Thiram; Pesticide Tolerance, 16302-16306 [2015-06981]
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appropriately enforced under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) as use
directions on the label.
VI. Statutory and Executive Order
Reviews
This action 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 action
has been exempted from review under
Executive Order 12866, this action 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 action 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 action 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 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
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67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (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
(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
and its major metabolites, transdeltamethrin, (S)-alpha-cyano-mphenoxybenzyl(1R,3S)-3-(2,2dibromovinyl)-2,2dimethylcyclopropanecarboxylate, and
alpha-R-deltamethrin, (R)-alpha-cyanom-phenoxybenzyl-(1R,3R)-3-(2,2dibromovinyl)-2,2dimethylcyclopropanecarboxylate, in or
on the commodity.
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[FR Doc. 2015–06861 Filed 3–26–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0632; FRL–9924–86]
Thiram; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
Therefore, 40 CFR chapter I is
amended as follows:
This regulation establishes a
tolerance for residues of thiram in or on
banana. Taminco US, Inc. requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
March 27, 2015. Objections and requests
for hearings must be received on or
before May 26, 2015, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
PART 180—[AMENDED]
ADDRESSES:
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 18, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.435, paragraph (a)(2) is
revised to read as:
■
§ 180.435 Deltamethrin; tolerances for
residues.
(a) General. * * *
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(2) A tolerance of 0.05 ppm is
established for residues of the
insecticide deltamethrin, including its
metabolites and degradates, in or on all
food/feed items (other than those
covered by a higher tolerance as a result
of use on growing crops) when
deltamethrin is used in food/feed
handling establishments or as a widearea mosquito adulticide. Compliance
with the tolerance levels specified is to
be determined by measuring only
deltamethrin, (1R,3R)-3-(2,2dibromovinyl)-2,2dimethylcyclopropanecarboxylic acid
(S)-alpha-cyano-3-phenoxybenzyl ester,
*
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SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0632, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
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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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2014–0632 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 May 26, 2015. 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–
2014–0632, by one of the following
methods:
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• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of December
17, 2014 (79 FR 75107) (FRL–9918–90),
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 4E8268) by
Taminco US, Inc., Two Windsor Plaza,
Suite 411, Allentown, PA 18195. The
petition requested that 40 CFR 180.132
be amended by establishing a tolerance
for residues of the fungicide thiram, in
or on banana at 0.8 parts per million
(ppm). That document referenced a
summary of the petition prepared by
Taminco US, Inc., the petitioner, which
is available in the docket, https://
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
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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. 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 2
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 no-observedadverse-effect-level (NOAEL) and this
endpoint is used for assessing the acute
dietary risk for the most sensitive
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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 acutetoxicity profile.
Specific information on the studies
received and the nature of the adverse
effects caused by thiram as well as the
NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Thiram. Update to the Aggregate Risk
Assessment to Support the Requested
PHI Reduction and Increased Tolerance
Request on Strawberry,’’ p. 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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for thiram used for human
risk assessment is discussed in Unit
III.B. of the final rule published in the
Federal Register of February 12, 2014
(79 FR 8295) (FRL–9904–22).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
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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 partially refined probabilistic acute
dietary-exposure assessment was
performed using 100 percent crop
treated (PCT), tolerance-level residues
the highest residue found during fieldtrials, distributions of field trial
residues, and empirical processing
factors.
ii. Chronic exposure. Tolerances-level
residues for banana and average field
trial residues for apples, peaches, and
strawberries along with 100 PCT were
used for the chronic dietary exposure
analysis for all crops. Empirical
processing factors were also used.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that thiram does not pose a
cancer risk to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use PCT
information in the dietary assessment
for thiram. The acute dietary assessment
used 100 PCT, tolerance-level residues,
the highest residue found during fieldtrials, distributions of field trial
residues, and empirical processing
factors; the chronic dietary assessment
used average field trial residues along
with tolerance-level residues. In
addition, 100 PCT were assumed for all
food commodities. 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.
2. Dietary exposure from drinking
water. The Agency used screening-level
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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
https://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
million (ppm) and 0.0025 ppm 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). Thiram is
not available for sale or use by
homeowner applicators; therefore, there
are no residential handler exposure
scenarios. 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 as described
in document ‘‘Thiram. Update to the
Aggregate Risk Assessment to Support
the Requested PHI Reduction and
Increased Tolerance Request on
Strawberry,’’ p. 15 in docket ID number
EPA–HQ–OPP–2012–0925.
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
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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
https://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 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
prenatal and postnatal exposures to rats.
There is evidence of quantitative
susceptibility in the DNT study.
However, there is low concern for the
enhanced susceptibility seen in the DNT
study because:
i. Clear NOAELs/LOAELs were
established for the offspring effects.
ii. The dose-response is well defined.
iii. The behavioral effect of concern
were observed only in females on one
evaluation time period.
iv. 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 prenatal and
postnatal toxicity.
Consequently, there are no residual
uncertainties for prenatal and postnatal
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,
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developmental, and reproductive
toxicity studies.
ii. As explained in this unit, there are
no residual uncertainties for prenatal
and postnatal toxicity.
iii. 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
field trial data along with the 100 PCT.
The chronic dietary exposure analysis
used tolerance level residues or average
field residues along with the 100 PCT.
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. 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
exposure estimates from dietary
consumption of food and drinking
water. The acute dietary risk estimates
are not of concern to EPA (<100%
aPAD) at the 95th exposure percentile
for the general U.S. population and all
other population subgroups. The acute
dietary exposure was 62% of the aPAD
for females 13–49 years old, the
population subgroup with the highest
percent aPAD. Therefore, the acute
aggregate risk associated with the
proposed uses of thiram is not of
concern to EPA for the general U.S.
population or any population
subgroups.
2. Chronic risk. The chronic aggregate
risk assessment takes into account
exposure estimates from dietary
consumption of thiram (food and
drinking water). The chronic dietary
risk estimates are not of concern to EPA
(<100% cPAD) for the general U.S.
population and all other population
subgroups. The chronic dietary
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exposure was 70% of the cPAD for
children 1–2 years old, the population
subgroup with the highest estimated
chronic dietary exposure. Therefore, the
chronic aggregate risk associated with
the proposed uses of thiram is not of
concern to EPA for the general U.S.
population or any population
subgroups.
3. Short-term and intermediate-term
risk. 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/intermediateterm food and residential aggregate
MOEs are 570, 540, and 280,
respectively. As these MOEs are above
the target MOE of 100, the short- and
intermediate-term aggregate risks are not
of concern. 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. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
thiram is not expected to pose a cancer
risk to humans.
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
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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations
(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 not
established a MRL for thiram in or on
banana.
asabaliauskas on DSK5VPTVN1PROD with RULES
V. Conclusion
Therefore, EPA is removing the
expiration/revocation date for the
current tolerance for residues of thiram,
in or on banana at 0.80 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
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 action
has been exempted from review under
Executive Order 12866, this action 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 action 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 action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
VerDate Sep<11>2014
16:44 Mar 26, 2015
Jkt 235001
this action alter the relationships or
distribution of power 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 action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (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
(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: March 19, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.132, the table in paragraph
(a) is revised to read as follows:
■
PO 00000
Frm 00056
Fmt 4700
Sfmt 4700
§ 180.132
Thiram; tolerances for residues.
(a) * * *
Commodity
Parts per million
Apple ...................................
Banana 1 .............................
Peach ..................................
Strawberry ..........................
7.0
0.80
7.0
20
1 No U.S. registrations as of September 23,
2009.
*
*
*
*
*
[FR Doc. 2015–06981 Filed 3–26–15; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 130403320–4891–02]
RIN 0648–XD828
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; SnapperGrouper Resources of the South
Atlantic; 2015–2016 Recreational
Fishing Season for Black Sea Bass
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; recreational
season length.
AGENCY:
NMFS announces that the
length of the recreational season for
black sea bass in the exclusive economic
zone (EEZ) of the South Atlantic will
extend throughout the fishing year.
Announcing the length of recreational
season for black sea bass is one of the
accountability measures (AMs) for the
recreational sector. This announcement
allows recreational fishermen to
maximize their opportunity to harvest
the recreational annual catch limit
(ACL) for black sea bass during the
fishing season while managing harvest
to protect the black sea bass resource.
DATES: This rule is effective from 12:01
a.m., local time, April 1, 2015, until
12:01 a.m., local time, April 1, 2016,
unless changed by subsequent
notification in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Nikhil Mehta, NMFS Southeast Regional
Office, telephone: 727–824–5305, email:
nikhil.mehta@noaa.gov.
SUPPLEMENTARY INFORMATION: The
snapper-grouper fishery includes black
sea bass in the South Atlantic and is
managed under the Fishery
Management Plan for the SnapperSUMMARY:
E:\FR\FM\27MRR1.SGM
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Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16302-16306]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06981]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0632; FRL-9924-86]
Thiram; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of thiram
in or on banana. Taminco US, Inc. requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 27, 2015. Objections and
requests for hearings must be received on or before May 26, 2015, 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-2014-0632, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
[[Page 16303]]
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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0632 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
May 26, 2015. 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-2014-0632, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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
4E8268) by Taminco US, Inc., Two Windsor Plaza, Suite 411, Allentown,
PA 18195. The petition requested that 40 CFR 180.132 be amended by
establishing a tolerance for residues of the fungicide thiram, in or on
banana at 0.8 parts per million (ppm). That document referenced a
summary of the petition prepared by Taminco US, Inc., the petitioner,
which is available in the docket, https://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.
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 2 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 no-observed-adverse-effect-level (NOAEL) and this endpoint is
used for assessing the acute dietary risk for the most sensitive
[[Page 16304]]
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 NOAEL and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be
found at https://www.regulations.gov in document ``Thiram. Update to the
Aggregate Risk Assessment to Support the Requested PHI Reduction and
Increased Tolerance Request on Strawberry,'' p. 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for thiram used for human
risk assessment is discussed in Unit III.B. of the final rule published
in the Federal Register of February 12, 2014 (79 FR 8295) (FRL-9904-
22).
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 partially refined probabilistic acute dietary-exposure assessment
was performed using 100 percent crop treated (PCT), tolerance-level
residues the highest residue found during field-trials, distributions
of field trial residues, and empirical processing factors.
ii. Chronic exposure. Tolerances-level residues for banana and
average field trial residues for apples, peaches, and strawberries
along with 100 PCT were used for the chronic dietary exposure analysis
for all crops. Empirical processing factors were also used.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that thiram does not pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the purpose of assessing cancer risk
is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use PCT
information in the dietary assessment for thiram. The acute dietary
assessment used 100 PCT, tolerance-level residues, the highest residue
found during field-trials, distributions of field trial residues, and
empirical processing factors; the chronic dietary assessment used
average field trial residues along with tolerance-level residues. In
addition, 100 PCT were assumed for all food commodities. 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.
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
https://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 million (ppm) and
0.0025 ppm 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. 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 as described in
document ``Thiram. Update to the Aggregate Risk Assessment to Support
the Requested PHI Reduction and Increased Tolerance Request on
Strawberry,'' p. 15 in docket ID number EPA-HQ-OPP-2012-0925.
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
[[Page 16305]]
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 https://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
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 prenatal and postnatal exposures to rats. There is
evidence of quantitative susceptibility in the DNT study. However,
there is low concern for the enhanced susceptibility seen in the DNT
study because:
i. Clear NOAELs/LOAELs were established for the offspring effects.
ii. The dose-response is well defined.
iii. The behavioral effect of concern were observed only in females
on one evaluation time period.
iv. 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 prenatal and postnatal
toxicity.
Consequently, there are no residual uncertainties for prenatal and
postnatal 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. As explained in this unit, there are no residual uncertainties
for prenatal and postnatal toxicity.
iii. 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 field
trial data along with the 100 PCT. The chronic dietary exposure
analysis used tolerance level residues or average field residues along
with the 100 PCT. 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. 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 exposure estimates from dietary consumption of food and
drinking water. The acute dietary risk estimates are not of concern to
EPA (<100% aPAD) at the 95th exposure percentile for the general U.S.
population and all other population subgroups. The acute dietary
exposure was 62% of the aPAD for females 13-49 years old, the
population subgroup with the highest percent aPAD. Therefore, the acute
aggregate risk associated with the proposed uses of thiram is not of
concern to EPA for the general U.S. population or any population
subgroups.
2. Chronic risk. The chronic aggregate risk assessment takes into
account exposure estimates from dietary consumption of thiram (food and
drinking water). The chronic dietary risk estimates are not of concern
to EPA (<100% cPAD) for the general U.S. population and all other
population subgroups. The chronic dietary exposure was 70% of the cPAD
for children 1-2 years old, the population subgroup with the highest
estimated chronic dietary exposure. Therefore, the chronic aggregate
risk associated with the proposed uses of thiram is not of concern to
EPA for the general U.S. population or any population subgroups.
3. Short-term and intermediate-term risk. 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 570, 540, and 280, respectively. As these MOEs are above the target
MOE of 100, the short- and intermediate-term aggregate risks are not of
concern. 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. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, thiram is not expected to pose a cancer risk to humans.
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
[[Page 16306]]
(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 not established a MRL for thiram in or on
banana.
V. Conclusion
Therefore, EPA is removing the expiration/revocation date for the
current tolerance for residues of thiram, in or on banana at 0.80 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 action 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 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: March 19, 2015.
Susan Lewis,
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, the table in paragraph (a) is revised to read as
follows:
Sec. 180.132 Thiram; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple................................................... 7.0
Banana \1\.............................................. 0.80
Peach................................................... 7.0
Strawberry.............................................. 20
------------------------------------------------------------------------
\1\ No U.S. registrations as of September 23, 2009.
* * * * *
[FR Doc. 2015-06981 Filed 3-26-15; 8:45 am]
BILLING CODE 6560-50-P