Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Rules and Regulations 54963 

Commodity Parts per 

million 

Wheat, straw ............................. 0.2 

1 There are no U.S. registrations for banana 

(whole) as of September 22, 1993. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

■ 25. Section 180.491 is amended by 

revising the tables in paragraphs (a)(1) 

and (a)(2) to read as follows: 

§180.491 Propylene oxide; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Cacao bean, dried bean ........... 200 

Cacao bean, cocoa powder ..... 200 

Fig ............................................. 3.0 

Garlic, dried .............................. 300 

Grape, raisin ............................. 1.0 

Herbs and spices, group 19, 

dried ...................................... 300 

Nut, tree, group 14 ................... 300 

Onion, dried .............................. 300 

Plum, prune, dried .................... 2.0 

(2) * * * 

Commodity Parts per 

million 

Basil, dried leaves .................... 6000 

Cacao bean, dried bean ........... 20.0 

Cacao bean, cocoa powder ..... 20.0 

Fig ............................................. 3.0 

Garlic, dried .............................. 6000 

Grape, raisin ............................. 4.0 

Herbs and spices, group 19, 

dried, except basil ................. 1500 

Nut, tree, group 14 ................... 10.0 

Onion, dried .............................. 6000 

Plum, prune, dried .................... 2.0 

* * * * * 

■ 26. Section 180.523 is revised to read 

as follows: 

§180.523 Metaldehyde; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

molluscicide metaldehyde in or on food 

commodities, as follows: 

Commodity Parts per 

million 

Artichoke, globe ........................ 0.07 

Berry group 13 .......................... 0.15 

Cactus ....................................... 0.07 

Fruit, citrus, group 10 ............... 0.26 

Lettuce ...................................... 1.73 

Strawberry ................................ 6.25 

Tomato ...................................... 0.24 

Commodity Parts per 

million 

Vegetable, brassica, leafy, 

group 5 .................................. 2.5 

Watercress ................................ 3.2 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

■ 27. Section 180.540 is revised to read 

as follows: 

§180.540 Fenitrothion; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide fenitrothion, O,O-dimethyl 

O-(4-nitro-m-tolyl) phosphorothioate, 

from the postharvest application of the 

insecticide to stored wheat in Australia, 

in or on the following food commodity: 

Commodity Parts per 

million 

Wheat, gluten1 .......................... 3.0 

1There are no U.S. registrations on food 

commodities since 1987. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E8–22078 Filed 9–23–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0405; FRL–8368–8] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

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 crayfish 

at 0.05 parts per million (ppm), and 

cotton gin byproducts at 3.0 ppm. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 24, 2008. Objections and 

requests for hearings must be received 

on or before November 24, 2008, 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–2008–0405. 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 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: Jim 

Tompkins, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5697; e-mail address: 

tompkins.jim@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 


rwilkins on PROD1PC63 with RULES
54964 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Rules and Regulations 

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 EPA’s tolerance 

regulations at 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 FFDCA, 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–2008–0405 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 24, 2008. 

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–2008–0405, 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. Petition for Tolerance 

In the Federal Register of June 13, 

2008 (73 FR 33814) (FRL–8367–3), 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 6F7098) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709. 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, in or on crayfish at 0.05 ppm, 

and cotton byproducts at 3.0 ppm. 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. No comments 

were received on 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 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 raw 

agricultural commodity crayfish at 0.05 

ppm, and cotton byproducts at 3.0 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 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. The 

thyroid is a target organ for 

pendimethalin in chronic studies. 

Thyroid toxicity in chronic and 

subchronic rat and mouse studies was 

manifested as alterations in thyroid 

hormones (decreased Total T4, and T3, 

increased percent of free T4 and T3) 

increased thyroid weight, and 

microscopic thyroid lesions (including 

increased thyroid follicular cell height, 

follicular cell hyperplasia, as well as 

follicular cell adenomas). 

The data provided no indication of 

increased susceptibility following pre-/ 

postnatal exposure in the twogeneration reproduction study in rats. 

Pendimethalin is classified as a ‘‘Group 

C’’, possible human carcinogen, 

chemical based on a statistically 

significant increased trend and pairwise comparison between the high dose 

group and controls for thyroid follicular 

cell adenomas in male and female rats. 

A non-quantitative cancer risk 

assessment approach is being followed 

since mode of action studies are 

available that demonstrate that the 

thyroid tumors are due to a thyroidpituitary imbalance, and also since 

pendimethalin was shown to be nonmutagenic in mammalian somatic cells 

and germ cells. The chronic risk 

assessment is considered to be 

protective of any cancer effects. 


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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 chemical name used for 

human risk assessment is shown in the 

table of this unit. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THE HERBICIDE PENDIMETHALIN, N-(1- 

ETHYLPROPYL)-3,4-DIMETHYL-2,6-DINITROBENZENAMINE, AND ITS METABOLITE, 4-[(1-ETHYLPROPYL) AMINO]-2-METHYL3,5-DINITROBENZYL ALCOHOL, FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Point of Departure Dose Used in Risk 

Assessment, UF 

RfD, PAD, Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute Dietary 

(Females 13–49) 

(General U.S population) 

NA NA NA No appropriate acute endpoint identified for 

these groups. There were no toxic effects 

attributable to a single dose. 

Chronic Dietary 

(All populations) 

NOAEL = 10 mg/kg/ 

day 

Chronic RfD = 0.03 

mg/kg/day 

UFH = 10X 

UFA = 3X 

UFDB = 10X 

Total UF = 300X 

Chronic RfD = 0.03 

mg/kg/day 

cPAD = Chronic÷RfD 

cPAD = 0.03 mg/kg/ 

day 

92–day thyroid function study in rats; 56– 

day thyroid study in rats; 14–day intra 

thyroid metabolism study in rats. 

LOAEL = 31 mg/kg/day based on hormonal 

and histopathological changes in the thyroid. 

Incidental Oral ShortTerm 

(1–30 days) 

Intermediate-Term 

(1–6 months) 

NOAEL = 10 mg/kg/ 

day 

UFH = 10X 

UFA = 3X 

UFDB = 10X 

Total UF = 300X 

Residential LOC = 

300 

92–day thyroid function study in rats; 56– 

day thyroid study in rats; 14–day intra 

thyroid metabolism study in rats. 

LOAEL = 31 mg/kg/day based on hormonal 

and histopathological changes in the thyroid. 

Dermal Short-Term 

(1–30 days) 

Intermediate-Term 

(1–6 months) 

Long-Term 

(> 6 months) 

NOAEL = 10 mg/kg/ 

day 

UFH = 10X 

UFA = 3X 

UFDB = 10X 

Total UF = 300X 

Dermal Absorption = 

3% 

Residential LOC = 

300 

92–day thyroid function study in rats; 56– 

day thyroid study in rats; 14–day intra 

thyroid metabolism study in rats. 

LOAEL = 31 mg/kg/day based on hormonal 

and histopathological changes in the thyroid. 

Inhalation Short-Term 

(1–30 days) 

Intermediate-Term 

(1–6 months) 

Long-Term 

(> 6 months) 

NOAEL = 10 mg/kg/ 

day 

UFH = 10X 

UFA = 3X 

UFDB = 10X 

Total UF = 300X 

Inhalation toxicity is 

assumed to be 

equivalent to oral 

toxicity. 

Residential LOC = 

300 

92–day thyroid function study in rats; 56– 

day thyroid study in rats; 14–day intra 

thyroid metabolism study in rats. 

LOAEL = 31 mg/kg/day based on hormonal 

and histopathological changes in the thyroid. 

Cancer 

(Oral, dermal, inhalation) 

Pendimethalin is classified as a Group C possible human carcinogen. 

The chronic dietary assessment using the cPAD is considered to be 

protective of cancer effects. 

2–year chronic/carcinogenicity study in rats. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). UFDB = to account for the absence of key data (i.e., lack 

of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = 

margin of exposure. LOC = level of concern. N/A = not applicable. 


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C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to the herbicide 

pendimethalin, and its metabolite (CL 

202347), EPA considered exposure 

under the petitioned-for tolerances as 

well as all existing tolerances for the 

herbicide pendimethalin, and its 

metabolite (CL 202347) in 40 CFR 

180.361. EPA assessed dietary 

exposures from the herbicide 

pendimethalin, and its metabolite (CL 

202347) 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 the herbicide 

pendimethalin, and its metabolite (CL 

202347); therefore, a quantitative acute 

dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment of 

the dietary Exposure Evaluation Model 

(DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the United 

States Department of Agriculture 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII) and 

accumulated exposure to the chemical 

for each commodity (CSFII, 1994–1996, 

and 1998). Tolerance-level residues 

were assumed for all food commodities 

with current and proposed 

pendimethalin tolerances, and it was 

assumed that all of the crops included 

in the analysis were treated (i.e., 100 

percent crop treated (PCT)). These 

assumptions result in highly 

conservative estimates of dietary 

exposure and risk. 

iii. Cancer. Pendimethalin is 

classified as a ‘‘Group C’’ possible 

human carcinogen, chemical 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., non-linear, RfD 

approach) was used by the Agency since 

mode of action studies are available that 

demonstrate that the thyroid tumors are 

due to a thyroid-pituitary imbalance, 

and also since pendimethalin was 

shown to be non-mutagenic in 

mammalian somatic cells and germ 

cells. The cPAD from the 92–day 

thyroid function study in rats; 56–day 

thyroid study in rats; 14–day intra 

thyroid metabolism study in rats used 

for the chronic dietary assessment 

provide adequate protection for the precancerous effect on the thyroid. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for the herbicide 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 in drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of the herbicide 

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, drinking water 

concentrations (EDWCs) of the herbicide 

pendimethalin were estimated. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 77.7 parts per 

billion (ppb) was used to assess the 

contribution to drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 6 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 residential non-dietary 

sites: Landscape, grounds plantings, 

ornamental crops, turf grass, and lawns. 

EPA assessed residential exposure using 

the following assumptions: Exposures 

are short-term in duration, and consist 

of dermal (for adults and children), and 

oral (hand-to-mouth, object-to-mouth, 

and soil ingestion, for children only). 

The Agency combines risk values 

resulting from separate exposure 

scenarios when it is likely they can 

occur simultaneously, based on the usepattern and the behavior associated with 

the exposed population. 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. The residential exposure for 

children results in a total MOE (dermal 

+ oral) of 410 at an application rate of 

2 lb ai/acre, and an MOE of 400 for an 

application rate of 3 lb 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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

pendimethalin and 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 

not assumed that pendimethalin has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

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 data base for pendimethalin does 

not indicate a potential for increased 

toxicological sensitivity from either 

prenatal or postnatal exposures. No 


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developmental toxicity was observed in 

either the rat or rabbit developmental 

toxicity studies, nor was there evidence 

in the 2–generation reproduction study 

of developmental or reproductive 

toxicity at dose levels below those in 

which parental toxicity was observed. 

There was no neurotoxicity observed in 

the submitted toxicity studies, and 

therefore a developmental neurotoxicity 

(DNT) study is not required. 

3. Conclusion. EPA has determined 

that the FQPA safety factor 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. This study has not yet 

been submitted. 

ii. There is no indication that 

pendimethalin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

pendimethalin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. However, 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. 

iv. 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. Conservative 

ground and surface water modeling 

estimates were used. Similarly, 

conservative Residential SOPs were 

used to assess post-application exposure 

of children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by pendimethalin. 

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 uncertainty factor 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 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. No toxic effects 

attributable to a single dose were 

identified for pendimethalin. Therefore, 

a quantitative acute risk assessment was 

not conducted for pendimethalin. 

2. Chronic risk. The dietary exposure 

(food and drinking water) pathway is 

the only source of exposure to 

pendimethalin that is expected to be of 

long term (180 to 365 days). Therefore, 

the long-term aggregate exposure and 

risk estimates are equivalent to the 

chronic dietary exposure and risk 

estimates. 

Using the exposure assumptions 

described in this unit for chronic 

exposure, EPA has concluded that 

chronic exposure to the herbicide 

pendimethalin from food and water will 

utilize 15% of the cPAD for (children 1– 

2 years of age) 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 the herbicide 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). 

The herbicide 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 the 

herbicide pendimethalin. 

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 the level of 

concern for oral, dermal, and inhalation 

exposure is an MOE of less than 300. 

The short-term aggregate exposure 

estimate for adult males results in an 

aggregate MOE of 650, while the shortterm aggregate exposure estimate for 

adult females results in an aggregate 

MOE of 580. The aggregate exposure 

estimate for children results in a total 

MOE of 350 at an application rate (to 

residential turf) of 2 lbs ai/A, and a total 

MOE of 340 for an application rate of 3 

lbs ai/A. Aggregate exposure is therefore 

not of concern for any of the population 

subgroups. 

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). 

The herbicide 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 the 

herbicide 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. EPA classified 

pendimethalin 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. EPA is following a nonquantitative approach since mode of 

action studies are available that 

demonstrate that the thyroid tumors are 

due to a thyroid-pituitary imbalance, 

and also since pendimethalin was 

shown to be non-mutagenic in 

mammalian somatic cells and germ 

cells. The chronic risk assessment is 

considered to be protective of any 


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54968 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Rules and Regulations 

cancer effects; therefore, a separate 

quantitative cancer aggregate risk 

assessment was not conducted. 

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 the herbicide 

pendimethalin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate methods are available for 

data collection and tolerance 

enforcement for existing and proposed 

uses of pendimethalin. Methods I 

through IV in the Pesticide Analytical 

Manuel (PAM) Vol. II are gas 

chromatography/electron capture (GC/ 

ECD) methods. Methods used for data 

collection are essentially the same as the 

PAM Vol. II methods, and have been 

adequately validated. 

The Food and Drug Administration’s 

PESTDATA data base (PAM Volume I, 

Appendix I) indicates that 

pendimethalin is completely recovered 

(>80%) by Multiresidue Methods 

Section 302 (Luke Method; Protocol D) 

and 303 (Mills, Onley, Gaither Method; 

Protocol E, nonfatty), and partially 

recovered (50–80%) by Multiresidue 

Method Section 304 (Mills Fatty Food 

Method; Protocol E, fatty). 

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 no established or proposed 

Codex Maxium Residue Levels (MRLs) 

for pendimethalin residues. Therefore, 

there are no questions of compatibility 

with respect to Codex MRLs and U.S. 

tolerances. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the submitted data, residues 

of pendimethalin in rice processed 

commodities are not expected to exceed 

those found in rice grain. Therefore, a 

tolerance for rice processing fraction at 

0.1 ppm is not necessary. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of the herbicide 

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

dimethyl-2,6- dinitro-benzenamine, and 

its metabolite, 4-[(1-ethylpropyl) 

amino]-2-methyl-3,5-dinitrobenzyl 

alcohol, in or on cotton, gin byproducts 

at 3.0 ppm, and crayfish at 0.05 ppm. 

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: September 9, 2008. 

Donald R. Stubbs, 

Acting 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, tolerance for 

residues. 

(a) * * * 

Commodity Parts per million 

*****

Cotton, gin byproducts ... 3.0 

*****

Crayfish ........................... 0.05 

*****


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Rules and Regulations 54969 

* * * * * 

[FR Doc. E8–22434 Filed 9–23–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0337; FRL–8382–5] 

Cyfluthrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

revises, or deletes tolerances for 

residues of cyfluthrin in or on numerous 

raw agricultural commodities. It also 

establishes tolerances for residues of 

beta-cyfluthrin in or on all commodities 

for which cyfluthrin tolerances exist. 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 24, 2008. Objections and 

requests for hearings must be received 

on or before November 24, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0337. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 pilot 

e-CFR site 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–2007–0337 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 24, 2008. 

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–2007–0337, 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 July 30, 

2008 (73 FR 44264) (FRL–8375–1), 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 7F7200) by Bayer 

CropScience, 2 T.W. Alexander Dr., P.O. 

Box 12014, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.436 be amended by: 

• Establishing tolerances for residues 

of the insecticide, cyfluthrin, cyano(4- 

fluoro-3-phenoxyphenyl)methyl-3-(2,2- 

dichloroethenyl)-2,2- 

dimethylcyclopropanecarboxylate, in or 

on food commodities barley, grain; 

buckwheat, grain; millet, grain; oat, 

grain; rye, grain; triticale, grain; and 

wheat, grain at 0.15 part per million 

(ppm); corn, field, grain; corn, pop, 

grain; and teosinte, grain at 0.05 ppm; 

sorghum, grain at 3.5 ppm; grain, cereal, 

forage, fodder and hay, group 16, forage, 

except rice at 25 ppm; grain, cereal, 

forage, fodder and hay, group 16, hay, 

except rice at 6.0 ppm; grain, cereal, 

forage, fodder and hay, group 16, stover, 

except rice at 30 ppm; and grain, cereal, 

forage, fodder and hay, group 16, straw, 

except rice at 7.0 ppm. 


rwilkins on PROD1PC63 with RULES