[Federal Register Volume 66, Number 180 (Monday, September 17, 2001)]
[Rules and Regulations]
[Pages 47994-48003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23088]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301170; FRL-6801-4]
RIN 2070-AB78


Mefenoxam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of mefenoxam in or on globe artichoke, starfruit, kiwifruit, papaya, 
black sapote, star apple, canistel, mamey sapote, mango, sapodilla, 
sugar apple, atemoya, custard apple, lingonberry, fresh herbs, and 
dried herbs. The Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. The risk 
assessment performed for mefenoxam is an aggregate risk assessment 
which includes the proposed new uses of mefenoxam and all current 
metalaxyl tolerances/uses. Consequently, EPA has reassessed a total of 
122 existing tolerances for metalaxyl. By law, EPA is required by 
August 2002 to reassess 66% of the tolerances in existence on August 2, 
1996, or about 6,400 tolerances. The 122 tolerances reassessed in this 
final rule count toward the August, 2002 review deadline.

DATES: This regulation is effective September 17, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301170, 
must be received by EPA on or before November 16, 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-301170 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet 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. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301170. 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 30, 2000 (65 FR 52746) (FRL-6739-
4), EPA issued notices 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 pesticide petitions (PP) 9F05044, 9E06005, and 9E06057 
for tolerances by IR-4, Technology Centre of New Jersey, 681 US Highway 
#1 South, North Brunswick, NJ 08902-3390. These notices included 
summaries of the petitions prepared by Novartis Crop Protection, the 
registrant. There were no comments received in response to the notice 
of filing.
    The petitions requested that 40 CFR part 180 be amended by 
establishing tolerances for combined residues of the fungicide 
mefenoxam, (R)- and (S)-2-[(2,6-dimethylphenyl)-methoxyacetylamino]-
propionic acid methyl ester, its metabolites containing the 2,6-
dimethylaniline moiety, and N-(2-hydroxymethyl-6-methylphenyl)-N-
(methoxyacetyl)alanine methyl ester,

[[Page 47995]]

each expressed as mefenoxam equivalents, in or on fresh herb subgroup 
at 5 part per million (ppm); dried herb subgroup at 30 ppm; fresh mint 
at 5 ppm; kiwifruit at 0.05 ppm; atemoya, globe artichoke, starfruit, 
sugar apple, sweepsop, and true custard at 0.1 ppm; papaya, black 
sapote, caimito, canistel, mamey sapote, mango, and sapodilla at 0.3 
ppm; and lingonberry at 1.0 ppm. IR-4 subsequently revised the 
petitions, deleting tolerances for mint, sweepsop, and caimito; and 
changing tolerances for fresh herb from 5.0 ppm to 8.0 ppm; dried herb 
from 30 ppm to 55 ppm; kiwifruit from 0.05 ppm to 0.10 ppm; globe 
artichoke from 0.1 ppm to 0.05 ppm; atemoya, starfruit, sugar apple, 
and custard apple from 0.1 ppm to 0.20 ppm; papaya, black sapote, 
canistel, mamey sapote, mango, and sapodilla from 0.3 ppm to 0.40 ppm; 
and lingonberry from 1.0 ppm to 2.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
these actions. 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 combined residues of mefenoxam on globe 
artichoke at 0.05 ppm, starfruit at 0.20 ppm, kiwifruit at 0.10 ppm, 
papaya at 0.40 ppm, black sapote at 0.40 ppm, star apple at 0.40 ppm, 
canistel at 0.40 ppm, mamey sapote at 0.40 ppm, mango at 0.40 ppm, 
sapodilla at 0.40 ppm, sugar apple at 0.20 ppm, atemoya at 0.20 ppm, 
custard apple at 0.20 ppm, lingonberry at 2.0 ppm, fresh herbs at 8.0 
ppm, and dried herbs at 55 ppm. EPA's assessment of exposures and risks 
associated with establishing these tolerances 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 mefenoxam 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. Metalaxyl is the racemic 
mixture of the R- and S- enantiomers; mefenoxam is the R-enantiomer. 
Metalaxyl has an extensive toxicity data base and a Reregistration 
Eligibility Decision document was completed in September 1994. Data 
have been accepted by EPA which bridge the necessary environmental 
fate, chemistry, and toxicology studies from metalaxyl to mefenoxam. 
The structural similarities between mefenoxam and metalaxyl are the 
basis for bridging data between the two active ingredients. Mefenoxam 
and metalaxyl have the same empirical formula, and being optical 
isomers, differ only in the spatial arrangement of atoms in their 
structure. Both the R and S enantiomers are considered residues of 
concern for both chemicals.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 44.8 mg/kg/day
                                          rodents (rats)             LOAEL = 90.5 mg/kg/day based on increased
                                                                      hepatocyte hypertrophy, increased
                                                                      lymphocytic infiltration of liver.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = 250 mg/kg/day
                                          nonrodents (dogs)          LOAEL = 1,250 mg/kg/day based on based on
                                                                      increased alkaline phosphatase activity
                                                                      and increased absolute and relative liver
                                                                      weights for both sexes.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-Day dermal toxicity      NOAEL = 1,000 mg/kg/day
                                                                     LOAEL >1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 50 mg/kg/day
                                          rodents (rats)             LOAEL = 250 mg/kg/day based on clinical
                                                                      signs, including post-dose convulsions.
                                                                     Developmental NOAEL = 250 mg/kg/day
                                                                     LOAEL = 400 mg/kg/day based on increased
                                                                      incidence of skeletal variations.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 150 mg/kg/day
                                          nonrodents (rabbits))      LOAEL = 300 mg/kg/day based on decreased
                                                                      body weight gain.
                                                                     Developmental NOAEL = 300 mg/kg/day
                                                                     LOAEL > 300 mg/kg/day.
----------------------------------------------------------------------------------------------------------------

[[Page 47996]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic male (M): NOAEL = 62.5 mg/
                                          effects (rats)              kg/day, female (F): NOAEL = 12.5 mg/kg/day
                                                                     M: LOAEL > 62.5 mg/kg/day, F:LOAEL = 62.5
                                                                      mg/kg/day based on increased relative
                                                                      liver weights.
                                                                     Reproductive NOAEL = 62.5 mg/kg/day LOAEL >
                                                                      62.5.
                                                                     Offspring NOAEL = 12.5 mg/kg/day; LOAEL =
                                                                      62.5 mg/kg/day based on histopathological
                                                                      changes in the livers of female pups.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL = M: 7.80 mg/kg/day, F: 7.41 mg/kg/
                                                                      day;
                                                                     LOAEL = M: 30.63 mg/kg/day, F: 32.36 mg/kg/
                                                                      day based on increased alkaline
                                                                      phosphatase, increased relative and
                                                                      absolute liver weights.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity/chronic     NOAEL = M: 9.43 mg/kg/day, F: 9.95 mg/kg/
                                          toxicity rats               day;
                                                                     LOAEL = M: 46.6 mg/kg/day, F: 55.0 mg/kg/
                                                                      day based on increased serum alanine amino-
                                                                      transferase and serum aspartate amino-
                                                                      transferase, increased periacinar
                                                                      vacuolation of hepatocytes, increased
                                                                      absolute and relative liver weights. No
                                                                      evidence of carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        NOAEL = M: 24.85 mg/kg/day, F: 29.59 mg/kg/
                                                                      day;
                                                                     LOAEL = M: 128.89 mg/kg/day, F: 148.16 mg/
                                                                      kg/day based on increased fatty
                                                                      infiltration of the liver. No evidence of
                                                                      carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene Mutation               There was no concentration related positive
                                                                      response of induced mutant colonies over
                                                                      background in Salmonella or E. coli
                                                                      strains.
----------------------------------------------------------------------------------------------------------------
870.5385                                 In vivo Cytogenetics        Metalaxyl had no effect on the incidence of
                                                                      nuclear anomalies.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              In the first 8 hours of treatment,
                                          pharmacokinetics            approximately 30% of the dose was absorbed
                                                                      with 1% of the test substance in the skin
                                                                      at the application site.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          At 24 hours after dosing, approximately 35%
                                                                      was absorbed.
----------------------------------------------------------------------------------------------------------------

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.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) 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 mefenoxam used for human risk assessment is shown in the 
following Table 2:

[[Page 47997]]



      Table 2.-- Summary of Toxicological Dose and Endpoints for Mefenoxam 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                     Not applicable           No appropriate study
 including infants and children                                                           was identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL = 7.41 mg/kg/day   FQPA SF = 1X             6-Month Feeding Study
                                       UF = 100...............  cPAD = chronic RfD/....   in Dogs
                                       Chronic RfD = 0.074 mg/   FQPA SF = 0.074 mg/kg/  LOAEL = 32.36 mg/kg/day
                                        kg/day.                  day.                     based on increased
                                                                                          liver weights and
                                                                                          clinical chemistry.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days)        None                     Not applicable           No systemic toxicity
(Residential)........................                                                     was seen at the limit
                                                                                          dose in a 21-day
                                                                                          dermal toxicity study
                                                                                          in rabbits.
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to    None                     Not applicable           No systemic toxicity
 several months)                                                                          was seen at the limit
(Residential)........................                                                     dose in a 21-day
                                                                                          dermal toxicity study
                                                                                          in rabbits.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    NOAEL= 7.41 mg/kg/day    LOC for MOE = 100        6-Month Feeding Study
 lifetime)                             UF = 100...............   (Residential).........   in Dogs
(Residential)........................  Chronic RfD = 0.074 mg/                           LOAEL = 32.36 mg/kg/day
                                        kg/day.                                           based on increased
                                       (dermal absorption rate                            liver weights and
                                        = 35%).                                           clinical chemistry.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days)    oral study NOAEL= 50 mg/ LOC for MOE = 100        Developmental Toxicity
(Residential)........................   kg/day                  (Residential)..........   in Rats
                                       (inhalation absorption                            LOAEL = 250 mg/kg/day
                                        rate = 100%).                                     based on decreased
                                                                                          body weight gains and
                                                                                          reduced food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week   oral study NOAEL = 7.41  LOC for MOE = 100        6-Month Feeding Study
 to several months)                     mg/kg/day               (Residential)..........   in Dogs
(Residential)........................  (inhalation absorption                            LOAEL = 32.36 mg/kg/day
                                        rate = 100%).                                     based on increased
                                                                                          liver weights and
                                                                                          clinical chemistry.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months   oral study NOAEL= 7.41   LOC for MOE = 100        6-Month Feeding Study
 to lifetime)                           mg/kg/day               (Residential)..........   in Dogs
(Residential)........................  (inhalation absorption                            LOAEL = 32.36 mg/kg/day
                                        rate = 100%).                                     based on increased
                                                                                          liver weights and
                                                                                          clinical chemistry.
----------------------------------------------------------------------------------------------------------------
Short-term oral (1 to 7 days)          oral study maternal      LOC for MOE = 100        Developmental toxicity
(Residential)........................   NOAEL = 50 mg/kg/day    (Residential)..........   study in rats
                                                                                          (mefenoxam).
                                                                                         LOAEL = 250 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gains and
                                                                                          reduced food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-term oral (1 week to      oral study NOAEL = 7.41  LOC for MOE = 100        6-Month Feeding Study
 several months)                        mg/kg/day               (Residential)..........   in Dogs (metalaxyl).
(Residential)........................                                                    LOAEL = 32.36 mg/kg/day
                                                                                          based on increased
                                                                                          liver weights and
                                                                                          clinical chemistry
                                                                                          (alkaline
                                                                                          phosphatase).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      None                     Not applicable           Based on the
                                                                                          classification of
                                                                                          metalaxyl,mefenoxam is
                                                                                          also considered ``not
                                                                                          likely to be a human
                                                                                          carcinogen.''
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. A time-limited 
tolerance has been established (40 CFR 180.546) for the combined 
residues of mefenoxam, in or on canola (expires December 31, 2001). No 
other tolerances have been established for mefenoxam per se. Since 
metalaxyl is the racemic mixture of the R- and S- enantiomers; the risk 
assessment performed for the proposed new uses of mefenoxam includes 
all current metalaxyl tolerances/uses. Tolerances have been established 
(40 CFR 180.408) for metalaxyl on various raw agricultural commodities 
and animal commodities. Tolerances have been established for metalaxyl 
and its metabolites containing the 2,6-dimethylaniline moiety, and N-
(2-hydroxymethyl-6-methylphenyl)-N-(methoxyacetyl)-alanine methyl 
ester, each expressed as metalaxyl equivalents, at 0.4 ppm in the fat, 
kidney, and liver of cattle, goats, hogs, horses, poultry, and sheep; 
0.05 ppm in meat and meat byproducts (except kidney and liver) of 
cattle, goats, hogs, horses, poultry, and sheep; 0.02 ppm in milk, and 
0.05 ppm in eggs. Risk assessments were conducted by EPA to assess 
dietary exposures from mefenoxam in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has

[[Page 47998]]

indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. An acute dietary risk assessment was 
not preformed for mefenoxam since an endpoint of concern was not 
identified during the review of the available studies.
    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 1994-1996 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: Since metalaxyl and mefenoxam share the same 
residues of concern, the chronic dietary exposure assessment was 
performed using established metalaxyl tolerances in addition to the 
proposed tolerances for mefenoxam. The chronic dietary analysis used 
residue values at the established and recommended tolerance levels, and 
assumed that 100 percent of the registered and proposed crops were 
treated. This Tier 1 chronic dietary analysis should be considered 
highly conservative.
    iii. Cancer. Metalaxyl has been classified as ``not likely to be 
carcinogenic in humans'' based on the results of a carcinogenicity 
study in mice and the combined chronic toxicity and carcinogenicity 
study in rats. Therefore, based on the classification of metalaxyl, 
mefenoxam is also considered ``not likely to be a human carcinogen.''
    2. Dietary exposure from drinking water. Sufficient acceptable 
bridging data have been submitted to verify that the environmental fate 
of mefenoxam is similar to that of metalaxyl. Therefore, based on the 
bridging data submitted (soil photolysis, aerobic soil metabolism and 
batch equilibrium and column leaching studies), EPA can conclude that 
environmental fate studies of metalaxyl, including the reviewed studies 
on mefenoxam, can be used to predict the environmental fate of 
mefenoxam. Metalaxyl was found to be moderately stable under normal 
environmental conditions; its degradates are mobile in sandy soils and 
those low in organic matter. EPA has determined that residues of 
metalaxyl and mefenoxam and their metabolites N-(2,6-dimethylphenyl)-N-
(methoxyacetyl)alanine (CGA-62826), each expressed as parent 
equivalents, should be included in the drinking water assessment.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
mefenoxam 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 mefenoxam.
    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 
Screening Concentrations in Ground Water (SCI-GROW), which predicts 
pesticide concentrations in groundwater. In general, EPA will use 
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a Percent of the Reference Dose 
(%RfD) or Percent of the Population Adjusted Dose (%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 mefenoxam they are further 
discussed in the aggregate risk sections below.
    The first-tier screening model GENEEC was used to estimate 
potential surface water concentrations, and the screening model SCI-
GROW was used to estimate potential ground water concentrations. The 
maximum annual lingonberry application rate of 5.4 lb a.i./acre (2.7 
ai/acre twice) was used to model mefenoxam concentrations in drinking 
water. The GENEEC simulation of the lingonberry use predicts an acute 
concentration of 180 ppb, and a 90-day chronic concentration of 109 
ppb. SCI-GROW modeling simulated mefenoxam concentrations in ground 
water of 13.5 ppb for this proposed use. For the degradate of concern, 
CGA-62826, GENEEC modeling results in estimates of 198 ppb for acute 
exposure and 194 ppb for chronic exposure, with limited environmental 
fate data. The predicted SCI-GROW concentration for this degradate is 
37 ppb in ground water. The combined (parent plus metabolite) EEC 
values are 101 ppb (109 ppb for parent + 194 ppb for degradate/3) for 
chronic surface water and 51 ppb (13.5 ppb for parent and 37 ppb for 
degradate) for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Mefenoxam is currently registered for use on the residential non-
dietary site turf. Risk assessments were conducted using the following 
residential exposure assumptions: Residential handler exposure has been 
assessed for two formulations of mefenoxam: an emulsifiable 
concentrate, (1) Subdue MAXX EC, and (2) a 
granular, Subdue MAXX GR both used at a maximum 
rate of 0.015 lb ai/1,000 ft2. Non-occupational 
(residential) handlers may be exposed during mixing, loading and 
application of mefenoxam using a variety of application methods for 
short-term durations (1-7 days) based on the mefenoxam turf use. 
Continuous exposure over intermediate-term (7 days to several months) 
or long-term (several months or more) time periods are not expected. 
Dermal exposure was not assessed because applicable endpoints were not 
identified. MOEs for inhalation exposure from non-occupational handler 
scenarios were above the target of 100, and thus do not exceed EPA's 
level of concern.
    Non-occupational postapplication exposures were also assessed for 
Subdue MAXX EC (46.6%) and Subdue 
MAXX GR (0.97%), two

[[Page 47999]]

major mefenoxam products on turf which are considered to represent the 
reasonable upper bound residential exposure potential. Adults and 
children may be exposed to mefenoxam residues following treatment of 
residential areas. However, postapplication exposure is limited to 
incidental oral exposure, since post application inhalation exposure is 
expected to be negligible and endpoints were not identified for short- 
or intermediate-term dermal risk assessment. Postapplication exposure 
assessments were performed for toddler's incidental ingestion of 
residues of mefenoxam on treated turf (hand-to-mouth, object-to-mouth) 
and ingestion of granules. MOEs for oral exposure to toddlers were all 
above 100 and thus do not exceed EPA's level of concern. Also, combined 
exposure from toddler's incidental ingestion of mefenoxam residues on 
treated turf and from object-to-mouth exposure from treated turfgrass 
and soil results in short-term MOEs that are greater than 100 and do 
not exceed EPA's level of concern.
    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 mefenoxam 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, 
mefenoxam 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 mefenoxam 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 mefenoxam 
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. The 
FQPA factor is removed 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 is not required at this time, and (3) the dietary 
(food and drinking water) and non-dietary exposure assessments will not 
underestimate the potential exposures for infants and children.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes 
with reasonable certainty that exposures to the pesticide in drinking 
water (when considered along with other sources of exposure for which 
OPP has reliable data) would not result in unacceptable levels of 
aggregate human health risk at this time. Because OPP considers the 
aggregate risk resulting from multiple exposure pathways associated 
with a pesticide's uses, levels of comparison in drinking water may 
vary as those uses change. If new uses are added in the future, OPP 
will reassess the potential impacts of residues of the pesticide in 
drinking water as a part of the aggregate risk assessment process.
    1. Acute risk. Acute aggregate risk consists of the combined 
dietary exposures from food and drinking water sources. The total 
exposure is compared to the acute RfD. An acute RfD was not identified. 
Therefore, an acute aggregate risk assessment was not performed.
    2. Chronic risk. EPA determined that the parent, mefenoxam, and the 
metabolite N-(2,6-dimethylphenyl)-N-(methoxyacetyl)alanine (CGA-62826), 
each expressed as parent equivalents, should be included in the 
drinking water assessment. Using the exposure assumptions described in 
this unit for chronic exposure, EPA has concluded that exposure to 
mefenoxam from food will utilize 17% of the cPAD for the U.S. 
population, 36% of the cPAD for children 1-6 years old and 14% of the 
cPAD for females 13-50 years old. Based on the use pattern, chronic 
residential exposure to residues of mefenoxam is not expected. In 
addition, there is potential for chronic dietary exposure to mefenoxam 
in drinking water. After calculating DWLOCs and comparing them to the 
EECs for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table 3:

[[Page 48000]]



               Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Mefenoxam
----------------------------------------------------------------------------------------------------------------
                                                                              Ground      Surface
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.074           17           51          101        2,100
----------------------------------------------------------------------------------------------------------------
Children 1-6 years                                     0.074           36           51          101          460
----------------------------------------------------------------------------------------------------------------
Females 13-50 years                                    0.074           14           51          101        1,900
----------------------------------------------------------------------------------------------------------------

    3. Short- and intermediate-term risk. Short and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Mefenoxam is currently registered for use that could result in 
short-and intermediate-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic food and water 
and short- and intermediate-term exposures for mefenoxam.
    Short-term and intermediate aggregate risks from mefenoxam were 
calculated based on exposures from the oral and inhalation routes of 
exposure. Inhalation exposure was assessed for the adult, residential 
pesticide handler only. Postapplication, inhalation exposure to the 
adult handler is not considered a significant route of exposure. 
Incidental oral risk was assessed for the postapplication exposure of 
toddlers in the home environment only. Dermal toxicity endpoints were 
not chosen for this chemical and thus an assessment of the dermal route 
of exposure was not performed.
    Short- and intermediate-term daily doses from the hand-to-mouth, 
turfgrass, and soil ingestion pathways were combined and represent the 
residential exposure potential for toddlers, represented as children 1 
to 6 years old. Short- and intermediate-term inhalation values from the 
residential activity which resulted in the greatest exposure, were used 
to calculate residential exposures to adult home applicators. In all 
cases, the residential exposures described above were added to the 
average food exposures to develop the aggregate exposure estimate. This 
exposure estimate was then compared to the appropriate toxicity 
endpoint.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 3,700 for the U.S. population, 
and 1,300 for children 1-6 years old, and 4,400 for females 13-50 yrs. 
These aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of mefenoxam in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern, as shown in the following Table 4:

                    Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Mefenoxam
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs                                      4,400          100          101           51       14,000
----------------------------------------------------------------------------------------------------------------
US Population                                          3,700          100          101           51       17,000
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs                                       1,300          100          101           51        4,600
----------------------------------------------------------------------------------------------------------------

    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 650 for 
females 13-50 years old, 560 for the U.S. population, and 230 for 
children 1-6 years old. These aggregate MOEs do not exceed the Agency's 
level of concern for aggregate exposure to food and residential uses. 
In addition, intermediate-term DWLOCs were calculated and compared to 
the EECs for chronic exposure of mefenoxam in ground and surface water. 
After calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect intermediate-term aggregate exposure 
to exceed the Agency's level of concern, as shown in the following 
Table 5:

                 Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Mefenoxam
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs                                      650          100          101           51         1,900
----------------------------------------------------------------------------------------------------------------
U.S. population                                        560          100          101           51         2,100
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs                                       230          100          101           51           420
----------------------------------------------------------------------------------------------------------------


[[Page 48001]]

    5. Aggregate cancer risk for U.S. population. Metalaxyl has been 
classified as ``not likely to be carcinogenic in humans'' based on the 
results of a carcinogenicity study in mice and the combined chronic 
toxicity and carcinogenicity study in rats. Therefore, based on the 
classification of metalaxyl, mefenoxam is also considered ``not likely 
to be a human carcinogen.''
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to mefenoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method, Method AG-395 (MRID 00148440; sent 
to FDA for inclusion in PAM II as Method III), is available to 
determine the regulated residues of mefenoxam i.e., the combined 
residues of (R)-and (S)-2-[(2,6-dimethylphenyl)-methoxyacetylamino]-
propionic acid methyl ester, its metabolites containing the 2,6-
dimethylaniline moiety, and N-(2-hydroxymethyl-6-methylphenyl)-N-
(methoxyacetyl)alanine methyl ester, each expressed as mefenoxam 
equivalents in artichoke, carambola (starfruit), sugar apple, sweetsop, 
atemoya, true custard apple, kiwifruit, papaya, black sapote, caimito, 
canistel, mamey sapote, mango, sapodilla, lingonberry, and herbs. 
Method AG-395 is an improved modification of Method I (Method AG-348) 
in PAM II. In AG-348, residues are converted to 2,6-dimethylaniline and 
analyzed by gas chromotography (GLC) with alkali flame ionization 
detection (AFID). Gas-liquid chromatography/mass spectrometry in the 
chemical ionization mode with selected ion monitoring is used in the 
determinative step of Method AG-348 for samples that show interference 
in the GLC/AFID analysis. In AG-395, residues are converted to 2,6-
dimethylaniline and analyzed by gas liquid chromatography (GLC) with a 
nitrogen/phosphorus detector operating in the nitrogen-specific mode. 
The limit of quantitation of Method AG-395 is 0.05 ppm for each 
commodity. Method I in PAM II and Method AG-395 do not distinguish 
between mefenoxam R-isomer) and metalaxyl which is a mixture of the R 
and S enantiomers). Method 456-98 can distinguish between R and S 
enantiomers. A successful EPA method validation has been completed by 
EPA for Method 456-98.
    Adequate enforcement methodology (example: Gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PIRIB, 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

    No Codex, Canadian, or Mexican Maximum Residue Limits or tolerances 
have been established for mefenoxam on artichoke, starfruit, kiwifruit, 
papaya, black sapote, caimito, canistel, mamey sapote, mango, 
sapodilla, sugar apple, sweetsop, atemoya, true custard apple, 
lingonberry, or herbs.

C. Rotational Crops

    An adequate confined rotational crop study is available on 
metalaxyl. Based on the metalaxyl confined rotational crop study, EPA 
has determined that the residues of mefenoxam to be regulated for the 
tolerance expression and for dietary risk assessments for rotational 
crops are (R)- and (S)-2-[(2,6-dimethylphenyl)-methoxyacetylamino]-
propionic acid methyl ester, its metabolites containing the 2,6-
dimethylaniline moiety, and N-(2-hydroxymethyl-6-methylphenyl)-N-
(methoxyacetyl)alanine methyl ester, each expressed as parent 
equivalents, except that 2-[(methoxyacetyl)(2-methoxy-1-methyl-2-
oxoethyl)amino]-3-methylbenzoic acid (CGA-108905) and N-(3-hydroxy-2,6-
dimethylphenyl)-N-(methoxyacetyl)alanine methyl ester (CGA-100255) will 
be considered in risk assessments involving the foliar use of mefenoxam 
on the treated crop. EPA concludes that U.S. tolerances are adequate to 
cover residues on crops grown in rotation with mefenoxam treated crops, 
provided crop rotation is limited to crops that have established 
metalaxyl or mefenoxam tolerances. Crop rotational studies are not 
required for globe artichoke, starfruit, kiwifruit, papaya, black 
sapote, star apple, canistel, mamey sapote, mango, sapodilla, sugar 
apple, atemoya, custard apple, lingonberry; it is not reasonably 
foreseeable that any other food or feed crop will be planted after 
harvest of these treated crops.

D. Conditions

    Registration for use of mefenoxam on papaya and kiwifruit will be 
conditional. Continued registration will be contingent upon EPA 
receiving additional residue field trials for papaya and kiwifruit. One 
additional field trial on kiwifruit from California is required. 
Additional field trials for papaya are needed from Hawaii and Florida.

V. Conclusion

    Therefore, these tolerances are established for the combined 
residues of mefenoxam, (R)- and (S)-2-[(2,6-dimethylphenyl)-
methoxyacetylamino]-propionic acid methyl ester, its metabolites 
containing the 2,6-dimethylaniline moiety, and N-(2-hydroxymethyl-6-
methylphenyl)-N-(methoxyacetyl)alanine methyl ester, in or on globe 
artichoke at 0.05 ppm, starfruit at 0.20 ppm, kiwifruit at 0.10 ppm, 
papaya at 0.40 ppm, black sapote at 0.40 ppm, star apple at 0.40 ppm, 
canistel at 0.40 ppm, mamey sapote at 0.40 ppm, mango at 0.40 ppm, 
sapodilla at 0.40 ppm, sugar apple at 0.20 ppm, atemoya at 0.20 ppm, 
custard apple at 0.20 ppm, lingonberry at 2.0 ppm, fresh herbs at 8.0 
ppm, and dried herbs at 55 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-301170 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 
16, 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

[[Page 48002]]

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-301170, 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 other 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

[[Page 48003]]

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, 
Agriculturalcommodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 6, 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 180.546 is amended by adding text to paragraph (a) to 
read as follows:


Sec. 180.546  Mefenoxam; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of (R)- and (S)-2-[(2,6-dimethyl(phenyl)-methoxyacetylamine]-propionic 
acid methyl ester, and its metabolites containing the 2,6 
dimethylaniline moiety, and N-(2-hydroxy methyl-6-methylphenyl)-N-
(methoxyacetyl)-alanine methyl ester, each expressed as mefenoxam 
equivalents, in or on the following food commodities:

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Artichoke, globe...............................                     0.05
Atemoya........................................                     0.20
Canistel.......................................                     0.40
Custard apple..................................                     0.20
Herbs, dried...................................                       55
Herbs, fresh...................................                      8.0
Kiwifruit......................................                     0.10
Lingonberry....................................                      2.0
Mango..........................................                     0.40
Papaya.........................................                     0.40
Sapodilla......................................                     0.40
Sapote, black..................................                     0.40
Sapote, mamey..................................                     0.40
Star apple.....................................                     0.40
Starfruit......................................                     0.20
Sugar apple....................................                     0.20
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-23088 Filed 9-14-01; 8:45 am]
BILLING CODE 6560-50-S