50556 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 

has been isolated as a rare contaminant 

from human infections. Thus, there are 

no threshold effects of concern and, as 

a result, the provision requiring an 

additional margin of safety does not 

apply. Further, the considerations of 

consumption patterns, special 

susceptibility, and cumulative effects do 

not apply to pesticides without a 

demonstrated significant adverse effect. 

VII. Other Considerations 

A. Endocrine Disruptors 

The Agency has no information to 

suggest that Bacillus subtilis GB03 has 

an effect on the endocrine system. No 

specific tests have been conducted with 

Bacillus subtilis GB03 to determine such 

effects. However, the submitted toxicity/ 

pathogenicity studies in rodents 

indicated that following several routes 

of exposure, the immune system is still 

intact and able to process and clear the 

active ingredient. Bacillus subtilis GB03 

is a ubiquitous organism in the 

environment and there have been no 

reports of the organism affecting 

endocrine systems. Therefore, it is 

unlikely that this organism would have 

estrogenic or endocrine effects and it is 

practically non-toxic to mammals. 

B. Analytical Method 

The Agency proposes to establish an 

exemption from the requirement of a 

tolerance without any numerical 

limitation; therefore, the Agency has 

concluded that an analytical method is 

not required for enforcement purposes 

for Bacillus subtilis GB03. 

C. Codex Maximum Residue Level 

No Codex maximum residue level 

exists for Bacillus subtilis GB03. 

VIII. Conclusions 

There is a reasonable certainty that no 

harm will result from aggregate 

exposure to the U.S. population, 

including infants and children, to 

residues of the Bacillus subtilis GB03 in 

or on all food and feed commodities. 

This includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. The 

Agency has arrived at this conclusion 

because, as discussed above, no toxicity 

or pathogenicity to mammals has been 

observed in test animals. 

IX. 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 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). 

X. 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: August 14, 2008 

W. Michael McDavit, 

Acting Director, Biopesticides and Pollution 

Prevention 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 180.1111 is revised to read 

as follows: 

§ 180.1111 Bacillus subtilis GB03; 

exemption from the requirement of a 

tolerance. 

The biofungicide Bacillus subtilis 

GB03 is exempted from the requirement 

of a tolerance in or on all raw 

agricultural commodities when used in 

accordance with good agricultural 

practices. 

[FR Doc. E8–19860 Filed 8–26–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0987; FRL–8376–4] 

Fenbuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of the 

fungicide fenbuconazole, alpha–[2–(4–


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chlorophenyl)– ethyl]–alpha–phenyl–3–

(1H–1,2,4–triazole)– 1–propanenitrile, 

and its metabolites RH–9129, cis–5–(4–

chlorophenyl)– dihydro–3–phenyl–3–

(1H–1,2,4– triazole–1–ylmethyl)–2–3 H–

furanone, and RH–9130, trans–5–(4–

chlorophenyl)dihydro–3–phenyl–3–

(1H–1,2,4–triazole–1–ylmethyl)–2–3 H–

furanone, expressed as fenbuconazole in 

or on pepper (7E7256). The 

Interregional Research Project Number 4 

(IR–4) requested this tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) on behalf of the registrant, 

Dow AgroSciences LLC. 

DATES: This regulation is effective 

August 27, 2008. Objections and 

requests for hearings must be received 

on or before October 27, 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–2007–0987. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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 an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, any 

person may file an objection to any 

aspect of this regulation and may also 

request a hearing on those objections. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2007–0987 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 October 27, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA–

HQ–OPP–2007–0987 by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

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

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of January 23, 

2008 (73 FR 3964) (FRL–8345–7), 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 7E7256) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.480 be 

amended by establishing tolerances for 

combined residues of the fungicide 

fenbuconazole, alpha–[2–(4–

chlorophenyl)– ethyl]–alpha–phenyl–3–

(1H–1,2,4–triazole)– 1–propanenitrile, 

and its metabolites RH–9129, cis–5–(4–

chlorophenyl)– dihydro–3–phenyl–3–

(1H–1,2,4– triazole–1–ylmethyl)–2–3 H–

furanone, and RH–9130, trans–5–(4–

chlorophenyl)dihydro–3–phenyl–3–

(1H–1,2,4–triazole–1–ylmethyl)–2–3 H–

furanone, expressed as fenbuconazole in 

or on pepper at 0.40 parts per million 

(ppm). That notice referenced a 

summary of the petition prepared by 

Dow AgroSciences LLC, 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. 

In addition, §180.480(a)(1), is revised 

to remove reference to ‘‘time-limited 

tolerance’’ as this section is dedicated 

to, and only contains, permanent 


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tolerances. Also, §180.480(a)(2) is 

deleted in its entirety as it relates solely 

to time-limited tolerances in paragraph 

(a)(1) and there are no such tolerances 

in paragraph (a)(1). In addition, the 

time-limited tolerance under 

§180.480(b) Section 18 emergency 

exemptions, for blueberry at 1.0 ppm 

that expired on 12/31/07 is deleted. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for combined residues of 

fenbuconazole on pepper at 0.40 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 their 

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. 

Fenbuconazole has low acute toxicity 

and is neither skin or eye irritants nor 

a dermal sensitizer. In subchronic and 

chronic feeding studies the liver was the 

main target of toxicity. At the LOAEL in 

the subchronic studies, there were 

changes in liver histopathology, 

predominantly hepatocellular 

hypertrophy. At doses higher than the 

LOAEL in the rat, the thyroid was a 

secondary target organ with increased 

follicular cell size. In the chronic 

studies, liver effects were seen 

(including hepatocellular hypertrophy 

and vacuolization, changes in liver 

enzymes, and increased liver weights), 

as well as decreased body weight gains. 

Again, in the chronic rat study, the 

thyroid was a secondary target with 

increased thyroid and parathyroid 

weights and thyroid follicular cell 

hypertrophy. In addition, increased 

mean T4 and decreased TSH were found 

in the high-dose rats near the end of the 

study. In the chronic dog study, kidney 

and adrenal weights were also 

increased. Males and females 

throughout the studies appeared to be 

equally sensitive to fenbuconazole 

toxicity, except in the chronic mouse 

study, where male mice appeared to be 

more sensitive than the females. 

In the rat and rabbit developmental 

toxicity studies and the two generation 

study in rats, all effects in the pups 

occurred in the presence of maternal 

toxicity, including changes in body 

weight and body weight gains in rats 

and decreased food consumption and 

clinical signs in rabbits. Developmental 

effects included increased postimplantation loss and decreased fetuses 

per dam in the rat developmental study; 

increased early resorptions in the rabbit 

developmental study; and decreased 

mean pup body weight, increased 

number of stillborn pups, decreased 

number of total offspring delivered, and 

decreased viability index of pups in the 

two generation study in rats. No 

increased qualitative or quantitative 

susceptibility was observed in any of 

the studies. There was no evidence of 

neurotoxicity in any of the studies 

available in the toxicology database. 

Fenbuconazole is not mutagenic. 

Fenbuconazole is classified as a Group 

C, possible human carcinogen, and 

febuconazole’s human cancer risk is 

assessed quantitatively by a low dose 

extrapolation model applied to the 

experimental animal tumor data. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenbuconazole as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Fenbuconazole (7E7256) – Human 

Health Risk Assessment for the 

Proposed Use on Peppers at page 14 in 

docket ID number EPA–HQ–OPP–2007–

0987–0003. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for fenbuconazole used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Fenbuconazole (7E7256) – Human 

Health Risk Assessment for the 

Proposed Use on Peppers at page 25 in 

docket ID number EPA–HQ–OPP–2007–

0987–0003. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenbuconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 


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existing fenbuconazole tolerances in (40 

CFR 180.480). EPA assessed dietary 

exposures from fenbuconazole 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. 

In estimating acute dietary exposure, 

EPA used the Dietary Exposure 

Evaluation Model (DEEM–FCID, Version 

2.03), which uses food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, the acute dietary exposure 

analysis is based on tolerance-level 

residues and 100% crop treated 

assumptions. The only population 

subgroup that is relevant for this acute 

assessment is females of child-bearing 

age (i.e., females 13–49 years old). 

ii. Chronic(non-cancer) exposure. In 

conducting the chronic dietary (food + 

water) exposure assessment EPA used 

the food consumption data from the 

USDA 1994–1996 and 1998 CSFII. As to 

residue levels in food, the chronic (noncancer) dietary exposure analyses uses 

average residues from field trials. For 

many of the crops, separate studies were 

submitted and reviewed. For those 

crops, multiple averages were calculated 

and the highest average value was used 

in the analysis. The non-cancer dietary 

analysis assumes 100% crop treated. 

iii. Cancer. The cancer exposure 

analysis uses average residues from field 

trials. In addition, estimates of average 

percent crop treated were used for 

certain commodities. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Anticipated residue data were used in 

the chronic (non-cancer) and cancer 

dietary risk analyses but not in the acute 

dietary risk analysis. For many crops, 

the anticipated residues used were the 

highest per-study-volume average 

residue value from the field trial studies 

for each crop that were submitted by the 

registrant. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

In the cancer dietary exposure 

analysis, the Agency used the following 

estimated PCT information: 

Apples 1%, apricots 10%, blueberries 

40%, cherries 20%, grapefruit 40%, 

nectarines 10%, oranges 1%, peaches 

15%, pecans 15%, prunes 1%, and 

tangerines 1%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 years. EPA uses an average PCT 

for chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in the preceding 

paragraphs have been met. With respect 

to Condition a, PCT estimates are 

derived from sources as discussed in the 

preceding paragraphs including Federal 

and private market survey data, which 

are reliable and have a valid basis. The 

Agency is reasonably certain that the 

percentage of the food treated is not 

likely to be an underestimation. As to 

Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which fenbuconazole may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models to determine the 

drinking water concentrations that were 

used in the dietary exposure analysis 

and risk assessment for fenbuconazole. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenbuconazole. 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 assessments included 

conservative estimated drinking water 

concentrations (EDWC) based on either 

the pepper or the cherry use. Modeled 

surface water EDWCs are based on the 

maximum label application rate to 

peppers (acute value) or cherries 

(chronic and cancer values) while the 

groundwater EDWC is based on the 

maximum label application rate to 

cherries. The acute assessment is highly 

conservative with respect to evaluating 

potential impacts of dietary exposure to 

fenbuconazole on human health. The 

chronic (non-cancer) and cancer 

assessments are moderately 

conservative with respect to evaluating 

potential impacts of dietary exposure to 

fenbuconazole on human health. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI–

GROW) models, the estimated drinking 


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water concentrations (EDWCs) of 

fenbuconazole for acute exposures are 

estimated to be 24.1 parts per billion 

(ppb) for surface water and 0.031 ppb 

for ground water. The EDWCs for 

chronic exposures for non-cancer 

assessments are estimated to be 16.5 

ppb for surface water and 0.031 ppb for 

ground water. The EDWCs for chronic 

exposures for cancer assessments are 

estimated to be 11.7 ppb for surface 

water and 0.031 ppb for ground 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). 

Fenbuconazole 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.’’

Fenbuconazole 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 biochemical 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. For information regarding 

EPA’s procedures for cumulating effects 

from substances found to have a 

common mechanism of toxicity, refer to 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

Fenbuconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazole alanine and triazole acetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

fenbuconazole, U.S. EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, triazole 

alanine, and triazole acetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

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 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10X 

FQPA safety factor for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment is found in the 

propiconazole reregistration docket at 

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

number EPA–HQ–OPP–2005–0497. 

Additional information regarding the 

use proposed for fenbuconazole in this 

action can also be found at http:// 

www.regulations.gov in document: 

‘‘Dietary Exposure Assessments for the 

Common Triazole Metabolites 1,2,4- 

Triazole, Triazolylalanine, 

Triazolylacetic Acid, and 

Triazolylypyruvic Acid; Updated to 

Include New Uses of Fenbuconazole, 

Ipconazole, Metconazole, Tebuconazole, 

and Uniconazole; and a Change in 

Plant-back Restriction for 

Tetraconazole’’ in docket ID number 

EPA–HQ–OPP–2007–0987–0006. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Available data provided no indication of 

increased susceptibility of rats or rabbits 

to in utero and/or postnatal exposure to 

fenbuconazole. In the prenatal 

developmental study in rats and rabbits 

and the 2-generation study in rats, 

effects in the offspring were observed 

only at or above those treatment levels 

which resulted in maternal toxicity. 

The degree of concern for infants and 

children exposed to fenbuconazole in 

utero and/or postnatally is low; there 

are no residual uncertainties. The 

toxicology database for fenbuconazole is 

complete and adequate for risk 

assessment purposes. Acceptable 

developmental studies in rats and 

rabbits and the 2-generation 

reproduction study in rats did not show 

evidence of increased susceptibility in 

offspring exposed to fenbuconazole in 

utero and/or postnatally. A NOAEL for 

acute effects has been selected for the 

subpopulation females (13–49 years old) 

based on developmental effects 

(increased resorptions and decreased 

live fetuses per dam) seen at the LOAEL 

in the developmental rat study. By 

regulating on the effects of concern for 

this subpopulation, the risk assessment 

is protective of potential effects to 

infants and children. 

3. Conclusion. There is a complete 

toxicity data base for fenbuconazole and 

exposure data are complete or are 

estimated based on data that reasonably 

account for potential exposures. 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 

fenbuconazole is complete. 

ii. There is no indication that 

fenbuconazole 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 

fenbuconazole results in increased 

susceptibility in utero to 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. 

Although somewhat refined, the dietary 

food exposure assessments were based 

on reliable data that will not 

underestimate exposure to 

fenbuconazole residues in food. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 


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to fenbuconazole in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by fenbuconazole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenbuconazole will occupy 3.1 % of the 

aPAD for females 13–49 years old, the 

only subgroup of concern because of the 

toxicological properties of 

fenbuconazole. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenbuconazole 

from food and water will utilize 6.8% of 

the cPAD for all infants less than 1 year 

old, the population group receiving the 

greatest exposure, and 2.3% of the cPAD 

for the general U.S. population. There 

are no residential uses for 

fenbuconazole that result in chronic 

exposure. EPA does not expect aggregate 

exposure to exceed 100% of the cPAD 

for any population subgroup. 

3. Short- and intermediate-term risks. 

Short- and intermediate-term aggregate 

exposures take into account short-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Fenbuconazole is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

exposure to fenbuconazole through food 

and water and will not be greater than 

the chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Dietary exposure (food + 

water) is the only source of exposure to 

fenbuconazole that is expected to be 

chronic (cancer exposure is considered 

to be life-time exposure). The chronic 

(cancer) aggregate exposure and risk 

estimates are based on those for the 

general U.S. population group. In this 

case the risk is based on a cancer 

potency (Q1*) value of 3.59 × 10¥3 and 

a dietary exposure to fenbuconazole of 

0.000473 mg/kg/day. The estimated 

cancer risk that resulted from this 

assessment is 1.7 × 10¥6. Typically, 

EPA is concerned when the cancer risk 

estimate associated with food and 

drinking water exceeds the range of 1 in 

1 million (1 × 10¥6) . This risk range 

includes computed risks as high as 3 × 

10¥6. As a result, cancer risk to the 

general U.S. population is below the 

Agency’s level of concern. 

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 

fenbuconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with nitrogenphosphorus detection) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

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

B. International Residue Limits 

Maximum Residue Levels (MRLs) for 

residues of fenbuconazole have been 

established by Codex, Canada, and 

Mexico. The residue definition for both 

Codex and Mexico is fenbuconazole, per 

se. The Canadian residue definition, 

however, is the combined residues of 

fenbuconazole and its metabolites, RH–

9129 and RH–9130, each expressed as 

parent (i.e., the same as the U.S. 

tolerance definition). There are no 

established or proposed Canadian, 

Mexican, or Codex MRLs for 

fenbuconazole on pepper. 

C. Revisions to Petitioned-For 

Tolerances 

By this action, §180.480(a)(1), is 

revised to remove reference to ‘‘timelimited tolerance’’ as this section is 

dedicated to, and only contains, 

permanent tolerances. Also, 

§180.480(a)(2) is deleted in its entirety 

as it relates solely to time-limited 

tolerances in paragraph (a)(1) and there 

are no such tolerances in paragraph 

(a)(1). In addition, the time-limited 

tolerance under §180.480(b), section 18 

emergency exemptions, for blueberry at 

1.0 ppm that expired on 12/31/07 is 

deleted. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of the fungicide 

fenbuconazole, alpha–[2–(4–

chlorophenyl)– ethyl]–alpha–phenyl–3–

(1H–1,2,4–triazole)– 1–propanenitrile, 

and its metabolites RH–9129, cis–5–(4–

chlorophenyl)– dihydro–3–phenyl–3–

(1H–1,2,4– triazole–1–ylmethyl)–2–3 H–

furanone, and RH–9130, trans–5–(4–

chlorophenyl)dihydro–3–phenyl–3–

(1H–1,2,4–triazole–1–ylmethyl)–2–3 H–

furanone, expressed as fenbuconazole in 

or on pepper at 0.40 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

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, 


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50562 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 15, 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 180.480 is amended by 

removing paragraph (a)(2); redesignating 

paragraph (a)(1) as paragraph (a); 

revising the introductory text in 

paragraph (a); adding alphabetically a 

commodity to the table in paragraph (a); 

and revising paragraph (b) to read as 

follows: 

§ 180.480 Fenbuconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for combined residues of the 

fungicide fenbuconazole, alpha–[2–(4–

chlorophenyl)– ethyl]–alpha–phenyl–3–

(1H–1,2,4–triazole)– 1–propanenitrile, 

and its metabolites RH–9129, cis–5–(4–

chlorophenyl)– dihydro–3–phenyl–3–

(1H–1,2,4– triazole–1–ylmethyl)–2–3 H–

furanone, and RH–9130, trans–5–(4–

chlorophenyl)dihydro–3–phenyl–3–

(1H–1,2,4–triazole–1–ylmethyl)–2–3 H–

furanone, expressed as fenbuconazole in 

or on the following agricultural 

commodities. 

Commodity Parts per million 

*****

Pepper 0.40 

*****

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for fenbuconazole (alpha-[2-4- 

chlorophenyl)-ethyl]alpha-phenyl-3-(1 

H -1,2,4-triazole)-1-propanenitrile] and 

its metabolites, cis-5-(4-chlorophenyl)- 

dihydro-3-phenyl-3-(1 H -1,2,4-triazole1-ylmethyl)-2-3 H -furanone and trans-5- 

(4-chlorophenyl)dihydro-3-phenyl-3-(1 

H 1,2,4-triazole-1-ylmethyl-2-3 H 

-furanone, expressed as fenbuconazole 

in or on the following raw agricultural 

commodities in connection with use of 

the pesticide under a section 18 

exemption granted by EPA. The timelimited tolerances will expire on the 

date specified in the following table. 

Commodity Parts per million Expiration/revocation date 

Cattle, fat 0.01 12/31/08 

Cattle, meat 0.01 12/31/08 

Goat, fat 0.01 12/31/08 

Goat, meat 0.01 12/31/08 

Hog, fat 0.01 12/31/08 

Hog, meat byproducts 0.01 12/31/08 

Hog, meat 0.01 12/31/08 

Horse, fat 0.01 12/31/08 

Horse, meat 0.01 12/31/08 

Sheep, fat 0.01 12/31/08 

Sheep, meat 0.01 12/31/08 


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Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 50563 

* * * * * 

[FR Doc. E8–19858 Filed 8–26–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0604; FRL–8377–7] 

Dichlobenil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

dichlobenil and its metabolite, 2,6- 

dichlorbenzamide, in or on bushberry 

subgroup 13–07B, caneberry subgroup 

13–07A and rhubarb. It also removes 

existing tolerances on individual 

members of bushberry subgroup 13–07B 

(blueberry) and caneberry subgroup 13–

07A (blackberry and raspberry) that are 

superseded by the new crop subgroup 

tolerances at the same tolerance levels. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

August 27, 2008. Objections and 

requests for hearings must be received 

on or before October 27, 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–2007–0604. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, any 

person may file an objection to any 

aspect of this regulation and may also 

request a hearing on those objections. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2007–0604 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 October 27, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA–

HQ–OPP–2007–0604, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

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

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of August 22, 

2007 (72 FR 47010) (FRL–8142–5), 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 7E7230) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 

201W, Princeton, NJ 08540–6635. The 

petition requested that 40 CFR 180.231 

be amended by establishing tolerances 

for combined residues of the herbicide 

dichlobenil, 2,6-dichlorobenzonitrile, 

and its metabolite, 2,6- 


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