[Federal Register Volume 65, Number 186 (Monday, September 25, 2000)]
[Rules and Regulations]
[Pages 57550-57557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24576]



[[Page 57550]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301042; FRL-6741-1]
RIN 2070-2078


Mefenoxam; Pesticide Tolerances for Emergency Exemptions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes a time-limited tolerance for 
mefenoxam in or on canola. This action is in response to EPA's granting 
of an emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of the pesticide on 
canola. This regulation establishes a maximum permissible level for 
residues of mefenoxam in this food commodity. The tolerance will expire 
and is revoked on December 31, 2001.

DATES:  This regulation is effective September 25, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301042, 
must be received by EPA on or before November 24, 2000.

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 VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301041 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Dan Rosenblatt, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number:(703) 308-9375 and e-mail address: 
rosenblatt.dan@;epa.gov.

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 categories and entities may include, but are not 
limited to:

 
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              Categories                    NAICS codes           Examples of 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  FURTHER INFORMATION CONTACT.

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301042. 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, 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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for the seed treatment 
mefenoxam, in or on canola at 0.05 part per million (ppm). This 
tolerance will expire and is revoked on December 31, 2001. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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

[[Page 57551]]

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.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State Agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act (FQPA). 
EPA has established regulations governing such emergency exemptions in 
40 CFR part 166.

III. Emergency Exemption for mefenoxam on canola and FFDCA 
Tolerances

    EPA has authorized under FIFRA section 18 the use of mefenoxam on 
canola seed for control of seed borne diseases in canola seed. EPA was 
petitioned for the use of a product that contains mefenoxam as one of 
its active ingredients under section 18 of FIFRA. After having reviewed 
the submission, EPA granted the emergency use.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of mefenoxam in or on canola. 
In doing so, EPA considered the safety standard in FFDCA section 
408(b)(2), and EPA decided that the necessary tolerance under FFDCA 
section 408(l)(6) would be consistent with the safety standard and with 
FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6). Although this tolerance will 
expire and is revoked on December 31, 2001, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on canola after that date 
will not be unlawful, provided the pesticide is applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by this tolerance at the time of that application. 
EPA will take action to revoke this tolerance earlier if any experience 
with, scientific data on, or other relevant information on this 
pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether mefenoxam 
meets EPA's registration requirements for use on canola or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of mefenoxam by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State to use this pesticide on this crop under section 18 of 
FIFRA without following all provisions of EPA's regulations 
implementing section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for mefenoxam, 
contact the Agency's Registration Division at the address provided 
under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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 November 26, 1997 (62 FR 62961) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of mefenoxam 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for a time-limited tolerance for mefenoxam in or on 
canola at 0.05 ppm.
    Mefenoxam is predominantly the R-enantiomer (94:3 ratio of R- to S-
enantiomers) of the racemic mixture of the fungicide metalaxyl. 
Metalaxyl is a 50:50 combination of the R- and S- enantiomers. In 
reaching regulatory decisions on mefenoxam, EPA reviewed data which 
bridges environmental fate, chemistry, and toxicology studies between 
metalaxyl and mefenoxam. EPA's assessment of the dietary exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no observed adverse effects are observed (NOAEL) 
from the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (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 (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (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. The doses and toxicological 
endpoints selected and the LOC for margins of exposure for various 
exposure senarios are summarized in the following Table 1:

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     Table 1.--Summary of Toxicological Dose and Endpoints for mefenoxam and metalaxyl for Use in Human Risk
                                                   Assessment
 
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                                                                 FQPA SF* and level of
          Exposure scenario               Dose used in risk         concern for risk     Study and toxicological
                                            assessment, UF             assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   None                     None
 age
Acute dietary general population       None                     None
 including infants and children
Chronic dietary all populations        NOAEL = 7.4 mg/kg/day    FQPA SF = 3 cPAD =       6 month feeding study -
                                        UF = 100 Chronic RfD =   chronic RfD FQPA SF =    dogs LOAEL = 32.4 mg/
                                        0.074 mg/kg/day          0.025 mg/kg/day          kg/day based on
                                                                                          increased alkaline
                                                                                          phosphatase and
                                                                                          increased absolute and
                                                                                          relative liver weight.
Short-term dermal (1 to 7 days) (1 to  None                     None
 7 days (Residential)
Interme diate-term Dermal (1 week to   None.                    None.
 several months) (Residential)
Long-term dermal (several months to    dermal (or oral) study   LOC for MOE = 100        6 month feeding study -
 lifetime) (Residential)                NOAEL= 7.4 mg/kg/day     (Residential)            dogs LOAEL = 32.4 mg/
                                        (dermal absorption                                kg/day based on
                                        rate = 30% when                                   increased alkaline
                                        appropriate)                                      phosphatase and
                                                                                          increased absolute and
                                                                                          relative liver weight.
Short-term Inhalation (1 to 7 days)    None                     None
 (Residential)
Interme diate-term Inhalation (1 week  None                     None
 to several months) (Residential)
Long-term Inhalation (several months   None                     None
 to lifetime) (Residential)
Cancer (oral, dermal, inhalation)                                                        The carcinogenicity
                                                                                          study in mice and
                                                                                          combined chronic
                                                                                          toxicity/
                                                                                          carcinogenicity study
                                                                                          in rats suggest
                                                                                          metalaxyl is best
                                                                                          considered for EPA
                                                                                          Group E (``not likely
                                                                                          to be carcinogenic in
                                                                                          humans'')
----------------------------------------------------------------------------------------------------------------

    The reference to the FQPA Safety Factor refers to any additional 
safety factor retained due to concerns unique to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances that permit 
residues for other registered uses of metalaxyl and mefenoxam have been 
published at 40 CFR 180.408 on a variety of raw agricultural 
commodities. Currently, there are no established tolerances for 
mefenoxam. Risk assessments in support of this action were conducted by 
EPA to assess dietary exposures from all registered uses of metalaxyl 
and mefenoxam in food based on the tolerances established at 40 CFR 
180.408 as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. EPA did not conduct an acute exposure risk 
assessment for mefenoxam. The rationale for this decision is that the 
laboratory data on metalaxyl and mefenoxam suggest that no toxic effect 
could be attributed to a single oral exposure. Therefore, no endpoints 
were selected for this exposure duration and no risk assessment was 
conducted.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: The risk assessment used the published tolerances for 
metalaxyl plus the tolerance associated with the requested exemption. 
Residues were assumed to be at tolerance levels. The use of tolerance 
level residues is considered a conservative assumption. For 
agricultural commodities, where such data were available, percent crop 
treated data were also used.
    iii. Cancer. EPA bridged data on the carcinogenicity of metalaxyl 
from a carcinogenicity study in mice and a combined chronic toxicity 
and carcinogenicity study in rats to assess the carcinogenicity of 
mefenoxam. Based on these data, mefenoxam is considered ``not likely to 
be carcinogenic in human.'' This corresponds to category ``E'' in EPA's 
cancer classification system. Thus, an aggregate cancer risk assessment 
was not conducted for this action.
    iv. Anticipated residue and percent crop treated information.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that 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 such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant sub population group; and 
Condition 3, if 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 percent crop 
treated (PCT) as required by section

[[Page 57553]]

408(b)(2)(F), EPA may require registrants to submit data on PCT.
    The Agency used percent crop treated (PCT) information as follows.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
conditions 2 and 3, regional consumption information and consumption 
information for significant sub populations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant sub populations 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 sub population 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 
information on the regional consumption of food to which metalaxyl or 
mefenoxam may be applied in a particular area.
    2.  Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for metalaxyl or 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 metalaxyl and 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 
SCI-GROW, which predicts pesticide concentrations in ground water. 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 %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to mefenoxam they are further 
discussed in the aggregate risk sections below.
    Since no acute dietary endpoint has been identified, no acute 
exposure estimated environmental concentrations (EECs) for metalaxyl 
and mefenoxam in surface water and ground water were calculated. The 
generic EECs for chronic exposures are estimated to be 63 ppb for 
surface water, based on the GENEEC model, and 5 ppb for ground water, 
based on the SCI-GROW model.
    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).
    Metalaxyl and mefenoxam are currently registered for use on the 
following residential non-dietary sites: turf and certain ornamental 
sites. For short-term and intermediate-term exposures, no toxicological 
endpoint was selected. Thus, no exposure assessment is needed. Chronic, 
non-dietary, exposure is considered to be 180 days or longer. This sort 
of exposure duration is not expected to result in association with the 
requested section 18 exemption. Similarly, chronic non-dietary 
exposures are not expected from the use of other registered metalaxyl 
and mefenoxam products. Thus, a quantitative risk assessment for 
chronic residential exposures was not performed.
    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 metalaxyl and 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, 
metalaxyl and 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 metalaxyl and 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 
November 26, 1997 (62 FR 62961).

C. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of

[[Page 57554]]

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 MOE analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Developmental toxicity studies. EPA has determined that there 
is adequate information about prenatal developmental toxicity to 
conclude that mefenoxam and metalaxyl do not pose a risk of increased 
sensitivity due to in utero exposure.
    iii. Reproductive toxicity study. The 2-generation reproduction 
study is unacceptable because no offspring or parental toxicity was 
demonstrated at any dose level. Therefore, reproductive toxicity is 
currently considered a data gap.
    iv. Prenatal and postnatal sensitivity. Based on reviewed 
laboratory data, there is no indication of increased sensitivity as a 
result of in utero exposure. There are no data gaps relative to in 
utero exposure. The 2-generation reproduction study is not considered 
to be acceptable because toxicity is absent in both offspring and 
parents at any dose level. This limitation makes it difficult to fully 
assess the effects of exposure to young animals following early 
postnatal exposure.
    v. Conclusion. In considering all of the information in this area, 
EPA chose to reduce the infant and children's safety factor to 3x for 
this action. There are several factors underlying this decision: (1) 
There are no data gaps for this assessment of effects following in 
utero exposure; (2) there is no indication of increased sensitivity of 
rats and or rabbits to in utero exposure to mefenoxam or metalaxyl and 
; (3) the exposure assessment will not underestimate the potential 
dietary and non-dietary exposure resulting from the use of mefenoxam. 
However, since the reproductive toxicity study is unacceptable the FQPA 
safety factor is 3x.

D. 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 + chronic non-dietary, non-occupational 
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, OPP concludes with reasonable certainty that 
exposures to metalaxyl and mefenoxam 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 metalaxyl and mefenoxam on drinking water as a part of the aggregate 
risk assessment process.
    1. Acute risk. As previously stated, no toxic effect was associated 
with a single dose or exposure to metalaxyl and mefenoxam in laboratory 
studies. Thus, an acute aggregate risk assessment is not needed.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to metalaxyl 
and mefenoxam from food will utilize 10% of the cPAD for the U.S. 
population, 11% of the cPAD for non-nursing infants and 19% of the cPAD 
for children 1-6 years. Based on the use pattern, chronic residential 
exposure to residues of the metalaxyl and mefenoxam is not expected. In 
addition, despite the potential for chronic dietary exposure to these 
pesticides in drinking water, after calculating the DWLOCs and 
comparing them to conservative model estimated environmental 
concentrations of metalaxyl and mefenoxam in surface and ground water, 
EPA does not expect the aggregate exposure to exceed 100% of the cPAD, 
as shown in the following Table 2:

               Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Mefenoxam
 
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/      cPAD      water EEC    water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.25          10%       63 ppb        5 ppb          780
children 1-6 years                                      0.25          19%       63 ppb     4.95 ppb          200
non-nursing infants                                     0.25          11%       63 ppb     4.95 ppb          220
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Though residential exposure could occur with the use of metalaxyl 
and mefenoxam, no toxicological effects have been identified for short-
term toxicity. Therefore, the aggregate risk is

[[Page 57555]]

the sum of the risk from food and water, which were previously 
addressed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Though residential exposure could occur with the use of metalaxyl 
and mefenoxam, no toxicological effects have been identified for 
intermediate-term toxicity. Therefore, the aggregate risk is the sum of 
the risk from food and water, which were previously addressed.
    5. Aggregate cancer risk for U.S. population. An aggregate cancer 
risk was not conducted for this action. Available data on metalaxyl and 
mefenoxam indicate that the chemical is considered ``not likely to be 
carcinogenic in 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, and to infants and children from aggregate 
exposure to mefenoxam residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Enforcement methodology to enforce residues associated with this 
use on agricultural and animal commodities for metalaxyl is available 
in the Pesticide Analytical Manual. A unique method for mefenoxam, 
predominantly the R-enantiomer of metalaxyl, is under review at this 
time.

B. International Residue Limits

    At this time, there are no Codex, Canadian, or Mexican residue 
tolerances for mefenoxam on canola. However, EPA is coordinating with 
the Canadian pesticide regulatory agency on this matter where a permit 
for the use of Helix on canola is under review. Thus, this time-limited 
tolerance for mefenoxam is expected to be compatible with future 
actions by Canadian officials on this matter.

C. Magnitude of Residues

    Residues of mefenoxam (R)-2-[(2,6-dimethylphenyl)-
methoxyacetylamino- propionic acid methyl ester and its metabolites 
containing the 2,6-dimethylaniline moiety, and N-(2-hydroxymethyl-6-
methylphenyl)-N-(methoxyacetyl)-alanine methyl ester each expressed as 
mefenoxam equivalents are not expected to exceed 0.05 ppm in/on canola 
seed or its processed commodities (meal and refined oil) as a result of 
this section 18 use.
    Secondary residues of mefenoxam in animal commodities as a result 
of this section 18 use are not expected to exceed the established 
tolerance for metalaxyl: 0.05 ppm for meat and meat byproducts (except 
kidney and liver) of cattle, goats, hogs, horses, poultry, and sheep; 
0.4 ppm for fat, kidney, and liver of cattle, goats, hogs, horses, 
poultry, and sheep; 0.02 ppm for milk; and 0.05 ppm for eggs.

VI. Conclusion

    Therefore, the tolerance is established for mefenoxam,, in or on 
canola at 0.05 ppm.

VII. 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-301042 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 
24, 2000.
    1.  Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at epa.gov">tompkins.jim@epa.gov, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3.  Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.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 the docket control number OPP-301042, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of

[[Page 57556]]

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: epa.gov">opp-docket@epa.gov. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 file 
format 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time limited tolerance under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review October 4, 1993 (58 FR 51735). 
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 prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments May 19, 1998, (63 FR 27655) 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations February 16, 1994 (59 FR 7629) 
or require OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks April 23, 1997 (62 FR 19885). 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 FIFRA section 18 
exemption under FFDCA section 408, 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 August 10, 1999 
(64 FR 43255). 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).

IX. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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


    Dated: September 11, 2000.

Susan B. Hazen,

Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.546 is added to read as follows:


Sec. 180.546  Mefenoxam; tolerances for residues.

    (a) General. [Reserved]
    (b)  Section 18 emergency exemptions. A time-limited tolerance is 
established for mefenoxam (R)-2-(2,6-dimethylphenyl)-
methoxyacetylamino-propionic acid methyl ester and 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 or on the following commodities food in 
connection with the use of the pesticide under a section 18 exemption 
granted by EPA. The time-limited tolerance will expire on the date 
specified in the following Table:

 
----------------------------------------------------------------------------------------------------------------
                Commodity                          Parts per million              Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
 Canola                                                                 0.05                            12/31/01
----------------------------------------------------------------------------------------------------------------


[[Page 57557]]

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[FR Doc. 00-24576 Filed 9-22-00; 8:45 am]
BILLING CODE 6560-50-S