11222 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

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. 

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: 

OPPChlorpyrifosInquiries@epa.gov. 

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 wellestablished 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 


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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 nonoccupational 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 steadystate 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 steadystate (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 nonthreshold 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 doseresponse 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 doseresponse 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 routespecific 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 ‘‘interspecies 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 preFQPA 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) 


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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 interspecies 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 longterm 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, lowdose extrapolation model that assumes 

that any amount of exposure will lead 

to some degree of risk. This doseresponse 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 worstcase 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 


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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 highend 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 


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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/pesticidescience-and-assessing-pesticide-risks/ 

models-pesticide-riskassessment#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 shortterm 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 sitespecific 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 regionalscale 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 


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certainty in the estimated pesticide 

concentration. Each successive tier 

integrates more focused pesticide, 

spatial, temporal, agronomic, and cropspecific 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 nonoccupational 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 nonoccupational 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-andcrevice treatments. 

The SOPs identify relevant generic 

data and construct algorithms for 

calculating application and postapplication 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 subpopulations (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, steadystate). 

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 nondietary). 

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 


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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 interand 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 AChEinhibiting 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 AChEinhibiting 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 


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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 


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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 timevarying 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 chemicallyinduced 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 


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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-HQOPP-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 indepth 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 chlorpyrifosoxon, 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 intraspecies 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 dosereconstruction 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-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-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 


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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-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-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 noncholinergic 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 


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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 


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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 


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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 foodonly 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 (nonoccupational) 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 


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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 


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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 


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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 


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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 nonoccupational 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 


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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 


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water, and EPA would need to consider 

whether those exposures to chlorpyrifos 

would be safe. The DWLOCs calculated 

for chlorpyrifos were 17 ppb for steadystate 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 


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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 highbenefit 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 


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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 healthprotective 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 cooccurrence 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 


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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 realworld 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 


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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 


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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-pesticideproduct-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 


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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)) 


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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 preand 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 


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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 wellcharacterized, 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 preand 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 


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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 wellestablished, 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, 


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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 


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incorporate any new data after the 

Court’s decision was issued. 

Courts have recognized that courtimposed 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 overestimates 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 chlorpyrifosoxon. 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 


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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 chlorpyrifosoxon 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 nonagricultural 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 


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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 


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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 chlorpyrifosoxon before it leaves the plant and 

travels to consumers. There are several 

reasons why chlorpyrifos and 

chlorpyrifos-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 


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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 


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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 highend 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 


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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 nonoccupational 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/faowho-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 


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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 phaseout of crop uses’’ to mitigate economic 

injury to itself and growers, Gharda 

argues that EPA’s selection of a sixmonth 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 


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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. 


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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 


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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 chlorpyrifosoxon 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 


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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 farmerowners 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 


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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 peracre 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 


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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 ‘‘illwill . . . 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 


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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, 


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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 


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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 openended 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 


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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/EPAHQ-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/final4.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 DataDerived 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/ddeffinal.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/EPAHQ-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-assessingpesticide-risks/choosing-percentileacute-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/EPAHQ-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-conductingpesticide-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/EPAHQ-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/usepaopp-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/EPAHQ-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-OPP2008-0316-DRAFT-0075.pdf. 


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20. U.S. EPA (2014). Chlorpyrifos: Revised 

Human Health Risk Assessment for 

Registration Review. December 29, 2014. 

Available at: https://

www.regulations.gov/document/EPAHQ-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/EPAHQ-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/EPAHQ-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/EPAHQ-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-Jul06.pdf. 

26. U.S. EPA (2011). Revised Chlorpyrifos 

Preliminary Registration Review 

Drinking Water Assessment. June 20, 

2011. Available at: https://

www.regulations.gov/document/EPAHQ-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/EPAHQ-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/EPAHQ-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/EPAHQ-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/EPAHQ-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-HQOPP-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/EPAHQ-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-HQOPP-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-HQOPP-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-HQOPP-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-HQOPP-2021-0523-0027. 

42. Drexel Chemical Company. Objections, 

Request for Stay, Request for Product 

Phase Out. Available at: https://

www.regulations.gov/comment/EPA-HQOPP-2021-0523-0021. 

43. International Pepper Community. 

Comment. Available at: https://

www.regulations.gov/comment/EPA-HQOPP-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-HQOPP-2021-0523-0023. 

45. Republic of Ecuador. Comments on 

Chlorpyrifos: Tolerance Revocations 

Rule by the EPA. Available at: https://

www.regulations.gov/comment/EPA-HQOPP-2021-0523-0026. 

46. National Association of Wheat Growers. 

Comment. Available at: https://

www.regulations.gov/comment/EPA-HQOPP-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-HQOPP-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-HQOPP-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-HQOPP-2021-0523-0004. 

51. U.S. EPA (2021). List of External 

Meetings Between EPA and Chlorpyrifos 

Stakeholders. Available at: https://

www.regulations.gov/document/EPAHQ-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-HQOPP-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-HQOPP-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-newmethodologies-estimate-pesticideconcentrations-surface-waters. 

55. Office of Information and Regulatory 

Affairs, Office of Management and 

Budget (OMB) (1993). Guidance for 

Implementing E.O. 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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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 11273 

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-addressrisk-chlorpyrifos-and-protect-childrenshealth. 

58. Republic of Columbia. Comment. 

Available at: https://

www.regulations.gov/comment/EPA-HQOPP-2021-0523-0020. 

59. World Trade Organization (WTO). The 

WTO Agreement on the Application of 

Sanitary and Phytosanitary Measures. 

Available at: https://www.wto.org/ 

english/tratop_e/sps_e/spsagr_e.htm. 

60. The Codex website contains a listing of 

current chlorpyrifos MRLs. (Last viewed 

February 13, 2022). Available at: https:// 

www.fao.org/fao-whocodexalimentarius/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-HQOPP-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-chlorpyrifos2021-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/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-questionsand-answers-regarding-channels-tradepolicy-human-food-commodities. 

66. Sugarbeet Associations. Request for Stay 

of Decision Revoking All Chlorpyrifos 

Tolerances. Available at: https://

www.regulations.gov/comment/EPA-HQOPP-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-HQOPP-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-HQOPP-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 


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