[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Rules and Regulations]
[Pages 7854-7861]
From the Federal Register Online via the Government Publishing 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:[email protected].

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
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure/Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
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).
--------------------------------------
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:[email protected].

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: [email protected]. 
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