[Federal Register Volume 66, Number 70 (Wednesday, April 11, 2001)]
[Rules and Regulations]
[Pages 18725-18733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8931]


=======================================================================
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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 [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not 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

[[Page 18726]]

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 m, 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
----------------------------------------------------------------------------------------------------------------

[[Page 18728]]

 
870.5265                                 Gene Mutation               Non-mutagenic when tested up to 5,000
                                                                      g/plate, in presenceand absence
                                                                      of activation, in S. typhimurium.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Cytogenetics                Non-mutagenic at the HGPRT locus in CHO
                                                                      cells tested upto 65 g/mL, in
                                                                      presence and absence of activation.
----------------------------------------------------------------------------------------------------------------
870.5375                                 Chromosome aberration       Did not induce structural chromosome
                                                                      aberration up to limitof toxicity (100
                                                                      g/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 (MOEcancer = 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:

[[Page 18729]]



      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

[[Page 18730]]

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 g/L 
for the annual peak concentration (acute) for grape and potato uses, 
respectively, and 48.3 and 45.1 g/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 g/L and from potatoes is not 
likely to exceed 20.9 g/L. The 1 in 10 year annual average 
concentration (non-cancer chronic) of zoxamide residues from grapes is 
not likely to exceed 21.8 g/L and from potatoes is not likely 
to exceed 6.2 g/L. The 36 year annual average concentration 
(cancer chronic) of zoxamide residues from grapes is not likely to 
exceed 12.4 g/L and from potatoes is not likely to exceed 4.1 
g/L.
     The SCI-GROW predicted concentration of zoxamide in shallow ground 
water is not expected to exceed 0.064 g/L. The SCI-GROW 
predicted concentration of zoxamide residues (zoxamide + degradation 
products) in shallow ground water is not expected to exceed 2.07 
g/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

[[Page 18731]]

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 
g/L for the U.S. population and 4,800 g/L for the 
most highly exposed subpopulation (children 1-6 years old). The chronic 
EECs (highest 48.3 g/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: [email protected]. 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.

[[Page 18732]]

    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: 
[email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and

[[Page 18733]]

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]
BILLING CODE 6560-50-S