[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Rules and Regulations]
[Pages 7854-7861]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2897]
[[Page 7854]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0214; FRL-7697-8]
Acibenzolar-S-methyl; Pesticide Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of acibenzolar-S-methyl in or on onion, dry bulb and onion,
green. This action is in response to EPA's granting of an emergency
exemption under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on onion, dry
bulb and onion, green. This regulation establishes a maximum
permissible level for residues of acibenzolar-S-methyl in these food
commodities. These tolerances will expire and are revoked on June 30,
2007.
DATES: This regulation is effective February 16, 2005. Objections and
requests for hearings must be received on or before April 18, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0214. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division
(7505C), Office of Pesticide Programs, EnvironmentalProtection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:703 308-9364; e-mail address:pemberton.libby@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:
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 provides
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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for residues of acibenzolar-S-
methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester, in
or on onion, dry bulb and onion, green at 0.05 parts per million (ppm).
These tolerances will expire and are revoked on June 30, 2007. EPA will
publish a document in the Federal Register to remove the revoked
tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the 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 the 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 the 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....''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Acibenzolar-S-methyl on Bulb Onions and
Green Onions and FFDCA Tolerances
Iris yellow spot virus is a new and expanding pest problem. Onion
thrips transmit the virus which cause leaf and flower stalk lesions, as
well as smaller sized bulbs. Production seed can also be infected.
Economic consequences can be significant due to yield losses. The virus
also reduces bulb size causing reduction in grade. EPA has authorized
under
[[Page 7855]]
FIFRA section 18 the use of acibenzolar-S-methyl on onion, dry bulb and
onion, green, for control of iris yellow spot virus in Colorado. After
having reviewed the submission, EPA concurs that emergency conditions
exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of acibenzolar-S-methyl in or
on onion, dry bulb and onion, green. In doing so, EPA considered the
safety standard in section 408(b)(2) of the FFDCA, and EPA decided that
the necessary tolerance under section 408(l)(6) of the FFDCA would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent, non-routine situation and to ensure that
the resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment as provided in
section 408(l)(6) of the FFDCA. Although these tolerances will expire
and are revoked on June 30, 2007, under section 408(l)(5) of the FFDCA,
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on onion, dry bulb and onion, green after
that date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by this tolerance at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether acibenzolar-S-
methyl meets EPA's registration requirements for use on onion, dry bulb
and onion, green or whether permanent tolerances for these uses would
be appropriate. Under these circumstances, EPA does not believe that
these tolerances serve as a basis for registration of acibenzolar-S-
methyl by a State for special local needs under FIFRA section 24(c).
Nor do these tolerances serve as the basis for any State other than
Colorado to use this pesticide on this crop under section 18 of FIFRA
without following all provisions of EPA's regulations implementing
FIFRA section 18 as identified in 40 CFR part 166. For additional
information regarding the emergency exemption for acibenzolar-S-methyl,
contact the Agency's Registration Division at the address provided
under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
Consistent with section 408(b)(2)(D) of the 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
acibenzolar-S-methyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of acibenzolar-S-methyl in or on onion, dry
bulb and onion, green at 0.05 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing these tolerances
follows.
A. Toxicological Endpoints
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. The toxicology database for
acibenzolar-S-methyl is incomplete. Subchronic neurotoxicity,
developmental neurotoxicity and an additional mutagenicity study (Ames
study) are required. EPA has considered available information
concerning the variability of the sensitivities of major identifiable
subgroups of consumers, including infants and children. The nature of
the toxic effects caused by acibenzolar-S- methyl are fully discussed
in a final rule published in the Federal Register on August 18, 2000
(65 FR 50438)(FRL-6737-6) that established tolerances for residues of
acibenzolar-S-methyl in or on bananas, Brassica (cole) leafy
vegetables, fruiting vegetables, leafy vegetables and spinach. Please
refer to that document for a complete discussion of the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies reviewed.
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect 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. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences. No NOAEL for developmental toxicity was
observed in the rat developmental study for acibenzolar-S-methyl.
Because no NOAEL was observed, an additional 3X uncertainty factor is
being applied to the 100X uncertainty factor to account for intra- and
inter-species variability, resulting in a 300X UF for toxicological
endpoints derived from this study.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point
[[Page 7856]]
of departure/exposures) is calculated. A summary of the toxicological
endpoints for acibenzolar-S-methyl used for human risk assessment is
shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for acibenzolar-S-methyl for Use in Human Risk Assessment
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FQPA SF* and Level of
Exposure/Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
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Acute Dietary (Females 13-50 years of NOAEL = 10 milligrams/ FQPA SF = 10........... Developmental toxicity
age) kilogram/day (mg/kg/ aPAD = acute RfD / FQPA .......................
day). SF = .0033 mg/kg/day. LOAEL = 10 mg/kg/day
UF = 300............... based on increased
Acute RfD = 0.033 mg/kg/ incidence of rare
day. malformations
(umbilical hernias).
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Acute Dietary (General population None................... None................... No toxicological
including infants and children) endpoint attributable
to a single exposure
was identified in the
available toxicology
studies on acibenzolar-
S-methyl that would be
applicable to the
general population
(including infants and
children).
--------------------------------------
Chronic Dietary (Females 13-50 years NOAEL= 10 mg/kg/day.... FQPA SF = 10........... Developmental toxicity
of age) UF = 300............... cPAD = chronic RfD / .......................
Chronic RfD = .033 mg/ FQPA SF = .0033 mg/kg/ LOAEL = 10 mg/kg/day
kg/day. day. based on increased
incidence of rare
malformations
(umbilical hernias).
--------------------------------------
Chronic Dietary (All other NOAEL= 10.8 mg/kg/day.. FQPA SF = 3............ Carcinogenicity study -
populations, including infants and UF = 100............... cPAD = chronic RfD / mice; LOAEL (Females)
children) Chronic RfD = 0.11 mg/ FQPA SF = 0.0367 mg/kg/ = 234 mg/kg/day based
kg/day. day. on mild hemolytic
anemia and
hemosiderosis of the
liver, spleen, and
bone marrow, and
extramedullary
hematopoiesis of the
spleen.
--------------------------------------
Cancer (oral, dermal, inhalation) None................... None................... Acibenzolar-S-methyl
has been classified as
a ``not likely'' human
carcinogen. This
classification is
based on the lack of
evidence of
carcinogenicity in
male and female rats
as well as in male and
female mice and on the
lack of unequivocal
genotoxicity in an
acceptable battery of
mutagenicity studies
performed on the
current technical
grade product.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.561) for the residues of acibenzolar-S-methyl,
in or on a variety of raw agricultural commodities including bananas,
Brassica (cole) leafy vegetables, fruiting vegetables, leafy
vegetables, spinach and tomato paste. Risk assessments were conducted
by EPA to assess dietary exposures from acibenzolar-S-methyl in food as
follows:
i. Acute exposure. Acute dietary 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 one day
or single exposure. Probabilistic (i.e., Monte Carlo) acute dietary
risk assessments were conducted for acibenzolar-S-methyl using the
Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03), which uses
food consumption data from the USDA's Continuing Surveys of Food
Intakes by Individuals (CSFII) from 1994-1996 and 1998 and accumulated
exposure to the chemical for each commodity. The following assumptions
were made for the acute exposure assessments: For onions, the
recommended tolerance level of 0.05 ppm was used and the assumption of
100% crop treated was made. DEEM default processing factors were used
for dried onion, dried banana, dried plantain, and dried tomato.
Empirical processing factors were used for tomato paste (7.1), tomato
puree (2.9), and tomato juice (1.0). Blended commodities were treated
differently than nonblended and partially blended commodities. Foods
were classified as blended, partially blended, or nonblended. For
blended commodities, the mean field trial values were used as a point
estimate for expected residues. A value of
1/89/21/13/23/85/83/8 the limit of quantitation( LOQ) was used
for samples that contained less than LOQ residues. Maximum percent crop
treated (PCT) estimates were used as residue adjustment factors. The
blended commodities included dried bananas, dried plantains, dried bell
peppers, dried nonbell peppers, dried tomatoes, tomato paste, and
tomato puree. For nonblended and partially blended commodities, the
distributions of the field trial data were used. Again, a value
[[Page 7857]]
of 1/89/21/13/23/85/83/8 LOQ was used for samples that
contained less than LOQ residues. Maximum PCT estimates were used for
brocolli, cabbage, cauliflower, celery, head lettuce, leaf lettuce,
spinach, peppers, and tomatoes.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the DEEM-FCID, Version 2.03, which uses food consumption
data from the USDA's CSFII from 1994-1996 and 1998 and accumulated
exposure to the chemical for each commodity. The following assumptions
were made for the chronic exposure assessments: tolerance level
residues for all crops and 100% crop treated were used.
iii. Cancer. Acibenzolar-S-methyl has been classified as not likely
to be carcinogenic to humans. Therefore, a quantitative exposure
assessment was not conducted to assess cancer risk.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the 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 chemicals that have been measured in food.
If EPA relies on such information, EPA must pursuant to section
408(f)(1) require 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. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. For the present action, EPA will issue such
data call-ins for information relating to anticipated residues as are
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA
section 408(f)(1). Such data call-ins will be required to be submitted
no later than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that 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 such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if 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 section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.
In assessing chronic risk, EPA did not use PCT data. In assessing
acute risk, The Agency used PCT information as follows: for onions the
assumption of 100% crop treated was made. The following maximum PCT
estimates were used: 1% of broccoli, 1% of cabbage, 1% of cauliflower,
1% celery, 12% head lettuce, 12% leaf lettuce, 1% peppers, 15% spinach
and 1% tomatoes. For all other commodities it was assumed 100% of the
crop was treated.
EPA believes that the PCT information described above for
acibenzolar-S-methyl on leafy vegetables, fruiting vegetables and
brassica (cole) leafy vegetables is reliable and has a valid basis. The
PCT information is based on reliable estimates of the potential market
for acibenzolar-S-methyl and the petitioner's estimate of the market
share it expects to capture. EPA believes the estimates do not
underestimate the percent of these crops that may be treated.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for acibenzolar-S-methyl in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of acibenzolar-S-methyl.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW (screening concentration in ground water), which predicts
pesticide concentrations in groundwater. In general, EPA will use
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a
screening-level assessment for surface water. The GENEEC model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to acibenzolar-S-methyl they
are further discussed in the aggregate risk sections below.
Based on the PRZM/EXAMS and SCI-GROW models the EECs of
acibenzolar-S-methyl for acute exposures are estimated to be 7.9 parts
per billion (ppb) for surface water and 0.02 ppb for ground water. The
EECs for chronic exposures are estimated to be 0.49 ppb for surface
water and 0.02 ppb for ground 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 use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to acibenzolar-S-methyl and
any other substances and acibenzolar-S-methyl does not appear to
produce a toxic
[[Page 7858]]
metabolite produced by other substances. EPA has also evaluated
comments submitted that suggested there might be a common mechanism
among acibenzolar-S-methyl and other named pesticides that cause brain
effects. EPA concluded that the evidence did not support a finding of
common mechanism for acibenzolar-S-methyl and the named pesticides. For
the purposes of this tolerance action, therefore, EPA has not assumed
that acibenzolar-S-methyl has 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 the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative/.
C. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold 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 that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA's
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using UFs (safety) in calculating a dose
level that poses no appreciable risk to humans.
2. Developmental toxicity studies. In a prenatal developmental
study in rats the maternal NOAEL is 200 mg/kg/day and the LOAEL is 400
mg/kg/day based on hemorrhagic perineal discharge. A developmental
NOAEL was not identified. The LOAEL is 10 mg/kg/day (lowest dose
tested) based on umbilical hernia.
In a prenatal developmental study in rabbits the maternal NOAEL is
50 mg/kg/day and the LOAEL is 300 mg/kg/day based on mortality,
clinical signs of toxicity, decreased maternal body weight and food
consumption. The developmental NOAEL is 300 mg/kg/day and the LOAEL is
600 mg/kg/day based on a marginal increase in vertebral anomalies.
3. Reproductive toxicity study. In a reproduction and fertility
study, the parental/systemic NOAEL is 11 to 31 mg/kg/day and the LOAEL
is 105 to 288 mg/kg/day based on increased weights and hemosiderosis of
the spleen. The reproductive NOAEL is 223 to 604 mg/kg/day and the
LOAEL is greater than 223 to 604 mg/kg/day based on no effects. The
offspring NOAEL is 11 to 31 mg/kg/day and the LOAEL is 105 to 288 mg/
kg/day based on reduced pup body weight gains and lower pup body
weights during lactation.
4. Prenatal and postnatal sensitivity. The Agency concluded that
there is concern for the increased susceptibility of infants and
children to exposure to acibenzolar-S-methyl based on the developmental
toxicity study in rats where treatment-related developmental
malformations, anomalies and variations were observed at doses equal to
or below the NOAEL for maternal toxicity.
5. Conclusion. The toxicology database for acibenzolar-S-methyl is
incomplete. Subchronic neurotoxicity, developmental neurotoxicity and
an additional mutagenicity study (Ames study) are required. When
assessing acute and chronic dietary exposures, the Agency concluded
that the FQPA safety factor should be retained at 10X for the female,
13 to 50 years old, population subgroup (the only population subgroup
of concern for acute exposures). The Agency recognizes that the fetal
effects occurring in the rat developmental study are of significant
toxicological concern and that a developmental neurotoxicity study has
been required to further define the neurotoxic potential observed in
this study. However, the Agency concluded that a safety factor of 10X
is adequate in this case since:
i. The Agency has accounted for the concern that these fetal
effects occurred at the lowest dose tested (no developmental NOAEL
established) by the requirement of an additional uncertainty factor of
3X when this endpoint is used for risk assessment.
ii. These fetal effects were only observed in one species (in the
rat but not in the rabbit).
iii. These fetal effects were not observed in the 2-generation
reproduction study.
iv. The exposure databases are well characterized and the exposure
assessments will not likely underestimate the exposure resulting from
the use of acibenzolar-S-methyl.
Therefore, the Agency concluded that the FQPA Safety Factor be retained
at 10X for females, 13 to 50 years old based on:
a. A quantitative increase in susceptibility of fetuses (compared
to dams) in the rat developmental toxicity study (developmental
malformations occurred at a dose level which was considerably below the
NOAEL for maternal toxicity).
b. A concern that the treatment-related developmental malformations
(umbilical hernia) observed in rat fetuses occurred at the lowest dose
tested (NOAEL was not established) in the rat developmental toxicity
study.
c. The requirement for a developmental neurotoxicity study in rats
based on the occurrence of treatment-related effects in nervous system
tissues in the rat developmental study.
The data provided no indication of increased susceptibility of
rabbit fetuses following in utero exposure or of rat fetuses/pups
following pre-/postnatal exposures. In these studies, developmental/
offspring effects were observed only at or above treatment levels which
produced maternal/parental toxicity. When assessing chronic dietary
exposure, the Agency concluded that the safety factor can be reduced to
3X for the general population, including infants and children (with the
exception of the aforementioned female 13 to 50 population subgroup)
since the concern for increased susceptibility seen after in utero
exposure in the developmental study has no bearing on chronic exposure
scenarios for persons other than Females 13 to 50. However, since there
still remains a data gap for a developmental neurotoxicity study in
rats the safety factor was only reduced to 3X.
D. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational exposure).
This allowable exposure through drinking water is used to calculate a
DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water
[[Page 7859]]
are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg
(adult female), and 1L/10 kg (child). Default body weights and drinking
water consumption values vary on an individual basis. This variation
will be taken into account in more refined screening-level and
quantitative drinking water exposure assessments. Different populations
will have different DWLOCs. Generally, a DWLOC is calculated for each
type of risk assessment used: Acute, short-term, intermediate-term,
chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes
with reasonable certainty that exposures to acibenzolar-S-methyl in
drinking water (when considered along with other sources of exposure
for which OPP has reliable data) would not result in unacceptable
levels of aggregate human health risk at this time. Because OPP
considers the aggregate risk resulting from multiple exposure pathways
associated with a pesticide's uses, levels of comparison in drinking
water may vary as those uses change. If new uses are added in the
future, OPP will reassess the potential impacts of acibenzolar-S-methyl
on drinking water as a part of the aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure (at the 99.9th
percentile of exposure), from food to acibenzolar-S-methyl will occupy
61% of the aPAD for females 13 to 49 years, the only population
subgroup of concern for acute dietary exposure (i.e., no significant
acute effects relevant to other subgroups were identified in acute
toxicity studies for acibenzolar-S-methyl). In addition, despite the
potential for acute dietary exposure to acibenzolar-S-methyl in
drinking water, after calculating DWLOCs and comparing them to
conservative model EECs of acibenzolar-S-methyl in surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the aPAD, as shown in Table 2 of this unit:
Table 2.--Aggregate Risk Assessment for Acute Exposure to acibenzolar-S-methyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup/ aPAD (mg/ % aPAD/ Water EEC/ Water EEC/ Acute DWLOC/
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-49 years 0.0033 61 7.9 0.02 39
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
acibenzolar-S-methyl from food will utilize 6% of the cPAD for the U.S.
population, 3% of the cPAD for all infants less than 1 year old, 12% of
the cPAD for children 1 to 2 years old, the children's subpopulation at
greatest exposure and 49% of the cPAD for females 13 to 50 years, the
subpopulation at greatest risk. There are no residential uses for
acibenzolar-S-methyl that result in chronic residential exposure to
acibenzolar-S-methyl. In addition, despite the potential for chronic
dietary exposure to acibenzolar-S-methyl in drinking water, after
calculating DWLOCs and comparing them to conservative model EECs of
acibenzolar-S-methyl in surface water and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to acibenzolar-S-methyl
----------------------------------------------------------------------------------------------------------------
Surface Water Ground/Water Chronic/DWLOC
Population/Subgroup cPAD/mg/kg/day %/cPAD/(Food) EEC/(ppb) EEC/(ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.0367 6 0.49 0.02 1,200
---------------------------------
Infants (<1 year old) 0.0367 3 0.49 0.02 360
---------------------------------
Children (1 to 2 years old) 0.0367 12 0.49 0.02 320
---------------------------------
Females (13 to 49 years old 0.0033 49 0.49 0.02 50
----------------------------------------------------------------------------------------------------------------
3. Short-term and Intermediate-term risks. Short-term and
intermediate-term aggregate exposure take into account non-dietary, and
non-occupational plus chronic exposure to food and water (considered to
be a background exposure level). Acibenzolar-S-methyl is not registered
for use on any sites that would result in residential exposure;
therefore, the aggregate risk is the sum of the risk from food and
water, which were previously addressed.
4. Aggregate cancer risk for U.S. population. Acibenzolar-S-methyl
has been classified as not likely to be carcinogenic to humans;
therefore, acibenzolar-S-methyl is expected to pose at most a
negligible cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to acibenzolar-S-methyl residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology (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 number: (410) 305-2905;
e-mail address:residuemethods@epa.gov.
B. International Residue Limits
There are no maximum residue limits for acibenzolar-S-methyl that
have been established by Codex or in Canada or Mexico; therefore, no
compatibility issues exist with Codex in regard to the proposed U.S.
tolerances discussed in this review.
VI. Conclusion
Therefore, the tolerances are established for residues of
acibenzolar-
[[Page 7860]]
S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester, in
or on onion, dry bulb and onion, green at 0.05 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0214 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 on or before April 18,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A.1.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by the docket ID number OPP-2004-0214, to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes time-limited tolerances under section
408 of the FFDCA. 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 rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). 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., or 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). 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);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerances 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. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
[[Page 7861]]
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, 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, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: February 7, 2005.
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 adding text to paragraph (b) to read
as follows:
Sec. 180.561 Acibenzolar-S-methyl; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of acibenzolar-S-methyl,
benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. The time-limited tolerances will expire and are revoked on the
date specified in the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Onion, dry bulb............................... 0.05 6/30/07
Onion, green.................................. 0.05 6/30/07
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-2897 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S