27456 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide) in or on the following raw 

agricultural commodities: 

Commodity Parts per million Expiration/revocation 

date 

Apple 0.25 05/01/2010 

Apple, wet pomace 0.60 05/01/2010 

Celery 7.0 05/01/2010 

Cucumber 0.10 05/01/2010 

Lettuce, head 4.0 05/01/2010 

Lettuce, leaf 8.0 05/01/2010 

Pear 0.30 05/01/2010 

Pepper 0.50 05/01/2010 

Spinach 13.0 05/01/2010 

Squash 0.40 05/01/2010 

Tomato 0.30 05/01/2010 

Watermelon 0.20 05/01/2010 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E7–9206 Filed 5–15–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0995; FRL–8120–2] 

Pendimethalin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

pendimethalin and its metabolite, 4-[(1- 

ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol in or on beans; 

beans, forage; beans, hay; and peas 

(except field peas) to replace the current 

tolerances for bean, lima, seed; bean, 

lima, succulent; bean, forage; bean, hay; 

and pea, succulent. BASF Corporation 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

16, 2007. Objections and requests for 

hearings must be received on or before 

July 16, 2007, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0995. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

web site to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available 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 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Philip V. Errico, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 

(703) 305–6663; e-mail address: 

errico.philip@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 27457 

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 athttp://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the 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–2006–0995 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 July 16, 2007. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA–

HQ–OPP–2006–0995, 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 telephone number is (703) 305–

5805. 

II. Petition for Tolerance 

In the Federal Register of January 24, 

2007 (72 FR 3130) (FRL–8109–7), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 6F7149) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.361 be amended by 

establishing a tolerance 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 beans; 

beans, forage; beans, hay; and peas 

(except field peas) each at 0.1 parts per 

million (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. There were 

no comments received in response to 

the notice of filing. 

These proposed tolerances seek to 

correct an inadvertent error made by 

EPA in 2001 when EPA amended the 

pendimethalin beans and peas 

tolerances following completion of the 

pendimethalin reregistration eligibility 

determination under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act, 7 U.S.C. 136 et seq., and FFDCA 

tolerance reassessment. (66 FR 63192, 

December 5, 2001). In an attempt to 

clarify the coverage of the then existing 

beans and peas tolerances, EPA 

mistakenly narrowed the scope of the 

existing tolerances. This action reestablishes the beans and peas 

tolerances with the same coverage that 

pre-dated the 2001 amendments and 

using the terms originally recommended 

by the tolerance reassessment decision. 

Specifically, the proposed amendments 

to the pendimethalin tolerance would 

replace the current tolerances for bean, 

lima, seed; bean, lima, succulent; bean, 

forage; bean, hay; with tolerances for 

beans; beans, forage; beans, hay and the 

current tolerance for pea, succulent with 

a tolerance for peas (except field peas). 

The terms beans and peas are defined 

under 40 CFR 180.1(g) to encompass 

bean and pea commodities not covered 

by the current tolerances. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . .’’ These 

provisions were added to the FFDCA by 

the Food Quality Protection Act (FQPA) 

of 1996. 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

section 408(b)(2)(D), 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 tolerance for 

combined residues of pendimethalin 

and its metabolite on beans; beans, 

forage; beans, hay; and peas (except 

field peas) each at 0.1 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the 

tolerance 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by pendimethalin as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 


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27458 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 

described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2006–0995 

in that docket. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the toxicological level of concern 

(LOC) is derived from 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) is sometimes 

used for risk assessment. Uncertainty/ 

safety factors (UF) are used in 

conjunction with the LOC 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 risks by comparing 

aggregate 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 LOC by all 

applicable uncertainty/safety factors. 

Short-, intermediate, and long-term risks 

are evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable 

uncertainty/safety factors is not 

exceeded. 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk and 

estimates risk in terms of the probability 

of occurrence of additional adverse 

cases. Generally, cancer risks are 

considered non-threshold. 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/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

A summary of the toxicological 

endpoints for pendimethalin used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of April 12, 2006 

(71 FR 18628) (FRL–7770–4). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pendimethalin, EPA 

considered exposure under the petition 

for tolerances as well as all existing 

pendimethalin tolerances in (40 CFR 

180.361). EPA assessed dietary 

exposures from pendimethalin in food 

as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for pendimethalin; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed all 

foods for which there are tolerances 

were treated and contain tolerance-level 

residues. 

iii. Cancer. Pendimethalin is 

classified ‘‘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. The Agency used a nonquantitative approach (i.e., non-linear, 

RfD 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. The chronic risk 

assessment is considered to be 

protective of any cancer effects; 

therefore, a separate quantitative cancer 

aggregate risk assessment is not 

required. 

iv. Anticipated residue and percent 

crop treated (PCT) information. 

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% crop treated). 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

pendimethalin in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the environmental fate characteristics of 

pendimethalin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found athttp://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentrations in Groundwater (SCIGROW) models, the estimated 

environmental concentrations (EECs) of 

pendimethalin for peak exposures are 

estimated to be 39 parts per billion 

(ppb) for surface water and 0.024 ppb 

for ground water. The EECs for chronic 

exposures are estimated to be 4.8 ppb 

for surface water and 0.024 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 39 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 the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 


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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 EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional (10X) tenfold margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base 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. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional FQPA 

safety factor value based on the use of 

traditional uncertainty/safety factors 

and/or special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

The database for pendimethalin does 

not indicate a potential for increased 

toxicological sensitivity from either 

prenatal or postnatal exposures. 

3. Conclusion. In September 2006 we 

said the following: There was no 

evidence of qualitative or quantitative 

susceptibility in the submitted data. 

Additionally, exposure estimates are 

based on very conservative data and 

assumptions that will overstate 

exposure to pendimethalin. There is, 

however, a concern that perturbation of 

thyroid homeostasis may lead to 

hypothyroidism, and possibly result in 

adverse effects on the developing 

nervous system. Since thyroid toxicity 

parameters were not measured in the 

developmental toxicity studies, the 

Agency has requested a developmental 

thyroid assay be conducted to evaluate 

the impact of pendimethalin on thyroid 

hormones, structure, and/or thyroid 

hormone homeostasis during 

development. The Agency has retained 

the additional 10X FQPA safety factor in 

the form of a database uncertainty factor 

(UF[DB]) for the lack of the study, to be 

applied in determining pendimethalin 

risks. 

E. Aggregate Risks and Determination of 

Safety 

Safety is assessed for acute and 

chronic risks by comparing aggregate 

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 LOC by all 

applicable uncertainty/safety factors. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given aggregate exposure. Short-, 

intermediate, and long-term risks are 

evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable 

uncertainty/safety factors is not 

exceeded. 

1. Acute risk. No toxic effects 

attributable to a single dose were 

identified for pendimethalin. Therefore, 

an acute risk assessment is not 

warranted for this chemical. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to pendimethalin from 

food and water will utilize 26% of the 

cPAD for the population group children 

1-2. Based the use pattern, chronic 

residential exposure to residues of 

pendimethalin is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Pendimethalin is currently registered 

for use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for pendimethalin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

580 for adult males, 520 for adult 

females, 310 for children for an 

application rate of 2 lbs ai/acre to 

residential turf, and 300 for children for 

an application rate of 3 lbs ai/acre to 

residential turf. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Based on currently 

requested uses, there are no scenarios 

that are likely to result in intermediateterm exposure (30 to 180 days, 

continuous. Therefore, an intermediateterm risk assessment was not 

conducted. 

5. Aggregate cancer risk for U.S. 

population. The Agency classifies 

pendimethalin as a ‘‘Group C’’ (possible 

human) cancinogen based on thyroid 

follicular cell adenomas in rats. A nonquantitative approach, non-linear RfD 

approach is used to assess the cancer 

risk using a chronic assessment, which 

is considerated protective of any cancer 

effects: Because exposure to 

pendimethalin does not exceed the 

chronic RfD, pendimethalin is not 

expected to pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

pendimethalin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Enforcement analytical methods using 

gas chromatography and an electron 

capture detector are available in the 

Pesticide Analytical Manual, Volume II. 

B. International Residue Limits 

There are no established or proposed 

Codex Maximum Residue Levles (MRLs) 

for pendimethalin residues. Therefore, 

there are no questions of compatibility 

with respect to Codex MRLs and U.S. 

tolerances. 

C. Response to Comments 

There were no responses to the Notice 

of Filing for the requested tolerance in 

beans and peas. 

V. Conclusion 

Therefore, the tolerance is established 

for combined residues of pendimethalin 

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

dinitrobenzenamine] and its metabolite, 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol, in or on beans; 

beans, forage; beans, hay; and peas 

(except field peas) all at 0.1 ppm each. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866, this rule is not 

subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 


jlentini on PROD1PC65 with RULES
27460 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000) do not apply 

to this rule. In addition, This rule does 

not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

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: May 8, 2007. 

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 

revising the tolerances for ‘‘Bean, lima, 

seed’’; ‘‘Bean, lima, succulent’’; ‘‘Bean, 

forage’’; ‘‘Bean, hay’’; and ‘‘Pea, 

succulent‘‘, which will be revoked due 

to an administrative error, with the 

entries to the table in paragraph (a) to 

read as follows: 

§ 180.361 Pendimethalin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

*****

Beans .............................. 0.10 

Beans, forage ................. 0.10 

Beans, hay ...................... 0.10 

*****

Peas (except field peas) 0.10 

*****

* * * * * 

[FR Doc. E7–9428 Filed 5–15–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0160; FRL–8130–6] 

Aspergillus flavus NRRL 21882 on 

Corn; Temporary Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the Aspergillus flavus NRRL 21882 on 

corn when applied aerially once per 

season at the first sign of corn tasseling 

to reduce aflatoxin-producing 

Aspergillus flavus. Acta Group, 1203 

Nineteenth St., NW., Suite 300, 

Washington, DC 20036–2401 on behalf 

of Circle One Global, Inc. One Arthur St. 

P.O. Box 28, Shellman, GA 39886–0028 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

requesting the temporary tolerance 

exemption. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of 

Aspergillus flavus NRRL 21882. The 

temporary tolerance exemption expires 

on May 2, 2009. 

DATES: This regulation is effective May 

16, 2007. Objections and requests for 

hearings must be received on or before 

June 15, 2007, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2007–0160. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

web site to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 


jlentini on PROD1PC65 with RULES