Acibenzolar- S -methyl; Time-Limited Pesticide Tolerances, 30402-30407 [2012-12410]
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30402
Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations
Indian Tribal Governments
This rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have a substantial
direct effect on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes.
environment. This rule is categorically
excluded, under figure 2–1, paragraph
(34)(g), of the Instruction. This rule fits
the category selected from paragraph
(34)(g), as it establishes a temporary
security zone for a limited period of
time.
An environmental analysis checklist
and a categorical exclusion
determination are available and
accessible in the docket as indicated in
the ADDRESSES section.
Energy Effects
We have analyzed this rule under
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use. We have
determined that it is not a ‘‘significant
energy action’’ under that order because
it is not a ‘‘significant regulatory action’’
under Executive Order 12866 and is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy. The Administrator of the Office
of Information and Regulatory Affairs
has not designated it as a significant
energy action. Therefore, it does not
require a Statement of Energy Effects
under Executive Order 13211.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
srobinson on DSK4SPTVN1PROD with RULES
Technical Standards
The National Technology Transfer
and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use
voluntary consensus standards in their
regulatory activities unless the agency
provides Congress, through the Office of
Management and Budget, with an
explanation of why using these
standards would be inconsistent with
applicable law or otherwise impractical.
Voluntary consensus standards are
technical standards (e.g., specifications
of materials, performance, design, or
operation; test methods; sampling
procedures; and related management
systems practices) that are developed or
adopted by voluntary consensus
standards bodies.
This rule does not use technical
standards. Therefore, we did not
consider the use of voluntary consensus
standards.
Environment
We have analyzed this rule under
Department of Homeland Security
Management Directive 023–01 and
Commandant Instruction M16475.lD,
which guide the Coast Guard in
complying with the National
Environmental Policy Act of 1969
(NEPA) (42 U.S.C. 4321–4370f), and
have concluded this action is one of a
category of actions which do not
individually or cumulatively have a
significant effect on the human
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PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 33 U.S.C. 1231; 46 U.S.C.
Chapter 701, 3306, 3703; 50 U.S.C. 191, 195;
33 CFR 1.05–1, 6.06–1, 6.05–6 and 160.5;
Pub. L. 107–295, 116 Stat. 2064; Department
of Homeland Security Delegation No. 0170.1.
2. Section 165.T08–040 is added to
read as follows:
■
§ 165.T08–040 Moving Security Zone,
Escorted Vessels.
(a) Location. The following areas are
security zones: Navigable waters of the
Lower Mississippi River, from mile
marker 90.0 to mile marker 110.0,
extending 300 yards in all directions of
escorted vessels. Escorted vessels will
be escorted by one or more Coast Guard
assets or other federal, state, or local law
enforcement agency assets clearly
identifiable by lights, vessel markings,
or with agency insignia.
(b) Effective period. This rule is
effective May 23, 2012 through August
15, 2012. Beginning April 1, 2012 this
rule is enforced through actual notice.
(c) Regulation. (1) Under the general
regulations in § 165.33 of this part,
vessels are prohibited from entering or
transiting the security zones described
in paragraph (a) of this temporary
section, § 165.T08–040.
(2) If granted permission to enter a
security zone, a vessel must operate at
the minimum speed necessary to
maintain a safe course, unless required
to maintain speed by the Navigation
Rules, and shall proceed as directed by
the Coast Guard. When within the
security zone, no vessel or person is
allowed within 50 yards of the escorted
vessel unless authorized by the Coast
Guard.
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(3) Persons or vessels requiring
deviations from this rule must request
permission from the Captain of the Port
New Orleans through the on-scene Coast
Guard or other agency asset, via VHF
Ch. 67 or the Coast Guard Vessel Traffic
Center at (504) 365–2230.
(4) All persons and vessels granted
permission to enter a security zone must
comply with the instructions of the
Captain of the Port New Orleans and
designated personnel. Designated
personnel include commissioned,
warrant and petty officers of the U.S.
Coast Guard, and local, state, and
federal law enforcement officers on
clearly identified law enforcement
agency vessels.
(d) Informational broadcasts. The
Captain of the Port or a designated
representative will inform the public
through marine safety information
bulletins or broadcast notices to
mariners of this regulation.
Dated: April 1, 2012.
John J. Arenstam,
Captain, U.S. Coast Guard, Acting, Captain
of the Port New Orleans.
[FR Doc. 2012–12313 Filed 5–22–12; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0674; FRL–9349–3]
Acibenzolar- S -methyl; Time-Limited
Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
acibenzolar-S-methyl in or on
grapefruit, apples and pears. Syngenta
Crop Protection LLC. requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
23, 2012. Objections and requests for
hearings must be received on or before
July 23, 2012, 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–2011–0674, is
available either electronically through
https://www.regulations.gov or in hard
copy at the OPP Docket in the
Environmental Protection Agency
Docket Center (EPA/DC), located in EPA
SUMMARY:
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West, 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: Rose
Kearns, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5611; email address: kearns.
rosemary@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. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
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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://ecfr.gpoaccess.gov/cgi/t/
text/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
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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–2011–0674 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 July 23, 2012. 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 part178, please
submit a copy of the filing that does not
contain any 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 a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2011–0674, 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
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), Mail Code: 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.
htm.
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 September
7, 2011 (76 FR 55331) (FRL–8886–7),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition 1G7889 by Syngenta
Crop Protection, LLC, P.O. Box 18300,
Greensboro, NC 27419–8300. The
petition requested that 40 CFR 180.561
be amended by establishing temporary
tolerances for residues of the fungicide,
acibenzolar-S-methyl, in or on apples,
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grapefruit and pears 0.05 parts per
million (ppm) in conjunction with
approval of an experimental use permit.
That notice referenced a summary of the
petition prepared by Syngenta Crop
Protection, LLC, the registrant, 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 section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for acibenzolar-Smethyl including exposure resulting
from the tolerances established by this
action. EPA’s assessment of exposures
and risks associated with acibenzolar-Smethyl 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.
General information on the toxicity of
acibenzolar-S-methyl can be found in a
recent tolerance rulemaking for this
pesticide in the Federal Register of
April 11, 2012 (77 FR 21670) (FRL–
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9343–3). Specific information on the
studies received and the nature of the
adverse effects caused by acibenzolar-Smethyl as well as the no-observedadverse-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 ‘‘Acibenzolar-S-methyl
Human Health Risk Assessment,’’ on
page 15 in docket ID number EPA–HQ–
OPP–2011–0674.
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 Acibenzolar-S-Methyl
used for human risk assessment is
shown in the recent tolerance
rulemaking document for acibenzolar-Smethyl in the Federal Register of April
11, 2012 (77 FR 21670).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to acibenzolar-S-methyl, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing acibenzolar-S-methyl tolerances
in 40 CFR 180.561. EPA assessed dietary
exposures from acibenzolar-S-methyl in
food as follows:
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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.
Such effects were identified for
acibenzolar-S-methyl. In estimating
acute dietary exposure, EPA used food
consumption information from the U.S.
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, EPA assumed a distribution of
residues based on field trial data and
tolerance level residues for apple,
grapefruit and pear. Empirical and
Dietary Exposure Evaluation Model
(DEEM) default processing factors were
used to modify the field trial data.
Maximum screening-level percent crop
treated (PCT) estimates were used for
commodities for which data were
available. If no PCT data were available,
100 PCT was assumed.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
used a conservative chronic dietary
exposure analysis for the general U.S.
population and various population
subgroups. Tolerance level residues and
100 crop treated assumptions were
used. DEEM default and empirical
processing factors were used to modify
the tolerance values.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that acibenzolar-S-methyl
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. 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.
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Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if
certain conditions are met. PCT data
was not used for conducting the chronic
dietary risk assessment.
2. Dietary exposure from drinking
water. The residues of concern for
drinking water are acibenzolar-S-methyl
benzo(1,2,3) thiadiazole-7-carbothioic
acid (-S-methyl ester, convertible to
benzo(1,2,3)thiadiazole-7-carboxylic
acid (CGA–210007) in drinking water.
These simulation model take into
account data on the physical, chemical,
and fate/transport characteristics of
acibenzolar-S-methyl. 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
acibenzolar-S-methyl for acute
exposures are estimated to be 45 parts
per billion (ppb) for surface water and
0.08 ppb for ground water, for chronic
exposures for non-cancer assessments
are estimated to be 19.1 ppb for surface
water and 0.08 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 45 ppb was used
to assess the contribution to drinking
water.
For chronic dietary risk assessment,
the water concentration of value 19.1
ppb was used to assess the contribution
to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Acibenzolar-S-methyl is currently
registered for the following uses that
could result in residential exposures:
Turfgrass use on sodfarms, golf courses,
collegiate athletic fields, and lawns
around commercial and industrial
buildings. Residential exposure was
assessed for adult handlers and for adult
and child post-application activities.
Exposure for adult and child golfers
were used to aggregate adult postapplication dermal exposure with
dietary and drinking water exposure.
The aggregate exposure assessment for
children combines dermal and
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incidental oral post-application
exposure with food and water exposure.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
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.’’
EPA has not found acibenzolar-Smethyl to share a common mechanism
of toxicity with any other substances,
and acibenzolar-S-methyl does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
acibenzolar-S-methyl 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.
The toxicology database for acibenzolarS-methyl is complete and adequate for
assessing increased susceptibility under
FQPA. The pre- and postnatal toxicity
database for acibenzolar-S-methyl
includes developmental toxicity studies
in rats and rabbits, a DNT study in rats,
and a 2-generation reproduction toxicity
study in rats. Based on the
developmental toxicity in rats and the
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developmental neurotoxicity studies in
rats, there is concern for increased
qualitative and/or quantitative
susceptibility following in utero
exposure to acibenzolar-S-methyl.
However, the degree of concern for the
increased susceptibility seen in these
studies is low as there are no residual
uncertainties with regard to pre- and/or
postnatal toxicity since NOAELs and
LOAELs have been identified for all
effects of concern, a clear dose response
has been well defined, and the PODs
selected for risk assessment are
protective of the fetal/offspring effects.
Additionally, the dietary and residential
risk assessments are conservative and
will not underestimate dietary exposure
and there are no residual uncertainties
in the exposure database.
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
acibenzolar-S-methyl is complete.
ii. There are no residual uncertainties
identified in the exposure databases.
The dietary risk assessment is
conservative and will not underestimate
dietary and/or non-dietary residential
exposure to acibenzolar-S-methyl. The
acute analysis assumed a distribution of
residues based on field trial data,
tolerance level residues for the
Experimental Use Permit (EUP) uses
and maximum PCT estimates were used
for commodities for which data were
available. The chronic dietary food
exposure assessment was performed
based on 100 PCT and tolerance-level
residues. EPA made conservative
(protective) assumptions in the ground
water and surface water modeling used
to assess exposure to acibenzolar-Smethyl in drinking water. EPA used
similarly conservative assumptions to
assess post-application exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by acibenzolar-S-methyl.
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
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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 the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water to acibenzolar-Smethyl will occupy 37% of the aPAD for
children 3–5 years old, the population
group receiving the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to acibenzolar-Smethyl from food and water will utilize
12% of the cPAD for children 1–2 years
old, the population group receiving the
greatest exposure. There are no
residential uses for acibenzolar-Smethyl. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of acibenzolar-S-methyl is not
expected.
3. Short-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).
Acibenzolar-S-methyl is currently
registered for uses that could result in
short-term residential exposure, and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
acibenzolar-S-methyl.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 700 for females 13–49 years
from handler activities, and, 1,600 for
females 13–49 years old, and 800–1,000
for children 1–2 and 6–12 years old,
respectively, from post-application
exposure. Because EPA’s level of
concern for acibenzolar-S-methyl is a
MOE of 100 or below, these short-termaggregate MOEs are not of concern.
4. Intermediate-term risk.
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).
An intermediate-term adverse effect
was identified; however, acibenzolar-Smethyl is not registered for any use
pattern that would result in
intermediate-term residential exposure.
Intermediate-term risk is assessed based
on intermediate-term residential
exposure plus chronic dietary exposure.
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Because there is no intermediate-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which at least one protective as
the POD used to assess intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for acibenzolar-S-methyl.
Because no intermediate-term adverse
effect was identified, acibenzolar-Smethyl is not expected to pose an
intermediate-term risk.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
acibenzolar-S-methyl is not expected to
pose a cancer risk to humans.
6. 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 acibenzolarS-methyl residues.
IV. Other Considerations
srobinson on DSK4SPTVN1PROD with RULES
A. Analytical Enforcement Methodology
Adequate enforcement methodology
high performance liquid
chromatography using ultra-violet
detection ((HPLC/UV) Method AG–
617A) 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 U.N.
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.
There are no established Codex,
Mexican, or Canadian maximum residue
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16:20 May 22, 2012
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limits for acibenzolar-S-methyl in/on
any commodity. Therefore, international
harmonization is not an issue for
acibenzolar-S-methyl.
V. Conclusion
Therefore, time-limited tolerances are
established for residues of acibenzolarS-methyl, in or on apple, grapefruit and
pear at 0.05 ppm. A time limitation been
imposed because these tolerances are
being established in conjunction with
approval of an EUP to use acibenzolarS-methyl on apple, pear and grapefruit.
The EUP approval period and timelimited tolerances will expire 12/31/
2015 which provides ample time for all
treated crops to be harvested, stored,
and out of channels of trade.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
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) (Pub. L. 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 14, 2012.
Lois Rossi,
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. Section 180.561 is amended as
follows:
■
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Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations
a. Redesignate paragraph (a) as (a)(1);
and
■ b. Add paragraph (a)(2).
The amendments read as follows:
This regulation is effective May
23, 2012. Objections and requests for
hearings must be received on or before
July 23, 2012, and must be filed in
accordance with the instructions
§ 180.561 Acibenzolar- S -methyl;
provided in 40 CFR part 178 (see also
tolerances for residues.
Unit I.C. of the SUPPLEMENTARY
(a) General.
INFORMATION).
(1) * * *
ADDRESSES: The docket for this action,
(2) Tolerances are established for
identified by docket identification (ID)
residues of acibenzolar- S -methyl,
number EPA–HQ–OPP–2012–0014, is
benzo(1,2,3)thiadiazole-7-carbothioic
available either electronically through
acid- S -methyl ester, including its
metabolites and degradates, in or on the https://www.regulations.gov or in hard
copy at the OPP Docket in the
commodities in the table below.
Environmental Protection Agency
Compliance with the tolerance levels
Docket Center (EPA/DC), located in EPA
specified below is to be determined by
West, Rm. 3334, 1301 Constitution Ave.
measuring only those acibenzolar- S
NW., Washington, DC 20460–0001. The
-methyl residues convertible to
Public Reading Room is open from
benzo(1,2,3)thiadiazole-7-carboxylic
8:30 a.m. to 4:30 p.m., Monday through
acid (CGA–210007), expressed as the
Friday, excluding legal holidays. The
Stoichiometric equivalent of
telephone number for the Public
acibenzolar- S -methyl, in or on the
following raw agricultural commodities. Reading Room is (202) 566–1744, and
the telephone number for the OPP
Expiration/
Docket is (703) 305–5805. Please review
Parts per
Commodity
revocation
the visitor instructions and additional
million
date
information about the docket available
Apple .................
0.05
12/31/2015 at https://www.epa.gov/dockets.
Grapefruit ..........
0.05
12/31/2015 FOR FURTHER INFORMATION CONTACT:
Pear ..................
0.05
12/31/2015 Anthony Britten, Registration Division
(7505P), Office of Pesticide Programs,
*
*
*
*
*
Environmental Protection Agency, 1200
[FR Doc. 2012–12410 Filed 5–22–12; 8:45 am]
Pennsylvania Ave. NW., Washington,
BILLING CODE 6560–50–P
DC 20460–0001; telephone number:
(703) 308–8179; email address:
britten.anthony@epa.gov.
ENVIRONMENTAL PROTECTION
SUPPLEMENTARY INFORMATION:
AGENCY
I. General Information
40 CFR Part 180
A. Does this action apply to me?
[EPA–HQ–OPP–2012–0014; FRL–9349–1]
You may be potentially affected by
1,2-Ethanediamine, N1-(2-aminoethyl)-, this action if you are an agricultural
producer, food manufacturer, or
polymer with 2, 4-diisocyanato-1pesticide manufacturer. Potentially
methylbenzene; Tolerance Exemption
affected entities may include, but are
AGENCY: Environmental Protection
not limited to:
Agency (EPA).
• Crop production (NAICS code 111).
• Animal production (NAICS code
ACTION: Final rule.
112).
SUMMARY: This regulation establishes an
• Food manufacturing (NAICS code
exemption from the requirement of a
311).
tolerance for residues of 1,2• Pesticide manufacturing (NAICS
ethanediamine, N1-(2-aminoethyl)-,
code 32532).
polymer with 2,4-diisocyanato-1This listing is not intended to be
methylbenzene, when used as an inert
exhaustive, but rather provides a guide
ingredient in a pesticide chemical
for readers regarding entities likely to be
formulation. ICR, Inc., on behalf of
affected by this action. Other types of
Triton Systems, Inc., submitted a
entities not listed in this unit could also
petition to EPA under the Federal Food, be affected. The North American
Drug, and Cosmetic Act (FFDCA),
Industrial Classification System
requesting an exemption from the
(NAICS) codes have been provided to
requirement of a tolerance. This
assist you and others in determining
regulation eliminates the need to
whether this action might apply to
establish a maximum permissible level
certain entities. If you have any
for residues of 1,2-ethanediamine, N1questions regarding the applicability of
(2-aminoethyl)-, polymer with 2,4this action to a particular entity, consult
diisocyanato-1-methylbenzene on food
the person listed under FOR FURTHER
or feed commodities.
INFORMATION CONTACT.
srobinson on DSK4SPTVN1PROD with RULES
■
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16:20 May 22, 2012
Jkt 226001
DATES:
PO 00000
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30407
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://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. Can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2012–0014 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 July 23, 2012. 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 that does not
contain any 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 a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2012–0014, by one of
the following methods.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of April 4,
2012 (77 FR 20334) (FRL–9340–4), EPA
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Agencies
[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Rules and Regulations]
[Pages 30402-30407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12410]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0674; FRL-9349-3]
Acibenzolar- S -methyl; Time-Limited Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of acibenzolar-S-methyl in or on grapefruit, apples and pears.
Syngenta Crop Protection LLC. requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 23, 2012. Objections and
requests for hearings must be received on or before July 23, 2012, 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-2011-0674, is available either
electronically through https://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA
[[Page 30403]]
West, 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: Rose Kearns, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-5611; email address: kearns.rosemary@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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I 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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0674 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
July 23, 2012. 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 part178, please submit a copy of
the filing that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0674, 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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 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.htm.
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 September 7, 2011 (76 FR 55331) (FRL-
8886-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition 1G7889
by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-
8300. The petition requested that 40 CFR 180.561 be amended by
establishing temporary tolerances for residues of the fungicide,
acibenzolar-S-methyl, in or on apples, grapefruit and pears 0.05 parts
per million (ppm) in conjunction with approval of an experimental use
permit. That notice referenced a summary of the petition prepared by
Syngenta Crop Protection, LLC, the registrant, 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for acibenzolar-S-methyl
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
acibenzolar-S-methyl 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.
General information on the toxicity of acibenzolar-S-methyl can be
found in a recent tolerance rulemaking for this pesticide in the
Federal Register of April 11, 2012 (77 FR 21670) (FRL-
[[Page 30404]]
9343-3). Specific information on the studies received and the nature of
the adverse effects caused by acibenzolar-S-methyl 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 ``Acibenzolar-S-methyl Human Health
Risk Assessment,'' on page 15 in docket ID number EPA-HQ-OPP-2011-0674.
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 Acibenzolar-S-Methyl
used for human risk assessment is shown in the recent tolerance
rulemaking document for acibenzolar-S-methyl in the Federal Register of
April 11, 2012 (77 FR 21670).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acibenzolar-S-methyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing acibenzolar-S-methyl
tolerances in 40 CFR 180.561. EPA assessed dietary exposures from
acibenzolar-S-methyl 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.
Such effects were identified for acibenzolar-S-methyl. In
estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed a distribution of
residues based on field trial data and tolerance level residues for
apple, grapefruit and pear. Empirical and Dietary Exposure Evaluation
Model (DEEM) default processing factors were used to modify the field
trial data. Maximum screening-level percent crop treated (PCT)
estimates were used for commodities for which data were available. If
no PCT data were available, 100 PCT was assumed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used a conservative
chronic dietary exposure analysis for the general U.S. population and
various population subgroups. Tolerance level residues and 100 crop
treated assumptions were used. DEEM default and empirical processing
factors were used to modify the tolerance values.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that acibenzolar-S-methyl 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. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if certain conditions are met. PCT data was not used for
conducting the chronic dietary risk assessment.
2. Dietary exposure from drinking water. The residues of concern
for drinking water are acibenzolar-S-methyl benzo(1,2,3) thiadiazole-7-
carbothioic acid (-S-methyl ester, convertible to
benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-210007) in drinking
water. These simulation model take into account data on the physical,
chemical, and fate/transport characteristics of acibenzolar-S-methyl.
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
acibenzolar-S-methyl for acute exposures are estimated to be 45 parts
per billion (ppb) for surface water and 0.08 ppb for ground water, for
chronic exposures for non-cancer assessments are estimated to be 19.1
ppb for surface water and 0.08 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 45 ppb was used to assess
the contribution to drinking water.
For chronic dietary risk assessment, the water concentration of
value 19.1 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Acibenzolar-S-methyl
is currently registered for the following uses that could result in
residential exposures: Turfgrass use on sodfarms, golf courses,
collegiate athletic fields, and lawns around commercial and industrial
buildings. Residential exposure was assessed for adult handlers and for
adult and child post-application activities. Exposure for adult and
child golfers were used to aggregate adult post-application dermal
exposure with dietary and drinking water exposure. The aggregate
exposure assessment for children combines dermal and
[[Page 30405]]
incidental oral post-application exposure with food and water exposure.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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.''
EPA has not found acibenzolar-S-methyl to share a common mechanism
of toxicity with any other substances, and acibenzolar-S-methyl does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that acibenzolar-S-methyl 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. The toxicology database for
acibenzolar-S-methyl is complete and adequate for assessing increased
susceptibility under FQPA. The pre- and postnatal toxicity database for
acibenzolar-S-methyl includes developmental toxicity studies in rats
and rabbits, a DNT study in rats, and a 2-generation reproduction
toxicity study in rats. Based on the developmental toxicity in rats and
the developmental neurotoxicity studies in rats, there is concern for
increased qualitative and/or quantitative susceptibility following in
utero exposure to acibenzolar-S-methyl. However, the degree of concern
for the increased susceptibility seen in these studies is low as there
are no residual uncertainties with regard to pre- and/or postnatal
toxicity since NOAELs and LOAELs have been identified for all effects
of concern, a clear dose response has been well defined, and the PODs
selected for risk assessment are protective of the fetal/offspring
effects. Additionally, the dietary and residential risk assessments are
conservative and will not underestimate dietary exposure and there are
no residual uncertainties in the exposure database.
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 acibenzolar-S-methyl is complete.
ii. There are no residual uncertainties identified in the exposure
databases. The dietary risk assessment is conservative and will not
underestimate dietary and/or non-dietary residential exposure to
acibenzolar-S-methyl. The acute analysis assumed a distribution of
residues based on field trial data, tolerance level residues for the
Experimental Use Permit (EUP) uses and maximum PCT estimates were used
for commodities for which data were available. The chronic dietary food
exposure assessment was performed based on 100 PCT and tolerance-level
residues. EPA made conservative (protective) assumptions in the ground
water and surface water modeling used to assess exposure to
acibenzolar-S-methyl in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by acibenzolar-S-methyl.
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 the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
acibenzolar-S-methyl will occupy 37% of the aPAD for children 3-5 years
old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
acibenzolar-S-methyl from food and water will utilize 12% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for acibenzolar-S-methyl. Based
on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of acibenzolar-S-
methyl is not expected.
3. Short-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).
Acibenzolar-S-methyl is currently registered for uses that could
result in short-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to acibenzolar-S-
methyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 700 for females
13-49 years from handler activities, and, 1,600 for females 13-49 years
old, and 800-1,000 for children 1-2 and 6-12 years old, respectively,
from post-application exposure. Because EPA's level of concern for
acibenzolar-S-methyl is a MOE of 100 or below, these short-term-
aggregate MOEs are not of concern.
4. Intermediate-term risk. 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).
An intermediate-term adverse effect was identified; however,
acibenzolar-S-methyl is not registered for any use pattern that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure.
[[Page 30406]]
Because there is no intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which at least one protective as the POD used to
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for acibenzolar-S-
methyl.
Because no intermediate-term adverse effect was identified,
acibenzolar-S-methyl is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, acibenzolar-S-methyl is not expected to pose a cancer risk to
humans.
6. 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 acibenzolar-S-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology high performance liquid
chromatography using ultra-violet detection ((HPLC/UV) Method AG-617A)
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 U.N. 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.
There are no established Codex, Mexican, or Canadian maximum
residue limits for acibenzolar-S-methyl in/on any commodity. Therefore,
international harmonization is not an issue for acibenzolar-S-methyl.
V. Conclusion
Therefore, time-limited tolerances are established for residues of
acibenzolar-S-methyl, in or on apple, grapefruit and pear at 0.05 ppm.
A time limitation been imposed because these tolerances are being
established in conjunction with approval of an EUP to use acibenzolar-
S-methyl on apple, pear and grapefruit. The EUP approval period and
time-limited tolerances will expire 12/31/2015 which provides ample
time for all treated crops to be harvested, stored, and out of channels
of trade.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 14, 2012.
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. Section 180.561 is amended as follows:
[[Page 30407]]
0
a. Redesignate paragraph (a) as (a)(1); and
0
b. Add paragraph (a)(2).
The amendments read as follows:
Sec. 180.561 Acibenzolar- S -methyl; tolerances for residues.
(a) General.
(1) * * *
(2) Tolerances are established for residues of acibenzolar- S -
methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid- S -methyl ester,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only those acibenzolar- S -methyl
residues convertible to benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-
210007), expressed as the Stoichiometric equivalent of acibenzolar- S -
methyl, in or on the following raw agricultural commodities.
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Apple......................................... 0.05 12/31/2015
Grapefruit.................................... 0.05 12/31/2015
Pear.......................................... 0.05 12/31/2015
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-12410 Filed 5-22-12; 8:45 am]
BILLING CODE 6560-50-P