
[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Rules and Regulations]
[Pages 8295-8301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03074]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0925; FRL-9904-22]


Thiram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of thiram 
in or on strawberry. Taminco, Inc. requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 12, 2014. Objections and 
requests for hearings must be received on or before April 14, 2014, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0925, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington,

[[Page 8296]]

DC 20460-0001; telephone number: (703) 305-7090; email address: 
RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0925 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 
April 14, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0925, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of January 16, 2013 (78, FR 3379) (FRL-
9375-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F8106) by Taminco, Inc., 7540 Windsor Drive, Suite 411, Allentown, PA 
18195. The petition requested that 40 CFR 180.132 be amended by 
increasing the level of the tolerance for residues of the fungicide 
thiram, in or on strawberry to 20 parts per million (ppm). This request 
was made to support a change in the preharvest interval (PHI) from 3 
days to 1 day for strawberry on the label for Spotrete-F (EPA Reg. No. 
45728-26). That document referenced a summary of the petition prepared 
by Taminco, Inc., the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 thiram including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with thiram 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.
    Thiram is a dimethyl dithiocarbamate fungicide. Thiram has been 
shown to cause neurotoxicity following acute and subchronic exposures. 
In the acute and subchronic neurotoxicity studies submitted, 
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-guideline study published in the open literature, 
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 DNT study. 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

[[Page 8297]]

susceptibility following in utero exposures to rats or rabbits and 
following pre- and post-natal exposures to rats for two generations. 
There is evidence of quantitative susceptibility in the developmental 
neurotoxicity (DNT) study. However, there is low concern for the 
increased susceptibility seen in the DNT study since the dose response 
is well defined with a clear NOAEL and this endpoint is used for 
assessing the acute dietary risk for the most sensitive population. 
Thiram is classified as ``not likely to be carcinogenic to humans'' 
based on lack of evidence for carcinogenicity in mice or rats. There 
are no mutagenic/genotoxic concerns with thiram. The available 
toxicological database for thiram suggests that this chemical has a low 
to moderate acute-toxicity profile.
    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 document Thiram. Update to the Aggregate Risk 
Assessment to Support the Requested PHI Reduction and Increased 
Tolerance Request on Strawberry at page 9 in docket ID number EPA-HQ-
OPP-2012-0925.

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.

    Table 1--Summary of Toxicological Doses and Endpoints for Thiram for Use in Human Health Risk Assessment
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                                                                                                   Study and
       Exposure/ Scenario                 PoD          Uncertainty/FQPA    RfD, PAD, LOC for     toxicological
                                                              SFs           risk assessment         effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General            BMDL10 = 64.94 mg/  UFA = 10x.........  Acute RfD = 0.6494  Acute
 Population).                      kg.                UFH = 10x.........   mg/kg/day.          Neurotoxicity
                                                      FQPA SF = 1x......  aPAD = 0.6494 mg/    Study--Rat. MRID
                                                                           kg/day.             42912401.
                                                                                              LOAEL = 150 mg/kg/
                                                                                               day based on FOB
                                                                                               effects
                                                                                               (lethargy, lower
                                                                                               temperature,
                                                                                               reduced startle
                                                                                               response, no tail-
                                                                                               pinch response),
                                                                                               reduced motor
                                                                                               activity, and
                                                                                               reduced brain
                                                                                               weights.
Acute Dietary (Females 13-49      NOAEL = 1.4 mg/kg.  UFA = 10x.........  Acute RfD = 0.014   Dev. Neurotoxicity
 years old).                                          UFH = 10x.........   mg/kg/day.          Study--Rat. MRID
                                                      FQPA SF = 1x......  aPAD = 0.014 mg/kg/  46455201.
                                                                           day.               LOAEL = 3.7 mg/kg/
                                                                                               day based on
                                                                                               increases in
                                                                                               motor activity
                                                                                               seen in female
                                                                                               offspring on PND
                                                                                               17.
Chronic Dietary (All              NOAEL = 1.5 mg/kg.  UFA = 10x.........  Chronic RfD =       Co-critical: (1)
 populations).                                        UFH = 10x.........   0.015 mg/kg/day.    Combined Chronic
                                                      FQPA SF = 1x......  cPAD = 0.015 mg/kg/  Toxicity/
                                                                           day.                Carcinogenicity
                                                                                               Study--Rat and
                                                                                               (2) Chronic Oral
                                                                                               Toxicity-Dog.
                                                                                              LOAEL = 7.3 mg/kg/
                                                                                               day based on
                                                                                               changes in
                                                                                               hematology,
                                                                                               clinical
                                                                                               chemistry,
                                                                                               incidences of
                                                                                               bile duct
                                                                                               hyperplasia, and
                                                                                               reduction in mean
                                                                                               body-weight gain
                                                                                               from the chronic
                                                                                               toxicity/
                                                                                               carcinogenicity
                                                                                               rat study in
                                                                                               conjunction with
                                                                                               elevated
                                                                                               cholesterol
                                                                                               levels and
                                                                                               increased liver
                                                                                               weights reported
                                                                                               in the Chronic
                                                                                               Oral Toxicity
                                                                                               Study in Dogs at
                                                                                               a LOAEL = 7.23 mg/
                                                                                               kg/day.
                                 -------------------------------------------------------------------------------
Short- and Intermediate-Term                         No incidental oral residential exposure.
 Incidental Oral.
                                 -------------------------------------------------------------------------------
Short-Term Dermal (1-30 days)...  NOAEL = 1.4 mg/kg/  UFA = 10x.........  Residential LOC     Dev. Neurotoxicity
                                   day.               UFH = 10x.........   for MOE = 100.      Study--Rat MRID
                                                      FQPA SF = 1x        Occupational LOC     46455201.
                                                       (Dermal-            for MOE = 100.     LOAEL = 3.7 mg/kg/
                                                       absorption factor                       day based on
                                                       = 1%).                                  increases in
                                                                                               motor activity
                                                                                               seen in female
                                                                                               offspring on PND
                                                                                               17.
Intermediate-Term Dermal (1 to 6  NOAEL = 1.4 mg/kg/  UFA = 10x.........  Residential LOC     Dev. Neurotoxicity
 months).                          day.               UFH = 10x.........   for MOE = 100.      Study--Rat MRID
                                                      FQPA SF = 1x        Occupational LOC     46455201.
                                                       (Dermal-            for MOE = 100.     LOAEL = 3.7 mg/kg/
                                                       absorption factor                       day based on
                                                       = 1%).                                  increases in
                                                                                               motor activity
                                                                                               seen in female
                                                                                               offspring on PND
                                                                                               17.
                                 -------------------------------------------------------------------------------

[[Page 8298]]

 
Short- and Intermediate-Term               Current assessment does not warrant an inhalation assessment.
 Inhalation.
                                 -------------------------------------------------------------------------------
Cancer (oral, dermal,                              ``Not Likely to be Carcinogenic to Humans''.
 inhalation).
----------------------------------------------------------------------------------------------------------------
Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (intraspecies). UFH = potential
  variation in sensitivity among members of the human population (interspecies). 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.

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.
    A refined probabilistic acute dietary exposure assessment was 
performed using maximum percent crop treated (PCT) values, tolerance, 
the highest residue found during field-trials, distribution of field 
trial residues, Federal Drug Administration (FDA) monitoring data for 
apples, and empirical processing factors. Dietary risk estimates were 
determined considering exposures from food and drinking water using 
estimated drinking water concentrations (EDWCs) for surface water 
sources.
    ii. Chronic exposure. A refined chronic dietary-exposure assessment 
was performed using tolerance level residues and average estimated PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
classified thiram as ``Not Likely to be Carcinogenic to Humans,'' 
therefore, a dietary exposure assessment for the purpose of assessing 
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 estimated the PCT in the acute dietary risk assessment 
for existing uses as follows apples: 10%; peaches: 2.5%; and 
strawberry: 30%. The Agency estimated the PCT in the chronic dietary 
risk assessments for existing uses as follows apples: 5%; peaches: 
1.0%; and strawberry: 20%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
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%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which chemical name may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment

[[Page 8299]]

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.
    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 0.0478 parts per billion (ppb) and 
0.0025 ppb for chronic exposures (for non-cancer assessments) for 
surface water. Ground water sources were not included (for acute or 
chronic exposures), as the EDWCs for ground water are minimal in 
comparison to those for surface water. Surface water EDWCs were 
incorporated in DEEM-FCID into the food categories ``water, direct, all 
sources'' and ``water, indirect, all sources'' for the dietary 
assessments.
    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; 
therefore, there are no residential handler exposure scenarios 
applicable to thiram. However, there is potential for residential post-
application dermal exposure from treated golf course greens and tees. 
Residential exposures resulting from dermal contact with thiram-treated 
turf were assessed for children 6 to <11 years old, children 11 to <16 
years old, and adults. When use is restricted to greens and tees, the 
duration of exposure is 1 hour to reflect the anticipated time a player 
would be spending in contact with those areas. Inhalation post-
application exposures for golf courses were not assessed since 
inhalation exposures are thought to be negligible in outdoor post-
application scenarios.
    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 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. There was no evidence of 
increased susceptibility following in utero exposure to rats or rabbits 
or following pre- and post natal exposures to rats. There is evidence 
of quantitative susceptibility in the DNT study. Offspring effects 
(increased locomotor activity in females on PND 17) occurred at a lower 
dose than maternal effects (increased number of rearing events and 
elevated incidences of hyperactivity in females at weeks 8 and 13). 
There is low concern for the enhanced susceptibility seen in the DNT 
study because: (1) Clear NOAELs/LOAELs were established for the 
offspring effects; (2) the dose-response is well defined; (3) the 
behavioral effect of concern were observed only in females on one 
evaluation time period; and (4) the dose/endpoint is used for acute 
dietary risk for the most sensitive population subgroup (females 13-49 
years old). Consequently, there are no residual uncertainties for pre- 
and post-natal toxicity.
    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 thiram is complete with acceptable 
neurotoxicity, developmental, and reproductive toxicity studies.
    ii. Thiram has been shown to cause neurotoxicity following acute 
and subchronic exposures only. There was no evidence of increased 
susceptibility following in utero exposure to rats or rabbits or 
following pre- and post-natal exposures to rats. Evidence of 
quantitative susceptibility was demonstrated in the DNT study; however, 
there is low concern for the susceptibility seen in the DNT study 
because clear NOAELs/LOAELs were established for the offspring effects, 
the dose-response is well defined, and the dose/endpoint is used for 
acute dietary risk for the most sensitive population (females 13-49 
years old) and therefore is protective. Consequently, there are no 
residual uncertainties for pre- and post-natal toxicity.
    iii. There is no other evidence that thiram 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, only in the DNT.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to thiram in 
drinking water. In addition, the acute dietary exposure analysis used 
FDA apple monitoring data and field trial data along with the maximum 
percent crop treated. The chronic dietary exposure analysis used 
tolerance level residues except for apple along with the average 
percent crop treated. In addition, washing studies were incorporated 
into the dietary analyses since thiram is not a systemic pesticide and 
will wash off during normal washing procedures. 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (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

[[Page 8300]]

exposure estimates from dietary consumption of food and drinking water. 
Using DEEM-FCIDTM, acute dietary exposure at the 99.9th 
exposure percentile is estimated at 0.020104 mg/kg bw/day for the 
general U.S. population (3.1% of the aPAD) and 0.010887 mg/kg bw/day 
(78% of the aPAD) for females 13-49 years old, the population subgroup 
with the highest estimated acute dietary exposure to thiram.
    2. Chronic risk. The chronic aggregate risk assessment takes into 
account exposure estimates from dietary consumption of thiram (food and 
drinking water). Dietary risk estimates were determined considering 
exposures from food and drinking water using EDWCs for surface water 
sources. Using DEEM-FCIDTM, dietary exposure is estimated at 
0.001384 mg/kg bw/day for the general U.S. population (9.2% of the 
cPAD) and 0.008369 mg/kg bw/day (56% of the cPAD) for children 1-2 
years old, the population subgroup with the highest estimated chronic 
dietary exposure to thiram.
    3. Short-term and Intermediate-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). 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).
    In aggregating short- and intermediate-term risk, the Agency 
routinely combines background chronic dietary exposure (food + water) 
with short/intermediate-term residential exposure (dermal only). The 
combined exposure may then be used to calculate an MOE for aggregate 
risk. Using the golfer scenario for adult males, adult females, and 
children >6 years old, combined with the applicable subpopulation with 
the greatest dietary exposure, the total short/intermediate-term food 
and residential aggregate MOEs are 600, 600, and 370, respectively. As 
these MOEs are greater than 100, the short- and intermediate-term 
aggregate risks do not exceed the Agency's LOC. For children <6 years 
old, there is no residential exposure, therefore, a short/intermediate 
term aggregate risk assessment is not required for this population.
    4. Aggregate cancer risk for U.S. population. Thiram is classified 
as ``Not Likely to be Carcinogenic to Humans'' based on lack of 
evidence for carcinogenicity in mice or rats; therefore, thiram is not 
expected to pose a 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 (colorimetric analytical method) 
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 United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for ``total dithiocarbamates, 
determined and expressed as mg carbon disulfide per kg'' in or on 
strawberry at 5 ppm. This MRL differs from the tolerance amendment for 
thiram on strawberry that was requested by the petitioner. As U.S. 
tolerances are currently established on the individual 
dithiocarbamates, compatibility is not possible with the proposed 
tolerances. EPA is considering modifying all tolerances for 
dithiocarbamates, including thiram, to express them in terms of carbon 
disulfide. At that time, the tolerance expression will be compatible 
with CODEX; however, the U.S. tolerance level for strawberry cannot be 
harmonized with the CODEX MRL level because of differences in 
agricultural practices between the U.S. and foreign countries where 
strawberries are grown. Actual residues seen in the U.S. field trials 
submitted to support the proposed strawberry tolerance amendment 
exceeded the CODEX MRL.

C. Revisions to Petitioned-for Tolerances

    The Agency has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of thiram not specifically mentioned.
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, the tolerance for residues of thiram, in or on 
strawberry, is amended to increase the level of the tolerance to 20 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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

[[Page 8301]]

and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). 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) (2 U.S.C. 
1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: January 27, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    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, revise the introductory text of paragraph (a) and 
revise the entry for ``Strawberry'' in the table in paragraph (a) to 
read as follows:


Sec.  180.132  Thiram; tolerances for residues.

    (a) General. Tolerances for residues of the fungicide thiram 
(tetramethyl thiuram disulfide), including its metabolites and 
degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels specified is to be determined by measuring 
only thiram.

------------------------------------------------------------------------
                                       Parts per        Expiration/
             Commodity                  million       revocation  date
------------------------------------------------------------------------
 
                                * * * * *
Strawberry.........................            20  None.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-03074 Filed 2-11-14; 8:45 am]
BILLING CODE 6560-50-P


