Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Rules and Regulations 12691 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0325; FRL–8813–7] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises the 

tolerance for combined residues of 

hexythiazox in or on grape. Gowan 

Company requested the tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

March 17, 2010. Objections and requests 

for hearings must be received on or 

before May 17, 2010, 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–2009–0325. 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: Olga 

Odiott, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9369 e-mail address: 

odiott.olga@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I 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 

cite at http://www.gpoaccess.gov/ecfr 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2009–0325 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 May 17, 2010. 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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0325, 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. Petition for Tolerance 

In the Federal Register of August 19, 

2009 (FR 41898) (FRL–8426–7), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 9F7556) by 

Gowan Company, 370 South Main 

Street; Yuma, AZ 85364. The petition 

requested that 40 CFR 180.448 be 

amended by revising the established 

tolerance for combined residues of the 

insecticide hexythiazox, (trans-5-(4- 

chlorophenyl)-N-cyclohexyl-4-methyl-2- 

oxothiazolidine-3-carboxamide) and its 

metabolites containing the (4- 

chlorophenyl)-4-methyl-2-oxo-3- 

thiazolidine moiety, in or on grape from 

0.75 to 1.0 part per million (ppm); plum 

from 0.10 to 1.0 ppm; and plum, prune, 

dried from 0.40 to 1.0 ppm. That notice 

referenced a summary of the petition 

prepared by Gowan Company, the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that there is insufficient 

residue chemistry data to support the 

proposed tolerances for the stone fruit 

use, therefore, this action only addresses 

the tolerance for grape. The Agency is 

also revising the tolerance expression 

for hexythiazox. The reason for these 

changes are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 


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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 hexythiazox 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with hexythiazox 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. Hexythiazox has a 

low order of acute toxicity by the oral, 

dermal and inhalation routes of 

exposure. It produces mild eye 

irritation, is not a dermal irritant, and is 

negative for dermal sensitization. 

The target organs of hexythiazox are 

the liver and adrenal glands in dogs, rats 

and mice, with the dog being the most 

sensitive species. The chronic dog study 

showed increased liver and adrenal 

weights, along with associated 

hypertrophy of the liver and adrenal 

glands. The subchronic toxicity study in 

rats showed increased liver and adrenal 

weights, as well as fatty degeneration of 

the adrenal zona fasciculate. Effects 

observed in the chronic feeding/ 

carcinogenicity studies in rats and mice 

included decreased body weight gain 

and increased liver weights. 

Hexythiazox is not a developmental 

or reproductive toxicant. The toxicology 

database for hexythiazox provides no 

indication of increased susceptibility in 

rats or rabbits from in utero and 

postnatal exposure to hexythiazox. The 

database does not show any evidence of 

treatment-related effects on the nervous 

system or the immune system. 

Hexythiazox is classified as ‘‘Likely to 

be Carcinogenic to Humans’’ based upon 

increased incidences of benign and 

malignant liver tumors in high-dose 

female mice, and benign mammary 

gland tumors, observed in high-dose 

male rats. There was no evidence of 

carcinogenicity in male mice and female 

rats. However, EPA determined that a 

non-quantitative risk assessment 

approach (i.e., nonlinear, reference dose 

(RfD) approach) was appropriate for 

hexythiazox based on the following 

considerations: 

1. The liver tumors in mice are a very 

common tumor in that species were 

only observed in high-dose females. 

2. The mammary tumors in rats were 

benign and were only observed in highdose male rats. 

3. Hexythiazox was shown to be nonmutagenic in mammalian somatic cells 

and germ cells. 

Additionally, the chronic noobserved-adverse-effect-level (NOAEL) 

used for establishing the chronic RfD 

(2.5 mg/kg/day, from the 1–year toxicity 

feeding study in the dog), is 

approximately 65-fold lower than the 

lowest dose that induced tumors (in 

female mice at 163 milligrams/kilogram/ 

day (mg/kg/day). Therefore, the chronic 

RfD of 0.025 mg/kg/day is judged to be 

protective of all chronic effects 

including potential carcinogenicity of 

hexythiazox. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by hexythiazox as well as 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Hexythiazox. Human Health Risk 

Assessment to Support Amended Use 

on Grapes Reducing the Preharvest 

Interval from 28-Days to 7-Days and to 

Add Uses on Turf, Gardens and 

Ornamentals,’’ page 27 in docket ID 

number EPA–HQ–OPP–2009–0325. 

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 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 NOAEL and the LOAEL 

of concern are identified. Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level generally referred to as a 

PAD or a 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 hexythiazox used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Hexythiazox.’’ ‘‘Human Health Risk 

Assessment to Support Amended Use 

on Grapes Reducing the Preharvest 

Interval from 28-Days to 7-Days and to 

Add Uses on Turf, Gardens and 

Ornamentals,’’ page 12 in docket ID 

number EPA–HQ–OPP–2009–0325 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to hexythiazox, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing hexythiazox tolerances in 40 

CFR 180.448. EPA assessed dietary 

exposures from hexythiazox 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 hexythiazox; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance level 

residues, assumed 100 percent crop 

treated (PCT), and incorporated default 

processing factors. 

iii. Cancer. As discussed in this unit, 

EPA has determined that the chronic 

RfD is sufficient to evaluate all chronic 


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risks for this chemical, including 

carcinogenic potential. Cancer risk was 

quantified using the same estimates as 

discussed in Unit III.C.1.ii., chronic 

exposure. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for hexythiazox. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for hexythiazox in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

hexythiazox. 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) the estimated 

drinking water concentration (EDWC) of 

hexythiazox for chronic exposures for 

non-cancer and cancer assessments is 

estimated to be 4.1 parts per billion 

(ppb) for surface water. Since surface 

water residue values greatly exceed 

groundwater EDWCs, surface water 

residues were used in the dietary risk 

assessment. 

The modeled EDWC was directly 

entered into the dietary exposure model. 

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). 

Hexythiazox is not currently 

registered for any specific use patterns 

that would result in residential 

exposure. However, the following uses 

that could result in residential 

exposures are pending registration in 

the near future and are included in this 

risk assessment: Turf, gardens, 

ornamental landscape plantings, 

ornamental plants, trees and vines in 

nurseries, residential fruit trees, nut 

trees and caneberries, and orchids. 

Residential handler exposures are 

expected to be short-term (1 to 30 days) 

via either the dermal or inhalation 

routes of exposures. Since a quantitative 

dermal risk assessment is not required 

for hexythiazox; MOEs were calculated 

for the inhalation route of exposure 

only. Both adults and children may be 

exposed to hexythiazox residues from 

contact with treated lawns or treated 

residential plants. Adult postapplication 

exposures were not assessed since no 

quantitative dermal risk assessment is 

required for hexythiazox and inhalation 

exposures are typically negligible in 

outdoor settings. The exposure 

assessment for children included 

incidental oral exposure resulting from 

transfer of residues from the hands or 

objects to the mouth, and from 

incidental ingestion of soil. No 

quantitative dermal risk assessment is 

required. 

Residential handler risks are not of 

concern as short-term inhalation MOEs 

range from 40,000,000 to 820,000,000. 

Postapplication risks for children are 

not of concern as incidental oral shortterm MOEs range from 2,600 to 

3,200,000 and intermediate-term MOEs 

range from 5,600 to 3,200,000 ( MOEs 

which exceed 100 are not of concern). 

None of the subject uses are expected to 

result in long-term residential 

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.’’ 

EPA has not found hexythiazox to 

share a common mechanism of toxicity 

with any other substances, and 

hexythiazox does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that hexythiazox does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

data base indicates no increased 

susceptibility of rats or rabbits to in 

utero and/or postnatal exposure to 

hexythiazox. 

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 

hexythiazox is incomplete under the 

new 40 CFR part 158 data requirements 

for conventional pesticides, which 

requires certain generic testing, 

including acute and subchronic 

neurotoxicity studies and an 

immunotoxicity study. However, the 

toxicology database does not show any 

evidence of treatment-related effects on 

the nervous system or the immune 

system. The overall weight of evidence 

suggests that this chemical does not 

directly target either system. Although 

acute and subchronic neurotoxicity 

studies and an immunotoxicity study 

are required as a part of new data 

requirements in the 40 CFR part 158 for 

conventional pesticide registrations, the 

Agency does not believe that conducting 

these studies will result in a lower POD 

than any currently used for risk 

assessment, and therefore, a database 

uncertainty factor (UFDB) is not needed 

to account for the lack of these studies. 

ii. There is no indication that 

hexythiazox is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

hexythiazox results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the two-generation 

reproduction study 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. The dietary 

risk assessment is highly conservative 

and not expected to underestimate risk. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to hexythiazox in drinking water. EPA 


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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 hexythiazox. 

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 acute population 

adjusted-dose (aPAD) and chronic 

population adjusted-dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, 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 An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, hexythiazox is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to hexythiazox 

from food and water will utilize 49% of 

the cPAD for (children 1 to 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 

hexythiazox is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

There are potential short-term 

exposures from the pending residential 

uses for hexythiazox. The Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to hexythiazox. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 16,000 for adults and 1,300 for 

children. Because EPA’s level of 

concern for hexythiazox is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

There are potential intermediate-term 

exposures from the pending residential 

uses for hexythiazox. The Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposure to hexythiazox. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 16,000 for adults 

and 1,700 for children. Because EPA’s 

level of concern for hexythiazox is a 

MOE of 100 or below, these MOEs are 

not of concern. 

5. Aggregate cancer risk for U.S. 

population. EPA has classified 

hexythiazox as ‘‘Likely to be 

Carcinogenic to Humans,’’ but has 

determined that there is insufficient 

evidence to quantify risk using a cancer 

slope factor. As discussed in Unit III.A 

EPA concluded that regulation based on 

the chronic RfD will be protective for 

both chronic and carcinogenic risks. As 

noted in this unit there are no chronic 

risks of concern. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to hexythiazox 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with UV detection 

(HPLC/UV)) 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

A Codex MRL is established at 1.0 

ppm for grape. The Agency has 

harmonized the residue level, but notes 

that it is not possible to harmonize the 

tolerance expression at this time as the 

Codex maxium residue limit (MRL) 

includes parent only. There are no 

currently established Canadian or 

Mexican MRLs for residues of 

hexythiazox in/on grape. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency has revised the tolerance 

expression to clarify 1. that, as provided 

in FFDCA section 408(a)(3), the 

tolerance covers metabolites and 

degradates of hexythiazox 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. The Agency 

determined that there is insufficient 

residue chemistry data to support the 

proposed tolerances for the stone fruit 

use; therefore, this action only addresses 

the tolerance for grape. 

V. Conclusion 

Therefore, the tolerance for residues 

of hexythiazox, in or on grape is revised 

from 0.75 ppm to 1.0 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 


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and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 8, 2010. 

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. § 180.448 revise the introductory 

text in paragraph (a), and revise the 

entry ‘‘Grape‘‘ in the table in paragraph 

(a), and revise introductory text in 

paragraphs (b), and (c) to read as 

follows: 

§180.448 Hexythiazox; tolerance for 

residues. 

(a) General. Tolerances are 

established for residues of hexythiazox, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

hexythiazox and its metabolites 

containing the (4-chlorophenyl)-4- 

methyl-2-oxo-3-thiazolidine moiety, 

calculated as the stoichiometric 

equivalent of hexythiazox. 

Commodity Parts per million 

*****

Grape ....................................................................................................................... 1.0

*****

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of hexythiazox, including 

its metabolites and degradates, in 

connection with use of the pesticide 

under section 18 emergency exemptions 

granted by EPA. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

hexythiazox and its metabolites 

containing the (4-chlorophenyl)-4- 

methyl-2-oxo-3-thiazolidine moiety, 

calculated as the stoichiometric 

equivalent of hexythiazox. These 

tolerances will expire and are revoked 

on the dates specified in the following 

table: 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations as defined by 40CFR 

180.1(n), are established for residues of 

hexythiazox, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only hexythiazox and its 

metabolites containing the (4- 

chlorophenyl)-4-methyl-2-oxo-3- 

thiazolidine moiety, calculated as the 

stoichiometric equivalent of 

hexythiazox. 

* * * * * 

[FR Doc. 2010–5692 Filed 3–16–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0845; FRL–8814–3] 

Tetraethoxysilane, Polymer with 

Hexamethyldisiloxane; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 

tetraethoxysilane, polymer with 

hexamethyldisiloxane, minimum 

number average molecular weight (in 

AMU) 2,500 (CAS Reg. No. 104133–09– 

7) when used as an inert ingredient in 

a pesticide chemical formulation under 

40 CFR 180.960. Wacker Chemical 

Corporation submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

tetraethoxysilane, polymer with 

hexamethyldisiloxane, on food or feed 

commodities. 

DATES: This regulation is effective 

March 17, 2010. Objections and requests 

for hearings must be received on or 

before May 17, 2010, 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 


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