Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 47065 

MRLs for tribenuron methyl on several 

plant commodities. However, no 

Canadian or Mexican MRLs for 

tribenuron methyl have been proposed 

or established for barley, hay; oat, 

forage; oat, hay; wheat, forage; or wheat, 

hay. 

C. Response to Comments 

A comment was received from a 

private citizen supporting the Agency’s 

updating of pesticide regulations. 

V. Conclusion 

Therefore, tolerances are established 

for residues of tribenuron methyl, 

methyl-2-[[[[(4-methoxy-6-methyl-1,3,5- 

triazin-2-yl)methylamino]

carbonyl]amino]sulfonyl]benzoate on 

barley, hay at 0.4 ppm; oat, forage at 

0.05 ppm; oat, hay at 0.05 ppm; wheat, 

forage at 0.3 ppm; and wheat, hay at 0.5 

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, 

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: July 31, 2008. 

Donald R. Stubbs, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.451 is amended by 

alphabetically adding the following 

entries to the table in paragraph (a) to 

read as follows: 

§ 180.451 Tribenuron Methyl; Tolerances 

for Residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Barley, hay .................................... 0.4 

* * * * * 

Oat, forage .................................... 0.05 

* * * * * 

Oat, hay ........................................ 0.05 

* * * * * 

Wheat, forage ............................... 0.3 

* * * * * 

Wheat, hay ................................... 0.5 

* * * * * 

* * * * * 

[FR Doc. E8–18189 Filed 8–12–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0097; FRL–8376–2] 

Tebuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tebuconazole 

in or on apple, wet pomace; asparagus; 

bean, succulent; bean, dry seed; beet, 

garden, tops; beet, garden, roots; 

brassica, leafy greens, subgroup 5B; 

coffee, green bean; coffee, roasted bean; 

corn, field, grain; corn, field, forage; 

corn, field, stover; corn, pop, grain; 

corn, pop, stover; corn, sweet, kernel 

plus cob with husks removed; corn, 

sweet, forage; corn, sweet, stover; 

cotton, undelinted seed; cotton, gin 

byproducts; Fruit, pome, group 11; fruit, 

stone, group 12, except cherry; grain, 

aspirated fractions; hop, dried cones; 

lychee; mango, postharvest; okra; onion, 

bulb, subgroup 3-07A; onion, green, 

subgroup 3-07B; plum, pre- and postharvest; turnip, roots; turnip, tops; 

soybean, forage; soybean, hay; soybean, 

seed; sunflower, seed; sunflower, meal; 

sunflower, refined oil; and vegetable, 

cucurbit, group 9. Bayer CropScience LP 

and Interregional Research Project No. 4 

(IR4) have requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 


hsrobinson on PROD1PC76 with RULES
47066 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 

DATES: This regulation is effective 

August 13, 2008. Objections and 

requests for hearings must be received 

on or before October 14, 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–2005–0097. 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: 

Tracy Keigwin, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6605; e-mail address: 

keigwin.tracy@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–2005–0097 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before October 14, 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–2005–0097, 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 May 18, 

2005 (70 FR 28527) (FRL–7708-5), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP) 6F4668, 0F6086, 

0E6091, 0F6129, 1F6289, 4E6842, and 

4F6854 by Bayer CropScience LP, P.O. 

Box 12014, 2 T.W. Alexander Drive, 

Research Triangle Park, NC 27709. The 

petitions requested that 40 CFR 180.474 

be amended by establishing tolerances 

for residues of the fungicide 

tebuconazole, alpha-[2-(4- 

Chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, in or on food commodities: 

Fruit, pome, group 11 at 0.05 parts per 

million (ppm) (PP 6F4668); bean, 

succulent at 0.1 ppm (PP 0F6086); bean, 

dry seed at 0.1 ppm (PP 0F6086); cotton, 

undelinted seed at 2.0 ppm (PP 0F6086); 

cotton, gin byproducts at 16 ppm (PP 

0F6086); asparagus at 0.01 ppm (PP 

0E6091); coffee, green bean, at 0.1 ppm 

(PP 0E6091); coffee, roasted bean, at 0.2 

ppm (PP 0E6091); garlic, dry bulb at 0.1 

ppm (PP 0E6091); onion, dry bulb at 0.1 

ppm (PP 0E6091); corn, field, grain at 

0.01 ppm (PP 0F6129); corn, field, 

forage at 3.0 ppm (PP 0F6129); corn, 

field, stover at 3.0 ppm (PP 0F6129); 

corn, pop, grain at 0.01 ppm (PP 

0F6129); corn, pop, stover at 3.0 ppm 

(PP 0F6129) corn, sweet, kernel plus cob 

with husks removed at 0.5 ppm (PP 

0F6129); corn, sweet, forage at 6.0 ppm 

(PP 0F6129); corn, sweet, stover at 5.0 

ppm (PP 0F6129); soybean, seed at 0.01 

ppm (PP 0F6129); soybean, forage at 

0.01 ppm (PP 0F6129); soybean, hay at 

0.05 ppm (PP 0F6129); fruit, stone, 

group 12, except cherry at 1.0 ppm (PP 

1F6289); hop, dried cones at 30.0 ppm 

(PP 4E6842); soybean, seed at 0.06 ppm 

(PP 4F6854); soybean, forage at 17 ppm 

(PP 4F6854); soybean, hay at 45 ppm 

(PP 4F6854); soybean, hulls at 0.06 ppm 

(PP 4F6854); and grain, aspirated 


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Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 47067 

fractions at 15 ppm (PP 4F6854). Bayer 

CropScience also proposed to add a 

postharvest use on cherries at the 

current 0–day pre-harvest tolerance 

level of 4.0 ppm. That notice referenced 

a summary of the petitions prepared by 

Bayer CropScience LP, the registrant, 

which is available to the public in the 

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

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Note that the tolerances proposed for 

the food commodities listed under PP 

0E6091 were import tolerances. 

Additionally, in the same Notice of 

filing, EPA announced the filing of PPs 

9E6045, 9E6046, 9E6048, 0E6103, 

0E6117, 0E6153, 0E6158, and 0E6212 

from Interregional Research Project No. 

4 (IR4), 681 U.S. Highway #1 South, 

North Brunswick, NJ 08902-3390. The 

petitions requested that 40 CFR 180.474 

be amended by establishing tolerances 

for residues of the fungicide 

tebuconazole, alpha-[2-(4- 

Chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, in or on food commodities: 

Turnip, tops at 8.0 ppm (PP 9E6045); 

turnip, roots at 0.4 ppm (PP 9E6045); 

hops at 5.0 ppm (9E6046); vegetable, 

cucurbit, group 9 at 0.1 ppm (PP 

9E6048); mango, postharvest at 0.2 ppm 

(PP 0E6103); fruit, stone, group 12, 

except cherry at 1.0 ppm (PP 0E6117); 

sunflower, seed at 0.05 ppm (PP 

0E6153); sunflower, refined oil at 0.2 

ppm (PP 0E6153); sunflower, meal at 0.2 

ppm (PP 0E6153); okra at 1.0 ppm (PP 

0E6158); and lychee at 1.5 ppm (PP 

0E6212). That notice referenced a 

summary of the petitions prepared by 

the IR-4, which is available to the public 

in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

In the Federal Register of April 12, 

2006 (71 FR 18746) (FRL–7773–4), EPA 

issued a notice pursuant to section 

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

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

6E7036 by Interregional Research 

Project No. 4 (IR4), 681 U.S. Highway 1 

South, North Brunswick, NJ 08902- 

3390. The petition requested that 40 

CFR 180.474 be amended by 

establishing tolerances for residues of 

the fungicide tebuconazole, alpha-[2-(4- 

Chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, in or on the food commodity 

asparagus at 0.05 ppm. That notice 

referenced a summary of the petition 

prepared by IR-4, which is available to 

the public in the docket, http:// 

www.regulations.gov. No comments 

were received in response to this Notice 

of Filing. 

In the Federal Register of June 27, 

2007 (72 FR 35237) (FRL–8133–4), EPA 

issued a notice pursuant to section 

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

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

6E7097 by Interregional Research 

Project No. 4 (IR4), 681 U.S. Highway 1 

South, North Brunswick, NJ 08902–

3390. The petition requested that 40 

CFR 180.474 be amended by 

establishing tolerances for residues of 

the fungicide tebuconazole, alpha-[2-(4- 

Chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, in or on food commodities 

vegetable, bulb, group 3 at 1.3 ppm; 

Brassica, leafy greens, subgroup 5B at 

2.5 ppm; beet, garden, roots at 0.7 ppm; 

and beet, garden, leaves at 5.0 ppm. 

That notice referenced a summary of the 

petition prepared by IR-4, which is 

available to the public in the docket, 

http://www.regulations.gov. No 

comments were received in response to 

this Notice of Filing. 

Based upon review of the data 

supporting the petitions, EPA has 

modified the level and/or the tolerance 

expression for all commodities except 

the following: Pome fruit; bean 

succulent, cotton, undelinted seed; 

corn, sweet kernel plus cob with husks 

removed; sunflower, seed; sunflower, 

meal; sunflower, oil; brassica, leafy 

greens subgroup 5B; and beet, garden 

root. The reason for these changes is 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’

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

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of tebuconazole. 

A. Toxicological Profile 

The toxicological profile for 

tebuconazole can be found in the final 

rule published in the Federal Register 

of May 14, 2008 (73 FR 27748-27756, 

FRL–8364–6). Refer to this Federal 

Register document, available at http:// 

www.regulations.gov for a detailed 

discussion of the toxicological profile of 

tebuconazole. 

B. Toxicological Endpoints 

The toxicological endpoints for 

tebuconazole can be found in the final 

rule published in the Federal Register 

of May 14, 2008 (73 FR 27748–27756, 

FRL–8364–6). Refer to this Federal 

Register document, available at http:// 

www.regulations.gov, for a detailed 

discussion of the toxicological endpoint 

selection for tebuconazole. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tebuconazole, EPA 

considered exposure under the 

petitioned-for tolerances, including 

other pending petitions, as well as all 

existing tebuconazole tolerances in (40 

CFR 180.474). EPA assessed dietary 

exposures from tebuconazole 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 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, anticipated residues for 

bananas, grapes, raisins, nectarines, 

peaches and peanut butter were derived 

using the latest USDA Pesticide Data 

Program (PDP) monitoring data from 

2002–2006. Anticipated residues for all 

other registered and proposed food 

commodities were based on field trial 

data. Projected percent crop treated 

estimates were used for apples, apricots, 

cherries, hops, plums and sweet corn. 

For the remaining crops, 100% crop 

treated was assumed. Available 


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47068 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 

processing data were used to refine 

anticipated residues for apples/pears 

(dried and juice), apricots (dried), 

cherry (juice), coffee (roasted bean), 

grapes (juice), plums (prunes/prune 

juice) and peanut (oil). For all other 

processed commodities, DEEM (ver. 

7.81) default processing factors were 

assumed. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the same assumptions as 

stated above for acute exposure (Unit 

III.C.1.i). 

iii. Cancer. As explained in the 

Federal Register of May 14, 2008 (73 FR 

27748–27756, FRL–8364–6), the chronic 

risk assessment is considered to be 

protective of any cancer effects; 

therefore, a separate quantitative cancer 

dietary risk assessment was not 

conducted. 

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. 

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. 

The Agency assumed PCT for grapes; 

grape, raisins; nectarines; oats; peaches; 

and peanuts. The PCT for each crop is 

as follows: Grapes: 25%; grape, raisin: 

25%; nectarine: 25%; oats: 2.5%; peach: 

20%; and peanuts: 45%. 

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 1. 

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 used projected percent 

crop treated (PPCT) information for 

tebuconazole on apple (44% acute 

assessment, 41% chronic assessment); 

apricot (56% acute assessment, 43% 

chronic assessment); cherry (preharvest: 42% acute assessment, 37% 

chronic assessment); cherry (postharvest: 100% acute assessment, 66% 

chronic assessment); corn, sweet (22% 

acute assessment, 14% chronic 

assessment); hop (64% acute 

assessment, 64% chronic assessment); 

plum, pre- and post-harvest (26% acute 

assessment, 24% chronic assessment); 

and turnip tops (68% acute assessment, 

44% chronic assessment). 

EPA estimates PPCT for a new 

pesticide use by assuming that its actual 

PCT during the initial 5 years of use on 

a specific use site will not exceed the 

recent PCT of the market leader (i.e., the 

one with the greatest PCT) on that site. 

An average market leader PCT, based on 

three recent surveys of pesticide usage, 

if available, is used for chronic risk 

assessment, while the maximum PCT 

from the same three recent surveys, if 

available, is used for acute risk 

assessment. The average and maximum 

market leader PCTs may each be based 

on one or two surveys if three are not 

available. Comparisons are only made 

among pesticides of the same pesticide 

types (i.e., the leading fungicide on the 

use site is selected for comparison with 

the new fungicide). The market leader 

PCTs used to determine the average and 

the maximum may be each for the same 

pesticide or for different pesticides 

since the same or different pesticides 

may dominate for each year. Typically, 

EPA uses USDA/NASS as the source for 

raw PCT data because it is publicly 

available. When a specific use site is not 

surveyed by USDA/NASS, EPA uses 

other sources including proprietary 

data. 

An estimated PPCT, based on the 

average PCT of the market leaders, is 

appropriate for use in chronic dietary 

risk assessment, and an estimated PPCT, 

based on the maximum PCT of the 

market leaders, is appropriate for use in 

acute dietary risk assessment. This 

method of estimating PPCTs for a new 

use of a registered pesticide or a new 

pesticide produces high-end estimates 

that are unlikely, in most cases, to be 

exceeded during the initial 5 years of 

actual use. Predominant factors that 

bear on whether the PPCTs could be 

exceeded may include PCTs of similar 

chemistries, pests controlled by 

alternatives, pest prevalence in the 

market and other factors. All relevant 

information currently available for 

predominant factors have been 

considered for tebuconazole on the 

seven crops, resulting in adjustments to 

the initial estimates for three crops to 

account for lack of confidence in 

projections based on less than three 

observations, old data and/or data based 

on expert opinion. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis, or conservative estimates based 

on information from agricultural 

experts. 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 


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which tebuconazole may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for tebuconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

tebuconazole. 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 

tebuconazole for acute exposures are 

estimated to be 78.5 parts per billion 

(ppb) for surface water and 1.56 ppb for 

ground water. The EDWCs for chronic, 

non-cancer are estimated to be 44.9 ppb 

for surface water and 1.56 ppb for 

ground water. The EDWCs for chronic, 

cancer exposures are estimated to be 

32.3 ppb for surface water and 1.56 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 78.5 ppb was 

used to assess the contribution to 

drinking water. For the chronic dietary 

risk assessment (which is protective of 

any possible cancer effects), the water 

concentration value of 44.9 ppb was 

used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Tebuconazole is currently registered 

for uses that could result in residential 

exposures. Short-term dermal and 

inhalation exposures are possible for 

residential adult handlers mixing, 

loading, and applying tebuconazole 

products outdoors to ornamental plants. 

Short- and intermediate-term dermal 

post application exposures to adults 

during golfing and children playing on 

treated wood structures are also 

possible. Children may also be exposed 

via the incidental oral route when 

playing on treated wood structures. 

Long-term exposure is not expected. As 

a result, risk assessments have been 

completed for residential handler 

scenarios as well as residential post 

application scenarios. 

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.’’

Tebuconazole is a member of the 

triazole-containing class of pesticides. 

Triazole-derived pesticides can form the 

common metabolite 1,2,4-triazole and 

two triazole conjugates (triazole alanine 

and triazole acetic acid). Refer to EPA’s 

recent tolerance rulemaking on 

tebuconazole in the Federal Register of 

May 14, 2008 (73 FR 27748-27756, FRL–

8364–6), for more information on this 

risk assessment. 

D. Safety Factor for Infants and 

Children 

In the Federal Register of May 14, 

2008 (73 FR 27748–27756, FRL–8364–6) 

the Agency published a Final rule 

establishing tolerances for residues of 

tebuconazole in or on various food 

commodities. When the Agency 

conducted the risk assessments in 

support of that tolerance action, it also 

assessed dietary exposure to 

tebuconazole assuming that all of the 

tolerances in this action were in place. 

Accordingly, EPA relies on the decision 

on the FQPA safety factor for infants 

and children as set out in that action. 

Refer to EPA’s recent tolerance 

rulemaking on tebuconazole, available 

at http://www.regulations.gov, for a 

detailed discussion and selection of a 

safety factor for infants and children for 

tebuconazole. For the reasons explained 

there, EPA reduced the FQPA safety 

factor to 3X for all potential exposure 

scenarios. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate 

safety factors (SFs). EPA calculates the 

aPAD and cPAD by dividing the point 

of departure (POD) by all applicable 

uncertainty factors (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. 

Below, EPA has summarized the 

conclusions from its recent tolerance 

rulemaking on tebuconazole which took 

into account exposure to tebuconazole 

from the food commodities covered by 

the tolerances in this action. Refer to 

EPA’s recent tolerance rulemaking on 

tebuconazole, available at http:// 

www.regulations.gov, for a detailed 

discussion of EPA’s safety 

determinations. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

tebuconazole will occupy 53% of the 

aPAD for the population group (all 

infants less than 1 year old) receiving 

the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to tebuconazole from food 

and water will utilize 4% of the cPAD 

for the U.S. population and 11% of the 

cPAD for the most highly exposed 

population group (infants less than 1 

year old). 

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). Tebuconazole is 

currently registered for uses that could 

result in short-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

tebuconazole. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

short-term aggregate MOE from dietary 

exposure (food + drinking water) and 

non-occupational/residential handler 

exposure for adults using a hose-end 

sprayer on ornamentals is 400. The 

short-term aggregate MOE from dietary 

exposure and exposure from golfing is 

1,800. The short-term aggregate MOE to 

children from dietary exposure and 

exposure from wood surfaces treated at 

the above ground use rate is 530. The 

short-term aggregate MOE to children 

from dietary exposure and exposure to 

wood surfaces treated at the below 

ground use rate is 230. The combined 

and aggregate MOEs for wood treated for 

below ground uses exceed the Agency’s 

LOC of 300, and indicate a potential risk 

of concern. However, the MOE of 230 is 

based on unrealistic assumptions and 

EPA has concluded that aggregate 


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exposure does not pose a risk of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Tebuconazole is currently registered for 

uses that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to tebuconazole. 

Since the POD, relevant exposure 

scenarios and exposure assumptions 

used for intermediate-term aggregate 

risk assessments are the same as those 

used for short-term aggregate risk 

assessments, the short-term aggregate 

risk assessments represent and are 

protective of both short- and 

intermediate-term exposure durations. 

5. Aggregate cancer risk for U.S. 

population. Although tebuconazole is 

classified as a Group C CarcinogenPossible Human Carcinogen, the Agency 

has concluded that the chronic RfD is 

protective of the cancer effects. 

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 tebuconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate gas chromatography/ 

nitrogen phosphorus detection and 

liquid chromatography/mass 

spectrometry/mass spectrometry (GC/ 

NPD and LC/MS/MS) methods are 

available for enforcing tolerances for 

tebuconazole and its metabolites in 

plant commodities, livestock matrices 

and processing studies. The methods 

have been adequately validated by an 

independent laboratory in conjunction 

with a previous petition. The method 

may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

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

B. International Residue Limits 

There are currently Codex, Canadian 

and Mexican maximum residue limits 

(MRLs) for residues of tebuconazole in 

or on a variety of plant and livestock 

commodities. The tolerance definition 

for residues in plants is tebuconazole, 

per se, for Codex, Canada, and Mexico. 

For livestock commodities, the tolerance 

expression is for the combined residues 

of tebuconazole and HWG 2061 in the 

United States and Canada, and 

tebuconazole, per se, for Codex. Where 

possible, the proposed tolerance levels 

have been harmonized with the MRLs 

from Canada, Mexico, and Codex. With 

regard to the pome fruit tolerance, the 

Agency recommended tolerance of 0.05 

ppm differs from the Codex MRL of 0.5 

mg/kg. Harmonization of the pome fruit 

tolerances is not possible because U.S. 

data were derived using long preharvest intervals (PHIs) of 75-129 days 

while Italian data were derived using 

maximum PHIs of 14 days. With regard 

to the cucurbit vegetable tolerance, the 

Agency recommended tolerance of 0.09 

ppm for vegetable, cucurbit, group 9, 

differs from the Codex MRL of 0.2 mg/ 

kg on cucumber and 0.02 mg/kg on 

summer squash. The Agency notes that 

some of the cucumber data from Spain 

were derived from trials conducted in 

greenhouses. Although the application 

rate used for the Spanish trials was 

similar to the trials conducted in the 

United States, it is quite normal for 

greenhouse trials to give higher 

residues. If the greenhouse trials are 

ignored, then the remaining Codex data 

are in the 0.02 – 0.04 range, consistent 

with the U.S. data and tolerance. In 

short, the higher Codex MRL for 

cucumber accommodates the 

greenhouse use. 

C. Response to Comments 

The Agency received a comment from 

a citizen of New Jersey. The commenter 

questioned the necessity of using 

taxpayer money through the agency of 

the Interregional Research Project No. 4 

to develop pesticides, challenged the 

appropriateness of conducting some of 

the tebuconazole field trials outside of 

the United States, expressed concern 

over whether specific warnings were 

given to residents of New Jersey prior to 

conducting field trials in that State, and 

worried that students at Rutgers 

University may have been injured in the 

tebuconazole toxicological tests on 

animals that were performed at that 

facility. 

In response, as to the commenter’s 

concern with field trials that were 

conducted in countries other than the 

United States, EPA notes that frequently 

field trials are conducted in other 

countries as well as in the United States 

so that EPA can understand the range of 

pesticide residues that may be present 

on a food. EPA received several 

applications for tebuconazole import 

tolerances and it is appropriate that the 

field trials would be conducted in the 

countries where the pesticide was to be 

used. Additionally, some tebuconazole 

import tolerances were proposed with 

foreign data, and then a U.S. use was 

proposed and U.S. data submitted. None 

of the other comments address the 

findings made in this action regarding 

the establishment of a tolerance. 

Nonetheless, EPA provides the 

following information regarding the 

comments. IR-4 was established by the 

USDA to help minor acreage; specialty 

crop producers obtain EPA tolerances 

and new registered uses of pesticides. 

As to whether warnings were given to 

residents of New Jersey regarding field 

trials, EPA would point out that 

experimental field trials are subject to 

EPA regulations at 40 CFR part 172. 

EPA also has regulations governing the 

toxicological data testing laboratories 

that are designed to insure data quality 

(40 CFR part 160). Federal jurisdiction 

concerning the safety of workers in 

testing laboratories would be under the 

Occupational Safety and Health 

Administration in the U.S. Department 

of Labor. EPA has responded to similar 

comments from this commenter on 

previous occasions. Refer to 70 FR 

37686 (June 30, 2005), 70 FR 1354 

(January 7, 2005), and 69 FR 63083 

(October 29, 2004). 

D. Revisions to Petitioned-for 

Tolerances 

Based upon review of the data 

supporting the petitions, EPA 

determined that the proposed tolerances 

should be revised as follows: Cotton, gin 

byproducts at 25.0 ppm; asparagus at 

0.05 ppm; coffee, green bean at 0.15 

ppm; coffee, roasted bean, at 0.3 ppm; 

onion, bulb, subgroup 3-07A at 0.2 ppm; 

corn, field, grain at 0.05 ppm; corn, 

field, forage at 4.0 ppm; corn, field, 

stover at 3.5 ppm; corn, pop, grain at 

0.05 ppm; corn, pop, stover at 3.5 ppm; 

corn, sweet, forage at 7.0 ppm; corn, 

sweet, stover at 6.0 ppm; turnip, tops 

(limited to east of the Rockies) at 7.0 

ppm; turnip, roots at 0.5 ppm; beet, 

garden, tops at 7.0 ppm; beet, garden, 

root at 0.70; hop, dried cones at 35.0 

ppm; vegetable, cucurbit, group 9 at 

0.09 ppm; mango, postharvest at 0.15 

ppm; plum, pre- and post-harvest at 1.0 

ppm; okra at 1.2 ppm; lychee at 1.6 

ppm; soybean, seed at 0.08 ppm; 

soybean, forage at 25 ppm; soybean, hay 

at 50 ppm; and grain, aspirated fractions 

16.0 ppm. A separate tolerance is 

required for apple, wet pomace at 0.1 

ppm. No tolerance is required for 

soybean hulls. A tolerance of 1.3 ppm 

is required for onion, green, subgroup 3- 

07B. The tolerance proposed by IR-4 for 

hops (PP 9E6046) is covered by the 

registrant proposed tolerance for hops, 

dried cones (PP 4E6842). EPA revised 


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most of these tolerance levels based on 

analysis of the residue field trial data 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data 

Standard Operating Procedure (SOP). 

For the proposed tolerances on 

asparagus; corn, field, grain; and by 

translation corn, pop grain the tolerance 

could not be set lower than the limit of 

quantitation (LOQ) of the enforcement 

analytical method, which was 0.05 ppm 

for tebuconazole. For corn, field, forage, 

the proposed tolerance was raised to 4.0 

ppm based on the maximum residue 

level in the field trials. 

Additionally, IR-4 petitioned for a 

tolerance on bulb vegetables group 3 as 

that crop group was defined at the time 

of the petition (6E7097). In the Federal 

Register of December 7, 2007 (72 FR 

69150–69158) (FRL–8340–6), EPA 

issued a final rule that revised the crop 

grouping regulations. EPA indicated in 

the December 7, 2007 final rule as well 

as the earlier May 23, 2007 proposed 

rule (72 FR 28920–28930) that, for 

existing petitions for which a Notice of 

Filing had been published, the Agency 

would attempt to conform these 

petitions to the rule. As part of this 

action, EPA expanded and revised bulb 

vegetables group 3. Changes to crop 

group 3 (bulb vegetables) included 

adding new commodities, creating 

subgroups for bulb and green onions, 

and changing the name of one of the 

representative commodities from 

‘‘onion, dry bulb’’ to ‘‘onion, bulb’’. The 

Bayer proposed tolerance for garlic 

(bulb) and onion (bulb) with no U. S. 

registration was superseded by the 

proposed tolerance for bulb vegetables. 

The proposed tolerance on bulb 

vegetables group 3 was determined to be 

inappropriate because the residues were 

found to be more than a factor of 5x. 

Thus, separate tolerances were set for 

the crop subgroups, onion, bulb, 

subgroup 3-07A at 0.2 ppm, and onion, 

green, subgroup 3-07B at 1.3 ppm. 

EPA concludes it is reasonable to 

revise the petitioned-for tolerance so 

that they agree with the recent crop 

grouping revisions because (1) although 

the new crop groups/subgroups include 

several new commodities, the added 

commodities are closely related minor 

crops which contribute little to overall 

dietary or aggregate exposure and risk; 

and tebuconazole exposure from these 

added commodities was considered 

when EPA conducted the dietary and 

aggregate risk assessments supporting 

this action; and (2) the representative 

commodities for the revised crop 

groups/subgroups have not changed. 

Finally, the proposed tolerance for 

hops, domestically grown, in PP 

4E6046, was superseded by the 

proposed tolerance for hops, dry cone 

(based on data for imported hops) in PP 

4E6842, since the latter proposed 

tolerance is higher, 30.0 ppm. The 

proposed tolerance for asparagus 

(domestic) at 0.2 ppm, in PP 6E7036, 

superseded the proposed tolerance for 

imported asparagus at 0.1 ppm, in PP 

0E6091. The tolerances for inadvertent 

residues of tebuconazole in soybeans 

planted in rotation with treated wheat 

in PP 0F6129, were superseded by the 

proposed tolerance for soybean 

following a direct treatment of 

tebuconazole in PP 4F6854. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the fungicide 

tebuconazole, alpha-[2-(4- 

Chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol, in or on food commodities 

apple, wet pomace at 0.1 ppm; 

asparagus at 0.05 ppm; bean, succulent 

at 0.1 ppm; bean, dry seed at 0.1 ppm; 

beet, garden, tops at 7.0 ppm; beet, 

garden, roots at 0.70 ppm; brassica, leafy 

greens, subgroup 5B at 2.5 ppm; coffee, 

green bean at 0.15 ppm; coffee, roasted 

bean at 0.3 ppm; corn, field, grain at 

0.05 ppm; corn, field, forage at 4.0 ppm; 

corn, field, stover at 3.5 ppm; corn, pop, 

grain at 0.05 ppm; corn, pop, stover at 

3.5 ppm; corn, sweet, kernel plus cob 

with husks removed at 0.5 ppm; corn, 

sweet, forage at 7.0 ppm; corn, sweet, 

stover at 6.0 ppm; cotton, undelinted 

seed at 2.0 ppm; cotton, gin byproducts 

at 25.0 ppm; Fruit, pome, group 11 at 

0.05 ppm; fruit, stone, group 12, except 

cherry at 1.0 ppm; grain, aspirated 

fractions at 16.0 ppm; hop, dried cones 

at 35.0 ppm; lychee at 1.6 ppm; mango, 

postharvest at 0.15 ppm; okra at 1.2 

ppm; onion, bulb, subgroup 3-07A at 0.2 

ppm; onion, green, subgroup 3-07B at 

1.3 ppm; plum, pre- and post-harvest at 

1.0 ppm; soybean, forage at 25 ppm; 

soybean, hay at 50 ppm; soybean, seed 

at 0.08 ppm; sunflower, seed at 0.05 

ppm; sunflower, meal at 0.2 ppm; 

sunflower, refined oil at 0.2 ppm; 

vegetable, cucurbit, group 9 at 0.09 

ppm; turnip, roots at 0.5 ppm; and 

turnip, tops at 7.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petitions submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

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). 


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47072 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 

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: July 29, 2008. 

Donald R. Stubbs, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180. 474 is amended by 

revising the introductory text of 

paragraph (a)(1), by alphabetically 

adding the following commodities to the 

table in paragraph (a)(1); by removing 

the text from paragraph (b) and 

reserving the paragraph designation and 

heading; and by adding a new paragraph 

(c). 

§ 180.474 Tebuconazole; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for the residues of the 

fungicide, tebuconazole, alpha-[2-(4- 

Chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol in or on the following 

commodities: 

Commodity Parts per 

million 

* * * * * 

Apple, wet pomace ....................... 0.1 

Asparagus ..................................... 0.05 

* * * * * 

Bean, succulent ............................ 0.1 

Bean, dry seed ............................. 0.1 

Beet, garden, roots ....................... 0.70 

Beet, garden, tops ........................ 7.0 

Commodity Parts per 

million 

Brassica, leafy greens, subgroup 

5B .............................................. 2.5 

Coffee, green bean1 ..................... 0.15 

Coffee, roasted bean1 .................. 0.3 

Corn, field, grain ........................... 0.05 

Corn, field, forage ......................... 4.0 

Corn, field, stover ......................... 3.5 

Corn, pop, grain ............................ 0.05 

Corn, pop, stover .......................... 3.5 

Corn, sweet, kernel plus cob with 

husks removed .......................... 0.5 

Corn, sweet, forage ...................... 7.0 

Corn, sweet, stover ...................... 6.0 

Cotton, undelinted seed ............... 2.0 

Cotton, gin byproducts ................. 25.0 

Fruit, pome, group 11 ................... 0.05 

Fruit, stone, group 12, except 

cherry ........................................ 1.0 

Grain, aspirated fractions ............. 16.0 

* * * * * 

Hop, dried cones .......................... 35.0 

Lychee .......................................... 1.6 

Mango, postharvest ...................... 0.15 

* * * * * 

Okra .............................................. 1.2 

Onion, bulb, subgroup 3-07A ....... 0.2 

Onion, green, subgroup 3-07B ..... 1.3 

* * * * * 

Plum, pre- and post-harvest ......... 1.0 

* * * * * 

Soybean, forage ........................... 25 

Soybean, hay ................................ 50 

Soybean, seed .............................. 0.08 

Sunflower, seed ............................ 0.05 

Sunflower, meal ............................ 0.2 

Sunflower, refined oil .................... 0.2 

Vegetable, cucurbit, group 9 ........ 0.09 

* * * * * 

1There are no U.S. registrations as of 7/31/ 

2008. 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations for the residues of the 

fungicide, tebuconazole, alpha-[2-(4- 

Chlorophenyl)ethyl]-alpha-(1,1- 

dimethylethyl)-1H-1,2,4-triazole-1- 

ethanol in or on the following 

commodities: 

Commodity Parts per 

million 

Turnip, roots ................................. 0.5 

Turnip, tops ................................... 7.0 

* * * * * 

[FR Doc. E8–18625 Filed 8–12–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0564; FRL–8374–4] 

Thifensulfuron Methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thifensulfuron 

methyl in or on barley, hay; oat, forage; 

oat, hay; wheat, forage, and wheat, hay. 

E.I. DuPont de Nemours and Company 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 13, 2008. Objections and 

requests for hearings must be received 

on or before October 14, 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–2007–0564. To access the 

electronic docket, go to http:// 

www.regulations.gov, and search for the 

docket ID number. 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: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 


hsrobinson on PROD1PC76 with RULES