Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 11489 

EPA APPROVED ALABAMA NON-REGULATORY PROVISIONS—Continued 

Name of nonregulatory 

SIP provision Applicable geographic or nonattainment area 

State submittal date/ 

effective 

date 

EPA approval date Explanation 

8-Hour Ozone Maintenance plan for the Birmingham area.Jefferson County and Shelby County .................. 1/26/06 5/12/06.

[FR Doc. E9–5732 Filed 3–17–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0513; FRL–8400–1] 

Pendimethalin; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances 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, in or on Bermuda 

grass forage and hay. This action is in 

response to crisis exemptions issued by 

the Texas Department of Agriculture 

and the Oklahoma Department of 

Agriculture under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on Bermuda grass 

pastures and hay fields. This regulation 

establishes a maximum permissible 

level for residues of pendimethalin in 

these feed commodities. The timelimited tolerances expire and are 

revoked on December 31, 2009. 

DATES: This regulation is effective 

March 18, 2009. Objections and requests 

for hearings must be received on or 

before May 18, 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–2008–0513. 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 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available 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 Food Quality 

Protection Act of 1996 (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–2008–0513 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 May 18, 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 


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11490 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0513, 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 FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing timelimited 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, in 

or on Bermuda grass forage and hay at 

25 parts per million (ppm) and 60 ppm, 

respectively. These time-limited 

tolerances expire and are revoked on 

December 31, 2009. EPA will publish a 

document in the Federal Register to 

remove the revoked tolerances from the 

Code of Federal Regulations (CFR). 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

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 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 timelimited tolerances to set binding 

precedents for the application of section 

408 of FFDCA to other tolerances and 

exemptions. Section 408(e) of 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 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. . . .’’ 

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.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemptions for 

Pendimethalin on Bermuda Grass 

Forage and Hay and FFDCA Tolerances 

The Texas and Oklahoma 

Departments of Agriculture requested 

emergency exemptions for use of 

pendimethalin on Bermuda grass to 

control common sandbur and other 

sandbur species (Cenchrus echinatus), 

and issued crisis exemptions for this use 

pursuant to 40 CFR part 166, subpart C. 

The states provided information 

indicating that sandbur species is a 

serious pest that commonly infests 

Bermuda grass forage and hay fields. 

Pendimethalin has been authorized 

under FIFRA section 18 for use on 

Bermuda grass forage and hay to control 

sandbur in Texas and Oklahoma under 

the crisis provision. 

As part of its evaluation of the 

emergency exemption applications, EPA 

assessed the potential risks presented by 

residues of pendimethalin in or on 

Bermuda grass forage and hay. In doing 

so, EPA considered the safety standard 

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

decided that the necessary tolerances 

under section 408(l)(6) of FFDCA would 

be consistent with the safety standard 

and with FIFRA section 18. Consistent 

with the need to move quickly on the 

emergency exemptions in order to 

address urgent non-routine situations 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing these 

tolerances without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although these time-limited tolerances 

expire and are revoked on December 31, 

2009, under section 408(l) (5) of FFDCA, 

residues of the pesticide not in excess 

of the amounts specified in the 

tolerances remaining in or on Bermuda 

grass forage and hay after that date will 

not be unlawful, provided the pesticide 

was applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

these time-limited tolerances at the time 

of that application. EPA will take action 

to revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether pendimethalin 

meets FIFRA’s registration requirements 

for use on Bermuda grass forage and hay 

or whether permanent tolerances for 

this use would be appropriate. Under 

these circumstances, EPA does not 

believe that these time-limited tolerance 

decisions serve as a basis for registration 

of pendimethalin by a State for special 

local needs under FIFRA section 24(c). 

Nor do these tolerances serve as the 

basis for persons in any States other 

than Texas and Oklahoma to use this 

pesticide on the applicable crops under 

FIFRA section 18 absent the issuance of 

an emergency exemption applicable 

within that State. For additional 

information regarding the emergency 

exemption for pendimethalin, contact 

the Agency’s Registration Division at the 

address provided under FOR FURTHER

INFORMATION CONTACT. 

IV. 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 


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Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 11491 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with the factors specified 

in FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of these actions. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure expected as a result 

of these emergency exemption requests 

and the time-limited tolerances 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 on Bermuda grass 

forage and hay at 25 ppm and 60 ppm, 

respectively. EPA’s assessment of 

exposures and risks associated with 

establishing time-limited tolerances 

follows. 

A. 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-term, intermediate-term, 

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 the May 

20, 2008 document: Pendamethalin. 

Human Health Risk Assessment for the 

Proposed Food/Feed Use of the 

Herbicide (associated with Section 18 

Registration) on Bermuda Grass Forage 

and Hay Fields in Texas on pages 6 and 

7 of 22 in docket ID number EPA–HQ– 

OPP–2008–0513. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pendimethalin, EPA 

considered exposure under the timelimited tolerances established by this 

action as well as exposures pursuant to 

existing tolerances in (40 CFR 180.361). 

EPA assessed dietary exposures from 

pendimethalin in food as follows: 

i. Acute exposure. No acute effects 

were identified in the toxicological 

studies for pendimethalin; therefore, a 

quantitative assessment of acute dietary 

exposure was not conducted. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Survey of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA assumed tolerancelevel residues of pendimethalin in or on 

all current and proposed raw 

agricultural commodities in 40 CFR 

180.361, empirical processing factors 

obtained from processing studies, 

maximum theoretical concentration 

factor of 8.0 for wheat bran and wheat 

germ, and 1.4 for wheat flour, Dietary 

Exposure Evaluation Model (DEEM) 

7.81 default processing factors were 

used for the remaining processed 

commodities, 100% crop treated, and 

0.006 ppm pendimethalin estimated 

drinking water concentration (EDWC). 

iii. Cancer. EPA has classified 

pendimethalin as a Group ‘‘C’’ possible 

human carcinogen, based on thyroid 

follicular cell adenomas observed in 

rats. The chronic dietary assessment 

using the cPAD is considered to be 

protective of any potential cancer effects 

because mode of action studies are 

available, which demonstrate that the 

thyroid tumors are due to a thyroidpituitary imbalance. Pendimethalin has 

shown to be nonmutagenic in 

mammalian somatic cells and germ 

cells. Therefore, a separate cancer 

exposure assessment was not 

conducted. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for pendimethalin. 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 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 EDWCs of 

pendimethalin for acute exposures are 

estimated to be 77.7 parts per billion 

(ppb) for surface water and 0.036 ppb 

for ground water. For chronic exposures 

non-cancer assessments are estimated to 

be 6.0 ppb for surface water and 0.036 

ppb for ground water. 

Modeled EDWCs were directly 

entered into the dietary exposure model. 

An acute dietary endpoint was not 

identified; therefore a quantitative 

assessment of risk was not conducted 

for pendimethalin. For the chronic 

dietary risk assessment, the water 

concentration of value 6.0 ppb was used 

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). 

Pendimethalin is currently registered 

for the following uses that could result 

in residential exposures: Recreational 

and residential turf (including home 

lawns, golf courses, athletic fields, etc.), 

and ornamentals. EPA assessed 

residential exposure using the following 

assumptions: Exposures are short-term 

in duration, and consist of the following 

scenarios: (i) Dermal (adult and 

children) exposed to residential turf and 

(ii) oral exposure from hand-to-mouth, 

object-to-mouth, and soil ingestion for 

children only. The Agency combined all 

non-dietary sources of handler and postVerDate Nov<24>2008 13:31 Mar 17, 2009 Jkt 217001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\18MRR1.SGM 18MRR1

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11492 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 

application exposure to obtain an 

estimate of potential aggregate exposure. 

The LOC for oral, dermal and inhalation 

exposure is an MOE of less than 300. 

The residential exposure estimate for 

adults (consisting of dermal exposure 

only) results in a total MOE of 740, and 

is therefore not of concern. Inhalation 

post-application was not assessed 

because there are no indoor residential 

uses associated with pendimethalin 

products, and inhalation exposure 

resulting from outdoor uses is expected 

to be negligible. The residential 

exposure for children results in total 

MOEs (dermal + oral) ≥400, based on 

application rates of 2 pounds active 

ingredient/acre (lbs. ai/acre) and 3 lbs. 

ai/acre. Residential aggregate exposure 

is not of concern. 

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 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(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 

pre-natal and post-natal 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Pre-natal and post-natal sensitivity. 

The pre- and post-natal toxicology 

database for pendimethalin includes rat 

and rabbit developmental toxicity 

studies and a 2–generation reproduction 

toxicity study in rats. There was no 

indication of pre-/or post-natal 

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 could not be determined in the 

developmental studies, the Agency has 

requested developmental thyroid 

toxicity data in order to determine 

potential thyroid toxicity following preand/or post-natal exposure to 

pendimethalin. 

The rabbit toxicity study with 

pendimethalin did not demonstrate 

maternal or developmental toxicity at 

doses up to 60 milligram/kilogram/day 

(mg/kg/day) (highest dose tested). Since 

neither maternal nor developmental 

toxicity was seen at the highest dose 

tested, potential for increased sensitivity 

of the offspring could not be 

determined. 

In the 2–generation reproduction 

study in rats, there was no evidence of 

increased susceptibility of offspring. 

Effects in the pups (decreased pup body 

weight gain and possible decrease in 

number of pups born alive and pup 

survival) were seen at doses that also 

resulted in parental toxicity (decreased 

body weight). 

3. Conclusion. EPA has determined 

that the FQPA SF of 10X must be 

retained. This decision is based on the 

following findings: 

i. The toxicity database for 

pendimethalin contains all of the 

standard toxicity studies. However, 

there is uncertainty regarding potential 

thyroid effects seen in some of these 

studies. 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. The 10X database UF will 

be retained for non-occupational 

exposure scenarios pending receipt of 

the study. 

ii. Although, there is no evidence that 

pendimethalin results in increased 

susceptibility in in-utero rats or rabbits 

in the pre-natal developmental studies 

or in young rats in the 2–generation 

reproduction study, the developmental 

studies were not adequate to fully assess 

the potential for susceptibility. 

Consequently, there is concern for 

potential increased sensitivity or 

susceptibility in offspring regarding 

thyroid effects. 

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. 

EPA has also determined that the 

traditional 10X UF to account for 

interspecies variation may be reduced to 

3X since it has been established that rats 

are more susceptible to thyroid effects 

than humans. These factors, together 

with the traditional 10X UF to account 

for intraspecies variation, result in a 

total uncertainty factor of 300X (10X, 

3X, and 10X). 

D. 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. Shortterm, intermediate-term, and chronicterm 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. None of the toxicology studies 

available for pendimethalin has 

indicated the possibility of an effect of 

concern occurring as a result of a 1–day 

or single exposure was identified, 

therefore, dietary exposure presents no 

acute risks of concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic dietary exposure to 


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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 use patterns, chronic residential 

exposure to residues of pendimethalin 

is not expected, so chronic risk is a 

function of dietary exposure alone. Thus 

the chronic aggregate exposure for the 

most exposed group is below EPA’s 

LOC. 

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 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. 

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 aggregated result 

in aggregate MOEs of 650 for adult 

males, 580 for adult females, and for 

children (1 to 2 years old) results in a 

total MOE of 350 or 340 depending on 

the application rate assessed at either 2 

lbs. ai/acre or 3lbs. ai/acre. The 

aggregate MOEs for adults are based on 

the residential turf scenario and include 

combined food, drinking water and 

post-application dermal exposures. The 

aggregate MOEs for children include 

food, drinking water, post-application 

dermal and incidental oral exposures 

from entering turf areas previously 

treated with pendimethalin. Since the 

LOC for oral, dermal, and inhalation 

exposure is an MOE of less than 300, 

short-term aggregate exposure is not of 

concern for any of the population 

subgroups. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational 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. Pendimethalin has been 

classified as a ‘‘Group C’’ possible 

human carcinogen based on thyroid 

follicular cell adenomas observed in 

rats. EPA concludes that the chronic 

dietary assessment is protective of any 

potential 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. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. Methods I through IV in the 

Pesticide Analytical Manual (PAM) 

Volume II are gas chromatography with 

electron capture detection (GC/ECD) 

methods for the determination of 

pendimethalin residues of concern in 

plant commodities. 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 Canadian, 

Mexican, or Codex maximum residue 

limits for pendimethalin on the 

commodities for which tolerances are 

being established. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established 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, in or on Bermuda 

grass forage and hay at 25 ppm and 60 

ppm. These tolerances expire and are 

revoked on December 31, 2009. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) of 

FFDCA on EPA’s own initiative. 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, 

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 in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

such as the tolerances 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). 

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. 


tjames on PRODPC61 with RULES
11494 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 

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: February 12, 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 paragraph (b) to read as follows: 

§ 180.361 Pendimethalin; tolerances for 

residues 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established 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, in 

or on the specified agricultural 

commodities, resulting from use of the 

pesticide pursuant to FIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the table. 

Commodity Parts per million Expiration/revocation date 

Bermuda grass, forage ................................................................................................................................ 25 12/31/09 

Bermuda grass, hay .................................................................................................................................... 60 12/31/09 

* * * * * 

[FR Doc. E9–5831 Filed 3–17–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0936; FRL–8402–8] 

Pyraclostrobin; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for combined 

residues of pyraclostrobin and its 

desmethoxy metabolite in or on 

sugarcane, cane and sugarcane, 

molasses. 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 on sugarcane. This 

regulation establishes a maximum 

permissible level for residues of 

pyraclostrobin and its desmethoxy 

metabolite in these food. The timelimited tolerances expire and are 

revoked on December 31, 2011. 

DATES: This regulation is effective 

March 18, 2009. Objections and requests 

for hearings must be received on or 

before May 18, 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–2008–0936. All documents in the 

docket are listed in the docket index 

available in 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: 

Libby Pemberton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9364; e-mail address: 

pemberton.libby@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 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 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 the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 


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