Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 55997 

Inert ingredients Limits Uses 

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Ammonium formate (CAS Reg. No. 540–69–2) Complexing or fixing agent 

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[FR Doc. 2010–22976 Filed 9–14–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2008–0347; FRL–8843–7] 

40 CFR Part 180 

Carbaryl; Order Denying NRDC’s 

Objections and Requests for Hearing 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Order. 

SUMMARY: In this order, the 

Environmental Protection Agency (EPA) 

denies objections, and requests for 

hearing on those objections, to a prior 

order denying a petition requesting that 

EPA revoke all pesticide tolerances for 

carbaryl under section 408(d) of the 

Federal Food, Drug, and Cosmetic Act. 

The objections and hearing requests 

were filed on December 29, 2008, by the 

Natural Resources Defense Council 

(NRDC). The original petition was also 

filed by NRDC. 

FOR FURTHER INFORMATION CONTACT: 

Jacqueline Guerry, Pesticide Reevaluation Division (7508P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (215) 814– 

2184; e-mail address: 

guerry.jacqueline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

In this document, EPA denies 

objections, and requests for hearing on 

those objections, submitted by NRDC in 

response to a prior order denying 

NRDC’s petition requesting that EPA 

revoke all pesticide tolerances for 

carbaryl. In addition to NRDC, and 

others interested in food safety issues 

generally, this action may 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 Get Copies of this 

Document and Other Related 

Information? 

EPA has established a docket for this 

action under docket identification (ID) 

number EPA–HQ–OPP–2008–0347. 

Publicly available docket materials are 

available either in the electronic docket 

at http://www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

II. Introduction 

A. What Action Is the Agency Taking? 

In this order, EPA denies objections, 

and requests for a hearing on those 

objections, to an earlier EPA Order, (73 

FR 64229 ), denying a petition to revoke 

all tolerances established for the 

pesticide, carbaryl, under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a, (Refs. 1 and 2). Both the 

objections and hearing requests, as well 

as the petition, were filed with EPA by 

NRDC. 

NRDC’s original petition, dated 

January 10, 2005, submitted to the 

carbaryl public docket during the public 

comment period for the 2004 Amended 

Interim Reregistration Eligibility 

Decision (IRED) for Carbaryl, and filed 

pursuant to FFDCA section 408(d)(1), 

asserted a number of grounds why 

carbaryl tolerances allegedly fail to meet 

the FFDCA’s safety standard. The main 

arguments raised in the petition 

concerned EPA’s drinking water 

assessment and EPA’s decision on the 

statutory safety factor to protect infants 

and children that supported the 2004 

IRED decision. NRDC also petitioned 

the Agency to cancel all carbaryl uses 

pursuant to the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

7 U.S.C. 136(bb) and 136a, and argued 

unreasonable risks on the environment. 

Subsequently, on November 26, 2007, 

NRDC petitioned EPA to cancel all 

carbaryl pet collar uses under FIFRA. 

(Ref. 3). EPA consolidated this latter 

petition with the 2005 FFDCA petition 

because NRDC argued in it that 

exposure to carbaryl pet collars make 

the risks presented by carbaryl unsafe 

within the meaning of FFDCA section 

408. 

On October 29, 2008, EPA responded 

to both the 2005 petition to revoke all 

carbaryl tolerances and the 2007 

petition to cancel all pet collar uses, 

denying them in their entirety. (73 FR 

64229, October 29, 2008) (Ref. 4). 

NRDC then filed objections to EPA’s 

denial of NRDC’s petition to revoke all 

carbaryl tolerances and requested a 

hearing on its objections. These 

objections and hearing requests were 

filed pursuant to the procedures in the 

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

346a(g)(2)). The objections narrowed 

NRDC’s claims to two main topics – that 

EPA lacks reliable data to reduce the 

Food Quality Protection Act (FQPA) 

Children’s Safety Factor and that EPA’s 

exposure assessment for carbaryl is 

flawed and underestimates the exposure 

to children from pet collar uses. After 

carefully reviewing the objections and 

hearing requests, EPA has determined 

that NRDC’s hearing requests do not 

satisfy the regulatory requirements for 

such requests and that its substantive 

objections are without merit. Therefore, 

EPA, in this final order, denies NRDC’s 

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55998 Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 

objections and its requests for a hearing 

on those objections. 

B. What is the Agency’s Authority for 

Taking This Action? 

NRDC petitioned to revoke the 

carbaryl tolerances pursuant to the 

petition procedures in FFDCA section 

408(d)(1). (21 U.S.C. 346a(d)(1)). Under 

section 408(d), EPA may respond to 

such a petition by either issuing a final 

or proposed rule modifying or revoking 

the tolerances or issuing an order 

denying the petition. (21 U.S.C. 

346a(d)(4)). Here, EPA responded by 

issuing an order under section 

408(d)(4)(iii) denying the petition. (73 

FR 64229, October 29, 2008). 

Orders issued under section 

408(d)(4)(iii) are subject to a statutorilycreated administrative review process. 

(21 U.S.C. 346a(g)(2)). Any person may 

file objections to a section 408(d)(4)(iii) 

order with EPA and request a hearing on 

those objections. (Id.). EPA is required 

by section 408(g)(2)(C) to issue a final 

order resolving the objections to the 

section 408(d)(4)(iii) order. (21 U.S.C. 

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

III. Statutory and Regulatory 

Background 

In this Unit, EPA provides 

background on the relevant statutes and 

regulations governing NRDC’s 

objections and requests for hearing as 

well as on pertinent Agency policies 

and practices. As noted, NRDC’s 

objections and requests for hearing raise 

two main claims: (1) that EPA has 

unlawfully failed to retain the full 

tenfold FQPA safety factor for the 

protection of infants and children and 

failed to apply an additional threefold 

factor due to a deficiency in a critical 

study; and (2) that EPA underestimated 

the exposure to children from pet collar 

uses. The first claim is based on 

assertions that additional safety factors 

are needed because of effects observed 

in a developmental neurotoxicity (DNT) 

study with carbaryl. The pet collar 

claim is primarily based upon 

allegations that EPA does not have 

sufficient or reliable data with which to 

assess pet collar exposures and that the 

assumptions made by EPA 

underestimate exposure to children. 

Background information on each of 

these topics is included in this Unit. 

Unit III.A. summarizes the 

requirements and procedures in section 

408 of the FFDCA and applicable 

regulations pertaining to pesticide 

tolerances, including the procedures for 

petitioning for revocation of tolerances 

and challenging the denial of such 

petitions and the substantive standards 

for evaluating the safety of pesticide 

tolerances. This unit also discusses the 

closely-related statute under which EPA 

regulates the sale, distribution, and use 

of pesticides, FIFRA, (7 U.S.C. 136 et 

seq.). 

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 Agency policies with 

particular relevance to this action. 

A. FFDCA/FIFRA and Applicable 

Regulations 

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 

(FDA) 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, additional 

protections for infants and children, and 

the estrogenic substances screening 

program. (Public Law 104–170, 110 Stat. 

1489 (1996)). 

EPA also regulates pesticides under 

FIFRA, (7 U.S.C. 136 et seq). While the 

FFDCA authorizes the establishment of 

legal limits for pesticide residues in 

food, FIFRA requires the approval of 

pesticides prior to their sale and 

distribution, (7 U.S.C. 136a(a)), and 

establishes a registration regime for 

regulating the use of pesticides. FIFRA 

regulates pesticide use in conjunction 

with its registration scheme by requiring 

EPA review and approval of pesticide 

labels and specifying that use of a 

pesticide inconsistent with its label is a 

violation of Federal law. (7 U.S.C. 

136j(a)(2)(G)). In the FQPA, Congress 

integrated action under the two statutes 

by requiring that the safety standard 

under the FFDCA be used as a criterion 

in FIFRA registration actions as to 

pesticide uses which result in dietary 

risk from residues in or on food, (7 

U.S.C. 136(bb)), and directing that EPA 

coordinate, to the extent practicable, 

revocations of tolerances with pesticide 

cancellations under FIFRA. (21 U.S.C. 

346a(l)(1)). 

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)). Section 408(b)(2)(D) 

directs EPA, in making a safety 

determination, to: 

consider, among other relevant 

factors- ... 

(v) available information 

concerning the cumulative effects of 

such residues and other substances 

that have a common mechanism of 

toxicity; 

(vi) available information 

concerning the aggregate exposure 

levels of consumers (and major 

identifiable subgroups of 

consumers) to the pesticide 

chemical residue and to other 

related substances, including 

dietary exposure under the 

tolerance and all other tolerances in 

effect for the pesticide chemical 

residue, and exposure from other 

non-occupational sources; 

(viii) such information as the 

Administrator may require on 

whether the pesticide chemical may 

have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen or 

other endocrine effects. ... EPA 

must also consider, in evaluating 

the safety of tolerances, ‘‘safety 

factors which . . . are generally 

recognized as appropriate for the 

use of animal experimentation 

data.’’ 

(21 U.S.C. 346a(b)(2)(D)(ix). 

Risks to infants and children are given 

special consideration. Specifically, 

section 408(b)(2)(C) states that EPA: 

shall assess the risk of the pesticide 

chemical based on— ... 

(II) available information 

concerning the special 

susceptibility of infants and 

children to the pesticide chemical 

residues, including neurological 

differences between infants and 

children and adults, and effects of 

in utero exposure to pesticide 

chemicals; and 

(III) available information 

concerning the cumulative effects 

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on infants and children of such 

residues and other substances that 

have a common mechanism of 

toxicity. ... 

This provision also creates a 

presumptive additional safety factor for 

the protection of infants and children. 

Specifically, 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.’’ 

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 either establishing, 

amending, or revoking the tolerance or 

denying the petition, any person may 

file objections with EPA and seek an 

evidentiary hearing on those objections. 

(21 U.S.C. 346a(g)(2)). Objections and 

hearing requests must be filed within 60 

days. (Id.). The statute provides that 

EPA shall ‘‘hold a public evidentiary 

hearing if and to the extent the 

Administrator determines that such a 

public hearing is necessary to receive 

factual evidence relevant to material 

issues of fact raised by the objections.’’ 

(21 U.S.C. 346a(g)(2)(B). EPA 

regulations make clear that hearings will 

only be granted where it is shown that 

there is ‘‘a genuine and substantial issue 

of fact,’’ the requestor has identified 

evidence ‘‘which, if established, resolve 

one or more of such issues in favor of 

the requestor,’’ and the issue is 

‘‘determinative’’ with regard to the relief 

requested. (40 CFR 178.32(b)). In 

addition, EPA regulations prescribe the 

form and manner of submissions for 

objections and for an evidentiary 

hearing. (40 CFR 178.25 and 178.27). 

EPA’s final order on the objections is 

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

346a(h)(1)). 

4. Tolerance reassessment and FIFRA 

reregistration. The FQPA required that 

EPA reassess the safety of all pesticide 

tolerances existing at the time of its 

enactment. (21 U.S.C. 346a(q)). EPA was 

given 10 years to reassess the 

approximately 10,000 tolerances in 

existence in 1996. In this reassessment, 

EPA was required to review existing 

pesticide tolerances under the new 

‘‘reasonable certainty that no harm will 

result’’ standard set forth in section 

408(b)(2)(A)(i). (21 U.S.C. 

346a(b)(2)(A)(i)). This reassessment was 

substantially completed by the August 

3, 2006 deadline. Tolerance 

reassessment was generally handled in 

conjunction with a similar program 

involving reregistration of pesticides 

under FIFRA. (7 U.S.C. 136a-1). 

Reassessment and reregistration 

decisions were generally combined in a 

document labeled a Reregistration 

Eligibility Decision (RED). 

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 dose-response 

analysis in test animals and ‘‘level of 

concern’’ with respect to human 

exposure to the pesticide; 

∑ Estimation of human exposure to the 

pesticide; and 

∑ Characterization of 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 

effects 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 cholinesterase), 

and behavioral or other gross effects 

identified through clinical observation 

and measurement. EPA examines 

whether adverse effects are caused by 

different durations of exposure ranging 

from short-term (e.g., acute) to longerterm (e.g., chronic) pesticide exposure, 

and different routes of exposure (oral, 

dermal, inhalation). EPA also evaluates 

potential adverse effects in different age 

groups. EPA requires testing for 

different durations and routes of 

exposure and different age groups in 

multiple species of laboratory animals 

(e.g., rat, mouse, dog, rabbit). 

EPA also considers whether the 

adverse effect has a threshold - a level 

below which exposure has no 

appreciable chance of causing the 

adverse effect. For 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 non-threshold effect. 

(Ref. 5 at 8–9). Because this matter 

involves a pesticide with threshold 

effects, assessment of non-threshold 

effects is not further discussed. 

Moreover, the toxic effects of carbaryl 

are short in duration (1 day or less) and, 

as such, long-term, chronic threshold 

effects are not discussed further here. 

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). 

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). Often, 

EPA will use the lowest NOAEL from 

the relevant available studies — for the 

duration and route for which risk is 

being assessed, as a starting point 

(called the Point of Departure (POD)) in 

estimating the level of concern for 

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56000 Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 

humans. (Ref. 5 at 9 (The POD is simply 

the ‘‘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 on the most sensitive endpoint as 

the POD when no NOAEL is identified 

in that study. Alternatively, in the 

absence of a NOAEL for the most 

sensitive adverse effect, EPA will use 

the LOAEL as the risk assessment POD, 

and determine an extrapolated NOAEL 

by dividing the LOAEL by an 

uncertainty factor. 

EPA is increasingly using modeling to 

ascertain what is referred to as a 

Benchmark Dose (BMD) as a substitute 

for a NOAEL in selecting a POD. In its 

revised assessment of carbaryl, EPA 

used a BMD approach for deriving the 

POD from the available rat toxicity 

studies. (Ref. 8). A benchmark dose, or 

BMD, is a point estimate along a doseresponse curve that corresponds to a 

specific response level. For example, a 

BMD10 represents a 10% change from 

the background level (the background 

level is typically derived from the 

control group). Generically, the 

direction of change from background 

can be an increase or a decrease 

depending on the biological parameter 

and the chemical of interest. In the case 

of carbaryl, a reduction in 

acetylcholinesterase (AChE) activity 

(referred to as ‘‘inhibition’’ of AChE) is 

the toxic effect of concern. In addition 

to a BMD, a ‘‘confidence limit’’ may also 

be calculated. Confidence limits express 

the uncertainty in a BMD that may be 

due to sampling and/or experimental 

error. The lower confidence limit on the 

dose used as the BMD is termed the 

BMDL, which the Agency uses as the 

POD. Use of the BMDL for deriving the 

POD rewards better experimental design 

and procedures that provide more 

precise estimates of the BMD, resulting 

in tighter confidence intervals. Use of 

the BMDL also helps ensure with high 

confidence (e.g., 95% confidence) that 

the selected percentage of AChE 

inhibition is not exceeded. 

Numerous scientific peer review 

panels over the last decade have 

supported the Agency’s application of 

the BMD approach as a scientifically 

supportable method for deriving PODs 

in human health risk assessment, and as 

an improvement over the historically 

applied approach of using NOAELs or 

LOAELs. The NOAEL/LOAEL approach 

does not account for the variability and 

uncertainty in the experimental results, 

which are due to characteristics of the 

study design, such as dose selection, 

dose spacing, and sample size. With the 

BMD approach, all the dose response 

data are used to derive a POD. 

Moreover, the response level used for 

setting regulatory limits can vary based 

on the chemical and/or type of toxic 

effect (Refs. 6, 7 and 8). 

The POD 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 

POD is at times used differently 

depending on whether the risk 

assessment addresses dietary or nondietary exposures. For dietary risks, 

EPA uses the POD to calculate an 

acceptable level of exposure or safe 

dose. This safe dose has been 

traditionally referred to as the reference 

dose (RfD). The RfD is defined as the 

risk assessment POD divided by all 

uncertainty/safety factors (UF/SFs) 

except those specific to FQPA. The 

Population Adjusted Dose (PAD), on the 

other hand, is defined as the POD 

divided by all UF/SFs, including those 

specific to FQPA. In cases where there 

are no UF/SFs specific to FQPA, the RfD 

and PAD are numerically identical. 

Typically, EPA uses a baseline safety/ 

uncertainty factor equal to 100. These 

factors include a factor of 10 (10X) 

where EPA is using data from laboratory 

animals (inter-species factor) to reflect 

potentially greater sensitivity in humans 

than laboratory animals and a factor of 

10X to account for potential variations 

in sensitivity among members of the 

human population (intra-species factor) 

as well as other unknowns. Additional 

uncertainty factors may be added to 

address data deficiencies or concerns 

raised by the existing data. Under the 

FQPA, a safety factor of 10X is 

presumptively applied to protect infants 

and children, unless reliable data 

support selection of a different factor. 

This FQPA safety factor largely replaces 

pre-FQPA EPA practice regarding 

additional safety factors. (Ref. 9 at 4– 

11). 

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)). EPA considers 

multiple routes of exposure (oral, 

dermal, and inhalation) and aggregates 

these exposures where scientifically 

appropriate. Because EPA exposure 

estimates are not involved in EPA’s 

determination of this matter, no further 

description of EPA exposure assessment 

practices is included. 

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, where appropriate, EPA 

aggregates exposures across different 

routes in characterizing risk. 

In estimating and describing the level 

of concern, the POD is at times used 

differently depending on whether the 

risk assessment addresses dietary or 

non-dietary exposures. For threshold 

risks, EPA estimates risk in one of two 

ways. Where EPA has calculated a RfD/ 

PAD, risk is estimated 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. Alternatively, EPA may 

express risk by comparing the Margin of 

Exposure (MOE) between estimated 

human exposure and the POD with the 

acceptable or target MOE. The 

acceptable or target MOE is the product 

of all applicable safety factors. To 

calculate the actual MOE for a pesticide, 

estimated human exposure to the 

pesticide is divided into the POD. In 

contrast to the RfD/PAD approach, the 

higher the MOE, the less risk posed by 

the pesticide. Accordingly, if the target 

MOE for a pesticide is 100, MOEs equal 

to or exceeding 100 would generally not 

be of concern. 

As a conceptual matter, the RfD/PAD 

and MOE approaches are fundamentally 

equivalent. For a given risk and given 

exposure of a pesticide, if exposure to 

a pesticide were found to be acceptable 

under an RfD/PAD analysis it would 

also pass under the MOE approach, and 

vice-versa. However, for any specific 

pesticide, risk assessments for different 

exposure durations or routes may yield 

different results. This is a function not 

of the choice of the RfD/PAD or MOE 

approach but of the fact that the levels 

of concern and the levels of exposure 

may differ depending on the duration 

and route of exposure. 

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 

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a critical role in the process. This is true 

for traditional 10X safety factors to 

account for potential differences 

between animals and humans when 

relying on studies in animals (interspecies safety factor) and potential 

differences among humans (intraspecies safety factor) as well as the 

FQPA 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 a 10X safety factor to the 10X 

inter-species and 10X intra-species 

safety factors. (Ref. 9 at 4, 11). Thus, 

EPA generally refers to the 10X 

children’s safety factor as a presumptive 

or default 10X factor. EPA has also 

made clear, however, that this 

presumption or default in favor of the 

10X children’ safety 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). 

3. EPA policy on cholinesterase 

inhibition. Carbaryl is a member of the 

N-methyl carbamate class of pesticides. 

Each member of this class shares the 

ability to inhibit the enzyme, 

acetylcholinesterase, leading to 

neurotoxicity. N-methyl carbamate 

neurotoxicity is characterized by the 

rapid onset (often 15–30 minutes) and 

rapid recovery (within hours). 

Cholinesterase inhibition is a disruption 

of the normal process in the body by 

which the nervous system chemically 

communicates with muscles and glands. 

Communication between nerve cells 

and a target cell (i.e., another nerve cell, 

a muscle fiber, or a gland) is facilitated 

by the chemical, acetylcholine. When a 

nerve cell is stimulated it releases 

acetylcholine into the synapse (or space) 

between the nerve cell and the target 

cell. The released acetylcholine binds to 

receptors in the target cell, stimulating 

the target cell in turn. As EPA has 

explained, ‘‘the end result of the 

stimulation of cholinergic pathway(s) 

includes, for example, the contraction of 

smooth (e.g., in the gastrointestinal 

tract) or skeletal muscle, changes in 

heart rate or glandular secretion (e.g., 

sweat glands) or communication 

between nerve cells in the brain or in 

the autonomic ganglia of the peripheral 

nervous system.’’ (Ref. 10 at 10). 

Acetylcholinesterase (AChE) is an 

enzyme that breaks down acetylcholine 

and terminates its stimulating action in 

the synapse between nerve cells and 

target cells. When AChE is inhibited, 

acetylcholine builds up, prolonging the 

stimulation of the target cell. This 

excessive stimulation potentially results 

in a broad range of adverse effects on 

many bodily functions including muscle 

cramping or paralysis, excessive 

glandular secretions, or effects on 

learning, memory, or other behavioral 

parameters. Depending on the degree of 

inhibition these effects can be serious, 

even fatal. 

EPA’s cholinesterase inhibition policy 

statement explains EPA’s approach to 

evaluating the risks posed by 

cholinesterase-inhibiting pesticides 

such as carbaryl. (Ref. 10). The policy 

focuses on three types of effects 

associated with cholinesteraseinhibiting pesticides that may be 

assessed in animal and human 

toxicological studies: (1) physiological 

and behavioral/functional effects; (2) 

cholinesterase inhibition in the central 

and peripheral nervous system; and (3) 

cholinesterase inhibition in red blood 

cells and blood plasma. The policy 

discusses how such data should be 

integrated in deriving a POD for a 

cholinesterase-inhibiting pesticide. 

EPA uses a weight-of-the-evidence 

approach to determine the toxic effect 

that will serve as the appropriate POD 

for a risk assessment for AChE 

inhibiting pesticides, such as carbaryl 

(Id). The neurotoxicity that is associated 

with these pesticides can occur in both 

the central (brain) and the peripheral 

nervous system. In its weight-of-theevidence analysis, EPA reviews data, 

such as AChE inhibition data from the 

brain, peripheral tissues and blood (e.g., 

red blood cell (RBC) or plasma), in 

addition to data on clinical signs and 

other functional effects related to AChE 

inhibition. Based on these data, EPA 

selects the most appropriate effect on 

which to regulate; such effects can 

include clinical signs of AChE 

inhibition, central or peripheral nervous 

tissue measurements of AChE 

inhibition, or RBC AChE measures (Id). 

Although RBC AChE inhibition is not 

adverse in itself, it is a surrogate for 

inhibition in peripheral tissues when 

peripheral data are not available. As 

such, RBC AChE inhibition provides an 

indirect indication of adverse effects on 

the nervous system (Id.). Measures of 

AChE inhibition in the peripheral 

nervous system are very rare for Nmethyl carbamate pesticides and no 

such peripheral data exists for carbaryl. 

For these reasons, other state and 

national agencies such as California, 

Washington, Canada, the European 

Union, as well as the World Health 

Organization (WHO), all use blood 

measures in human health risk 

assessment and/or worker safety 

monitoring programs. 

4. EPA policy on assessing risk from 

cumulative effects from pesticides with 

a common mechanism of toxicity. 

Section 408(b)(2)(D) of the FFDCA 

directs EPA to consider available 

information on the cumulative effects 

on human health resulting from 

exposure to multiple pesticide 

chemicals that have a common 

mechanism of toxicity. EPA begins a 

cumulative risk assessment by 

identifying a group of pesticides, called 

a common mechanism group, that bring 

about the same toxic effect by a common 

mechanism of toxicity. Pesticides share 

a common mechanism of toxicity if they 

act the same way in the body; that is, 

if the same toxic effect occurs in the 

same organ or tissue by essentially the 

same sequence of major biochemical 

events. 

There are many steps involved in 

quantitatively assessing the potential 

human health risk associated with 

exposure to the N-methyl carbamate 

pesticides. The complex series of 

evaluations involve hazard and doseresponse analyses; assessments of food, 

drinking water, residential/nonoccupational exposures; combining 

exposures to produce a cumulative risk 

estimate; and risk characterization. 

Given the complexity of the analyses, 

EPA’s policy is to only conduct a 

cumulative assessment if each of the 

individual chemicals in the assessment 

has been determined to be ‘‘safe,’’ based 

on aggregate exposures only to that 

individual chemical. 

IV. Regulatory History of Carbaryl 

A. In General 

Carbaryl is a carbamate insecticide 

and molluscide that was first registered 

in 1959 for use on cotton. Carbaryl has 

many trade names, but is most 

commonly known as Sevin®. At the 

time carbaryl was assessed for purposes 

of reregistration, carbaryl was registered 

for use on over 400 agricultural and 

non-agricultural use sites, and there 

were more than 140 tolerances for 

carbaryl in the Code of Federal 

Regulations (40 CFR 180.169). The 

primary risk of concern from exposure 

to carbaryl is acute neurotoxic effects. 

Carbaryl is a member of the N-methyl 

carbamate class of pesticides. This 

group shares a common mechanism of 

toxicity; namely, the ability to inhibit 

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the enzyme acetylcholinesterase (AChE) 

through carbamylation of the active site. 

Pesticides included is this group, other 

than carbaryl, are aldicarb, carbofuran, 

formetanate hydrochloride, methiocarb, 

methomyl, oxamyl, pirimicarb, 

propoxur, and thiodicarb. 

B. FFDCA Tolerance Reassessment and 

FIFRA Pesticide Reregistration 

1. Interim reregistration eligibility 

decision. EPA completed an interim 

reregistration eligibility decision (IRED) 

for carbaryl on June 30, 2003 (2003 

IRED). The decision on reregistration 

was treated as interim because of 

carbaryl’s membership in the N-methyl 

carbamate cumulative group. When EPA 

determines that a pesticide shares a 

common mechanism of toxicity with 

other substances, EPA cannot complete 

either the assessment or reassessment of 

a tolerance or a registration or 

reregistration determination until it has 

assessed available information regarding 

exposures to the other substances. For 

these pesticides, EPA’s practice is to 

issue an IRED pending completion of 

the tolerance reassessment activities. An 

IRED memorializes EPA’s determination 

on a narrowly defined issue: Whether a 

given active ingredient alone is eligible 

for reregistration under FIFRA and 

tolerance reassessment under the 

FFDCA, pending a cumulative 

assessment for pesticides sharing a 

common mechanism of toxicity. 

Although EPA found in the 2003 IRED 

that carbaryl dietary exposures from 

food and water were below the relevant 

safe doses (i.e., the acute PAD (aPAD) 

and chronic PAD (cPAD)), EPA 

concluded that numerous residential 

uses posed a risk of concern. 

Accordingly, the 2003 IRED specified 

various changes to the carbaryl 

registration to address these risks, 

including: Canceling liquid broadcast 

applications to home lawns pending 

EPA review of pharmacokinetic data to 

refine post-application risk estimates; 

repackaging home garden/ornamental 

dust products in ready-to-use shaker can 

containers, with no more than 0.05 lbs. 

active ingredient (ai) per container; 

canceling the following uses and 

application methods — all pet uses 

(dusts and liquids) except collars, 

aerosol products for various uses, belly 

grinder applications of granular and bait 

products for lawns, hand applications of 

granular, and bait products for 

ornamentals and gardens. 

2. Amended interim reregistration 

eligibility decision. The Agency 

amended the 2003 IRED on October 22, 

2004 (2004 Amended IRED), and 

published a formal Notice of 

Availability for the document, which 

provided for a 60–day public comment 

period. EPA received numerous 

comments on the carbaryl 2004 

Amended IRED, including the NRDC 

petition requesting that EPA cancel all 

carbaryl registrations and revoke all 

tolerances. The mitigation detailed in 

the 2004 Amended IRED for residential 

uses included limiting applications of 

liquid formulations to residential turf 

areas to spot treatment only; requiring 

dust formulations to be packaged in a 

ready-to-use container containing no 

more than 0.05 lbs ai/container; and 

cancelation of all pet uses, except for 

carbaryl treated pet collars. On March 9, 

2005, EPA issued a cancellation order 

for the liquid broadcast use of carbaryl 

on residential turf to address postapplication risk to toddlers. (Ref. 11). In 

March 2005, EPA also issued generic 

and product-specific data call-ins (DCIs) 

for carbaryl. The carbaryl generic DCI 

required several studies of the active 

ingredient carbaryl, including 

additional toxicology, worker exposure 

monitoring, and environmental fate 

data. The product-specific DCI required 

acute toxicity and product chemistry 

data for all pesticide products 

containing carbaryl; these data are being 

used for product labeling. EPA has 

received numerous studies in response 

to these DCIs, and, where appropriate, 

these studies were considered in the 

tolerance reassessment. 

In response to the DCIs, many 

carbaryl registrants chose to voluntarily 

cancel their carbaryl products, rather 

than revise their labels or conduct 

studies to support these products. EPA 

published a notice of receipt of these 

requests in the Federal Register on 

October 28, 2005 (70 FR 62112), 

followed by a cancellation order issued 

on July 3, 2006. One technical 

registrant, Burlington Scientific, chose 

to cancel their technical product, 

leaving Bayer CropScience (Bayer) as 

the sole technical registrant for carbaryl. 

Approximately two-thirds of all of the 

carbaryl products registered at the time 

of the 2003 IRED have been canceled 

through this process. 

Bayer subsequently requested that all 

of their carbaryl registrations be 

amended to delete the following uses: 

carbaryl use in or on pea and bean, 

succulent shelled (subgroup 6B); millet; 

wheat; pre-plant root dip for sweet 

potato; pre-plant root dip/drench for 

nursery stocks, vegetable transplants, 

bedding plants, and foliage plants; use 

of granular formulations on leafy 

vegetables (except Brassica); ultra low 

volume (ULV) application for adult 

mosquito control; and dust applications 

in agriculture. EPA notified all affected 

registrants that these uses and 

application methods must be deleted 

from their carbaryl product labels. EPA 

identified 34 product labels from 14 

registrants (other than Bayer) bearing 

these end uses. All of these registrants 

requested that their affected carbaryl 

product registrations be amended to 

delete these uses. EPA published 

Notices of receipt of these requests from 

Bayer and all 14 registrants in the 

Federal Register on August 20, 2008 

and October 15, 2008. On March 18, 

2009, the Agency published an order 

granting the requests to delete uses (74 

FR 11553). Most recently, in a letter 

dated September 30, 2009, Wellmark 

International submitted a request to 

voluntarily cancel its pet collar 

registrations pursuant to section 6(f) of 

FIFRA (74 FR 54045, October 21, 2009). 

These are the only carbaryl pet collar 

registrations and the last remaining pet 

product registrations for carbaryl. EPA 

issued its final order cancelling carbaryl 

registrations for pet collar uses on 

December 16, 2009. (74 FR 66642, 

December 16, 2009). 

3. Reregistration eligibility decision. 

As noted, the reregistration eligibility 

decision had to remain interim in nature 

until the N-methyl carbamate 

cumulative risk assessment was 

completed. That assessment was issued 

on September 26, 2007, and EPA 

concluded that the cumulative risks 

associated with the N-methyl carbamate 

pesticides meet the safety standard set 

forth in section 408(b)(2) of the FFDCA, 

provided that the mitigation specified in 

the N-methyl carbamate cumulative risk 

assessment is implemented, such as 

cancellation of all uses of carbofuran, 

termination of methomyl use on grapes, 

etc. EPA has therefore terminated the 

tolerance reassessment process under 

408(q) of the FFDCA. (See Ref. 12 for 

additional information). 

In conjunction with the N-methyl 

carbamate cumulative risk assessment, 

EPA completed a RED for carbaryl on 

September 24, 2007 (the RED was issued 

on October 17, 2007 with a formal 

Notice of Availability in the Federal 

Register (72 FR 58844)). (Ref. 12). In 

addition to relying on the N-methyl 

carbamate cumulative risk assessment to 

determine that the cumulative effects 

from exposure to all N-methyl 

carbamate residues, including carbaryl, 

was safe, the carbaryl RED relied upon 

the revised assessments and the 

mitigation that had already been 

implemented (e.g., cancellation of pet 

uses except for collars). Additionally, 

the RED included additional mitigation 

with respect to granular turf products 

for residential use; namely, that product 

labels direct users to water the product 

in immediately after application. EPA 

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subsequently completed an addendum 

to the carbaryl RED, dated August 25, 

2008, which incorporated the results of 

a revised occupational risk assessment 

and modified mitigation measures for 

the protection of workers. The Agency 

issued a Notice of Availability for the 

RED addendum in the October 29, 2008 

Federal Register (73 FR 64317). 

4. Risk assessment issues with the 

IRED and RED relevant to NRDC 

petition—a. selection of POD. When 

deriving Points of Departure and 

assigning uncertainty/safety factors in 

risk assessment, EPA looks at all the 

appropriate data available at a given 

time. In cases when new data become 

available improving the quality of the 

overall toxicological database, it is 

typical practice to re-consider previous 

decisions of the most appropriate 

Point(s) of Departure and uncertainty 

factors. Specific to carbaryl, Points of 

Departures and uncertainty/safety 

factors have changed over time as new 

data have become available to fill data 

gaps, provide additional information on 

existing data, and describe the effects in 

juvenile animals. 

For the 2003 IRED and 2004 Amended 

IRED, the POD for acute exposure was 

from a developmental neurotoxicity 

(DNT) study. The POD used for risk 

assessment was 1 milligrams/kilogram/ 

day (mg/kg/day) based upon the results 

of the DNT study. In the DNT study the 

LOAEL was 10 mg/kg/day based upon 

functional observational changes 

(pinpoint pupils, tremors, and gait 

abnormalities). Also occurring in this 

study were morphometric changes in 

the brain with a LOAEL of 10 mg/kg/ 

day: bilateral decrease in the size of the 

forebrain in adult males; a bilateral 

decrease in the length of the cerebella in 

female pups; and a bilateral increase in 

the length of the cerebella in female 

adults. A NOAEL for these effects was 

not identified in the study because a 

morphometric analysis was conducted 

in only the control and high-dose 

groups (10 mg/kg/day), but not in lowdose (0.1 mg/kg/day) or mid-dose (1.0 

mg/kg/day) groups. Initially, upon 

review of the data, EPA had requested 

that morphometric analysis of the lowdose and mid-dose groups be 

conducted, but this was not possible 

because the brain tissues had dried 

during the preservation process. 

Nonetheless, EPA determined that the 

developmental NOAEL was likely 1 mg/ 

kg/day. This conclusion was based on 

the finding that the morphometric 

changes, although statistically 

significant, were minimal in nature and, 

therefore, judged not likely to be present 

at the mid-dose of 1 mg/kg/day. (Refs. 

13, 14, and 15). 

Subsequently, in November of 2006, 

OPP received data from a carbaryl 

comparative cholinesterase assay study 

(CCA study) performed by EPA’s Office 

of Research and Development. CCA 

studies are specially designed toxicity 

studies that evaluate comparative 

sensitivity in adult and juvenile rats 

with respect to inhibition of 

cholinesterase activity. In the case of the 

carbaryl CCA study, the juvenile rats 

were aged post-natal day 11 and 17 

(PND11 and PND17). 

In the carbaryl CCA, a time course 

study was first conducted to determine 

the time to peak ChE effects followed by 

a dose-response study where rats were 

dosed by oral gavage with corn oil or 3, 

7.5, 15, or 30 mg carbaryl/kg body 

weight. All ages received the same dose 

so as to better compare the effects across 

ages. The dose was given at 2 ml/kg. 

Therefore, the dosing solutions were 0, 

1.5, 3.75, 7.5, or 15 mg/ml. In 2007, EPA 

conducted a BMD analysis for the 

carbaryl CCA study, using the same 

modeling methodology used in the Nmethyl carbamate cumulative risk 

assessment. This BMD analysis 

demonstrated sensitivity of PND11 and 

PND17 pups compared to adult ORD 

ChE data. Previously, in 2005 and in 

support of the N-methyl carbamate 

cumulative risk assessment, the Agency 

also conducted a BMD analysis of brain 

and RBC cholinesterase inhibition in rat 

oral toxicity studies for adults. (Ref. 16, 

see also Refs. 17 and 18). The BMD10 is 

the estimated benchmark doses that 

results in 10% cholinesterase inhibition 

(a level generally regarded as not an 

adverse effect), and the BMDL10 is the 

lower 95% confidence interval on the 

BMD10, for the data evaluated. 

Generally, the BMD10 is used to 

compare across compartments and 

across ages but the BMDL10 is used as 

the POD. The results of the study are 

presented in the following table in terms 

of the BMD10 and BMDL10: 

Age 

Brain (mg/kg) RBC (mg/kg 

BMD10 BMDL10 BMD BMDL10

PND11 1.46 1.14 1.11 0.78 

PND17 3.00 2.37 1.41 1.05 

Adults 2.63 2.03 0.96 0.73 

As the table shows, juvenile 11–day 

old (PND11) pups were 1.8 times more 

sensitive to inhibition of brain 

cholinesterase than adult rats in terms 

of BMDs. The BMD analyses show that 

the brain BMD for pups is protective of 

adults since the pup BMD values are 

lower than adult values. For the red 

blood cell cholinesterase (RBC ChE) 

compartment, the RBC BMD10 in PND11 

pups is similar to that in adults. 

Although the RBC BMDL10 for PND11 

pups is numerically lower (0.8 mg/kg) 

than the BMDL10 for PND11 brain AChE 

inhibition (1.1 mg/kg), the magnitude of 

this difference is not biologically 

meaningful, particularly in light of the 

similarity in BMD10s, and considering 

the higher variability typically seen in 

RBC measurements relative to brain. 

Brain represents the target tissue for the 

N-methyl carbamates as opposed to 

using a surrogate measure (RBC) and the 

brain BMDL10 of 1.1 mg/kg would be 

protective of both central nervous 

system and peripheral nervous system 

effects. (Refs. 17 and 18). 

For the carbaryl risk assessment, the 

BMDL10 for inhibition of brain 

cholinesterase in PND11 juveniles from 

the CCA study was chosen as the most 

sensitive and appropriate POD for 

calculating a safe dose instead of using 

an extrapolated NOAEL from the DNT 

study. Several factors were critical to 

that determination. First, the CCA study 

is considered a sentinel study for the Nmethyl carbamates as it evaluates the 

most sensitive endpoint (cholinesterase 

inhibition) in the most sensitive age 

group (PND11) at the time of peak effect. 

For each N-methyl carbamate with a 

valid CCA study, this study is being 

used in the risk assessment to inform 

the children’s safety factor or the POD. 

EPA has high confidence in the quality 

of the data from the carbaryl study 

because it used a broad range of doses 

and used the radiometric method of 

measuring AChE inhibition. (Ref. 19). 

The radiometric method for assaying 

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1Two values are provided for males/females. 

ACHe inhibition provides the most 

appropriate method for measuring 

cholinesterase inhibition due to Nmethyl carbamate exposure because 

factors (i.e., assay temperature, dilution, 

and incubation time) which promote 

reversibility are minimized. 

Second, gavage studies, such as the 

CCA study, are the preferred and most 

sensitive studies for carbaryl. The 

toxicity profile of carbaryl and other Nmethyl carbamates is characterized by a 

rapid onset of toxicity with a peak time 

of effect around 15 to 60 minutes and 

rapid recovery (typical half-lives in 

adult rats are 1 to 2 hours). This pattern 

of toxicity is shown in Figure 1 for 

carbaryl. 

With N-methyl carbamates, due to 

rapid recovery, toxicity does not 

accumulate in juveniles or adults with 

repeated exposures. As such, EPA is 

most concerned about acute effects, 

particularly those which occur at the 

peak time of effect. The Agency has 

found for these pesticides that acute 

studies, particularly via gavage 

administration, provide the most 

sensitive effects (i.e., more health 

protective) for risk assessment. 

Specifically, acute gavage studies 

provide more sensitive effects than 

studies administered in the diet, even 

studies of much longer durations. For 

example, the NOAEL and LOAEL for 

RBC AChE inhibition in the carbaryl 

dietary 2–year rat chronic/ 

carcinogenicity study are 10/121 mg/kg/ 

day and 60.2/78.6 mg/kg/day in adult 

rats, whereas the BMD10/BMDL10 for 

RBC AChE inhibition in adult rats in 

acute gavage studies are 0.96 and 0.73 

mg/kg. Based on this comparison, the 

acute gavage study provides toxicity 

values almost tenfold more sensitive 

than in the 2–year feeding study. 

This pattern of toxicity is somewhat 

unique to this class of pesticides and 

can be attributed to the pharmacokinetic 

and pharmacodynamic properties of Nmethyl carbamates, like carbaryl. The 

parent active ingredient, carbaryl, is the 

toxicologically active compound. As 

such, no metabolic activation is 

required; instead, metabolism results in 

detoxification of carbaryl. As evidenced 

by the rapid onset of toxicity, these 

pesticides are rapidly absorbed, 

distributed, and cleared from the body. 

For this class of pesticides, 

neurotoxicity is correlated to peak 

concentrations of carbaryl. Specifically, 

brain tissue levels and inhibition of 

brain AChE at the time of peak effect are 

highly correlated. In dietary 

administration studies like the 2–year 

study and the DNT study, rats are 

exposed to carbaryl over several hours 

of feeding. This is in contrast to a bolus 

dose in gavage studies where the entire 

dose is given at one time. In the dietary 

studies, the total administered dose of 

carbaryl consumed may be equal or 

even higher than the gavage dose. 

However, it is the internal dose of 

carbaryl at the target tissues which is 

related to the magnitude to toxicity. In 

the dietary studies, due to the rapid 

metabolism and clearance, carbaryl does 

not reach a peak level like that in gavage 

studies at the target tissues and thus the 

degree of toxicity in dietary studies is 

far less than that for gavage studies. As 

a result, acute gavage studies tend to be 

far more sensitive than dietary studies 

for N-methyl carbamates. This is the 

case for carbaryl as shown by the high 

quality and sensitive data from the CCA 

study. 

Finally, the changes in brain 

morphometrics (10 mg/kg) from the 

DNT study originally used in the POD 

derivation were determined to be a 

marginal effect not consistently seen in 

carbarmate pesticides. (See Unit 

IV.B.4.b. for a full discussion of EPA’s 

review of the DNT study.) Although a 

10X uncertainty factor was originally 

applied to the marginal brain 

morphometric endpoint, the real 

NOAEL is likely greater than 1 mg/kg 

and less than 10 mg/kg. 

In any event, the extrapolated NOAEL 

from the DNT study is essentially 


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equivalent to the BMDL10 for PND11 

juveniles in the CCA study (i.e., 1 mg/ 

kg/day as compared to 1.1 mg/kg/day). 

As explained below, if the LOAEL from 

the DNT was used in calculating a safe 

dose, EPA would retain a children’s 

safety factor of no greater than 10X due 

to the lack of a NOAEL in that study. 

Retention of a children’s safety factor of 

10X would make the extrapolated 

NOAEL for the DNT study essentially 

equivalent to the BMDL10 for PND11 

juveniles in the CCA study (i.e., 1 mg/ 

kg/day as compared to 1.1 mg/kg/day). 

b. Children’s safety factor. With 

respect to the children’s safety factor, in 

preliminary reviews undertaken in 1999 

and 2001, EPA initially retained the full 

10X safety factor for carbaryl. The 

reasons for retaining the 10X children’s 

safety factor were that EPA was missing 

a two-generation reproduction study for 

carbaryl and the DNT study showed 

changes in brain morphometric 

measurements of the offspring which 

raised concerns. The data from the DNT 

study showed that for the first 

generation pups, there were no 

treatment-related effects on pup weight, 

pup survival indices, developmental 

landmarks (tooth eruption and eye 

opening), Functional Observational 

Battery (FOB) measurements or motor 

activity assessments. There were also no 

treatment related effects on brain weight 

and gross or microscopic pathology. 

There were, however, changes noted in 

brain morphometric measurements at 

the high dose (10 mg/kg/day): Bilateral 

decrease in the size of the forebrain in 

adult males; a bilateral decrease in the 

length of the cerebella in female pups; 

and a bilateral increase in the length of 

the cerebella in female adults. EPA 

requested that a morphometric analysis 

of the low-dose and mid-dose groups be 

conducted, but this was not possible 

because brain samples had not been 

prepared for measurement and the 

tissues had dried during the 

preservation process. At the time, EPA 

found these changes at the high dose to 

be significant. (See generally Refs. 20, 

21, 22, 23, 24, 25 and 26). 

When new information became 

available in 2002, EPA removed the 10X 

safety factor for acute dietary and shortand intermediate-term exposures. (Refs. 

13, 14 and 15). Not only did EPA 

receive a new two-generation 

reproduction study (and therefore no 

longer had any data gaps) but EPA also 

obtained new brain morphometric 

measurements from the DNT study for 

the control and high-dose groups. The 

new measurements demonstrated that 

even at the high dose, the morphometric 

changes, although statistically 

significant, were minimal in nature. 

This is consistent with the DNT study 

results for other N-methyl carbamates 

(aldicarb and carbofuran), which did not 

show any changes in morphometrics. In 

addition, the DNTs available for all 

three N-methyl carbamates have not 

shown any long-term effects, including 

effects on behavior. The Agency is also 

not aware of any literature studies that 

have shown any changes in brain 

histopathology following N-methyl 

carbamate exposure to animals of any 

age. Based on this information, EPA 

concluded that the brain morphometic 

effects were not likely to be present at 

the mid-dose. (Refs. 13, 14 and 15). 

Because the developmental effects in 

the DNT were now well-characterized 

and the evidence strongly indicated that 

no brain morphometric changes would 

have been present at the mid-dose (1 

mg/kg/day), EPA determined that the 

children’s safety factor was not needed. 

In addition, there were no concerns or 

residual uncertainties for pre- and/or 

postnatal toxicity from other carbaryl 

development studies. 

After EPA received the CCA study in 

2006, it modified its decision on the 

children’s safety factor slightly. As 

explained above, the BMDL10 for PND11 

juveniles from the CCA study was 

chosen for the POD in calculating a safe 

dose. Because (1) EPA had a complete 

data set for carbaryl including high 

quality data comparing the relative 

sensitivity of adults and the young, (2) 

the effects in the young had been wellcharacterized, and (3) the most sensitive 

effect in the young (the BMDL10 from 

the CCA study) was being used to 

calculate the safe dose (i.e., the BMDL10

was divided by inter- and intra-species 

safety factors), EPA determined that a 

children’s safety factor was not needed 

for risk assessments based on the CCA 

study. Where carbaryl assessments 

relied on other data not involving the 

testing of juveniles, EPA retained a 

children’s safety factor of 1.8X reflecting 

the degree of sensitivity of the young 

observed in the CCA study. 

c. Calculation of safe dose/aPAD for 

carbaryl. For dietary risks, EPA 

calculated the aPAD by dividing the 

dietary POD (the BMDL10 for PND11 

juveniles in the CCA study) by the interspecies and intra-species safety factors 

(100X) to yield a value of 0.01 mg/kg. 

For dermal risks, instead of calculating 

an aPAD, EPA assessed risk under a 

MOE approach. The acceptable or target 

MOE was calculated using a POD of 86 

mg/kg. The POD was obtained by 

multiplying the BMDL10 of 30.56 mg/kg 

from the dermal toxicity study by 2.8, 

because in an in vitro dermal absorption 

study, rat skin was 2.8 times more 

permeable than human skin to carbaryl. 

The target MOE for risk assessment is 

100 for adults because the inter-species 

and intra-species safety factors total 

100X. The target MOE for risk 

assessment for infants and children is 

180 because, in addition to the 100X, 

the children’s safety factor is 1.8X. 

V. NRDC Petitions Regarding Carbaryl 

In the underlying petition, NRDC 

requested, among other things, that EPA 

cancel all carbaryl registrations and 

revoke all carbaryl tolerances. (Ref. 2). 

NRDC’s January 10, 2005 petition was 

submitted in the form of comments on 

and requests for changes to the Carbaryl 

Interim Reregistration Eligibility 

Decision published in the Federal 

Register on October 27, 2004, 70 FR 

62663. Nonetheless, in the introduction 

to the comments, NRDC included a 

statement that NRDC was also 

petitioning the Agency to revoke all 

carbaryl tolerances. Among other things, 

NRDC raised issues with the dietary 

assessment, and in particular, EPA’s 

drinking water assessment that 

supported the 2004 IRED decision. 

NRDC also raised concerns about the 

data surrounding EPA’s selection of a 

children’s safety factor. NRDC raised 

other safety factor issues, particularly as 

they relate to EPA use of the DNT study. 

NRDC’s petition also included generic 

disagreements with how EPA conducts 

its assessments. 

Subsequently, as part of its comments 

on the N-methyl carbamate cumulative 

assessment dated November 26, 2007, 

NRDC requested that EPA cancel all 

carbaryl pet collar registrations. (Ref. 3). 

The basis for NRDC’s petition to cancel 

all pet collar registrations rested on 

issues related to EPA’s assessment of 

cumulative effects under the FFDCA. In 

addition, NRDC incorporated by 

reference its earlier petition to revoke all 

carbaryl tolerances. Accordingly, EPA 

addressed the exposure issues raised in 

the subsequent pet collar petition as 

part of its response to the earlier 

petition to revoke all carbaryl 

tolerances. 

VI. EPA’s Response to the Petitions to 

Revoke Carbaryl Tolerances 

On October 29, 2008, EPA denied 

NRDC’s petition to revoke all pesticide 

tolerances for carbaryl under section 

408(d) of the FFDCA. (73 FR 64229). 

EPA’s Order also constituted a response 

to NRDC’s petition dated November 26, 

2007, to cancel carbaryl pet collar 

registrations submitted as part of 

NRDC’s comments on the N-methyl 

carbamate cumulative assessment. 

Again, EPA’s response to NRDC’s 

petition to cancel pet collar registrations 

was addressed in that Order because the 

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basis for the petition to cancel pet 

collars rested on issues related to EPA’s 

assessment of cumulative effects under 

the FFDCA. 

VII. NRDC’s Objections and Requests 

for Hearing 

On December 28, 2008, NRDC filed, 

pursuant to FFDCA section 408(g)(2), 

objections to EPA’s denial of its 

tolerance revocation petition and 

requested a hearing on those objections. 

As indicated above, NRDC’s objections 

and requests for hearing raise two main 

claims: (1) that EPA lacks reliable data 

to reduce the default tenfold safety 

factor and (2) that EPA’s exposure 

assessment for carbaryl is flawed and 

underestimates the exposure to children 

from pet collar uses. 

NRDC asserts that EPA failed to 

consider the available developmental 

neurotoxicity data and, therefore, 

unlawfully lowered the 10X children’s 

safety factor. Specifically, NRDC argues 

that the DNT study showed adverse 

developmental abnormalities in juvenile 

test animals at doses that had no effect 

on adult test animals. According to 

NRDC, this finding alone supports a full 

10X children’s safety factor. In addition, 

NRDC asserts that the DNT study did 

not identify a no-effect level in juvenile 

animals, supporting a further 3X safety 

factor. Thus, NRDC argues that EPA 

should have applied a 30X safety factor 

(10X for age sensitivity and 3X for 

failure to identify a no-effect level) to 

the end-point from the DNT to establish 

a final POD. According to NRDC, to do 

otherwise is ‘‘arbitrary and capricious, 

and contrary to the law.’’ (Ref. 1 at 8.) 

NRDC also asserts that EPA’s 

exposure assessment underestimates 

exposure to children from pet collar 

uses. NRDC further asserts that EPA 

relied on flawed studies and data, and, 

therefore, the Agency’s determination 

that tolerances are safe is improper. 

Among other things, NRDC argues that 

at the time of EPA’s determination, data 

on exposure from use of carbaryl in pet 

collars required by a 2005 DCI had not 

been submitted and that without the 

data EPA’s decision is ‘‘arbitrary and 

capricious and contrary to law.’’ (Ref. 1 

at 9). 

EPA regulations make clear that to be 

considered by the Administrator, a 

request for an evidentiary hearing must 

meet certain criteria. (40 CFR 178.27). 

One such criteria is that the request 

must include a copy of any report, 

article, survey, or other written 

document (or the pertinent pages 

thereof) upon which the objector relies 

to justify an evidentiary hearing, unless 

the document is an EPA document that 

is routinely available to any member of 

the public. 

In support of its request for a hearing, 

NRDC submitted the following 

documents as evidence that a hearing is 

appropriate: (1) Poisons on Pets Health 

Hazards from Flea and Tick Products, 

David Wallinga, MD., MPA and Linda 

Greer, Ph.D (NRDC, November 2000); 

and (2) Opportunities to Improve Data 

Quality and Children’s Health through 

the Food Quality Protection Act (EPAOIG Evaluation Report; Report # 2006– 

P-00009) (January 10, 2006). 

In addition, NRDC cited to the 

following EPA documents: (1) Amended 

Carbaryl Reregistration Eligibility 

Decision (RED) (August, 2008); (2) 

Carbaryl RED (September, 2007); (3) 

Carbaryl Interim RED (IRED) (June, 

2003); Organophosphate Cumulative 

Risk Assessment (2006); and, Revised NMethyl Carbamate Cumulative Risk 

Assessment [DRAFT] (2007). 

VIII. Response to Objections and 

Requests for Hearing 

A. Overview 

EPA denies NRDC’s objections as well 

as its hearing requests. NRDC’s hearing 

requests fail to meet the statutory and 

regulatory requirements for holding a 

hearing. NRDC has failed to proffer 

evidence on its hearing requests which 

would, if established, resolve one or 

more issues in its favor. Most 

significant, however, is that NRDC’s 

claims do not present genuine and 

substantial issues of fact. On the merits, 

NRDC’s objections with respect to the 

use of particular studies to establish an 

appropriate POD as well as appropriate 

safety factors are denied on scientific, 

policy, and legal grounds. Finally, 

NRDC’s objection with respect to EPA 

exposure assessment of pet collars is 

denied as moot because EPA has already 

issued a cancellation order under 

section 6(f) of FIFRA for the last 

remaining carbaryl pet collar product 

registration. 

The remainder of this Unit is 

organized in the following manner. Unit 

VIII.B. describes in greater detail the 

requirements pertaining to when it is 

appropriate to grant a hearing request. 

Unit VIII.C. examines the evidence 

proffered by NRDC in support of its 

hearing requests. Unit VIII.D. provides 

EPA’s response to the NRDC’s 

objections and hearing requests. 

B. The Standard for Granting an 

Evidentiary Hearing 

EPA has established regulations 

governing objections to tolerance 

rulemakings and tolerance petition 

denials and requests for hearings on 

those objections. (40 CFR part 178; 55 

FR 50291, December 5, 1990). Those 

regulations prescribe both the form and 

content of hearing requests and the 

standard under which EPA is to 

evaluate requests for an evidentiary 

hearing. 

As a threshold matter, EPA’s 

regulations limit the issues that can be 

raised in any hearing as well as in 

objections. In general, the provisions of 

FFDCA section 408(g) establish an 

informal rulemaking process that is 

governed by section 553 of the 

Administrative Procedure Act (APA) 

and the case law interpreting these 

requirements, except to the extent that 

section 408 provides otherwise. For 

example, section 408(d) allows the 

Agency to proceed to a final rule after 

publication of a submitted petition, 

rather than requiring publication of a 

proposal. In this regard, it is well 

established that the failure to raise 

factual or legal issues during the 

comment period of a rulemaking 

constitutes waiver of the issues in 

further proceedings. See generally, 74 

FR 59608, 59624–59629, November 18, 

2009. 

The fact that FFDCA section 408 in 

certain limited circumstances 

supplements the informal rulemaking 

with a hearing does not fundamentally 

alter the requirements applicable to 

informal rulemakings. Nor does it 

convert this into a formal rulemaking, 

subject to the exception in section 553 

of the APA. Section 408 of the FFDCA 

establishes a unique statutory structure 

with multiple procedural stages, and 

delegates to EPA the discretion to 

determine the implementation that best 

achieves the statutory objectives. 

Accordingly, EPA interprets the notice 

and comment rulemaking portion of the 

FFDCA section 408 process as an 

integral part of the FFDCA process, 

inextricably linked to the administrative 

hearing. The point of the rulemaking is 

to resolve the issues that can be 

resolved, and to identify and narrow 

any remaining issues for adjudication. 

Consequently, the administrative 

hearing does not represent an unlimited 

opportunity to supplement the record, 

particularly with information that was 

available during the comment period, 

but that commenters have chosen to 

withhold. 

EPA has consistently interpreted 

FFDCA section 408 in this fashion since 

the 1996 amendments. For example, 

EPA previously ruled that a petitioner 

could not raise new issues in filing 

objections to EPA’s denial of its original 

petition. (See 72 FR 39318, 39324, July 

18, 2007.) (EPA’s tolerance revocation 

procedures ‘‘are not some sort of ‘game,’ 

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whereby a party may petition to revoke 

a tolerance on one ground, and then, 

after the petition is denied, file 

objections to the denial based on an 

entirely new ground not relied upon by 

EPA in denying the petition.’’). EPA 

reasoned that new issues were not 

cognizable because they are ‘‘not an 

objection to the ‘provisions of the ... 

order [denying the petition]’ ’’ (Id.). 

Similarly, EPA denied a request for a 

hearing because the requestor had failed 

in their original petition to raise the 

claim asserted in their objection. (73 FR 

42683, 42696, July 23, 2008). EPA noted 

that although requestor did argue in its 

petition that EPA cannot make a safety 

finding without completing the 

endocrine screening program under 

FFDCA section 408(p), it did not assert 

claims regarding the endocrine data and 

the children’s safety factor. Citing its 

previous decision, EPA denied the 

objections and hearing requests as to the 

children’s safety factor. (Id.). In that 

same decision, EPA also denied a 

number of hearing requests on the 

ground that the requestor failed to 

proffer supporting evidence; EPA 

opined that a failure to offer evidence at 

an earlier stage of the administrative 

proceeding could not be cured by 

suddenly submitting such evidence 

with a hearing request. See 73 FR 42710 

(‘‘Presumably Congress created a multistage administrative process for 

resolution of tolerance petitions to give 

EPA the opportunity in the first stage of 

the proceedings to resolve factual 

issues, where possible, through a noticeand-comment process, prior to requiring 

EPA to hold a full evidentiary hearing, 

which can involve a substantial 

investment of resources by all parties 

taking part .... Accordingly, if a party 

were to withhold evidence from the first 

stage of a tolerance petition proceeding 

and only produce it as part of a request 

for a hearing on an objection, EPA might 

very likely determine that such an 

untimely submission of supporting 

evidence constituted an amendment to 

the original petition requiring a return 

to the first stage of the administrative 

proceeding (if, consideration of 

information that was previously 

available is appropriate at all’’)). Finally, 

in a recent decision, the United States 

Court of Appeals for the District of 

Columbia Circuit upheld this 

interpretation of section 408. See Nat’l 

Corn Growers Assn. v. EPA, No 09-1284, 

slip op. at 9-10 (C.A.D.C. July 23, 

2010)(‘‘We agree with EPA....[T]he 

comment period would be redundant 

and superfluous is the same concerns 

could be raised at the objections stage.’’) 

Nonetheless, EPA does not interpret 

the statute and regulations to preclude 

the submission of any new information 

as part of the objections phase. Such a 

position would in fact be inconsistent 

with EPA’s own regulations and past 

practice, which require that in order to 

support a hearing request, a party 

submit more than ‘‘mere allegations or 

denials.’’ (40 CFR 178.32(b)(2)). Rather, 

EPA’s interpretation in this regard is 

analogous to the determination of 

whether a final rule is the logical 

outgrowth of the proposal and the 

comments. Ultimately, EPA’s policy is 

merely that the objections phase does 

not present an opportunity for parties to 

begin the process entirely anew, by 

raising issues or information that could 

have been fairly presented as comments 

on the proposed rule or Notice of Filing 

of the pesticide petition. Nor is the 

statute’s additional procedural step an 

excuse to withhold information that was 

clearly available at the time of the 

rulemaking. 

As to the form and content of a 

hearing request, the regulations specify 

that a hearing request must include: (1) 

a statement of the factual issues on 

which a hearing is requested and the 

requestor’s contentions on those issues; 

(2) a copy of any report, article, or other 

written document ‘‘upon which the 

objector relies to justify an evidentiary 

hearing;’’ and (3) a summary of any 

other evidence relied upon to justify a 

hearing. (40 CFR 178.27). 

The standard for granting a hearing 

request is set forth in 40 CFR 178.32. 

That section provides that a hearing will 

be granted if EPA determines that the 

‘‘material submitted’’ shows all of the 

following: 

(1) There is a genuine and 

substantial issue of fact for 

resolution at a hearing. An 

evidentiary hearing will not be 

granted on issues of policy or law. 

(2) There is a reasonable possibility 

that available evidence identified 

by the requestor would, if 

established, resolve one or more of 

such issues in favor of the 

requestor, taking into account 

uncontested claims or facts to the 

contrary. An evidentiary hearing 

will not be granted on the basis of 

mere allegations, denials, or general 

descriptions of positions and 

contentions, nor if the 

Administrator concludes that the 

data and information submitted, 

even if accurate, would be 

insufficient to justify the factual 

determination urged. 

(3) Resolution of the factual issue(s) 

in the manner sought by the person 

requesting the hearing would be 

adequate to justify the action 

requested. An evidentiary hearing 

will not be granted on factual issues 

that are not determinative with 

respect to the action requested. For 

example, a hearing will not be 

granted if the Administrator 

concludes that the action would be 

the same even if the factual issue 

were resolved in the manner 

sought. 

(40 CFR 178.32(b)). 

This provision essentially imposes 

four requirements upon a hearing 

requestor. First, the requestor must 

show it is raising a question of fact, not 

one of law or policy. Hearings are for 

resolving factual issues not for debating 

law or policy questions. Second, the 

requestor must demonstrate that there is 

a genuine dispute as to the issue of fact. 

If the facts are undisputed or the record 

is clear that no genuine dispute exists, 

there is no need for a hearing. Third, the 

requestor must show that the disputed 

factual question is material, i.e., that it 

is outcome determinative with regard to 

the relief requested in the objections. 

Finally, the requestor must make a 

sufficient evidentiary proffer to 

demonstrate that there is a reasonable 

possibility that the issue could be 

resolved in favor of the requestor. 

Hearings are for the purpose of 

providing objectors with an opportunity 

to present evidence supporting their 

objections; as the regulation states, 

hearings will not be granted on the basis 

of ‘‘mere allegations, denials, or general 

descriptions of positions or 

contentions.’’ (40 CFR 178.32(b)(2)). 

EPA’s hearing request requirements 

are based heavily on FDA regulations 

establishing similar requirements for 

hearing requests filed under other 

provisions of the FFDCA. (53 FR 41126, 

41129, October 19, 1988). FDA 

pioneered the use of summary 

judgment-type procedures to limit 

hearings to disputed material factual 

issues and thereby conserve agency 

resources. FDA’s use of such procedures 

was upheld by the Supreme Court in 

1972, (Weinberger v. Hynson, Westcott & 

Dunning, Inc., 412 U.S. 609 (1973)), 

and, in 1975, FDA promulgated generic 

regulations establishing the standard for 

evaluating hearing requests. (40 FR 

22950, May 27, 1975). It is these 

regulations upon which EPA relied in 

promulgating its hearing regulations in 

1990. 

Unlike EPA, FDA has had numerous 

occasions to apply its regulations on 

hearing requests. FDA’s summary of the 

thrust of its regulations, which has been 

repeatedly published in the Federal 

Register in orders ruling on hearing 

requests over the last 26 years, is 

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instructive on the proper interpretation 

of the regulatory requirements. That 

summary states: 

A party seeking a hearing is 

required to meet a ‘threshold 

burden of tendering evidence 

suggesting the need for a hearing.’ 

[] An allegation that a hearing is 

necessary to sharpen the issues’ or 

fully develop the facts’ does not 

meet this test. If a hearing request 

fails to identify any evidence that 

would be the subject of a hearing, 

there is no point in holding one. 

A hearing request must not only 

contain evidence, but that evidence 

should raise a material issue of fact 

concerning which a meaningful 

hearing might be held. [] FDA need 

not grant a hearing in each case 

where an objection submits 

additional information or posits a 

novel interpretation of existing 

information. [] Stated another way, 

a hearing is justified only if the 

objections are made in good faith 

and if they ‘‘draw in question in a 

material way the underpinnings of 

the regulation at issue.’’ Finally, 

courts have uniformly recognized 

that a hearing need not be held to 

resolve questions of law or policy. 

(49 FR 6672, 6673, February 22, 1984; 

72 FR 39557, 39558, July 19, 2007) 

(citations omitted)). EPA has been 

guided by FDA’s application of its 

regulations in this proceeding. Congress 

confirmed EPA’s authority to use 

summary judgment-type procedures 

with hearing requests when it amended 

FFDCA section 408 in 1996. Although 

the statute had been silent on this issue 

previously, the FQPA added language 

specifying that when a hearing is 

requested, EPA ‘‘shall...’’ hold a public 

evidentiary hearing if and to the extent 

the Administrator determines that such 

a public hearing is necessary to receive 

factual evidence relevant to material 

issues of fact raised by the objections.’’ 

(21 U.S.C. 346a(g)(2)(B)). This language 

explicitly grants EPA broad discretion to 

deny a hearing. Specifically, the 

language in section 408 provides that 

EPA is to determine whether a hearing 

is ‘‘necessary to receive factual 

evidence’’ as well as whether the issues 

raised in objections are ‘‘material’’ issues 

of fact. Thus, even where evidence 

relevant to an issue of material fact is 

proffered (essentially the standard set 

forth in 40 CFR 178.32), EPA construes 

the statutory language as requiring it to 

hold a hearing only where EPA 

determines a hearing is necessary to 

receive proffered evidence. In other 

words, the statute grants EPA the 

discretion to determine that the issues 

could be resolved entirely on the basis 

of the existing written record. See 74 FR 

at 59627. 

C. Evidentiary Proffer by NRDC 

As noted above, the purpose for 

holding hearings is ‘‘to receive factual 

evidence.’’ (21 U.S.C. 346a(g)(2)(B); 53 

FR 41126, 41129, October 19, 1988 

(‘‘Hearings are for the purpose of 

gathering evidence on disputed factual 

issues . . . .’’)). A requestor must identify 

evidence relied upon to justify a hearing 

and either submit copies of that 

evidence or summarize it. (40 CFR 

178.27). After reviewing the proffer, 

EPA must find that there is a reasonable 

possibility that the proffered evidence, 

if established, would resolve one or 

more genuinely-disputed, material 

factual issues in a requestor’s favor. (40 

CFR 178.32(b)). Because a substantial 

portion of NRDC’s evidentiary proffer is 

deficient on its face, EPA finds it most 

efficient to preliminarily review the 

proffer before turning to the individual 

issues raised by NRDC. 

NRDC identifies the following as 

‘‘relevant documentation’’: Order 

denying NRDC’s petition to revoke 

tolerances (October 29, 2008); Amended 

Carbaryl Registration Eligibility 

Decision (RED) (August 2008); Carbaryl 

RED (September 2007); and Carbaryl 

Interim RED (2003 IRED) (June 2003). 

NRDC also includes a reference to 

information on EPA’s reregistration of 

carbaryl, available online at http:/ 

www.epa.gov/pesticides/reregistration/ 

carbaryl/. EPA assumes that these are 

the documents NRDC intends to proffer 

as evidence in support of its request for 

a hearing. 

In addition, throughout it objections 

and request for a hearing, NRDC 

includes footnotes with citations to 

additional documents. As a general 

matter, EPA assumes NRDC is doing so 

in the context of it supporting its 

objections, rather than as a proffer of 

evidence to justify a hearing. Indeed, 

merely citing to a document in a 

footnote does not constitute a proffer of 

evidence. Nevertheless, in an effort to 

address NRDC’s hearing request as 

comprehensibly as possible, EPA will 

address these footnote citations as well. 

In the future, however, NRDC would be 

well advised to make clear exactly what 

evidence it is proffering as a 

justification for its hearing request. 

The documents cited in footnotes 

generally fall into three categories. The 

first are EPA documents that can be 

grouped in the same category as the 

documents NRDC identified as ‘‘relevant 

documents.’’ These documents are: EPA 

Fact Sheet for Carbaryl (revised on 10/ 

22/04); EPA’s Organophospate 

Cumulative Risk Assessment (USEPA 

2006); EPA’s Revised N-Methyl 

Carbamate Cumulative Risk Assessment 

[DRAFT] (USEPA 2007). 

This group of EPA documents, 

combined with the other EPA 

documents identified by NRDC as 

‘‘relevant documents’’ (including 

‘‘[i]nformation on EPA’s reregistration of 

carbaryl [] available online at http:// 

www.epa.gov/pesticides/reregistration/ 

carbaryl/’’) do not present evidence of a 

genuinely-disputed, material issue of 

fact. (73 FR 42694–95, July 23, 2008) 

(citing to EPA decision-making record is 

vague and fails to identify new evidence 

which, if established, would resolve an 

issue in petitioner’s favor)). First, given 

that the purpose of a hearing is to gather 

or receive evidence, proffering evidence 

already considered and relied upon by 

EPA is not sufficient justification for 

holding a hearing. Second, as a matter 

of law, EPA does not understand how it 

can be argued that a proffer consisting 

of a general reference to the decisionmaking record—which EPA has found 

supports one result, could constitute 

evidence that if established would 

justify the opposite conclusion. Third, 

EPA concludes that the non-specific 

citation to numerous documents related 

to the multi-year process of conducting 

FIFRA reregistration and FFDCA 

tolerance reassessment is so vague a 

proffer as to not constitute a proffer at 

all. (Id.) 

It should be noted, however, that in 

two cases, NRDC does offer a specific 

citation in the 2008 Amended Carbaryl 

RED. First, NRDC cites to a specific page 

as a reference for the largest uses of 

carbaryl (based upon pounds of active 

ingredient used per year): apples, 

asparagus, cherries, corn, grapefruit, 

grapes, hay, oranges, peaches, pecans, 

soybeans, and turf. While use 

information is relevant to EPA’s overall 

reregistration decision, it is not material 

to NRDC’s objections or its request for 

a hearing. As such it does not identify 

evidence that would justify holding a 

hearing. 

Similarly, NRDC cites to a specific 

page in the 2008 Amended Carbaryl 

RED for the proposition that EPA issued 

a data call-in for data on exposure from 

the use of carbaryl in pet collars but that 

those results had not been submitted. 

NRDC objects to EPA’s assessment of 

carbaryl tolerances in part because EPA 

did not have these data. However, EPA 

has since received the data. Moreover, 

while this issue may be relevant to 

NRDC’s objection, arguing that EPA did 

not have sufficient data upon which to 

make a decision (without offering into 

evidence data EPA should have but did 

not consider) is not a basis upon which 

to grant a hearing. Again, a hearing is for 

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the purpose of gathering or receiving 

evidence and to resolve material factual 

disputes. It is undisputed that at the 

time, EPA had not received the data. It 

is also undisputed that the data has 

since been submitted. Thus, there is no 

issue in dispute over the submission of 

the data or evidence to suggest 

otherwise. In sum, EPA does not 

consider NRDC’s citations to EPA’s 

decision-making record a sufficient 

proffer of evidence to justify a hearing. 

The second category of documents 

cited in footnotes consists of the 

following documents, loosely described 

as articles and reports: ‘‘Poisons on Pets. 

Health Hazards from Flea and Tick 

Products’’ NRDC November, 2000; 

NRDC’s 2008 Green Paws report 

available at http://www.greenpaws.org/ 

better.php; Opportunities to Improve 

Data Quality and Children’s Health 

through the Food Quality Protection Act 

(FQPA) (EPA Inspector General Report 

No. 2006–P-00009 (January 10, 2006)); 

2007/2008 American Pet Products 

Manufacturing Association (APPA) 

National Pet Owners Survey; and 

Kansas State University Press Release. 

‘‘K-State Expert Says Fleas Can Be An 

Itchy Situation’’ (November 16, 1999). 

None of these documents proffer 

evidence of a genuinely-disputed, 

material issue of fact. EPA will address 

each in turn. 

The NRDC publication ‘‘Poison on 

Pets’’ focuses on seven organophosphate 

insecticides used in flea and tick control 

products; namely, chlorpyrifos, 

dichlorvos, phosmet, naled, 

tetrachlorvinpos, diazinon, and 

malathion. As a preliminary matter, 

EPA need not determine whether the 

information in this publication raises a 

material issue of fact about which a 

meaningful hearing might be held 

because, as explained in Unit VIII.D.2, 

the cancellation of all carbaryl pet collar 

product registrations renders NRDC’s 

hearing request moot. In addition, 

factually, the document’s relevance to 

carbaryl is at most tangential. While the 

report does mention carbaryl, it does so 

primarily in the context of arguing 

against the use of carbamates. 

Specifically, on page 49 of 67, the report 

notes that carbaryl and propoxur are the 

two major carbamates used for flea 

control, combining for approximately 

8% of all active ingredients used to treat 

pets and kennels. The report states that 

NRDC scientists believes that carbaryl is 

one of the most significant pesticide 

disrupters of the endocrine system, 

interfering with sperm structure and 

function as well as increasing the risk of 

miscarriage. The report concludes its 

paragraph on carbamates by noting that 

‘‘[f]ortunately, use of pet products with 

carbaryl already has decreased.’’ 

(Poisons on Pets at 50). In its objections, 

NRDC relies on the report to reiterate 

generally applicable arguments that 

NRDC made regarding organophosphate 

pesticides to argue why NRDC also 

believes EPA’s exposure assessment of 

carbaryl is flawed. This document, 

however, adds no justification for a 

hearing not otherwise included in 

NRDC’s objections. In short, the report 

does not proffer evidence of a 

genuinely-disputed, material issue of 

fact related specifically to carbaryl. 

As best EPA can determine, NRDC’s 

Green Paws report is a website page 

devoted to alternative, non-toxic 

methods of flea and tick control, such as 

using a flea comb and regular bathing. 

Again, EPA need not determine whether 

the information in this ‘‘report’’ raises a 

material issue of fact about which a 

meaningful hearing might be held 

because, as explained in Unit VIII.D.2, 

the cancellation of all carbaryl pet collar 

product registrations renders NRDC’s 

hearing request moot. In addition, this 

‘‘report’’ does not contain carbarylspecific information and does not 

provide any evidence of a genuinelydisputed, material issue of fact related 

to NRDC’s objections or request for a 

hearing. As such, it does not provide 

factual evidence justifying a hearing. 

Similarly, NRDC generally relies on 

the EPA Inspector General Report to 

emphasize the importance of DNT test 

data. This report, however, does not 

contain carbaryl-specific information 

and does not provide any evidence of a 

genuinely-disputed, material issue of 

fact related to NRDC’s objections or 

request for a hearing. At best, the report 

implies that registration decisions 

should not be made in the absence of a 

DNT study. However, EPA’s assessment 

of carbaryl included the submission and 

review of a DNT study. In sum, the 

report does not identify factual evidence 

that would, if established, resolve an 

issue in NRDC’s favor. 

NRDC also cites to the 2007/2008 

American Pet Product Association 

(APPA) National Pet Owners Survey for 

the proposition that ‘‘nearly two out of 

every three households owns a pet, 

which equates to 88.3 million cats and 

74.8 million dogs.’’ First, although 

NRDC asserts the survey is available at 

the APPA website on-line, as far as EPA 

is able to determine this is proprietary 

information. For non-members, the 

2009/2010 survey (at the time of this 

writing) was available at a cost of 

$1,695. EPA did not purchase a copy for 

purposes of responding to NRDC’s 

hearing request and, therefore, was 

unable to independently verify the 

survey results. Second, EPA need not 

determine whether the information in 

this survey raises a material issue of fact 

about which a meaningful hearing might 

be held because, as explained in Unit 

VIII.D.2, the cancellation of all carbaryl 

pet collar product registrations renders 

NRDC’s hearing request moot. Third, a 

statement—even a factual one, as to the 

number of households that own a pet 

does not present evidence of a 

genuinely-disputed, material issue of 

fact related to NRDC’s objections or 

request for a hearing. At best, this 

information implies that because there 

are so many pet owners, the probability 

that some owners use carbaryl pet 

collars and would be exposed is not 

insignificant. However, EPA’s 

assessment of carbaryl pet collars 

assumes exposure, including exposure 

to children. Accordingly, even if the 

evidence here were established, it 

would not resolve the issue identified 

by NRDC in its favor; namely, that EPA 

underestimated the exposure of children 

that come into contact with pets 

wearing carbaryl pet collars. In sum, a 

survey on the number of households 

that have pets does not present evidence 

to justify a hearing regarding the 

assumptions EPA made regarding 

children’s exposure to pets wearing 

carbaryl pet collars. 

Finally, NRDC cites to a 1999 press 

release for the proposition that ‘‘[e]very 

year Americans spend over one billion 

dollars on products designed to kill 

fleas and ticks on our pets.’’ First, EPA 

was unable to access a copy of the press 

release through the web link provided 

by NRDC. Thus, it is unclear that this 

document could even be introduced as 

evidence. Second, EPA need not 

determine whether the information in 

this press release raises a material issue 

of fact about which a meaningful 

hearing might be held because, as 

explained in Unit VIII.D.2, the 

cancellation of all carbaryl pet collar 

product registrations renders NRDC’s 

hearing request moot. Third, a statement 

as to the sales of flea and tick control 

products generally does not present any 

factual evidence specific to carbaryl or 

information related to NRDC’s 

objections or request for a hearing. 

Fourth, the reference is more than a 

decade old. Thus, even if it were 

relevant to a current genuinelydisputed, material issue of fact, this 

information is simply out-of-date. In 

sum, there can be no serious contention 

that the proffer of an outdated press 

release that generally refers to the 

amount Americans spend on pesticides 

to control fleas and ticks presents 

evidence to justify a hearing. 

The third category consists of one 

document: Xue J, Zartarian V, Moya J, 

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Freeman N, Beamer P, Black K, Tulve N, 

Shalat S: A meta-analysis of children’s 

hand-to-mouth frequency data for 

estimating nondietary ingestion 

exposure (Risk Anal. 2007 Apr.; 27(2): 

411–20). The Xue, et al. 2007 paper 

collected hand-to-mouth frequency data 

from 9 available studies representing 

429 subjects and more than 2,000 hours 

of behavior observation. A meta-analysis 

was conducted on these data to study 

differences in hand-to-mouth frequency 

based on study, age group, gender, and 

location (indoor vs. outdoor), to fit 

variability and uncertainty distributions 

that can be used in probabilistic 

exposure assessments, and to identify 

any data gaps. Results of this analysis 

indicate that age and location are 

important for hand-to-mouth frequency, 

but study and gender are not. This paper 

represents the first comprehensive effort 

to fit hand-to-mouth frequency 

variability and uncertainty distributions 

by indoor/outdoor location and by age 

groups, using the new standard set of 

age groups recommended by the U.S. 

Environmental Protection Agency for 

assessing childhood exposures. 

This document is ‘‘proffered’’ in 

connection with NRDC’s objections and 

request for a hearing on issues related to 

EPA exposure assessment of carbaryl 

pet collar products. EPA need not 

determine whether the information in 

this meta-analysis raises a material issue 

of fact about which a meaningful 

hearing might be held because, as 

explained in Unit VIII.D.2, the 

cancellation of all carbaryl pet collar 

product registrations renders NRDC’s 

hearing request moot. Nonetheless, EPA 

notes that NRDC’s proffer is improper. 

NRDC’s original Petition did not address 

this information because it pre-dated the 

Xue paper. However, NRDC’s 

subsequent petition, dated November 

26, 2007, regarding pet collars, which in 

essence amended its previous petition, 

also did not reference or rely in any 

manner on this information. To the 

contrary, in its pet collar petition, NRDC 

generally takes issue with modifications 

EPA made to the assumptions 

underlying the carbaryl pet collar 

residential exposure component of the 

probabilistic risk assessment of the Nmethyl carbamate cumulative 

assessment (as compared to the carbaryl, 

single chemical, determinative 

assessment). In so doing, NRDC 

generally asserted that the net result of 

these changes is that EPA 

underestimated the exposure of children 

to carbaryl from pet collars. It is only in 

its request for a hearing and objections 

that NRDC raises for the first time a host 

of specific issues based upon the 

analysis in the Xue paper related to the 

carbaryl pet collar residential exposure 

component of the N-methyl carbamate 

cumulative assessment. Thus, even if 

the issues concerning pet collars were 

not moot, it would be inappropriate to 

allow NRDC to now cure a poorly 

drafted petition by recasting its 

arguments or raising issues for the first 

time—and proffering evidence that was 

previously available in support of such 

arguments had they been raised 

earlier—at the hearing and objections 

stage of the process. See Nat’l Corn 

Growers Assc. v. EPA, No. 09–1284, slip 

op. at 8–9 (C.A.D.C. July 23, 2010) 

(upholding EPA’s refusal to consider at 

the objections stage evidence and 

arguments that could have been but 

were not submitted during the comment 

period); see also 72 FR at 39324 

(tolerance revocation procedures are not 

‘‘game,’’ whereby a party may file 

objections to denial based on entirely 

new ground(s) not relied upon in 

denying the petition.); 73 FR at 42710 

(inappropriate to cure failure to offer 

evidence at an earlier stage of 

administrative proceeding by submitting 

such evidence with a hearing request). 

In sum, NRDC has failed to identify 

factual evidence sufficient to justify a 

hearing. Specifically, NRDC has failed 

to proffer evidence that, if established, 

would resolve one or more genuinelydisputed, material factual issues in its 

favor. Accordingly, in addition to the 

reasons discussed below, NRDC’s 

hearing request is denied. 

D. Response to Specific Issues Raised in 

Objections and Hearing Requests 

1. Failure to apply a 10X children’s 

safety factor and another 3X additional 

safety factor to the DNT study LOAEL in 

calculating a safe dose for carbaryl or to 

otherwise rely on the DNT study in 

assessing the risk of carbaryl. In its 

objection to EPA’s calculation of a safe 

dose for carbaryl, NRDC makes three, 

separate but related arguments: (1) it 

was unlawful for EPA to calculate the 

safe dose for carbaryl without applying 

a 10X children’s safety factor (in 

addition to the inter- and intra-species 

safety factors) to the LOAEL from the 

DNT study; (2) it was unlawful for EPA 

to calculate the safe dose for carbaryl 

without applying an additional 3X 

safety factor (in addition to the interand intra-species and children’s safety 

factors) to the LOAEL from the DNT 

study to account for the lack of a 

NOAEL in this study; and (3) ‘‘[e]ven if 

the DNT data were not used to derive 

a [safe dose], EPA’s failure to 

incorporate the important information 

on age-sensitivity that is provided by 

the DNT is arbitrary and capricious, and 

contrary to law.’’ (Ref. 1 at 8). 

NRDC’s arguments concerning the 

application of additional safety factors 

of 10X and 3X to the DNT study LOAEL 

is material to its request for the 

revocation of the carbaryl tolerances 

only if both arguments are accepted – 

i.e., it is determined that both additional 

safety factors should be used in 

assessing the safety of carbaryl. This is 

because there is already essentially a 

tenfold difference between the DNT 

study LOAEL (10 mg/kg/day) and the 

POD used in calculating the safe dose 

for carbaryl. That POD is the BMDL10 of 

1.1 mg/kg/day for brain cholinesterase 

inhibition in PND11 juveniles in the 

CCA study. Use of either the 10X safety 

factor or the 3X factor alone applied to 

the DNT study LOAEL would not 

produce a value lower than the existing 

POD, only a combined 30X would do 

that. For this reason, for NRDC to 

sustain on materiality grounds its 

objection and hearing request as to its 

first two arguments it must either show 

(1) it is entitled to a hearing on both 

arguments; (2) it is entitled to a hearing 

on one argument and, as to the other, 

even if it is not entitled to a hearing, its 

substantive argument is meritorious, or 

(3) if it is not entitled to a hearing on 

either argument, that both of its 

substantive arguments are meritorious. 

As explained below, NRDC has not 

made such a showing. 

a. Application of a 10X children’s 

safety factor and a 3X safety factor for 

lack of a NOAEL to the DNT study. 

NRDC states that it ‘‘provides a scientific 

and legal argument that EPA must apply 

a 30X adjustment factor, based on a 10X 

FQPA factor to account for evidence for 

permanent structural brain damage in 

juvenile animals in the DNT study ..., 

and a 3X factor for the failure of the 

DNT study to identify with confidence 

an observable no-effect level for juvenile 

animals exposed to carbaryl.’’ (Obj. at 7). 

Its legal argument appears to be that the 

children’s safety factor provision in 

FFDCA section 408(b)(2)(C) compels 

EPA to apply a 10X safety factor when 

a study reveals juveniles are more 

sensitive than adults. EPA bases this 

conclusion on three considerations: (1) 

the children’s safety factor is a statutory 

requirement; (2) NRDC has phrased its 

argument regarding juvenile sensitivity 

and the 10X children’s safety factor in 

mandatory terms (Ref. 2 at 4 (‘‘Based on 

the reports available in the EPA 

documents demonstrating increased 

susceptibility in fetuses and newborn 

animals, the EPA is obligated to retain 

the FQPA 10X factor, in accordance 

with the law.’’)); and (3) there are not 

specific legal requirements in FFDCA 

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section 408 regarding a safety factor to 

address the lack of a NOAEL in a 

toxicity study. 

Hearings are not granted on legal 

questions. (40 CFR 178.32(b)(1)). EPA 

has repeatedly concluded, and NRDC 

appears to have admitted, that its 

argument regarding retention of the 

children’s safety factor to address 

juvenile sensitivity is a question of law. 

(73 FR 5439, 5445, January 30, 2008; 72 

FR 52108, 52115–52117, September 12, 

2007; 71 FR 43906, 43919, August 2, 

2006). Accordingly, NRDC’s hearing 

request on this issue is denied. 

Turning to the merits of the 

objection—at least insofar as EPA is able 

to discern the basis for the objection, 

NRDC’s objection, as well as its 

corresponding hearing request, is 

initially denied for a lack of 

particularity in the objection. EPA 

should not have to guess at the 

substance or basis for an objection. 

NRDC’s objection is also being denied 

on the following separate grounds. EPA 

finds no basis for NRDC’s interpretation 

of FFDCA section 408(b)(2)(C). EPA has 

on a number of occasions rejected the 

interpretation that the children’s safety 

factor provision mandates that the 

absence of a particular study or a 

finding of pre- or post-natal toxicity or 

increased sensitivity in the young 

removes EPA’s discretion to choose a 

different safety factor. (73 FR 5439, 

5444, January 30, 2008; 72 FR 52108, 

52115–52117, September 12, 2007; 71 

FR 43906, 43919, August 2, 2006). EPA 

explained its rationale recently in 

responding to NRDC objections that 

made the same argument as in this case: 

The statute does direct EPA to 

consider ‘‘susceptibility of infants 

and children’’ to pesticides. (21 

U.S.C. 346a(b)(2)(C)(i)(II)). It also 

states that an additional safety 

factor to protect infants and 

children shall be applied ‘‘to take 

into account potential pre- and 

post-natal toxicity . . . .’’ (21 U.S.C. 

346a(b)(2)(C)). Nonetheless, in clear 

and unmistakable language, 

Congress decreed that, 

‘‘[n]otwithstanding such 

requirement for an additional 

margin of safety’’ to take into 

account potential pre- and postnatal toxicity, EPA is authorized to 

choose a different safety factor if 

EPA has reliable data showing a 

different factor is safe. (Id.). 

Interpreting the statute as creating a 

rigid, per se rule that the 

identification of sensitivity in the 

young removes EPA’s discretion to 

choose a different safety factor is 

inconsistent with this language and 

the flexibility granted to the 

Agency. 

(72 FR at 52117; see also 73 FR at 5444). 

NRDC has raised no arguments in its 

current objections that convince EPA to 

vary from its long-held interpretation. 

Accordingly, EPA denies NRDC’s 

objection with respect to retaining a 10X 

children’s safety factor. 

Even giving NRDC every benefit of the 

doubt, and assuming it did not intend 

its argument on the 10X children’s 

safety factor to be only a legal question, 

NRDC is still not entitled to a hearing 

or relief on the merits. Perhaps NRDC 

was suggesting that (1) its assertion that 

the brain effects in the DNT were 

‘‘severe and permanent’’ and (2) its claim 

that the DNT is a particularly important 

study due to its focus on cognitive 

effects, were sufficient factual reasons, 

when combined with the sensitivity 

finding, to compel EPA to retain the 10X 

children’s safety factor even if EPA was 

not legally required to do so solely 

based on a finding of sensitivity in the 

young. 

There are several reasons no hearing 

is required on this re-articulation of 

NRDC’s claim. First, NRDC has 

proffered no evidence in support of its 

assertion on sensitivity and nature of 

the effects in the young. EPA reached 

quite different conclusions on the 

significance of the effects seen in the 

pups at the LOAEL in the DNT study. 

Nonetheless, NRDC has merely recycled 

its prior comments without 

acknowledging EPA’s findings or 

attempting to assert that there is a 

disputed question of fact regarding how 

EPA has characterized the effects in the 

study. Critically, NRDC proffers no 

evidence (or even arguments) in support 

of its assertions. As such, NRDC’s 

claims about sensitivity and the nature 

of the effects in pups in the DNT study 

are nothing more than ‘‘mere 

allegations’’ and hardly qualify as a 

relevant objection. Indeed, EPA’s 

regulations specifically state that ‘‘[a]n 

evidentiary hearing will not be granted 

on the basis of mere allegations, denials, 

or general descriptions of positions and 

contentions . . . .’’ (40 CFR 178.32(b)(2)). 

Second, NRDC’s argument that, as 

between the carbaryl CCA and the DNT 

study, EPA failed to give proper 

consideration and weight to the DNT 

study does not present a genuine issue 

of material fact to be resolved at a 

hearing. Nat’l Corn Growers Assc. v. 

EPA, No. 09–1284, slip op. at 13 

(C.A.D.C. July 23, 2010) (‘‘there is no 

material issue of fact based upon ‘[m]ere 

differences in the weight or credence 

given to particular scientific studies.’’’); 

(47 FR at 55474) (‘‘[Objectors] assertion 

about this evidence is, at best, an 

argument that a different inference (i.e., 

that the pieces are not ‘reasonably 

uniform’ and ‘cube shaped’) should be 

drawn from established fact (the 

dimensions of the pieces) than the 

agency has drawn. No hearing is 

required in such circumstances.’’); C.f. 

Norvich, 773 F.2d 1363 (‘‘differences in 

the weight or credence given to 

particular scientific studies ... are 

insufficient [to show a material issue of 

fact for a hearing]’’). Here, all NRDC has 

done is point to a study already in the 

record that EPA has reviewed and 

considered numerous times. Thus, 

NRDC has failed to proffer any evidence 

to suggest that there is a factual, rather 

than an interpretive, matter to be 

resolved at a hearing. See Nat’l Corn 

Growers Assc. v. EPA, No. 09–1284, slip 

op. at 13 (a ‘‘dispute between experts’’ as 

to the weight or credence given a 

particular scientific study does not 

present a material issue of fact for a 

hearing). 

Third, NRDC’s claims regarding the 

unique endpoints examined in the DNT 

study and its importance in evaluating 

the safety of pesticides are not disputed 

facts. EPA does not contest these points. 

A hearing will only be granted if there 

is a ‘‘genuine and substantial issue of 

fact for resolution at a hearing.’’ (40 CFR 

178.32(b)(1)). 

Finally, a hearing is also denied on 

this re-articulated claim because at 

bottom it calls for a policy 

determination. NRDC is claiming that 

based on certain facts an additional 

safety factor is needed. This is a policy 

judgment for EPA not a factual 

determination on which evidence could 

be submitted for adjudication. ‘‘An 

evidentiary hearing will not be granted 

on issues of policy or law.’’ (Id.) 

On the merits, this re-articulated 

claim fails as well. First, it is denied 

because it has not been made with the 

particularity required. The statute 

requires that objections ‘‘specif[y] with 

particularity the provisions of the 

regulation or order deemed 

objectionable and stating reasonable 

grounds therefore,’’ and EPA’s 

regulations make clear that for an 

objection to be properly presented it 

must explain ‘‘with particularity . . . [its] 

basis . . . .’’ (40 CFR 178.25(a)(2)); see 

Nat’l Corn Growers Assc. v. EPA, No. 

09–1284, slip op. at 11. Second, EPA’s 

conclusions on sensitivity and the 

nature of the effects on the pups in the 

DNT study differ significantly from 

NRDC’s assertions and are well 

supported in the record. On the nature 

of the effects, EPA concluded that the 

changes in brain morphometrics for 

pups seen in the DNT were minimal. 

(See Unit IV.B.4.b). In addition, the data 

from the DNT study showed that for the 

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first generation pups, there were no 

treatment-related effects on pup weight, 

pup survival indices, developmental 

landmarks, FOB measurements, or 

motor activity assessments. These 

conclusions are found on a careful 

analysis of the DNT study. On the other 

hand, NRDC merely restates its previous 

comments and neither offers an 

explanation for its characterization of 

the DNT study results nor proffers any 

evidence in support of its allegation. 

(Id.) (‘‘by simply resubmitting their 

Comments, without addressing the 

responses the EPA had made to them ... 

[petitioners] ‘failed to lodge a relevant 

objection’’’). On the sensitivity of the 

young, EPA concluded that the brain 

morphometric effects in the juvenile rats 

in the DNT study would not be present 

at 1 mg/kg/day. Thus, EPA has 

determined that the LOAELs and 

NOAELs for adults and juveniles in the 

DNT study were the same. NRDC has 

offered no reasons as to why EPA’s 

findings on these points was in error. 

(Id.) Indeed, there is nothing to suggest 

that EPA’s conclusion that these 

findings on sensitivity and the nature of 

the effects in the young did not require 

retention of a 10X factor was 

unreasonable. To the contrary, this 

conclusion is consistent with both EPA 

policy and practice. While on occasion 

EPA has applied an additional 

children’s safety factor based solely on 

the nature of the effects seen in the 

young, such additional safety factors 

have only been utilized in situations 

involving significantly different factual 

circumstances. (See 74 FR 39545, 

39549–39550, August 7, 2009) (for 

pesticide that showed sensitivity in the 

young, 3X children’s safety factor 

retained due to very narrow dose range 

(3X) from NOAEL to fatal dose level). 

Third, as to the NRDC’s assertions 

regarding the importance of the DNT 

study, EPA would note that there is a 

DNT study for carbaryl and it has been 

fully considered in assessing the risk of 

carbaryl. Importantly, in evaluating that 

study, EPA determined based on the 

effects seen in that study at what level 

a NOAEL for pup effects was likely to 

have been seen and that level is nearly 

identical to the level used as the POD 

for assessing carbaryl risks. For all of 

these reasons, this objection is denied. 

Having denied NRDC’s objection that 

a 10X children’s safety factor is required 

due to the alleged identification of age 

sensitivity, NRDC’s claim regarding a 3X 

factor due to the lack of a NOAEL in the 

DNT study becomes immaterial. As 

noted above, additional factors of 10X or 

below applied to the DNT study LOAEL 

for pups (along with the standard interand intra-species safety factors) will not 

result in a lower aPAD for carbaryl and 

thus granting NRDC’s objection would 

not change EPA’s safety determination. 

Because NRDC’s objection on this issue 

is not outcome-determinative, it is 

denied on the basis of immateriality. 

See Nat’l Corn Growers Assc. v. EPA, 

No. 09–1284, slip op. at 13; 72 FR 

39318, 39323–39324, July 18, 2007. In 

addition, there are no disputed facts 

with regard to the question of whether 

an additional safety factor is needed to 

address the lack of a NOAEL in the DNT 

study. NRDC asserts that an additional 

3X safety factor should be applied to the 

DNT study LOAEL for pups because no 

NOAEL was identified for that test 

group. EPA agrees that if it were using 

the pup LOAEL from the DNT study as 

a POD, at least a 3X factor is needed to 

account for the lack of a NOAEL in that 

study. In fact, in its risk assessment, 

EPA essentially applied a safety factor 

of 10X to the DNT study’s LOAEL (10 

mg/kg/day) by its determination that no 

brain morphometric effects would be 

expected at the mid-dose (1 mg/kg/day). 

Thus, EPA does not disagree with 

NRDC’s assertion that an additional 

safety factor is needed to address the 

lack of a NOAEL in the DNT study. In 

sum, because this objection is 

immaterial and there are no disputed 

material facts, NRDC’s hearing request 

and objection on this issue are denied. 

(40 CFR 178.32(b)). 

b. Arbitrary and capricious. NRDC 

argues that even if EPA uses the BMDL10

for PND11 juveniles from the CCA study 

for the POD for calculating the carbaryl 

safe dose, it must ‘‘incorporate the 

important information on age-sensitivity 

that is provided by the DNT [study]’’ 

into its risk assessment and that EPA’s 

failure to do so was arbitrary and 

capricious. (Ref. 1 at 8). The only hint 

that NRDC provides as to what it means 

by this vague allegation is a table 

appearing on page eight of its objections 

in which NRDC suggests that the 

additional 10X and 3X safety factors it 

argues are needed for the DNT study 

should be applied to the BMDL10 for 

PND11 juveniles in the CCA study in 

computing the safe dose. NRDC 

advances no specific argument as to 

why this approach should be taken and 

proffers no evidence in support of it. As 

an initial matter, therefore, this 

objection and its corresponding hearing 

request is denied for a lack of 

particularity in the objection. EPA 

should not have to guess at the 

substance of an objection. 

Even assuming the objection passes 

the particularity requirement, it is 

without merit. The predicate to this 

argument is that additional safety 

factors are needed as to the pup LOAEL 

in the DNT study. Thus, this objection 

and hearing request stand in the shoes 

of the objections and hearing requests 

regarding the alleged need for additional 

10X and 3X safety factors on the pup 

LOAEL in the DNT study. As to the 

additional 10X children’s safety factor, 

NRDC’s objection and hearing request is 

denied for the identical reasons that 

EPA denied NRDC’s direct claims 

regarding an additional 10X children’s 

safety factor. As to the 3X safety factor, 

NRDC’s assertion that a lack of a 

NOAEL in the DNT study necessitates 

the application of an additional safety 

factor to the POD in the CCA study does 

not warrant a hearing and is 

substantively meritless because it is 

nothing more than a mere allegation 

without any supporting basis. (40 CFR 

178.32(b)(2)). NRDC offers no evidence 

as to why a LOAEL-to-NOAEL safety 

factor should be transferred from a 

study where it is needed (the DNT 

study) to a study where a clear NOAEL 

or its equivalent (a BMDL10) is 

identified (the CCA study). Further, to 

the extent that NRDC intended to make 

some other point by its vague claim that 

it was arbitrary and capricious for EPA 

not to take the DNT study results into 

account in its carbaryl safety 

determination, its hearing request is 

denied as being no more than a ‘‘general 

description of [a] position[],’’ 40 CFR 

178.32(b)(2), and the objection is denied 

on the ground that the record, on its 

face, shows that EPA carefully 

considered the results of the DNT study 

in making its safety determination on 

carbaryl. (See Unit IV.B.4.b). 

2. Improper reliance on flawed data 

for exposure assessment resulting in 

underestimation of exposure to children 

from pet collars. NRDC makes several 

arguments as to why EPA’s exposure 

assessment is flawed and, therefore, 

EPA cannot make its tolerance safety 

finding for carbaryl. NRDC first argues 

that EPA cannot make its safety finding 

because required transferable residue 

studies have not yet been submitted. 

NRDC further argues that the exposure 

studies that EPA did rely on are highly 

variable and unreliable and, therefore, 

EPA cannot be reasonably certain that 

children in the highly exposed tails of 

the exposure curve will be protected. 

NRDC also argues that EPA made 

several unfounded or faulty 

assumptions in it exposure assessment 

such that EPA cannot show that there is 

an unreasonable certainty of no harm 

from the aggregate exposures to 

carbaryl. 

EPA denies both the hearing request 

and the objections as moot because all 

carbaryl pet collar registrations have 

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been cancelled. In a letter dated 

September 30, 2009, Wellmark 

International submitted a request to 

voluntarily cancel its pet collar 

registrations pursuant to section 6(f) of 

FIFRA. (74 FR 54045, October 21, 2009). 

These are the only carbaryl pet collar 

registrations and the last remaining pet 

product registration for carbaryl. EPA 

issued its final order cancelling carbaryl 

registrations for pet collar uses on 

December 16, 2009. (74 FR 66642). 

E. Conclusion on Objections and 

Request for a Hearing 

For the reasons stated above, all of the 

NRDC’s objections as well as its request 

for a hearing are denied. 

IX. Regulatory Assessment 

Requirements 

As indicated previously, this action 

announces the Agency’s final order 

regarding objections filed under section 

408 of FFDCA. As such, this action is an 

adjudication and not a rule. The 

regulatory assessment requirements 

imposed on rulemaking do not, 

therefore, apply to this action. 

X. 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). 

XI. References 

1. Natural Resources Defense Council, 

‘‘Objections to the Order Denying NRDC’s 

Petition to Revoke All Tolerances for 

Carbaryl, and Request for Public Evidentiary 

Hearing’’ (December 29, 2008). 

2. Natural Resources Defense Council, 

Petition to Revoke All Carbaryl Tolerances 

and Cancel All Carbaryl Registrations, 

(January 10, 2005). 

3. Natural Resources Defense Council, 

Petition to Cancel Carbaryl and Propoxur for 

Pet Collar Uses, (November 26, 2007). 

4. US EPA, Carbaryl; Order Denying 

NRDC’s Petition to Revoke Tolerances, 73 FR 

64229, October 29, 2008. 

5. US EPA, ‘‘A User’s Guide to Available 

EPA Information on Assessing Exposure to 

Pesticides in Food’’ (June 21, 2000). 

6. FIFRA Science Advisory Panel. 2002. 

Methods Used to Conduct a Preliminary 

Cumulative Risk Assessment for 

Organophosphate Pesticides. Final Report 

from the FIFRA Scientific Advisory Panel 

Meeting of February 5–7, 2002 (Report dated 

March 19, 2002). FIFRA Scientific Advisory 

Panel, Office of Science Coordination and 

Policy, Office of Prevention, Pesticides and 

Toxic Substances, U.S. Environmental 

Protection Agency. Washington, DC. SAP 

Report 2002–01. 

7. FIFRA Science Advisory Panel. 2005a. 

Final report on N-Methyl Carbamate 

Cumulative Risk Assessment: Pilot 

Cumulative Analysis. Final Report from the 

FIFRA Scientific Advisory Panel Meeting of 

February 2005 (Report dated September 2, 

1998). Available at: http://www.epa.gov/ 

scipoly/sap/2005/february/minutes.pdf. 

8. FIFRA Science Advisory Panel. 2005b. 

Final report on Preliminary N-Methyl 

Carbamate Cumulative Risk Assessment. 

Final Report from the FIFRA Scientific 

Advisory Panel Meeting of July 29–30, 2005 

(Report dated September -, 2005). Available 

at: http://www.epa.gov/scipoly/sap/2005/ 

august/minutes.pdf. 

9. Office of Pesticide Programs, US EPA, 

‘‘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). 

10. US EPA Office of Pesticide Programs, 

‘‘The Use of Data on Cholinesterase Inhibition 

for Risk Assessments of Organophosphorous 

and Carbamate Pesticides’’ (August 18, 2000). 

11. US EPA Office of Pesticide Programs. 

March 9, 2005 letter to Peg Cherney, Bayer 

Crop Science, Final Cancellation Order for 

Carbaryl Liquid Broadcast Application to 

Lawns/Turf; EPA Registration Numbers 264– 

324, 264–325, and 264–328. 

12. US EPA Office of Pesticide Programs. 

2007. Office of Prevention, Pesticides and 

Toxic Substances, EPA, Reregistration 

Eligibility Decision for Carbaryl (September 

24, 2007). 

13. US EPA Office of Pesticide Programs. 

2002. Hazard Identification Assessment 

Review Committee (HIARC) report (March 5, 

2002). 

14. US EPA Office of Pesticide Programs. 

2002. FQPA SF Committee report (April 3, 

2002). 

15. US EPA Office of Pesticide Programs. 

2002. HIARC report (May 9, 2002). 

16. Moser, G. (2007) Report of 

Cholinesterase Comparative Sensitivity 

Study of Carbaryl. Unpublished study 

prepared by US EPA, ORD, NHEERL. (MRID 

47143001). 

17. US EPA Office of Pesticide Programs. 

2007. Carbaryl: Updated Endpoint Selection 

for Single Chemical Risk Assessment (June 

29, 2007). 

18. US EPA Office of Pesticide Programs. 

2007b. Carbaryl. HED Chapter of the 

Reregistration Eligibility Decision Document 

(RED). EPA–HQ–OPP–2007–0941–0003. PC 

Code: 056801, DP Barcode: D334770. (June 

28, 2007). 

19. Johnson, C.D. and Russell, R.L. (1975) 

A rapid, simple radiometric assay for 

cholinesterase, suitable for multiple 

determinations. Analytical Biochemistry. 

64:229–238. 

20. US EPA Office of Pesticide Programs. 

1998. Hazard Identification Assessment 

Review Committee (HIARC) report (July 7, 

1998). 

21. US EPA Office of Pesticide Programs. 

1998. FQPA SF Committee report (August 27, 

1998). 

22. US EPA Office of Pesticide Programs. 

1999. HIARC report (April 27, 1999). 

23. US EPA Office of Pesticide Programs. 

1999. HIARC report (November 15, 1999). 

24. US EPA Office of Pesticide Programs. 

1999. FQPA SF Committee report (December 

13, 1999). 

25. US EPA Office of Pesticide Programs. 

2001. HIARC report (April 5, 2001). 

26. US EPA Office of Pesticide Programs. 

2001. FQPA SF Committee report (April 30, 

2001). 

List of Subjects in 40 CFR Part 180 

Environmental protection, Carbaryl, 

Pesticides and pests. 

Dated: September 8, 2010. 

Steven Bradbury, 

Director, Office of Pesticide Programs 

[FR Doc. 2010–22987 Filed 9–14–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0756; FRL–8844–7] 

Technical Amendments to Pesticide 

Regulations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is issuing this technical 

amendment to change references in 

several sections of 40 CFR part 180. 

These changes are necessary because of 

a final rule which was issued in the 

Federal Register of June 8, 2005. That 

final rule made miscellaneous changes 

to 40 CFR part 180 to update generic 

provisions of EPA’s procedural 

regulations relating to pesticide 

chemicals. The update was made 

necessary because of various changes 

made by the Food Quality Protection 

Act of 1996. 

DATES: This final rule is effective 

September 15, 2010. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0756. All documents in the 

docket are listed in the docket index 

available at http://www.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. 

mstockstill on DSKH9S0YB1PROD with RULES