Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Rules and Regulations 77703 

Dated: November 28, 2011. 

Karl Brooks, 

Regional Administrator, Region 7. 

Chapter I, title 40 of the Code of 

Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart AA—Missouri 

■ 2. In § 52.1320 the table in paragraph 

(c) is amended by revising entry for 10– 

6.110 to read as follows: 

§ 52.1320 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED MISSOURI REGULATIONS

Missouri citation Title State effective 

date EPA approval date Explanation 

Missouri Department of Natural Resources 

*******

Chapter 6—Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of 

Missouri 

*******

10–6.110 ................................. Submission of Emission Data, 

Emission Fees, and Process Information.

09/30/2010 12/14/2011 [insert FR page 

number where the document begins].

Section (3)(A), Emissions 

Fees, has not been approved as part of the SIP 

*******

* * * * * 

PART 70—[AMENDED] 

■ 3. The authority citation for part 70 

continues to read as follows: 

Authority: 42 U.S.C. 7401, et seq. 

Appendix A—[Amended] 

■ 4. Appendix A to part 70 is amended 

by revising paragraph (v) under 

Missouri to read as follows: 

Appendix A to Part 70—Approval Status of 

State and Local Operating Permits Programs 

* * * * * 

Missouri 

* * * * * 

(v) The Missouri Department of Natural 

Resources submitted revisions to Missouri 

rule 10 CSR 10–6.110, ‘‘Submission of 

Emission Data, Emission Fees, and Process 

Information’’ on August 31, 2010; approval of 

section (3)(A) effective February 13, 2012. 

* * * * * 

[FR Doc. 2011–31919 Filed 12–13–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0916; FRL–9327–7] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

new tolerances and revises existing 

tolerances for residues of hexythiazox in 

or on multiple commodities which are 

identified and discussed later in this 

document. Gowan Company and the 

Interregional Research Project Number 4 

(IR–4) requested the tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 14, 2011. Objections and 

requests for hearings must be received 

on or before February 13, 2012, 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–2010–0916. 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; email 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 

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77704 Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Rules and Regulations 

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. 

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–2010–0916 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 February 13, 2012. 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–2010–0916, 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 Registers of December 

15, 2010 (75 FR 78240) (FRL–8853–1) 

and February 4, 2011 (76 FR 6465) 

(FRL–8858–7), EPA issued notices 

pursuant to section 408(d)(3) of FFDCA, 

21 U.S.C. 346a(d)(3), announcing the 

filing of pesticide petitions (PP 0F7773) 

by Gowan Company, 370 South Main 

St., Yuma, AZ 85364; and (PP 0E7787) 

by the Interregional Research Project 

Number 4 (IR–4), 500 College Road East, 

Suite 201 W, Princeton, NJ 08540. The 

petitions requested that 40 CFR 180.448 

be amended by establishing tolerances 

for residues of the insecticide 

hexythiazox,(trans-5-(4-chlorophenyl)- 

N-cyclohexyl-4-methyl-2- 

oxothiazolidine-3-carboxamide), 

including its metabolites containing the 

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

thiazolidine moiety, in or on aspirated 

grain fractions (PP 0F7773) at 0.5 parts 

per million (ppm) and greenhouse 

tomatoes (PP 0E7787) at 0.5 ppm; by 

increasing the existing tolerance for 

corn, field, stover from 2.5 ppm to 6 

ppm, and by removing the designation 

of ‘‘Tolerances with regional 

registrations’’ from the tolerances for 

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

corn, field, stover (PP 0F7773). That 

notice referenced a summary of the 

petition prepared by Gowan Company, 

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 on EPA’s review, Gowan 

Company revised their petition (PP 

0F7773) as follows: 

i. By increasing the proposed 

tolerance for corn, field, stover to 7.0 

ppm; 

ii. By adding a request for an increase 

in the established tolerances for cattle, 

meat byproducts; goat, meat byproducts; 

hog, meat byproducts; horse, meat 

byproducts; and sheep, meat byproducts 

to 0.05 ppm; and 

iii. By adding a request for a decrease 

in the established tolerance for corn, 

field, forage to 3.0 ppm. 

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 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 low 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 

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Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Rules and Regulations 77705 

target organs of hexythiazox are the liver 

and adrenal glands. Developmental 

toxicity was not observed in rabbits at 

the limit dose. Developmental effects 

observed in the rat occurred only at a 

dose level where maternal toxicity was 

observed. Hexythiazox is not a 

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’’. EPA has 

determined that a non-quantitative risk 

assessment approach (i.e., nonlinear, 

reference dose (RfD) approach) was 

appropriate and 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 no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Hexythiazox. Human Health Risk 

Assessment to Support Amended Use 

on Field Corn and New Use on 

Greenhouse Tomatoes’’ in docket ID 

number EPA–HQ–OPP–2010–0916. 

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 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 hexythiazox used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX 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 (All populations).No risk is expected from this exposure scenario as no hazard was identified in any toxicity study for this duration 

of exposure. 

Chronic dietary (All populations).NOAEL= 2.5 mg/kg/day .... Chronic RfD = 0.025 mg/ 

kg/day.

One-Year Toxicity Feeding Study—Dog. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cPAD = 0.025 mg/kg/day .. LOAEL = 12.5 mg/kg/day based on increased absolute and relative adrenal weights and associated adrenal histopathology. 

Incidental oral short-term (1 

to 30 days ) and intermediate-term (1 to 6 

months).

NOAEL= 30 mg/kg/day .....

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 .......... 2-Generation Reproduction Study—Rat. 

LOAEL = 180 mg/kg/day based on decreased pup 

body weight during lactation and delayed hair 

growth and/or eye opening, and decreased parental 

body-weight gain and increased absolute and relative liver, kidney, and adrenal weights. 

13-Week Oral Toxicity Study—Rat. 

NOAEL = 5.5 mg/kg/day. 

LOAEL = 38 mg/kg/day, based on increased absolute 

and relative liver weights in both sexes, increased 

relative ovarian and kidney weights, and fatty degeneration of the adrenal zona fasciculata. 

@ 397.5/257.6 mg/kg/day, decreased body-weight 

gain in females, slight swelling of hepatocytes in 

central zone (both sexes), increased incidence of 

glomerulonephrosis in males, increased adrenal 

weights. 

Cancer (oral, dermal, inhalation).Classification: ‘‘Likely to be Carcinogenic to Humans’’. Insufficient evidence to warrant a quantitative estimation of 

human risk using a cancer slope factor based on the common liver tumors (benign and malignant) observed only 

in high dose female mice, and benign mammary gland tumors of no biological significance, observed only in high 

dose male rats in the absence of mutagenic concerns. The chronic RfD is protective of all chronic effects including potential carcinogenicity of hexythiazox. 

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 = acute, c = chronic). RfD = reference 

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

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77706 Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Rules and Regulations 

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 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 used 

tolerance level residues, assumed 100 

percent crop treated (PCT), and 

incorporated DEEM default processing 

factors. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A of the 

Federal Register of March 17, 2010 (75 

FR 12691) (FRL–8813–7), EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to hexythiazox. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii., 

chronic exposure. 

iv. Anticipated residue and percent 

crop treated (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 4.5 parts per billion for 

surface water. Since surface water 

residues values greatly exceed 

groundwater EDWCs, surface water 

residues were used in the dietary risk 

assessment. Modeled estimates of 

drinking water concentrations were 

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 and 

are included in this risk assessment: 

Turf, ornamental landscape plantings, 

ornamental plants, trees and vines in 

nurseries, residential fruit trees, nut 

trees, 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 needed 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. Post application 

exposures are expected to be short-term 

(1 to 30 days) and intermediate-term 

(1 to 6 months) in duration. Adult 

postapplication exposures were not 

assessed since no quantitative dermal 

risk assessment is needed 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. 

Details of the residential exposure and 

risk assessment can be found at http:// 

www.regulations.gov in document 

‘‘Hexythiazox. Human Health Risk 

Assessment to Support Amended Use 

on Field Corn and New Use on 

Greenhouse Tomatoes,’’ in docket ID 

number EPA–HQ–OPP–2010–0916. 

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 Web site 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. 

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Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Rules and Regulations 77707 

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 complete with the 

exception of certain new generic testing 

requirements under revised 40 CFR part 

158, 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 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 2-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 

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-, 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. 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 51% of 

the cPAD for children 1 to 2 years of 

age, 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 14,000 for adults and 1,900 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 exposures 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 14,000 for adults 

and 2,100 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. As discussed in Unit III. 

C.1.iii., EPA concluded that regulation 

based on the chronic reference dose 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 method with ultra 

violet 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; 

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. 

Codex MRLs are established for 

residues of hexythiazox on ‘‘edible offal 

(mammalian)’’ and ‘‘poultry, edible 

offal’’ at 0.05 ppm. A Codex MRL is 

established for tomatoes at 0.1 ppm. No 

other Codex, Canadian or Mexican 

MRLs are established for the 

commodities that are the subject of 

these petitions. Codex and U.S. 

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77708 Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Rules and Regulations 

tolerance expressions are harmonized at 

this time. Since the maximum residue 

seen in the U.S. green house tomato data 

is 0.34 ppm, harmonizing with the 

Codex MRL of 0.1 ppm at this time is 

not possible as over tolerance residues 

in the U.S. could result if the Codex 

MRL were adopted. 

C. Revisions to Petitioned-For 

Tolerances 

Based on EPA’s review, Gowan 

Company revised their petition (PP 

0F7773) by increasing the proposed 

tolerance for corn, field, stover to 7.0 

ppm; by requesting an increase in the 

established tolerances for cattle, meat 

byproducts; goat, meat byproducts; hog, 

meat byproducts; horse, meat 

byproducts; and sheep, meat byproducts 

to 0.5 ppm; and by requesting a decrease 

in the established tolerance for corn, 

field, forage to 3.0 ppm. The Agency 

concluded that based on the residue 

data, these changes are required to 

support the amended and new uses. The 

decrease in the field corn forage 

tolerance and the increase in the stover 

tolerance were recommended by the 

Agency as a result of analyzing the 

submitted field trial data for these 

commodities using the OECD MRL 

(Maximum Residue Limit) calculator. 

The increase in the meat byproduct 

tolerances is driven by the anticipated 

increase in residues in field corn animal 

feed items as a result of the revised use 

pattern for hexythiazox on field corn 

and was set numerically to be 

harmonized with the current Codex 

MRL for meat byproducts. 

EPA is also removing expired Section 

18 tolerances for corn, field, forage; 

corn, field, grain; and corn, field, stover. 

V. Conclusion 

Therefore, tolerances are established 

for residues of hexythiazox, including 

its metabolites containing the (4- 

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

thiazolidine moiety, as requested in the 

revised petitions. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

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 tolerances 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: November 23, 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. Amend § 180.448 as follows: 

■ i. In the table to paragraph (a), revise 

the entries for ‘‘cattle, meat 

byproducts;’’ ‘‘goat, meat by products;’’ 

‘‘hog, meat byproducts;’’ ‘‘horse, meat 

byproducts;’’ and ‘‘sheep, meat 

byproducts.’’ 

■ ii. In the table to paragraph (a), add 

entries for ‘‘corn, field, forage;’’ ‘‘corn, 

field, grain;’’ ‘‘corn, field, stover;’’ 

‘‘grain, aspirated fractions;’’ and 

‘‘tomato.’’ 

■ iii. In the table to paragraph (b), 

remove the entries for ‘‘corn, field, 

forage;’’ ‘‘corn, field, grain;’’ and ‘‘corn, 

field, stover.’’ 

The added and revised text reads as 

follows: 

§ 180.448 Hexythiazox; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, meat byproducts ......... 0 .05 

* * * * * 

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

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

Corn, field, stover ................... 7 .0 

* * * * * 

Goat, meat byproducts ........... 0 .05 

Grain, aspirated fractions ....... 0 .50 

* * * * * 

Hog, meat byproducts ............ 0 .05 

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Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Rules and Regulations 77709 

Commodity Parts per 

million 

* * * * * 

Horse, meat byproducts ......... 0 .05 

* * * * * 

Sheep, meat byproducts ........ 0 .05 

* * * * * 

Tomato .................................... 0 .50 

* * * * * 

[FR Doc. 2011–32086 Filed 12–13–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0732; FRL–9327–6] 

Butyl acrylate-methacrylic acid-styrene 

polymer; 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 2-Propenoic 

acid, 2-methyl-, polymer with butyl 2- 

propenoate and ethenylbenzene (CAS 

Reg. No. 25036–16–2); also known as 

butyl acrylate-methacrylic acid-styrene 

polymer when used as an inert 

ingredient in a pesticide chemical 

formulation. Momentive Performance 

Materials 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 2- 

Propenoic acid, 2-methyl-, polymer with 

butyl 2-propenoate and ethenylbenzene 

on food or feed commodities. 

DATES: This regulation is effective 

December 14, 2011. Objections and 

requests for hearings must be received 

on or before February 13, 2012, 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–2011–0732. 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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; email address: fertich.

elizabeth@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). 

• 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 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 get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://ecfr.

gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. 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–2011–0732 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 February 13, 2012. 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–2011–0732, 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. Background and Statutory Findings 

In the Federal Register of October 5, 

2011 (76 FR 61647) (FRL–8890–5), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the receipt of a pesticide petition (PP 

1E7909) filed by Momentive 

Performance Materials, 3500 South State 

Route 2; Friendly, WV 26146. The 

petition requested that 40 CFR 180.960 

be amended by establishing an 

exemption from the requirement of a 

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