[Federal Register Volume 66, Number 187 (Wednesday, September 26, 2001)]
[Rules and Regulations]
[Pages 49110-49118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23640]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301176; FRL-6803-7]
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 a tolerance for 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 tomato and cucurbit vegetables 
group. Rohm and Haas Company requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996.

DATES: This regulation is effective September 26, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301176, 
must be received by EPA on or before November 26, 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-301176 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301176. 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 August 24, 2000, 65 FR 51612 (FRL-6739-
1), 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 9F5058) for tolerance by Rohm 
and Haas Company, 100 Independence Mall West, Philadelphia, PA 19108-
2399. This notice included a summary of the petition prepared by Rohm 
and Haas, the registrant. There were no comments received in response 
to the notice of filing. A correction to the notice of filing was 
published in the Federal Register on December 15, 2000, 65 FR 78490 
(FRL-6756-3).
    The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance 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 tomatoes and cucurbit 
vegetables group at 2.0 part per million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and

[[Page 49111]]

children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for combined residues of zoxamide and its 
metabolites 2,4-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-
141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-
141452) on tomatoes at 2.0 ppm and cucurbit vegetables group at 1.0 
ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by zoxamide are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                          Table 1. 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)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[Page 49112]]

 
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 in albumin
                                                                      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 in females; LOAEL = not
                                                                      established. No evidence of
                                                                      carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5265                                 Gene Mutation               Non-mutagenic when tested up to 5,000
                                                                      g/plate, in presence and absence
                                                                      of activation, in S. typhimurium.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Cytogenetics                Non-mutagenic at the HGPRT locus in CHO
                                                                      cells tested up to 65 g/mL, in
                                                                      presence and absence of activation.
----------------------------------------------------------------------------------------------------------------
870.5375                                 Chromosome aberration       Did not induce structural chromosome
                                                                      aberration up to limit of toxicity (100
                                                                      g/mL), but did induce increased
                                                                      levels of numerical aberrations, in
                                                                      presence and absence of activation.
----------------------------------------------------------------------------------------------------------------
870.5395                                 Micronucleus                Non-mutagenic in mouse bone marrow
                                                                      micronucleus assay up 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 intra species 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

[[Page 49113]]

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 development neurotoxicity study 
conducted with zoxamide is not required; and (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:

      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
                                                                                          HIARC on 11/18/99 for
                                                                                          acute dietary
                                                                                          exposure. Did not
                                                                                          identify hazard.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (all populations)      NOAEL= 48                FQPA                     Chronic Toxicity Study
                                       mg//kg/day.............  SF = 1x................    Dog
                                       UF = 100...............  cPAD = chronic RfD/FQPA  LOAEL in males/females
                                       Chronic RfD = 0.48.....   SF.                      = 255/277 mg/kg/day
                                       mg/kg/day..............  = 0.48 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
                                                                 dose (1000 mg/kg/day).
                                                                 Did not identify
                                                                 hazard.
----------------------------------------------------------------------------------------------------------------
Any time period Inhalation             oral NOAEL= 48           LOC for MOE = 100        Chronic Toxicity Study
 (Occupational/Residential)            mg/kg/day..............   (Occupational/            Dog
                                       Use route-to-route        Residential)            LOAEL in males/females
                                        extrapolation                                     = 255/277 mg/kg/day
                                        (inhalation absorption                            based on body weight
                                        rate = 100%).                                     changes, increases in
                                                                                          liver and thyroid
                                                                                          weights, and increases
                                                                                          in alkaline
                                                                                          phosphatase.
----------------------------------------------------------------------------------------------------------------
* UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowestobserved adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin ofexposure, LOC = level of concern. The reference to the FQPA Safety Factor refers to any
  additional safety factorretained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR part 180) for the combined residues of zoxamide and 
its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and 
RH141455) and (3,5-(dichloro-1,4-hydromethylbenzoic acid (RH-1452 and 
RH-141452, in or on potatoes and Zoxamide on grapes. 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. Chronic assessments use an average of the reported 
consumption values for each food form of a commodity multiplied by the 
residue concentration value, in this case a tolerance value, to 
estimate chronic dietary exposure.
    The Tier I chronic analysis for zoxamide is a conservative estimate 
of the dietary exposure using tolerance-level residues of 100% crop-
treated for all commodities. The chronic analysis was performed 
assuming tolerance level

[[Page 49114]]

residues for tomatoes and curcurbit vegetables at 2.0 and 1.0 ppm, 
respectively and 100% crop treated was assumed for all other 
commodites. The tolerance level residues for processed commodities were 
based on the actual processing data, the DEEM default concentration 
factors for tomato paste and puree were set to 1x. Residues did not 
concentrate in tomato processed fractions in this study. The highest 
resulting dietary estimate was 1.7% of the cPAD for children. 1-6 years 
old. For chronic dietary risk estimates the level of concern is >100% 
CPAD. Even without refinements, the estimated risk from chronic dietary 
exposure to zoxamide, as represented by the % cPAD, is below the level 
of concern for the population and all population subgroups.

              Table 4.--Chronic Dietary Exposure Estimates
------------------------------------------------------------------------
                                   Exposure, mg/kg/
     Population subgroup\1\               day              %cPAD\2\
------------------------------------------------------------------------
U.S. population                   0.0031              <1
All infants <1 year)              0.0018              <1
Children 1-6 yrs\3\               0.0084              1.7
Females 13-50 yrs                 0.0024              <1
Males 13-19 yrs                   0.0026              <1
------------------------------------------------------------------------
\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 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 for acute and 
chronic exposures are as follows:
    A drinking water risk assessment was not performed as the proposed 
use rates do not exceed those already assessed. Therefore new dietary 
risk estimates from drinking water sources were not performed. Drinking 
water monitoring data are not available for zoxamide. No new EECs were 
provided for cucurbits and tomatoes because the application rates for 
these new uses approaches the maximum rate for grapes.
    Tier I (GENEEC) modeling estimates that zoxamide residues (zoxamide 
+ degradation products) in surface water, from aerial and ground 
application, are not likely to exceed 48.3 and 45.1 g/L for 
the 56 day average concentration (chronic) for grape and potato uses, 
respectively. However, it is the Agency's policy to divide chronic Tier 
1 GENEEC EECs by a factor of 3 for comparison to DWLOCs. Therefore, the 
chronic surface water EECs based on GENEEC are 16.1 and 15 g/L 
for grape and potato uses, respectively.
    Tier II (PRZM/EXAMS) surface water modeling for zoxamide residues 
(zoxamide + degradation products), using the index reservoir with the 
percent cropped area, predicts the 1 in 10 year annual average (non-
cancer chronic) concentration 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 SCI-GROW predicted concentration of zoxamide residues (zoxamide 
+ degradation products) in shallow ground water is not expected to 
exceed 2.07 g/L.]
    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,

[[Page 49115]]

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. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Conclusion. There is a complete toxicity data base for zoxamide 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that the 
10x safety factor to protect infants and children should be removed. 
The FQPA factor is removed because:
    i. There 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. The resulting dietary food exposures, from 
cucurbits and tomatoes, 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 1.7% 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.
    The EECs provided by the Agency for assessing chronic aggregate 
dietary risk are 2.07 g/L (for ground water, based on SCI-
GROW) and 21.8 g/Lin surface water, based on PRZM/EXAMS 
modeling, 1 in 10 year annual average). The back-calculated DWLOCs for 
cucurbits and tomatoes (Table 5) for assessing chronic aggregate 
dietary risk range from 4800 g/L for the population subgroup 
with the highest food exposure (Children, 1 to 6 years old) to 16,800 
g/L for the U.S. population (total) and Males 13-19 years.
    The SCI-GROW and PRZM/EXAMS chronic EECs are less than the Agency's 
level of comparison (the DWLOC value for each population subgroup) for 
zoxamide residues in drinking water as a contribution to chronic 
aggregate exposure. Thus, the Agency 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. There are no residential uses for zoxamide 
that result in chronic residential exposure to zoxamide.

                                      Table 5.--Chronic DWLOC Calculations
----------------------------------------------------------------------------------------------------------------
                                                                 Chronic Scenario
                                --------------------------------------------------------------------------------
                                                             Maximum
     Population Subgroup\1\                       Food        Water      EEC Ground-  EEC Surface-     Chronic
                                 cPAD (mg/kg/   Exposure     Exposure       water         water         DWLOC
                                     day)     (mg/kg/day)    (mg/kg/    (g/  (g/  (g/
                                                             day)\2\        L)\3\         L)\4\         L)\5\
----------------------------------------------------------------------------------------------------------------
U.S. population                         0.48       0.0031         0.48          2.07          21.8        16,800
Children 1-6 yrs                        0.48       0.0018         0.48          2.07          21.8         4,800
Females 13-50                           0.48       0.0084         0.48          2.07          21.8        14,400
Males 13-19                             0.48       0.0026         0.48          2.07          21.8       16,800
----------------------------------------------------------------------------------------------------------------
\1\ The exposure for the highest representative population subgroup was reported. Body weights varied by
  subgroup: 70 kg for an adult male; 60 kg for an adult female; 10 kg for a child.
\2\ Maximum Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Dietary Exposure from DEEM (mg/kg/day)
\3\ The value from the model and crop producing the highest level was used (i.e. SCI-GROW value).
\4\ The value from the model and crop producing the highest level was used (i.e. PRZM/EXAMS value for grapes).
\5\ DWLOC(g/L) = [maximum water exposure (mg/kg/day) x body weight (kg)]/[water consumption (L) x 10-
  \3\ mg/g]

    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

[[Page 49116]]

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 proposes a GC/ECD method, with LOD and validated LOQ 
of 0.003 and 0.01 ppm respectively, for the enforcement of tolerances 
on cucurbits and tomatoes. A GC/MSD method is proposed as a 
confirmatory method. Method validation recoveries indicate that the GC/
ECD method adequately recovers residues of zoxamide from cucurbits, 
tomatoes, and tomato processed commodities. Adequate confirmatory 
method validation, radiovalidation, and independent method validation 
have been submitted for this method. The submitted GC/ECD method is 
similar to the enforcement method proposed for grapes and potatoes 
under PP 9F05058 which has been forwarded to ACB/BEAD for a petition 
method validation . A petition method validation was also requested for 
the GC/ECD enforcement method proposed for tomatoes and cucurbits (PP 
0F06093).
    The methods were successfully validated for tomatoes and cucurbits 
in one trial by the independent laboratory. A slight modification was 
made but only with the instrumental parameters. For tomatoes, the head 
pressure in the oven ramp was lowered from 13 to 7.5 psi because 
hydrogen was substituted as the carrier gas and the total detector flow 
was set at 15 mL/min of N2 instead of 60 mL/min. For 
cucumber, the detection temperature was set at 315+C instead 
of 300 +C and the total detector flow was set at 12 mL/min 
instead of 60mL/min.). The changes were found necessary to optimize 
sensitivity of the Varian 3500 ECD and allow detection of zoxamide at 
the LOQ of 0.01 ppm. Apparent residues of zoxamide were nondetectable 
(<0.01 ppm) in/on two control samples each of cucumbers and tomatoes. 
The recoveries were between 70 - 120% with an RSD below 15% which were 
within the acceptable limits. Extraction of 6 samples took about 6-8 
hours and analysis of samples and standards took about 5-6 hours.
    Plant commodity samples collected from the field, processing, and 
storage stability studies were analyzed for residues of zoxamide using 
either the GC/ECD or GC/MSD method. The concurrent method recoveries 
indicate that both methods are adequate for data collection for 
cucurbits and tomatoes.
    The methods are adequate for a conditional registration pending 
successful validation results and comments from ACB/BEAD.
    The Residue Analytical Method - Plant Commodities are adequate for 
a conditional registration pending successful validation results and 
comments from The Analytical Chemistry Branch Laboratories, BEAD 
(7503C), Office of Pesticides 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 validation will be available the Analytical 
Chemistry Branch (ACB), BEAD (7503C) Environmental Science Center, 701 
Mapes Road, Ft. George C. Meade, MD 29755-5350. Contact Francis D. 
Griffith, Jr., telephone (410) 305-2905, e-mail: 
[email protected]. The analytical standards are also available 
from the EPA National Pesticide Standard Repository at the same 
location.
    The MRMs are adequate for enforcement of the proposed tolerances 
for zoxamide in/on cucurbits and tomatoes. The submission has been 
forwarded to FDA for complete evaluation in conjunction with the 
earlier petition.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) or tolerances for residues of zoxamide 
in/on tomatoes and cucurbits. Therefore, no compatibility issues exist 
with regard to the proposed U.S. tolerances discussed in this petition 
review.

C. Conditions

    Additional storage stability data are required for residues of 
zoxamide in/on cucurbit vegetables stored 15.6 months, tomato fruit 
stored 15.2 months and tomato paste and puree stored 11.5 months. The 
additional storage stability data for tomatoes, tomato paste and puree 
and cucumber is a condition for the registration of zoxamide for use on 
tomatoes and cucurbits.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
zoxamide and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid 
(RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethlbenzoic acid 
(RH-1452 and RH-141452), in or on tomatoes at 2.0 ppm and cucurbit 
vegetable group at 1.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301176 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
26, 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

[[Page 49117]]

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-301176, 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 Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any 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

[[Page 49118]]

Executive Order to include regulations that have ``substantial direct 
effects on one or more Indian tribes, on the relationship between the 
Federal government and the Indian tribes, or on the distribution of 
power and responsibilities between the Federal government and Indian 
tribes.'' This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 13, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

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

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

    2. Section 180.567 is amended by alphabetically adding commodities 
to the table in paragraph (a)(2) to read as follows:


Sec. 180.567  Zoxamide;tolerance for residues.

    (a) * * *
    (2)* * *

 
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Cucurbit vegetable group                    1.0
              *        *        *        *        *
Tomato                                      2.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-23640 Filed 9-25-01; 8:45 am]
BILLING CODE 6560-50-S