Thiram; Time-Limited Pesticide Tolerances, 18818-18822 [2014-07556]
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2. In § 180.490, add alphabetically the
following commodity, and footnote 1, to
the table in paragraph (a)(1) to read as
follows:
■
§ 180.490 Imazapic; tolerances for
residues.
(a) General. (1) * * *
Parts per
million
Commodity
*
*
*
*
Soybean, seed 1 ........................
*
*
*
*
*
0.40
*
1 There are no US registrations as of April 4,
2014.
*
*
*
*
*
[FR Doc. 2014–07585 Filed 4–3–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0143; FRL–9909–02]
Thiram; Time-Limited Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
thiram in or on banana. Taminco US,
Inc. requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA). The tolerances expire on
March 31, 2015.
DATES: This regulation is effective April
4, 2014. Objections and requests for
hearings must be received on or before
June 3, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0143, 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), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
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ADDRESSES:
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the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 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.
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–2014–0143 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 June 3, 2014. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
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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–
2014–0143, 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
Tolerances
In the Federal Register of February
25, 2014 (79 FR 10458) (FRL–9906–77),
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 4E8243) by
Taminco US, Inc., Two Windsor Plaza,
Suite 411, Allentown, PA 18195. The
petition requested that 40 CFR 180.132
be amended by extending the expiration
date on the tolerance for residues of the
fungicide thiram in or on banana at 0.8
parts per million (ppm) from March 31,
2014, to March 31, 2015. That document
referenced a summary of the petition
prepared by Taminco US, Inc., the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing. These tolerances expire
on March 31, 2015.
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
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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
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evidence for increased susceptibility
following in utero exposures to rats or
rabbits and following pre- 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 NOAEL and this endpoint
is used for assessing the acute dietary
risk for the most sensitive population.
Thiram is classified as ‘‘not likely to be
carcinogenic to humans’’ based on lack
of evidence for carcinogenicity in mice
or rats. There are no mutagenic/
genotoxic concerns with thiram. The
available toxicological database for
thiram suggests that this chemical has a
low to moderate acute-toxicity profile.
Specific information on the studies
received and the nature of the toxic
effects caused by thiram as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at 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
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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 from 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, 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
classified thiram as ‘‘Not Likely to be
Carcinogenic to Humans,’’ therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is not
needed.
iv. Anticipated residue information.
EPA did not use PCT information in the
dietary assessment for thiram. The acute
used field trial residues for the majority
of commodities. The chronic dietary
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
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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
billion (ppb) and 0.0025 ppb for chronic
exposures (for non-cancer assessments)
for surface water. Ground water sources
were not included (for acute or chronic
exposures), as the EDWCs for ground
water are minimal in comparison to
those for surface water. Surface water
EDWCs were incorporated in DEEM–
FCID into the food categories ‘‘water,
direct, all sources’’ and ‘‘water, indirect,
all sources’’ for the dietary assessments.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to 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. 8299 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
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pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike the N-methyl carbamate
pesticides, EPA has not found thiram (a
dithiocarbamate) to share a common
mechanism of toxicity with any other
substances, and thiram does not appear
to produce a toxic metabolite produced
by other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that thiram does not have a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at 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
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There was no evidence of increased
susceptibility following in utero
exposure to rats or rabbits or following
pre-and post natal exposures to rats.
There is evidence of quantitative
susceptibility in the DNT study.
Offspring effects (increased locomotor
activity in females on PND 17) occurred
at a lower dose than maternal effects
(increased number of rearing events and
elevated incidences of hyperactivity in
females at weeks 8 and 13). There is low
concern for the enhanced susceptibility
seen in the DNT study because:
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. and
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 pre- and postnatal toxicity.
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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 pre- and
post-natal 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
FDA apple monitoring data and field
trial data along with the maximum PCT.
The chronic dietary exposure analysis
used tolerance level residues except for
apple along with the average 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. Using DEEM–FCID, acute dietary
exposure at the 95th exposure percentile
is estimated at 0.012053 mg/kg bw/day
for the general U.S. population (1.9% of
the aPAD) and 0.008637 mg/kg bw/day
(62% of the aPAD) for females 13–49
years old, the population subgroup with
the highest % aPAD dietary exposure to
thiram.
2. Chronic risk. The chronic aggregate
risk assessment takes into account
exposure estimates from dietary
consumption of thiram (food and
drinking water). Dietary risk estimates
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were determined considering exposures
from food and drinking water using
EDWCs for surface water sources. Using
the DEEM–FCID software, dietary
exposure is estimated at 0.002257 mg/kg
bw/day for the general U.S. population
(15% of the cPAD) and 0.011943 mg/kg
bw/day (80% of the cPAD) for children
1–2 years old, the population subgroup
with the highest estimated chronic
dietary exposure to thiram.
3. Short-term and intermediate-term
risk. Short-term aggregate exposure
takes into account short-term residential
exposure plus chronic exposure to food
and water (considered to be a
background exposure level).
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
In aggregating short- and
intermediate-term risk, the Agency
routinely combines background chronic
dietary exposure (food + water) with
short/intermediate-term residential
exposure (dermal only). The combined
exposure may then be used to calculate
an MOE for aggregate risk. Using the
golfer scenario for adult males, adult
females, and children >6 years old,
combined with the applicable
subpopulation with the greatest dietary
exposure, the total short/intermediateterm food and residential aggregate
MOEs are 600, 600, and 370,
respectively. As these MOEs are greater
than 100, the short- and intermediateterm aggregate risks do not exceed the
Agency’s LOC.
4. Aggregate cancer risk for U.S.
population. Thiram is classified as ‘‘Not
Likely to be Carcinogenic to Humans’’
based on lack of evidence for
carcinogenicity in mice or rats;
therefore, thiram is not expected to pose
a cancer risk.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population or to infants and children
from aggregate exposure to thiram
residues.
IV. Other Considerations
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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.
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B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for thiram in or on banana.
V. Conclusion
Therefore, the expiration date on
time-limited tolerance for residues of
thiram in or on banana at 0.8 ppm is
being extended until March 31, 2015.
An extension of the time limited
tolerance has been imposed to allow the
Agency time to review additional
residue data submitted in consideration
of a permanent tolerance for banana.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children From Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
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18821
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
E:\FR\FM\04APR1.SGM
04APR1
18822
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Rules and Regulations
TKELLEY on DSK3SPTVN1PROD with RULES
Dated: March 28, 2014.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
environment and resulting exposures of
aquatic and sediment dwelling
organisms to D4, contributing to the
Agency’s efforts to understand potential
environmental effects of D4. This
Therefore, 40 CFR chapter I is
document revises the listing for D4 in
amended as follows:
the table of testing consent orders for
substances and mixtures with Chemical
PART 180—[AMENDED]
Abstract Service (CAS) Registry
■ 1. The authority citation for part 180
Numbers. This document announces the
ECA and the Order that incorporates the
continues to read as follows:
ECA for this testing, and summarizes
Authority: 21 U.S.C. 321(q), 346a and 371.
the terms of the ECA. As a result of this
■ 2. In § 180.132, in the table in
action, exporters of D4, CAS No. 556–
paragraph (a), in the entry for ‘‘Banana’’, 67–2, including persons who do not
revise the Expiration/revocation date,
sign the ECA, are subject to TSCA
‘‘3/31/14’’ to read ‘‘3/31/15’’ to read as
export notification requirements.
follows:
DATES: The effective date of the ECA,
the Order that incorporates the ECA,
§ 180.132 Thiram; tolerances for residues.
and this action is April 4, 2014.
(a) * * *
ADDRESSES: The docket for this action,
identified by docket identification (ID)
Parts
Expiration/
number EPA–HQ–OPPT–2012–0209, is
Commodity
per
revocation
million
date
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
*
*
*
*
*
Environmental Protection Agency
1 ...............
Banana
* * *
3/31/15 Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington,
*
*
*
*
*
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
1 No U.S. registrations as of September 23,
through Friday, excluding legal
2009.
holidays. The telephone number for the
*
*
*
*
*
Public Reading Room is (202) 566–1744,
[FR Doc. 2014–07556 Filed 4–3–14; 8:45 am]
and the telephone number for the OPPT
BILLING CODE 6560–50–P
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
ENVIRONMENTAL PROTECTION
at https://www.epa.gov/dockets.
AGENCY
FOR FURTHER INFORMATION CONTACT: For
information on the ECA, contact: Mark
40 CFR Part 799
Seltzer, Chemical Control Division
[EPA–HQ–OPPT–2012–0209; FRL–9907–36]
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Final Enforceable Consent Agreement
Agency, 1200 Pennsylvania Ave. NW.,
and Testing Consent Order for
Washington, DC 20460–0001; telephone
Octamethylcyclotetrasiloxane (D4);
number: (202) 564–2901; email address:
Export Notification
seltzer.mark@epa.gov.
For general information contact: The
AGENCY: Environmental Protection
TSCA-Hotline, ABVI-Goodwill, 422
Agency (EPA).
South Clinton Ave., Rochester, NY
ACTION: Final rule; enforceable consent
14620; telephone number: (202) 554–
agreement and testing consent order.
1404; email address: TSCAHotline@epa.gov.
SUMMARY: Under the Toxic Substances
Control Act (TSCA), EPA has issued a
SUPPLEMENTARY INFORMATION:
testing consent order (Order) that
I. Does this action apply to me?
incorporates an enforceable consent
agreement (ECA) with Dow Corning
This action is directed to the public
Corporation, Evonik Corporation,
in general. The requirements in the ECA
Momentive Performance Materials USA and the Order that incorporates the ECA
Inc., Shin-Etsu Silicones of America,
only apply to those companies that are
Inc., and Wacker Chemical Corporation
specifically named in the ECA. As of
(the Companies). The Companies have
April 4, 2014 any person who exports or
agreed to certain environmental testing
intends to export any chemical that is
that will be used by EPA to characterize the subject of the ECA and the Order
sources and pathways of release of
that incorporates the ECA is subject to
octamethylcyclotetrasiloxane (D4) to the the export notification requirements of
VerDate Mar<15>2010
16:26 Apr 03, 2014
Jkt 232001
PO 00000
Frm 00058
Fmt 4700
Sfmt 4700
TSCA section 12(b) (see 40 CFR part
707, subpart D, and Unit IV.B.).
Although other types of entities could
also be affected, most chemical
manufacturers are usually identified
under North American Industrial
Classification System (NAICS) code 325
(Chemical manufacturing).
II. Background
A. What is
Octamethylcyclotetrasiloxane (D4)?
D4 is used as an intermediate for
silicone copolymers and other
chemicals. D4 is also used in industrial
processing applications as a solvent
(which becomes part of a product
formulation or mixture), finishing agent,
and an adhesive and sealant chemical
(Ref. 1). It is also used for both
consumer and commercial purposes in
paints and coatings, and plastic and
rubber products (Ref. 1) and has
consumer uses in polishes, sanitation,
soaps, detergents, adhesives, and
sealants (Ref. 2).
B. Why does EPA need environmental
effects data on D4?
D4 persists in sediment and
bioaccumulates in aquatic species. Data
show D4 to be toxic to aquatic and
sediment-dwelling species. EPA has
concerns regarding the environmental
effects of D4. Environmental testing will
help develop a better understanding of
the potential effects of this chemical in
the environment.
III. ECA Development and Conclusion
A. How is EPA going to obtain
environmental testing on D4?
EPA initiated steps and agreed to
enter into this ECA with the Companies.
On February 26, 2014, EPA received the
ECA signed by the Companies, and on
March 28, 2014, EPA signed the ECA
and the Order that incorporates the
ECA. The effective date of the ECA and
the Order that incorporates the ECA is
April 4, 2014.
EPA uses ECAs to accomplish testing
of chemicals for public health and
environmental effects where a
consensus exists concerning the need
for and scope of testing (40 CFR
790.1(c)). The procedures for ECA
negotiations and the factors for
determining whether a consensus exists
are described at 40 CFR 790.22.
B. What is the subject of the ECA and
order incorporating the ECA?
As specified in the ECA, the purpose
of the testing program is to conduct
environmental testing to help in
characterizing sources and pathways of
release of D4 to the environment and
E:\FR\FM\04APR1.SGM
04APR1
Agencies
[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18818-18822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07556]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0143; FRL-9909-02]
Thiram; Time-Limited Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of thiram in or on banana. Taminco US, Inc. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The
tolerances expire on March 31, 2015.
DATES: This regulation is effective April 4, 2014. Objections and
requests for hearings must be received on or before June 3, 2014, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0143, 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), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 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-2014-0143 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
June 3, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0143, 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 Tolerances
In the Federal Register of February 25, 2014 (79 FR 10458) (FRL-
9906-77), 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
4E8243) by Taminco US, Inc., Two Windsor Plaza, Suite 411, Allentown,
PA 18195. The petition requested that 40 CFR 180.132 be amended by
extending the expiration date on the tolerance for residues of the
fungicide thiram in or on banana at 0.8 parts per million (ppm) from
March 31, 2014, to March 31, 2015. That document referenced a summary
of the petition prepared by Taminco US, Inc., the registrant, which is
available to the public in the docket, https://www.regulations.gov.
There were no comments received in response to the notice of filing.
These tolerances expire on March 31, 2015.
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
[[Page 18819]]
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 pre- and
post-natal 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 NOAEL and this endpoint is used for assessing the acute dietary
risk for the most sensitive population. Thiram is classified as ``not
likely to be carcinogenic to humans'' based on lack of evidence for
carcinogenicity in mice or rats. There are no mutagenic/genotoxic
concerns with thiram. The available toxicological database for thiram
suggests that this chemical has a low to moderate acute-toxicity
profile.
Specific information on the studies received and the nature of the
toxic 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 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 from 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, 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
classified thiram as ``Not Likely to be Carcinogenic to Humans,''
therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is not needed.
iv. Anticipated residue information. EPA did not use PCT
information in the dietary assessment for thiram. The acute used field
trial residues for the majority of commodities. The chronic dietary
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
[[Page 18820]]
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 billion (ppb) and
0.0025 ppb for chronic exposures (for non-cancer assessments) for
surface water. Ground water sources were not included (for acute or
chronic exposures), as the EDWCs for ground water are minimal in
comparison to those for surface water. Surface water EDWCs were
incorporated in DEEM-FCID into the food categories ``water, direct, all
sources'' and ``water, indirect, all sources'' for the dietary
assessments.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Thiram is not
available for sale or use by homeowner applicators; therefore, there
are no residential handler exposure scenarios. 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. 8299 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 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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility following in utero exposure to rats or rabbits
or following pre-and post natal exposures to rats. There is evidence of
quantitative susceptibility in the DNT study. Offspring effects
(increased locomotor activity in females on PND 17) occurred at a lower
dose than maternal effects (increased number of rearing events and
elevated incidences of hyperactivity in females at weeks 8 and 13).
There is low concern for the enhanced susceptibility seen in the DNT
study because:
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. and
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 pre- and post-natal toxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for thiram is complete with acceptable
neurotoxicity, developmental, and reproductive toxicity studies.
ii. As explained in this unit, there are no residual uncertainties
for pre- and post-natal 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
FDA apple monitoring data and field trial data along with the maximum
PCT. The chronic dietary exposure analysis used tolerance level
residues except for apple along with the average 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. Using DEEM-FCID, acute dietary exposure at the 95th
exposure percentile is estimated at 0.012053 mg/kg bw/day for the
general U.S. population (1.9% of the aPAD) and 0.008637 mg/kg bw/day
(62% of the aPAD) for females 13-49 years old, the population subgroup
with the highest % aPAD dietary exposure to thiram.
2. Chronic risk. The chronic aggregate risk assessment takes into
account exposure estimates from dietary consumption of thiram (food and
drinking water). Dietary risk estimates
[[Page 18821]]
were determined considering exposures from food and drinking water
using EDWCs for surface water sources. Using the DEEM-FCID software,
dietary exposure is estimated at 0.002257 mg/kg bw/day for the general
U.S. population (15% of the cPAD) and 0.011943 mg/kg bw/day (80% of the
cPAD) for children 1-2 years old, the population subgroup with the
highest estimated chronic dietary exposure to thiram.
3. Short-term and intermediate-term risk. Short-term aggregate
exposure takes into account short-term residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level). Intermediate-term aggregate exposure takes into
account intermediate-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level).
In aggregating short- and intermediate-term risk, the Agency
routinely combines background chronic dietary exposure (food + water)
with short/intermediate-term residential exposure (dermal only). The
combined exposure may then be used to calculate an MOE for aggregate
risk. Using the golfer scenario for adult males, adult females, and
children >6 years old, combined with the applicable subpopulation with
the greatest dietary exposure, the total short/intermediate-term food
and residential aggregate MOEs are 600, 600, and 370, respectively. As
these MOEs are greater than 100, the short- and intermediate-term
aggregate risks do not exceed the Agency's LOC.
4. Aggregate cancer risk for U.S. population. Thiram is classified
as ``Not Likely to be Carcinogenic to Humans'' based on lack of
evidence for carcinogenicity in mice or rats; therefore, thiram is not
expected to pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to thiram residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (colorimetric analytical method)
is available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for thiram in or on banana.
V. Conclusion
Therefore, the expiration date on time-limited tolerance for
residues of thiram in or on banana at 0.8 ppm is being extended until
March 31, 2015. An extension of the time limited tolerance has been
imposed to allow the Agency time to review additional residue data
submitted in consideration of a permanent tolerance for banana.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 18822]]
Dated: March 28, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.132, in the table in paragraph (a), in the entry for
``Banana'', revise the Expiration/revocation date, ``3/31/14'' to read
``3/31/15'' to read as follows:
Sec. 180.132 Thiram; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation
date
------------------------------------------------------------------------
* * * * *
Banana \1\........................... * * * 3/31/15
* * * * *
------------------------------------------------------------------------
\1\ No U.S. registrations as of September 23, 2009.
* * * * *
[FR Doc. 2014-07556 Filed 4-3-14; 8:45 am]
BILLING CODE 6560-50-P