[Federal Register Volume 65, Number 161 (Friday, August 18, 2000)]
[Rules and Regulations]
[Pages 50438-50446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21080]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301037; FRL-6737-6]
RIN 2070-AB78


Acibenzolar-S-Methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
acibenzolar-S-methyl in or on bananas; Brassica (cole) leafy 
vegetables; fruiting vegetables; tomato, paste; leafy vegetables 
(except spinach); and spinach. Novartis Crop Protection, Inc. requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective August 18, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301037 
must be received by EPA on or before October 17, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301037 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Daniel Kenny, Acting PM-22, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-7546; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1.Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2.In person. The Agency has established an official record for this 
action under docket control number OPP-301037. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

[[Page 50439]]

II. Background and Statutory Findings

    In theFederal Register of February 18, 1999 (64 FR 8102) (FRL-6061-
4) and theFederal Register of February 4, 2000 (65 FR 5639) (FRL-6398-
9), EPA issued notices pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing 
the filing of pesticide petitions (PP) for tolerance by Novartis Crop 
Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. These notices 
included summaries of the petitions prepared by Novartis Crop 
Protection, Inc., the registrant. There were no comments received in 
response to the notices of filing.
    The petitions requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide acibenzolar-S-
methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester, in 
or on bananas at 0.1 part per million (ppm), Brassica (cole) leafy 
vegetables at 1.0 ppm, fruiting vegetables at 1.0 ppm, leafy vegetables 
(except spinach) at 0.25 ppm and spinach at 1.0 ppm. Agency review of 
data submitted in support of the petitions indicated that a separate 
tolerance of 3.0 ppm for tomato, paste should also be established.
    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) 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) 
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....''
    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 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).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for residues of acibenzolar-S-methyl on 
bananas at 0.1 ppm; Brassica (cole) leafy vegetables at 1.0 ppm; 
fruiting vegetables at 1.0 ppm; tomato, paste at 3.0 ppm; leafy 
vegetables (except spinach) at 0.25 ppm; and spinach at 1.0 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by acibenzolar-S-
methyl are discussed in this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

             Table 1.--Subchronic, Chronic and Other Toxicity
------------------------------------------------------------------------
        Guideline No./Study Type                     Results
------------------------------------------------------------------------
870.3100 90-Day oral toxicity rats       NOAEL: Males:126 mg/kg/day;
                                          Females: 131 mg/kg/day
                                         LOAEL: Males = 516 mg/kg/day;
                                          Females = 554 mg/kg/day based
                                          on decreased mean body
                                          weights, decreased food
                                          consumption and efficiency,
                                          and increased liver and spleen
                                          weights with correlates of
                                          glycogen deposition and
                                          hemosiderosis for the liver
                                          and spleen, respectively.
------------------------------------------------------------------------
870.3150 90-Day oral toxicity dogs       NOAEL = 50 mg/kg/day
                                         LOAEL = 200 mg/kg/day based on
                                          regenerative hemolytic anemia.
------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity rats  NOAEL = 1,000 mg/kg/day
                                         LOAEL = not identified
------------------------------------------------------------------------
870.3700a Prenatal developmental rats    Maternal NOAEL = 200 mg/kg/day;
                                          LOAEL = 400 mg/kg/day based on
                                          hemorrhagic perineal
                                          discharge.
                                         Developmental NOAEL = not
                                          identified (10 mg/kg/day)
                                          LOAEL = 10 mg/kg/day (lowest
                                          dose tested) based on
                                          umbilical hernia.
------------------------------------------------------------------------
870.3700b Prenatal developmental         Maternal NOAEL = 50 mg/kg/day
 rabbits
                                         LOAEL = 300 mg/kg/day based on
                                          mortality, clinical signs of
                                          toxicity, decreased maternal
                                          body weight and food
                                          consumption.
                                         Developmental NOAEL = 300 mg/kg/
                                          day LOAEL = 600 mg/kg/day
                                          based on a marginal increase
                                          in vertebral anomalies.
------------------------------------------------------------------------
870.3800 Reproduction and fertility      Parental/Systemic NOAEL = 11-31
 effects rats                             mg/kg/day LOAEL = 105-288 mg/
                                          kg/day based on increased
                                          weights and hemosiderosis of
                                          the spleen.
                                         Reproductive NOAEL = 223-604 mg/
                                          kg/day LOAEL >223-604 mg/kg/
                                          day based on no effects.
                                         Offspring NOAEL = 11-31 mg/kg/
                                          day LOAEL = 105-288 mg/kg/day
                                          based on reduced pup body
                                          weight gains and lower pup
                                          body weights during lactation.
------------------------------------------------------------------------

[[Page 50440]]

 
870.4100a Chronic toxicity rats          NOAEL = Males: 96.9 mg/kg/day;
                                          Females: 111 mg/kg/day
                                         LOAEL = Males: 312 mg/kg/day;
                                          Females: 388 mg/kg/day based
                                          on decreased body weight, body
                                          weight gain and food
                                          efficiency, mild hemolytic
                                          anemia, and increased
                                          incidence of alveolar foam
                                          cells (females only).
------------------------------------------------------------------------
870.4100b Chronic toxicity dogs          NOAEL = 25 mg/kg/day
                                         LOAEL = 200 mg/kg/day based on
                                          effects consistent with
                                          hemolytic anemia, including
                                          hematological effects,
                                          hemosiderosis of the liver and
                                          spleen, extramedullary
                                          hematopoiesis of the spleen,
                                          and increased liver weights.
------------------------------------------------------------------------
870.4200a Carcinogenicity rats           NOAEL = Males: 96.9 mg/kg/day;
                                          Females: 111 mg/kg/day
                                         LOAEL = Males: 312 mg/kg/day;
                                          Females: 388 mg/kg/day based
                                          on decreased body weight, body
                                          weight gain and food
                                          efficiency, mild hemolytic
                                          anemia, and increased
                                          incidence of alveolar foam
                                          cells (females only).
                                         No evidence of carcinogenicity
------------------------------------------------------------------------
870.4200b Carcinogenicity mice           NOAEL = Males:11.1 mg/kg/day;
                                          Females: 10.8 mg/kg/day
                                         LOAEL = Males: 237 mg/kg/day;
                                          Females: 234 mg/kg/day based
                                          on mild hemolytic anemia and
                                          hemosiderosis of the liver,
                                          spleen, and bone marrow, and
                                          extramedullary hematopoiesis
                                          of the spleen.
                                         No evidence of carcinogenicity
------------------------------------------------------------------------
870.5100 Bacterial reverse mutation      Negative with and without S-9
 assay (Ames test)                        activation at 5000 g/
                                          plate and less.
------------------------------------------------------------------------
870.5100 Bacterial reverse mutation      Positive inS. typhimurium
 assay (Ames test) Test Material: CGA-    strain TA1537 at 277.8 g/plate and higher in the
 methyl)                                  absence of S-9. Negative with
                                          S-9 activation at 5000 g/plate and less.
------------------------------------------------------------------------
870.5100 Bacterial reverse mutation      Negative with or without S-9
 assay (Ames test) Test Material: NOA-    activation at 5000 g/
 419191 (by-product of acibenzolar-S-     plate and less
 methyl)
------------------------------------------------------------------------
870.5100 Bacterial reverse mutation      Negative with or without S-9
 assay (Ames test) Test Material: CGA-    activation at 5000 g/
 323060 (plant metabolite of              plate and less
 acibenzolar-S-methyl)
------------------------------------------------------------------------
870.5300In vitro mammalian gene          Negative with S-9 activation up
 mutation assay                           to 1000 g/ml.
                                          Negative without S-9
                                          activation up to 100 g/ml.
                                         Compound tested to cytotoxic
                                          concentrations.
------------------------------------------------------------------------
870.5375In vitro mammalian chromosome    Suggestive of clastogenicity in
 aberration (CHO cells)                   the absence of S-9 activation
                                          at 30 and 60 g/mL at
                                          the 18-hour cell harvest time;
                                          effect observed only in the
                                          presence of cytotoxicity.
                                          Increase in polyploid cells at
                                          30 and 60 g/mL at the
                                          42 hour harvest time both with
                                          and without S- 9. Evidence of
                                          cell cycle arresting activity
                                          at G2.
------------------------------------------------------------------------
870.5395 Mammalian erythrocyte           Negative at 16, 24, and 48,
 micronucleus test                        hour sacrifices.
------------------------------------------------------------------------
870.5550 UDS in primary rat hepatocytes  Negative at 500 g/ml
                                          and less.
------------------------------------------------------------------------
870.7485 Metabolism and                  Following oral treatment of
 pharmacokinetics rats                    rats, acibenzolar-S-methyl was
                                          rapidly and nearly completely
                                          (>90% of administered dose)
                                          absorbed from the
                                          gastrointestinal tract into
                                          the general circulation. The
                                          majority (88-95%) of the
                                          administered dose was excreted
                                          in the urine within the first
                                          48 hours. The major metabolite
                                          (79-92%) in the urine was the
                                          carboxylic acid derivative of
                                          the parent.
------------------------------------------------------------------------
Special studies: 28-Day dietary rats     NOAEL = M: 403 mg/kg/day; F:
                                          376 mg/kg/day
                                         LOAEL = M: 1070 mg/kg/day; F:
                                          1,000 mg/kg/day based on
                                          decreased mean body weights,
                                          decreased liver weights,
                                          altered hematology parameters
                                          accompanied by increased
                                          spleen weights.
------------------------------------------------------------------------
28-Day oral gavage rats                  NOAEL = 100 mg/kg/day
                                         LOAEL = 800 mg/kg/day based on
                                          decreased body weights, and
                                          decreased hemoglobin-related
                                          parameters accompanied by
                                          hemosiderosis of the spleen,
                                          increased liver and spleen
                                          weights, and decreased thymus
                                          weights.
------------------------------------------------------------------------
28-Day oral capsule dogs                 NOAEL = 50 mg/kg/day
                                         LOAEL = 250 mg/kg/day based on
                                          decreased body weight,
                                          decreased hemoglobin-related
                                          parameters, hepatic and
                                          splenic hemosiderosis.

[[Page 50441]]

 
------------------------------------------------------------------------
90-Day Dietary mice                      NOAEL = M: 30.6 mg/kg/day; F:
                                          47.4 mg/kg/day;
                                         LOAEL = M: 152 mg/kg/day; F:
                                          220 mg/kg/day based on
                                          decreased mean body weights
                                          and body weight gain in males,
                                          increased spleen weights and
                                          splenic histopathology in both
                                          sexes.
------------------------------------------------------------------------
Special Developmental toxicity rats      Maternal and developmental
                                          NOAELS and LOAELS could not be
                                          identified by this protocol.
                                          The most pronounced maternal
                                          and developmental toxicity
                                          occurred when dams were
                                          treated on GD 6-15.
------------------------------------------------------------------------
Special Developmental toxicity rats      Maternal and developmental
                                          NOAELS and LOAELS could not be
                                          identified by this protocol.
                                          The most pronounced maternal
                                          and developmental toxicity
                                          occurred when dams were
                                          treated on GD 6-7 and 8-9.
------------------------------------------------------------------------
Dermal developmental toxicity rats       Maternal NOAEL 500
                                          mg/kg/day LOAEL >500 mg/kg/day
                                          based on no effects.
                                         Developmental NOAEL 500 mg/kg/day LOAEL >500 mg/
                                          kg/day based on no effects.
------------------------------------------------------------------------
Range-finding 1-generation reproduction  Parental/Systemic NOAEL = 209
 rats                                     mg/kg/day LOAEL = 410 mg/kg/
                                          day based on decreased body
                                          weight gain and food
                                          consumption in females.
                                         Reproductive NOAEL = 410 mg/kg/
                                          day LOAEL = 728 mg/kg/day
                                          based on total resorptions in
                                          all dams.
                                         Offspring NOAEL = 209 mg/kg/day
                                          LOAEL = 410 mg/kg/day based on
                                          reduced pup body weight gains
                                          and lower pup body weights
                                          during lactation.
------------------------------------------------------------------------

B. Toxicological Endpoints

    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 level of concern 
(LOC). 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 intra species 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 Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the 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 of 
departure/exposures) is calculated.

 Table 2.--Summary of Toxicological Dose and Endpoints for Acibenzolar-S-Methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  FQPA SF\1\ and Level
          Exposure Scenario                Dose Used in Risk      of Concern for Risk            Study and
                                            Assessment, UF             Assessment         Toxicological Effects
----------------------------------------------------------------------------------------------------------------
 Acute Dietary females 13-50 years of  LOAEL = 10 mg/kg/day UF  FQPA SF = 10; aPAD =     Developmental toxicity
 age.                                   = 300 Acute RfD =        acute RfD         rats; LOAEL = 10 mg/
                                        0.033 mg/kg/day          FQPA SF = 0.0033 mg/kg/  kg/day based on
                                                                 day                      increased incidence of
                                                                                          rare malformations
                                                                                          (umbilical hernias).
----------------------------------------------------------------------------------------------------------------
 Chronic Dietary females 13-50 years   LOAEL = 10 mg/kg/day UF  FQPA SF = 10 aPAD =      Developmental toxicity
 of age.                                = 300 Acute RfD =        acute RfD         rats; LOAEL = 10 mg/
                                        0.033 mg/kg/day          FQPA SF = 0.0033 mg/kg/  kg/day based on
                                                                 day                      increased incidence of
                                                                                          rare malformations
                                                                                          (umbilical hernias).
----------------------------------------------------------------------------------------------------------------

[[Page 50442]]

 
 Chronic Dietary all other             NOAEL = 10.8 mg/kg/day   FQPA SF = 3; cPAD =      Carcinogenicity - mice;
 populations, including infants and     UF = 100; Chronic RfD    chronic RfD      LOAEL = Females = 234
 children.                              = 0.11 mg/kg/day         FQPA SF = 0.0367 mg/kg/  mg/kg/day based on
                                                                 day                      mild hemolytic anemia
                                                                                          and hemosiderosis of
                                                                                          the liver, spleen, and
                                                                                          bone marrow, and
                                                                                          extramedullary
                                                                                          hematopoiesis of the
                                                                                          spleen.
----------------------------------------------------------------------------------------------------------------
\1\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
previously been established for acibenzolar-S-methyl. 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 1 day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. After a Tier I acute dietary analysis based on 
tolerance level residues and assuming 100 percent crop treated resulted 
in risk estimates that were unacceptably high, a probabilistic (i.e., 
Monte Carlo) acute dietary exposure assessment was performed using the 
distribution of residues observed in the crop field trials and 
projected percent market share information (leafy vegetables,16%; 
fruiting vegetables 14%; brassica vegetables (2%). The refined analysis 
estimated acute dietary exposure of females, 13-50 years old, to 
acibenzolar-S-methyl at the 99.9th percentile of exposure.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: that residues would be present in or on treated 
crops at tolerance levels and that 100% of crops would be treated.
    iii. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) 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 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. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) 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 percent crop 
treated (PCT) as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used percent crop treated (PCT) information as follows:
    A probabilistic (i.e., Monte Carlo) acute dietary risk assessment 
for acibenzolar-S-methyl was based on the following PCT projections: 
leafy vegetables (16%); fruiting vegetables (14%); brassica vegetables 
(2%).
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described above for acibenzolar-S-methyl on leafy 
vegetables, fruiting vegetables and brassica 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. Based on available 
information, including the petitioner's research and experience in 
these markets, information on other registered pesticides, and 
prevalence of target weeds, EPA believes the petitioner's estimates do 
not underestimate the percent of these crops that may be treated. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which acibenzolar-S-
methyl may be applied in a particular area.
    2. Dietary exposure from drinking water. The 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

[[Page 50443]]

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, 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 that 
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 GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of acibenzolar-S-methyl in surface water and 
ground water for acute exposures are estimated to be 0.64 parts per 
billion (ppb) for surface water and negligible for ground water. The 
EECs for chronic exposures are estimated to be 0.02 ppb for surface 
water and negligible 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) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether acibenzolar-S-methyl has a common mechanism of toxicity with 
other substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
acibenzolar-S-methyl does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has 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 final rule for Bifenthrin Pesticide Tolerances (62 
FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. 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 
data base 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 uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. 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.
    iii. Conclusion. The toxicology database for Acibenzolar-S-Methyl 
is incomplete. Subchronic neurotoxicity, developmental neurotoxicity 
and an additional mutagenicity study (Ames study) are required. The 
Agency concluded that the FQPA Safety Factor be retained at 10X based 
on (1) 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); (2) 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; (3) 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 toxicity study; and (4) the potential for the requested 
uses of acibenzolar-S-methyl to result in acute and chronic dietary 
exposure. When assessing acute and chronic dietary exposures, the 
Agency concluded that the FQPA safety factor should be retained at 10X 
for the female, 13-50 years old, population subgroup (the only 
population subgroup of concern for acute exposures). When assessing 
chronic dietary exposure, however, the Committee 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 13-50 population subgroup) since there is no 
concern for increased susceptibility due toin utero exposure for 
persons other than females 13-50, but there still remains a data gap 
for a developmental neurotoxicity study in rats.

E. 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

[[Page 50444]]

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 + residential 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 are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Actual 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, OPP concludes with reasonable certainty that 
exposures to the pesticide 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 residues of the pesticide in 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 
87% of the aPAD for females 13 years and older, 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, there is 
potential for acute dietary exposure to acibenzolar-S-methyl in 
drinking water. After calculating DWLOCs and comparing them to the EECs 
for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD.

                 Table 3.--Aggregate Risk Assessment for Acute Exposure to Acibenzolar-S-Methyl
----------------------------------------------------------------------------------------------------------------
                                                                          Surface     Ground
               Population Subgroup                 a PAD (mg/   % aPAD   Water EEC  Water EEC  Acute DWLOC (ppb)
                                                      kg)       (Food)     (ppb)      (ppb)
----------------------------------------------------------------------------------------------------------------
 Females 13-50 years                                  0.0033         87       0.64  Negligibl                 12
                                                                                            e
----------------------------------------------------------------------------------------------------------------

    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, 52% of the cPAD for females 13 to 50 years old, 3% of the 
cPAD for infants less than 1 year old and 11% of the cPAD for children 
1 to 6 years old, the subgroup of children with the highest estimated 
food exposure to acibenzolar-S-methyl. There are no residential uses 
for acibenzolar-S-methyl that result in chronic residential exposure to 
acibenzolar-S-methyl. In addition, there is potential for chronic 
dietary exposure to acibenzolar-S-methyl in drinking water. After 
calculating the DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD.

          Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Acibenzolar-S-Methyl
----------------------------------------------------------------------------------------------------------------
                                                                                  Surface     Ground    Chronic
                   Population Subgroup                      cPAD mg/    % cPAD   Water EEC  Water EEC    DWLOC
                                                             kg/day     (Food)     (ppb)      (ppb)      (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                               0.0367          6       0.02  negligibl       1200
                                                                                                    e
----------------------------------------------------------------------------------------------------------------
All Infants 1 year                                            0.0367          3       0.02  negligibl        360
                                                                                                    e
Children 1-6 years                                            0.0367         11       0.02  negligibl        320
                                                                                                    e
----------------------------------------------------------------------------------------------------------------
Females 13-50 years                                          0. 0033         52       0.02  negligibl         50
                                                                                                    e
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure 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 do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure 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 do not exceed the Agency's level of 
concern.
    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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed a residue analytical method for 
tolerance

[[Page 50445]]

enforcement that uses liquid chromatography with UV detection (HPLC-
UV). This method is currently being validated by the Analytical 
Chemistry Branch laboratories, BEAD (7503C), Office of Pesticide 
Programs. Upon successful completion of the EPA validation and the 
granting of this registration the method will be forwarded to FDA for 
publication in a future revision of the Pesticide Analytical Manual, 
Vol-II (PAM-II). Prior to publication in PAM-II and upon request, the 
method will be available prior to the harvest season from the 
Analytical Chemistry Branch (ACB), BEAD (7503C), Environmental Science 
Center, 701 Mapes Road, Ft George G. Meade, MD 20755-5350; contact 
Francis D. Griffith, Jr, telephone (410) 305-2905, e-mail 
[email protected]. The analytical standards for this method are 
also available from the EPA National Pesticide Standard Repository at 
the same location.

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.

C. Conditions

    The registration of acibenzolar-S-methyl will be conditioned upon 
submission of the following toxicology studies: Developmental 
neurotoxicity study in rats; subchronic neurotoxicity study in rats; 
and an additional mutagenicity study (Ames test).

V. Conclusion

    Therefore, tolerances are established for residues of acibenzolar-
S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-methyl ester, in 
or on bananas at 0.1 ppm; Brassica (cole) leafy vegetables at 1.0 ppm; 
fruiting vegetables at 1.0 ppm; tomato, paste at 3.0 ppm; leafy 
vegetables (except spinach) at 0.25 ppm; and spinach at 1.0 ppm

VI. 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301037 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 October 
17, 2000.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301037, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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 file format 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

[[Page 50446]]

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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitledRegulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501et 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 prior consultation as specified by Executive Order 
13084, entitledConsultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitledFederal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require OMB review or 
any Agency action under Executive Order 13045, entitledProtection 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 petition under FFDCA section 408(d), such 
as the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. 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 
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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801et 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: August 9, 2000.

Joseph J. Merenda
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

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

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


    2. Section 180.561 is added to read as follows:


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

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 Bananas\1\..................................................        0.1
Brassica (cole) leafy vegetables.............................        1.0
Fruiting vegetables..........................................        1.0
Leafy vegetables.............................................       0.25
Spinach......................................................        1.0
Tomato, paste................................................       3.0
------------------------------------------------------------------------
\1\ There are no United States registrations for bananas.

    (b)Section 18 emergency exemptions. [Reserved]
    (c)Tolerances with regional registrations. [Reserved]
    (d)Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-21080 Filed 8-17-00; 8:45 am]
BILLING CODE 6560-50-S