Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 11777 

understanding the rule so that they 

could better evaluate its effects on them 

and participate in the rulemaking 

process. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1–

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this rule under that Order and have 

determined that it does not have 

implications for federalism. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 or more in any one year. 

Though this rule will not result in such 

an expenditure, we do discuss the 

effects of this rule elsewhere in this 

preamble. 

Taking of Private Property 

This rule will not affect a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

would not create an environmental risk 

to health or risk to safety that might 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Commandant Instruction M16475.lD, 

and Department of Homeland Security 

Management Directive 5100.1, which 

guides the Coast Guard in complying 

with the National Environmental Policy 

Act of 1969 (NEPA) (42 U.S.C. 4321–

4370f), and have concluded that there 

are no factors in this case that would 

limit the use of a categorical exclusion 

under section 2.B.2 of the Instruction. 

Therefore, this rule is categorically 

excluded, under figure 2–1, paragraph 

(32)(e) of the Instruction, from further 

environmental documentation. Under 

figure 2–1, paragraph (32)(e), of the 

Instruction, an ‘‘Environmental Analysis 

Check List’’ and a ‘‘Categorical 

Exclusion Determination’’ are not 

required for this rule. 

List of Subjects in 33 CFR Part 117 

Bridges. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 117 as follows: 

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS 

■ 1. The authority citation for part 117 

continues to read as follows: 

Authority: 33 U.S.C. 499; Department of 

Homeland Security Delegation No. 0170.1; 33 

CFR 1.05–1(g); § 117.255 also issued under 

the authority of Pub. L. 102–587, 106 Stat. 

5039. 

■ 2. Revise § 117.323 to read as follows: 

§ 117.323 Outer Clam Bay 

The drawspan of the Outer Clam Bay 

Boardwalk Drawbridge shall open on 

signal if at least 30 minutes advance 

notice is given. 

Dated: March 2, 2007. 

D.W. Kunkel, 

Rear Admiral, U.S. Coast Guard Commander, 

Seventh Coast Guard District. 

[FR Doc. E7–4590 Filed 3–13–07; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0312; FRL–8113–6] 

Prothioconazole; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

prothioconazole and prothioconazoleVerDate Aug<31>2005 14:23 Mar 13, 2007 Jkt 211001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1

cprice-sewell on PROD1PC66 with RULES
11778 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 

desthio calculated as parent in or on 

barley, grain/hay/straw; grain, aspirated 

grain fractions; pea and bean, dried 

shelled, except soybeans, subgroup 6C; 

peanut; peanut hay; rapeseed, seed; 

wheat, grain/forage/hay/straw; and for 

combined residues of prothioconazole, 

prothioconazole-desthio and conjugates 

that can be converted to these two 

compounds by acid hydrolysis, 

calculated as parent in or on cattle, 

meat/meat byproducts/fat/milk; poultry, 

liver; goat, fat/meat/meat byproducts; 

hog, meat byproducts; horse, fat/meat/ 

meat byproducts; sheep, fat/meat/meat 

byproducts. Bayer CropScience 

requested tolerances under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the Food Quality 

Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

March 14, 2007. Objections and requests 

for hearings must be received on or 

before May 14, 2007, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2005–0312. 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: 

Tony Kish, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9443; e-mail address: 

kish.tony@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

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

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

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

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

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

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2005–0312 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before May 14, 2007. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2005–0312, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

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

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of November 

30, 2005 (70 FR 71831) (FRL–7747–6), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 4F6830) by Bayer 

CropScience, 2 T.W. Alexander Dr., 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the fungicide 

prothioconazole, 2-[2-(1- 

chlorocyclopropyl)-3-(2-chlorophenyl)- 

2-hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione, in or on barley, grain 

at 0.2 parts per million (ppm); barley, 

hay at 7.0 ppm; barley, straw at 2.0 

ppm; barley, pearled at 0.2 ppm; barley, 

bran at 0.4 ppm; black mustard, seed at 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 11779 

0.1 ppm; borage, seed at 0.1 ppm; 

canola, seed at 0.1 ppm; crambe, seed at 

0.1 ppm; field mustard, seed at 0.1 ppm; 

flax, seed at 0.1 ppm; grain, aspirated 

fractions at 13.0 ppm; Indian mustard, 

seed at 0.1 ppm; Indian rapeseed 0.1 

ppm; pea and bean, dried shelled 

(except soybeans) at 0.8; peanut, 

nutmeat at 0.02 ppm; peanut, hay at 5.0 

ppm; peanut, meal at 0.3 ppm; rapeseed, 

seed at 0.1 ppm; rice, grain at 0.25 ppm; 

rice, straw at 1.5 ppm; rice, hulls at 1.0 

ppm; wheat, grain at 0.06 ppm; wheat, 

bran at 1.5 ppm; wheat, forage at 7.0 

ppm; wheat, germ at 0.15 ppm; wheat, 

hay at 4.0 ppm; wheat, straw at 2.3 ppm 

and for combined residues of 

prothioconazole, its desthio and 4- 

hydroxy metabolites, and conjugates of 

each in cattle, meat at 0.01 ppm; cattle, 

meat byproducts at 1.2 ppm; cattle, fat 

at 0.1 ppm; and milk at 0.006 ppm. That 

notice included a summary of the 

petition prepared by Bayer CropScience, 

the registrant. Comments were received 

on the notice of filing. EPA’s response 

to these comments is discussed in Unit 

IV.C. 

For the reasons stated in Unit V., EPA 

is not establishing at this time the 

following petitioned-for tolerances: 

Rice; black mustard; borage; flax; Indian 

mustard; barley, pearled barley; barley, 

bran; canola; crambe; field mustard; 

Indian rapeseed; peanut, meal; wheat, 

bran; and wheat, germ. 

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see http:// 

www.epa.gov/oppfead1/trac/science. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for combined 

residues of prothioconazole and 

prothioconazole-desthio, calculated as 

parent in or on barley, grain at 0.35 

ppm; barley, hay at 7.0 ppm; barley, 

straw at 4.0 ppm; grain, aspirated grain 

fractions at 11.0 ppm; pea and bean, 

dried shelled, except soybeans, 

subgroup 6C at 0.9; peanut at 0.02 ppm; 

peanut, hay at 6.0 ppm; rapeseed, seed 

at 0.15 ppm; wheat, grain at 0.07 ppm; 

wheat, forage at 6.0 ppm; wheat, hay at 

4.5 ppm; wheat, straw at 5.0 ppm and 

for combined residues of 

prothioconazole, prothioconazoledesthio, and conjugates that can be 

converted to these two compounds by 

acid hydrolysis, calculated as parent in 

or on cattle, meat at 0.02 ppm; cattle, 

meat byproducts at 0.2 ppm; cattle, fat 

at 0.1 ppm; goat, fat at 0.1 ppm; goat, 

meat at 0.02 ppm; goat, meat byproducts 

at 0.2 ppm; hog, meat byproducts at 0.05 

ppm; horse, fat at 0.1 ppm; horse, meat 

at 0.02 ppm; horse, meat byproducts at 

0.2 ppm; milk at 0.02 ppm; poultry, 

liver at 0.02 ppm; sheep, fat at 0.1 ppm; 

sheep, meat at 0.02 ppm and sheep, 

meat byproducts at 0.2 ppm. 

EPA’s assessment of exposures and 

risks associated with establishing the 

tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

prothioconazole as well as the noobserved-adverse-effect-level (NOAEL) 

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

can be found at http:// 

www.regulations.gov. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, and estimates risk in terms 

of the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at: 

1. http://www.epa.gov/oppfead1/trac/ 

science. 

2. http://www.epa.gov/pesticides/ 

factsheets/riskassess.htm. 

3. http://www.epa.gov/pesticides/trac/ 

science/aggregate/pdf. 

Both prothioconazole and 

prothioconazole-desthio have low acute 

toxicities by oral, dermal, and 

inhalation routes. Neither compound is 

a dermal sensitizer, nor a skin or eye 

irritant. 

Subchronic toxicity studies show that 

the target organs at the LOAEL include 

the liver, kidney, urinary bladder, 

thyroid, and blood. NOAEL/LOAEL 

values across the family of chemicals 

(i.e., prothioconazole, and metabolites 

prothioconazole-desthio, and 

prothioconazole sulfonic acid potassium 

salt) in the toxicity database indicate 

that prothioconazole-desthio is a more 

toxic chemical. 

The profile of chronic toxicity is 

similar to that of subchronic toxicity, 

and also includes body weight and food 

consumption changes, and toxicity to 

the lymphatic and gastrointestintal (GI) 

systems. The relative potency of 

prothioconazole-desthio is greater than 

prothioconazole. 

The data from developmental toxicity 

studies indicate that prothioconazole 

and the three metabolites evaluated (i.e., 

prothioconazole-desthio, 

prothioconazole sulfonic acid potassium 

salt, and prothioconazole-deschloro) 

variously produce prenatal 

developmental effects at levels equal to 

or below maternally toxic levels. 

Prothioconazole-desthio is a 

developmental neurotoxicant, 


cprice-sewell on PROD1PC66 with RULES
11780 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 

producing changes in brain 

morphometrics and increases in the 

occurrence of peripheral nerve lesions 

in the neonate. A NOAEL was not 

determined, since these observations 

were looked for only at the high dose 

level. Prothioconazole-desthio is the 

most toxic orally or dermally, with 

LOAELs significantly below that of the 

other chemicals. 

In reproduction studies in the rat, 

conducted using prothioconazole and 

prothioconazole-desthio, reproductive 

and offspring toxicities are observed 

only in the presence of parental toxicity. 

The nature of parental toxicity is similar 

to what was observed in the subchronic 

studies, such as body weight and food 

consumption changes, liver effects, etc. 

Reproductive effects include decreases 

in reproductive indices such as those 

that indicate pup survival and growth. 

Offspring toxicity is manifested by 

decreased pup weights and 

malformations such as cleft palate. The 

data show that prothioconazole-desthio 

is more toxic by an order of magnitude. 

Acute and subchronic neurotoxicity 

studies were conducted in the rat using 

prothioconazole. The acute 

neurotoxicity study produced reduced 

motor and locomotor activity at a 

relatively high dose level, while no 

neurotoxicity was observed in the 

subchronic neurotoxicity study. As 

mentioned in the discussion of 

developmental toxicity, a 

developmental neurotoxicity study was 

conducted in the rat using 

prothioconazole-desthio, and neurotoxic 

effects were at the high dose level only 

were included in the report. Judging 

from these three neurotoxicity studies, 

prothioconazole-desthio is the more 

potent neurotoxicant, which is 

consistent with its relative potency in 

other areas of toxicity. 

A battery of mutagenicity studies was 

conducted using both prothioconazole 

and its desthio metabolite. In addition, 

carcinogenicity studies were conducted 

in rats and mice using these two 

chemicals. The available data indicate 

that neither of these compounds is 

mutagenic or carcinogenic in the species 

tested, which mitigates against concern 

for carcinogenicity in humans. 

A summary of the toxicological 

endpoints for prothioconazole used for 

human risk assessment is shown in 

Table 1 of this unit: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PROTHIOCONAZOLE FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/scenario 

Dose used in risk assessment, 

interspecies and intraspecies and 

any traditional UF 

FQPA safety factor (SF) and 

level of concern for risk assessment Study and toxicological effects 

Acute dietary 

(Females 13–49 years of age) 

NOAEL = 2.0 milligram/kilogram/ 

day (mg/kg/day) 

UF = 100 X acute reference dose 

(RfD) = 0.002 mg/kg/day 

FQPA SF = 10X 

acute population adjusted dose 

(aPAD) = acute RfD/Special 

FQPA SF = 0.002 mg/kg/day 

Developmental Toxicity study in 

rabbits 

LOAEL = 10 mg/kg/day based on 

structural alterations including 

malformed vertebral body and 

ribs, arthrogryposis, and multiple malformations 

Chronic dietary 

(All populations) 

NOAEL= 1.1 mg/kg/day 

UF = 100 X chronic RfD = 0.001 

mg/kg/day 

FQPA SF = 10X 

chronic population adjusted dose 

(cPAD) = chronic RfD/FQPA 

SF = 0.001 mg/kg/day 

Chronic/Oncogenicity study in 

rats 

LOAEL = 8.0 mg/kg/day based 

on liver histopathology 

(hepatocellular vacuolation and 

fatty change (single cell, 

centrilobular, and periportal)) 

Cancer 

(Oral, dermal, inhalation) 

Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. 

Note: The toxicity endpoints for prothioconazole-desthio were used for the prothioconazole risk assessment because they were slightly more 

conservative than those for prothioconazole per se. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have not been 

previously established for the combined 

residues of prothioconazole and 

prothioconazole-desthio, calculated as 

parent, in or on a variety of raw 

agricultural commodities and combined 

residues of prothioconazole and 

prothioconazole-desthio and conjugates 

that can be converted to these two 

compounds by acid hydrolysis, 

calculated as parent, in or on milk and 

edible animal products. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

prothioconazole 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 conducting the acute dietary 

exposure assessment EPA used the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM-FCIDTM, version 

2.03), which incorporates food 

consumption data as reported by 

respondents in the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII), and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the acute 

exposure assessments: A moderately 

refined acute dietary exposure 

assessment was conducted for 

prothioconazole. Empirical processing 

factors (PFs) and livestock maximum 

residues were incorporated, and 100 

percent crop treated (PCT) was assumed 

for the acute assessment. Average 

residue levels were also used, since all 

of the plant commodities included in 

this assessment are blended food forms. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used DEEM-FCIDTM, version 2.03, 

which incorporates food consumption 

data as reported by respondents in the 

USDA 1994–1996 and 1998 CSFII, and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the chronic 

exposure assessments: A moderately 

refined chronic dietary exposure 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 11781 

assessment was performed. Empirical 

PFs, average residues, and livestock 

maximum residues were incorporated 

into the chronic assessment and 100 

PCT was assumed. 

iii. Cancer. The Agency classified 

prothioconazole and/or its metabolites 

as ‘‘Not likely to be Carcinogenic to 

Humans’’ according to the 2005 Cancer 

Guidelines, based on available studies 

in the mouse and rat that showed no 

increase in tumor incidence. 

Accordingly, no exposure assessment is 

necessary for assessing cancer risk. 

iv. Anticipated residue and PCT 

information. For assessment of acute 

dietary risk, empirical PFs and livestock 

maximum residues were incorporated, 

and 100 PCT was assumed for the acute 

assessment. Average residue levels were 

also used, since all of the plant 

commodities included in this 

assessment are blended food forms. 

Likewise for the assessment of chronic 

dietary risk, empirical PFs, average 

residues, and livestock maximum 

residues were incorporated into the 

chronic assessment and 100 PCT was 

also assumed. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

prothioconazole in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

prothioconazole. 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 Groundwater (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

prothioconazole for acute exposures are 

estimated to be 22 parts per billion 

(ppb) for surface water. The EDWCs for 

chronic exposures are estimated to be 11 

ppb for surface water. EPA used the 

EDWCs for surface water in assessing 

the risk from prothioconazole because 

the EWDCs for ground water are 

minimal in comparison to surface 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). 

Prothioconazole is not registered for 

use on any sites 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.’’

Prothioconazole 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, see 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

Prothioconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazolylalanine and triazolylacetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

prothioconazole, EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

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

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

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

Agency retained the additional 10X 

FQPA SF 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. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the 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. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. In applying this provision, 

EPA either retains the default value of 

10X when reliable data do not support 

the choice of a different factor, or, if 

reliable data are available, EPA uses a 

different additional SF value based on 

the use of traditional UFs and/or special 

FQPA SFs, as appropriate. 

2. Prenatal and postnatal sensitivity—

i. Prenatal. Available evidence from rat 

developmental toxicity studies with 

prothioconazole (oral) and its desthio 

(oral and dermal) and sufonic acid K 

salt (oral) metabolites, rabbit 

developmental with desthio metabolite 

(oral), and rat developmental 

neurotoxicity with desthio metabolite 

(oral), as well as a multi-generation 

reproduction study with the desthio 

metabolite, indicate that there is 

concern for prenatal toxicity. Effects 

include skeletal structural 

abnormalities, such as cleft palate, 

deviated snout, malocclusion, and extra 

ribs; developmental delays; other effects 

include changes in brain morphometry, 

peripheral nerve lesions, and death. 

ii. Postnatal. Available data also show 

that the skeletal effects such as extra 

ribs are not completely reversible after 

birth in the rat, but persist as 

development continues. Data from the 

developmental neurotoxicity study also 

show that brain morphometry is 


cprice-sewell on PROD1PC66 with RULES
11782 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 

abnormal postnatally, and there is an 

increased incidence of lesions of the 

peripheral nerves postnatally. 

3. Conclusion. The toxicity database 

for prothioconazole (and its metabolites) 

is adequate for endpoint selection for 

exposure risk assessment scenarios and 

for FQPA evaluation, with the exception 

of missing data on brain morphometry 

at lower does from the developmental 

neurotoxicity study. Effects are seen in 

the 2–generation reproduction studies 

in rats; developmental studies in rats 

and rabbits; and a developmental 

neurotoxicity study in rats which 

suggest that pups are more susceptible: 

Pup effects were seen at levels below 

the LOAELs for maternal toxicity and, 

in general, were of comparable or 

greater severity compared to the effects 

observed in adults. Additionally, there 

is uncertainty concerning the LOAEL/ 

NOAEL for developmental effects seen 

in the developmental neurotoxicity 

study in rats (abnormal brain 

morphometry at high dose) due to a lack 

of information on brain morphometry at 

lower doses. Given that both 

quantitative and qualitative sensitivity 

was observed in pups in several studies 

and in more than one species and in at 

least one of these studies there is 

uncertainty concerning identification of 

the LOAEL/NOAEL for developmental 

effects, the additional 10X factor for the 

protection of infants and children is 

being retained. 

E. Aggregate Risks and Determination of 

Safety 

To assess aggregate risk, drinking 

water estimates were incorporated 

directly into the dietary analysis, rather 

than using back-calculated drinking 

water levels of comparison (DWLOCs). 

To better evaluate aggregate risk 

associated with exposure through food 

and drinking water, EPA is no longer 

comparing EDWCs generated by water 

quality models with DWLOCs. Instead, 

EPA is now directly incorporating the 

actual water quality model output 

concentrations into the risk assessment. 

This method of incorporating water 

concentration into our aggregate 

assessments relies on actual CSFIIreported drinking water consumptions 

and more appropriately reflects the full 

distribution of drinking water 

concentrations. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to prothioconazole 

will occupy 11% of the aPAD for 

females 13 years and older, the only 

population subgroup of concern. In 

addition, there is potential for acute 

dietary exposure to prothioconazole in 

drinking water. The acute dietary 

exposure from food plus water to 

prothioconazole will occupy 60% of the 

aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to prothioconazole from 

food will utilize 12% of the cPAD for 

the U.S. population, 17% of the cPAD 

for all infants (< 1 year old), and 48% 

of the cPAD for children 1–2 years old, 

the subpopulation at greatest exposure. 

There are no residential uses for 

prothioconazole that result in chronic 

residential exposure to prothioconazole. 

In addition, there is potential for 

chronic dietary exposure to 

prothioconazole in drinking water. The 

chronic dietary exposure for food plus 

water will occupy 86% of the cPAD for 

all infants (< 1 year old). All other 

population subgroups are lower. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Prothioconazole is not registered for 

use on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Prothioconazole is not registered for 

use on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. The available toxicology 

studies in the mouse and rat showed no 

increase in tumor incidence, and 

therefore the Agency concluded that 

prothioconazole or its metabolites are 

not carcinogenic, and classified ‘‘Not 

Likely to be Carcinogenic to Humans’’

according to the 2005 Cancer 

Guidelines. Therefore, prothioconazole 

is not expected to pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

prothioconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

high performance liquid 

chromatography/tandem mass 

spectrometry (HPLC-MS/MS) and liquid 

chromatography (with electrospray 

ionization) and tandem mass 

spectrometry (LC-MS/MS)) 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 

There are currently no U.S., Canadian, 

Mexican, or international Codex 

tolerances established for 

prothioconazole. There are no 

maximum residue limits (MRLs) 

established for prothioconazole in 

Codex or in Mexico. Maximum residue 

limits have been established in Canada 

as a result of this Joint Review. 

C. Response to Comments 

A private citizen responded to PP 

4F6830. Comments were received on 

November 30, 2005, objecting to sale 

and use of this product. The comments 

further stated that there are not enough 

long-term testing, short-term testing is 

useless and unreliable and that research 

is not exhaustive enough to support use. 

The Agency response is as follows: 

The Agency considers the database for 

prothioconazole to be complete and 

adequate for exposure risk assessment, 

including several long-term studies. The 

commenter submitted no scientific 

information to support the claims. 

These comments, as well as related 

comments regarding animal testing, 

have been responded to by the Agency 

on several occasions. For example, 70 

FR 1349 (January 7, 2005) (FRL–7691–

4) and 69 FR 63083 (October 29, 2004) 

(FRL–7681–9). 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of 

prothioconazole, 2-[2-(1- 

chlorocyclopropyl)-3-(2-chlorophenyl)- 

2-hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione, and prothioconazoledesthio, a-(1-chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, calculated as parent in or on 

barley, grain at 0.35 ppm; barley, hay at 

7.0 ppm; barley, straw at 4.0 ppm; grain, 

aspirated grain fractions at 11.0 ppm; 

pea and bean, dried shelled, except 

soybeans, subgroup 6C at 0.9; peanut at 

0.02 ppm; peanut, hay at 6.0 ppm; 

rapeseed, seed at 0.15 ppm; wheat, grain 

at 0.07 ppm; wheat, forage at 6.0 ppm; 

wheat, hay at 4.5 ppm; wheat, straw at 

5.0 ppm and for combined residues of 

prothioconazole, 2-[2-(1- 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 11783 

chlorocyclopropyl)-3-(2-chlorophenyl)- 

2-hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione, and prothioconazoledesthio, a-(1-chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, and conjugates that can be 

converted to these two compounds by 

acid hydrolysis, calculated as parent in 

or on cattle, meat at 0.02 ppm; cattle, 

meat byproducts at 0.2 ppm; cattle, fat 

at 0.1 ppm; goat, fat at 0.1 ppm; goat, 

meat at 0.02 ppm; goat, meat byproducts 

at 0.2 ppm; hog, meat byproducts at 0.05 

ppm; horse, fat at 0.1 ppm, horse, meat 

at 0.02 ppm; horse, meat byproducts at 

0.2 ppm; milk at 0.02 ppm; poultry, 

liver at 0.02 ppm; sheep, fat at 0.1 ppm; 

sheep, meat at 0.2 ppm and sheet, meat 

byproducts at 0.2 ppm. 

Using upper bound residues for water 

derived from the proposed use in rice, 

acute dietary estimates exceeded the 

Agency’s level of concern for food plus 

water. Further data is needed to resolve 

uncertainties regarding residues of 

prothioconazole in rice application. 

Therefore, a tolerance for rice is not 

established at this time. 

Additional crop field trial data are 

needed to support tolerances for black 

mustard, borage, flax and Indian 

mustard. Tolerances for these 

commodities are not established at this 

time. 

Separate tolerances are not needed for 

barley, pearled barley; barley, bran; 

peanut, meal; wheat, bran; and wheat, 

germ. As per 40 CFR 180.1(h), the 

tolerance for rapeseed will cover the 

following commodities: Canola seed, 

crambe seed, field mustard seed, and 

Indian rapeseed. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this 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). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

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: March 2, 2007. 

James Jones, 

Director, 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 ollows: 

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

■ 2. Section 180.626 is added to subpart 

C to read as follows: 

§ 180.626 Prothioconazole; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for combined residues of the 

fungicide prothioconazole, 2-[2-(1- 

chlorocyclopropyl)-3-(2-chlorophenyl)- 


cprice-sewell on PROD1PC66 with RULES
11784 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Rules and Regulations 

2-hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione, and prothioconazoledesthio, a-(1-chlorocyclopropyl)-a-[(2- chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, calculated as parent in or on the following commodities: 

Commodity Parts per million 

Barley, grain ............................................................................................................. 0.35 

Barley, hay ............................................................................................................... 7.0 

Barley, straw ............................................................................................................ 4.0 

Grain, aspirated grain fractions ............................................................................... 11 

Pea and bean, dried shelled, except soybean, subgroup 6C ................................. 0.9 

Peanut ...................................................................................................................... 0.02 

Peanut, hay .............................................................................................................. 6.0 

Rapeseed, seed ....................................................................................................... 0.15 

Wheat, forage .......................................................................................................... 6.0 

Wheat, grain ............................................................................................................ 0.07 

Wheat, hay ............................................................................................................... 4.5 

Wheat, straw ............................................................................................................ 5.0 

(2) Tolerances are established for 

combined residues of the fungicide 

prothioconazole, 2-[2-(1- 

chlorocyclopropyl)-3-(2-chlorophenyl)- 

2-hydroxypropyl]-1,2-dihydro-3H-1,2,4- 

triazole-3-thione, and prothioconazoledesthio, a-(1-chlorocyclopropyl)-a-[(2- 

chlorophenyl)methyl]-1H-1,2,4-triazole1-ethanol, and conjugates that can be 

converted to these two compounds by 

acid hydrolysis, calculated as parent in 

or on the following commodities: 

Commodity Parts per million 

Cattle, fat ................................................................................................................. 0.1

Cattle, meat ............................................................................................................. 0.02 

Cattle, meat byproducts ........................................................................................... 0.2 

Goat, fat ................................................................................................................... 0.1

Goat, meat ............................................................................................................... 0.02 

Goat, meat byproducts ............................................................................................ 0.2 

Hog, meat byproducts ............................................................................................. 0.05 

Horse, fat ................................................................................................................. 0.1 

Horse, meat ............................................................................................................. 0.02 

Horse, meat byproducts .......................................................................................... 0.2 

Milk ........................................................................................................................... 0.02 

Poultry liver .............................................................................................................. 0.02

Sheep, fat ................................................................................................................ 0.1 

Sheep, meat ............................................................................................................ 0.02 

Sheep, meat byproducts .......................................................................................... 0.2 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E7–4405 Filed 3–13–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0207; FRL–8117–2] 

Tribenuron Methyl; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tribenuron 

methyl in or on corn, field, forage; corn, 

field, grain; corn, field, stover; rice, 

grain; rice, straw; sorghum, forage; 

sorghum, grain, grain; sorghum, grain, 

stover; soybean, seed; and sunflower, 

seed. E.I. DuPont de Nemours and 

Company, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). 

DATES: This regulation is effective 

March 14, 2007. Objections and requests 

for hearings must be received on or 

before May 14, 2007, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0207. All documents in the 

docket are listed in the index for the 

docket. 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 Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305-5805. 

FOR FURTHER INFORMATION CONTACT: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 703- 

305-7504; e-mail address: 

walters.vickie@epa.gov. 

SUPPLEMENTARY INFORMATION: 


cprice-sewell on PROD1PC66 with RULES