[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Rules and Regulations]
[Pages 4542-4548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1655]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0713; FRL-8855-1]


Mefenoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mefenoxam in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally removes 
the individual tolerance on lingonberry, as it will be superseded by 
inclusion in bushberry subgroup 13-07B. Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 26, 2011. Objections and 
requests for hearings must be received on or before March 28, 2011, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0713. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7509P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any 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 electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

[[Page 4543]]

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0713 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
March 28, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0713, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerances

    In the Federal Register of October 7, 2009 (74 FR 51597) (FRL-8792-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7591) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.546 be amended by 
establishing tolerances for residues of the fungicide mefenoxam, (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 
bean, snap, succulent at 0.35 parts per million (ppm); caneberry 
subgroup 13-07A at 0.80 ppm; bushberry subgroup 13-07B at 2.0 ppm; 
onion, bulb, subgroup 3-07A at 3.0 ppm; onion, green, subgroup 3-07B at 
10.0 ppm; and spinach at 8.0 ppm. The notice additionally requested to 
remove the individual tolerance for lingonberry at 2.0 ppm, as it will 
be superseded by inclusion in bushberry subgroup 13-07B. That notice 
referenced a summary of the petition prepared on behalf of IR-4 by 
Syngenta Crop Protection, Inc., the registrant, which is available in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance levels for several commodities. EPA has 
also revised the tolerance expression for all established commodities 
to be consistent with current Agency policy. The reasons for these 
changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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. * * 
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 for mefenoxam including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with mefenoxam 
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.
    Mefenoxam, is the R-enantiomer of metalaxyl which is a racemic 
mixture that contains approximately 50% each of the R- and S-
enantiomers. EPA conducted a side-by-side comparison of the available 
toxicity data for mefenoxam and metalaxyl and concluded that mefenoxam 
has similar toxicity to that of metalaxyl. Therefore, metalaxyl data 
may be used to support the registration of mefenoxam.
    The database for mefenoxam/metalaxyl indicates that the liver is 
the major target organ. Liver effects observed in oral studies in rats, 
mice, and dogs include increased liver enzymes (alanine amino-
transferase, aspartate amino-transferase, and alkaline phosphatase), 
increased incidence of pathological observations in the liver 
(hepatocyte hypertrophy, vacuolation of hepatocytes, and fatty 
infiltration) and increased relative and absolute liver weights. In 
guideline studies, the dog appears to be the most sensitive species.
    The developmental toxicity studies in rat and rabbit and the 
multigeneration reproduction study did not show metalaxyl/mefenoxam to 
be a developmental or reproductive toxicant. There was no indication of 
increased susceptibility in pups following prenatal and postnatal 
exposures to mefenoxam. In the rat and rabbit developmental toxicity 
studies, in which animals were administered metalaxyl by gavage at 
relatively high doses, both rat and rabbit dams exhibited clinical 
signs (ataxia, body tremors, reduced activity, and righting reflex). 
These clinical signs are believed to result from metalaxyl/mefenoxam 
induced bradycardia mediated through alpha-adrenoreceptors and not from 
neurotoxicity.
    Metalaxyl has been classified as ``not likely to be carcinogenic to 
humans'' based on the results of a carcinogenicity

[[Page 4544]]

study in mice and the combined chronic toxicity and carcinogenicity 
studies in rats. Based on the classification of metalaxyl, mefenoxam is 
also considered ``not likely to be carcinogenic to humans.'' 
Mutagenicity studies do not indicate increased mutagenic potential 
following exposure to metalaxyl/mefenoxam.
    Specific information on the studies received and the nature of the 
adverse effects caused by mefenoxam as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Mefenoxam. Human Health Risk 
Assessment for Proposed Uses on Snap Beans and the Caneberry Subgroup, 
Expanded Uses on the Bulb and Green Onion Subgroups and the Bushberry 
Subgroup, and Amended Use on Spinach.'' at pages 51-53 in docket ID 
number EPA-HQ-OPP-2009-0713.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level-generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)-and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for mefenoxam used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Mefenoxam for Use in Human Health Risk Assessment
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                                      Point of departure and      RfD, PAD, LOC for     Study and toxicological
         Exposure/scenario          uncertainty/safety factors     risk assessment              effects
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Acute dietary (Females 13-50 years   None. No appropriate endpoint attributable to a single dose was identified.
 of age and the general population
 including infants and children).
                                   -----------------------------------------------------------------------------
Chronic dietary (All populations).  NOAEL = 7.41 mg/kg/day,     Chronic RfD = 0.074    6-Month Feeding
                                     UFA = 10x, UFH = 10x,       mg/kg/day.             (Metalaxyl) Study in
                                     FQPA SF = 1x.              cPAD = 0.074 mg/kg/     Dog, LOAEL = 39 mg/kg/
                                                                 day.                   day, based on increased
                                                                                        liver weights and
                                                                                        clinical chemistry
                                                                                        (alkaline phosphatase).
Incidental oral short-term (1 to    NOAEL = 50 mg/kg/day, UFA   LOC for MOE = 100....  Developmental Toxicity in
 30 days).                           = 10x, UFH = 10x, FQPA SF                          Rat (Metalaxyl), LOAEL =
                                     = 1x.                                              250 mg/kg/day based on
                                                                                        clinical signs of
                                                                                        toxicity including post-
                                                                                        dosing convulsions.
Incidental oral intermediate-term   NOAEL = 7.41 mg/kg/day,     LOC for MOE = 100....  6-Month Feeding
 (1 to 6 months).                    UFA = 10x, UFH = 10x,                              (Metalaxyl) Study in
                                     FQPA SF = 1x.                                      Dog, LOAEL = 39 mg/kg/
                                                                                        day based on increased
                                                                                        liver weights and
                                                                                        clinical chemistry
                                                                                        (alkaline phosphatase).
Inhalation short-term (1 to 30      Inhalation (or oral) study  LOC for MOE = 100....  Developmental Toxicity in
 days).                              NOAEL = 50 mg/kg/day                               Rat (Metalaxyl), LOAEL =
                                     (inhalation absorption                             250 mg/kg/day based on
                                     rate = 100%), UFA = 10x,                           clinical signs of
                                     UFH = 10x, FQPA SF = 1x.                           toxicity including post-
                                                                                        dosing convulsions.
                                   -----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).    Classification: ``Not likely to be carcinogenic to humans'' based on the
                                            absence of significant tumor increases in two adequate rodent
                                                               carcinogenicity studies.
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UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).
FQPA SF = Food Quality Protection Act Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose.
MOE = margin of exposure.
LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mefenoxam, EPA considered exposure under the petitioned-for 
tolerances as well as all existing mefenoxam tolerances in 40 CFR 
180.546 and metalaxyl tolerances in 40 CFR 180.408. EPA assessed 
dietary exposures from mefenoxam/metalaxyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure. No such effects were 
identified in the toxicological studies

[[Page 4545]]

for mefenoxam; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food 
Intakes by Individuals (CSFII). As to residue levels in food, EPA 
assumed tolerance-level residues for most commodities. Additional 
factors derived from available residue chemistry data were applied to 
the tolerance values for leafy vegetables, grain seed (including dried 
beans), with the exception of flour cereal grains, nut commodities, 
succulent snap beans, and caneberries to address concerns regarding the 
adequacy of the residue analytical method to determine all metalaxyl/
mefenoxam residues of concern, including metabolites, in plant and 
animal commodities. This was accomplished by calculating parent and 
metabolite to parent ratios to residue levels of concern for risk 
assessment purposes.
    Additionally, EPA used DEEM default processing factors except where 
specific mefenoxam/metalaxyl tolerances exist for processed commodities 
or where metabolism and processing data are available to establish 
specific processing factors. Tolerances were used for dried apricot, 
tomato paste, tomato puree, and potato processed commodities and a 
data-derived processing factor was applied for fruit juices based on 
available metabolism and processing data. Finally, the dietary 
assessment incorporated average percent crop treated (PCT) information, 
when available, for mefenoxam because it showed higher estimates than 
metalaxyl. One hundred PCT was used for all other commodities, 
including the proposed uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that mefenoxam does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on 
the actual percent of food treated for assessing chronic dietary risk 
only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:

 
 
 
Almond, 1%                               Honeydew, 5%
Apple, 1% 5%                             Lemon, 5%
Artichoke; 5%                            Lettuce, 10%
Asparagus, 10%                           Onion, 30%
Avocado, 2.5%                            Orange, 5%
Blueberry, 1%                            Peach, 1%
Broccoli, 10%                            Peanut, 1%
Cabbage, 10%                             Pea, green, 2.5%
Cantaloupe, 10%                          Pepper, 15%
Tomato, 15%                              Potato, 20%
Carrot, 35%                              Pumpkin, 5%
Cauliflower, 5%                          Rice, 1%
Celery, 5%                               Soybean, 10%
Cherry, 1%                               Squash, 10%
Cotton, 5%                               Strawberry, 10%
Cucumber, 10%                            Sugar beet, 1%
Dry bean and pea, 1%                     Sweet corn, 1%
Garlic, 15%                              Tangerine, 10%
Grapefruit, 5%                           Walnut, 1%
Grape, 1%                                Watermelon, 15%
 

    In most cases, EPA uses available data from the USDA/National 
Agricultural Statistics Service (USDA/NASS), proprietary market 
surveys, and the National Pesticide Use Database for the chemical/crop 
combination for the most recent 6-7 years. EPA uses an average PCT for 
chronic dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which mefenoxam may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for metalaxyl/mefenoxam in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of mefenoxam. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier II Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) and Tier I Screening Concentration in 
Ground Water (SCI-GROW) models, the estimated drinking water 
concentrations (EDWCs) of mefenoxam for chronic exposures for non-
cancer assessments are estimated to be 36.7 parts per billion (ppb) for 
surface water and 1.72 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 36.7 ppb was used to 
assess the contribution to drinking 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 the following uses that could result in 
residential exposures: Residential turf and ornamentals and 
recreational turf,

[[Page 4546]]

such as golf courses and athletic fields. EPA assessed residential 
exposure using the following assumptions: Exposure to adults may occur 
from handling mefenoxam, and to children from postapplication contact 
with treated areas. Therefore, adult handlers were assessed for short-
term inhalation exposure resulting from residential application of 
mefenoxam; intermediate-term handler exposure is not expected. For 
children, short- and intermediate-term postapplication oral exposures 
(hand-to-mouth, object-to-mouth, and incidental ingestion of soil) were 
assessed. Dermal toxicity endpoints were not identified for any 
mefenoxam use pattern and chronic residential exposure is not expected; 
therefore, these exposure scenarios were not assessed. It was also 
determined that postapplication mefenoxam exposures to adults and 
children at recreational use sites would be similar to those assessed 
for residential use sites and, therefore, a separate recreational 
exposure assessment is not necessary.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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 has not found mefenoxam to share a common mechanism of toxicity 
with any other substances, and mefenoxam does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that mefenoxam does not 
have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence that 
mefenoxam results in increased susceptibility from in utero exposure to 
rats or rabbits in the prenatal developmental studies or exposure to 
young rats in the 2-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for mefenoxam is complete except for 
immunotoxicity, acute neurotoxicity, and subchronic neurotoxicity 
testing. Recent changes to 40 CFR part 158 require acute and subchronic 
neurotoxicity testing (OPPTS Guideline 870.6200), and immunotoxicity 
testing (OPPTS Guideline 870.7800) for pesticide registration. However, 
the existing data are sufficient for endpoint selection for exposure/
risk assessment scenarios, and for evaluation of the requirements under 
the FQPA. The available studies do not indicate potential for 
immunotoxicity, as evidenced by the lack of effects seen in the spleen, 
thymus, or hematological parameters. Also, metalaxyl and mefenoxam do 
not belong to a class of compounds (e.g., the organotins, heavy metals, 
or halogenated aromatic hydrocarbons) that would be expected to be 
toxic to the immune system.
    ii. With respect to neurotoxicity, clinical signs (ataxia, body 
tremors, reduced activity, and righting reflex) were observed in 
maternal animals in rat and rabbit developmental studies at relatively 
high doses (>= 150 mg/kg/day), where metalaxyl was administered by 
gavage only. These clinical signs were unlikely neurotoxically 
mediated, but rather resulted from the bradycardia mediated through 
alpha-adrenoreceptors. Therefore, there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that mefenoxam results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. Although one additional field trial with residue decline 
measures is needed to complete the geographic distribution for 
caneberry crops, there are no uncertainties in the exposure database 
due to the fact that: (1) There is no significant difference in 
residues in blackberry/raspberry samples from field trials conducted in 
four regions including the major production region (~70%) and 
relatively low production (6-15%) in the remaining regions; and (2) 
existing decline data indicate that residues decline with increasing 
sampling intervals.
    The chronic dietary food exposure assessment was somewhat refined, 
using estimated average PCT data, when available, and 100 PCT for all 
other commodities. The assessment was also performed based on 
tolerance-level residues or additional factors to address concerns 
regarding the adequacy of the residue analytical method in some 
commodities and DEEM default processing factors unless specific 
tolerances were established for processed commodities or metabolism and 
processing data were available to establish specific processing 
factors. These assumptions are based on reliable data which will not 
underestimate potential dietary exposures. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to mefenoxam in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
mefenoxam.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was

[[Page 4547]]

selected. Therefore, mefenoxam is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
mefenoxam from food and water will utilize 60% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of mefenoxam is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Mefenoxam is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to mefenoxam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 2,500 for the 
general U.S. population; 920 for children 3-5 years old; and 880 for 
children 1-2 years old. Because EPA's level of concern for mefenoxam is 
a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Mefenoxam is currently registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to mefenoxam.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 150 for children 3-5 years old and 140 for children 
1-2 years old. Because EPA's level of concern for mefenoxam is a MOE of 
100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, mefenoxam is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to mefenoxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For the purposes of this tolerance action, adequate enforcement 
methodologies including a gas-liquid chromatography with alkali flame-
ionization detection (GLC/AFID) (Method AG-348) and a GLC with 
nitrogen-phosphorus detection (NPD) (Method AG-395) are available to 
enforce the tolerance expression for plant commodities. However, the 
Agency determined that the current residue analytical methods available 
for tolerance enforcement will not adequately recover all of the 
metalaxyl/mefenoxam residues of concern in the revised tolerance 
expression. For this action, therefore, the Agency applied additional 
factors derived from available residue chemistry data to certain 
commodities to account for all residues of concern for dietary risk 
assessments, as previously described in Unit III.C.ii.
    Neither Method AG-348 nor Method AG-395 distinguish between the R- 
and S-enantiomers of metalaxyl/mefenoxam; however, a confirmatory high 
performance liquid chromatography method with mass spectrometric 
detection that utilizes a chiral column (chiral LC/MS), Method 456-98, 
is available for the enantioselective determination of the D- and L-
enantiomers of metalaxyl in crops. Therefore, EPA has determined for 
future actions that the multiresidue method Protocol D, which 
completely recovers metalaxyl/mefenoxam per se, is an adequate 
enforcement method for the determination of metalaxyl/mefenoxam per se 
in plant and livestock commodities; and analysis using a 2,6-DMA common 
moiety method, including recovery data for parent, CGA-62826, and CGA-
94689, can be used in order to refine dietary risk assessments.
    Method AG-;348 may be found in PAM Vol. II; Method AG-395 and 
Method 456-98 have been submitted for inclusion in PAM Vol. II; and 
Multiresidue method Protocol D may be found in PAM, Vol. I Section 302. 
Methods not published in PAM may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Pending revocation of Codex MRLs for metalaxyl, Codex MRLs for 
metalaxyl-m (mefenoxam) have not been advanced to final status. 
Therefore, there are currently no Codex MRLs established for residues 
of mefenoxam in or on the commodities associated with this petition. 
However, with the adoption of the revised tolerance expression, the 
U.S. tolerance expression will be harmonized with the tolerance 
expression for Codex.
    Canadian MRLs for mefenoxam (metalaxyl-m) are covered by MRLs 
established for metalaxyl, and Canadian MRLs have been established for 
residues of metalaxyl in or on spinach at 10 ppm, bulb onion at 3.0 
ppm, green onion at 10 ppm, bean at 0.2 ppm, raspberry at 0.2 ppm, and 
blueberry at 2.0 ppm. The Canadian MRLs are harmonized with U.S. 
tolerance levels in or on the commodities associated with this 
petition, with the exception of caneberry subgroup 13-07A, which is 
being established at 0.70 ppm (the Canadian MRL for raspberry is 0.2 
ppm). The U.S. tolerance on caneberry subgroup 13-07A cannot be 
harmonized with the Canadian MRL on raspberry at this time because the 
field trial data supporting the U.S. tolerance result in residues above 
0.2 ppm. Additionally, with the adoption of the revised tolerance 
expression for mefenoxam, the U.S. tolerance expression will not be in 
harmonization with Canadian MRLs.

C. Revisions to Petitioned-for Tolerances

    Based on analysis of the residue field trial data supporting the 
petition, EPA revised the proposed tolerances on bean, snap, succulent 
from 0.35 ppm to

[[Page 4548]]

0.20 ppm; caneberry subgroup 13-07A from 0.80 ppm to 0.70 ppm; and 
spinach from 8.0 ppm to 10 ppm. The Agency revised these tolerance 
levels based on analysis of the residue field trial data using the 
Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance 
for Setting Pesticide Tolerances Based on Field Trial Data. 
Additionally, EPA has revised the tolerance expression to clarify: (1) 
That, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of mefenoxam not specifically mentioned; and 
(2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam, 
including its metabolites and degradates, in or on bean, snap, 
succulent at 0.20 ppm; caneberry subgroup 13-07A at 0.70 ppm; bushberry 
subgroup 13-07B at 2.0 ppm; onion, bulb, subgroup 3-07A at 3.0 ppm; 
onion, green, subgroup 3-07B at 10 ppm; and spinach at 10 ppm. 
Compliance with the specified tolerance levels is to be determined by 
measuring only metalaxyl (methyl N-(2,6-dimethylphenyl)-N-
(methoxyacetyl)-DL-alaninate). Additionally, this regulation deletes 
the individual tolerance in or on lingonberry at 2.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: January 13, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Section 180.546 is amended by revising paragraph (a) introductory 
text; removing the entry for ``Lingonberry'' from the table; and 
alphabetically adding the following commodities to the table in 
paragraph (a) to read as follows:


Sec.  180.546  Mefenoxam; tolerances for residues.

    (a) General. Tolerances are established for residues of mefenoxam, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only metalaxyl (methyl N-(2,6-
dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bean, snap, succulent.....................................          0.20
Bushberry subgroup 13-07B.................................          2.0
Caneberry subgroup 13-07A.................................          0.70
 
                                * * * * *
Onion, bulb, subgroup 3-07A...............................          3.0
Onion, green, subgroup 3-07B..............................         10
 
                                * * * * *
Spinach...................................................         10
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-1655 Filed 1-25-11; 8:45 am]
BILLING CODE 6560-50-P