Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 47475 

Laws, Pymetrozine – Acute, Chronic 

and Cancer Combined Dietary (Food + 

Drinking Water) Exposure and Risk 

Assessments (April 2, 2010). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 27, 2010. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

[FR Doc. 2010–19423 Filed 8–5–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0190; FRL–8836–7] 

Acetamiprid, Mepiquat; Order Denying 

NRDC’s Objections on Remand: 

Environmental Protection Agency 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final order. 

SUMMARY: In this order, EPA again 

denies objections by the Natural 

Resources Defense Council (NRDC) to 

actions establishing tolerance 

regulations for the pesticides 

acetamiprid and mepiquat under section 

408 of the Federal Food, Drug, and 

Cosmetic Act (FFDCA). EPA’s previous 

denial of NRDC’s objections, published 

in the Federal Register on August 10, 

2005, was remanded to EPA by the U.S. 

Court of Appeals, Ninth Circuit, for 

further explanation of EPA’s decision on 

the application of the FFDCA’s 

requirement concerning an additional 

safety factor for the protection of infants 

and children to these pesticide 

tolerances. On remand, EPA is denying 

NRDC’s objections because the 

objections are now either moot or not 

sufficient to justify the relief requested. 

DATES: This order is effective August 6, 

2010. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2005–0190. To access the 

electronic docket, go to http:// 

www.regulations.gov, and search for the 

docket number. Follow the instructions 

on the regulations.gov website to view 

the docket index or access available 

documents. All documents in the docket 

are listed in the docket index available 

in regulations.gov. Although listed in 

the index, some information is not 

publicly available, e.g., Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available in the electronic 

docket at http://www.regulations.gov, 

or, if only available in hard copy, at the 

OPP Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Meredith Laws, Registration Division 

(7510P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–7038; e-mail address: 

laws.meredith@epa.gov. 

SUPPLEMENTARY INFORMATION:. 

I. General Information 

A. Does this Action Apply to Me? 

In this document EPA denies 

objections by the Natural Resources 

Defense Council (‘‘NRDC’’) to EPA’s to 

establishment of certain pesticide 

tolerances. This action may also be of 

interest to agricultural producers, food 

manufacturers, or pesticide 

manufacturers. Potentially affected 

entities may include, but are not limited 

to those engaged in the following 

activities: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. 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 person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

II. Introduction 

A. What Action Is the Agency Taking? 

In this order, EPA denies objections 

filed by the NRDC to regulations 

establishing pesticide tolerances for 

acetamiprid and mepiquat under section 

408 of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a. 

EPA previously denied NRDC’s 

objections in an order dated August 10, 

2005. (70 FR 46706 (August 10, 2005)). 

NRDC sought judicial review of the 

August, 2005 order, and the U.S. Court 

of Appeals, Ninth Circuit, remanded the 

order to EPA on the sole ground that 

EPA had not provided an adequate 

explanation as to one aspect of its 

decision. (NCAP v. EPA, 544 F.3d 1043, 

1052 (9th Cir. 2008)). Specifically, the 

court held that EPA did not provide 

‘‘enough information’’ on why it chose to 

deviate from the presumptive ten-fold 

(10X) additional safety factor for the 

protection of infants and children in 

FFDCA section 408(b)(2)(C). (Id.). In 

response to the remand, EPA is again 

denying the objections; however, EPA 

has not provided further information on 

its decision on the children’s safety 

factor because that issue is now either 

moot or not outcome-determinative with 

regard to the challenged tolerances. 

B. What Is the Agency’s Authority for 

Taking This Action? 

EPA’s authority for issuing pesticide 

tolerances is contained in FFDCA 

section 408(d) and the statutory 

provisions governing the administrative 

review process for tolerances is in 

FFDCA section 408(g)(2). (21 U.S.C. 

346a(d) and (g)(2)). 


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III. Statutory and Regulatory 

Background 

In this unit, EPA provides background 

on the relevant statutes and regulations 

governing NRDC’s objections as well as 

on pertinent Agency policies and 

practices. Unit III.A. summarizes the 

requirements and procedures in section 

408 of the FFDCA and applicable 

regulations pertaining to pesticide 

tolerances. Unit III.B. provides an 

overview of EPA’s 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 EPA’s policy with 

regard to the statutory safety factor for 

the protection of infants and children. 

A. FFDCA 

1. In general. EPA establishes 

maximum residue limits, or 

‘‘tolerances,’’ for pesticide residues in 

food under section 408 of the FFDCA. 

(21 U.S.C. 346a). Without such a 

tolerance or an exemption from the 

requirement of a tolerance, a food 

containing a pesticide residue is 

‘‘adulterated’’ under section 402 of the 

FFDCA and may not be legally moved 

in interstate commerce. (21 U.S.C. 331, 

342). 

2. Safety standard for pesticide 

tolerances.A pesticide tolerance may 

only be promulgated by EPA if the 

tolerance is ‘‘safe.’’ (21 U.S.C. 

346a(b)(2)(A)(i)). ‘‘Safe’’ is defined by the 

statute 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.’’ (21 U.S.C. 

346a(b)(2)(A)(ii)). In making this safety 

determination, risks to infants and 

children are given special consideration. 

Specifically, this provision creates a 

presumptive additional safety factor for 

the protection of infants and children. It 

directs that ‘‘[i]n the case of threshold 

effects, ... an additional 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 

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)). 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.). The additional safety 

margin for infants and children is 

referred to throughout this Order as the 

‘‘children’s safety factor.’’ These 

provisions on pesticide safety were a 

part of major revisions to section 408 

enacted by the Food Quality Protection 

Act of 1996 (FQPA). (Pub. L. 104–170, 

110 Stat. 1489). 

3. Procedures for establishing, 

amending, or revoking tolerances. 

Tolerances are established, amended, or 

revoked by rulemaking under the 

unique procedural framework set forth 

in the 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 of the petition filing and requests 

public comment. (21 U.S.C. 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 to do the same, or deny the 

petition. (21 U.S.C. 346a(d)(4)). 

Once EPA takes final action on the 

petition by 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. 

(Id.). EPA’s final order on the objections 

is subject to judicial review. (21 U.S.C. 

346a(h)(1)). 

B. EPA Risk Assessment for Tolerances 

– 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: Identification of the 

toxicological hazards posed by a 

pesticide; determination of the ‘‘level of 

concern’’ with respect to human 

exposure to the pesticide; estimation of 

human exposure to the pesticide; and 

characterization of the risk posed to 

humans by the pesticide based on 

comparison of human exposure to the 

level of concern. 

a. Hazard identification. In evaluating 

toxicity or hazard, EPA reviews toxicity 

studies, primarily in laboratory animals, 

to identify any adverse effects on the 

test subjects. Animal studies typically 

involve investigating a broad range of 

endpoints including 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 

aminotransfersase and cholinesterases), 

and behavioral or other gross effects 

identified through clinical observation 

and measurement. EPA examines 

whether adverse effects are caused by 

either short-term (e.g., ‘‘acute’’) or 

longer-term (e.g., ‘‘chronic’’) pesticide 

exposure and the effects of pre-natal and 

post-natal exposure in animals. EPA 

also considers whether the adverse 

effect has a threshold - a level below 

which exposure has no appreciable 

chance of causing the effect. 

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 

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. Because this 

document is only concerned with 

pesticide hazards that pose a hazard 

above a defined threshold, only such 

threshold effects are discussed. 

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 next lower 

dose at which there are no observed 

adverse affect levels (NOAEL). 

Generally, EPA will use the lowest 

NOAEL from the available studies as a 

starting point (called ‘‘the Point of 

Departure’’) in estimating the level of 

concern for humans. (Ref. 1 at 9 (The 

Point of Departure ‘‘is simply the toxic 

dose that serves as the ‘starting point’ in 

extrapolating a risk to the human 

population.’’)). 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. The Point of Departure is in 


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turn used in choosing a level of concern. 

EPA will make separate determinations 

as to the Points of Departure, and 

correspondingly levels of concern, for 

both short and long exposure periods as 

well as for the different routes of 

exposure (oral, dermal, and inhalation). 

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 Point of 

Departure to calculate an acceptable 

level of exposure or reference dose 

(RfD). The RfD is calculated by dividing 

the Point of Departure by applicable 

safety or uncertainty factors. Typically, 

EPA uses a baseline safety/uncertainty 

factor of 100X. That value includes a 

factor of ten (10X) where EPA is using 

data from laboratory animals to reflect 

potentially greater sensitivity in humans 

than animals and a factor of 10X to 

account for potential variations in 

sensitivity among members of the 

human population as well as other 

unknowns. 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 pre-FQPA EPA practice 

regarding additional safety factors. (Ref. 

2 at 4-11). 

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 any 

portion of the FQPA safety factor that 

does not correspond to one of the 

traditional additional safety factors used 

in general Agency risk assessments. 

(Ref. 2 at 13-16). The reason for 

calculating PADs is so that other parts 

of the Agency, which are not governed 

by FFDCA section 408, can, when 

evaluating the same or similar 

substances, easily identify which 

aspects of a pesticide risk assessment 

are a function of the particular statutory 

commands in FFDCA section 408. 

Today, RfDs and PADs are generally 

calculated for both acute and chronic 

dietary risks although traditionally a 

RfD or PAD was only calculated for 

chronic dietary risks. Throughout this 

document general references to EPA’s 

calculated safe dose are denoted as a 

RfD/PAD. 

Because this order only addresses 

dietary risks, EPA’s approach to nondietary risk assessment is not further 

discussed. 

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 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)). 

i. Exposure from food. There are two 

critical variables in estimating exposure 

in food: 

• The types and amount of food that 

is consumed; and 

• 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 United 

States Department of Agriculture. (Ref. 1 

at 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. (Id. at 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 (i.e., ‘‘Tier 1’’), 

assesses exposure using the worst case 

assumptions that 100 percent of the 

crops for which tolerances exist or are 

proposed are treated with the pesticide 

and 100 percent of the food from those 

crops contain pesticide residues at the 

tolerance level. (Id. at 11). When such 

an assessment shows no risks of 

concern, a more complex risk 

assessment is unnecessary. By avoiding 

a more complex risk assessment, EPA’s 

resources are conserved and regulated 

parties are spared the cost of any 

additional studies that may be needed. 

If, however, a Tier 1 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 actually 

treated with the pesticide and data on 

the level of residues that may be present 

on the treated crop. These latter data are 

used to estimate what has been 

traditionally referred to by EPA as 

‘‘anticipated residues.’’ More 

information on how EPA refines 

estimates of exposure from pesticides in 

food can be found in U.S. EPA, A User’s 

Guide to Available EPA Information on 

Assessing Exposure to Pesticides in 

Food (June 21, 2000). (See 73 FR 42683, 

42687 (July 23, 2008)). 

ii. Exposure from water. 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. 

In estimating pesticide exposure 

levels in drinking water, EPA most 

frequently uses mathematical water 

exposure models. EPA’s models are 

based on extensive monitoring data and 

detailed information on soil properties, 

crop characteristics, and weather 

patterns. (69 FR 30042, 30058-30065 

(May 26, 2004)). 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. These 

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 storms. 

Typically EPA uses a two-tiered 

approach to modeling pesticide 

concentrations in surface and ground 

water. The first tier model uses high-end 

and worst-case assumptions as a screen 

to identify pesticides that will not result 

in residues in water that pose a concern. 

If the first tier model suggests that 

pesticide levels in water may be 

unacceptably high, a more refined 

model is used as a second tier 

assessment. Second tier models 

substitute more detailed information for 

the high-end or worst-case assumptions 

used in first tier models. For example, 

a second tier model may incorporate 

information on the maximum 

percentage of acreage surrounding a 

drinking water reservoir that may be 

devoted to agriculture instead of 


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assuming that 100 percent of the 

watershed is, in fact, farmland. 

iii. Residential exposures. Generally, 

in assessing residential exposure to 

pesticides EPA relies on its Residential 

Standard Operating Procedures (SOPs). 

(Ref. 3). The SOPs establish models for 

estimating application and postapplication exposures in a residential 

setting where pesticide-specific 

monitoring data are not available. SOPs 

have been developed for many common 

exposure scenarios including pesticide 

treatment of lawns, garden plants, trees, 

swimming pools, pets, and indoor 

surfaces including crack and crevice 

treatments. The SOPs are based on 

existing monitoring and survey data 

including information on activity 

patterns, particularly for children. 

Where available, EPA relies on 

pesticide-specific data in estimating 

residential exposures. 

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). 

For threshold dietary risks, EPA 

typically estimates risk by expressing 

human exposure as a percentage of the 

RfD/PAD. Exposures lower than 100 

percent of the RfD/PAD are generally 

not of concern. Under current 

procedures, EPA aggregates pesticide 

exposure from food and drinking water 

prior to comparing exposure to the RfD/ 

PAD. 

Prior to developing appropriate 

modeling techniques for combining 

pesticide exposures from food and 

drinking water, EPA evaluated aggregate 

dietary exposure and risk in two 

separate steps. (Ref. 4 at 3-5). First, EPA 

would compare pesticide exposure from 

food to the safe level of exposure (i.e., 

the RfD/PAD). If pesticide exposure 

from food was less than 100 percent of 

the RfD/PAD, then EPA would calculate 

what was called a Drinking Water Level 

of Comparison (DWLOC) and compare 

the pesticide exposure concentration in 

water to the DWLOC. The DWLOC 

represented the maximum safe 

concentration of pesticide residue that 

could be present in drinking water 

taking into account the level of pesticide 

exposure from food. The DWLOC was 

calculated by subtracting pesticide 

exposure in food from the RfD/PAD and 

dividing that amount by the maximum 

water consumption level. So long as the 

actual pesticide concentration in 

drinking water was below the DWLOC, 

aggregate exposure to the pesticide 

(exposure from food and water) was 

generally regarded as safe. A numerical 

example may help explicate this 

procedure. (To simplify the example, 

units of exposure are expressed in terms 

of milligrams of pesticide per day (mg/ 

day) instead of the more standard 

milligrams of pesticide per kilogram of 

human body weight per day (mg/kg/ 

day).) Suppose the safe level of 

exposure to a pesticide (i.e., the RfD/ 

PAD) is 10 mg/day and consumption of 

food results in exposure to residues of 

this pesticide at a level of 2 mg/day. 

Under these facts, exposure to the 

pesticide from food represents 20 

percent of the RfD/PAD. If it is assumed 

that a person drinks 2 liters of water per 

day, the DWLOC can be calculated by 

subtracting pesticide exposure from 

food from the RfD/PAD (10 mg/day – 2 

mg/day = 8 mg/day) and dividing by 2 

liters. The resulting DWLOC of 4 mg/ 

liter is the maximum safe concentration 

of pesticide in drinking water. It follows 

that so long as actual water 

concentrations of the pesticide do not 

exceed 4 mg/liter, EPA can conclude 

that aggregate dietary exposure to the 

pesticide from food and water do not 

exceed the RfD/PAD. If the actual level 

of the pesticide residue in drinking 

water were 0.1 mg/liter, then the 

pesticide concentration in drinking 

water would be 2.5 percent of the 

allowable amount or DWLOC ((0.1 mg/ 

liter ÷ 4 mg/liter) x 100 percent) and 

would represent 2 percent of the RfD/ 

PAD (((2 liters/day x0.1 mg/liter) ÷ 10 

mg/kg/day) x 100 percent). 

2. EPA policy on the children’s safety 

factor. As the brief summary of EPA’s 

risk assessment practice in this unit 

indicates, the use of safety factors plays 

a critical role in the process. This is true 

for the use of traditional 10X safety 

factors to account for potential 

differences between animals and 

humans when relying on studies in 

animals (inter-species safety factor) and 

potential differences among humans 

(intra-species safety factor) as well as 

the use of the FQPA’s additional 10X 

children’s safety factor. 

In applying the children’s safety 

factor provision, EPA has interpreted it 

as imposing a presumption in favor of 

applying an additional 10X safety factor. 

(Ref. 2 at 4, 11). Thus, EPA generally 

refers to the additional 10X factor as a 

presumptive or default 10X factor. EPA 

has also made clear, however, that this 

presumption or default in favor of the 

additional 10X 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) - the completeness of the 

toxicity database, the completeness of 

the exposure database, and potential 

pre- and post-natal toxicity. In 

examining these factors, EPA strives to 

make sure that its choice of a safety 

factor, based on a weight-of-theevidence evaluation, does not 

understate the risk to children. (Id. at 

24-25, 35). 

IV. Challenged Tolerance Regulations 

for Mepiquat and Acetamiprid 

A. Mepiquat 

1. In general. NRDC challenged a 

January 23, 2002 action establishing 

tolerances for mepiquat on cotton gin 

byproducts and meat byproducts of 

cattle, goats, hogs, horses and sheep. (67 

FR 3113 (January, 23, 2002)). Given 

mepiquat’s exposure pattern and 

toxicological characteristics, EPA 

determined that mepiquat potentially 

presented acute and chronic risks and 

EPA quantitatively assessed these risks 

in making its safety determination. (67 

FR at 3116). All of these risks were 

found to be below the Agency’s level of 

concern. (Id.). 

2. Children’s safety factor 

determination. For mepiquat, EPA 

identified increased uncertainty 

regarding effects on the young because 

a developmental neurotoxicity (DNT) 

study was outstanding. (65 FR 1790, 

1794 (January 12, 2000)). EPA 

concluded, however, that this 

uncertainty was offset by a number of 

factors and removed the additional 10X 

safety factor. First, EPA noted that no 

increased sensitivity in young animals 

was observed in the pre- and post-natal 

studies with mepiquat. (65 FR at 1794). 

In fact, in two out of the three studies 

involving young animals no effects were 

seen in the offspring at all 

(developmental study in rats; 2- 

generation reproduction study in rats). 

(Ref. 5 at 2). Further, even in the third 

study concerning pre- and post-natal 

effects there were reasons to accord 

reduced weight to the pre- or post-natal 

effects observed given that effects were 

seen in the offspring and the parents 

only at the highest dose tested 

(developmental study in rabbits). (Id.). 

Second, although neurotoxic behavioral 

effects in adult animals were found 

(triggering the DNT study requirement), 

there was no evidence reflecting special 


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concern for developing fetuses or the 

young such as ‘‘neuropathy in adult 

animals; [central nervous system] 

malformations following prenatal 

exposure; brain weight or sexual 

maturation changes in offspring; and/or 

functional changes in offspring.’’ (65 FR 

at 1794). Finally, exposure estimates 

were found not to understate exposure 

given that the estimates for food were 

‘‘Tier 1’’ conservative assumptions 

which would not underestimate 

exposure. (65 FR at 1793). 

B. Acetamiprid 

1. In general. NRDC challenged a 

March 27, 2002, action establishing 

tolerances for acetamiprid on dried 

citrus pulp, the citrus fruit crop group, 

cotton gin byproducts, cotton 

undelinted seed, grapes, the fruiting 

vegetable crop group, the leafy brassica 

vegetable crop group, the leafy vegetable 

crop group, the pome fruit group, 

tomato paste, as well as various animal 

products. (67 FR 14649 (March 27, 

2002)). Given acetamiprid ’s exposure 

pattern and toxicological characteristics, 

EPA determined that acetamiprid 

potentially presented acute, chronic, 

short-term, and intermediate-term risks 

and EPA quantitatively assessed these 

risks in making its safety determination. 

(Id. at 14656-14657). All of these risks 

were found to be below the Agency’s 

level of concern. (Id.). 

2. Children’s safety factor 

determination. For acetamiprid, two 

factors increased uncertainty or raised 

concern about the impacts on children: 

That a DNT study was outstanding; and 

that increased sensitivity in the young 

was observed in the 2-generation 

reproduction study. (67 FR at 14655). 

EPA concluded, however, that these 

concerns were offset by other 

considerations. First, the DNT study had 

been required based only on neurotoxic 

behavioral effects seen in adults, and 

not out of a special concern for 

developing fetuses or the young. 

Second, the increased sensitivity 

observed in the 2-generation 

reproduction study was only qualitative. 

Sensitivity is considered to be 

qualitative only when effects occur at 

the same dose levels in adult and 

juvenile animals but the effects in the 

juvenile animals are qualitatively more 

severe than the effects in the adults. 

Third, the other two studies 

investigating pre- or post-natal effects in 

the young showed either no adverse 

effects even at levels that showed 

toxicity in parental animals, or adverse 

effects of the same qualitative nature at 

the same dose in parental and young 

animals. (Id.). Finally, exposure 

estimates were judged unlikely to 

underestimate exposure, especially 

because ‘‘highly conservative’’ ‘‘Tier 1’’ 

assumptions were used for exposure in 

food. (67 FR at 14654). Weighing all of 

these considerations EPA retained a 3X 

additional safety factor to address 

chronic risks and waived the factor 

entirely for acute risks. No additional 

factor was deemed necessary as to acute 

risks because qualitative sensitivity in 

the young was only observed in a study 

involving chronic dosing and as to an 

adverse effect related to repeat dosing. 

V. Subsequent Tolerance Actions for 

Mepiquat and Acetamiprid 

A. Mepiquat 

Since January, 2002, EPA has received 

no further tolerance petitions 

concerning mepiquat and EPA has 

undertaken no tolerance rulemakings for 

mepiquat. 

B. Acetamiprid 

Since March, 2002, EPA has received 

several petitions for additional 

acetamiprid tolerances and has 

established tolerance regulations on four 

occasions. Because section 408 requires 

EPA in setting a pesticide tolerance to 

consider aggregate exposure to the 

pesticide, ‘‘including dietary exposure 

under . . . all other tolerances for the 

pesticide chemical residue,’’ in each of 

these subsequent actions EPA took into 

account exposure to acetamiprid under 

challenged tolerances established on 

March 27, 2002 (dried citrus pulp, the 

citrus fruit crop group, cotton gin 

byproducts, cotton undelinted seed, 

grapes, the fruiting vegetable crop 

group, the leafy brassica vegetable crop 

group, the leafy vegetable crop group, 

the pome fruit group, tomato paste, as 

well as various animal products). Each 

of the subsequent tolerance rulemakings 

is described below. 

1. 2005 – Tolerances for tuberous and 

corm vegetables. On April 13, 2005, 

EPA established tolerances for 

acetamiprid on tuberous and corm 

vegetables. (70 FR 19283 (April 13, 

2005)). EPA concluded that the 

additional exposure from these new 

tolerances, when aggregated with 

exposure under existing tolerances, was 

safe. 

With regard the children’s safety 

factor, EPA relied on a revised analysis 

taking into account its Children’s Safety 

Factor Policy, which had not been 

released at the time of the risk 

assessment for the NRDC-challenged 

tolerances and recently-submitted data 

on acetamiprid and other similar 

pesticides. EPA concluded that the 

presumptive 10X children’s safety factor 

could be removed entirely. (70 FR at 

19289). Although increased sensitivity 

to the young had been observed in the 

2-generation rat study and a recentlysubmitted DNT study had not been fully 

evaluated, EPA determined that other 

factors outweighed these concerns. As 

to the increased sensitivity, EPA noted 

that: ‘‘i. There is a clear NOAEL for [the 

effects seen in] the offspring, and; ii. 

These effects occurred in the presence 

of parental toxicity and only at the 

highest dose tested.’’ (Id.). Further, EPA 

noted that either the NOAEL for the 

offspring in the reproduction study or 

some lower NOAEL was used in each 

risk assessment for acetamiprid. That 

meant the standard 10X factor to 

account for intra-human variability (in 

addition to the 10X factor for interspecies variability) was applied to the 

clearly-defined NOAEL for offspring 

effects or to some lower NOAEL. As to 

the recently-submitted DNT, EPA stated 

that a ‘‘preliminary review of the study 

indicates the results are not likely to 

have a significant impact on risks for the 

currently proposed use, or on existing 

uses of acetamiprid . . . [and that] 

developmental neurotoxicity data 

received and reviewed for other 

compounds in this chemical class 

indicate that the results of the required 

DNT will not likely impact the 

regulatory doses selected for the 

proposed uses of acetamiprid.’’ (Id.). 

Finally, EPA relied upon the fact that 

the exposure assessment for acetamiprid 

was conservative in that it assumed all 

foods with tolerances are treated with 

acetamiprid and bear tolerance-level 

residues (i.e., a Tier 1 assessment). 

2. 2007 – Tolerances for almond hulls, 

et al. On November 28, 2007, EPA 

established tolerances for acetamiprid 

on almond, hulls; fruit, stone, group 12, 

except plum, prune; nut, tree, group 14; 

pea and bean, succulent shelled, 

subgroup 6B; pistachio; plum, prune, 

dried; plum, prune, fresh; vegetable, 

cucurbit, group 9; and vegetable, 

legume, edible podded, subgroup 6A. 

(72 FR 67256 (November 28, 2007)). 

EPA concluded that the additional 

exposure from these new tolerances, 

when aggregated with exposure under 

existing tolerances, was safe. 

With regard to the children’s safety 

factor, EPA relied on a revised analysis 

taking into account its now-completed 

review of the acetamiprid DNT study. 

EPA again concluded that the 

presumptive 10X children’s safety factor 

could be removed entirely. Although 

qualitatively increased sensitivity to the 

young had been observed in the 2- 

generation rat study and the DNT study, 

EPA ‘‘characterized the degree of 

concern for the effects observed in the 

acetamiprid DNT and the 2-generation 


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reproduction study as low, noting that 

there is a clear NOAEL for the offspring 

effects in both studies, the toxicology 

database is complete, and regulatory 

doses [Points of Departure] were 

selected to be protective of potential 

offspring effects in both the DNT and 

the 2-generation study.’’ (72 FR at 

67260). Specifically, as to the last 

consideration, EPA cited the fact that 

the Points of Departure for calculating 

the RfD/PADs were at or below the 

clearly-defined NOAELs from the 2- 

generation reproduction and DNT 

studies. That means that at least a 100- 

fold margin of safety was being 

provided with respect to the clearlydefined NOAELs from these studies. 

Further, even though the exposure 

assessment was more refined than in 

prior acetamiprid tolerance actions, EPA 

still relied on conservative values from 

field trial studies and drinking water 

modeling. 

3. 2008 – Tolerances for bushberries, 

et al. On January 16, 2008, EPA 

established tolerances for acetamiprid 

on the bushberry subgroup 13-07B; the 

caneberry subgroup 13-07A; the low 

growing berry subgroup 13-07G; the 

onion, bulb, subgroup 3-07A; and the 

onion, green, subgroup 3-07B. (73 FR 

2809 (January 16, 2008)). EPA 

concluded that the additional exposure 

from these new tolerances, when 

aggregated with exposure under existing 

tolerances, was safe. EPA relied upon its 

November 28, 2007 acetamiprid 

rulemaking to make its safety 

determination, noting that the 

tolerances in this action had been 

included in the risk assessment 

performed to support the 2007 action. 

(73 FR at 2811). 

4. 2010 – Tolerances for small vine 

climbing fruit, et al. On February 10, 

2010, EPA established tolerances for 

acetamiprid on the small vine climbing 

fruit, except fuzzy kiwifruit, subgroup 

13-07F; and tea, dried. (75 FR 6576 

(February 10, 2010)). EPA concluded 

that the additional exposure from these 

new tolerances, when aggregated with 

exposure under existing tolerances, was 

safe. With regard the children’s safety 

factor, EPA concluded that the 

presumptive 10X children’s safety factor 

could be removed entirely based on the 

rationale in the 2007 acetamiprid 

rulemaking. (75 FR at 6581). 

VI. Summary of NRDC Objections, 

Administrative Review of the 

Objections, and Judicial Review of 

EPA’s Order Denying the Objections 

A. NRDC’s Objections 

On four occasions in the first half of 

2002, the NRDC and various other 

parties filed objections with EPA to final 

rules under FFDCA section establishing 

pesticide tolerances for various 

pesticides. (69 FR 30042 (May 26, 

2004)). The objections applied to 14 

pesticides and 112 separate pesticide 

tolerances. The challenged tolerances 

included the tolerances for mepiquat 

and acetamiprid addressed in today’s 

order. The objections to the mepiquat 

tolerances were filed on March 19, 2002, 

and grouped with objections to 

tolerances for imidacloprid, bifenazate, 

zeta-cypermethrin, and diflubenzuron. 

The objections to the acetamiprid 

tolerances were filed on May 21, 2002, 

and grouped with objections to 

tolerances for isoxadifen-ethyl, 

propiconazole, fenhexamid, and 

fluazinam. 

Although NRDC’s petitions raised 

dozens of issues, most of the issues 

related to two main claims: That EPA 

had not properly applied the additional 

10X safety factor for the protection of 

infants and children in section 

408(b)(2)(C); and that EPA had not 

accurately assessed the aggregate 

exposure of farm children to pesticide 

residues. Many of the issues were not 

fact-specific to the challenged tolerances 

but rather represented a generic 

challenge to EPA’s implementation of 

the FQPA. 

Two specific issues raised by NRDC 

are worthy of greater description 

because they later figured in the judicial 

review of EPA’s disposition of the 

objections. First, as to several of the 

pesticides, NRDC argued that EPA had 

unlawfully removed the 10X children’s 

safety factor because EPA had required 

that a DNT study be submitted for the 

pesticides but such study had not yet 

been completed. NRDC framed the issue 

as follows: 

EPA has required DNT tests for 

imidacloprid, mepiquat, and zetacypermethrin, and these studies 

have not been conducted. EPA, 

therefore cannot argue that ‘‘reliable 

data’’ justifies removing the 

statutory presumptive 10X FQPA 

safety factor. 

(Ref. 6 at 9). Second, NRDC argued that 

EPA could not lawfully remove the 

children’s safety factor as to all of the 

challenged pesticides because EPA 

relied on a drinking water exposure 

models to estimate pesticide exposure 

levels in water instead of ‘‘collect[ing] 

pesticide-specific data on water-based 

exposure.’’ (Ref. 6 at 6; Ref. 7 at 5). 

According to NRDC, drinking water 

models, as a definitional matter, could 

not supply the ‘‘reliable data’’ needed to 

choose a children’s safety factor 

differing from the presumptive value. 

(Ref. 6 at 6; Ref. 7 at 5-6). 

B. EPA’s Denial of the Objections 

EPA denied NRDC’s objections in two 

separate orders. The first was issued on 

May 26, 2004, and addressed only the 

tolerances for imidacloprid. (69 FR 

30042 (May 26, 2004). The second was 

released on August 10, 2005 and 

addressed the tolerances for the 

remaining 14 pesticides. (70 FR 46706 

(August 10, 2005)). The second order 

relied heavily on the imidacloprid order 

because, in the process of resolving the 

claims pertaining to imidacloprid, EPA 

resolved many of NRDC’s generic 

attacks on EPA’s interpretation of the 

FQPA. 

As to the DNT study and the 

children’s safety factor, EPA rejected 

‘‘NRDC’s contention that an EPA finding 

that a DNT study is needed in 

evaluating the risks posed by the 

pesticide is outcome-determinative as 

regards to retaining the children’s safety 

factor until such time as the DNT study 

is submitted and reviewed.’’ (70 FR at 

46724). EPA carefully reviewed all of 

the evidence cited by NRDC regarding 

the DNT study and concluded that 

NRDC had not shown that the DNT was 

so critical to the protection of children 

that in the absence of that study EPA 

was conclusively precluded from 

exercising its statutory authority to 

make a case-by-case determination 

regarding the appropriate children’s 

safety factor. EPA specifically did not 

address the factual considerations 

relating to its individual children’s 

safety factor decisions as to mepiquat 

and acetamiprid (and the other 

pesticides), noting that ‘‘NRDC has 

offered no pesticide-specific arguments 

as to the pesticides in this proceeding as 

to why the absence of a DNT study 

requires the retention of the default 10X 

additional factor.’’ (Id.) 

With regard to whether reliance on 

drinking water models precluded 

lowering of the children’s safety factor, 

EPA exhaustively reviewed the 

underlying factual basis for its models, 

the scientific peer review they had 

received, and how the models had 

worked in practice. EPA concluded that 

‘‘the models are based on reliable data 

and will produce estimates that are 

unlikely to underestimate exposure to 

pesticides in drinking water.’’ (Id. at 

46726). Accordingly, NRDC’s claim that 

only actual pesticide-specific water 

monitoring data could provide ‘‘reliable 

data’’ on the levels of pesticides in 

drinking water was rejected. 


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C. Judicial Review 

1. NRDC’s Petition for Review. In 

August, 2005, NRDC and the Northwest 

Coalition for Alternatives to Pesticides 

(NCAP) filed petitions for review of 

EPA’s August 10, 2005 order. No 

challenge had been filed to the May 26, 

2004 order. The petitions were filed in 

the Second and Ninth Circuits and the 

matter was assigned to the Ninth 

Circuit. The consolidated petitions 

sought review as to EPA’s denial of 

NRDC’s objections as they pertained to 

the tolerances of the following seven 

pesticides: acetamiprid, fenhexamid, 

halosulfuron-methyl, isoxadifen-ethyl, 

mepiquat, pymetrozine, and zetacypermethrin. 

NRDC/NCAP’s brief argued that EPA 

had unlawfully removed or lowered the 

children’s safety factor as to these seven 

pesticides and that EPA’s establishment 

of tolerances for the seven pesticides 

was arbitrary and capricious. (Ref. 8). As 

to the contentions regarding the 

children’s safety factor, NRDC/NCAP 

made several independent claims as to 

why EPA’s action was unlawful. These 

claims were: 

i. As to acetamiprid, halosulfuronmethyl, mepiquat, pymetrozine, 

and zeta-cypermethrin, EPA had no 

discretion to alter the children’s 

safety factor because it had 

determined that a DNT study was 

specifically needed to address 

concerns regarding these pesticides 

(DNT studies were not required on 

fenhexamid and isoxadifen-ethyl); 

ii. EPA’s decision on the children’s 

safety factor could not be upheld 

because EPA provided ‘‘no 

pesticide-specific response to 

NRDC’s objections with respect to 

the missing DNT studies, and does 

not offer any explanation or 

justification for the agency’s 

departure from the tenfold 

children’s safety factor for these five 

pesticides;’’ 

iii. EPA lacked reliable data on 

pesticide exposure levels in 

drinking water for each of the 

pesticides and such data are 

necessary to justify altering the 

children’s safety factor; and 

iv. EPA must retain the children’s 

safety factor for each of the 

pesticides because data showed that 

they resulted in pre- or post-natal 

toxicity. 

NRDC argued EPA’s decision was 

arbitrary and capricious because EPA 

determined that additional data were 

needed on the pesticides but EPA had 

not waited for submission of that data 

before establishing the pesticide 

tolerances and because EPA had not 

offered a sufficient explanation of its 

decisions on the children’s safety factor. 

2. The Ninth Circuit’s decision. On 

September 19, 2008, the Ninth Circuit 

unanimously determined that: 

i. It was not arbitrary and capricious 

for EPA to have established the 

tolerances for acetamiprid, 

mepiquat, and pymetrozine without 

waiting for DNT studies for these 

pesticides; 

ii. EPA had offered a reasoned 

explanation for why, as a general 

matter, the children’s safety factor 

could be reduced in the absence of 

a DNT study; and 

iii. It was reasonable for EPA to rely 

on drinking water models in 

estimating pesticide levels in water 

in making children’s safety factor 

determinations. 

(NCAP v. EPA, 544 F.3d 1043, 1049- 

1051 (9th Cir. 2008)). Additionally, by a 

2-to-1 vote, the court remanded to EPA 

its decision on the children’s safety 

factor for acetamiprid, mepiquat, and 

pymetrozine. The majority found that 

EPA’s order on NRDC’s objections had 

not adequately explained the pesticidespecific reasons for removing or 

reducing the children’s safety factor as 

to these pesticides in the absence of a 

required DNT study. (Id. at 1052). 

Without elaborating, the court 

dismissed all other issues raised by 

NRDC/NCAP. (Id. at 1053). 

Although NRDC/NCAP’s petition for 

review concerned seven pesticides, the 

court only remanded to EPA the 

tolerance decisions on acetamiprid, 

mepiquat, and pymetrozine. The 

petition for review was denied as to the 

other four pesticides because the 

remand only pertained to pesticides for 

which there was a question concerning 

EPA’s pesticide-specific choice of a 

children’s safety factor in the absence of 

a required DNT study. As to the 

fenhexamid and isoxadifen-ethyl 

tolerances, a DNT study had not been 

required by EPA. For halosulfuronmethyl and zeta-cypermethrin 

tolerances a DNT study had been 

required and had not been submitted at 

the time of the tolerance action; 

however, by the time of the oral 

argument, the circumstances had 

changed. As to zeta-cypermethrin, the 

DNT study had been submitted and 

reviewed by EPA and EPA had 

established further tolerances in 

reliance on the DNT study. As to 

halosulfuron-methyl, EPA had 

withdrawn the requirement for a DNT. 

EPA notified the court that there was no 

longer a live controversy as to the 

tolerances for halosulfuron-methyl and 

zeta-cypermethrin and NRDC/NCAP 

and the court agreed the petition was 

moot as to these pesticides. (544 F.3d at 

1048 n.4; Refs. 9, 10). 

VII. Revised Order on Remand 

On remand, EPA has determined that 

NRDC’s objections should again be 

denied. NRDC’s objections to the 

acetamiprid tolerances are now moot for 

the same reasons that the objections to 

the zeta-cypermethrin and halosulfuronmethyl tolerances were found to be 

moot. The objections to the mepiquat 

tolerance are denied because all issues 

which could have affected EPA’s 

decision on that tolerance have been 

resolved by the Ninth Circuit. 

A. Acetamiprid and Mepiquat 

Like zeta-cypermethrin, EPA has 

received a DNT study for acetamiprid 

and relied on that study in establishing 

additional tolerances for acetamiprid. 

(72 FR 67256 (November 28, 2007); 73 

FR 2809 (January 16, 2008); 75 FR 6576 

(February 10, 2010)). In establishing 

new tolerances for acetamiprid, EPA 

concluded that aggregate exposure 

under the new tolerances as well as all 

existing tolerances (including the ones 

challenged in NRDC’s 2002 objections) 

is safe. No objections to these new 

acetamiprid tolerances were filed within 

the 60 day statutory timeframe for 

objections. Accordingly, just as the 

Ninth Circuit concluded (and NRDC 

agreed) that there was no live 

controversy concerning the zetacypermethrin tolerances and ‘‘EPA’s 

[alleged] failure to explain why it had 

reliable data in the absence of [a DNT 

study],’’ (544 F.3d at 1408), there is no 

live controversy as to whether EPA 

provided an adequate explanation for its 

now-superseded tolerance decision that 

it had reliable data to reduce or remove 

the children’s safety factor for 

acetamiprid in the absence of a DNT 

study. 

B. Mepiquat 

EPA has not taken regulatory action as 

to mepiquat subsequent to the 

challenged tolerance action and, thus, 

NRDC’s challenge to the mepiquat 

tolerance is not moot. Nonetheless, due 

to the circumstances of the mepiquat 

tolerance, EPA does not need to address 

the merits of the only remaining 

objection before EPA — that EPA lacks 

reliable data justifying removal of the 

children’s safety factor for mepiquat. As 

EPA ruled in a prior order, it may 

‘‘refuse to adjudicate the merits of 

claims where it can be shown that the 

claims - even if true - do not justify the 

relief requested.’’ (72 FR 39318, 39323- 


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39324 (July 18, 2007)). That principle 

applies to the mepiquat objection 

because, as explained below, even if 

EPA retains the 10X children’s safety it 

would not change EPA’s safety 

determination. Thus, NRDC’s objection 

to the removal of the children’s safety 

factor, even if upheld, would not 

support the relief it requested - ‘‘that 

EPA refrain from establishing the new 

tolerances for . . .mepiquat . . . until the 

pesticide tolerances have been assessed 

and determined to be safe[,] consistent 

with the requirements of the FQPA.’’ 

(Ref. 6 at 22). 

An EPA decision to retain the 10X 

children’s safety factor has the effect of 

decreasing the ‘‘safe dose’’ or RfD/PAD 

by a factor of 10. Thus, if prior to 

application of the 10X children’s safety 

factor, the level of exposure from a 

particular pesticide constituted 5 

percent of the RfD/PAD, after 

application of the safety factor the level 

of exposure to the pesticide would rise 

by a factor of 10 to 50 percent of the 

RfD/PAD. Similarly, a pesticide which 

had an exposure level at 50 percent of 

the RfD/PAD before applying the 10X 

children’s safety factor, would have an 

exposure level of 500 percent of the 

RfD/PAD after application of the factor. 

Only in the latter case, would retention 

of the children’s safety factor raise a 

safety concern. Thus, for pesticides with 

sufficiently low risks, the decision on 

retention or removal of the children’s 

safety factor is not outcomedeterminative as to EPA’s safety finding. 

(71 FR 43906, 43916-43917 (August 2, 

2006)). 

Mepiquat is one of those low risk 

pesticides. As EPA noted in the 

challenged tolerance document, acute 

exposure to mepiquat from residues in 

food equaled 1.5 percent of the acute 

RfD/PAD and acute exposure to 

mepiquat in water was an infinitesimal. 

(67 FR at 3115; 65 FR 1790, 1793 

(January 12, 2000) (acute exposure to 

mepiquat in drinking water is 0.031 

percent of the allowable amount – i.e. 

the acute DWLOC was 6,000 ppb and 

estimated acute exposure level was 1.9 

ppb); see Unit III.B.1.d. (explaining how 

allowable amounts of pesticide residues 

in drinking water were calculated)). 

Similarly, chronic exposure to mepiquat 

from residues in food equaled 0.3 

percent of the chronic RfD/PAD and 

chronic exposure to mepiquat in water 

was also infinitesimal. (67 FR at 3115; 

65 FR at 1794 (chronic exposure to 

mepiquat in drinking water is 0.018 

percent of the allowable amount — i.e. 

the chronic DWLOC was 6,000 ppb and 

the estimated chronic exposure level 

was 1.1 ppb)). Retention of the 10X 

children’s safety would raise the 

percentage exposure to approximately 

15 percent of the acute RfD/PAD and 3 

percent of the chronic RfD/PAD. 

Because these exposure levels would 

still be well below the applicable RfD/ 

PADs, they would not change EPA’s 

determination that the petitioned-for 

mepiquat tolerances are safe. 

Accordingly, because NRDC’s objection 

to removal of the children’s safety factor 

does not justify its request for EPA to 

refrain from establishing the mepiquat 

tolerances, it is denied. 

VIII. Regulatory Assessment 

Requirements 

As indicated previously, this action 

announces the Agency’s final order 

regarding objections filed under section 

408 of FFDCA. The FFDCA specifically 

directs that objections be resolved by 

‘‘order,’’ and thus this action is an 

adjudication and not a rule. (21 U.S.C. 

346a(g)(2)(C)). The regulatory 

assessment requirements imposed on 

rulemaking do not, therefore, apply to 

this action. 

IX. Submission to Congress and the 

Comptroller General 

The Congressional Review Act, (5 

U.S.C. 801 et seq.), as added by the 

Small Business Regulatory Enforcement 

Fairness Act of 1996, does not apply 

because this action is not a rule for 

purposes of 5 U.S.C. 804(3). 

X. References 

1. USEPA, A User’s Guide to 

Available EPA Information on Assessing 

Exposure to Pesticides in Food (June 21, 

2000). 

2. Office of Pesticide Programs, 

USEPA, Office of Pesticide Programs’ 

Policy on the Determination of the 

Appropriate FQPA Safety Factor(s) For 

Use in the Tolerance Setting Process 

(February 28, 2002). 

3. Office of Pesticide Programs, 

USEPA, Standard Operating Procedures 

(SOPs) for Residential Exposure 

Assessments (Draft December 19, 1997). 

4. Office of Pesticide Programs, 

USEPA, ‘‘Estimating the Drinking Water 

Component of a Dietary Exposure 

Assessment’’ (November 2, 1999). 

5. Office of Prevention, Pesticides and 

Toxic Substances, USEPA, 

Memorandum from Brenda Tarplee to 

Margarita Collantes, ‘‘Mepiquat 

Choloride – Report of the FQPA Safety 

Factor Committee’’ (November 1, 1999). 

6. NRDC, Objections to the 

Establishment of Tolerances for 

Pesticide Chemical Residues: 

Imidacloprid, Mepiquat, Bifenazate, 

Zeta-cypermethrin, and Diflubenzuron 

Tolerances (filed March 19, 2002). 

7. NRDC, Objections to the 

Establishment of Tolerances for 

Pesticide Chemical Residues: 

Isoxadifen-ethyl, Acetamiprid, 

Propiconazole, Furilazole, Fenhexamid, 

and Fluazinam Tolerances (filed May 

20, 2002). 

8. Petitioners’ Brief, NCAP v. EPA, 

Case Nos. 75255, 76807 (9th Cir. March 

6, 2006). 

9. Letter from Kent E. Hanson, U.S. 

Department of Justice to Cathy 

Catterson, Clerk of the Court, United 

States Court of Appeals, Ninth Circuit, 

Notice of Supplemental Authority in 

Northwest Coalition for Alternatives to 

Pesticides v. EPA, Nos. 05-75255 & 05- 

76807 (May 25, 2007). 

10. Letter from Aaron Colangelo, U.S. 

Department of Justice to Cathy 

Catterson, Clerk of the Court, United 

States Court of Appeals, Ninth Circuit, 

Response to EPA’s Notice of 

Supplemental Authority in Northwest 

Coalition for Alternatives to Pesticides 

v. EPA, Nos. 05-75255 & 05-76807 (May 

29, 2007). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 27, 2010. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

[FR Doc. 2010–19431 Filed 8–5–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2000–0006; FRL–9185–4] 

National Oil and Hazardous Substance 

Pollution Contingency Plan; National 

Priorities List: Deletion of the Peter 

Cooper Corporation (Markhams) 

Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA), Region 2 is publishing a 

direct final notice of deletion of the 

Peter Cooper Corporation (Markhams) 

Superfund Site (Markhams Site) located 

in the Town of Dayton, Cattaraugus 

County, New York from the National 

Priorities List (NPL). 

The NPL, promulgated pursuant to 

section 105 of the Comprehensive 

Environmental Response, 


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