Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4279 

Commodity Parts per million 

Vegetable, fruiting, group 

8 .................................. 1.0 

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[FR Doc. 2010–1609 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0876; FRL–8804–2] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues or 

residues of pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, in or on grass 

forage, fodder, and hay crop group 17, 

forage; grass forage, fodder, and hay 

crop group 17, hay; and grass forage, 

fodder, and hay crop group 17, straw. 

BASF Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 27, 2010. Objections and 

requests for hearings must be received 

on or before March 29, 2010, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0876. 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. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Phil 

Errico, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6663; e-mail address: 

errico.philip@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 those engaged in the 

following activities: 

• 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 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 Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

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–2008–0876 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 

as required by 40 CFR part 178 on or 

before March 29, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0876, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of April 13, 

2009 (74 FR 16866) (FRL–8396–6), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8F7396) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709–3528. The 

petition requested that 40 CFR 180.361 

be amended by establishing tolerances 

for combined residues of the herbicide, 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, 

expressed as the stoichiometric 

equivalent of pendimethalin, in or on 

grass forage, fodder, and hay crop group 

17, forage; grass forage, fodder, and hay 

crop group 17, hay; and grass forage, 

fodder, and hay crop group 17, straw at 

40 parts per million (ppm), 80 ppm, and 

4.5 ppm, respectively. That notice 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available to the 

public in the docket, at http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 


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4280 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

Based upon review of the data 

supporting the petition, EPA has 

changed the requested tolerances for the 

combined residues for pendimethalin 

and its metabolite in or on grass forage, 

fodder, and hay, crop group 17, forage; 

grass forage, fodder, and hay, crop group 

17, hay; and grass forage, fodder, and 

hay crop group 17, straw from 40 ppm, 

80 ppm, and 4.5 ppm, respectively, to 

20 ppm, 13 ppm, and 4.0 ppm, 

respectively. EPA also changed the 

commodities names to reflect the 

regulatory names as stated in 40 CFR 

180.41(c). The reason for these changes 

are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of 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 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 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. . . .’’ 

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

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of 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 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for combined residues of 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, on 

grass forage, fodder, and hay crop group 

17, forage; grass forage, fodder, and hay 

crop group 17, hay; grass forage, fodder, 

and hay, crop group 17, straw at 20 

ppm, 13 ppm, and 4.0 ppm, 

respectively. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Pendimethalin has low acute oral, 

dermal, and inhalation toxicity, and is 

not a dermal sensitizer. The thyroid is 

a target organ for pendimethalin. 

Thyroid toxicity in chronic and 

subchronic rat and mouse studies was 

manifested as alterations in thyroid 

hormones, increased thyroid weight, 

and microscopic thyroid lesions. The 

available prenatal and postnatal 

developmental toxicity data provided 

no indication of qualitative or 

quantitative susceptibility to the young. 

Pendimethalin is considered a possible 

human carcinogen based on a 

statistically significant increased trend 

and pair-wise comparison between the 

high dose group and controls for thyroid 

folliculate cell adenomas in male and 

female rats. A threshold approach is 

being used to evaluate cancer risk 

because mode of action studies are 

available demonstrating that the thyroid 

tumors are due to a thyroid-pituitary 

imbalance (a threshold effect), and also 

because pendimethalin was shown to be 

non-mutagenic in mammaliam somatic 

cells and germ cells. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by pendimethalin, N-(1-ethylpropyl)- 

3,4-dimethyl-2,6-dinitrobenzenamine, 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in the 

document titled ‘‘Pendimethalin: 

Human Health Risk and Exposure 

Assessment for Proposed Section 3 

Registration for use on Grasses for Seed 

Production and Dormant Bermudagrass 

Pasture and Hay Fields,’’ page 10, in 

docket ID number EPA–HQ–OPP–2008– 

0876. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

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. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, used for human 

risk assessment can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Pendimethalin: Human Health 

Risk and Exposure Assessment for 

Proposed Section 3 Registration for use 

on Grasses for Seed Production and 

Dormant Bermudagrass Pasture and Hay 

Fields,’’ page 29 in docket ID number 

EPA–HQ–OPP–2008–0876. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, 

tolerances in (40 CFR 180.361). EPA 

assessed dietary exposures from 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 


hsrobinson on DSK69SOYB1PROD with RULES
Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4281 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for pendimethalin, 

N-(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 1994– 

1996 and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII). As to residue levels in food, the 

chronic dietary exposure analysis was 

based on the following assumptions: 

a. All currently registered raw 

agricultural commodities (RACs) and all 

proposed uses on RACs have tolerance 

level residues of pendimethalin and its 

metabolite, 4-[(1-ethylpropy)amino]-2- 

methyl-3,5-dinitrobenzyl alcohol. 

b. All crops for which tolerances exist 

or are proposed were treated, i.e., 100 

percent crop treated (PCT). 

iii. Cancer. Pendimethalin is 

classified as a ‘‘Group C,’’ possible 

human carcinogen, based on a 

statistically significant increase trend 

and pair-wise comparison between the 

high dose group and controls for thyroid 

follicular cell adenomas in male and 

female rats. A non-quantitative 

approach (i.e., non-linear, RfD 

approach) was employed by the Agency 

since mode of action studies are 

available that demonstrate that the 

thyroid tumors are due to a thyroidpituitary imbalance. Pendimethalin was 

shown to be non-mutagenic in 

mammalian somatic cells and germ 

cells. Cancer risk was assessed using the 

same estimates as discussed in Unit 

III.C.1.ii., chronic exposure. Based on 

concern for the hormonal changes 

(alterations in thyroid weights and 

histopathological lesions) seen in 

several studies following oral 

administration of pendimethalin for 14, 

28, and 92 days, as well as the following 

chronic exposure and the likelihood 

that pendimethalin may cause 

disruption in the thyroid, the Agency 

has required a developmental thyroid 

study to further characterize these 

effects. This study has not been 

submitted. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for pendimethalin, N-(1-ethylpropyl)- 

3,4-dimethyl-2,6-dinitrobenzenamine. 

Tolerance level residues and/or 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pendimethalin, N-(1-ethylpropyl)- 

3,4-dimethyl-2,6-dinitrobenzenamine, 

in drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine. Further 

information regarding EPA drinking 

water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, acute 

exposures are estimated to be 77.7 parts 

per billion (ppb) for surface water and 

0.036 ppb for ground water. Chronic 

exposures for non-cancer assessments 

are estimated to be 6.0 ppb for surface 

water and 0.036 ppb for ground water, 

and for chronic exposures for cancer 

assessments are estimated to be 4.8 ppb 

for surface water. Due to the tight 

sorption to soil, pendimethalin is not 

considered a cancer risk in ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model for 

PRZM-EXAMS concentrations. 

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). 

Pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, is 

currently registered for the following 

uses that could result in residential 

exposures: Turf grass. EPA assessed 

residential exposure using the following 

assumptions: The scenarios used were 

short-term in duration and consisted of 

dermal (for adults and children), and 

oral (hand-to-mouth, and soil ingestion, 

for children only) exposure. The level of 

concern for oral, dermal, and inhalation 

exposure is an MOE of less than 300. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of 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.’’ 

EPA has not found pendimethalin, N- 

(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, to share a common 

mechanism of toxicity with any other 

substances, and pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, does not have 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 EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) 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 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The Agency concluded there is potential 

for prenatal and/or postnatal toxicity 

(thyroid) in developing offspring 

resulting from exposure to 

pendimethalin. There was no indication 

of prenatal and/or postnatal qualitative 

or quantitative increased susceptibility 

in the developmental studies in rats and 

rabbits or the 2–generation reproduction 

studies in rats. However, because 

developmental LOAELs for thyroid 

toxicity could not be determined in the 

developmental studies, the Agency has 

requested developmental thyroid 

toxicity data to determine potential 

thyroid toxicity following prenatal and/ 

or postnatal exposure to pendimethalin. 

3. Conclusion. Based on the following 

considerations, EPA has determined 

that the FQPA SF should be retained for 

the subchronic and chronic thyroid 

endpoints: 


hsrobinson on DSK69SOYB1PROD with RULES
4282 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

i. The toxicity database for 

pendimethalin is not complete. Based 

on the hormonal changes, alterations in 

thyroid weights and histopathological 

lesions, observed in several studies 

following oral administration of 

pendimethalin, it is likely that 

pendimethalin may cause disruption in 

the endocrine system. There is concern 

that perturbation of thyroid homeostasis 

may lead to hypothyroidism and 

possibly result in adverse effects on the 

developing nervous system. 

Consequently, EPA has recommended 

that a developmental thyroid assay be 

conducted to evaluate the impact of 

pendimethalin on thyroid hormones, 

structure, and/or thyroid hormone 

homeostasis during development. This 

study has not yet been submitted. 

In accordance with 40 CFR part 158 

Toxicology Data Requirements, acute 

and subchronic neurotoxicity studies 

and an immunotoxicity study are 

required for pendimethalin. However, 

since there was no evidence of 

neurotoxic clinical signs, changes in 

brain weight, or histopathology of the 

nervous system in any study with 

pendimethalin, the Agency determined 

that an additional factor for database 

uncertainties is not needed to account 

for lack of these data. Additionally, 

there is no need for a developmental 

neurotoxicity study. In the absence of 

specific immunotoxicity studies, EPA 

has evaluated the available 

pendimethalin toxicity data to 

determine whether an additional 

database uncertainty factor is needed to 

account for potential immunotoxicity. 

There are no indications in the available 

studies that organs associated with 

immune function, such as the thymus 

and spleen, are affected by 

pendimethalin, and pendimethalin does 

not belong to a class of chemicals (e.g., 

the organotins, heavy metals, or 

halogenated aromatic hydrocarbons) 

that would be expected to be 

immunotoxic. 

Therefore, the Agency determined 

that an additional uncertainty factor for 

database uncertainties is not need to 

account for lack of these data. 

ii. There was no indication of prenatal 

and/or postnatal qualitative or 

quantitative increased susceptibility in 

the developmental studies in rats and 

rabbits or the 2–generation reproduction 

studies in rats. However, the 

developmental studies in rats and 

rabbits were not adequate to determine 

the potential for thyroid toxicity during 

development. Consequently, there is 

concern for potential increased 

sensitivity or susceptibility in offspring 

regarding thyroid effects, and a 

developmental thyroid toxicity study 

has been required. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine. 

Although the exposure estimate is 

very conservative and there are no 

neurotoxic concerns for pendimethalin, 

there is sufficient uncertainty regarding 

thyroid effects, particularly thyroid 

effects in the young, that EPA is 

retaining the 10X FQPA SF for all 

subchronic and chronic exposures 

whose endpoint is based on thyroid 

effects. Pendimethalin has not been 

shown to cause acute effects. EPA has 

also determined that the traditional 10X 

uncertainty factor to account for 

interspecies variation may be reduced to 

3X for these subchronic and chronic 

exposures, since it has been established 

that rats are more susceptible to thyroid 

effects than humans. These factors, 

together with the traditional 10X 

uncertainty factor to account for 

intraspecies variation, result in a total 

uncertainty factor of 300X (10X, 3X, and 

10X). 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, pendimethalin, N- 

(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, is not expected to 

pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to pendimethalin, 

N-(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, from food and 

water will utilize 15% of the cPAD for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, is not expected to 

exceed the MOEs of concern. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, is 

currently registered for uses that could 

result in short-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 650 for adult 

males and 580 for adult females. The 

aggregate exposure estimate for children 

results in a total MOE of 350 and 340 

due to a residential exposure estimate of 

0.024 mg/kg/day and 0.025 mg/kg/day 

when children are exposed to 

application rates (to residential turf) of 

2 lbs ai/Acre and 3 lbs ai/Acre, 

respectively. The level of concern is a 

value less than 300, therefore these 

MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Therefore, the 

intermediate-term aggregate risk is the 


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Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4283 

sum of the risk from exposure to 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, 

through food and water, which has 

already been addressed, and will not be 

greater than the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. As explained in Unit 

III.C.iii, the chronic risk assessment is 

considered to be protective of any 

cancer effects since available studies 

demonstrate that the thyroid tumors are 

due to a thyroid pituitary imbalance, 

and pendimethalin was shown to be 

non-mutagenic in mammalian somatic 

cells and germ cells. 

6. 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, or to infants and children 

from aggregate exposure to 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

using liquid chromatography/mass 

spectrometry analysis (LC/MS/MS), is 

available to enforce the tolerance 

expression. The method 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 currently no established or 

proposed Codex Maximum Residue 

Levels (MRLs) for pendimethalin. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has revised the requested 

tolerances to reflect the residue 

chemistry data submitted to support the 

proposed label for the use of 

pendimethalin on grass grown for seed 

and dormant Bermuda grass as 

requested by the petitioner. The 

commodity names were also changed to 

coincide with the regulatory Crop Group 

names as stated in 40 CFR 180.41(c). 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, 

expressed as the stoichiometric 

equivalent of pendimethalin, in or on 

grass forage, fodder, and hay, crop group 

17, forage; grass forage, fodder, and hay, 

crop group 17, hay; grass forage, fodder, 

and hay, crop group 17, straw at 20 

ppm, 13 ppm, and 4.0 ppm, 

respectively. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. 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: January 19, 2010. 

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 180.361 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.361 Pendimethalin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Grass forage, fodder, and 

hay crop group 17, forage .............................. 20 

Grass forage, fodder, and 

hay crop group 17, hay 13 


hsrobinson on DSK69SOYB1PROD with RULES
4284 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

Commodity Parts per million 

Grass forage, fodder, and 

hay crop group 17, 

straw ............................ 4.0 

* * * * * 

* * * * * 

[FR Doc. 2010–1610 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0276; FRL–8808–6] 

Triticonazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of triticonazole 

in or on grain, cereal, group 15, except 

rice, and grain, cereal, forage, fodder 

and straw, group 16, except rice. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 27, 2010. Objections and 

requests for hearings must be received 

on or before March 29, 2010, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0276. 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. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308-8050; e-mail address: 

Maignan.Tawanda@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 those engaged in the 

following activities: 

•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 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 Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left-side 

navigation menu. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

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–2009–0276 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 

as required by 40 CFR part 178 on or 

before March 29, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0276, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of August 19, 

2009, (74 FR 41900) (FRL–8426–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8F7420) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27709-3528. The 

petition requested that 40 CFR 180.583 

be amended by establishing tolerances 

for residues of the fungicide 

triticonazole, (1RS)-(E)-5-[(4- 

chlorophenyl)methylene]-2,2-dimethyl1-(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol, in or on grain, 

cereal, group 15, except rice, and grain, 

cereal, forage, fodder and straw, group 

16, except rice, at 0.05 and 0.10 parts 

per million (ppm), respectively. That 

notice referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. Based upon review of 

the data supporting the petition, EPA 

has modified both the crop group 

terminology, and tolerance levels for 


hsrobinson on DSK69SOYB1PROD with RULES