Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26317 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0237; FRL–8127–3] 

Fenpyroximate; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for combined 

residues of fenpyroximate in or on 

honey. This action is in response to 

EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide in managed 

beehives. This regulation establishes a 

maximum permissible level for residues 

of fenpyroximate in this food 

commodity. The tolerance expires and 

is revoked on December 31, 2010. 

DATES: This regulation is effective May 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 2007, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2007–0237. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

web site to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available 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. 

FOR FURTHER INFORMATION CONTACT: 

Stacey Groce, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–2505; e-mail address: 

groce.stacey@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the FQPA, any person 

may file an objection to any aspect of 

this regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2007–0237 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before July 9, 2007. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2007–0237 by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S-4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of the Federal Food, Drug, and 

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

is establishing a time-limited tolerance 

for combined residues of the miticide 

fenpyroximate in or on honey at 0.10 

parts per million (ppm). This tolerance 

expires and is revoked on December 31, 

2010. EPA will publish a document in 

the Federal Register to remove the 

revoked tolerance from the Code of 

Federal Regulations (CFR). 

Section 408(l)(6) of the FFDCA 

requires EPA to establish a tolerance or 

exemption from the requirement for a 

tolerance for pesticide chemical 

residues in food that will result from the 

use of a pesticide under an emergency 


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26318 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

exemption granted by EPA under 

section 18 of FIFRA. Such tolerances 

can be established without providing 

notice or period for public comment. 

EPA does not intend for its actions on 

section 18 related tolerances to set 

binding precedents for the application 

of section 408 of the FFDCA and the 

new safety standard to other tolerances 

and exemptions. Section 408(e) of the 

FFDCA allows EPA to establish a 

tolerance or an exemption from the 

requirement of a tolerance on its own 

initiative, i.e., without having received 

any petition from an outside party. 

Section 408(b)(2)(A)(i) of the FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of the FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of the FFDCA requires EPA 

to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . .’’

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’

This provision was not amended by the 

Food Quality Protection Act of 1996 

(FQPA). EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Fenpyroximate on Honey and FFDCA 

Tolerances 

The varroa mite, (Varroa jacobsoni), is 

an ectoparasite of honeybees. It was first 

detected in the continental United 

States in 1979 and is currently the most 

important pest of honey bee colonies. 

The feeding of varroa mites has a 

number of effects on the bee from 

damaging tissue to shortening the bee’s 

life span as an adult. Further, the mites 

vector disease viruses and heavy levels 

of parasitism increase bee mortality and 

weaken colonies. Fluvalinate is 

currently registered for the control of 

varroa mites; however, populations of 

varroa mites have developed resistance 

to fluvalinate. The applicants for this 

use pattern assert that the continued 

survival of managed bee colonies is 

critical to the production of many 

agricultural crops and it is becoming 

increasingly difficult to control varroa 

mites due to pesticide resistance. EPA 

has authorized under FIFRA section 18 

the use of fenpyroximate on honey for 

control of varroa mites in Nebraska, 

North Dakota, New York, Idaho, Oregon, 

and Washington States. In addition, 

EPA has authorized under the FIFRA 

section 18 crisis provision the use of 

fenpyroximate in beehives for control of 

varroa mites in Texas. After having 

reviewed the submission, EPA concurs 

that emergency conditions exist for 

these States. 

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

fenpyroximate in or on honey. In doing 

so, EPA considered the safety standard 

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

EPA decided that the necessary 

tolerance under section 408(l)(6) of the 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this time-limited tolerance without 

notice and opportunity for public 

comment as provided in section 

408(l)(6) of the FFDCA. Although this 

time-limited tolerance expires and is 

revoked on December 31, 2010, under 

section 408(l)(5) of the FFDCA, residues 

of the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on honey after that date 

will not be unlawful, provided the 

pesticide is applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this 

tolerance earlier if any experience with, 

scientific data on, or other relevant 

information on this pesticide indicate 

that the residues are not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether fenpyroximate 

meets EPA’s registration requirements 

for use on honey or whether a 

permanent tolerance for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this tolerance serves as a basis for 

registration of fenpyroximate by a State 

for special local needs under FIFRA 

section 24(c). Nor does this time-limited 

tolerance serve as the basis for any 

States other than Idaho, Nebraska, 

Minnesota, New York, North Dakota, 

Texas, and Washington States to use 

this pesticide on bee hives under 

section 18 of FIFRA without following 

all provisions of EPA’s regulations 

implementing FIFRA section 18 as 

identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for fenpyroximate 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

Consistent with section 408(b)(2)(D) 

of the FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of fenpyroximate and to 

make a determination on aggregate 

exposure, consistent with section 

408(b)(2) of the FFDCA, for a timelimited tolerance for combined residues 

of fenpyroximate in or on honey at 0.10 

ppm. EPA’s assessment of the dietary 

exposures and risks associated with 

establishing the tolerance follows. 

A. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological 

endpoint. However, the lowest dose at 

which adverse effects of concern are 

identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences. 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by the appropriate UF (RfD = NOAEL/ 

UF). Where an additional safety factor is 

retained due to concerns unique to the 


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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26319 

FQPA, this additional factor is applied 

to the RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of FQPA SF. 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the level of concern (LOC). 

For example, when 100 is the 

appropriate UF (10X to account for 

interspecies differences and 10X for 

intraspecies differences) the LOC is 100. 

To estimate risk, a ratio of the NOAEL 

to exposures (margin of exposure (MOE) 

= NOAEL/exposure) is calculated and 

compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk is expressed as 1 X 106 or one 

in a million). Under certain specific 

circumstances, MOE calculations will 

be used for the carcinogenic risk 

assessment. In this non-linear approach, 

a ‘‘point of departure’’ is identified 

below which carcinogenic effects are 

not expected. The point of departure is 

typically a NOAEL based on an 

endpoint related to cancer effects 

though it may be a different value 

derived from the dose response curve. 

To estimate risk, a ratio of the point of 

departure to exposure (MOEcancer = point 

of departure/exposures) is calculated. A 

summary of the toxicological endpoints 

for fenpyroximate used for human risk 

assessment is discussed in Table 1 on 

page 5 of the Fenpyroximate Human 

Health Risk Assessment dated December 

4, 2006: Section 18 Request for Use in 

Bee Hives, and can be located by 

searching for docket ID number EPA–

HQ–OPP–2007–0237. Double-click on 

the document to view the referenced 

information. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.566) for the 

combined residues of the miticide 

fenpyroximate in or on a variety of raw 

agricultural commodities. Tolerances 

have also been established for 

fenpyroximate and its metabolites (E)-4- 

[(1,3-dimethyl-5-phenoxypyrazol-4-yl)- 

methylene aminooxymethyl] benzoic 

acid and (E)-1,1-dimethylethyl-2- 

hydroxyethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1 H-pyrazol-4-yl) methylene] 

amino]oxy]methyl]benzoate, calculated 

as the parent compound at 0.015 ppm 

in milk, and the fat, meat, and meat 

byproducts (excluding liver and kidney) 

of cattle, goat, horse, and sheep at 0.03 

ppm. Risk assessments were conducted 

by EPA to assess dietary exposures from 

fenpyroximate in food as follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a 1–day 

or single exposure. The Dietary 

Exposure Evaluation Model (DEEMFCIDTM) version 2.02 analysis evaluated 

the individual food consumption as 

reported by respondents in the USDA 

1994–1996 and 1998 nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII) and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: An unrefined Tier I acute 

dietary-exposure assessment was 

conducted for females 13–49 years old. 

The unrefined Tier I acute dietary 

analyses assumed that fenpyroximate 

residues were present in all 

commodities at tolerance levels and that 

100% of all commodities (registered and 

proposed uses) are treated. Adequate 

processing data on apples, grapes, 

oranges, and mint are available. 

Modified processing factors based on 

these data were used for apple juice, 

pear juice, grape juice, raisins, citrus 

juice (orange, grapefruit, lemon, lime) 

and mint oils (peppermint and 

spearmint). The DEEM-FCIDTM default 

processing factors were used for all 

other processing commodities. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

DEEM-FCIDTM version 2.02 analysis 

evaluated the individual food 

consumption as reported by 

respondents in the USDA 1994–1996 

and 1998 nationwide CSFII and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the chronic 

exposure assessments: An unrefined 

Tier I chronic dietary-exposure 

assessment was conducted for the 

general U.S. population and various 

sub-populations. The unrefined Tier I 

chronic dietary analyses assumed that 

fenpyroximate residues were present in 

all commodities at tolerance levels and 

that 100% of all commodities (registered 

and proposed uses) are treated. 

Adequate processing data on apples, 

grapes, oranges, and mint are available. 

Modified processing factors based on 

these data were used for apple juice, 

pear juice, grape juice, raisins, citrus 

juice (orange, grapefruit, lemon, lime) 

and mint oils (peppermint and 

spearmint). The DEEM-FCIDTM default 

processing factors were used for all 

other processing commodities. 

iii. Cancer. Fenpyroximate is 

classified as ‘‘not likely’’ to be a human 

carcinogen. Therefore a cancer risk 

assessment was not performed. 

2. Dietary exposure from drinking 

water. The Agency determined that in 

addition to the parent compound, 

known as fenpyroximate, M-1, the z 

isomer of fenpyroximate, and the M-3 

metabolite should be included in the 

drinking water assessment for 

fenpyroximate based on their structural 

similarity. Some surface water and 

ground water contamination may occur 

based on the proposed application rates 

and the environmental fate properties of 

fenpyroximate. However, the risk of 

water contamination from the parent 

compound is relatively low, based on its 

high sorption potential. Unlike the 

parent compound, sorption of the M-3 

metabolite is much less, and it may 

move into water resources more readily. 

Fenpyroximate and M-1 are not 

expected to persist under terrestrial 

environmental conditions, with 

metabolism as the primary route of 

dissipation. Hydrolysis and 

photodegradation on soil are not 

expected to be significant routes of 

dissipation, but photodegradation in 

water could be significant assuming 

clear, well-mixed, shallow water bodies. 

Based on Tier II screening-level 

surface water modeling for drinking 

water, the Agency estimated 

concentrations in surface water to be 

used for acute, chronic non-cancer, and 

cancer exposure assessment. Tier II 

surface water concentrations for parent 

fenpyroximate and M-1 were calculated 

using the Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM-EXAMS) shell. The acute and 

chronic non-cancer concentrations for 

Georgia (GA) pecan (highest exposure) 

are 12.9 and 1.8 microgram/Liter (ug/L), 

respectively. EPA used the Screening 

Concentration Ground Water (SCIGROW2) model to estimate a ground 

water concentration of 0.059 parts per 

billion (ppb). These results for both 

surface water and ground water are 

consistent with the fate and transport 

properties of fenpyroximate. 

Modeled estimates of drinking water 

concentrations were incorporated 

directly into the dietary assessment 

using the estimated drinking water 

concentrations (EDWC) for surface water 

generated by the PRZM-EXAMS model. 

For the acute assessment, the peak 

concentration of 12.9 ppb was used to 

assess the contribution to drinking 

water; for the chronic assessment, the 

annual mean value of 1.8 ppb was used 


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26320 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

to assess the contribution to drinking 

water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fenpyroximate is not registered for use 

on any sites that would result in 

residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fenpyroximate and any other substances 

and fenpyroximate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that fenpyroximate has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

C. Safety Factor for Infants and Children 

1. In general. Section 408 of the 

FFDCA provides that EPA shall apply 

an additional tenfold margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

that a different margin of safety will be 

safe for infants and children. Margins of 

safety are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

The rat and rabbit developmental 

toxicity studies were tested at doses that 

produced minimal maternal toxicity. 

These doses were supported partly by 

range finding data. The 2–generation 

reproductive toxicity study indicated 

that maternal (decreased body weight) 

and offspring toxicity (decreased 

lactational weight gain) occurred at the 

same dose, suggesting no evidence of 

increased sensitivity or susceptibility. 

Reproductive parameters were not 

affected in this 2–generation 

reproduction study. There are no 

neurotoxicity studies other than a 

negative delayed acute neurotoxicity 

study in the hen. There was no 

indication of neurotoxicity present in 

any of the existing subchronic or 

chronic toxicity studies. The toxicology 

database is complete for FQPA purposes 

and there are no residual uncertainties 

for prenatal/postnatal toxicity. 

3. Conclusion. There is a complete 

toxicity database for fenpyroximate and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. EPA 

determined that the 10X safety factor to 

protect infants and children should be 

changed to 1X for the following reasons: 

i. There are no concerns or residual 

uncertainties for prenatal or postnatal 

toxicity. 

ii. The toxicological database is 

complete for the assessment of toxicity 

and susceptibility following prenatal 

and/or postnatal exposures. No clinical 

signs of neurotoxicity or neuropathology 

were observed in the database. 

iii. There are no residual concerns 

regarding completeness of the exposure 

database. 

iv. The dietary food exposure 

assessment is an unrefined, Tier I, acute 

and chronic analyses, which assumed 

that fenpyroximate residues were 

present in all commodities at tolerance 

levels and that 100% of all commodities 

(registered and proposed uses) were 

treated with fenpyroximate. By using 

these screening level assessments, 

actual exposures /risks will not be 

underestimated. 

v. The dietary drinking water 

assessment utilizes water concentration 

values generated by models and 

associated modeling parameters which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations that will not likely 

be exceeded. 

vi. There are currently no registered 

or proposed residential uses of 

fenpyroximate. 

D. Aggregate Risks and Determination of 

Safety 

The Agency currently has two ways to 

estimate total aggregate exposure to a 

pesticide from food, drinking water, and 

residential uses. First, a screening 

assessment can be used, in which the 

Agency calculates drinking water levels 

of comparison (DWLOCs), which are 

used as a point of comparison against 

estimated drinking water concentrations 

(EDWCs). The DWLOC values are not 

regulatory standards for drinking water, 

but are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. More information on the use of 

DWLOCs in dietary aggregate risk 

assessments can be found at http:/ 

www.epa.gov/oppfead1/trac/science/ 

screeningsop.pdf. 

More recently, the Agency has used 

another approach to estimate aggregate 

exposure through food, residential and 

drinking water pathways. In this 

approach, modeled surface water and 

ground water EDWCs are directly 

incorporated into the dietary exposure 

analysis, along with food. This approach 

provides a more realistic estimate of 

exposure because actual body weights 

and water exposures are then added to 

estimated and water consumption form 

the CSFII are used. The combined food 

and water exposures are then added to 

estimated exposure from residential 

sources to calculate aggregate risks. The 

resulting exposure and risk estimates 

are still considered to be high end, due 

to the assumptions used in developing 

drinking water modeling inputs. The 

risk assessment for fenpyroximate used 

in this tolerance document uses this 

approach of incorporating water 

exposure directly into the dietary 

exposure analysis. 

There are no registered or proposed 

uses of fenpyroximate, which result in 

residential exposures, so the aggregate 

exposure assessment required by 

FFDCA section 408(b)(2)(D)(vi) consists 

solely of dietary (food + drinking water) 

exposures. 

Aggregate exposure risk assessments 

were conducted by incorporating the 

drinking water concentrations directly 

into the dietary exposure assessment for 

the acute and chronic aggregate 

exposures (food + drinking water). 

These aggregate exposures do not 

exceed the Agency’s level of concern 

since they were less than 100% of the 

respective population adjusted doses 

(PADs). 


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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26321 

1. Acute risk. An unrefined acute 

dietary-exposure assessment was 

conducted for females 13 to 49 years 

old. Since an effect of concern 

attributable to a single dose in toxicity 

studies was not identified for the 

general U.S. population, an acute 

dietary-exposure assessment was not 

performed for this population. Using the 

exposure assumptions discussed in this 

unit for acute exposure, the acute 

dietary exposure from food and water to 

fenpyroximate will occupy 6.8% of the 

acute population adjusted dose (aPAD) 

for females 13 years and older. EPA 

does not expect the aggregate exposure 

to exceed 100% of the aPAD. 

2. Chronic risk. Using the exposure 

assumptions discussed in this unit for 

chronic exposure, EPA has concluded 

that exposure to fenpyroximate from 

food and water will utilize 9.8% of the 

chronic population adjusted dose 

(cPAD) for the U.S. population, 20% of 

the cPAD for all infants, 1 year old, and 

34% of the cPAD for children 1 to 2 

years old. There are no residential uses 

for fenpyroximate which result in 

chronic residential exposure to 

fenpyroximate. Therefore, EPA does not 

expect the aggregate exposure to exceed 

100% of the cPAD. 

3. Aggregate cancer risk for U.S. 

population. A cancer aggregate-risk 

assessment was not performed because 

fenpyroximate has been classified as not 

likely to be carcinogenic to humans. 

4. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

fenpyroximate residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

and high-performance liquid 

chromatography/mass spectrometry/ 

mass spectrometry (HPLC/MS/MS) is 

available to enforce the tolerance 

expression. The methods may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail 

address:residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian, or 

Mexican maximum residue limits 

(MRLs) for the residues of 

fenpyroximate in honey. Therefore, 

there are no international harmonization 

concerns at this time. 

VI. Conclusion 

Therefore, the time-limited tolerance 

is established for combined residues of 

fenpyroximate, (E)-1,1-dimethylethyl 4- 

[[[(E)-[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene] 

amino]oxy]methyl]benzoate, in or on 

honey at 0.10 ppm. This tolerance 

expires and is revoked on December 31, 

2010. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866, this rule is not 

subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000) do not apply 

to this rule. In addition, This rule does 

not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 26, 2007. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.566 is amended by 

adding text and a table to paragraph (b) 

to read as follows: 

§ 180.566 Fenpyroximate; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemption. 

Time-limited tolerance is established for 

the combined residues of 

fenpyroximate, (E)-1,1-dimethylethyl 4- 


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26322 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

[[[(E)-[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl) methylene] amino]oxy] methyl]benzoate in or on honey at 0.10 

ppm. This tolerance expires and is 

revoked on the date specified in the 

following table. 

Commodity Parts per million Expiration/revocation date 

Honey ........................................................................................................................................................... 0.10 ppm 12/31/2010 

* * * * * 

[FR Doc. E7–8954 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0880; FRL–8125–5] 

Foramsulfuron; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of foramsulfuron 

on corn, sweet (K+CWHR); corn, sweet, 

forage; corn, sweet, stover; corn, pop 

grain; and corn, pop, stover when 

applied/used as a herbicide. The 

Interregional Project Number 4 (IR-4) 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of foramsulfuron. 

DATES: This regulation is effective May 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 2007, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0880. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

web site to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available 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. 

FOR FURTHER INFORMATION CONTACT: 

Shaja R. Brothers, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–3194; e-mail address: 

brothers.shaja@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides 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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

[insert appropriate cite to either another 

unit in the preamble or a section in a 

rule]. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2006–0880 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before July 9, 2007. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0880, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 


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