecies Extrapolation. September 2014. EPA Document ID No. EPA/
100/R-14/002F. Available at: https://www.epa.gov/sites/default/files/2015-01/documents/ddef-final.pdf.
9. U.S. EPA (2002). Determination of the Appropriate FQPA Safety 
Factor(s) For Use in the Tolerance Assessment. February 28, 2002. 
Available at: https://www.epa.gov/sites/default/files/2015-07/documents/determ.pdf.
10. U.S. EPA (1996). Residue Chemistry Test Guidelines: OPPTS 
860.1500 Crop Field Trials. August 1996. EPA Document ID No. 712-C-
96-183. Available at: https://www.regulations.gov/document/EPA-HQ-OPPT-2009-0155-0013.
11. U.S. EPA (2000). Choosing a Percentile of Acute Dietary Exposure 
as a Threshold of Regulatory Concern. March 16, 2000. Available at: 
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/choosing-percentile-acute-dietary-exposure.
12. FIFRA Scientific Advisory Panel (2020). Approaches for 
Quantitative Use of Surface Water Monitoring Data in Pesticide 
Drinking Water Assessments. Final Report from the FIFRA Scientific 
Advisory Panel Meeting of November 19-21, 2019. Report dated 
February 18, 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2019-0417-0019.
13. U.S. EPA (2020). Framework for Conducting Pesticide Drinking 
Water Assessments for Surface Water. September 2020. Available at: 
https://www.epa.gov/sites/default/files/2020-09/documents/framework-conducting-pesticide-dw-sw.pdf.
14. U.S. EPA (2001). General Principles for Performing Aggregate 
Exposure and Risk Assessments. November 28, 2001. Available at: 
https://www.epa.gov/sites/default/files/2015-07/documents/aggregate.pdf.
15. U.S. EPA (2020). Appendix B. Case Study for Integrating a 
Distributional Approach to Using Percent Crop Area (PCA) and Percent 
Crop Treated (PCT) into Drinking Water Assessment. June 2020. 
Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2020-0279-0002.
16. U.S. EPA (2012). Standard Operating Procedures for Residential 
Pesticide Exposure Assessment. October 2012. Available at: https://www.epa.gov/sites/default/files/2015-08/documents/usepa-opp-hed_residential_sops_oct2012.pdf.
17. U.S. EPA (2000). Office of Pesticide Programs Science Policy on: 
The Use of Data on Cholinesterase Inhibition for Risk Assessments of 
Organophosphorous and Carbamate Pesticides. August 18, 2000. 
Available at: https://www.epa.gov/sites/default/files/2015-07/documents/cholin.pdf.
18. U.S. EPA (2011). Chlorpyrifos: Preliminary Human Health Risk 
Assessment for Registration Review. June 30, 2011. Available at: 
https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0025.
19. U.S. EPA (2016). Office of Pesticide Programs' Framework for 
Incorporating Human Epidemiologic & Incident Data in Risk 
Assessments for Pesticides. December 28, 2016. Available at: https://www3.epa.gov/pesticides/EPA-HQ-OPP-2008-0316-DRAFT-0075.pdf.

[[Page 11272]]

20. U.S. EPA (2014). Chlorpyrifos: Revised Human Health Risk 
Assessment for Registration Review. December 29, 2014. Available at: 
https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0195.
21. FIFRA Scientific Advisory Panel (2012). Scientific Issues 
Associated with Chlorpyrifos. Final Report from the FIFRA Scientific 
Advisory Panel Meeting of April 10-12, 2012. Report dated July 11, 
2012. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2012-0040-0029.
22. FIFRA Scientific Advisory Panel (2016). Analysis of 
Biomonitoring Data. Final Report from the FIFRA Scientific Advisory 
Panel Meeting of April 19-21, 2016. Report dated July 20, 2016. 
Available at: https://www.epa.gov/sites/default/files/2016-07/documents/chlorpyrifos_sap_april_2016_final_minutes.pdf.
23. U.S. EPA (2020). The Use of New Approach Methodologies (NAMs) to 
Derive Extrapolation Factors and Evaluate Developmental 
Neurotoxicity for Human Health Risk Assessment. August 25, 2020. 
Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2020-0263-0033.
24. FIFRA Scientific Advisory Panel (2020). Peer Review of the Use 
of New Approach Methodologies (NAMs) to Derive Extrapolation Factors 
and Evaluate Developmental Neurotoxicity for Human Health Risk 
Assessment. Final Report from the FIFRA Scientific Advisory Panel 
Meeting of September 15-18, 2020. Report dated December 15, 2020. 
Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2020-0263-0054.
25. U.S. EPA (2006). Reregistration Eligibility Decision for 
Chlorpyrifos. July 31, 2006. Available at: https://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/red_PC-059101_1-Jul-06.pdf.
26. U.S. EPA (2011). Revised Chlorpyrifos Preliminary Registration 
Review Drinking Water Assessment. June 20, 2011. Available at: 
https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0026.
27. U.S. EPA (2014). Updated Drinking Water Assessment for 
Registration Review. December 23. 2014. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0198.
28. U.S. EPA (2016). Chlorpyrifos: Revised Human Health Risk 
Assessment for Registration Review. November 3, 2016. Available at: 
https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0454.
29. U.S. EPA (2016). Chlorpyrifos Refined Drinking Water Assessment 
for Registration Review. April 14, 2016. https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0437.
30. U.S. EPA (2020). Updated Chlorpyrifos Refined Drinking Water 
Assessment for Registration Review. September 15, 2020. Available 
at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0941.
31. U.S. EPA (2020). Chlorpyrifos Proposed Interim Registration 
Review Decision. December 3, 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0971.
32. FIFRA Scientific Advisory Panel (2008). The Agency's Evaluation 
of the Toxicity Profile of Chlorpyrifos. Final Report from the FIFRA 
Scientific Advisory Panel Meeting of September 16-18, 2008. Report 
dated December 17, 2008. Available at: https://www.regulations.gov/docket/EPA-HQ-OPP-2008-0274-0064.
33. FIFRA Scientific Advisory Panel (2010). Draft Framework and Case 
Studies on Atrazine, Human Incidents, and the Agricultural Health 
Study: Incorporation of Epidemiology and Human Incident Data into 
Human Health Risk Assessment. Final Report from the FIFRA Scientific 
Advisory Panel Meeting of February 2-4, 2010. Report dated April 22, 
2010. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2009-0851-0059.
34. The Petition from NRDC and PANNA, EPA's various responses to it, 
and the objections submitted on the Petition denial are available in 
docket number EPA-HQ-OPP-2007-1005 at https://www.regulations.gov.
35. U.S. EPA (2009). Chlorpyrifos Final Work Plan. September 25, 
2009. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0020.
36. American Soybean Association. Objections, Request for 
Evidentiary Hearing, Request to Stay Tolerance Revocations. 
Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0022.
37. American Sugarbeet Growers Association, U.S. Beet Sugar 
Association. Objections to Decision Revoking All Chlorpyrifos 
Tolerances. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0029.
38. Cherry Marketing Institute. Formal Written Objections and 
Request for Evidentiary Hearing for Chlorpyrifos Tolerance 
Revocation. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0024.
39. Gharda Chemicals International, Inc.'s Objections to the Final 
Rule Revoking All Tolerances for Chlorpyrifos. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0028.
40. U.S. EPA, Administrative Law Judge (2020). Order Urging 
Electronic Service and Filing. April 10, 2020. Available at: https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
41. Columbia Ministry of Trade, Industry and Tourism. Comment. 
Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0027.
42. Drexel Chemical Company. Objections, Request for Stay, Request 
for Product Phase Out. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0021.
43. International Pepper Community. Comment. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0014.
44. Oregonians for Food & Shelter. Formal Objections and Request to 
Stay Tolerance Revocation of Chlorpyrifos. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0023.
45. Republic of Ecuador. Comments on Chlorpyrifos: Tolerance 
Revocations Rule by the EPA. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0026.
46. National Association of Wheat Growers. Comment. Available at: 
https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0016.
47. Agricultural Retailers Association et al. Formal Written 
Objections and Request to Stay Tolerance Revocations: Chlorpyrifos. 
Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0007.
48. Cranberry Industry comments on EPA's Pesticide Registration 
Review: Proposed Interim Decision for Chlorpyrifos. Available at: 
https://www.regulations.gov/comment/EPA-HQ-OPP-2008-0850-1075.
49. Minor Crop Farmer Alliance. Objections to the Revocation of 
Chlorpyrifos Tolerances Final Rule. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0018.
50. CropLife America and Responsible Industry for a Sound 
Environment. Objections, Request for Stay, Request for Guidance. 
Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0004.
51. U.S. EPA (2021). List of External Meetings Between EPA and 
Chlorpyrifos Stakeholders. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0002.
52. California Citrus Quality Council. Objections to the Revocation 
of Chlorpyrifos Tolerances Final Rule. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0019.
53. Coalition of Organophosphate (OP) Registrants. Written Objection 
on Chlorpyrifos Tolerance Revocation Final Rule. Available at: 
https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0003.
54. U.S. EPA (2020). EPA Requests Comments on New Methodologies to 
Estimate Pesticide Concentrations in Surface Waters. January 15, 
2020. See announcement at: https://www.epa.gov/pesticides/epa-requests-comments-new-methodologies-estimate-pesticide-concentrations-surface-waters.
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12866. October 12, 1993. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/inforeg/eo12866_implementation_guidance.pdf.
56. U.S. EPA (2020). Revised Benefits of Agricultural Uses of 
Chlorpyrifos s (PC#

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059101). November 18, 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969.
57. U.S. EPA (2021). EPA Takes Action to Address Risk from 
Chlorpyrifos and Protect Children's Health. Announcement. August 18, 
2021. Available at: https://www.epa.gov/newsreleases/epa-takes-action-address-risk-chlorpyrifos-and-protect-childrens-health.
58. Republic of Columbia. Comment. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0020.
59. World Trade Organization (WTO). The WTO Agreement on the 
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60. The Codex website contains a listing of current chlorpyrifos 
MRLs. (Last viewed February 13, 2022). Available at: https://www.fao.org/fao-who-codexalimentarius/codex-texts/dbs/pestres/pesticide-detail/en/?p_id=17.
61. WTO (2001). Doha Decision on Implementation-Related Issues and 
Concerns. WT/MIN(01)/17 (2001).
62. Michigan Vegetable Council. Formal Written Objections and 
Request to Stay Tolerance Revocations: Chlorpyrifos. Available at: 
https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0005.
63. U.S. EPA (2022). Frequent Questions about the Chlorpyrifos 2021 
Final Rule. (Last viewed February 13, 2022). Available at: https://www.epa.gov/ingredients-used-pesticide-products/frequent-questions-about-chlorpyrifos-2021-final-rule#question-10.
64. Willard Jack. Formal Written Objections and Request to Stay 
Tolerance Revocations: Chlorpyrifos. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0013.
65. U.S. FDA (2022). Guidance for Industry: Questions and Answers 
Regarding Channels of Trade Policy for Human Food Commodities with 
Chlorpyrifos Residues. February 2022. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-channels-trade-policy-human-food-commodities.
66. Sugarbeet Associations. Request for Stay of Decision Revoking 
All Chlorpyrifos Tolerances. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0029.
67. Gharda. Petition to Stay the Effective Date of the Revocation of 
All Tolerances for Chlorpyrifos. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0028.
68. U.S. EPA (2021). Chlorpyrifos Revocation Small Business and 
Employment Analysis. August 12, 2021. Available at: https://www.regulations.gov/docket/EPA-HQ-OPP-2021-0523.
69. Earthjustice. LULAC Petitioners' Feedback on the Environmental 
Protection Agency's Chlorpyrifos Tolerance Revocation Rule and 
Comments on Growers' Objections. Available at: https://www.regulations.gov/comment/EPA-HQ-OPP-2021-0523-0017.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-04139 Filed 2-25-22; 8:45 am]
BILLING CODE 6560-50-P