Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Rules and Regulations 46377 

Commodity Parts per million 

* * * * * 

* * * * * 

■ 39. Section 180.517 is amended by 

removing the entries for ‘‘Fat of cattle, 

goat, horse and sheep,’’ ‘‘Liver of cattle, 

goat, horse and sheep,’’ ‘‘Meat 

Byproducts, except liver of cattle, goat, 

horse, and sheep,’’ and ‘‘Meat of cattle, 

goat, horse and sheep’’ and adding 

alphabetically the following entries to 

the table in paragraph (a) to read as 

follows: 

§ 180.517 Fipronil; tolerances for residues. 

(a) * * * 

Commodity Parts per million 

Cattle, fat ...................... 0.40 

Cattle, liver ................... 0.10 

Cattle, meat .................. 0.04 

Cattle, meat byproducts, except liver ....... 0.04 

* * * * * 

Goat, fat ........................ 0.40 

Goat, liver ..................... 0.10 

Goat, meat .................... 0.04 

Goat, meat byproducts, 

except liver ................ 0.04 

* * * * * 

Horse, fat ...................... 0.40 

Horse, liver ................... 0.10 

Horse, meat .................. 0.04 

Horse, meat byproducts, except liver ....... 0.04 

* * * * * 

Sheep, fat ..................... 0.40 

Sheep, liver .................. 0.10 

Sheep, meat ................. 0.04 

Sheep, meat byproducts, except liver ....... 0.04 

* * * * * 

■ 40. Section 180.554 is amended by 

removing the entry for ‘‘Apple pomace’’ 

and by adding alphabetically the 

following entries to the table in 

paragraph (a)(1) to read as follows: 

§ 180.554 Kresoxim-methyl; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per million 

Apple, dry pomace .... 1.0 

Apple, wet pomace ... 1.0 

* * * * * 

* * * * * 

■ 41. Section 180.615 is amended by 

removing the entry for ‘‘Wheat, milled 

byproducts’’ and adding alphabetically 

the following entries to the table in 

paragraph (d) to read as follows: 

§ 180.615 Amicarbazone; tolerances for 

residues. 

* * * * * 

(d) * * * 

Commodity Parts per million 

* * * * * 

Wheat, bran .................. 0.15 

Wheat, flour .................. 0.15 

* * * * * 

Wheat, germ ................. 0.15 

* * * * * 

Wheat, middlings, ......... 0.15 

Wheat, shorts ............... 0.15 

* * * * * 

[FR Doc. E9–21416 Filed 9–8–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0876; FRL–8431–2] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of the 

herbicide pendimethalin including its 

metabolites and degradates in or on 

olive at 0.1 parts per million (ppm). The 

Interregional Research Project Number 4 

(IR–4) requested this tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 9, 2009. Objections and 

requests for hearings must be received 

on or before November 9, 2009, 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e–CFR 

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


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46378 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Rules and Regulations 

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 November 9, 2009. 

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 22202. 

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 8E7404) by IR–4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.361 be 

amended by establishing tolerances for 

combined residues of the herbicide 

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

methyl-2,6-dinitrobenzenamine and its 

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

methyl-3, 5-dinitrobenzyl alcohol in or 

on olive at 0.1 parts per million (ppm). 

That notice referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, on behalf of IR–4 and is 

available to the public in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

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 including its metabolites 

and degradates on olive at 0.1 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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 moderate oral and 

eye toxicity and low dermal and 

inhalation toxicity. Pendimethalin is not 

a dermal sensitizer. The target organ for 

pendimethalin in chronic and 

subchronic rat and mouse studies is the 

thyroid. Effects seen in these studies 

include alterations in thyroid hormones, 

increased thyroid weight, and 

microscopic thyroid lesions (including 

increased thyroid follicular cell height, 

follicular cell hyperplasia, as well as 

follicular cell adenomas). 

Prenatal developmental toxicity 

studies in rats and rabbits show no 

indication of qualitative or quantitative 

susceptibility following prenatal and 

postnatal exposure in 2-generation 

reproduction studies in rats. A 

developmental thyroid study has been 

requested to provide additional 

information to evaluate thyroid toxicity 

in the developing fetus following 

prenatal and postnatal exposure. 

In a combined chronic/ 

carcinogenicity study in rats, the lowestobserved-adverse-effect level (LOAEL) 

of 250 milligrams/kilogram/day (mg/kg/ 

day) is based on decreased survival, 

body weight gain and food 

consumption, increased gamma 

glutamyl transferase and cholesterol, 

increase in absolute and/or relative liver 

weight, generalized icterus, dark 

adipose tissue in females, diffusely dark 

thyroids and follicular cell hyperplasia 

of the thyroid. Thyroid tumors were 

observed in both male and female rats. 

In the carcinogenicity study in mice, the 

LOAELs of 622.1 and 806.99 mg/kg/day 

for males and females, respectivley, are 

based on increased mortality in females, 

decreased body weight in females, 

increased absolute thyroid, liver and 

gall bladder weights and/or relative 

body and brain weight ratios in males 

and females as well as amyloidosis in 

males. There were no tumors observed 

in mice. 

Pendimethalin is classified as a 

‘‘Group C’’, possible human carcinogen, 

based on a statistically significant 

increased 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., nonlinear, 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. 

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 following 

chronic exposure and the likelihood 

that pendimethalin may cause 

disruption in the thyroid, the Agency 


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required a developmental thyroid study 

to be submitted to further characterize 

these effects. 

There is no evidence of neurotoxicity 

or potential immunotoxicity for 

pendimethalin in the toxicology 

database. An immunotoxicity and acute 

and subchronic neurotoxicity studies 

are required as part of the revised 40 

CFR part 158 toxicology data 

requirements for pendimethalin. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pendimethalin as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Pendimethalin: Human Health Risk 

and Exposure Assessment for Proposed 

Section 3 Registration for Use on Olive,’’ 

dated May 28, 2009, at 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 used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Pendimethalin: Human Health Risk 

and Exposure Assessment for Proposed 

Section 3 Registration for Use on Olive,’’ 

dated May 28, 2009, at page 10 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, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pendimethalin tolerances in 40 

CFR 180.361. EPA assessed dietary 

exposures from pendimethalin 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 

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; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used Dietary Exposure Evaluation 

Model (DEEM-FCID, version 2.00), 

which uses food consumption data from 

the U.S. Department of Agriculture 

(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 

b. All crops for which tolerances exist 

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

crop treated (CT). 

In estimating residues in processed 

commodities EPA used empirical 

processing factors obtained from the 

processing studies, where available; 

maximum theoretical concentration 

factors of 8.0 for the processed 

commodities of wheat bran and wheat 

germ and 1.4 for wheat flour; and DEEM 

7.81 default-processing factors were 

used for the remaining processed 

commodities. 

iii. Cancer. As explained in Unit II.A., 

EPA has concluded that the chronic risk 

assessment will be protective of the 

precursor events that have led to cancer 

effects in animal studies. Therefore, a 

separate quantitative dietary exposure 

assessment to evaluate cancer risk was 

not conducted. 

iv. Anticipated residue and percent 

crop treated. The Agency did not use 

anticipated residue or percent crop 

treated (PCT) in the dietary assessment 

for pendimethalin. The assumption of 

100% CT and tolerance level residues 

was made for all registered and 

proposed food commodity uses of 

pendimethalin. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pendimethalin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pendimethalin. 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 were estimated. Modeled 

estimates of drinking water were 

entered into the dietary exposure model. 

For chronic exposures for non-cancer 

assessments, the concentration values of 

pendimethalin are estimated to be 6.0 

ppb for surface water and 0.036 ppb for 

ground 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). 

Pendimethalin is currently registered 

for the following residential non-dietary 

sites: Recreational and residential turf 

(including home lawns, golf courses, 

athletic fields, etc.) and ornamentals. 

EPA assessed residential exposure based 

on applications to residential turf (i.e., 

home lawns), since this use is expected 

to result in the greatest residential 

exposure. 

There is a potential for short-term 

exposure of homeowners applying 

products containing pendimethalin on 

home lawns. There is also a potential for 

short-term post-application exposure of 

adults and children entering lawn and 


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46380 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Rules and Regulations 

recreation areas previously treated with 

pendimethalin. Exposures from treated 

recreational sites are expected to be 

similar to, or lower than, those from 

treated residential turf sites; therefore, a 

separate exposure assessment for 

recreational turf sites was not 

conducted. EPA assessed exposures 

from the following residential turf postapplication scenarios: 

i. Adult and toddler post-application 

dermal exposure from contact with 

treated lawns. 

ii. Toddlers’ incidental ingestion of 

pesticide residues on lawns from handto-mouth transfer. 

iii. Toddlers’ object-to-mouth transfer 

from mouthing of pesticide-treated 

turfgrass. 

iv. Toddlers’ incidental ingestion of 

soil from pesticide-treated residential 

areas. 

The post-application risk assessment 

was conducted in accordance with the 

Residential Standard Operating 

Procedures (SOPs) and recommended 

approaches of the EPA Health Effects 

Division’s (HED’s) Science Advisory 

Council for Exposure (ExpoSAC). 

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 to 

share a common mechanism of toxicity 

with any other substances, and 

pendimethalin 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 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 Web site 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 

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, in order 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 safety factor should be 

retained for the subchronic and chronic 

thyroid endpoints: 

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. 

ii. There was no indication of 

pendimethalin neurotoxicity in 

subchronic or chronic toxicity studies 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. 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, as 

discussed above, a developmental 

thyroid toxicity study has been 

required. 

iv. The available studies do not 

indicate potential immunotoxicity and 

pendimethalin does not belong to the 

class of compounds (e.g., the organotins, 

heavy metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be toxic to the immune system. Based 

on the available data the 

immunotoxicity is not expected to 

provide a Point of Departure (POD) 

lower than that currently used for 

overall risk assessments. Therefore, at 

this time a database uncertainty factor is 

not needed for the lack of these studies. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The chronic food exposure assessments 

are considered to be highly 

conservative, as they assume that all 

crops registered and proposed have 

residues at tolerance-level. The drinking 

water estimates were derived from 

conservative screening models. The 

residential exposure assessment utilizes 

reasonable high-end variables set out in 

EPA’s Residential Exposure SOPs 

(Standard Operating Procedures). The 

aggregate assessment is based upon 

reasonable high-end residential 

exposure assumptions, and is also not 

likely to under estimate exposure to any 

subpopulation, including those 

comprised of infants and children. 


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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 safety factor 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 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 

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 is not expected. 

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 is currently registered 

for use(s) 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. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, water, and 

residential exposures 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 at an application rate (to 

residential turf) of 2 lbs active 

ingredient/Acre (ai/A), and a total MOE 

of 340 for an application rate of 3 lbs ai/ 

A. As the level of concern is for MOEs 

that are lower than 300, 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 is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to pendimethalin 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 II.A., 

the chronic risk assessment is 

considered to be protective of any 

cancer effects. 

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 residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

liquid chromatography/mass 

spectrometry (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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no established or 

proposed Codex or Canadian Maximum 

Residue Levels (MRLs) for 

pendimethalin. Mexico has established 

MRLs (expressed as pendimethalin per 

se) for several crops but none for olives. 

V. Conclusion 

Therefore, a tolerance is established 

for combined residues of 

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

dimethyl-2,6-dinitrobenzenamine], 

including its metabolites and 

degradates, in or on olive at 0.1 ppm. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring only 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 the commodity. 

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 


jlentini on DSKJ8SOYB1PROD with RULES
46382 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Rules and Regulations 

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: September 1, 2009. 

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 

revising the introductory text to 

paragraph (a) and adding alphabetically 

an entry for ‘‘olive’’ to the table in 

paragraph (a) to read as follows: 

§ 180.361 Pendimethalin; tolerance for 

residues. 

(a) General. Tolerances are 

established for the combined residues of 

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

dimethyl-2,6-dinitrobenzenamine], 

including its metabolites and 

degradates. Compliance with the 

tolerance levels specified is to be 

determined by measuring only 

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 

the following raw agricultural 

commodities. 

Commodity Parts per million 

* * * * * 

Olive ................................ 0.1 

* * * * * 

* * * * * 

[FR Doc. E9–21719 Filed 9–8–09; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 74 

[MB Docket No. 07–172; FCC 09–59]. 

Amendment of Service and Eligibility 

Rules for FM Broadcast Translator 

Stations 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection requirements 

associated with 47 CFR 74.1284, FCC 

Form 303–S and FCC Form 345. 

Therefore, this rule and forms will take 

effect on October 1, 2009. On September 

1, 2009, the Commission published the 

summary document of the Report and 

Order, In the Matter of the Amendment 

of Service and Eligibility Rules for FM 

Broadcast Translator Stations, MB 

Docket No. 07–172, FCC 09–59, at 74 FR 

45126. The Ordering Clause of the 

Report and Order stated that the 

Commission would publish a notice in 

the Federal Register announcing when 

OMB approval for Section 74.1284 and 

information collection requirements 

(revisions to FCC Form 303–S and 345) 

have been received and when the 

revised rule and requirements will take 

effect. This notice is consistent with the 

statement in the Report and Order. 

FCC Form 349 has not received OMB 

approval to date. The Commission will 

publish a notice in the Federal Register 

announcing when OMB approval has 

been received. 

DATES: The amendments to 47 CFR 

74.1284, published September 1, 2009 

(74 FR 45130) are effective on October 

1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Cathy Williams, cathy.williams@fcc.gov 

or on (202) 418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on 

September 1, 2009, OMB approved, for 

a period of three years, the information 

collection requirement(s) contained in 

Section 74.1284 of the rules and 

revisions to FCC Forms 303–S and 345. 

The Commission publishes this notice 

to announce the effective date of this 

rule and requirements. If you have any 

comments on the burden estimates 

listed below, or how the Commission 

can improve the collections and reduce 

any burdens caused thereby, please 

contact Cathy Williams, Federal 

Communications Commission, Room 1– 

C823, 445 12th Street, SW, Washington, 

DC 20554. Please include OMB Control 

Numbers, 3060–0075 (Form 345), 3060– 

0110 (Form 303–S) and 3060–0250 

(Section 74.1284) in your 

correspondence. The Commission will 

also accept your comments via the 

Internet if you send them to 

PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an e–mail to 

fcc504@fcc.gov or call the Consumer & 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

SYNOPSIS 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the Commission is notifying the public 

that it received OMB approval on 

September 1, 2009, for the information 

collection requirement(s) contained in 

the Commission’s rules at 47 CFR 

74.1284 and revisions to FCC Forms 

303–S and 345. 

Under 5 CFR 1320, an agency may not 

conduct or sponsor a collection of 

information unless it displays a current, 

valid OMB Control Number. 


jlentini on DSKJ8SOYB1PROD with RULES