Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 47465 

Telephone: (202) 707–8380. Telefax: 

(202) 707–8366. 

SUPPLEMENTARY INFORMATION: The 

Copyright Office makes a non– 

substantive correcting amendment to 

the final rule governing exemption to 

prohibition on circumvention of 

copyright protection systems for access 

control technologies which was 

published July 27, 2010. 

List of Subjects in 37 CFR 201 

Copyright, Exemptions to prohibition 

against circumvention. 

Correction 

For the reason set forth in the 

preamble, 37 CFR part 201 is corrected 

by making the following technical 

amendment: 

PART 201–GENERAL PROVISIONS 

■ 1. The authority citation for part 201 

continues to read as follows: 

Authority: 17 U.S.C. 702 

■ 2. Amend § 201.40 (b) introductory 

text by removing the word ‘‘five’’. 

Dated: July 28, 2010 

Marybeth Peters, 

Register of Copyrights. 

[FR Doc. 2010–19007 Filed 8–5–10; 8:45 am] 

BILLING CODE 1410–30–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0190; FRL–8836–8] 

Pymetrozine; Regulation Denying 

NRDC’s Objections on Remand 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final Regulation. 

SUMMARY: In this regulation, EPA again 

denies objections by the Natural 

Resources Defense Council (NRDC) to 

an action establishing tolerance 

regulations for the pesticide 

pymetrozine 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 tenfold safety 

factor for the protection of infants and 

children to these pesticide tolerances. In 

the challenged action, EPA had applied 

a reduced additional safety factor to 

several risk assessments for 

pymetrozine. EPA has reviewed its 

decision on the children’s safety factor 

in light of the current data on 

pymetrozine and now determined that 

the full additional children’s safety 

factor should be applied in assessing the 

risk of the pymetrozine tolerances. 

However, EPA still denies NRDC’s 

objections because the increase in the 

children’s safety factor does not change 

EPA’s conclusion that the tolerances are 

safe. EPA’s explanation for its decisions 

on the children’s safety factor and the 

safety of pymetrozine tolerances are 

included in this regulation. 

DATES: This regulation is effective 

August 6, 2010. Objections and requests 

for hearings must be received on or 

before October 5, 2010, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2004–0190. 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) 304–7038; 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 NRDC to EPA’s 

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 North American 

Industrial Classification System 

(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. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 


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47466 Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2005–0190 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

received by the Hearing Clerk as 

required by 40 CFR part 178 on or 

before October 5, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2005–0190, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Introduction 

A. What Action Is the Agency Taking? 

This action is being taken in response 

to a remand to EPA of a final order 

denying objections filed by the NRDC to 

regulations establishing pesticide 

tolerances for pymetrozine under 

section 408 of the FFDCA, 21 U.S.C. 

346a. (70 FR 46706, August 10, 2005); 

(Ref. 1). The order was remanded to 

EPA by the U.S. Court of Appeals, Ninth 

Circuit, for an explanation of the basis 

for EPA’s decision on the FFDCA’s 

provision requiring a presumptive 

additional tenfold (10X) safety factor for 

the protection of infants and children. 

(NCAP v. EPA, 544 F.3d 1043, 1052 (9th 

Cir. 2008)). Specifically, the court held 

that EPA did not provide ‘‘enough 

information’’ on why in evaluating the 

risk of pymetrozine it chose to deviate 

from this presumptive safety factor. 

(Id.). In response to the remand, EPA is 

again denying the objections. In light of 

new data received on pymetrozine, EPA 

has now determined that the 

presumptive safety factor for infants and 

children should be retained; however, 

the objections are denied because 

retention of this additional safety factor 

does not show the pymetrozine 

tolerances to be unsafe. 

Because EPA has taken new 

information into account in issuing this 

decision upon remand, EPA is issuing 

the remand decision as a regulation 

under FFDCA section 408(d)(4)(i). Any 

person may file objections to a FFDCA 

section 408(d)(4)(i) regulation with EPA 

and request a hearing on those 

objections. (Id.). If this decision was 

issued as a revised final order on 

NRDC’s objections under FFDCA 

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

346a(g)(2)(C)), then any party who 

wished to contest EPA’s determination 

would have no opportunity to submit 

factual contentions to the record 

concerning the new information prior to 

seeking judicial review. 

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)). 

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). Monitoring and enforcement of 

pesticide tolerances are carried out by 

the U.S. Food and Drug Administration 

and the U.S. Department of Agriculture 

(USDA). Section 408 was substantially 

rewritten by the Food Quality Protection 

Act of 1996 (FQPA), which added the 

provisions discussed below establishing 

a detailed safety standard for pesticides 

and additional protections for infants 

and children. (Public Law 104–170, 110 

Stat. 1489 (1996)). 

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)). The statute explains 

that aggregate exposure to a pesticide 

includes ‘‘dietary exposure under the 

tolerance and all other tolerances in 

effect for the pesticide chemical residue, 

and exposure from other nonoccupational sources.’’ (21 U.S.C. 

346a(b)(2)(D)(vi)). 

In making the safety determination for 

a tolerance, risks to infants and children 

are given special consideration. 

Specifically, section 408(b)(2)(C) 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 document as the 

‘‘children’s safety factor.’’ 

3. Procedures for establishing, 

amending, or revoking tolerances. 

Tolerances are established, amended, or 

revoked by rulemaking under the 


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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 

after date of publication in the Federal 

Register. (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 body 

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 longerterm (e.g., chronic) pesticide exposure 

and the effects of pre-natal and postnatal 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. 

For non-threshold effects, EPA assumes 

that any exposure to the substance 

increases the risk that the adverse effect 

may occur. At present, EPA only 

considers one adverse effect, the chronic 

effect of cancer, to potentially be a nonthreshold effect. (Ref. 2 at 4–9). Not all 

carcinogens, however, pose a risk at any 

exposure level (i.e., ‘‘a non-threshold 

effect or risk’’). Advances in the 

understanding of the mode of action of 

carcinogenesis have increasingly led 

EPA to conclude that some pesticides 

that cause carcinogenic effects in animal 

studies only cause such effects above a 

certain threshold of exposure. 

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. The assessment of this 

relationship is 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 next lower dose at which there 

are no observed adverse effect 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. 2 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 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. 

(Pymetrozine is not expected to result in 

any meaningful non-dietary exposure 

and thus risk assessment of non-dietary 

exposure is not further discussed in this 

document.) For dietary risks, EPA uses 

the Point of Departure to calculate an 

safe or acceptable level of exposure 

designated as the 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. 3 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. 3 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 


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calculated safe dose are denoted as a 

RfD/PAD. 

ii. Non-threshold effects. For risk 

assessments for non-threshold effects, 

EPA does not use the RfD/PAD 

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 using a linear, low-dose 

extrapolation model that assumes that 

any amount of exposure will lead to 

some degree of risk. This dose-response 

analysis will be used in the risk 

characterization stage to estimate the 

risk to humans of the non-threshold 

effect. Linear, low-dose extrapolation is 

typically used as the default approach 

for estimating the risk to carcinogens, 

unless there are mode of action data 

indicating a threshold response (or 

nonlinearity). 

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: (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. 2 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.’’ EPA refinement 

of an exposure assessment ‘‘can have 

dramatic effects on the level of exposure 

predicted, reducing worst case estimates 

by 1 or 2 orders of magnitude or more.’’ 

(73 FR 42683, 42687, July 23, 2008). 

More information on how EPA refines 

estimates of exposure from pesticides in 

food can be found in the following EPA 

publication, ‘‘A User’s Guide to 

Available EPA Information on Assessing 

Exposure to Pesticides in Food.’’ (Ref. 2; 

see also 73 FR at 42687). 

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, 30054–30065 

(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 

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. 4). 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 


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not of concern. Under current 

procedures, EPA aggregates pesticide 

exposure from food and drinking water 

prior to comparing exposure to the RfD/ 

PAD. 

2. EPA policy on the children’s safety 

factor. As the above brief summary of 

EPA’s risk assessment practice 

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 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. 3 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 Regulation 

for Pymetrozine 

1. In general. NRDC challenged a 

December 27, 2001, action establishing 

tolerances for pymetrozine on cotton 

seed; cotton gin byproducts; fruiting, 

cucurbit, leafy, and Brassica vegetables; 

turnip greens; hops; and pecans. (66 FR 

66786, December 27, 2001). Given 

pymetrozine’s exposure pattern and 

toxicological characteristics, EPA 

determined that pymetrozine potentially 

presented acute, short-term, chronic, 

and cancer risks and EPA quantitatively 

assessed these risks in making its safety 

determination. (Id. at 66791–66792). All 

of these risks were found to be below 

the Agency’s level of concern. (Id.). 

2. Children’s safety factor 

determination. For pymetrozine, EPA 

concluded there was uncertainty 

regarding its effects on the young 

because a DNT was outstanding and a 

NOAEL had not been identified in an 

acute neurotoxicity study. (66 FR at 

66791; 64 FR 52438, 52444, September 

29, 1999). EPA determined, however, 

that these uncertainties were partially 

offset by a number of factors. First, EPA 

noted that there was no increased 

sensitivity in young animals observed in 

the pre- and post-natal studies 

conducted with pymetrozine, and that 

these studies showed no evidence of 

abnormalities in the fetal nervous 

system. (Ref. 5 at 5). Second, the 

evidence on pymetrozine’s 

neurotoxicity was mixed. Although the 

acute neurotoxicity study had identified 

behavioral effects at 125 milligrams per 

kilogram of body weight per day (mg/kg 

bw/day), the subchronic neurotoxicity 

only showed ‘‘indefinite evidence’’ of 

neurotoxicity at significantly higher 

doses (201 mg/kg/day for males, 228 

mg/kg/day for females). (Id. at 2). Third, 

exposure data were deemed adequate 

not to underestimate exposure. (Id. at 5). 

Weighing all of this evidence, EPA 

determined that the safety of infants and 

children would be protected by an 

additional 3X safety factor applied to all 

risk assessments; (66 FR at 55791) and 

a second additional 3X safety factor for 

assessing acute risks to the general 

population, including infants and 

children. The second additional safety 

factor was only applied to the acute 

assessment because it was only in an 

acute neurotoxicity study that a NOAEL 

had not been identified. (64 FR at 

52444). Given the two 3X safety factors 

for acute risk, EPA essentially retained 

the full 10X FQPA safety factor for the 

acute risk assessment. The second 

additional 3X safety factor was not 

retained as to the acute assessment for 

women of child-bearing age because this 

assessment was based on an acute study 

in which a NOAEL was obtained. (Id.). 

V. Subsequent Tolerance Action for 

Pymetrozine 

Since December 2001, EPA has 

established an additional tolerance for 

pymetrozine on asparagus. (70 FR 

43292, July 27, 2005). 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 this subsequent action EPA 

took into account exposure to 

pymetrozine under challenged 

tolerances established on December 27, 

2001 (cotton seed; cotton gin 

byproducts; fruiting, cucurbit, leafy, and 

Brassica vegetables; turnip greens; hops; 

and pecans). In its action on the 

asparagus tolerance in 2005, EPA 

concluded that the additional exposure 

from the new tolerance, when 

aggregated with exposure under existing 

tolerances, was safe. (70 FR at 43297). 

With regard to the children’s safety 

factor in this subsequent action, 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 December 27, 2001 

tolerance action. This revised analysis 

focused on how the expected dose level 

in the requested DNT study compared to 

the existing Points of Departure for 

acute and chronic risks. The dose levels 

in the DNT study are generally guided 

by the results of the two-generation 

study in rats because it is a study 

involving the young and is conducted in 

the same species as the DNT study. 

Noting that the Points of Departure for 

acute risk were generally in the same 

order of magnitude of the NOAEL in the 

reproduction study, EPA concluded that 

full additional 10X safety factor should 

be retained for acute risk assessments 

because the DNT study could 

potentially lower the existing Point of 

Departure significantly and thus EPA 

lacked reliable data to choose a factor 

other than the default value. EPA 

reasoned that if the DNT study showed 

adverse effects at the lowest dose tested 

(presumably a dose in the range of the 

current Point of Departure), then a 

revised Point of Departure would be 

tenfold lower than the existing Point of 

Departure once EPA compensated for a 

lack of NOAEL in the DNT study. The 

opposite conclusion was reached for 

chronic risks because the Point of 

Departure for chronic risk assessment 

was already 30X lower than the 

expected low dose in the DNT study. 

Due to this significant difference in the 

chronic Point of Departure and the 

expected low dose in the DNT study, 

the results of the DNT study were 

unlikely to affect the chronic Point of 

Departure and thus an additional safety 

factor was not needed to protect infants 

and children in the absence of the DNT 

study. (Ref. 6). 

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 section 408 of the FFDCA, 

(21 U.S.C. 346a), establishing pesticide 

tolerances for various pesticides. The 

objections applied to 14 pesticides and 

112 separate pesticide tolerances. The 

challenged tolerances included the 

tolerances for pymetrozine addressed in 


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today’s regulation. The objections to the 

pymetrozine tolerances were filed on 

February 25, 2002, and grouped with 

objections to tolerances for 

halosulfuron-methyl. 

Although NRDC’s petitions raised 

dozens of issues, most of the issues 

related to two main claims: (1) 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 (2) 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. Specifically as to 

pymetrozine, NRDC asserted that: 

Even though . . . DNT results are 

required and overdue, EPA has 

established new tolerances for 

pymetrozine. In doing so, EPA 

failed to apply the required 10X 

safety factor for children that is 

intended to compensate for just 

such data gaps. 

(Ref. 1 at 4). 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 drinking water exposure 

models to estimate pesticide exposure 

levels in water instead of ‘‘collect[ing] 

pesticide-specific data on water-based 

exposure.’’ (Ref. 7 at 5; Ref. 8 at 6). 

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. 7 at 4–6; Ref. 8 at 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. (70 FR at 46711, 46716, 46725, 

46726, 46730). 

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 specific factual 

considerations relating to its individual 

children’s safety factor decisions as to 

pymetrozine (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 

‘‘they are based on reliable data and 

have produced estimates that EPA can 

reliably conclude will not 

underestimate exposure to pesticides in 

drinking water.’’ (70 FR 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. 

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. NRDC had 

not challenged the May 26, 2004 

imidacloprid 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 zeta-cypermethrin. 

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. 9). 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: 

a. 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); 

b. 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;’’ 

c. EPA lacked the 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 

d. 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/NCAP argued that EPA’s decision 

was arbitrary and capricious because 

EPA determined that additional data 

were needed on the pesticides but 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: 

a. 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; 

b. 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 

c. It was reasonable for EPA to rely 


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in drinking water models in 

estimating pesticide levels in water 

in making children’s safety factor 

determinations. 

(NCAP v. EPA, 544 F.3d 1043, 1044– 

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 fenhexamid 

and isoxadifen-ethyl, a DNT study had 

not been required by EPA. For 

halosulfuron-methyl and zetacypermethrin 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 

study. 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. 10 and 11). 

VII. Revised Regulation on Remand 

On remand, EPA has determined that 

NRDC’s objections should again be 

denied because the remanded objections 

do not show that the pymetrozine 

tolerances are not safe. EPA has now 

received and reviewed a DNT study on 

pymetrozine. The results of the DNT 

study, when considered in combination 

with the rest of the pymetrozine 

database, convince EPA that the 10X 

children’s safety factor should be 

retained for pymetrozine. EPA evaluated 

the risk of pymetrozine, taking into 

account the additional 10X children’s 

safety factor and has concluded that 

pymetrozine tolerances are safe. A 

summary of EPA’s reasons for retaining 

the 10X children’s safety factor and of 

EPA’s risk assessment is provided 

below. 

A. DNT Study for Pymetrozine 

A DNT study with pymetrozine was 

performed in Wistar-derived rats. (Ref. 

12). Dose levels in the study were 0 

(control), 100, 500, or 2,500 parts per 

million (ppm). To translate these doses 

to humans they are expressed in terms 

of the daily dose in milligrams of 

pymetrozine per kilogram of body 

weight of the experimental animals. 

Additionally, because of significant 

body weight changes between fetuses 

during the period of gestation and postnatal animals during lactation, that 

weight change is incorporated into the 

expression of dose by using separate 

dose calculations for gestation and 

lactation. Expressed in these terms, the 

doses in the pymetrozine DNT study 

were 0/0 (gestation/lactation), 8.1/16.8, 

38.7/82.6, and 173.1 milligrams/ 

kilogram of body weight/day (mg/kg/ 

day). No dose is provided for the high 

dose group of lactation animals because 

higher than expected mortality was 

observed during littering, resulting in an 

insufficient number of litters. Therefore, 

the study was terminated for the high 

dose group prior to lactation. 

Effects in pups, as well as maternal 

animals, were evaluated through both 

in-life and post-mortem observations. 

To investigate potential neurotoxic 

effects, the in-life observations included 

monitoring of motor activity, testing of 

acoustic startle response, learning and 

memory evaluation, and use of a 

functional observation battery (FOB). 

The FOB is a noninvasive procedure 

designed to detect gross functional 

deficits resulting from exposure to 

chemicals and to better quantify 

neurotoxic effects detected in other 

studies. The FOB consists of six types 

of observations: home cage, handling, 

open field, sensory, neuromuscular, and 

physiological responses. Post-mortem 

evaluation included examination of the 

major portions of the central and 

peripheral nervous system for any sign 

of neuropathology. 

The primary effect seen in the 

maternal animals was loss of the litter. 

At the 38.7 mg/kg/day dose, total litter 

loss was experienced between birth and 

post-natal-day 5 by 5 out of 29 treated 

maternal animals (17.2%) compared to 

2 out of 30 controls (6.7%). On gestation 

day 24, one maternal animal with 

staining around the nose was sacrificed 

due to difficult parturition, and another 

animal was pale. Food consumption 

was decreased (↓21%; statistical 

significance of p≤0.01) during lactation 

days 1–5. However, body weights at this 

dose were comparable to controls 

throughout treatment. At the 8.1/16.8 

mg/kg/day dose, no treatment-related 

effects were seen on litter loss, survival, 

clinical signs, body weight, body weight 

gain, food consumption, or reproductive 

performances. EPA determined that the 

maternal LOAEL is 38.7 mg/kg/day and 

the maternal NOAEL is 8.1 mg/kg/day. 

Pymetrozine caused a dose-dependent 

increase in the number of pups dying 

during post-natal-days 1–5; 57 pups at 

8.1/16.8 mg/kg/day, 95 pups at 38.7/ 

82.6 mg/kg/day, and 151 pups at 173.1 

mg/kg/day, compared to 48 pups in the 

controls. This was due to the increase in 

the number of whole litter losses at 8.1/ 

16.8 mg/kg/day (3 litters), 38.7/82.6 mg/ 

kg/day (5 litters), and 173.1 mg/kg/day 

(4 litters) compared to controls (2 

litters). When whole litter losses are 

excluded, no treatment-related findings 

were observed on litter size or viability. 

Treatment had no adverse effects on 

pup body weight, body weight gain, 

food consumption, developmental 

landmarks, clinical signs, FOB, motor 

activity, auditory startle reflex, learning 

and memory, or brain weights. 

However, measurement of brain 

morphometry showed the following 

differences (p≤0.05) from controls: (i) 

Increased thickness of the corpus 

callosum in the 38.7/82.6 mg/kg/day 

males on post-natal-day 12 (↑15%) and 

in the 8.1/16.8 mg/kg/day males on 

post-natal-day 63 (↑4–13%); (ii) 

increased thickness of the inner 

granular and molecular layers of the 

pre-pyramidal fissure in the cerebellum 

in the 38.7/82.6 mg/kg/day males on 

post-natal-day 63 (↑4–19%); and (iii) 

increased thickness of the dorsal cortex 

in the 8.1/16.8 mg/kg/day females on 

post-natal-day 12 (↑4–10%). 

EPA determined that the offspring 

LOAEL is 8.1 mg/kg/day, the lowest 

dose tested, based on morphometric 

changes in the brains of female pups on 

post-natal-day 12 and male pups on 

post-natal-day 63. The offspring NOAEL 

was not established. 

B. Children’s Safety Factor Decision for 

Pymetrozine 

In evaluating the children’s safety 

factor for pymetrozine, EPA considered 

the completeness of the toxicity and 

exposure databases as well as the 

potential for pymetrozine to cause preor post-natal toxicity, particularly where 

such toxicity indicates increased 

sensitivity in juvenile animals 

compared to adult animals. (Ref. 13) 

1. Toxicity database. With the receipt 

of the DNT study, the toxicity database 


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47472 Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 

for pymetrozine is complete in terms of 

the requirements in place at the time of 

the challenged pymetrozine tolerance 

action in 2001. However, since that 

time, EPA has amended data 

requirements pertaining to registration 

of pesticides under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act, (7 U.S.C. 136 et seq.), and 

establishment of tolerances under the 

FFDCA. (72 FR 60934, October 26, 

2007). Several new requirements apply 

to agricultural pesticides such as 

pymetrozine but the only new data 

requirement for pymetrozine that has 

not yet been fulfilled is the requirement 

for an immunotoxicity study. 

In the absence of this study, EPA 

examined the pymetrozine database to 

evaluate pymetrozine’s immunotoxic 

potential. EPA concluded that the liver 

is the primary target organ of 

pymetrozine and that apparent 

immunotoxic effects are the result of 

exceedingly high doses. 

Potential immune organ effects 

include atrophy of the thymus in the 

subchronic rat and dog studies at 360 

and 54 mg/kg/day, respectively; 

decreased thymus weight in the chronic 

mouse study at 675 mg/kg/day; 

increased leucocytes in the subchronic 

rat study at 360 mg/kg/day; and 

hyperplasia of the splenic lymphocyte 

follicles in the reproduction study at 

136.9 mg/kg/day. Clear NOAELs were 

identified for these potential 

immunotoxic effects at higher doses 

than the endpoint that was selected for 

risk assessment, i.e., the 8.1 mg/kg/day 

LOAEL from the DNT study based on 

brain morphometric changes in the 

offspring. Lymphocytic infiltration in 

the prostrate and thyroid was observed 

at 14 mg/kg/day in the subchronic dog 

study but these organs are not a primary 

part of the immune system and the 

lymphocytic infiltration is considered 

an immune system reaction to other 

toxic effects on these organs and not an 

immunotoxic effect. 

The Agency does not believe that 

conducting a functional immunotoxicity 

study will result in a lower Point of 

Departure than the endpoint currently 

selected for overall risk assessment (i.e. 

the extrapolated NOAEL from the DNT 

study—see discussion below in Unit 

VII.C.1.a.) based on: 

a. The only potential immunotoxic 

responses occurred at doses greater 

than the endpoint selected for risk 

assessment, 

b. Clear NOAELs were identified for 

the potential immunotoxic effects, 

again at doses greater the endpoint 

selected for risk assessment; and 

c. The lymphohistocytic effects 

were determined not to be 

immunotoxic effects but a reaction 

to other toxic effects. 

The other concern with the toxicity 

database is that a NOAEL was not 

identified for juvenile animals in the 

DNT study. The LOAEL in that study 

was based on differences from controls 

in the measurement of brain 

morphometrics. The concern with this 

effect, however, is lessened somewhat 

here in that no effects were seen in other 

barometers of effects on developmental 

neurology such as developmental 

landmarks, clinical signs, FOB, motor 

activity, auditory startle reflex, learning 

and memory, or brain weights. 

2. Potential pre- and post-natal 

toxicity. No indications of qualitative or 

quantitative sensitivity in the young 

were seen in the developmental studies 

in rats and rabbits or in the two 

generation reproduction study in rats. 

NOAELs were identified for all effects 

in the young seen in these studies. On 

the other hand, EPA has assumed that 

quantitative sensitivity was detected in 

the DNT study in rats given that toxicity 

was observed in the juveniles (brain 

morphometric changes) in the absence 

of maternal toxicity. This is a 

conservative assumption on EPA’s part 

in that the maternal animals’ brains 

were not examined for morphometric 

changes. 

3. Exposure database. EPA’s exposure 

estimate is based mainly on a 2005 

exposure assessment performed for the 

last pymetrozine tolerance action. (70 

FR 43292, July 27, 2005). For the acute 

exposure assessment, EPA used the very 

conservative approach of assuming 

pymetrozine was used on all foods with 

a tolerance and residues were at the 

tolerance level. The chronic exposure 

assessment is more refined in that for 

most crops EPA relied on average values 

from pesticide residue field trials for all 

commodities and data on the percentage 

of crops that are treated with 

pymetrozine for most of the more 

heavily-consumed commodities. 

Because several years have passed since 

the 2005 pymetrozine tolerance action, 

EPA updated the percent crop treated 

data in assessing exposure. Although 

pymetrozine is licensed for use on 

ornamentals, EPA expects exposure to 

the public, including children, from this 

use to be negligible because 

pymetrozine may only be applied by 

commercial applicators (hence, no 

applicator exposure for the public) and 

post-application contact with 

ornamentals is infrequent and brief 

compared with, for example, turf. 

4. Conclusion. The primary factor of 

concern from the above is the weakness 

in the toxicity database due to the 

failure to identify a NOAEL in the DNT 

study. This deficiency is heightened by 

the fact that, although pre- and postnatal animals were generally not more 

sensitive than adults, the DNT study 

showed quantitative sensitivity in rat 

pups due to the identification of adverse 

brain morphometric changes in rat pups 

at a dose that did not cause maternal 

toxicity. Although the brain 

morphometric effects seen at the LOAEL 

in the DNT study were not confirmed by 

other barometers of developmental 

neurotoxicity, the absence of a NOAEL 

for these effects creates sufficient 

uncertainty that reliable data are not 

available to revise the default 10X 

children’s safety factor. Therefore, EPA 

is retaining the full 10X children’s 

safety factor in assessing risk based on 

the DNT study. As discussed in Unit 

VII.C.1. below, the DNT study provides 

the Point of Departure for both acute 

and chronic risk assessments. Retention 

of the full children’s safety factor 

reduces any concerns from lack of an 

immunotoxicity study as the NOAELs 

from the potential immunotoxic organ 

effects are all greater than 1000X higher 

than the level of concern (aPAD and 

cPAD) when the 10X children’s safety 

factor is taken into account. Despite the 

lack of a NOAEL in the DNT study and 

the increased sensitivity in juveniles 

shown in that study, EPA does not 

believe that the weight of the evidence 

supports an additional safety factor 

higher than 10X given that the brain 

morphometric effects seen at the LOAEL 

in the DNT study were not confirmed by 

any other measures of neurological 

effect. 

C. Risk Assessment and Safety 

Determination for Pymetrozine 

Given the new data on developmental 

neurotoxicity and EPA’s revised 

children’s safety factor determination, 

EPA has recalculated the risks of 

pymetrozine taking this information 

into account. EPA last assessed the risks 

of pymetrozine in connection with a 

tolerance rulemaking for pymetrozine 

on asparagus in 2005. (70 FR 43292, July 

27, 2005). The new information affects 

the hazard identification and doseresponse aspects of the risk assessment 

for acute and chronic non-cancer risk. 

EPA has also updated the exposure 

assessment performed for the 2005 

assessment because exposure 

information is needed in completing a 

revised acute and chronic risk 

assessment. 

1. Hazard identification/dose 

response—a. Point of Departure. As 

previously explained, EPA chooses a 

Point of Departure from toxicology 

studies for use in calculating a safe level 

of exposure to humans. This safe level 


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of exposure is called a Reference Dose 

(RfD) or Population-Adjusted Dose 

(PAD). In the 2002 tolerance 

rulemaking, EPA used the following 

Points of Departure: for acute risk to the 

general population (including infants 

and children) a LOAEL of 125 mg/kg/ 

day from the acute neurotoxicity study 

in rats; for acute risk to pre-natal infants 

(focusing on exposure to females of 

child-bearing age) a NOAEL of 10 mg/ 

kg/day from the rabbit developmental 

study; and for chronic risk to the general 

population (including infants and 

children) a NOAEL of 0.377 from the 

chronic toxicity study in rats. The same 

Points of Departure were used in risk 

assessment for the 2005 rulemaking. 

The Points of Departure have been 

changed based on a review of the DNT 

study. EPA determined that the LOAEL 

of 8.1 mg/kg/day from the DNT study 

(no NOAEL was established) would be 

used as the Point of Departure for both 

acute risk (all population groups 

including infants and children and 

women of child-bearing age) and 

chronic risk (again, all population 

groups). As described above, the effect 

seen at the LOAEL was changes in brain 

morphometrics in the offspring. The 

LOAEL from the DNT study was chosen 

for the Point of Departure for assessing 

acute risk because it is lower than either 

of the two doses previously used (the 

LOAEL from the acute neurotoxicity 

study and the NOAEL from the rabbit 

developmental study). Selection of this 

LOAEL for the Point of Departure for 

acute risk assessment is conservative 

because the brain morphometric 

changes were observed in the absence of 

impacts on other parameters, including 

developmental landmarks, clinical 

signs, FOB, motor activity, acoustic 

startle response, learning and memory, 

or brain weight. It is additionally 

conservative because EPA has assumed 

that these brain changes could occur 

from a single dose. 

The Agency is using the LOAEL from 

the DNT study as the Point of Departure 

for chronic risk because brain 

morphometric changes may be the result 

of single or multiple doses and this 

LOAEL produces the most protective 

cPAD. Previously, EPA used the NOAEL 

from the chronic rat study as the Point 

of Departure but the LOAEL from that 

study is based on hepatic hypertrophy 

and EPA no longer considers hepatic 

hypertrophy in the absence of liver 

pathology or changes in relevant clinical 

chemistry parameters to be an adverse 

effect. Hepatocellular hypertrophy is 

often an adaptive and reversible effect 

in response to the presence of a 

chemical (i.e. induction of microsomal 

enzymes in the liver). Although there 

are other NOAELs in the pymtrozine 

database at or slightly below the LOAEL 

from the DNT study, once an additional 

safety factor (see above) is retained to 

address the lack of a NOAEL in the DNT 

study, reliance on the LOAEL from this 

study produces the most protective 

cPAD. 

b. Dose response. To calculate both 

the aPAD and cPAD, EPA divided the 

LOAEL from the DNT study by 1,000, 

representing a 10X factor to account for 

inter-species variability, a 10X factor to 

account for intra-species variability, and 

an additional 10X safety factor for the 

protection of infants and children due to 

the lack of a NOAEL in the DNT study. 

As noted above, the retention of the full 

10X children’s safety factor is 

conservative given the fact that the brain 

morphometric changes were noted in 

the absence of any confirming clinical 

or neuropathological signs. 

2. Exposure. As explained in Unit 

VII.B. above, EPA relied on the exposure 

assessment for the 2005 pymetrozine 

tolerance rulemaking updated to 

incorporate more recent percent crop 

treated information. Residue levels in 

drinking water were estimated for that 

exposure assessment based upon EPA’s 

screening level drinking water models. 

This assessment is very conservative 

with regard to acute exposure, and, 

while more refined for chronic 

exposure, still retains significant 

conservatisms. (Refs. 13 and 14). 

3. Safety Determination. Table 1 

below shows how exposure to 

pymetrozine residues in food and 

drinking water compared to the aPAD 

and cPAD for the general population 

and major population subgroups based 

on age. The highest subgroups for acute 

and chronic exposure are shown in 

bold. 

TABLE 1—SUMMARY OF COMBINED DIETARY (FOOD + DRINKING WATER) EXPOSURE AND RISK ESTIMATES FOR

PYMETROZINE

Population Subgroup 

Acute (95th Percentile) Chronic 

Exposure (mg/ 

kg/day) % aPAD Exposure(mg/ kg/day) % cPAD 

General U.S. Population 0.002831 35 0.000237 2.9 

All Infants (1 year old) 0.003882 48 0.000707 8.7 

Children 1–2 years old 0.004368 54 0.000350 4.3 

Children 3–5 years old 0.004034 50 0.000329 4.1 

Children 4–12 years old 0.003027 37 0.000224 2.8 

Youth 13–19 years old 0.002312 28 0.000174 2.2 

Adults 24–49 years old 0.002698 33 0.000222 2.7 

Adults 50+ years old 0.002669 33 0.000235 2.9 

Females 13–49 years old 0.002625 32 0.000217 2.7 

Given the data and analysis 

underlying the derivation of the 

pymetrozine aPAD and cPAD and the 

pymetrozine exposure assessment, EPA 

concludes that its finding that exposure 

for the highest exposed population 

subgroup is below the aPAD and cPAD 

shows that there is a reasonable 

certainty of no harm from aggregate 

exposure to pymetrozine for all 

population subgroups including infants 

and children. (Refs. 13 and 14). 


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D. Conclusion 

Because EPA’s revised risk 

assessment – which incorporates both 

the DNT study and the 10X children’s 

safety factor – shows pymetrozine 

exposure to be safe, NRDC’s objection to 

the establishment of the pymterozine 

tolerances is denied. 

VIII. Regulatory Assessment 

Requirements 

This final rule reaffirms, over 

objections, tolerances established under 

section 408(d) of FFDCA in response to 

a petition submitted to the Agency. The 

Office of Management and Budget 

(OMB) has exempted these types of 

actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

IX. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. Here, the 

underlying rule establishing 

pymetrozine tolerances is currently in 

effect. (See 66 FR 66786, December 27, 

2001). The EPA order denying 

objections to that rule, however, has 

been remanded to EPA for a further 

explanation of the basis for EPA’s 

decision on the objections. Importantly, 

the court remanded the matter to EPA 

without vacating the underlying rule. 

Today’s action reaffirming the prior rule 

responds to the judicial remand and 

does not affect the status of the 

underlying rule. EPA will submit a 

report containing today’s action 

reaffirming the pymetrozine tolerance 

regulation and other required 

information to the U.S. Senate, the U.S. 

House of Representatives, and the 

Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. The 

reaffirmed pymetrozine tolerance 

regulation is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

X. References 

1. Objections to the Establishment of 

Tolerances for Pesticide Chemical 

Residues: Halosulfuron-methyl and 

Pymetrozine Tolerances (filed February 

25, 2002). 

2. USEPA, A User’s Guide to 

Available EPA Information on Assessing 

Exposure to Pesticides in Food (June 21, 

2000). 

3. 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). 

4. Office of Pesticide Programs, 

USEPA, Standard Operating Procedures 

(SOPs) for Residential Exposure 

Assessments (Draft December 19, 1997). 

5. Office Of Prevention, Pesticides 

and Toxic Substances, USEPA, 

Memorandum from Brenda Tarplee to 

Michael Doherty, Pymetrozine - Report 

of the FQPA Safety Factor Committee 

(July 21, 1999). 

6. Office Of Prevention, Pesticides 

and Toxic Substances, USEPA, 

Memorandum from Brenda Tarplee to 

Michael Doherty, Pymetrozine - 3rd 

Report of the Hazard Identification 

Assessment Review Committee 

(February 9, 2003). 

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. NRDC, Objections to the 

Establishment of Tolerances for 

Pesticide Chemical Residues: 

Imidacloprid, Mepiquat, Bifenazate, 

Zeta-cypermethrin, and Diflubenzuron 

Tolerances (filed March 19, 2002). 

9. Petitioners’ Brief, NCAP v. EPA, 

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

6, 2006). 

10. 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. 04–75255 & 04– 

76807 (May 25, 2007). 

11. 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. 04–75255 & 04–76807 (May 

29, 2007). 

12. Office Of Prevention, Pesticides 

and Toxic Substances, USEPA, 

Memorandum from Robert J. Mitkus to 

Daniel Peacock, Pymetrozine – Review 

of Developmental Neurotoxicity Study 

in Rats (July 13, 2005). 

13. Office Of Prevention, Pesticides 

and Toxic Substances, USEPA, 

Memorandum from Christina Swartz to 

Daniel B. Peacock and Meredith F. 

Laws, Pymetrozine. Updated Aggregate 

Human Health Risk Assessment (April 

2, 2010). 

14. Office Of Prevention, Pesticides 

and Toxic Substances, USEPA, 

Memorandum from Christina Swartz to 

Daniel B. Peacock and Meredith F. 


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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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