PMEP Home Page --> Pesticide Active Ingredient Information --> Fungicides and Nematicides --> Fungicides, T to Z --> Zoxamide --> Zoxamide - Pesticide Tolerance 3/01

Zoxamide - Pesticide Tolerance 3/01

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301110; FRL-6774-8]
RIN 2070-AB78
Zoxamide 3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-
4-methylbenzamide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for the combined
residues of zoxamide and its metabolites 3,5-dichloro-1,4-
benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-
hydroxymethylbenzoic acid (RH-1452 and RH-141452) in or on potato,
tuber; potato, granule/flake; potato, wet peel and residues of zoxamide
in or on grape; and grape, raisins. Rohm and Haas requested these
tolerances under the Federal Food, Drug, and Cosmetic Act, as amended
by the Food Quality Protection Act of 1996.

DATES: This regulation is effective April 11, 2001. Objections and
requests for hearings, identified by docket control number OPP-301110
must be received by EPA on or before June 11, 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-301110 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: CynthiaGiles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-7740; and e-mail
address: Cynthia Giles-Parker@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                 Examples of potentially

             Categories                 NAICS       affected entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not thisaction 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. A frequently updated electronic version of 40 CFR part
180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/
Title_40/40cfr--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-301110. 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 1, 1999 (64 FR 47795) (FRL-
6096-8), 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 a pesticide petition (PP) for tolerance by
Rohm and Haas. This notice included a summary of the petition prepared
by Rohm and Haas, the registrant. There were no comments received in
response to thenotice of filing.
    The petition requested that 40 CFR part 180 be amended by
establishing tolerances for combined residues of the fungicide zoxamide
3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2- oxopropyl)-4-
methylbenzamide, and its metabolites in or on grapes, raisins and
potatoes at 5.0, 15.0 and 0.1 part per million (ppm), respectively.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information." This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to "ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue...."
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for the combined residues of zoxamide and its
metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-
141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-
141452) in or on potato, tuber at 0.060 ppm; potato, granule/flake at
0.30 ppm; potato, wet peel at 0.10 ppm and zoxamide in or on grape at
3.0 ppm; grape, raisins at 15 ppm. Several of the tolerances that are
being established by this rule ae different from those proposed by Rohm
and Haas. EPA's review of the data submitted by the company lead to an
Agency decision to modify the proposed tolerances. 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 zoxamide are
discussed in Table 2 below as well as the no observed adverse effect
level (NOAEL) and the lowest observed adverse effect level (LOAEL) from
the toxicity studies reviewed.
    Zoxamide has low acute toxicity (Toxicity Category IV for acute
oral, inhalation toxicity and Category III for acute dermal toxicity
and ocular irritation). Zoxamide is considered to be a dermal
sensitizer, but it is not a skin irritant (Toxicity Category IV). In
addition, a concern was identified for the potential of zoxamide to be
an inhalation sensitizer for the following reasons: (1) up to 50% of
the wettable powder formulation's dispersed particle size is less than
5 μm, and thus inhalable to the alveolar region in humans; and
(2) zoxamide's mechanism of action is binding to tubulin, and therefore
may bind to other proteins. See Table 1 for a discussion of EPA's our
findings.

                          Table 1.--Acute Toxicity of Zoxamide--Technical (RH-117,281)
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type Results           Toxicity Category
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute Oral-Rat LD50 > 5,000 mg/kg (males                 IV
and females, combined)
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute-Oral-Mouse LD50 > 5,000 mg/kg (males                 IV
and females, combined)
----------------------------------------------------------------------------------------------------------------
870.1200                                 Acute Dermal-Rat LD50 > 2,000 mg/kg (males                III
and females, combined)
----------------------------------------------------------------------------------------------------------------

[[Page 18727]]

870.1300                                 Acute Inhalation-Rat LC50 > 5.3 mg/L (males                    IV
and females, combined)
----------------------------------------------------------------------------------------------------------------
870.2400                                 Primary Eye Irritation- Moderate irritant;                       III
                                          Rabbit Corneal opacity on 6/6
rabbits with resolution
by day 7. Iritis on 1/6
rabbits at 24 hours with
resolution by 48 hours.
Conjunctivitis on all
rabbits at one hour with
resolution by day 7.
----------------------------------------------------------------------------------------------------------------
870.2500                                 Primary Skin Irritation- Not an irritant                           IV
                                          Rabbit
----------------------------------------------------------------------------------------------------------------
870.2600                                 Dermal Sensitization: Strong sensitizer.                        NA
                                          Maximization-Guinea pig Maximization Test: 100%
treated showed erythema.
----------------------------------------------------------------------------------------------------------------
870.2600                                 Dermal Sensitization: Strong sensitizer.                        NA
                                          Buehler's Method-Guinea Buehler's Test: 80-90%
                                          pig treated showed erythema,
grade 3 out of possible
4, appearing at 3rd
induction phase and
challenge phase.
----------------------------------------------------------------------------------------------------------------

    The primary target organ for oral exposure is the liver. In chronic
and subchronic dog studies, liver and thyroid weights were increased
along with liver histopathological changes and increases in alkaline
phosphatase in the chronic study. There was no evidence of
developmental or reproductive toxicity. The data demonstrate no
increase sensitivity of rats or rabbits to in utero or early postnatal
exposure to zoxamide. Carcinogenicity studies in rats and mice did not
show increased incidence of spontaneous tumor formation. Zoxamide is
classified as "not likely" human carcinogen. There was no evidence of
neurotoxicity in the acute or subchronic neurotoxicity studies or in
any other study in the data base. The toxicity data base for zoxamide
is complete. See the following Table 2 for a discussion EPA's findings.

                                Table 2.--Toxicity Profile of Zoxamide Technical
----------------------------------------------------------------------------------------------------------------

                                           Study Type (All Studies
             Guideline No.                       Acceptable) Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity NOAEL = 1,666 mg/kg/day; LOAEL not
                                          rodents-mouse established
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in NOAEL = 62 mg/kg/day in females, 281 mg/kg/
                                          nonrodents-dog day in males.LOAEL = 322 mg/kg/day in
females and 1,139 mg/kg/day in males based
on increased liver weights, hepatocellular
hypertrophy (males), decrease inalbumin
and albumin/golbulin ratios (males).
----------------------------------------------------------------------------------------------------------------
870.3200                                 28-Day dermal toxicity-rat Systemic: NOAEL 1,000 mg/kg, LOAEL not
established; Dermal: NOAEL not established
LOAEL < 150 mg/kg/day based on dermal
scabbing increase with dosage in males and
females, and epidermis of treated skin
sites showed hyperplasia, hyperkeratosis,
and inflammation.
----------------------------------------------------------------------------------------------------------------
870.3700a                                Prenatal developmental in Maternal NOAEL = 1,000 mg/kg/day; LOAEL >
                                          rodents-rat 1,000 mg/kg/day. Developmental NOAEL =
1,000 mg/kg/day LOAEL > 1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental in Maternal NOAEL = 1,000 mg/kg/day; LOAEL >
                                          nonrodents-rabbit 1,000 mg/kg/day. Developmental NOAEL =
1,000 mg/kg/day; LOAEL > 1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility Parental/Systemic NOAEL = 409 mg/kg/day in
                                          effects-rat females, 1,474 mg/kg/day in males; LOAEL =
1,624 mg/kg/day based on female decreased
body weight and body weight gains.
Reproductive NOAEL  2,091 mg/kg/day in
males, 2,239 mg/kg/day in females; LOAEL =
not established.Offspring NOAEL  2,091 mg/
kg/day in males, 2,239 mg/kg/day in
females; LOAEL = not established.
----------------------------------------------------------------------------------------------------------------
870.4100b                                Chronic toxicity dogs NOAEL = 50 mg/kg/day in males, 48 mg/kg/day
in females; LOAEL = 255 mg/kg/day in
males, 278 mg/kg/day in females based on
decreased body weights, increased liver
and thyroid weights, and increased
alkaline phosphatase.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Chronic/Carcinogenicity NOAEL = 1,058 mg/kg/day; LOAEL = not
                                          rats established. No evidence of
carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice NOAEL = 1,021 mg/kg/day in males, 1,289 mg/
kg/day infemales; LOAEL = not established.
No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------

870.5265                                 Gene Mutation Non-mutagenic when tested up to 5,000
μg/plate, in presenceand absence
of activation, in S. typhimurium.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Cytogenetics Non-mutagenic at the HGPRT locus in CHO
cells tested upto 65 μg/mL, in
presence and absence of activation.
----------------------------------------------------------------------------------------------------------------
870.5375                                 Chromosome aberration Did not induce structural chromosome
aberration up to limitof toxicity (100
μg/mL), but did induce increased
levels of numericalaberrations, in
presence and absence of activation.
----------------------------------------------------------------------------------------------------------------
870.5395                                 Micronucleus Non-mutagenic in mouse bone marrow
micronucleus assayup to 2,000 mg/kg.
----------------------------------------------------------------------------------------------------------------
870.6200a                                Acute neurotoxicity NOAEL = 2,000 mg/kg/day; LOAEL = not
                                          screening battery-rat established.
----------------------------------------------------------------------------------------------------------------
870.6200b                                Subchronic neurotoxicity NOAEL = 1,509 mg/kg/day in males, 1,622 mg/
                                          screening battery-rat kg/day in females; LOAEL = not
established.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and 120 hours post-dosing, 96-102% recovered
                                          pharmacokinetics - rat from the low and high single-dose groups.
Fecal excretion was the primary route of
elimination. Parent compound was the
principal component excreted, a total of
36 metabolites were detected in the urine
and feces.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration-rat Total dermal absorption rate after 10-hour
is 8.8% (includes amount on skin after
                                                                      wash).
----------------------------------------------------------------------------------------------------------------

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. The
Agency evaluated the available hazard and exposure data for zoxamide
and made the recommendation for the FQPA safety factor to be used in
human health risk assessments (as required by the FQPA of August 3,
1996). The Agency concluded that the FQPA safety factor could be
removed (i.e., reduced to 1x) in assessing the risk posed by this
chemical because:
    1. There is no indication of quantitative or qualitative increased
susceptibility of rats or rabbits to in utero and/or postnatal
exposure.
     2. A developmental neurotoxicity study conducted with zoxamide is
not required.
     3. The dietary (food and drinking water) exposure assessments will
not underestimate the potential exposures for infants and children.
Additionally, there are currently no residential uses.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10**6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
"point of departure" is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE-cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for zoxamide used for human risk assessment is shown in the
following Table 3:

      Table 3.-- Summary of Toxicological Dose and Endpoints for Zoxamide for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk Concern for Risk     Study and Toxicological
                                            Assessment, UF Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       None                     None No appropriate endpoint
 including infants and children was identified by the
Hazardous Assessment
Review Committee on 11/
18/99 for acute
dietary exposure.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 48 mg/kg/day; UF  FQPA SF = 1X; cPAD =     Chronic Toxicity Study
                                        = 100; Chronic RfD = chronic Rfd/FQPA SF =     Dog (MRID 44731817)
                                        0.48 mg/kg/day           0.48 mg/kg/day           LOAEL in males/females
= 255/277 mg/kg/day
based on body weight
changes, increases in
liver and thyroid
weights, and increases
in alkaline
phosphatase.
----------------------------------------------------------------------------------------------------------------
Short-, Intermediate-, and Long-Term   None                     No systemic toxicity     28-Day Repeated Dose
 Dermal (Occupational/ Residential)                              was seen at the limit    Dermal - Rat (MRID
                                                                 dose (1000 mg/kg/day).   44731818)
----------------------------------------------------------------------------------------------------------------

Any time period Inhalation             Oral NOAEL= 48 mg/kg/    LOC for MOE = 100        Chronic Toxicity Study
 (Occupational/ Residential)            day Use route-to-route (Occupational/            Dog (MRID 44731817)
                                        extrapolation Residential)             LOAEL in males/females
                                        (inhalation absorption = 255/277 mg/kg/day
                                        rate = 100% of oral) based on body weight
changes, increases in
liver and thyroid
weights, and increases
in alkaline
phosphatase.
----------------------------------------------------------------------------------------------------------------
* 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. Tolerances are being
established under 40 CFR part 180 for the combined residues of zoxamide
and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455
and RH-141455) and (3,5-dichloro-1,-4-hydroxymethylbenzoic acid (RH-
1452 and RH-141452), in or on potato and zoxamide in or on grape raw
agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures from zoxamide 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. Based on available data, a suitable endpoint for
acute dietary risk assessment was not identified since no effects were
observed in oral toxicity studies (including developmental studies)
which could be attributed to a single-dose exposure. Therefore, an
acute dietary risk assessment 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 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 Tier I chronic DEEM® analysis was performed. The
assumptions of this Tier I analysis were tolerance level residues and
100 percent crop-treated. The following tolerance levels were used in
the analysis: grapes at 3.0 ppm, raisins at 15.0 ppm, potatoes at 0.060
ppm, potato flakes and chips at 0.30 ppm, and potato wet peel at 0.10
ppm. Since the tolerance levels for processed commodities used in the
analysis were based upon processing studies, default concentration
factors for grape juice; raisins; wine and sherry; potatoes, white-dry;
potatoes, white peeled; and potatoes, white peel only, were set to 1x.
     The chronic dietary exposure (food only) to zoxamide for some
population subgroups are presented in the following Table 3. The
resulting dietary food exposures occupy <1% of the Chronic PAD for all
population subgroups included in the analysis, except for Children (1
to 6 years old) which is the highest exposed subgroup. The exposure for
Children (1 to 6 years old) utilizes 1% of the cPAD. The results of
this dietary exposure analysis should be viewed as very conservative
(health protective). Refinements such as use of percent crop-treated
information and/or anticipated residue values would yield even lower
estimates of chronic dietary exposure.

              Table 4.--Chronic Dietary Exposure Estimates
------------------------------------------------------------------------
                                                 Exposure,    % cPADpad
            Population subgroup \1\              mg/kg/day       \2\
------------------------------------------------------------------------
U.S. population                                      0.0015         <1.0
------------------------------------------------------------------------
All infants(<1 year)                                 0.0038         <1.0
------------------------------------------------------------------------
Children 1-6 yrs \3\                                 0.0050          1.0
------------------------------------------------------------------------
Children 7-12 yrs                                    0.0015         <1.0
------------------------------------------------------------------------
Females 13-50 yrs                                    0.0011         <1.0
------------------------------------------------------------------------
Males 13-19 yrs                                     0.00064         <1.0
------------------------------------------------------------------------
Males 20+ yrs                                       0.00092         <1.0
------------------------------------------------------------------------
Seniors 55+                                          0.0011         <1.0
------------------------------------------------------------------------
\1\ The subgroups listed are: (1) the U.S. Population (total); (2) those
  for infants and children; and, (3) the most highly exposed of the
  adult females and males subgroups (in this case, Females, ≤13 years, nursing)
\2\ Percent Chronic PAD = (Exposure / Chronic PAD) x 100%.
\3\ There are no other subgroups, with the exception of Children, 1 to 6
  years old, for which the percentage of the Chronic PAD occupied is
  greater than that occupied by the subgroup U. S. Population (total).

     iii.  Cancer. Zoxamide is not mutagenic in Ames assays, in CHO
cells assay at the Hypoxonthine guanine phosphoribosyle transferase
(HGPRT) locus, and in the mouse bone marrow micronucleus assay.
Zoxamide did not induce structural chromosome aberrations in cultured
CHO cells treated up to the limit of toxicity, but
did induce increased levels of numerical aberrations. Carcinogenicity
studies in rat and mice did not show increased incidence of spontaneous
tumor formation. The Agency classified zoxamide as not likely to be a
human carcinogen. Thus, a cancer risk assessment is not required for
zoxamide.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for zoxamide 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 zoxamide.
    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.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow groundwater. For a screening-level assessment for surface water
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. While both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, 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 zoxamide they are further
discussed in the aggregate risk sections below.
    Based on the GENEEC and PRZM/EXAMS and SCI-GROW models the
estimated environmental concentrations (EECs) of zoxamide and its
degradates for acute and chronic exposures are as follows:
     Tier 1 (GENEEC) modeling estimates that zoxamide residues
(zoxamide + degradation products) in surface water, from aerial and
ground application, are not likely to exceed 61.1 and 57.0 μg/L
for the annual peak concentration (acute) for grape and potato uses,
respectively, and 48.3 and 45.1 μg/L for the 56 day average
concentration (chronic) for grape and potato uses, respectively.
     Tier 2 (PRZM/EXAMS) surface water modeling for zoxamide residues
(zoxamide + degradation products), using the index reservoir with the
percent cropped area (PCA=0.87 for grapes and potatoes), predicts the 1
in 10 year peak (acute) concentration of zoxamide residues from grapes
is not likely to exceed 77.7 μg/L and from potatoes is not
likely to exceed 20.9 μg/L. The 1 in 10 year annual average
concentration (non-cancer chronic) of zoxamide residues from grapes is
not likely to exceed 21.8 μg/L and from potatoes is not likely
to exceed 6.2 μg/L. The 36 year annual average concentration
(cancer chronic) of zoxamide residues from grapes is not likely to
exceed 12.4 μg/L and from potatoes is not likely to exceed 4.1
μg/L.
     The SCI-GROW predicted concentration of zoxamide in shallow ground
water is not expected to exceed 0.064 μg/L. The SCI-GROW
predicted concentration of zoxamide residues (zoxamide + degradation
products) in shallow ground water is not expected to exceed 2.07
μg/L.start
    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). Zoxamide 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 zoxamide 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,
zoxamide 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 zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-
methyl-2-oxopropyl)-4-methylbenzamide 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
database on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA 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. Conclusion. There is a complete toxicity database for zoxamide
and exposure data are complete or are estimated based on data that
reasonably account for potential exposures. EPA determined that the 10X
safety factor to protect infants and children should be removed (i.e.
reduced to 1x). The FQPA factor is removed because:
    i. There is no indication of quantitative or qualitative increased
susceptibility of rats or rabbits to in utero and/or postnatal
exposure;
    ii. A developmental neurotoxicity study conducted with zoxamide is
not required; and
    iii. The dietary (food and drinking water) exposure assessments
will not underestimate the potential exposures for infants and
children. Additionally, there are currently no residential uses.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Based on the data, EPA concluded that zoxamide does
not pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to zoxamide
from food will utilize <1% of the cPAD for the U.S. population, 1% of
the cPAD for children (1-6 years old). There are no residential uses
for zoxamide that result in chronic residential exposure to zoxamide.
    Chronic risk estimates resulting from aggregate exposure to
zoxamide in food and water are below the Agency's level of concern.
Surface and ground water EECs were used to compare against back-
calculated Drinking Water Levels of Comparison (DWLOCs) for the
aggregate assessment. For the chronic scenario, the DWLOCs are 17,000
μg/L for the U.S. population and 4,800 μg/L for the
most highly exposed subpopulation (children 1-6 years old). The chronic
EECs (highest 48.3 μg/L) are less than the Agency's DWLOCs for
zoxamide residues in drinking water as a contribution to chronic
aggregate exposure. EPA thus concludes with reasonable certainty that
residues of zoxamide in drinking water will not contribute
significantly to the aggregate chronic human health risk and that the
chronic aggregate exposure from zoxamide residues in food and drinking
water will not exceed the Agency's level of concern (100% of the
Chronic PAD) for chronic dietary aggregate exposure by any population
subgroup. EPA generally has no concern for exposures below 100% of the
Chronic PAD, because it is a level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to the
health and safety of any population subgroup. This risk assessment is
considered high confidence, very conservative, and very protective of
human health.
    3. Short-term risk. The Agency did not identify a short-term dermal
endpoint for zoxamide. There are no residential uses proposed for this
fungicide, short-term aggregate risk assessments based on exposure from
oral, inhalation, and dermal routes. For these reasons, no short-term
risk is expected.
    4. Intermediate-term risk. The Agency did not identify an
intermediate-term dermal endpoint for zoxamide. There are no
residential uses proposed for this fungicide, intermediate-term
aggregate risk assessments based on exposure from oral, inhalation and
dermal routes. For these reasons, no intermediate-term risk is
expected.
     5. Aggregate cancer risk for U.S. population. The Agency
classified zoxamide as not likely to be a human carcinogen. Therefore,
no cancer risk is expected.
     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 zoxamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed a method (TR 34-98-150, MRID No.
44732115) utilizing gas chromatography with electron capture detection
(GC/ECD) for enforcement of tolerances for zoxamide in/on grape and
grape processed commodities and Method TR 34-98-142 (MRID No. 44732114)
for enforcement of tolerances for zoxamide and its acid metabolites in/
on potatoes and potato processed commodities. Method TR 34-98-142
utilizes GC with mass selection detection (GC/MSD).
    For zoxamide and the two acid metabolites (RH-1452 and RH-1455),
in/on potato tubers and potato processed fractions, the GC/MSD method
is proposed as the primary method and the GC/ECD method as the
confirmatory method of analysis. The estimated limit of detection (LOD)
and validated limit of quantitation (LOQ) for the analysis of residues
of zoxamide and its acid metabolites in/on potato commodities, were
0.006 and 0.02 ppm, respectively. For zoxamide in/on grape commodities,
the GC/ECD method is proposed as the primary enforcement method and the
GC/MSD method is proposed as the confirmatory method of analysis. The
reported LOD and the validated LOQ for the analysis of zoxamide
residues in/on grape commodities were 0.003 and 0.01 ppm, respectively.
For both methods, each method of analysis may be used as the
confirmatory method for the other.
    The above methods are proposed for tolerance enforcement, and are
used as the data-collection methods in the analyses of samples obtained
from the field, processing, and storage stability studies. The
concurrent method recovery data indicate that the methods are adequate
for data collection. Both methods were successfully radiovalidated
using samples from the grape and potato metabolism studies. These
methods were also successfully validated by an independent laboratory.
     This method is currently being validated by the Analytical
Chemistry Branch Laboratories, BEAD (7503C), Office of Pesticide
Programs. Upon successful completion of the EPA validation and the
granting of this registration, the method will be forwarded to FDA for
publication in a future revision of the Pesticide Analytical Manual,
Vol-II (PAM-II). Prior to publication and upon request, the method will
be available prior to the harvest season from the Analytical Chemistry
Branch (ACB), BEAD (7503C) Environmental Science Center, 701 Mapes
Road,Ft. George C. Meade, MD 20755-5350. Contact Francis D. Griffith,
Jr., telephone (410) 305-2905, e-mail:
griffith.francis@epa.gov. The
analytical standars are also available from the EPA National Pesticide
Standard Repossitory at the same location.
    The petitioner submitted data concerning the recovery of residues
of zoxamide and its metabolites RH-1452 and RH-1455 using FDA multi-
residue method protocols (PAM Vol. I). Zoxamide was successfully
recovered using Protocols D and E. RH-1452 and RH-1452 RH-1455 did not
chromatograph acceptably on any of the GC columns tested. Therefore,
these would not be expected to be analyzable by Protocols D and E. The
methylation of the compounds produced derivatives that are analyzable
by GC but have poor and variable recoveries through Protocol B,
indicating that none of the protocols are suitable for the recovery of
either of the acid metabolites RH-1452 and RH-1455. The MRMs are
adequate for enforcement of the proposed tolerances for residues in/on
grapes, but not for potatoes. The submission will be forwarded to FDA
for complete evaluation.
    Adequate enforcement methodology (example: gas chromotography) is
available to enforce the tolerance expression. 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:
furlow.calvin@epa.gov.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican
maximum residue limits (MRLs) for residues of zoxamide in/on plant or
livestock commodities. Section F of the petition indicated that MRLs
are being sought in Canada and Mexico concurrently with this U.S.
registration. As the registration of zoxamide is a joint review with
Canada , the US tolerances and Canadian MRLs for Zoxamide in or on
grape and potato commodities will be set at identical levels.Therefore,
no compatibility issues exist with regard to the proposed U.S.
tolerances discussed in this petition review.

V. Conclusion

    Therefore, the tolerances are established for the combined residues
of zoxamide and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic
acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic
acid (RH-1452 and RH-141452), in or on potato, tuber; potato, granule/
flake; potato, wet peel at 0.060 ppm; 0.30 ppm; and 0.10 ppm,
respectively and zoxamide in or on grape at 3.0 ppm and grape, raisins
at 15 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-301110 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 June 11,
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 tompkins.jim@epa.gov,
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-301110, 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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, 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 special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
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: March 30, 2001.
Joseph J. Merenda,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.567 is added to read as follows:

Sec. 180.567  Zoxamide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grape......................................................          3.0
Grape, raisins.............................................         15.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of
zoxamide and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid
(RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid
(RH-1452 and RH-141452) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Potato, tuber..............................................        0.060
Potato, granule/flakes.....................................         0.30
Potato, wet peel...........................................         0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 01-8931 Filed 4-10-01; 8:45 am]