[Federal Register Volume 74, Number 183 (Wednesday, September 23, 2009)]
[Rules and Regulations]
[Pages 48386-48391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22520]


-----------------------------------------------------------------------

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: [email protected].

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

[[Page 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 non-compensable 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-observed-adverse-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

[[Page 48388]]

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 dietary-exposure 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 (SCI-
GROW) 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.

[[Page 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 non-occupational, 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 dose-response 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 short-term 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

[[Page 48390]]

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. Short-term, intermediate-term, and 
chronic-term 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: [email protected].

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

[[Page 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.132 paragraph (a) is revised to read as follows:


Sec.  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:

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Apple.............................                7.0               None
Banana\1\.........................               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