50898 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

and degradates, in or on squash/ 

cucumber subgroup 9B at 0.50 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, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the 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) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 10, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.609 is amended by 

alphabetically adding the following 

commodity to the table in paragraph 

(a)(1) to read as follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Squash/cucumber subgroup 9B 0.50 

* * * * * 

* * * * * 

[FR Doc. 2011–20835 Filed 8–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0621; FRL–8882–7] 

Metconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of metconazole 

in or on the bushberry subgroup 13–07B 

and the tuberous and corm vegetable 

subgroup 1C. The Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 17, 2011. Objections and 

requests for hearings must be received 

on or before October 17, 2011, 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–2010–0621. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@epa.gov. 


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Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50899 

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 Get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0621 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before October 17, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0621, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

8, 2010 (75 FR 54629) (FRL–8843–3), 

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 0E7743) by 

Interregional Research Project Number 4 

(IR–4) Project Headquarters, Rutgers, 

The State University of New Jersey, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08450. The petition 

requested that 40 CFR 180.617 be 

amended by establishing tolerances for 

residues of the fungicide metconazole, 

5-[(4-chlorophenyl)-methyl]-2,2- 

dimethyl-1-(1 H -1,2,4-triazol-1- 

ylmethyl) cyclopentanol), measured as 

the sum of cis- and trans isomers, in or 

on bushberry subgroup 13–07B at 0.35 

parts per million (ppm); and tuberous 

and corm vegetable subgroup 1C at 0.02 

ppm. That notice referenced a summary 

of the petition prepared by Valent, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established for the tuberous 

and corm vegetables subgroup 1C and 

the bushberry subgroup 13–07B. 

Additionally, the commodity definition 

for the tuberous and corm vegetables 

subgroup 1C is being corrected. The 

reasons for these changes are explained 

in Unit IV.C. 

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 metconazole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with metconazole 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. 

Acute oral and dermal toxicities to 

metconazole are moderate, while acute 

inhalation toxicity is low. Metconazole 

is a moderate eye irritant and a mild 

skin irritant. It is not a skin sensitizer. 

The liver is the primary target organ in 

the mouse, rat and dog following oral 

exposure to metconazole via subchronic 

or chronic exposure durations. 

Developmental studies in rats and 


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rabbits show some evidence of 

developmental effects, but only at dose 

levels that are maternally toxic. 

Metconazole did not demonstrate the 

potential for neurotoxicity in the four 

species (mouse, rat, dog and rabbit) 

tested. Metconazole is considered nongenotoxic and liver tumors seen in a 

chronic mouse study appear to have 

been formed via a mitogenic mode of 

action and therefore, metconazole is 

classified as ‘‘not likely to be 

carcinogenic to humans’’ at levels that 

do not cause mitogenesis. There was no 

evidence of immunotoxicity at dose 

levels that produced systemic toxicity. 

No immunotoxic effects are evident for 

metconazole at dose levels as high as 52 

milligrams/kilogram/day (mg/kg/day) in 

rats, which is 12 times higher than the 

chronic dietary point of departure (4.3 

mg/kg/day). Metconazole did not 

demonstrate neurotoxicity in the 

subchronic neurotoxicity study or the 

other submitted studies including acute, 

subchronic and chronic studies in 

several species, developmental toxicity 

studies in the rat and rabbit and a 2- 

generation reproduction study in the rat. 

No effects were noted on brain weights 

and no clinical signs possibly related to 

neurotoxicity were noted up to and 

including the high doses in all studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by metconazole as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2010–0621 on 

pages 44–50 of the document titled 

‘‘Metconazole: Human Health Risk 

Assessment for Proposed Uses on 

Tuberous and Corm Vegetables 

Subgroup 1C and Bushberry Subgroup 

13–07B.’’ 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for metconazole used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METCONAZOLE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute Dietary (General Population, 

including Infants and Children).

An appropriate dose/endpoint attributable to a single dose was not observed in the available oral toxicity 

studies reviewed. 

Acute dietary (Females 13–49 

years of age).

NOAEL = 12 mg/kg/day ...............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.12 mg/kg/day ........

aPAD = 0.12 mg/kg/day 

Developmental toxicity in rats: 

LOAEL = 30 mg/kg/day based 

on increases in skeletal variations. 

Chronic dietary (All populations) .... NOAEL = 4.3 mg/kg/day ..............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.04 mg/kg/day .....

cPAD = 0.04 mg/kg/day 

Chronic oral toxicity study in rats: 

LOAEL = 13.1 mg/kg/day based 

on increased liver Males (M) 

weights and associated 

hepatocellular lipid vacuolation 

(M) and centrilobular hypertrophy (M). Similar effects were 

observed in Females (F) at 54 

mg/kg/day, plus increased 

spleen weight. 

Incidental oral short-term (1 to 30 

days).

NOAEL = 9.1 mg/kg/day ..............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... 28-Day oral toxicity study in rats: 

LOAEL = 90.5 mg/kg/day based 

on decreased body weight (M), 

increased liver and kidney 

weight and hepatocellular hypertrophy and vacuolation (M/ 

F). 

Incidental oral intermediate-term (1 

to 6 months).

NOAEL= 6.4 mg/kg/day ................

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... 90-Day oral toxicity study in rats: 

LOAEL = 19.2 mg/kg/day based 

on increased spleen wt (F) and 

hepatic vacuolation (M). 

Inhalation short-term (1 to 30 

days).

NOAEL= 9.1 mg/kg/day ................

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... 28-Day oral toxicity study in rats: 

LOAEL = 90.5 mg/kg/day based 

on decreased body weight (M), 

increased liver and kidney 

weight and hepatocellular hypertrophy and vacuolation (M/ 

F). 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METCONAZOLE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation (1 to 6 months) .............. NOAEL= 6.4 mg/kg/day ................

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... 90-Day oral toxicity study in rats: 

LOAEL = 19.2 mg/kg/day based 

on increased spleen wt (F) and 

hepatic vacuolation (M). 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Not likely to be Carcinogenic to Humans.’’ 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = actue, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to metconazole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing metconazole tolerances in 40 

CFR 180.617. EPA assessed dietary 

exposures from metconazole in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for metconazole for 

the general U.S. population including 

infants and children; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary for these 

population subgroups. However, such 

effects were identified for metconazole 

for females 13–49 years of age. In 

estimating acute dietary exposure, EPA 

used food consumption information 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA assumed 

that metconazole residues are present in 

all registered and proposed food 

commodities at tolerance levels and that 

100% of the crops were treated. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed that metconazole residues are 

present in all registered and proposed 

food commodities at tolerance levels 

and that 100% of the crops were treated. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that metconazole does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for metconazole in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

metconazole. 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 (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of 

metconazole for acute exposures are 

estimated to be 45.48 parts per billion 

(ppb) for surface water and 0.064 ppb 

for ground water. For chronic exposures 

for non-cancer assessments they are 

estimated to be 38.16 ppb for surface 

water and 0.064 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 45.48 ppb was 

used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 38.16 

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). 

Metconazole is currently registered for 

the following uses that could result in 

residential exposures: Turf and 

ornamentals. EPA assessed residential 

exposure using the following 

assumptions: Adults, adolescents, and 

children may be exposed to 

metconazole from its currently 

registered uses on turf and ornamentals. 

No dermal toxicity endpoints for shortand intermediate-term durations were 

identified up to the limit dose. 

Therefore, only residential handler and 

postapplication inhalation exposures for 

adults, and residential post-application 

incidental oral exposures for children 

have been assessed. For adults applying 

metconazole to turf, short- and 

intermediate-term exposures were 

assessed for mixer/loader/applicators 

with a low pressure handwand sprayer. 

Post-application risks to children 

following the application of 

metconazole to home lawns were 

calculated for short- and intermediateterm incidental oral exposures. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

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

science/trac6a05.pdf. 

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.’’ 

Metconazole 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 


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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 Web site at http://www.epa.gov/ 

pesticides/cumulative. 

Metconazole is a triazole-derived 

pesticide. Triazole-derived pesticides 

can form the common metabolite, 1,2,4- 

triazole and three triazole conjugates 

(triazole alanine, triazole acetic acid, 

and triazolylpyruvic acid). To support 

existing tolerances and to establish new 

tolerances for triazole-derivative 

pesticides, including metconazole, EPA 

conducted a human health risk 

assessment for exposure to 1,2,4- 

triazole, triazole alanine, and triazole 

acetic acid resulting from the use of all 

current and pending uses of any 

triazole-derived fungicide. The risk 

assessment is a highly conservative, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors) and 

potential dietary and non-dietary 

exposures (i.e., high end estimates of 

both dietary and non-dietary exposures). 

In addition, the Agency retained the 

additional 10X FQPA SF for the 

protection of infants and children. The 

assessment included evaluations of risks 

for various subgroups, including those 

comprised of infants and children. The 

Agency’s risk assessment can be found 

in the propiconazole reregistration 

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

Docket Identification Number EPA–HQ– 

OPP– 2005–0497 and an update to 

assess the addition of the commodities 

included in this action may be found in 

docket ID number EPA–HQ–OPP–2010– 

0621 in the document titled ‘‘Common 

Triazole Metabolites: Updated Aggregate 

Human Health Risk Assessment To 

Address Tolerance Petitions for 

Metconazole.’’ 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

Acceptable developmental toxicity 

studies are available in the rat and 

rabbit as well as a 2-generation 

reproductive toxicity study in the rat. 

There is no evidence of susceptibility 

following in utero exposure in the 

rabbit. In the rat there is qualitative 

evidence of susceptibility, however the 

concern is low since the developmental 

effects are characterized as variations 

(not malformations), occur in the 

presence of maternal toxicity, the 

NOAELs are well defined, and the dose/ 

endpoint is used for acute dietary risk 

assessment for the sensitive population. 

There is no evidence of increased 

susceptibility in the offspring based on 

the result of the 2-generation 

reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for 

metconazole is complete except for a 

neurotoxicity study. Changes to 40 CFR 

180.158 make the acute neurotoxicity 

testing (OPPTS Guideline 870.6200) 

required for pesticide registration. 

Although this study is not yet available 

for metconazole, the available data do 

not show any evidence of neurotoxicity. 

Metconazole did not demonstrate 

neurotoxicity in the subchronic 

neurotoxicity study or the other 

submitted studies including acute, 

subchronic and chronic studies in 

several species, developmental toxicity 

studies in the rat and rabbit and a 2- 

generation reproduction study in the rat. 

No effects were noted on brain weights 

and no clinical signs possibly related to 

neurotoxicity were noted up to and 

including the high doses in all studies. 

Therefore, EPA does not believe that 

conducting the acute neurotoxicity 

study will result in an endpoint lower 

than the ones used in risk assessment 

for metconazole. Consequently, an 

additional database uncertainty factor 

does not need to be applied. 

ii. There is no evidence of 

susceptibility following in utero 

exposure in the rabbit. In the rat there 

is qualitative evidence of susceptibility, 

however the concern is low since the 

developmental effects are characterized 

as variations (not malformations), occur 

in the presence of maternal toxicity, the 

NOAELs are well defined, and the dose/ 

endpoint is used for acute dietary risk 

assessment for the sensitive population. 

There is no evidence of increased 

susceptibility in the offspring based on 

the result of the 2-generation 

reproduction study. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 percent 

crop treated and tolerance-level 

residues. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to metconazole in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by metconazole. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

metconazole will occupy 3.8% of the 

aPAD for females 13–49, the only 

population subgroup of concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to metconazole 

from food and water will utilize 12.6% 

of the cPAD for children 1–2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

metconazole is not expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 


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Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 50903 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Metconazole is currently registered 

for uses that could result in short- and 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to metconazole. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded, that the short-and 

intermediate-term aggregate MOEs from 

dietary exposure (food + drinking water) 

and non-occupational/residential 

handler exposure (inhalation) for adults 

are 1,700 for both. 

The short-and intermediate-term 

aggregate MOEs from dietary exposure 

(food + drinking water) and nonoccupational/residential postapplication exposure (incidental oral) 

for children 1–2 years old are 420 and 

460, respectively. Because EPA’s level 

of concern for metconazole is a MOE of 

100 or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

metconazole is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to metconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography 

method with nitrogen-phosphorusdetection (GC/NPD) is available for data 

collection and enforcement of tolerances 

for residues of metconazole parent 

isomers (cis- and trans-metconazole) in 

plant commodities based on Valent 

Method RM–41C–1, ‘‘Determination of 

cis and trans-Metconazole in Crops.’’ 

An adequate high performance liquid 

chromatography (HPLC) method is 

available for data collection and 

enforcement of tolerances for residues of 

1,2,4-triazole (T), triazole alanine (TA), 

and triazole acetic acid (TAA). The 

methods 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 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for metconazole on potato or blueberry 

or the respective crop subgroups. 

C. Revisions to Petitioned-For 

Tolerances 

IR–4 proposed establishing tolerances 

on the bushberry subgroup 13–07B at 

0.35 ppm and the tuberous and corm 

vegetable subgroup 1C at 0.02 ppm. 

Upon review, these levels are being 

revised to 0.40 ppm and 0.04 ppm, 

respectively. EPA used the tolerance 

spreadsheet in the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data to determine the 

appropriate tolerance level for 

bushberries. The tolerance spreadsheet 

was not used to calculate the tolerance 

for tuberous and corm vegetables 

because residues in potatoes were below 

the LOQ (< 0.04 ppm). The proposed 

tolerance of 0.02 ppm for tuberous and 

corm vegetables is too low. The 

tolerance should be established at 0.04 

ppm, reflecting the combined LOQs of 

the metconazole enforcement method of 

0.02 ppm for each of the cis- and transisomers of metconazole. Also, the 

correct commodity definition for 

tuberous and corm vegetables subgroup 

1C is ‘‘Vegetable, tuberous and corm, 

subgroup 1C’’ and is being changed 

accordingly. Finally, EPA has revised 

the tolerance expression in paragraph 

(a)(1) to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

metconazole not specifically mentioned; 

and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

Because the tolerance expressions in 

paragraphs (a)(1) and (a)(2) are now 

identical, EPA is combining (a)(1) and 

(a)(2) into a newly designated paragraph 

(a) and placing all the commodities from 

these two paragraphs into a single table. 

V. Conclusion 

Therefore, tolerances are established 

for residues of metconazole, 5-[(4- 

chlorophenyl)-methyl]-2,2-dimethyl-1- 

(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol, measured as 

the sum of cis- and trans- isomers, in or 

on the bushberry subgroup 13–07B at 

0.40 ppm, and vegetable, tuberous and 

corm, subgroup 1C at 0.04 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, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 


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50904 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Rules and Regulations 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 9, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.617 is amended by 

revising paragraph (a) to read as follows: 

§ 180.617 Metconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of metconazole, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified below is to 

be determined by measuring only 

metconazole [5-[(4- 

chlorophenyl)methyl]-2,2-dimethyl-1- 

(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol] as the sum of 

its cis- and trans-isomers in or on the 

following commodities: 

Commodity Parts per 

million 

Almond, hulls ............................ 4 .0 

Banana 1 ................................... 0 .1 

Barley, grain ............................. 2 .5 

Barley, hay ................................ 7 .0 

Barley, straw ............................. 7 .0 

Beet, sugar, dried pulp ............. 0 .70 

Beet, sugar, molasses .............. 0 .08 

Beet, sugar, roots ..................... 0 .07 

Bushberry subgroup 13–07B .... 0 .40 

Canola seed ............................. 0 .04 

Cattle, meat byproducts ........... 0 .04 

Corn, field, forage ..................... 3 .0 

Corn, field, grain ....................... 0 .02 

Corn, field, stover ..................... 4 .5 

Corn, pop, grain ........................ 0 .02 

Corn, pop, stover ...................... 4 .5 

Corn, sweet, forage .................. 3 .0 

Corn, sweet, kernel plus cob 

with husks removed .............. 0 .01 

Corn, sweet, stover .................. 4 .5 

Cotton, gin byproducts ............. 8 .0 

Cotton, undelinted seed ........... 0 .25 

Egg ........................................... 0 .04 

Fruit, stone, group 12 ............... 0 .20 

Goat, meat byproducts ............. 0 .04 

Grain, aspirated grain fractions 7 .0 

Horse, meat byproducts ........... 0 .04 

Nut, tree, group 14 ................... 0 .04 

Oat, grain .................................. 1 .0 

Oat, hay .................................... 17 

Oat, straw ................................. 6 .0 

Peanut ...................................... 0 .04 

Peanut, refined oil .................... 0 .05 

Pistachio ................................... 0 .04 

Rye, grain ................................. 0 .25 

Rye, straw ................................. 14 

Sheep, meat byproducts .......... 0 .04 

Soybean, forage ....................... 3 .0 

Soybean, hay ............................ 6 .0 

Soybean, hulls .......................... 0 .08 

Soybean, seed .......................... 0 .05 

Vegetable, tuberous and corn, 

subgroup 1C ......................... 0 .04 

Wheat, grain ............................. 0 .15 

Wheat, hay ............................... 16 

Wheat, milled byproducts ......... 0 .20 

Wheat, straw ............................. 18 

1 No U.S. registration as of August 30, 2006. 

* * * * * 

[FR Doc. 2011–20841 Filed 8–16–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0481; FRL–8874–9] 

Thiamethoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thiamethoxam 

in or on peanut; peanut, hay; peanut, 

meal; alfalfa, forage; alfalfa, hay; and in 

food/feed commodities in food/feed 

handling establishments. Syngenta Crop 

Protection, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 17, 2011. Objections and 

requests for hearings must be received 

on or before October 17, 2011, 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: This final rule addresses 

three petitions for tolerances. EPA has 

established a docket under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0481 which contains only 

this final rule and is a summary docket 

used to lead the user to the individual 

docket established for each of the three 

petitions for tolerances addressed in this 

final rule: EPA–HQ–OPP–2010–0041 

(peanut), EPA–HQ–OPP–2010–0324 

(alfalfa), EPA–HQ–OPP–2010–0602 

(food/feed commodities in food/feed 

handling establishments). The user 

should look in the individual dockets to 

view the previous Federal Register 

publications and supporting documents 

for each tolerance petition. All 

documents in the docket are listed in 

the docket index available at http:// 

www.regulations.gov. Although listed in 

the index, some information is not 

publicly available, e.g., Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available in the electronic 

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

or, if only available in hard copy, at the 

OPP Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 


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