[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Rules and Regulations]
[Page 48386-48391]
[DOCID:fr23se09-6]

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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.

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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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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

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<PHONE_NUMBER>.

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

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.

    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

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:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
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

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


[Federal Register: September 21, 2010 (Volume 75, Number 182)]
[Notices]
[Page 57546-57548]
[DOCID:fr21se10-141]

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

DEPARTMENT OF TRANSPORTATION

[Docket No. FRA 2010-0005-N-18]

Notice and Request for Comments

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice and Request for Comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Requirements (ICRs) abstracted below have been forwarded to
the Office of Management and Budget (OMB) for review and comment. The
ICRs describes the nature of the information collection and their
expected burden. The Federal Register notice with a 60-day comment
period soliciting comments on the following collection of information
was published on July 13, 2010 (75 FR 40021).

DATES: Comments must be submitted on or before October 21, 2010.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Safety,
Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590 (telephone:<PHONE_NUMBER>), or Ms. Kimberly Toone, Office of
Information Technology, RAD-20, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone:
(202) 493-6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION:  The Paperwork Reduction Act of 1995 (PRA),
Public Law No. 104-13, Section 2, 109 Stat. 163 (1995) (codified as
revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5
CFR Part 1320, require Federal agencies to issue two notices seeking
public comment on information collection activities before OMB may
approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5,
1320.8(d)(1), 1320.12. On July 13, 2010, FRA published a 60-day notice
in the Federal Register soliciting comment on ICRs for which the agency
was seeking OMB approval. 75 FR 40021. FRA

received no comments in response to this notice.
    Before OMB decides whether to approve a proposed collection of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30-day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure having their full effect. 5 CFR 1320.12(c); see also 60
FR 44983, Aug. 29, 1995.
    The summary below describes the nature of the information
collection requirements (ICRs) and the expected burden, and are being
submitted for clearance by OMB as required by the PRA.
    Title: Causal Analysis and Countermeasures to Reduce Rail-Related
Suicides.
    OMB Control Number: 2130-0572.
    Type of Request: Extension without Change of a Previously Approved
Information Collection.
    Affected Public: 280 Railroad Personnel/Members of the Public/
Affected Families and Friends.
    Abstract: Pedestrian trespassing on railroad property resulting in
serious injury or death is one of the two most serious safety problems
(the second being grade crossing collisions) facing the railroad
industry and its regulators not only in the United States but also in
other countries. It is widely believed in this country that the
reported prevalence and incidence of railway suicide vastly under-
represents the nature and extent of the problem. There is no central
reporting system within the railroad industry or the suicide prevention
field that provides verifiable information about how many trespass
deaths are accidental vs. intentional. Therefore, there are no
verifiable measures of the extent of rail-related suicides in the
United States. While railroad companies must report trespass incidents
resulting in serious injury or death to the U.S. Federal Railroad
Administration (FRA), injuries or deaths that are ruled by a medical
examiner or coroner to be intentional are not reported. Preliminary
figures from 2006 indicate there were approximately 500 deaths and 360
injuries reported to the FRA--an increase of 100 incidents over the
previous year--but suicides are not represented in these numbers.
Unverifiable estimates from a number of sources range from 150 to more
than 300 suicides per year on the U.S. railways.
    Like any other incident on the rail system, a suicide on the tracks
results in equipment and facility damage, delays to train schedules,
and trauma to railroad personnel involved in the incidents. As a
result, FRA last year awarded a grant for the first phase of a 5-year
project to reduce suicides on the rail system to the Railroad Research
Foundation (part of the Association of American Railroads) and its
subcontractor, the American Association of Suicidology (AAS). In the
course of five years, the research project's goals include:
     A prevalence assessment to determine verifiable numbers of
suicides on the rail system,
     Development of a standardized reporting tool for industry
use,
     A causal analysis and root cause analysis of suicide
incidents that occur during the grant cycle, and
     Design and implementation of suicide prevention measures
for the Nation's rail system to reduce suicide injuries and deaths.
    This request to the Office of Management and Budget is for re-
approval in order to complete Phase II of the project, the causal
analysis. In order to understand as much as possible about people who
intend to die by placing themselves in the path of a train, and
therefore to design prevention strategies, AAS has been conducting 60
psychological autopsies over the course of two years on people who die
by rail-related suicide. Psychological autopsy is a recognized and
accepted method for obtaining information about physical, emotional and
circumstantial contributors to a person's death. The 60 psychological
autopsies for the FRA project involve interviews with informants to
these incidents including family members and friends, employers and co-
workers, and rail personnel involved in the incidents.
    After conducting a root cause analysis of this data, AAS will then
work with the industry to design, pilot test and implement effective
countermeasures with the goal of reducing deaths, injuries and
psychological trauma.
    Form Number(s): FRA F 6180.125A; FRA F 6180.125B.
    Annual Estimated Burden Hours: 537 hours.
    Title: Confidential Close Call Reporting System Evaluation-Related
Interview Data Collection.
    OMB Control Number: 2130-0574.
    Type of Request: Revision of a Previously Approved Collection.
    Affected Public: Rail Employees and Key Non-railroad Stakeholders.
    Abstract: In the U.S. railroad industry, injury rates have been
declining over the last 25 years. Indeed, the industry incident rate
fell from a high of 12.1 incidents per 100 workers per year in 1978 to
3.66 in 1996. As the number of incidents has decreased, the mix of
causes has also changed toward a higher proportion of incidents that
can be attributed to human and organizational factors. This combination
of trends--decrease in overall rates but increasing proportion of human
factors-related incidents--has left safety managers with a need to
shift tactics in reducing injuries to even lower rates than they are
now.
    In recognition of the need for new approaches to improving safety,
FRA has instituted the Confidential Close Call Reporting System
(C\3\RS). The operating assumption behind C\3\RS is that by assuring
confidentiality, employees will report events which, if dealt with,
will decrease the likelihood of accidents. C\3\RS, therefore, has both
a confidential reporting component, and a problem analysis/solution
component. C\3\RS is expected to affect safety in two ways. First, it
will lead to problem solving concerning specific safety conditions.
Second, it will engender an organizational culture and climate that
supports greater awareness of safety and a greater cooperative
willingness to improve safety.
    If C\3\RS works as intended, it could have an important impact on
improving safety and safety culture in the railroad industry. While
C\3\RS has been developed and implemented with the participation of
FRA, railroad labor, and railroad management, there are legitimate
questions about whether it is being implemented in the most beneficial
way, and whether it will have its intended effect. Further, even if
C\3\RS is successful, it will be necessary to know if it is successful
enough to implement on a wide scale. To address these important
questions, FRA is implementing a formative evaluation to guide program
development, a summative evaluation to assess impact, and a
sustainability evaluation to determine how C\3\RS can continue after
the test period is over. The evaluation is needed to provide FRA with
guidance as to how it can improve the program, and how it might be
scaled up throughout the railroad industry.
    Program evaluation is an inherently data driven activity. Its basic
tenet is that as change is implemented, data can be collected to track
the course and

consequences of the change. Because of the setting in which C\3\RS is
being implemented, that data must come from the railroad employees
(labor and management) who may be affected. Critical data include
beliefs about safety and issues related to safety, and opinions/
observations about the operation of C\3\RS.
    The ongoing study is a five-year demonstration project to improve
rail safety, and is designed to identify safety issues and propose
corrective action based on voluntary reports of close calls submitted
to the Bureau of Transportation Statistics. Because of the innovative
nature of this program, FRA is implementing an evaluation to determine
whether the program is succeeding, how it can be improved and, if
successful, what is needed to spread the program throughout the
railroad industry. Interviews to evaluate the close call reporting
system will be conducted with two groups: (1) Key stakeholders to the
process (e.g., FRA officials, industry labor, and carrier management
within participating railroads); and (2) Employees in participating
railroads who are eligible to submit close call reports to the
Confidential Close Call Reporting System. Different questions will be
addressed to each of these two groups. Interviews will be semi-
structured, with follow-up questions asked as appropriate depending on
the respondent's initial answer.
    The confidentiality of the interview data is protected by the
Privacy Act of 1974. FRA fully complies with all laws pertaining to
confidentiality, including the Privacy Act. Thus, information obtained
by or acquired by FRA's contractor, the Volpe Center, from key
stakeholders and railroad employees will be used strictly for
evaluation purposes. None of the information that might be identifying
will be disseminated or disclosed in any way. In addition, the
participating railroad sites involved will require Volpe to establish a
non-disclosure agreement that prohibits disclosure of company
confidential information without the carrier's authorization. Also, the
information is protected under the Department of Transportation
regulation Title 49 CFR Part 9,which is in part concerned with the
Department involvement in proceedings between private litigants.
According to this statute, if data are subpoenaed, Volpe and Volpe
contractors can not ``provide testimony or produce any material
contained in the files of the Department, or disclose any information
or produce any material acquired as part of the performance of that
employee's official duties or because of that employee's official duty
status'' unless authorized by agency counsel after determining that, in
legal proceedings between private litigants, such testimony would be in
the best interests of the Department or that of the United States
Government if disclosed. Finally, the name of those interviewed will
not be requested.
    Annual Estimated Burden Hours: 242 hours
    Addressee: Send comments regarding this information collection to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 Seventeenth Street, NW., Washington, DC 20503,
Attention: FRA Desk Officer. Comments may also be sent electronically
via e-mail to the Office of Information and Regulatory Affairs (OIRA)
at the following address<EMAIL_ADDRESS>    Comments are invited on the following: Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; the accuracy of the Department's estimate of
the burden of the proposed information collection; ways to enhance the
quality, utility, and clarity of the information to be collected; and
ways to minimize the burden of the collection of information on
respondents, including the use of automated collection techniques or
other forms of information technology.
    A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC, on September 15, 2010.
Kimberly Coronel,
Director, Office of Financial Management.
[FR Doc. 2010-23478 Filed 9-20-10; 8:45 am]
BILLING CODE 4910-06-P


Date:  July 1, 2014

Meeting:  Webinar  -  "Implementation"

Rule(s) Discussed: Clean Power Plan Proposal -- Docket number EPA-HQ-OAR-2013-0602

Attendee List:  Attached.  Presenters  -  Marguerite McLamb and Julia Miller

Written Materials? Yes/No  -  Presentation Attached

Summary of Relevant, Factual Information Received: This was the third in a series of three webinars EPA offered to state and tribal officials about aspects of the June 2014 proposed Clean Power Plan; the subject of this webinar was Implementation.  The webinar is posted online at www.epa.gov/cleanpowerplan


NAICS: 3250A1

Pesticide Registrants

Labor Category:
Formula
                                  Managerial
                                   Technical
                                   Clerical
Unloaded Hourly Rate[1]
 = W
                                    $65.52
                                    $34.27
                                    $21.85
Benefits Percentage[2]
Lb = B/W
                                     45.8%
                                     45.8%
                                     45.8%
Benefits per hour
B = W*Lb
                                    $30.01
                                    $15.69
                                    $10.01
Loaded Hourly Rate
Wb = W + B = W(1+Lb)
                                    $95.53
                                    $49.96
                                    $31.86
Overhead Percentage[3]
Lo = OH/Wb
                                      50%
                                      50%
                                      50%
Overhead per hour
OH = Wb*Lo
                                    $47.76
                                    $24.98
                                    $15.93
Fully Loaded Hourly Rate
Wf = Wb + OH
 = W + B + OH
                                   $143.29
                                    $74.95
                                    $47.78

1.  Data Source:  BLS
https://www.bls.gov/oes/current/naics4_3250A1.htm
May 2018
     NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing
     Standard Occupational Classification (SOC):

       Management:
11-0000, Management Occupations

       Technical:
19-0000, Life, Physical, and Social Science Occupations
       Clerical:
43-0000, Office and Administrative Support Occupations

2. Fringe benefits/wage per hour.  The average for non-farm, non-federal civilian workers.
3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The loading for indirect costs is within the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.

NAICS: 999100

EPA or Federal Government

Labor Category:
Formula
                                  Managerial
                                   Technical
                                   Clerical
Unloaded Hourly Rate[1]
 = W
                                    $60.42
                                    $39.89
                                    $22.33
Benefits Percentage[2]
Lb = B/W
                                     45.8%
                                     45.8%
                                     45.8%
Benefits per hour
B = W*Lb
                                    $27.67
                                    $18.27
                                    $10.23
Loaded Hourly Rate
Wb = W + B = W(1+Lb)
                                    $88.09
                                    $58.16
                                    $32.56
Overhead Percentage[3]
Lo = OH/Wb
                                      50%
                                      50%
                                      50%
Overhead per hour
OH = Wb*Lo
                                    $44.05
                                    $29.08
                                    $16.28
Fully Loaded Hourly Rate
Wf = Wb + OH
 = W + B + OH
                                   $132.14
                                    $87.24
                                    $48.83

1.  Data Source:  BLS
http://www.bls.gov/oes/current/naics4_999100.htm
May 2018
     NAICS 999100 - Federal Executive Branch

     Standard Occupational Classification (SOC):

       Management:
11-0000, Management Occupations

       Technical:
19-0000, Life, Physical, and Social Science Occupations
       Clerical:
43-0000, Office and Administrative Support Occupations
2. Fringe benefits/wage per hour.  The average for non-farm, non-federal civilian workers.
3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The loading for indirect costs is within the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.