45624 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established 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). 

IX. 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 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 26, 2008. 

Debra Edwards, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 174.501 in subpart D is 

revised to read as follows: 

§ 174.501 Bacillus thuringiensis Vip3Aa 

protein in corn and cotton; exemption from 

the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Vip3Aa proteins in or on corn or cotton 

are exempt from the requirement of a 

tolerance when used as plant–

incorporated protectants in or on the 

food and feed commodities of corn; 

corn, field; corn, sweet; corn, pop; and 

cotton; cotton, undelinted seed; cotton, 

refined oil; cotton, meal; cotton, hay; 

cotton, hulls; cotton, forage; and cotton, 

gin byproducts. 

§ 174.528 [Removed] 

■ 3. Section 174.528 is removed from 

Subpart D. 

[FR Doc. E8–17931 Filed 8–5–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0484; FRL–8375–5] 

Difenoconazole; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

difenoconazole, 1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H-1,2,4-triazole 

in or on almond, almond hulls, 

cantaloupe, cucumber, and watermelon. 

This action is in response to EPA’s 

granting crisis exemptions to the 

California Environmental Protection 

Agency and the Georgia Department of 

Agriculture under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on almond, almond 

hulls, cantaloupe, cucumber, and 

watermelon. This regulation establishes 

a maximum permissible level for 

residues of difenoconazole in these food 

commodities. The time-limited 

tolerances expire and are revoked on 

December 31, 2011. 

DATES: This regulation is effective 

August 6, 2008. Objections and requests 

for hearings must be received on or 

before October 6, 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–2008–0484. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either in the electronic docket 


yshivers on PROD1PC62 with RULES
Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 45625 

at http://www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Stacey Groce, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–2505; e-mail address: 

groce.stacey@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the Food Quality 

Protection Act of 1996 (FQPA), any 

person may file an objection to any 

aspect of this regulation and may also 

request a hearing on those objections. 

The EPA procedural regulations which 

govern the submission of objections and 

requests for hearings appear in 40 CFR 

part 178. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2008–0484 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before October 6, 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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0484, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing timelimited tolerances for residues of the 

fungicide difenoconazole, in or on 

almond at 0.05 parts per million (ppm), 

almond, hulls at 5.0 (ppm), cantaloupe 

at 1.0 (ppm), cucumber at 1.0 (ppm), 

and watermelon at 1.0 (ppm). These 

time-limited tolerances expire and are 

revoked on December 31, 2011. EPA 

will publish a document in the Federal 

Register to remove the revoked 

tolerances from the CFR. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related timelimited tolerances to set binding 

precedents for the application of section 

408 of FFDCA to other tolerances and 

exemptions. Section 408(e) of FFDCA 

allows EPA to establish a tolerance or an 

exemption from the requirement of a 

tolerance on its own initiative, i.e., 

without having received any petition 

from an outside party. 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemptions for 

Difenoconazole on Various 

Commodities: Almond, Almond Hulls, 

Cantaloupe, Cucumber, and 

Watermelon and FFDCA Tolerances 

The California Environmental 

Protection Agency, Department of 

Pesticide Regulation, requested an 


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45626 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

emergency exemption for 

difenoconazole on almond and almond 

hulls to control Alternaria leaf blight 

disease, and issued a crisis exemption 

for this use pursuant to 40 CFR part 166, 

subpart C. Alternaria leaf spot disease is 

caused by a common fungus that results 

in premature defoliation and 

interference with hull split and nut 

removal of almonds. Further, it appears 

that in California a significant portion of 

the spores that cause Alternaria leaf 

blight disease has developed resistance 

against registered alternative fungicides. 

In addition, the Georgia Department 

of Agriculture requested a specific 

emergency exemption and subsequently 

issued a crisis exemption for the use of 

difenoconazole on cucurbits (cucumber, 

cantaloupe, and watermelon) as a tank 

mixture with cyprodinil to control 

gummy stem blight disease (caused by 

Didymella bryonia). 

After having reviewed the 

submissions, EPA determined that the 

conditions described by the California 

Department of Environmental Protection 

and the Georgia Department of 

Agriculture meet the criteria for 

emergency exemptions. EPA authorized 

under FIFRA section 18 the use of 

difenoconazole on almond, and almond, 

hulls for control of Alternaria leaf and 

stem blight in California, and on 

cantaloupe, cucumber, and watermelon 

in Georgia to control Gummy stem 

blight disease. 

As part of its evaluation of the 

emergency exemption applications, EPA 

assessed the potential risks presented by 

residues of difenoconazole in or on 

almond, cantaloupe, cucumber, and 

watermelon. In doing so, EPA 

considered the safety standard in 

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

decided that the necessary tolerances 

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

be consistent with the safety standard 

and with FIFRA section 18. Consistent 

with the need to move quickly on the 

emergency exemptions in order to 

address urgent non-routine situations 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing these 

tolerances without notice and 

opportunity for public comment as 

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

Although these time-limited tolerances 

expire and are revoked on December 31, 

2011, under section 408(l)(5) of FFDCA, 

residues of the pesticide not in excess 

of the amounts specified in the 

tolerances remaining in or on almond, 

cantaloupe, cucumber, and watermelon 

after that date will not be unlawful, 

provided the pesticide was applied in a 

manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by these timelimited tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether difenoconazole 

meets FIFRA’s registration requirements 

for use on almond, cantaloupe, 

cucumber, and watermelon or whether 

permanent tolerances for these uses 

would be appropriate. Under these 

circumstances, EPA does not believe 

that these time-limited tolerance 

decisions serve as a basis for registration 

of difenoconazole by a State for special 

local needs under FIFRA section 24(c). 

Nor do these tolerances serve as the 

basis for persons in any State other than 

California and Georgia to use this 

pesticide on the applicable crops under 

FIFRA section 18 absent the issuance of 

an emergency exemption applicable 

within that State. For additional 

information regarding the emergency 

exemption for difenoconazole contact 

the Agency’s Registration Division at the 

address provided under FOR FURTHER

INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’

Consistent with the factors specified 

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

has reviewed the available scientific 

data and other relevant information in 

support of these actions. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure expected as a result 

of these emergency exemption requests 

and the time-limited tolerances for 

residues of difenoconazole on almond at 

0.05 ppm, almond, hulls at 5.0 ppm, 

cantaloupe at 1.0 ppm, cucumber at 1.0 

ppm, and watermelon at 1.0 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing these timelimited tolerances follows. 

A. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, 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 difenoconazole used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

November 9, 2007 document: 

Difenoconazole in/on Fruiting 

Vegetables, Pome Fruit, Sugar Beets, 


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Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 45627 

Tuberous and Corn Vegetables, and 

Imported Papaya. Health Effects 

Division (HED) Revised Risk 

Assessment, pages 13 and 14 of 57 in 

docket ID number EPA–HQ–OPP–2008–

0484. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to difenoconazole, EPA 

considered exposure under the timelimited tolerances established by this 

action as well as all existing 

difenoconazole tolerances in (40 CFR 

180.475). EPA assessed dietary 

exposures from difenoconazole in food 

as follows: 

i. Acute exposure. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA’s acute 

dietary analysis assumed tolerance-level 

residues and 100% crop treated (PCT) 

for all registered and proposed crops. 

Tolerance-level residues were also 

assumed for all livestock tissues in this 

assessment. Experimental processing 

factors were used for apple juice (0.04x), 

potato chips (0.5x), potato granules/ 

flakes (0.5x), sugar beet molasses (0.6x), 

sugar beet refined sugar (0.6x), tomato 

paste (1.6x), and tomato puree (0.5x). 

The Dietary Exposure Evaluation Model 

(DEEM)TM version 7.76 default 

processing factors were assumed (when 

appropriate) for other processed 

commodities. The resulting acute 

dietary (food + water) exposure 

estimates are not of concern to the 

Agency (<100% of the aPAD at the 95th

percentile of the exposure distribution 

for the U.S. general population (2.9% 

aPAD) and all population subgroups. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, 

EPA’s chronic dietary analysis assumed 

tolerance-level residues and 100 PCT for 

all registered and proposed crops. 

Tolerance level residues were also 

assumed for all livestock tissues in this 

assessment. Experimental processing 

factors were used for apple juice (0.04x), 

potato chips (0.5x), potato granules/ 

flakes (0.5x), sugar beet molasses (0.6x), 

sugar beet refined sugar (0.6x), tomato 

paste (1.6x), and tomato puree (0.5x). 

The DEEMTM version 7.76 default 

processing factors were assumed (when 

appropriate) for other processed 

commodities. The resulting chronic 

dietary (food + water) exposure 

estimates are not of concern to the 

Agency (<100% of the cPAD for the U.S. 

general population (23% cPAD) and all 

population subgroups. 

iii. Cancer. A cancer dietary 

assessment was not conducted for 

difenoconazole because the cancer noobservable-adverse-effect level (NOAEL) 

is higher than the chronic reference 

dose (RfD); therefore, the chronic 

dietary risk estimate is protective of any 

cancer effects. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for difenoconazole. 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 difenoconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

difenoconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

difenoconazole for acute exposures are 

estimated to be 13.3 parts per billion 

(ppb) for surface water and 0.00128 ppb 

for ground water and for chronic 

exposures for non-cancer assessments 

are estimated to be 9.43 ppb for surface 

water and 0.00108 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. In this 

assessment, 1-in-10–year annual peak 

(13.3 ppb) and 1-in-10–year annual 

mean (9.43 ppb) residue values were 

used for acute and chronic dietary 

exposure assessments respectively. 

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). 

Difenoconazole is currently registered 

for ornamental foliar treatment that 

could result in residential exposure. 

EPA assessed residential exposure using 

the following assumptions: Residential 

pesticide handlers will be exposed to 

short-term duration (1 to 30 days) only. 

The dermal and inhalation (short-term) 

residential exposure was assessed for 

homeowners (mixer/loader/applicator) 

wearing short pants and short-sleeved 

shirts as well as shoes plus socks using 

garden hose-end sprayer, pump-up 

compressed air sprayer, and backpack 

sprayer. With regard to residential postapplication exposures, no significant 

post application exposure is anticipated 

from ornamentals by residents. 

Therefore, no residential postapplication assessment was conducted. 

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.’’

Difenoconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biological events. In conazoles, 

however, a variable pattern of 

toxicological responses is found. Some 

are hepatotoxic and hepatocarcinogenic 

in mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive, and neurological effects in 

rodents. Furthermore, the conazoles 

produce a diverse range of biochemical 

events including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to their 

toxicological outcomes. Thus, there is 

currently no evidence to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. 

However, this class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derived pesticides, including 

difenoconazole, EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 


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45628 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

UFs) and potential dietary and nondietary exposures (i.e., high-end 

estimates of both dietary and nondietary exposures). In addition, the 

Agency retained the additional 10X 

FQPA safety factor for the protection of 

infants and children. The assessment 

included evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment can be found 

in the propiconazole reregistration 

docket at http://www.regulations.gov, 

(Docket ID number EPA–HQ–OPP–

2005–0497). 

For information regarding EPA’s 

efforts to determine which chemicals 

have a common mechanism of toxicity 

and to evaluate the cumulative effects of 

such chemicals, see the policy 

statements released by EPA’s Office of 

Pesticide Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

C. Safety Factor for Infants and Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

Developmental toxicity studies showed 

no increased sensitivity in fetuses as 

compared to maternal animals following 

in utero exposures in rats and rabbits, 

and prenatal/postnatal exposure in the 

2–generation toxicity study in arts. 

There was no evidence of abnormalities 

in the development of the fetal nervous 

system in the prenatal/postnatal studies. 

3. Conclusion. EPA has determined 

that reliable data show that 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 

difenoconazole is complete. 

ii. There is no indication that 

difenoconazole 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 

difenoconazole 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. 

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. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

difenoconazole in drinking water. EPA 

used similarly conservative assumptions 

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 difenoconazole. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

difenoconazole will occupy 9% of the 

aPAD for (the population group all 

infants (< 1 year old)) the population 

group receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to difenoconazole 

from food and water will utilize 65% of 

the cPAD for (children 1-2 years old) the 

population group receiving the greatest 

exposure. Based on the residential use 

patterns, chronic residential exposure to 

residues of difenoconazole 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). 

Difenoconazole is currently registered 

for an ornamental foliar use 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 

difenoconazole. 

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 greater than or 

equal to 170. Therefore, short-term 

aggregate exposure to difenoconazole is 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). The Agency believes 

residential pesticide handlers will be 

exposed to short-term duration (1-30 

days) only. Therefore, intermediate and 

long-term aggregate risks are not of 

concern. 

Difenoconazole 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 difenoconazole 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.The chronic dietary risk 

assessment is protective of carcinogenic 

effects of difenoconazole. The cancer 

NOAEL is higher than the chronic RfD. 

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 

difenoconazole residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Method AG-575B) 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; 


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telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian, or 

Mexican Maximum Residue Limits 

(MRLs) for difenoconazole. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of 

difenoconazole, 1-[2-[2-chloro-4-(4- 

chlorophenoxy) phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H-1,2,4-triazole, 

in or on almond at 0.05 parts per 

million (ppm), almond, hulls at 5.0 

(ppm), and cantaloupe at 1.0 (ppm), 

cucumber at 1.0 (ppm), and watermelon 

at 1.0 (ppm). These tolerances expire 

and are revoked on December 31, 2011. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established in accordance with 

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

such as the tolerances in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

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: July 25, 2008. 

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 180.475 is amended by 

adding text to paragraph (b) to read as 

follows: 

§ 180.475 Difenoconazole; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the fungicide difenoconazole 

in or on the specified agricultural 

commodities, resulting from use of the 

pesticide pursuant to FIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Almond .............. 0.05 12/31/11 

Almond, hulls .... 5.0 12/31/11 

Cantaloupe ....... 1.0 12/31/11 

Cucumber ......... 1.0 12/31/11 

Watermelon ...... 1.0 12/31/11 

* * * * * 

[FR Doc. E8–17937 Filed 8–5–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0221; FRL–8367–5] 

Dodine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dodine in or 

on bananas and peanuts. Agriphar S.A. 

c/o Ceres International LLC requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 6, 2008. Objections and requests 

for hearings must be received on or 

before October 6, 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–2007–0221. 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 


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