Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9351 

PART 747—ADMINISTRATIVE 

ACTIONS, ADJUDICATIVE HEARINGS, 

RULES OF PRACTICE AND 

PROCEDURE, AND INVESTIGATIONS 

■ 1. The authority citation for part 747 

continues to read as follows: 

Authority: 12 U.S.C. 1766, 1782, 1784, 

1785, 1786, 1787; 42 U.S.C. 4012a; Public 

Law 101–410; Public Law 104–134. 

■ 2. Subpart K is revised to read as 

follows: 

Subpart K—Inflation Adjustment of 

Civil Monetary Penalties 

§ 747.1001 Adjustment of civil money 

penalties by the rate of inflation. 

(a) NCUA is required by the Federal 

Civil Penalties Inflation Adjustment Act 

of 1990 (Pub. L. 101–410, 104 Stat. 890, 

as amended (28 U.S.C. 2461 note)) to 

adjust the maximum amount of each 

civil money penalty within its 

jurisdiction by the rate of inflation. The 

following chart displays those 

adjustments, as calculated pursuant to 

the statute: 

U.S. code citation CMP description New maximum amount 

(1) 12 U.S.C. 1782(a)(3) .................................... Inadvertent failure to submit a report or the inadvertent submission of a false or misleading report.$2,200. 

(2) 12 U.S.C. 1782(a)(3) .................................... Non-inadvertent failure to submit a report or 

the non-inadvertent submission of a false or 

misleading report.

$22,000. 

(3) 12 U.S.C. 1782(a)(3) .................................... Failure to submit a report or the submission of 

a false or misleading report done knowingly 

or with reckless disregard.

$1,300,000 or 1 percent of the total assets of 

the credit union, whichever is less. 

(4) 12 U.S.C. 1782(d)(2)(A) ................................ First tier ............................................................ $2,200. 

(5) 12 U.S.C. 1782(d)(2)(B) ................................ Second tier ....................................................... $22,000. 

(6) 12 U.S.C. 1782(d)(2)(C) ............................... Third tier ........................................................... $1,300,000 or 1 percent of the total assets of 

the credit union, whichever is less. 

(7) 12 U.S.C. 1785(e)(3) .................................... Non-compliance with NCUA security regulations.$110. 

(8) 12 U.S.C. 1786(k)(2)(A) ................................ First tier ............................................................ $7,500. 

(9) 12 U.S.C. 1786(k)(2)(B) ................................ Second tier ....................................................... $37,500. 

(10) 12 U.S.C. 1786(k)(2)(C) .............................. Third tier ........................................................... For a person other than an insured credit 

union: $1,375,000; 

For an insured credit union: $1,375,000 or 1 

percent of the total assets of the credit 

union, whichever is less. 

(11) 42 U.S.C. 4012a(f) ...................................... Per violation ..................................................... $385. 

Per calendar year ............................................ $130,000. 

(b) The adjustments displayed in 

paragraph (a) of this section apply to 

acts occurring after the date of 

publication in the Federal Register. 

[FR Doc. E9–4608 Filed 3–3–09; 8:45 am] 

BILLING CODE 7535–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0258; FRL–8401–6] 

Dimethomorph; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dimethomorph 

in or on ginseng and turnip, greens. 

Additionally, it establishes tolerances 

with regional registrations in or on 

beans, lima, succulent and grape. This 

regulation also deletes the existing grape 

import tolerance, as a regional tolerance 

supersedes it. Finally, it increases the 

existing tolerance level for potato, wet 

peel and re-establishes the tolerance for 

potato. The Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 4, 2009. Objections and requests 

for hearings must be received on or 

before May 4, 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–2008–0258. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@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). 

9352 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0258 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 May 4, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0258, 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 May 16, 

2008 (73 FR 28461) (FRL–8361–6), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8E7314) by 

Interregional Research Project (IR-4), 

500 College Rd. East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.493 be 

amended by establishing tolerances for 

residues of the fungicide 

dimethomorph, (E,Z) 4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propenyl]morpholine, in or on 

beans, lima at 0.60 parts per million 

(ppm); ginseng at 0.85 ppm; grape at 3.5 

ppm; grape, raisin at 6.0 ppm; and 

turnip, greens at 20.0 ppm. In the 

Federal Register of October 8, 2008 (73 

FR 58962) (FRL–8383–7), EPA issued a 

notice pursuant to section 408(d)(3) of 

FFDCA, 21 U.S.C. 346a(d)(3), 

announcing the filing of an amendment 

to the pesticide petition (PP 8E7314) by 

IR-4, which requested that 40 CFR 

180.493 be amended for residues of the 

fungicide dimethomorph by increasing 

the tolerance in or on potato, wet peel 

from 0.15 ppm to 0.20 ppm, and reestablishing the tolerance in or on 

potato at 0.05 ppm. These notices 

referenced a summary of the petition 

prepared on behalf of IR-4 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 notices of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the proposed tolerance 

level for ginseng should be increased. 

EPA has additionally determined that 

the proposed tolerances for beans, lima 

and grape should be established as 

regional tolerances, and that the import 

tolerance for grape, raisin should 

remain. The reasons for these changes 

are explained in Unit IV.D. 

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 residues of dimethomorph 

on beans, lima at 0.60 ppm; ginseng at 

0.90 ppm; grape at 3.5 ppm; grape, 

raisin at 6.0 ppm; potato at 0.05 ppm; 

potato, wet peel at 0.20 ppm; and 

turnip, greens at 20 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. 

The existing dimethomorph data 

indicate that it possesses relatively low 

toxicity. No appropriate toxicological 

endpoints attributable to a single 

exposure were identified in oral studies. 

Consequently, it was determined that 

there was no basis for selecting a dose 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9353 

and endpoint for an acute reference 

dose (aRfD). 

In the dimethomorph rat chronic 

dietary feeding study, there were 

significant body weight decrements, and 

liver effects in female rats. Available 

data for dimethomorph do not show 

potential for immunotoxic nor 

neurotoxic effects. Neither the 

subchronic nor chronic toxicity studies 

in rats or dogs, nor the developmental 

toxicity studies indicated that the 

nervous system was affected by 

treatment with dimethomorph. 

Based on the toxicity profile for 

dimethomorph, a developmental 

neurotoxicity (DNT) study in rats is not 

required. In a carcinogenicity study in 

rat, there was no evidence of increased 

incidence of any neopolasms at any 

doses. In a carcinogenicity study in 

mice, there was no dose-related 

decrease in survival, or in any 

parameter examined on necropsy. At the 

maximum dose required by the test 

guidelines for a dietary oncogenicity 

study, there was no evidence of 

carcinogenicity. Therefore, the EPA 

classified dimethomorph as ‘‘not likely 

to be carcinogenic to humans.’’ 

The toxicology data on dimethomorph 

provides no indication of enhanced 

sensitivity of infants and children, 

based on the results from developmental 

studies conducted with rats and rabbits, 

as well as a 2-generation reproduction 

study conducted with rats. There were 

no toxic effects observed in either the 

rat developmental toxicity, or the rat 2- 

generation reproductive toxicity studies, 

that were observed at lower doses than 

those which produced toxic effects in 

the parents. No developmental toxicity 

was demonstrated in the rabbit 

developmental toxicity study. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by dimethomorph as well 

as the no-observed-adverse-effect-level 

and the lowest-observed-adverse-effectlevel from the toxicity studies can be 

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

document ‘‘Dimethomorph. Human 

Health Risk Assessment for the 

Proposed Food/Feed Use of the 

Fungicide (Associated with Section 3 

Registration) on Succulent Lima Beans, 

Ginseng, Grapes and Turnip Tops’’ at 

pages 46–49 in docket ID number EPA– 

HQ–OPP–2008–0258. 

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-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 dimethomorph used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Dimethomorph. Human Health Risk 

Assessment for the Proposed Food/Feed 

Use of the Fungicide (Associated with 

Section 3 Registration) on Succulent 

Lima Beans, Ginseng, Grapes and 

Turnip Tops’’ at pages 17–18 in docket 

ID number EPA–HQ–OPP–2008–0258. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to dimethomorph, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing dimethomorph tolerances in (40 

CFR 180.493). EPA assessed dietary 

exposures from dimethomorph 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 dimethomorph; 

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 U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA used 

tolerance-level residues, the Dietary 

Exposure Evaluation Model (DEEM) 

default processing factors, and assumed 

100 percent crop treated (PCT) for all 

proposed commodities. 

iii. Cancer. Based on the results of the 

carcinogenicity studies in rats and mice, 

dimethomorph has been classified as 

‘‘not likely to be carcinogenic to 

humans;’’ therefore, a quantitative 

exposure assessment to evaluate cancer 

risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for dimethomorph. 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 dimethomorph in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

dimethomorph. 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. 

The First Index Reservoir Screening 

Tool (FIRST) Tier 1 model was used to 

estimate concentrations for 

dimethomorph in surface water. The 

Tier 1 Screening Concentration in 

Ground Water (SCI-GROW) model was 

utilized to predict concentrations in 

ground water. The Tier 1 Generic 

Estimated Environmental Concentration 

(GENEEC) model, from a previous 

drinking water assessment, calculated 

another estimated drinking water 

concentration (EDWC) for 

dimethomorph in surface water. The 

EDWCs of dimethomorph for acute 

exposures are estimated to be 81.1 parts 

per billion (ppb) for surface water and 

0.264 ppb for ground water. For chronic 

exposures, the non-cancer assessments 

are estimated to be 24.7 ppb for surface 

water, 28.5 ppb for a previously 

9354 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

determined surface water assessment, 

and 0.264 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

most conservative water concentration 

of value 28.5 ppb, from GENEEC 

modeling, 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). 

Dimethomorph is not registered for any 

specific use patterns that would result 

in residential exposure. 

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 dimethomorph to 

share a common mechanism of toxicity 

with any other substances, and 

dimethomorph does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that dimethomorph does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

The toxicology data on dimethomorph 

provides no indication of enhanced 

sensitivity of infants and children, 

based on the results from developmental 

studies conducted with rats and rabbits, 

as well as a 2–generation reproduction 

study conducted with rats. There were 

no toxic effects observed in either the 

rat developmental toxicity, or the rat 2– 

generation reproductive toxicity studies, 

that were observed at lower doses than 

those which produced toxic effects in 

the parents. Further, clear NOAELs were 

observed for all effects observed in 

fetuses. These NOAELs are well above 

the NOAEL used as a point of departure 

in assessing the safety of 

dimethomorph. No developmental 

toxicity was demonstrated in the rabbit 

developmental toxicity study. 

Additionally, there is no evidence of 

neurotoxicity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

dimethomorph is complete except for 

the immunotoxicity, acute 

neurotoxicity, and subchronic 

neurotoxicity studies. Recent changes to 

40 CFR part 158 make acute and 

subchronic neurotoxicity testing 

(OPPTS Guideline 870.6200), and 

immunotoxicity testing (OPPTS 

Guideline 870.7800) required for 

pesticide registration. The available data 

for dimethomorph do not show 

potential for immunotoxic or neurotoxic 

effects. Therefore, EPA does not believe 

that conducting OPPTS Guideline 

870.6200 neurotoxicity and OPPTS 

Guideline 870.7800 immunotoxicity 

studies will result in a NOAEL lower 

than the NOAEL of 11 milligram/ 

kilogram/day (mg/kg/day) already set 

for dimethomorph. Consequently, an 

additional database uncertainty factor 

(UF) does not need to be applied. 

ii. There is no indication that 

dimethomorph is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. The developmental and 

reproductive toxicity data did not 

indicate increased quantitative or 

qualitative susceptibility of rats or 

rabbits to in utero and/or postnatal 

exposure to dimethomorph. There are 

no residual concerns regarding 

developmental effects in the young. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

Dietary food exposure assessments were 

performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

dimethomorph in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by 

dimethomorph. 

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. 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. No acute dietary endpoint was 

identified for any segment of the U.S. 

population. Therefore, dimethomorph is 

not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to dimethomorph 

from food and water will utilize 20% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for dimethomorph to consider. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Dimethomorph is not registered for 

any use patterns that would result in 

residential exposure. Therefore, the 

short-term and intermediate-term 

aggregate risk is the sum of the risk from 

exposure to dimethomorph through 

food and water and will not be greater 

than the chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in mice and 

rats at doses that were judged to be 

adequate to assess the carcinogenic 

potential, dimethomorph was classified 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 9355 

as ‘‘not likely to be carcinogenic to 

humans.’’ Therefore, dimethomorph is 

not expected to pose a cancer risk to 

humans. 

5. 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 

dimethomorph residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(High-Performance Liquid 

Chromatography using Ultraviolet 

detection (HPLC/UV) Method, (FAMS) 

002–04) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no Canadian or Mexican 

maximum residue limits (MRLs) 

established for residues of 

dimethomorph in crops associated with 

this review. Codex MRLs have been 

finalized in grapes and grape, raisins at 

2 and 5 ppm, respectively. However, the 

proposed tolerances in grape and grape, 

raisin (3.5 and 6.0 ppm, respectively) 

cannot be harmonized with the Codex 

MRLs on these commodities because 

field trial data shows residue levels for 

grape that are higher than 2 ppm. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA revised the 

proposed tolerance for ginseng, from 

0.85 ppm to 0.90 ppm. EPA revised the 

proposed tolerance based on analysis of 

the residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. EPA also changed 

the commodity term from ‘‘bean, lima’’ 

to ‘‘bean, lima, succulent’’ because field 

trial data for dry lima beans was not 

submitted. Use on lima beans is 

restricted to those varieties intended for 

harvest as succulent seed. Use on lima 

beans is also restricted to areas east of 

the Rocky Mountains, and will therefore 

be established as a regional tolerance 

under paragraph (c) Tolerances with 

regional registrations in §180.493. The 

proposed tolerance for grape will also be 

restricted to a regional tolerance under 

§180.493(c), since data were submitted 

to support use of dimethomorph on 

grapes grown east of the Rocky 

Mountains. Since grapes processed for 

raisin production are only grown west 

of the Rock Mountains, the import 

tolerance for raisins will remain, and a 

tolerance for raisin under § 180.493(c) 

will not be established. 

V. Conclusion 

Therefore, tolerances are established 

for residues of dimethomorph (E,Z) 4-[3- 

(4-chlorophenyl)-3-(3,4- 

dimethoxyphenyl)-1-oxo-2- 

propenyl]morpholine, in or on ginseng 

at 0.90 ppm and turnip, greens at 20.0 

ppm. Tolerances with regional 

registrations are established in or on 

bean, lima, succulent at 0.6 ppm and 

grape at 3.5 ppm. This regulation also 

deletes the existing tolerance for use in 

or on grape, as the regional tolerance 

supersedes it. Finally, it increases the 

existing import tolerance level for 

potato, wet peel from 0.15 to 0.20 ppm 

and re-establishes the tolerance for 

potato at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions 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 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). 

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. 

9356 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Rules and Regulations 

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 180.493 is amended as 

follows: 

■ i. In paragraph (a), by revising the 

introductory text; in the table by 

removing the entry ‘‘Grape,’’ by revising 

the entry ‘‘Potato, wet peel’’ and 

Footnote 1, and by alphabetically 

adding the following commodities to the 

table to read as follows: 

■ ii. By revising paragraph (c) to read as 

follows: 

§ 180.493 Dimethomorph; tolerances for 

residues. 

(a) General. Tolerances are 

established for the residues of the 

fungicide dimethomorph, (E,Z) 4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propenyl]morpholine, in or on 

the following commodities: 

Commodity Parts per 

million 

* * * * * 

Ginseng .................................... 0.90 

Grape, raisin1 ........................... 6.0 

* * * * * 

Potato ....................................... 0.05 

Potato, wet peel ........................ 0.20 

* * * * * 

Turnip, greens .......................... 20.0 

* * * * * * 

1 There are no U.S. registrations as of 

March 4, 2009, for the use of dimethomorph 

on grapes grown for raisin production. 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations are established for residues 

of the fungicide dimethomorph, (E,Z) 4- 

[3-(4-chlorophenyl)-3-(3,4- 

dimethoxyphenyl)-1-oxo-2- 

propenyl]morpholine, in or on the 

following commodities: 

Commodity Parts per 

million 

Bean, lima, succulent ............... 0.60 

Grape ........................................ 3.5 

* * * * * 

[FR Doc. E9–4370 Filed 3–3–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0097; FRL–8399–3] 

Tebuconazole; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises the 

existing tolerance for residues of 

tebuconazole in or on cherry, pre- and 

post-harvest. Interregional Research 

Project Number 4 (IR-4) requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 4, 2009. Objections and requests 

for hearings must be received on or 

before May 4, 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–2005–0097. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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–2005–0097 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 May 4, 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