[Federal Register Volume 66, Number 2 (Wednesday, January 3, 2001)]
[Rules and Regulations]
[Pages 298-306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301085; FRL-6757-9]
RIN 2070-AB78


Myclobutanil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of myclobutanil in or on sugarbeet roots, tops and 
by-products. This action is in response to the declaration of a crisis 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on sugarbeets in the state of Idaho. This regulation establishes a 
maximum permissible level for residues of myclobutanil in these food 
commodities. The tolerances will expire and are revoked on December 31, 
2002.

DATES: This regulation is effective January 3, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301085, 
must be received by EPA on or before March 5, 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 VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301085 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9364; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

[[Page 299]]



------------------------------------------------------------------------
                                                          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 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/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301085. 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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for combined residues of the 
fungicide myclobutanil in or on beet, sugar, roots at 0.05 part per 
million (ppm); beet, sugar, tops at 1.0 ppm; beet, sugar, dried pulp at 
1.0 ppm; beet, sugar, molasses at 1.0 ppm; and beet, sugar, refined 
sugar at 0.70 ppm. These tolerances will expire and are revoked on 
December 31, 2002. EPA will publish a document in the Federal Register 
to remove the revoked tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) 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. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from 
any provision of FIFRA, if EPA determines that ``emergency conditions 
exist which require such exemption.'' This provision was not amended by 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Myclobutanil on Sugarbeets and FFDCA 
Tolerances

     EPA has authorized under FIFRA section 18 the use of myclobutanil 
on sugarbeets for control of powdery mildew in Idaho. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of myclobutanil in or on 
sugar beets and sugar beet byproducts. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerance under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. Consistent with the 
need to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing these tolerances without notice and 
opportunity for public comment as provided in section 408(l)(6). 
Although these tolerances will expire and are revoked on December 31, 
2002, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerances remaining in or on 
sugar beets and the sugar beet byproducts after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by these tolerances at the time of that application. EPA will take 
action to revoke these tolerances earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether myclobutanil 
meets EPA's registration requirements for use on sugarbeets or whether 
permanent tolerances for this use would be

[[Page 300]]

appropriate. Under these circumstances, EPA does not believe that these 
tolerances serve as a basis for registration of myclobutanil by a State 
for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for any State other than Idaho to use 
this pesticide on this crop under section 18 of FIFRA without following 
all provisions of EPA's regulations implementing section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemption for myclobutanil, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), 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 
myclobutanil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
combined residues of myclobutanil in or on beet, sugar, roots at 0.05 
ppm; beet, sugar, tops at 1.0 ppm; beet, sugar, dried pulp at 1.0 ppm; 
beet, sugar, molasses at 1.0 ppm; and beet, sugar, refined sugar at 
0.70 ppm.
    EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerances follows.

A. 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 endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (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 level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1x10-\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 myclobutanil used for human risk assessment is shown in 
the following Table 1:

     Table 1.--Summary of Toxicological Dose and Endpoints for Myclobutanil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF\1\ and LOC for  Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk  Assessment             Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of   NOAEL = 60 mg/kg/day UF  FQPA SF = 1 aPAD =       Developmental Toxicity
 age                                    = 100 Acute RfD = 0.60   acute RfD FQPA SF =       rabbit\2\ LOAEL = 200
                                        mg/kg/day                0.60 mg/kg/day           mg/kg/day based on
                                                                                          increased resorptions,
                                                                                          decreased litter size
                                                                                          and a decrease in the
                                                                                          viability index.
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       none                     not applicable           not applicable
 including infants and children
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 2.49 mg/kg/day    FQPA SF = 1 cPAD =       Chronic Toxicity/
                                        UF = 100 Chronic RfD =   chronic RfD FQPA SF =    Carcinogenicity - rat
                                        0.025 mg/kg/day          0.025 mg/kg/day          LOAEL = 9.94 mg/kg/day
                                                                                          based on decreased
                                                                                          testicular weights and
                                                                                          increased testicular
                                                                                          atrophy.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1-7 days)           dermal study NOAEL= 100  Acceptable MOE = 100     28-day Dermal Toxicity-
 (Occupational/Residential)             mg/kg/day                (Occupational)           rat LOAEL = >100 mg/kg/
                                                                 Acceptable MOE = 100     day based on no signs
                                                                 (Residential, includes   of toxicity at the
                                                                 the FQPA SF)             high dose of 100 mg/kg
                                                                                          a.i.
----------------------------------------------------------------------------------------------------------------

[[Page 301]]

 
Intermediate-Term Dermal (1 week-      oral study NOAEL= 10 mg/ Acceptable MOE = 100     2-Generation
 several months) (Occupational/         kg/day (dermal           (Occupational)           Reproduction Toxicity
 Residential)                           absorption rate = 50%)   Acceptable MOE = 100      rat LOAEL = 50 mg/kg/
                                                                 (Residential, includes   day based on atrophy
                                                                 the FQPA SF)             of the testes and
                                                                                          prostate as well as an
                                                                                          increase in the number
                                                                                          of stillborn pups and
                                                                                          a decrease in pup
                                                                                          weight gain during
                                                                                          lactation.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months -     oral study NOAEL= 2.49   Acceptable MOE = 100     Chronic Toxicity/
 lifetime) (Occupational/Residential)   mg/kg/day (dermal        (Occupational)           Carcinogenicity - rat
                                        absorption rate = 50%)   Acceptable MOE = 100     LOAEL = 9.94 mg/kg/day
                                                                 (Residential, includes   based on decreased
                                                                 the FQPA SF)             testicular weights and
                                                                                          increased testicular
                                                                                          atrophy.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1-7 days)       oral study NOAEL= 10 mg/ Acceptable MOE = 100     2-Generation
 (Occupational/Residential)             kg/day (inhalation       (Occupational)           Reproduction Toxicity
                                        absorption rate =        Acceptable MOE = 100      rat LOAEL = 50 mg/kg/
                                        100%)                    (Residential, includes   day based on atrophy
                                                                 the FQPA SF)             of the testes and
                                                                                          prostate as well as an
                                                                                          increase in the number
                                                                                          of stillborn pups and
                                                                                          a decrease in pup
                                                                                          weight gain during
                                                                                          lactation.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week - oral study NOAEL= 10 mg/ Acceptable MOE = 100     2-Generation
  several months) (Occupational/        kg/day (inhalation       (Occupational)           Reproduction Toxicity
 Residential)                           absorption rate =        Acceptable MOE = 100      rat LOAEL = 50 mg/kg/
                                        100%)                    (Residential, includes   day based on atrophy
                                                                 the FQPA SF)             of the testes and
                                                                                          prostate as well as an
                                                                                          increase in the number
                                                                                          of stillborn pups and
                                                                                          a decrease in pup
                                                                                          weight gain during
                                                                                          lactation.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months - oral study NOAEL= 2.49   Acceptable MOE = 100     Chronic Toxicity/
  lifetime) (Occupational/              mg/kg/day (inhalation    (Occupational)           Carcinogenicity - rat
 Residential)                           absorption rate =        Acceptable MOE = 100     LOAEL = 9.94 mg/kg/day
                                        100%)                    (Residential, includes   based on decreased
                                                                 the FQPA SF)             testicular weights and
                                                                                          increased testicular
                                                                                          atrophy.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Group E''              not applicable           not applicable
----------------------------------------------------------------------------------------------------------------
\1\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.
\2.\ The HIARC document (dated 9/2/99) table incorrectly lists this as rat.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.443) for the combined residues of myclobutanil, 
[-butyl--(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile] plus its alcohol metabolite [-(3-
hydroxybutyl)--(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile] (free and bound), in or on a variety of raw 
agricultural commodities at levels ranging from 25.0 ppm in raisin 
waste to 0.02 ppm in cottonseed. Tolerances have also been established 
(40 CFR 180.443(b)) for the combined residues of myclobutanil plus its 
alcohol metabolite (free and bound) and diol metabolite [-(4-
chlorophenyl)--(3,4-dihydroxybutyl)-1H-1,2,4-triazole-1-
propanenitrile], in meat, milk, poultry and eggs, at levels ranging 
from 0.02 ppm to 1.0 ppm. Risk assessments were conducted by EPA to 
assess dietary exposures from myclobutanil in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. 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 acute exposure assessments: The acute analysis was performed 
for females 13-50 years old using published and proposed tolerance 
level residues and 100% CT for all commodities. Therefore, the acute 
risk was analyzed at the 95th percentile. The aPAD for females 13-50 
years old is 0.6 mg/kg/day. For acute dietary risk, EPA's level of 
concern is >100% aPAD. No acute dietary exposure analysis was performed 
for the general U.S. population, including infants and children, 
because no endpoint was chosen for these population subgroups.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the 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

[[Page 302]]

the chronic exposure assessments: The chronic analysis was performed 
using published and proposed tolerance levels for all commodities. For 
the chronic analysis, percent CT information was used for apples, 
apricots, cherries, grapes, nectarines, peaches, pears, plums, and 
cotton and 100% CT was assumed for all other commodities.
    iii. Anticipated residue and percent crop treated information. 
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 PCT information as follows: apples at 40%, apricots 
at 15%, cherries at 40%, grapes at 45%, nectarines at 20%, peaches at 
10%, plums at 15% and cotton at 1%.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. 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 myclobutanil 
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 myclobutanil 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 myclobutanil.
    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 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 myclobutanil they are 
further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of myclobutanil for acute exposures are estimated 
to be 115 parts per billion (ppb) for surface water and 2 ppb for 
ground water. The EECs for chronic exposures are estimated to be 92 ppb 
for surface water and 2 ppb for ground water.
    3. From non-dietary exposure. Myclobutanil is currently registered 
for use on the following residential non-dietary sites: Homeowner use 
on turf, roses, flowers, shrubs and trees. The term ``residential 
exposure'' is used in this document to refer to non- occupation, 
nondietary exposure resulting from pesticide uses in residential 
settings (e.g., pesticide uses for lawn and garden pest control, indoor 
pest control, termiticides, and flea and tick control on pets.) The 
risk assessment was conducted using the following exposure assumptions:
    i. Residential handler exposure. Based on the residential use- 
patterns associated with myclobutanil, there is potential for exposures 
to handlers of myclobutanil. In order to present a high-end scenario of 
residential exposure, it was assumed that one person would complete all 
mixing, loading and application of myclobutanil. Exposure scenarios 
were assessed, at the maximum application rate, for mixing, loading, 
and application of a soluble concentrate product by trigger bottle 
sprayer (treating ornamental plants), and by hose-end sprayer (treating 
turfgrass) to represent the worst-case scenario for the proposed uses. 
There are no chemical specific data available

[[Page 303]]

to support the residential use scenarios of myclobutanil. Therefore, 
modeling (PHED v 1.1 surrogate table) was used to represent the highest 
potential for exposure from homeowner application of myclobutanil.
    ii. Residential post application exposure. Potential residential 
exposures are expected following applications to lawns, ornamentals and 
home garden sites. Chemical-specific data are available to determine 
the potential risks from post-application activities. The registrant 
submitted a dislodgeable foliar residue (DFR) study on grapes for 
myclobutanil. Short-term post-application exposure estimates were done 
using the study determined DFR of 0.175 g/cm\2\ (on day 0). 
For intermediate-term post-application exposure, an average of DFRs 
from day 0 through day 14 was used. The post-application risk 
assessment is based on DFR data from the submitted study on grapes and 
generic assumptions as specified by the recently revised Residential 
SOPs.
    Based on the use pattern, exposure to myclobutanil-treated 
ornamentals is expected to be incidental and short-term. Both short- 
and intermediate-term exposures are expected following lawn 
applications of myclobutanil. Short-term aggregate post-application 
exposure for the adult was done for dermal exposure to treated turf and 
ornamentals. Since there is no intermediate-term exposure for the 
residential handler, there is no aggregate intermediate-term exposure 
for the adult.
    Short-term, non-dietary ingestion exposure to toddlers is not 
assessed since EPA did not detect an acute dietary or oral endpoint 
applicable to infants and children. Therefore, EPA does not expect 
short-term non-dietary exposure to pose a risk to infants and children. 
The only short-term toddler exposure that was considered consists of 
dermal post-application exposure. However, EPA determined that the 
short-term dermal exposure should not be aggregated with the short-term 
oral exposure because the toxic effects are different.
    Additionally, intermediate-term, non-dietary ingestion exposure for 
toddlers is possible and was assessed using the intermediate-term dose 
and endpoint identified from the two generation reproduction toxicity 
study in rats. Intermediate-term aggregate exposure for toddlers 
combines non-dietary ingestion and dermal exposure from treated turf.
    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 myclobutanil 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, 
myclobutanil 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 myclobutanil 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).

C. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the 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.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility in the developmental toxicity studies with 
rats and rabbits. The data from the 2-generation reproduction study in 
rats provided no indication of quantitative or qualitative increased 
susceptibility since maternal toxicity and reproductive toxicity 
occurred at the same dose.
    3. Conclusion. There is a complete toxicity data base for 
myclobutanil and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures.
    EPA determined that the 10X safety factor to protect infants and 
children should be removed. The FQPA factor is removed because:
    i. There are no toxicity or residential exposure data gaps in the 
consideration of the FQPA Safety Factor;
    ii. There was no evidence of increased susceptibility in the 
developmental toxicity studies with rats and rabbits and the 2-
generation reproduction study in rats provided no indication of 
quantitative or qualitative increased susceptibility since maternal 
toxicity and reproductive toxicity occurred at the same dose;
    iii. A developmental neurotoxicity study is not required because 
neurotoxic compounds of similar structure were not identified and there 
was no evidence of neurotoxicity in the current toxicity data base; and
    iv. The exposure assessments will not underestimate the potential 
dietary (food and drinking water) and residential (non-occupational) 
exposures for infants and children from the use of myclobutanil.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 Liters (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.

[[Page 304]]

    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to myclobutanil 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 
myclobutanil on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
myclobutanil will occupy 2% of the aPAD for females 13 years and older. 
In addition, despite the potential for acute dietary exposure to 
myclobutanil in drinking water, after calculating DWLOCs and comparing 
them to conservative model estimated environmental concentrations of 
myclobutanil in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in the 
following Table 2:

                     Table 2.--Aggregate Risk Assessment for Acute Exposure to myclobutanil
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      %aPAD      Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years)                                0.60            2          115            2        18000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
myclobutanil from food will utilize 18% of the cPAD for the U.S. 
population, 50% of the cPAD for infants 1 year old and 54% of the cPAD 
for children 1 to 6 years old. There are no residential uses for 
myclobutanil that result in chronic residential exposure to 
myclobutanil. In addition, despite the potential for chronic dietary 
exposure to myclobutanil in drinking water, after calculating DWLOCs 
and comparing them to conservative model estimated environmental 
concentrations of myclobutanil in 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 myclobutanil
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.025           18           31            2          720
All infants (1 year old)                               0.025           50           31            2          130
Children 1 to 6 years                                  0.025           54           31            2          120
Children 7 to 12 years                                 0.025           27           31            2          180
----------------------------------------------------------------------------------------------------------------

    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). EPA has determined that 
oral and dermal exposures can not be aggregated due to differences in 
the toxicological endpoints via the oral (developmental study) and 
dermal routes. Therefore, short-term aggregate risk is captured by 
assessment of acute risk above.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Myclobutanil is currently registered for use(s) that could 
result in intermediate-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic food and water 
and intermediate-term exposures for myclobutanil.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 650 for 
the U.S. population and 300 for infants and children. These aggregate 
MOEs do not exceed the Agency's level of concern for aggregate exposure 
to food and residential uses. In addition, intermediate-term DWLOCs 
were calculated and compared to the EECs for chronic exposure of 
myclobutanil in ground water and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect intermediate-term aggregate exposure to exceed the 
Agency's level of concern, as shown in the following Table 4:

               Table 4.--Aggregate Risk Assessment for Intermediate-Term Exposure to myclobutanil
----------------------------------------------------------------------------------------------------------------
                                                Aggregate    Aggregate
                                              MOE  (Food +    Level of     Surface       Ground    Intermediate-
             Population Subgroup                              Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        650          100           31            2          3000
Infants and Children                                   300          100           31            2           670
----------------------------------------------------------------------------------------------------------------


[[Page 305]]

    5. Aggregate cancer risk for U.S. population. Myclobutanil is not 
carcinogenic in either the rat or mouse and, therefore, is not expected 
to pose a cancer risk to humans.
    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 myclobutanil residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method (Rohm and Haas Method 34S-88-10) is 
available to enforce the proposed tolerances. Quantitation is by GLC 
using a nitrogen/phosphorus detector for myclobutanil and an electron 
capture detector (Ni63) for residues measured as the alcohol 
metabolite. 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 no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRL) for myclobutanil on sugar beets. Thus, harmonization is not an 
issue for this section 18.

C. Conditions

    For permanent tolerances and a section 3 registration, the 
petitioner must submit adequate residue field trial data. A final 
decision on the appropriate tolerance levels will be withheld pending 
submission of the requisite residue data. The submitted residue data 
support a 28-day PHI. No processed commodity data were submitted in 
support of the emergency exemption request. Therefore, in order to 
represent the worst case scenario, maximum theoretical concentration 
factors were used to determine the appropriate tolerances on sugar beet 
processed commodities. Adequate processed commodity data must be 
submitted for registration and permanent tolerances. Once these data 
are submitted and reviewed, EPA will determine if tolerances on sugar 
beet processed commodities are needed.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
myclobutanil, in or on beet, sugar, roots at 0.05 ppm; beet, sugar, 
tops at 1.0 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, 
molasses at 1.0 ppm; and beet, sugar, refined sugar at 0.70 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA 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-301085 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 March 5, 
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 VII.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 the docket control number OPP-301085, 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

[[Page 306]]

include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes time limited tolerances under FFDCA 
section 408. 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). 
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 from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under FFDCA section 408, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and 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).

IX. 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: December 19, 2000.
James Jones,
Director, Registration Division, 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 180.443 is amended by alphabetically adding commodities 
to the table in paragraph (b) to read as follows:


Sec. 180.443  Myclobutanil; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
                 *        *        *        *          *
Beet, sugar, dried pulp           1.0                 12/31/02
Beet, sugar, molasses             1.0                 12/31/02
Beet, sugar, refined sugar        0.70                12/31/02
Beet, sugar, roots                0.05                12/31/02
Beet, sugar, tops                 1.0                 12/31/02
                  *        *        *        *        *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-26 Filed 1-2-01; 8:45 am]
BILLING CODE 6560-50-S