[Federal Register Volume 66, Number 181 (Tuesday, September 18, 2001)]
[Rules and Regulations]
[Pages 48089-48097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23227]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301175; FRL-6803-2]
RIN 2070-AB78


Bispyribac-Sodium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
bispyribac-sodium in or on rice. Valent U.S.A. Corporation (as agent 
for K-I Chemical U.S.A., Inc.) requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective September 18, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301175, 
must be received by EPA on or before November 19, 2001.

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-301175 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: 703-305-5697; 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
           Categories                 NAICS Codes         Potentially
                                                       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 homepage at http://www.epa.gov/. 
To access this document, on the homepage 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 theFederal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301175. 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.

II. Background and Statutory Findings

    In the Federal Register of September 20, 2000 (65 FR 56901) (FRL-
6742-7), EPA issued a notice 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

[[Page 48090]]

a pesticide petition (PP) for tolerance by Valent U.S.A. Corporation 
(as agent for K-I Chemical U.S.A., Inc.), 1333 North California Blvd., 
Suite 600, Walnut Creek, CA 94569. This notice included a summary of 
the petition prepared by Valent U.S.A. Corporation, the registrant. 
There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for residues of the herbicide bispyribac-
sodium, sodium 2,6-bis[(4,6-dimethoxy-pyrimidin-2-yl)oxy]benzoate, in 
or on rice, grain and rice, straw at 0.02 part per million (ppm).
    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 a tolerance for residues of bispyribac-sodium on rice at 
0.02 ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerance 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 bispyribac-sodium 
are discussed in the following Table 1 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        NOAEL = 71.9/79.9 mg/kg/day (M/F)
                                          rodents (rat)              LOAEL = 724.0/790.8 mg/kg/day (M/F), based
                                                                      on decreased body weight gain, increased
                                                                      absolute and relative liver weights,
                                                                      increased alkaline phosphatase and gamma-
                                                                      GTP, and increased incidence of grossly
                                                                      dilated bile duct lumen in males, and
                                                                      microscopic lesions in the liver, biliary
                                                                      system and urinary bladder in both sexes.
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 68.6/79.0 mg/kg/day (M/F)
                                          rodents (mouse)            LOAEL = 699.1/806.1 mg/kg/day (M/F), based
                                                                      on liver cell swelling and slight liver
                                                                      cell granulation in females
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = 100 mg/kg/day
                                          nonrodents (dog)           LOAEL = 600 mg/kg/day (M/F), based on
                                                                      increased salivation and slight
                                                                      proliferation of intrahepatic bile duct
----------------------------------------------------------------------------------------------------------------
870.3200                                 21/28-Day dermal toxicity   NOAEL = 1,000 mg/kg/day (M/F)
                                          (rat)                      LOAEL >1,000 mg/kg/day (M/F). No systemic
                                                                      toxicity or dermal irritation noted.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal
                                          rodents (rat)              NOAEL = 1,000 mg/kg/day
                                                                     LOAEL = >1,000 mg/kg/day
                                                                     Developmental
                                                                     NOAEL = 1,000 mg/kg/day
                                                                     LOAEL = >1,000 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal
                                          nonrodents (rabbit)        NOAEL = 100 mg/kg/day
                                                                     LOAEL = 300 mg/kg/day, based on lethargy,
                                                                      diarrhea, and decreased body weight gain
                                                                      in the range finding study
                                                                     Developmental
                                                                     NOAEL = 300 mg/kg/day
                                                                     LOAEL was not established
----------------------------------------------------------------------------------------------------------------

[[Page 48091]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic
                                          effects (rats)             NOAEL = 1.5 mg/kg/day
                                                                     LOAEL = 75.7 mg/kg/day (M/F), based on
                                                                      trace to mild choledocus
                                                                     Reproductive
                                                                     NOAEL = 759.0 mg/kg/day
                                                                     LOAEL = >759 mg/kg/day
                                                                     Offspring
                                                                     NOAEL = 75.7 mg/kg/day
                                                                     LOAEL = 759 mg/kg/day (M/F), based on
                                                                      decreased body weights, body weight gains,
                                                                      and liver weights, and increased incidence
                                                                      of consolidation and circumscribed areas
                                                                      in the liver
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity (dogs)     NOAEL = 10 mg/kg/day
                                                                     LOAEL = 100 mg/kg/day (M/F), based on dose-
                                                                      related increase in intrahepatic bile duct
                                                                      hyperplasia and liver granulation in
                                                                      females
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined chronic toxicity/  NOAEL = 10.9 mg/kg/day
                                          carcinogenicity rodents    LOAEL = 194.5 mg/kg/day (M), based on
                                          (rat)                       macrosopic (yellowish liver, dilated
                                                                      choledochus lumen), microscopic (cellular
                                                                      infiltration, vacuolic changes in the bile
                                                                      ducts), and clinical signs (morbundity,
                                                                      wasting, piloerection, subnormal
                                                                      temperature, and decreased spontaneous
                                                                      motor activity.
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity (mice)      NOAEL = 14.1/17.4 (M/F) mg/kg/day
                                                                     LOAEL = 353.0/447.8 mg/kg/day (M/F), based
                                                                      on decreased body weight gain, and food
                                                                      efficiency, and increased incidence of
                                                                      microscopic lesions in the liver and gall
                                                                      bladder (M)
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     There was no evidence of induced mutant
                                          gene mutation assay in      colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5375                                 Cytogenetics - in vitro     Not clastogenic with or without S9
                                          mammalian cytogenetic       activation, at any dose tested
                                          assay
----------------------------------------------------------------------------------------------------------------
870.5395                                 Other effects - in vivo     Did not induce micronucleated polychromatic
                                          mammalian cytogenetic       erythrocytes (PMCEs) in bone marrow at any
                                          assay                       dose
----------------------------------------------------------------------------------------------------------------
870.5500                                 Other genotoxic effects -   No zones of inhibition and the differential
                                          bacterial DNA damage and    killing index suggesting potential DNA
                                          repair test                 damage
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other genotoxic effects -   Did not induce UDS at any dose
                                          UDS synthesis in
                                          mammalian cell culture
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              A series of rat metabolism studies with
                                          pharmacokinetics (rat)      14CPy-bispyribac-sodium and 14C-Bn-
                                                                      bispyribac-sodium indicated that
                                                                      pretreatment, dose level, sex and position
                                                                      of the radiolabel made little effect on
                                                                      the absorption, distribution, elimination
                                                                      and metabolism. It was readily absorbed by
                                                                      male and female rats following intravenous
                                                                      or oral dosing. The total recovery of the
                                                                      administered radioactivity was 95.8 -
                                                                      101.6% for all treatment groups. Most of
                                                                      the dose (>43%) of the administered dose
                                                                      was excreted in feces within 48 hours and
                                                                      essentially complete within 5 days. Less
                                                                      than 2% of the administered dose remained
                                                                      in the carcass and tissues and <0.1% of
                                                                      the dose was recovered in air. Parent and
                                                                      5 metabolites were identified in the
                                                                      excreta of male and females following
                                                                      administered of 14Cpy-bispyribac-sodium
                                                                      and Parent and 3 metabolites identified
                                                                      with of 14C-Bn-bispyribac-sodium
                                                                      administration. The parent compound,
                                                                      bispyribac-sodium, was the major component
                                                                      identified in the feces (37 - 69% of the
                                                                      dose) and urine (5 - 41% of the dose), in
                                                                      both sexes. Metabolites identified in the
                                                                      excreta constituted 8.3 - 14.6% and
                                                                      unknown metabolites constituted 0.7 - 5.2%
                                                                      of the dose.
----------------------------------------------------------------------------------------------------------------
Non-guideline                            Serum bile acids (mice)     Bile acids increased 115% and slight cecal
                                                                      enlargement in 9/10 treated mice
----------------------------------------------------------------------------------------------------------------
Non-guideline                            Reversibility (mice)        Bispyribac-sodium was associated with liver
                                                                      lesions, bile duct hyperplasia and dilated
                                                                      gall bladders in subchronic and
                                                                      oncogenicity studies were not replicated
                                                                      in this reversibility study
----------------------------------------------------------------------------------------------------------------

[[Page 48092]]

 
Non-guideline                            Serum bile acids (rat)      Total bile acids increased 1,072% (12-
                                                                      fold). The concentration of glycocholic
                                                                      acid, taurocholic acid, deoxycholic acid
                                                                      increased 2,127%, 2,991% and 138%,
                                                                      respectively, where as chenodeoxy cholic
                                                                      acid levels were similar to controls.
                                                                      Hyodeoxycholic acid was reduced from 34.0%
                                                                      to 3.3 of the total bile acids. Treatment
                                                                      altered the degree of conjugation;
                                                                      hyodeoxycholic acid increased 84% and
                                                                      deoxycholic acid increased 1,133%.
----------------------------------------------------------------------------------------------------------------
Non-guideline                            Reversibility (rat)         Bispyribac-sodium was associated with
                                                                      urinary bladder epithelial hyperplasia in
                                                                      subchronic study and bile duct
                                                                      hyperplasia, enlarged bile ducts, and
                                                                      liver cell hypertrophy and fibrosis in
                                                                      chronic study. Upon removal of bispyribac-
                                                                      sodium from the diet, resulted complete
                                                                      recovery in liver enzymes, food
                                                                      consumption, food efficiency, body
                                                                      weights, however, muscular hypertrophy of
                                                                      choledocus was still evident. The study
                                                                      did not duplicate urinary bladder lesions
                                                                      noted in the subchronic study.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite DesMe-2023 did not induce
                                          gene mutation assay in      mutantcolonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite 2,4-dihydroxy-6-mehtoxy
                                          gene mutation assay in      pyrimidine did not induce mutant colonies
                                          bacteria                    over background
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite KIH-2023-M-8-Na did not induce
                                          gene mutation assay in      mutant colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite KIH-2023-M-9-Na did not induce
                                          gene mutation assay in      mutant colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite BIX-180 did not induce mutant
                                          gene mutation assay in      colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite Me2BA did not induce mutant
                                          gene mutation assay in      colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite KIH-2023-I-1 did not induce
                                          gene mutation assay in      mutant colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite KIH-2023-I-2 did not induce
                                          gene mutation assay in      mutant colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation - reverse     Metabolite KIH-2023-I-4 did not induce
                                          gene mutation assay in      mutant colonies over background
                                          bacteria
----------------------------------------------------------------------------------------------------------------

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 intraspecies differences.
    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

[[Page 48093]]

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. A summary of the toxicological endpoints for bispyribac-
sodium used for human risk assessment is shown in the following Table 
2:

  Table 2.--Summary of Toxicological Dose and Endpoints for Bispyribac-sodium 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
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 10 mg/kg/day     FQPA SF = 1x             Chronic toxicity study
                                       UF = 100...............  cPAD = chronic RfD         dog
                                       Chronic RfD = 0.1 mg/kg/   FQPA SF.       LOAEL = 100 mg/kg/day
                                        day.                    = 0.1 mg/kg/day........   based on dose-related
                                                                                          increases in
                                                                                          hyperplasia of the
                                                                                          intrahepatic bile
                                                                                          ducts in males and
                                                                                          females and
                                                                                          granulation of the
                                                                                          liver in the females.
----------------------------------------------------------------------------------------------------------------
Short-term incidental oral (1-30       NOAEL = 100 mg/kg/day    LOC for MOE = 100        Developmental toxicity
 days) (residential)                                             (residential, includes   study - rabbit
                                                                 the FQPA SF).           Maternal LOAEL = 300 mg/
                                                                                          kg/day based on
                                                                                          lethargy, diarrhea and
                                                                                          decreased body weight
                                                                                          gain in the range
                                                                                          finding study
----------------------------------------------------------------------------------------------------------------
Intermediate-term incidental oral (1-  NOAEL = 100 mg/kg/day    LOC for MOE = 100        90-Day feeding study -
 6 months) (residential)                                         (residential, includes   dog
                                                                 the FQPA SF)            LOAEL = 600 mg/kg/day
                                                                                          based upon salivation
                                                                                          and slight
                                                                                          proliferation of
                                                                                          intrahepatic bile duct
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1-30 days)      Oral study               LOC for MOE = 100        Developmental toxicity
 (occupational/residential)            NOAEL = 100 mg/kg/day     (occupational)           study - rabbit
                                        (inhalation absorption  LOC for MOE = 100        Maternal LOAEL = 300 mg/
                                        rate = 100%).            (residential, includes   kg/day based on
                                                                 the FQPA SF).            lethargy, diarrhea and
                                                                                          decreased body weight
                                                                                          gain.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1-6      Oral study               LOC for MOE = 100        90-Day feeding study -
 months) (occupational/residential)    NOAEL = 100 mg/kg/day     (Occupational)           dog
                                        (inhalation absorption  LOC for MOE = 100        LOAEL = 600 mg/kg/day
                                        rate = 100%).            (residential, includes   based upon salivation
                                                                 the FQPA SF).            and slight
                                                                                          proliferation of
                                                                                          intrahepatic bile duct
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (<6 months)       Oral study               LOC for MOE = 100        Chronic toxicity study
 (occupational/residential)            NOAEL = 10 mg/kg/day      (occupational)            dog
                                        (inhalation absorption  LOC for MOE = 100        LOAEL = 100 mg/kg/day
                                        rate = 100%).            (residential, includes   based on dose-related
                                                                 the FQPA SF).            increases in
                                                                                          hyperplasia of the
                                                                                          intrahepatic bile
                                                                                          ducts in males and
                                                                                          females and
                                                                                          granulation of the
                                                                                          liver in the females.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``not likely''           Not applicable           No evidence of
                                                                                          carcinogenic or
                                                                                          mutagenic potential. A
                                                                                          cancer risk assessment
                                                                                          is not required.
----------------------------------------------------------------------------------------------------------------
*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 previous tolerances 
have been established for the residues of bispyribac-sodium. Risk 
assessments were conducted by EPA to assess dietary exposures from 
bispyribac-sodium 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. Acute doses and endpoints were not selected for the 
general U.S. population (including infants and children) or the females 
13-50 years old population subgroup for bispyribac-sodium; therefore, 
an acute dietary exposure analysis was not performed.
    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 insert 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: A conservative, deterministic chronic dietary 
exposure analysis for bispyribac-sodium was performed for the general 
U.S. population and all population subgroups using proposed tolerance 
level residues and 100% crop treated information for all rice 
commodities. The results of the analysis indicate that the estimated 
chronic dietary risks associated with the proposed use of bispyribac-
sodium do not exceed HED's level of concern for the general U.S. 
population or any population subgroups.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a

[[Page 48094]]

comprehensive dietary exposure analysis and risk assessment for 
bispyribac-sodium 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 bispyribac-sodium. The SCI-GROW 
model is used to predict pesticide concentrations in ground water. 
Because the Agency currently has no official model for calculating the 
estimated environmental concentrations (EECs) in surface water due to 
rice culture, a screening calculation method was developed; thus, the 
resulting EECs are provisional only. Estimates were done for each of 
the three major rice growing regions in the United States, the Gulf 
Coast of Louisiana and Texas, the Mississippi Valley including parts of 
northern Louisiana, Mississippi, Arkansas, and southern Missouri, and 
California in the Sacramento River Basin. The surface water EEC is a 
point estimate representing only peak or acute concentrations. However, 
as no attempt has been made to determine chronic exposure and the 
chronic exposure should be less than the acute estimate, the resulting 
EECs can be used for both acute and chronic risk assessments. Since 
acute risk assessment is not required due to the lack of an acute 
dietary endpoint for bispyribac-sodium, the resulting EECs will be used 
for chronic risk assessment.
    None of these models or screening calculation methods 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 and calculation methods used are considered to be 
screening tools in the risk assessment process, the Agency does not use 
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 
bispyribac-sodium, they are further discussed in the aggregate risk 
sections below.
    Based on the screening calculation method described above and SCI-
GROW model the EECs of bispyribac-sodium for acute exposures are 
estimated to be 0.317 parts per billion (ppb) for surface water and 
0.0072 ppb for ground water. The EECs for chronic exposures are 
estimated to be 0.317 ppb for surface water and 0.0072 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).
    Bispyribac-sodium 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 bispyribac-sodium 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, 
bispyribac-sodium 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 bispyribac-sodium 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 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. Based on the lack of 
developmental and offspring effects in both the developmental studies 
in rats and rabbits and the reproduction study in rats, the data for 
bispyribac-sodium demonstrate no indication of quantitative or 
qualitative increased susceptibility to bispyribac-sodium from prenatal 
or postnatal exposures.
    iii. Conclusion. The toxicological data base for bispyribac-sodium 
is essentially complete with the exception of a 28-day inhalation 
toxicity study and an in vitro mammalian cell gene mutation assay. EPA 
determined that the 10X safety factor to protect infants and children 
should be removed. The FQPA factor is removed based on the following 
factors. There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero or postnatal 
exposure. In addition, a developmental neurotoxicity study (DNT) with 
bispyribac-sodium is not required. The dietary food and drinking water 
exposure assessments will not underestimate the potential exposures for 
infants and children. Finally, there are currently no registered or 
proposed residential (non-occupational) uses of bispyribac-sodium.

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 and screening 
calculation 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 + 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

[[Page 48095]]

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). 
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 ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA 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, EPA 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. An acute aggregate risk assessment was not performed 
because an acute dietary endpoint was not selected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
bispyribac-sodium from food will utilize less than 1% of the cPAD for 
the U.S. population and all population subgroups. There are no 
residential uses for bispyribac-sodium that result in chronic 
residential exposure to bispyribac-sodium. In addition, there is 
potential for chronic dietary exposure to bispyribac-sodium 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 cPAD, as shown in the following Table 3:

                               Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bispyribac-Sodium
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Surface Water EEC   Ground Water EEC    Chronic DWLOC
                   Population Subgroup                       cPAD mg/kg/day      %cPAD (Food)          (ppb)              (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                          0.1                 <1              0.317             0.0072              3,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                                0.1                 <1              0.317             0.0072              1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                                 0.1                 <1              0.317             0.0072              1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                                0.1                 <1              0.317             0.0072              1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                                0.1                 <1              0.317             0.0072              3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                                  0.1                 <1              0.317             0.0072              3,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                                    0.1                 <1              0.317             0.0072              3,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                                  0.1                 <1              0.317             0.0072              3,500
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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). Bispyribac-sodium 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). Bispyribac-
sodium 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. Aggregate cancer risk for U.S. population. A cancer aggregate 
risk assessment was not performed because bispyribac-sodium was 
negative for carcinogenicity and classified as ``not likely human 
carcinogen.''
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to bispyribac-sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed gas chromatography (GC) method RM-35R-2 
for the enforcement of tolerances on rice grain and straw. The reported 
method limits of detection and quatitation for residues of bispyribac-
sodium are 0.01 ppm and 0.02 ppm, respectively, in/on rice grain and 
straw. Adequate radiovalidation and independent laboratory validation 
data have been submitted for this method. The GC method RM-35R-2 has 
been forwarded to the EPA's Analytical Chemistry Branch of the 
Biological Economic Analysis Division for validation. The method 
includes procedures for confirmation of residues (analysis using a 
different GC column, and/or analysis by GC with mass selective 
detection).
    The method may be requested from: Calvin Furlow, PRRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-5229; e-mail address: [email protected].

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for residues of bispyribac-sodium in/on 
plant or livestock commodities.

C. Conditions

    Registration of bispyribac-sodium on rice is conditional on the 
acceptable submission of storage stability data for the benzene-labeled 
rice metabolism study, a poultry feeding study, a 28-day inhalation 
toxicity study, and an in vitro mammalian cell gene mutation assay.

[[Page 48096]]

V. Conclusion

    Therefore, the tolerance is established for residues of bispyribac-
sodium, sodium 2,6-bis[(4,6-dimethoxy-pyrimidin-2-yl)oxy]benzoate, in 
or on rice, grain and rice, straw at 0.02 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-301175 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 November 
19, 2001.
    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-301175, 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 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).

VII. Regulatory Assessment Requirements

    This final rule establishes tolerances 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, 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 prior consultation as specified by 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 27655, May 19, 1998); special 
considerations as required by Executive Order 12898, entitled Federal 
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, entitled 
Protection of Children

[[Page 48097]]

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). 
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.

VIII. Submission to Congress and the Comptroller General

    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: September 7, 2001.
James Jones,
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), 346(a) and 371.

    2. Section 180.577 is added to read as follows:


Sec. 180.577  Bispyribac-sodium; tolerances for residues.

    (a) General. Tolerances are established for residues of bispyribac-
sodium, sodium 2,6-bis[(4,6-dimethoxy-pyrimidin-2-yl)oxy]benzoate, in 
or on the following raw agricultural commodities:

 
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Rice, grain...............................                          0.02
Rice, straw...............................                          0.02
------------------------------------------------------------------------

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

[FR Doc. 01-23227 Filed 9-17-01; 8:45 am]
BILLING CODE 6560-50-S