48386 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart B—Alabama 

■ 2. In § 52.50(c) the table is amended 

by revising the entry for ‘‘Section 335– 

3–17.01’’ to read as follows: 

§ 52.50 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED ALABAMA REGULATIONS

State citation Title/subject State effective 

date EPA approval date Explanation 

* * * * * * * 

Chapter 335–3–17 Conformity of Federal Actions to State Implementation Plans 

Section 335–3–17.01 ...................... Transportation Conformity ............. 04/03/07 09/23/09 [Insert citation of publication].

* * * * * * * 

* * * * * 

[FR Doc. E9–22814 Filed 9–22–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0020; FRL–8431–9] 

Thiram; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

thiram, (tetramethyl thiuram disulfide) 

in or on banana, import. Taminco 

Incorporated requested a tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 23, 2009. Objections and 

requests for hearings must be received 

on or before November 23, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0020. 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: 

Bryant Crowe, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0025; e-mail address: 

crowe.bryant@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

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–2007–0020 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before November 23, 2009. 

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 

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Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48387 

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–2007–0020, 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 June 27, 

2007 (72 FR 35237) (FRL–8133–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP) 6E7144 by 

Taminco, Inc. (inadvertently listed as 

Tamico, Inc. in the notice of filing), 

1950 Lake Park Drive, Smyrna, GA 

30080. The petition requested that 40 

CFR 180.132 be amended by 

establishing an import tolerance for 

residues of the fungicide thiram, 

(tetramethyl thiuram disulfide), in or on 

banana, whole at 0.5 parts per million 

(ppm); and banana, pulp at 0.3 ppm. 

The notice referenced a summary of the 

petition prepared by Taminco, Inc., 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 an increase in the tolerance 

for banana, whole at 0.80 ppm, formerly 

proposed at 0.5 ppm; and the removal 

of banana, pulp, formerly proposed at 

0.3 ppm. The Agency has also identified 

the correct commodity expression for 

banana, whole as banana. The reason for 

these changes is 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 the petitioned-for 

tolerance for residues of thiram in or on 

banana at 0.80 ppm. EPA’s assessment 

of exposures and risks associated with 

establishing this tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The available toxicological database 

for thiram suggests that this chemical 

has a low to moderate acute-toxicity 

profile. Thiram has been shown to cause 

neurotoxicity following acute and 

subchronic exposures. In the acute and 

subchronic neurotoxicity studies 

submitted to the Agency, neurotoxicity 

is characterized as lethargy, reduced 

and/or tail pinch response, changes in 

the functional-observation battery (FOB) 

parameters, increased hyperactivity, 

changes in motor activity, and increased 

occurrences of rearing events. No 

treatment-related changes were 

observed in brain weights or in the 

histopathology of the nervous system. In 

a non-OPPTS Harmonized Test 

Guidlines study published in the open 

literature (which means no more than 

literature that is considered a noncompensable reference/citation which 

offers scientific data intended for the 

support of the registrant’s action), 

chronic feeding of thiram to rats caused 

neurotoxicity, with onset of ataxia in 

some animals 5–19 months after 

beginning of treatment. However, no 

evidence of neurotoxicity was seen 

following chronic exposures in mice or 

rats in guideline studies submitted to 

the Agency. In addition, no adverse 

effects on the developing fetal nervous 

system were seen in a developmental 

neurotoxicity study (DNT). The chronic 

toxicity profile for thiram indicates that 

the liver, blood, and urinary system are 

the target organs for this chemical in 

mice, rats, and dogs. There is no 

evidence for increased susceptibility 

following in utero exposures to rats or 

rabbits and following prenatal and 

postnatal exposures to rats for two 

generations. There is low concern for 

the increased susceptibility seen in the 

developmental toxicity study since the 

dose response is well defined and this 

endpoint is used for assessing the acute 

dietary risk for the most sensitive 

population. Thiram is classified as ‘‘not 

likely to be a human carcinogen’’ based 

on lack of evidence for carcinogenicity 

in mice or rats. There are no mutagenic/ 

genotoxic concerns with thiram. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by thiram 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 the document 

Thiram in/on Imported Bananas. 

Revised Human-Health Risk 

Assessment, pages 39–42 in docket ID 

number EPA–HQ–OPP–2007–0020. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

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48388 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

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 greater than that 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; 

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

science; and http://www.epa.gov/ 

pesticides/trac/science/aggregate.pdf. 

A summary of the toxicological 

endpoints for thiram used for human 

risk assessment can be found at http:// 

www.regulations.gov in the document 

Thiram in/on Imported Bananas. 

Revised Human-Health Risk 

Assessment, pages 27–28 in docket ID 

number EPA–HQ–OPP–2007–0020. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to thiram, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing thiram 

tolerances in 40 CFR 180.132. EPA 

assessed dietary exposures from thiram 

in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA performed 

a refined probabilistic acute dietaryexposure assessment using percent crop 

treated (PCT), distributions of field-trial 

residue values, and empirical 

processing factors. 

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 

performed a conservative chronic 

dietary-exposure assessment performed 

using 100 PCT, average field-trial 

residues, and empirical processing 

factors. 

iii. Cancer. Thiram is considered as 

‘‘Not Likely to be Carcinogenic to 

Humans’’ based on the results (no 

increase in tumor incidence) in the rat 

chronic toxicity/carcinogenicity study, 

and the mouse carcinogenicity study. 

Thus, an exposure assessment to 

evaluate cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency used PCT information as 

follows: 

+Caneberries <2.5%; Cherries <2.5%; 

Cotton <2.5%; Peaches < 2.5%; Prunes 

<2.5%; Soybeans <2.5%; Pears 5%; 

Apples 7%; and Strawberries 55% 

+ = Crops not known to be listed on 

active end-use products registrations 

when BEAD SLUA report was run (data 

years 2001 to 2007). 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 years. EPA uses an average PCT 

for chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for thiram in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of thiram. 

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. 

Because monitoring data are 

unavailable, estimates of thiram 

concentrations were made with only 

mathematical models. The modeling 

was based on turf application (the 

highest application rate) for this 

assessment. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of thiram 

for acute exposures are estimated to be 

47.8 parts per billion (ppb) for surface 

water and 0.84 ppb for ground water. 

For chronic, exposures for non-cancer 

assessments are estimated to be 2.5 ppb 

for surface water and 0.84 ppb for 

ground water. 

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Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48389 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 0.0478 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 0.0025 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). 

Thiram is not available for sale or use 

by homeowner applicators. However, 

there is potential residential exposure to 

thiram from treated golf courses and 

tees. All thiram turf uses that would 

conceivably lead to children’s exposure 

on treated turf have been cancelled by 

the registrant. Therefore, EPA assessed 

residential exposure and risk only for 

the following scenario: Post-application 

(dermal contact) with thiram treated turf 

assessed during short-term and 

intermediate-term exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Unlike the N-methyl carbamate 

pesticides, EPA has not found thiram (a 

dithiocarbamate) to share a common 

mechanism of toxicity with any other 

substances, and thiram does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that thiram 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

No quantitative or qualitative sensitivity 

was seen in a rat developmental toxicity 

study, three rabbit developmental 

toxicity study, and two 2–generation 

reproduction studies in the rat. 

Quantitative sensitivity was seen in the 

DNT in rats. In the DNT study, the 

maternal NOAEL (3.7 milligrams/ 

kilogram/day (mg/kg/day)) is based on 

decreased body weight, body weight 

gain, and food consumption, clinical 

signs of toxicity, and FOB, while the 

developmental NOAEL (1.4 mg/kg/day) 

is based on increased locomotor activity 

seen in postnatal day (PND) 17 females. 

These data indicate that PND 17 females 

experienced an adverse effect at a dose 

level that failed to elicit a response in 

adult animals. Quantitative 

susceptibility was also reported in an 

unacceptable/OPPTS Harmonized Test 

Guideline prenatal developmental 

toxicity study in rats. However, this 

finding was determined to be unreliable 

due to numerous technical deficiencies 

in the conduct of the study and because 

the results of that study were not 

replicated in a guideline study that was 

conducted in accordance with the 

Agency’s Good Laboratory Practice 

(GLP) regulations. There is low concern 

for the enhanced susceptibility seen in 

the DNT study since clear NOAELs/ 

LOAELs have been identified for the 

effects of concern, and the doseresponse relationships for the effects of 

concern are well-characterized. 

3. Conclusion. The existing data are 

sufficient for endpoint selection for 

exposure/risk assessment scenarios and 

for evaluation of the requirements under 

FQPA. 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 thiram is 

complete, except for the requirements 

for an immunotoxicity study and 

cholinesterase activity assessment 

screening assay. EPA began requiring 

neurotoxicity testing and functional 

immunotoxicity testing of all food and 

non-food use pesticides on December 

26, 2007. Acceptable acute, subchronic 

and developmental neurotoxicity 

studies are available for thiram. 

However, since this requirement went 

into effect well after the tolerance 

petition was submitted, immunotoxicity 

studies are not yet available for thiram. 

In the absence of specific 

immunotoxicity studies, EPA evaluated 

the available thiram toxicity data to 

determine whether an additional 

database uncertainty factor (UF) is 

needed to account for potential 

immunotoxicity and determined that an 

additional UF is not required to account 

for potential immunotoxicity. No 

evidence of immunotoxicity was found 

in the thiram database. Due to the lack 

of evidence of immunotoxicity for 

thiram, EPA does not believe that 

conducting immunotoxicity testing will 

result in a NOAEL that are lower than 

the current regulatory endpoints and an 

additional factor for database 

uncertainties (UFDB) is not needed to 

account for potential immunotoxicity. 

Thiram is a dithiocarbamate pesticide. 

Unlike organophosphates and N-methyl 

carbamates pesticides, dithiocarbamates 

generally have little or no cholinesterase 

inhibiting properties and there is no 

evidence of cholinesterase inhibition in 

the thiram database. However, 

subchronic exposure to another 

dithiocarbamate has been reported to 

elicit cholinesterase inhibition. Given 

that this is an isolated finding reported 

in one study for only one other chemical 

in the class, the Agency has required the 

cholinesterase assay for thiram as 

confirmatory data out of an abundance 

of caution. EPA believes that the current 

regulatory endpoints are protective for 

all potential adverse health effects that 

this compound may elicit, and no 

additional factor is needed to account 

for the lack of the cholinesterase assay. 

ii. There is low concern for the 

enhanced susceptibility seen in the DNT 

study since clear NOAELs/LOAELs have 

been identified for the effects of 

concern, and the dose-response 

relationships for the effects of concern 

are well-characterized. No increased 

sensitivity was seen in the other 

acceptable guideline studies which 

examined prenatal and postnatal 

exposure. 

iii. An acceptable/guideline DNT 

study has been submitted and reviewed 

by the Agency. The study results have 

been incorporated into the risk 

assessment and are the basis for the 

point of departure for the acute females 

13+ dietary assessment and all shortterm and intermediate-term (incidental 

oral, dermal, inhalation, and aggregate) 

assessments. 

iv. There are no residual uncertainties 

in the hazard or exposure database. The 

dietary food for the acute exposure 

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48390 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

assessment was performed based on the 

estimated maximum of PCT. The 

refinements are based on reliable data 

and will not underestimate the exposure 

and risk. EPA made conservative 

(protective) assumptions in the ground 

water and surface water modeling used 

to assess exposure to thiram in drinking 

water. EPA used similarly conservative 

assumptions in the residential exposure 

assessment. These assessments will not 

underestimate the exposure and risks 

posed by thiram. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to thiram will 

occupy 96% of the aPAD for females 

13–49 years old, the population group 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to thiram from 

food and water will utilize 57% 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 thiram is not expected. 

3. Short-term and Intermediate-term 

risks. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

a background exposure level). Thiram is 

currently registered for use(s) (i.e., golf 

courses) that could result in short-term 

and intermediate-term residential 

exposures and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure to thiram 

through food and water with short-term 

and intermediate-term exposures for 

thiram. 

Using the golfer scenario exposure 

assumption described in this unit for 

short-term and intermediate-term 

exposures, EPA has concluded that the 

total short-term and intermediate-term 

food, water, and residential exposures 

results in an aggregate MOE of 580. 

These MOEs are greater than 100, and 

therefore does not exceed the Agency’s 

LOC. 

4. Aggregate cancer risk for U.S. 

population. The Agency has classified 

thiram as ‘‘Not Likely to be 

Carcinogenic to Humans,’’ based on the 

results (no increase in tumor incidence) 

in the rat chronic toxicity/ 

carcinogenicity study, and the mouse 

carcinogenicity study. Based on these 

data, EPA concludes that thiram poses 

no greater than a negligible cancer risk. 

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 thiram 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography (HPLC), Method 

A7193) 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 

There are currently no established 

Canadian or Mexican maximum residue 

limits (MRLs) for thiram. The Codex 

Alimentarius has established MRLs, for 

‘‘total dithiocarbamates, determined and 

expressed as mg carbon disulfide per 

kg’’ in banana of 2 mg/kg. As U.S. 

tolerances are established on the 

individual dithiocarbamates, 

compatibility is not possible with the 

proposed tolerance. 

C. Revisions to Petitioned-For 

Tolerances 

EPA determined the tolerance for 

banana, to be established at 0.80 ppm 

based on the rounding procedure 

outlined in the Guidance for Setting 

Pesticide Tolerances Based on Field 

Trial Data Standard of Operating 

Procedures (SOP). Also rather than 

setting tolerances on ‘‘banana, whole’’ 

and ‘‘banana, pulp’’ as requested by the 

petitioner, EPA has set a tolerance on 

‘‘banana’’ which is the standardized 

term EPA uses for tolerances on bananas 

as per Table 1 of OPPTS Harmonized 

Test Guideline 860.1000. 

V. Conclusion 

Therefore, tolerances are established 

for residues of thiram, 

tetramethylthiuram disulfide, in or on 

banana at 0.80 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 

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Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48391 

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: September 8, 2009. 

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. In § 180.132 paragraph (a) is revised 

to read as follows: 

§ 180.132 Thiram; tolerances for residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

thiram (tetramethyl thiuram disulfide) 

in or on raw agricultural commodities as 

follows: 

Commodity Parts per million Expiration/revocation date 

Apple ............................................................................................................................................................ 7.0 None 

Banana1 ....................................................................................................................................................... 0.80 3/31/14 

Peach ........................................................................................................................................................... 7.0 None 

Strawberry .................................................................................................................................................... 7.0 None 

1 No U.S. registrations as of September 23, 2009. 

* * * * * 

[FR Doc. E9–22520 Filed 9–22–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0854; FRL–8429–7] 

Meptyldinocap; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

import tolerances for combined residues 

of meptyldinocap, 2-(1-methylheptyl)- 

4,6-dinitrophenyl (2E)-2-butenoate and 

2,4-DNOP, 2,4-dinitro-6-(1- 

methylheptyl)phenol expressed as 

meptyldinocap in or on grape. Dow 

AgroSciences LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 23, 2009. Objections and 

requests for hearings must be received 

on or before November 23, 2009, 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–2008–0854. 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: 

Mary L. Waller, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary @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 

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