FR Doc E9-12142

[Federal Register: May 26, 2009 (Volume 74, Number 99)]
[Rules and Regulations]
[Page 24705-24711]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my09-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0270; FRL-8413-7]

Acibenzolar-S-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
acibenzolar-S-methyl in or on onion, bulb, subgroup 3-07A; and
vegetable, cucurbit, group 9. It also removes the section 18 time-
limited tolerance on onion, bulb which is superseded by the new
tolerance on onion, bulb, subgroup 3-07A. Interregional Research
Project Number 4 (IR-4) and Syngenta Crop Protection requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 26, 2009. Objections and
requests for hearings must be received on or before July 27, 2009, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0270. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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 Access Electronic Copies of this Document?

In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0270 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before July 27, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0270, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

In the Federal Register of May 16, 2008 (73FR 28461) (FRL-8361-6),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 8E7337)
by Interregional Research Project Number 4 (IR-4), 500 College Road
East, Suite 201W, Princeton, NJ 08540. The petition requested that 40
CFR 180.561 be amended by establishing a tolerance for residues of the
fungicide acibenzolar-S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic
acid-S-methyl ester, in or on onion, bulb, subgroup 3-07A at 0.07 parts
per million (ppm). That notice referenced a summary of the petition
prepared on behalf of IR-4 by Syngenta Crop Protection, the registrant,
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.

[[Page 24706]]

In the Federal Register of December 3, 2008 (73 FR 73644) (FRL-
8386-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7352) by Syngenta Crop Protection, Regulatory Affairs, P.O. Box
18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR
180.561 be amended by establishing a tolerance for residues of the
fungicide acibenzolar-S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic
acid-S-methyl ester, in or on vegetable, cucurbit, group 9 at 1.0 ppm.
That notice referenced a summary of the petition prepared by Syngenta
Crop Protection, the registrant, which is available to the public in
docket ID number EPA-HQ-OPP-2008-0733 at http://www.regulations.gov.
There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petitions, EPA has
revised the tolerance expression and increased the tolerance level for
onion, bulb, subgroup 3-07A from 0.07 ppm to 0.1 ppm; and for
vegetable, cucurbit, group 9 from 1.0 ppm to 2.0 ppm. The reasons for
these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of acibenzolar-S-methyl on onion, bulb,
subgroup 3-07A at 0.1 ppm; and vegetable, cucurbit, group 9 at 2.0 ppm.
EPA's assessment of exposures and risks associated with establishing
tolerances 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.
Acibenzolar-S-methyl showed no significant toxicity in a battery of
acute toxicity tests but showed considerable skin-sensitivity. In
subchronic and chronic oral studies in rats, dogs and mice, signs of
mild regenerative hemolytic anemia were consistently observed in all
three species. Additional toxic effects observed in these studies
included decreases in body weight, body weight gain and/or food
consumption. No other significant treatment-related effects of
toxicological concern were observed in these subchronic and chronic
oral studies. No neurotoxic effects were seen at the highest dose
tested in a subchronic neurotoxicity study in rats. In a 28-day dermal
toxicity study in rats no systemic or dermal effects were seen at the
limit dose.
In developmental toxicity and developmental neurotoxicity (DNT)
studies in rats, treatment-related effects (visceral malformations and
skeletal variations; changes in brain morphometrics in the cerebellum)
were observed in fetuses at levels that were not toxic to the parent,
indicating increased sensitivity of rat fetuses compared to adults.
Increased sensitivity was not observed in a developmental toxicity
study in rabbits, or in 1-generation and 2-generation reproduction
studies in rats. In a 28-day dermal developmental toxicity study in
rats, no maternal or developmental toxicity was observed at dose levels
up to 500 mg/kg/day, the highest dose level tested.
Acibenzolar-S-methyl was classified by EPA as a ``not likely''
human carcinogen based on the lack of evidence of carcinogenicity in
male and female rats and mice and lack of evidence of genotoxicity in
an acceptable battery of mutagenicity studies.
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 http://
www.regulations.gov in the document Revised Acibenzolar-S-methyl Human
Health Risk Assessment for Proposed Use of Acibenzolar-S-methyl on
Cucurbits and Bulb Onions page 34 in docket ID number EPA-HQ-OPP-2008-
0270.

B. Toxicological Endpoints

For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for acibenzolar-S-methyl
used for human risk assessment can be found at http://
www.regulations.gov in the document Revised Acibenzolar-S-

[[Page 24707]]

methyl Human Health Risk Assessment for Proposed Use of Acibenzolar-S-
methyl on Cucurbits and Bulb Onions page 21 in docket ID number EPA-HQ-
OPP-2008-0270.

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. EPA identified such an
effect (changes in brain morphometrics in the cerebellum of offspring)
in the developmental neurotoxicity study in rats. This acute endpoint
is relevant to the population subgroup, females 13 to 49 years old. No
acute endpoint of concern was identified for the general population or
other population subgroups.
In estimating acute dietary exposure of females 13 to 49 years old,
EPA used food consumption information from the United States Department
of Agriculture (USDA) 1994-1996 Nationwide Continuing Surveys of Food
Intakes by Individuals (CSFII). EPA conducted a partially refined,
probabilistic acute dietary exposure assessment using the distribution
of residues from field trial data for each food commodity. The
probabilistic assessment incorporated empirical processing factors for
some processed commodities (tomato paste, puree and juice) and DEEM\TM\
default processing factors for the remaining processed commodities.
Exposure estimates were further refined using maximum percent crop
treated (PCT) information for most existing uses of acibenzolar-S-
methyl. EPA assumed 100 PCT for the new uses on onions and cucurbits.
The acibenzolar residues of concern for risk assessment include
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), expressed as acibenzolar-S-methyl; and its 4-hydroxy CGA-
210007 (CGA-323060) and 5-hydroxy CGA-210007 (CGA-324041) metabolites.
A factor of 1.5x, based on the relative abundance of the hydroxy
metabolites (CGA-323060 and CGA-324041) and residues convertible to the
carboxylic acid metabolite (CGA-210007) found in the lettuce metabolism
study, was applied to estimates of acibenzolar-S-methyl residues to
account for all of the residues of concern for dietary risk (including
CGA-210007, CGA-323060 and CGA-324041).
ii. Chronic exposure. EPA identified different chronic effects of
concern for the general population (hemolytic anemia with compensatory
response observed in the chronic dog study) and for females 13 to 49
years old (changes in brain morphometrics in the cerebellum of
offspring in the DNT study). The cPAD for the general population has
been established at 0.25 mg/kg/day; whereas, the cPAD for females 13 to
49 years old is lower (0.082 mg/kg/day), due to the more sensitive
endpoint on which it is based. 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 assumed
tolerance-level residues (adjusted by a factor of 1.5x to account for
all metabolites of concern), DEEM\TM\ default processing factors and
100 PCT for all commodities.
iii. Cancer. Based on the lack of evidence of carcinogenicity in
male and female rats and mice and lack of evidence of genotoxicity in
an acceptable battery of mutagenicity studies, EPA classified
acibenzolar-S-methyl as a ``not likely'' human carcinogen. Therefore,
an exposure assessment for evaluating cancer risk is not needed for
this chemical.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows:
Broccoli 5%, cabbage 2.5%, cauliflower 5%, celery 1%, lettuce (head
and leaf) 12%, pepper (bell and non-bell) 5%, spinach 30%, and tomato
5%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk

[[Page 24708]]

assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available reliable information on the
regional consumption of food to which acibenzolar-S-methyl may be
applied in a particular area.
2. Dietary exposure from drinking water. The residues of concern
for drinking water include acibenzolar-S-methyl and residues
convertible to CGA-210007. The Agency used screening level water
exposure models in the dietary exposure analysis and risk assessment
for acibenzolar-S-methyl and CGA-210007 in drinking water. These
simulation models 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 http://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
acibenzolar-S-methyl and CGA-210007 for acute exposures are estimated
to be 0.74 and 14.21 parts per billion (ppb), respectively, for surface
water and 0.000041 and 0.557 ppb, respectively, for ground water. EDWCs
of acibenzolar-S-methyl and CGA-210007 for chronic exposures for non-
cancer assessments are estimated to be 0.10 and 9.48 ppb, respectively,
for surface water and 0.000041 and 0.557 ppb, respectively, for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. CGA-210007 drinking water
residues were included in the dietary exposure assessment as
acibenzolar-S-methyl equivalents. CGA 210007 residues were converted to
acibenzolar-S-methyl equivalents based on molecular weight (mol. wt. of
acibenzolar (210) / mol. wt. of CGA 210007 (180) x EDWC for CGA
210007). For acute dietary risk assessment, the water concentration
value of 17 ppb was used to assess the contribution to drinking water.
For chronic dietary risk assessment, the water concentration of value
11 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 not registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 website at
http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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.
In previous risk assessments for acibenzolar-S-methyl the 10X FQPA
safety factor was retained for increased quantitative susceptibility
(umbilical hernia) observed in a rat developmental toxicity study and
the lack of a developmental-neurotoxicity (DNT) study. A DNT study has
now been submitted and reviewed by EPA; and, based on reevaluation of
existing data and review of newly submitted data, the umbilical hernias
are no longer considered to be treatment-related. EPA concluded that
the incidence of umbilical hernias at 10 milligram/kilogram/day (mg/kg/
day) was not a treatment-related adverse effect because the effect is
not dose-related (i.e., it was seen only at the low dose of 10 mg/kg/
day); the effect was not seen in dosed animals in other studies,
including developmental toxicity studies and reproduction studies;
umbilical hernia was observed in the control animals in the rat dermal
developmental toxicity study (1/336 fetuses in 1 of 24 litters); and
the effect is known to occur spontaneously in the rat strain used in
this study. New studies, including a DNT study in rats, a developmental
toxicity study in rats and two non-standard investigative, phase-
specific studies, support the finding that incidence of umbilical
hernias is not treatment-related. Based on these findings, EPA has
reconsidered the FQPA safety factor for acibenzolar-S-methyl.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for acibenzolar-S-methyl includes acceptable
developmental toxicity studies in rats (two oral and one dermal) and
rabbits (one oral); a DNT study in the rat; and 1-generation and 2-
generation reproduction toxicity studies in the rat.
There was no evidence of increased susceptibility of fetuses or
offspring in the rat dermal developmental toxicity study, the rabbit
developmental toxicity study or the rat reproduction toxicity studies.
No maternal or fetal effects were observed in the dermal developmental
study at any dose tested. In the rabbit developmental study, maternal
effects (mortality, clinical signs, decreased maternal body weight and
food consumption) were seen at a lower dose than fetal effects
(marginal increase in vertebral anomalies). In the rat reproduction
studies, parental effects (increased weights and hemosiderosis of the
spleen; decreased body weight gain and food consumption in females) and
offspring effects (reduced pup body weight gains and lower pup body
weights during lactation) were seen at the same dose.
In the developmental toxicity and DNT studies in rats, treatment-
related effects (visceral malformations and skeletal variations; and
changes in brain morphometrics in the cerebellum) were observed in
offspring at levels that were not toxic to the parent, indicating
potential increased quantitative susceptibility of offspring compared
to adults. The developmental no-observed

[[Page 24709]]

adversed-effect level (NOAEL) from the DNT study (8.2 mg/kg/day) is the
lowest NOAEL from any study in the acibenzolar database and is the POD
used in both the acute and chronic dietary exposure assessments for
females, 13 to 49 years old, the relevant population subgroup for
assessing potential developmental effects. Since there is a well-
defined NOAEL for these effects and the NOAEL is being used as the POD
in the risk assessment, there are no residual uncertainties with regard
to pre- or postnatal sensitivity.
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,
except for immunotoxicity studies, and EPA has determined that an
additional uncertainty factor is not required to account for potential
immunotoxicity. The reasons for this determination are explained below:
EPA began requiring functional immunotoxicity testing of all food
and non-food use pesticides on December 26, 2007. Since this
requirement is relatively new, these studies are not yet available for
acibenzolar-S-methyl. In the absence of specific immunotoxicity
studies, EPA has evaluated the available acibenzolar-S-methyl toxicity
data to determine whether an additional database uncertainty factor is
needed to account for potential immunotoxicity. There are no
indications in the available studies that organs associated with immune
function, such as the thymus and spleen, are affected by acibenzolar-S-
methyl. While effects on the spleen were observed in association with
hematologic effects, these were considered to be secondary to the
primary effects on blood hematology. Effects on the thymus were seen in
only one study in one animal at a high dose (400 mg/kg/day) and were,
therefore, considered to be spurious. Due to the lack of evidence of
immunotoxicity for acibenzolar-S-methyl, EPA does not believe that
conducting immunotoxicity testing will result in a NOAEL less than the
chronic NOAELs of 8.2 mg/kg/day (females, 13 to 49 years old) or 25 mg/
kg/day (all other populations) already established for acibenzolar-S-
methyl, and an additional factor (UFDB) for database uncertainties is
not needed to account for potential immunotoxicity.
ii. There was no evidence of neurotoxicity in the subchronic
neurotoxicity study submitted for acibenzolar-S-methyl. Based on the
results of this study, EPA has determined that an acute neurotoxicity
study is not required. There was evidence of offspring neurotoxicity
(changes in brain morphometrics in the cerebellum) in the rat DNT study
in the absence of maternal toxicity; however, since the NOAEL for these
effects is being used in the acute and chronic risk assessments for
females, 13 to 49 years old, there are no residual uncertainties with
regard to these effects and no need for additional UFs to account for
neurotoxicity.
iii. Although there was evidence of increased quantitative
susceptibility of offspring to acibenzolar-S-methyl in the rat
developmental toxicity and DNT studies, the Agency did not identify any
residual uncertainties after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
tolerance levels or anticipated residues derived from reliable field
trials and screening-level PCT estimates. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to acibenzolar-S-methyl in drinking water.
Residential exposure to acibenzolar-S-methyl is not expected. 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 pesticide exposures are
safe by comparing aggregate exposure estimates to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD represent the highest safe exposures, taking into account
all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the
POD by all applicable UFs. For linear cancer risks, EPA calculates the
probability of additional cancer cases given the estimated aggregate
exposure. Short-term, intermediate-term, and chronic-term risks are
evaluated by comparing the estimated aggregate food, water, and
residential exposure to the POD to ensure that the MOE called for by
the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
acibenzolar-S-methyl will occupy 12% of the aPAD for females, 13 to 49
years old, the only population group for which an acute endpoint of
toxicological concern was identified.
2. Chronic risk. EPA performed two different chronic risk
assessments - one focusing on females 13 to 49 years old and designed
to protect against neurotoxic effects in offspring and the other
focusing on chronic effects (hemolytic anemia) relevant to all other
population groups. The more sensitive chronic endpoint was seen as to
offspring effects rather than other chronic effects. Using the exposure
assumptions described in this unit for chronic exposure, EPA has
concluded that for females, 13 to 49 years old, chronic exposure to
acibenzolar-S-methyl from food and water will utilize 5% of the cPAD
addressing offspring effects. As to other chronic effects, chronic
exposure to acibenzolar-S-methyl from food and water will utilize 4% of
the cPAD for children, 1 to 2 years old, the population group receiving
the greatest exposure. There are no residential uses for acibenzolar-S-
methyl.
3. Short-term intermediate-term risk. Short-term and intermediate-
term aggregate exposures take into account short-term and intermediate-
term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Acibenzolar-S-methyl is
not registered for any use patterns that would result in residential
exposure. Therefore, the short-term and intermediate-term aggregate
risk is the sum of the risk from exposure to acibenzolar-S-methyl
through food and water and will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S. population. Acibenzolar is
classified as a ``not likely'' human carcinogen and is, therefore, 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 acibenzolar-S-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (High Performance Liquid
Chromatography with Ultraviolet Detection (HPLC/UV) Method AG-671A) 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

[[Page 24710]]

number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

No Codex, Mexican or Canadian maximum residue limits have been
established for acibenzolar-S-methyl on any commodity.

C. Revisions to Petitioned-For Tolerances

The petitioners proposed tolerances for residues of ``acibenzolar-
S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester.''
Since the analytical method for acibenzolar is a common-moiety method
that converts all residues containing the benzo(1,2,3)thiadiazole-7-
carboxylic acid (CGA-210007) moiety to CGA-210007, EPA has revised the
tolerance expression to read ``acibenzolar-S-methyl,
benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester, including
its metabolites and degradates.
EPA has also increased the tolerance level for onion, bulb,
subgroup 3-07A from 0.07 ppm to 0.1 ppm; and for vegetable, cucurbit,
group 9 from 1.0 ppm to 2.0 ppm. The residue data submitted for onions
and previously submitted data for tobacco suggest that drying may tend
to concentrate residues of acibenzolar-S-methyl. To ensure that the
tolerance level is adequate, EPA has increased the tolerance for onion,
bulb, subgroup 3-07A from 0.07 to 0.1 ppm. EPA increased the tolerance
for cucurbits from 1.0 to 2.0 ppm based on the indication of
variability within and between the cucurbit vegetable data sets
(cantaloupe, cucumber and summer squash), as well as the demonstrated
potential for significant increases in acibenzolar-S-methyl residues 0
to 7 days before harvest.

V. Conclusion

Therefore, 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 onion, bulb,
subgroup 3-07A at 0.1 ppm; and vegetable, cucurbit, group 9 at 2.0 ppm.
Compliance with the specified tolerance levels 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
commodity.

VI. Statutory and Executive Order Reviews

This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: May 15, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.561 is amended by revising paragraph (a) and paragraph
(b) in the table by removing the entry for onion, bulb to read as
follows:

Sec. 180.561 Acibenzolar-S-methyl; tolerances for residues.

(a) General. (1) Tolerances are established for residues of
acibenzolar-S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-
methyl ester, in or on the following raw agricultural commodities:

[[Page 24711]]

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Banana\1\............................................. 0.1
Spinach............................................... 1.0
Tomato, paste......................................... 3.0
Vegetable, brassica, leafy, group 5................... 1.0
Vegetable, fruiting, group 8.......................... 1.0
Vegetable, leafy, group 4............................. 0.25
----------------------------------------------------------------------------------------------------------------
1There are no United States registrations for banana.

(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 commodity.

* * * * *
[FR Doc. E9-12142 Filed 5-22-09; 8:45 am]

BILLING CODE 6560-50-S