[Federal Register Volume 65, Number 225 (Tuesday, November 21, 2000)]
[Rules and Regulations]
[Pages 69876-69883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29770]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301075; FRL-6752-4]
RIN 2070-AB78


Fenhexamid; 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 
residues of fenhexamid in or on pears. 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 pears. This regulation establishes a maximum 
permissible level for residues of fenhexamid in this food commodity. 
The tolerance will expire and is revoked on December 31, 2002.

DATES:  This regulation is effective November 21, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301075, 
must be received by EPA on or before January 22, 2001.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301075 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6463; and 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 categories and entities may include, but are not 
limited to:

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

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301075. 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 residues of the fungicide 
fenhexamid, (N-2,3-dichloro-4-hydroxyphenyl)-1-methyl 
cyclohexanecarboxamide), in or on pears at 15 parts per million (ppm). 
This tolerance will expire and is revoked on December 31, 2002. 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 residential settings, 
but does not include

[[Page 69877]]

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 Federal Insecticide, Fungicide, and Rodenticide 
Act (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 Fenhexamid on Pears and FFDCA 
Tolerances

    According to the Applicant, development of thiabenzadole resistance 
in California Botrytis populations has left packing houses without an 
effective tool to control the disease. Registered alternatives include 
thiabenzadole, captan, Bio-Save Pseudomonas syringae, Aspire Candida 
oleophila, chlorine and ozone. Testing in the laboratory and in the 
field suggests that thiabenzadole resistance may be developing above 
historic levels. Captan is not considered a viable alternative because 
several countries have banned the import of captan-treated fruit. The 
Applicant additionally claims that the unpredictable efficacy and 
results of biological controls have kept the pear industry from 
adopting this technology, and chlorine and ozone are claimed to burn 
the fruit. While the Agency does not fully agree with all of the 
arguments presented by the Applicant, EPA concurs that emergency 
conditions could exist for some packing houses in this State. On 
September 21, 2000, the Applicant availed of itself the authority to 
declare a crisis exemption under section 18 of FIFRA for the 
postharvest use of fenhexamid on pears to control gray mold.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of fenhexamid in or on pears. 
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, 2002, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on pears 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 fenhexamid 
meets EPA's registration requirements for use on pears 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 fenhexamid by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State other than California 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 
fenhexamid, 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 (62 FR 62961, November 26, 1997) (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 
fenhexamid and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of fenhexamid in or on pears at 15 ppm. 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 effect level (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 lowest observed adverse effect level (LOAEL) of concern 
are identified is sometimes used for risk assessment if no NOAEL was 
achieved in the toxicology study selected. An uncertainty factor (UF) 
is applied to reflect uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. An UF 
of 100 is routinely used, 10X to account for interspecies differences 
and 10X for intraspecies differences.
    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

[[Page 69878]]

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 (MOE cancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for fenhexamid used for human risk assessment is shown in the 
following Table 1:

     Table 1. -- Summary of Toxicological Dose and Endpoints for Fenhexamid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of   None                     None                     None
 age
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       None                     None                     None
 including infants and children
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 17 mg/kg/day UF  FQPA SF = 3 cPAD =       1-Year Feeding Study in
                                        = 100 Chronic RfD =      chronic RfD      Dogs LOAEL = 124/133
                                        0.17 mg/kg/day           FQPA SF = 0.057 mg/kg/   mg/kg/day in males/
                                                                 day                      females, based on
                                                                                          decreased RBC counts,
                                                                                          hemoglobin and
                                                                                          hematocrit and
                                                                                          increased Heinz bodies
                                                                                          in RBC. Also, in
                                                                                          females, increased
                                                                                          absolute and relative
                                                                                          adrenal weights
                                                                                          correlated with
                                                                                          histopathological
                                                                                          observations of
                                                                                          increases in incidence
                                                                                          and severity of
                                                                                          intracytoplasmic
                                                                                          vacuoles in the
                                                                                          adrenal cortex.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days)        Dermal NOAEL = 1,000 mg/ LOC for MOE = 300        21-Day Dermal Study -
 (Residential)                          kg/day (limit dose)      (Residential)            Rabbits No rabbits
                                        (dermal absorption                                died during this
                                        rate = 20%)                                       study. No skin
                                                                                          irritation was
                                                                                          observed in any
                                                                                          treated animals. There
                                                                                          were no compound
                                                                                          related effects on
                                                                                          clinical signs, body
                                                                                          weight, food
                                                                                          consumption,
                                                                                          hematology, clinical
                                                                                          chemistry, organ
                                                                                          weights, or gross and
                                                                                          histologic pathology.
                                                                                          Dermal administration
                                                                                          of fenhexamid was well
                                                                                          tolerated by both
                                                                                          sexes for 21-days at
                                                                                          the limit dose of
                                                                                          1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to    Dermal NOAEL = 1,000 mg/ LOC for MOE = 300        21-Day Dermal Study -
 several months) (Residential)          kg/day (limit dose)      (Residential)            Rabbits No rabbits
                                        (dermal absorption                                died during this
                                        rate = 20%                                        study. No skin
                                                                                          irritation was
                                                                                          observed in any
                                                                                          treated animals. There
                                                                                          were no compound
                                                                                          related effects on
                                                                                          clinical signs, body
                                                                                          weight, food
                                                                                          consumption,
                                                                                          hematology, clinical
                                                                                          chemistry, organ
                                                                                          weights, or gross and
                                                                                          histologic pathology.
                                                                                          Dermal administration
                                                                                          of fenhexamid was well
                                                                                          tolerated by both
                                                                                          sexes for 21-days at
                                                                                          the limit dose of
                                                                                          1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    None                     None                     None
 lifetime) (Residential)
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)    None                     None                     None
 (Residential)
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week   None                     None                     None
 to several months) (Residential)
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   None                     None                     None
 to lifetime) (Residential)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      None                     None                     The Agency has
                                                                                          classified Fenhexamid
                                                                                          as a ``not likely''
                                                                                          carcinogen. This
                                                                                          classification is
                                                                                          based on the lack of
                                                                                          evidence of
                                                                                          carcinogenicity in
                                                                                          male and female rats
                                                                                          as well as in male and
                                                                                          female mice and on the
                                                                                          lack of genotoxicity
                                                                                          in an acceptable
                                                                                          battery of
                                                                                          mutagenicity studies.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.


[[Page 69879]]

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.553) for the residues of fenhexamid, in or on a 
variety of raw agricultural commodities including grapes, raisins and 
strawberries. Risk assessments were conducted by EPA to assess dietary 
exposures from fenhexamid in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. No acute dietary endpoint has been identified. 
Therefore, no assessment was conducted for acute dietary exposures.
    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: use of tolerance level residues and 100% of the crop was 
treated.
    iii. Cancer. The Agency has classified fenhexamid as a ``not 
likely'' carcinogen. Therefore, no exposure assessment was conducted to 
assess cancer concerns.
    2. Dietary exposure from drinking water. The use pattern associated 
with the emergency exemption (use of fenhexamid as a postharvest 
treatment on pears) is not expected to impact water resources. However, 
the Agency is required to perform an aggregate risk assessment which 
includes all registered uses of fenhexamid that would lead to exposure 
to humans through drinking water. Therefore, the Agency estimated 
environmental concentrates in drinking water from the use of fenhexamid 
on strawberries to determine the aggregate risk assessment.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
fenhexamid 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 fenhexamid.
    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 fenhexamid they are further 
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of fenhexamid for chronic exposures are estimated 
to be 4.8 parts per billion (ppb) for surface water and 0.0007 ppb for 
ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Fenhexamid is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether fenhexamid 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, 
fenhexamid 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 fenhexamid has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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 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. In a developmental toxicity 
study in rats, maternal toxicity (marginally decreased body weight gain 
and decreased food consumption during the treatment period only) was 
observed at the LOAEL of 1,044 milligrams/kilograms/day (mg/kg/day) 
(only dose level tested). The NOAEL for maternal toxicity was <1,044 
mg/kg/day. At the same dose level of 1,044 mg/kg/day, no treatment-
related signs of developmental toxicity were observed in the fetuses. 
The NOAEL for developmental toxicity was 1,044 mg/

[[Page 69880]]

kg/day and the LOAEL was not established (>1,044 mg/kg/day). Although a 
NOAEL was not determined for maternal toxicity in this study, the study 
need not be repeated because the effects at the LOAEL were only 
marginal and of minimal toxicological concern.
    In a developmental toxicity study in rabbits, the NOAEL for 
maternal toxicity was 100 mg/kg/day and the LOAEL was 300 mg/kg/day, 
based on alterations of excretory products (discolored urine, scant 
feces, small scybala), decreased body weight gain and decreased food 
consumption (especially during the first week of dosing) and decreased 
placental weight. At the next higher dose level of 1,000 mg/kg/day, the 
maternal effects were increased in severity. A decreased gestation 
index, based on a slightly increased incidence of abortions and total 
litter resorptions, was not considered to be treatment-related because 
the incidences of abortions and resorptions fell within the historical 
control range submitted with the study. The NOAEL for developmental 
toxicity was 300 mg/kg/day and the LOAEL was 1,000 mg/kg/day, based on 
slightly decreased fetal body weights (<5%) in males only and increased 
delayed ossification in several bones (especially the 5th sternal 
segments and the 15th caudal vertebrae).
    iii. Reproductive toxicity study. In a 2-generation (1 litter/
generation) reproduction study in rats, there were no treatment-related 
effects on mortality, clinical signs, behavior or reproductive 
parameters for adult (parent) animals. The NOAEL for reproductive 
toxicity was 1,814/2,043 mg/kg/day (M/F) (HDT). The NOAEL for parental 
toxicity was 38/45 mg/kg/day (M/F) and the LOAEL was 406/477 mg/kg/day 
(M/F). In males at the LOAEL of 406 mg/kg/day, increased serum 
creatinine levels and decreased kidney weights indicated mild kidney 
damage and increased serum alkaline phosphatase levels and decreased 
liver weights indicated mild liver damage. In females at the LOAEL of 
477 mg/kg/day, increased serum alkaline phosphatase levels and very 
slightly increased serum GGT levels suggested mild liver damage. At the 
next higher dose level of 1,814/2,043 mg/kg/day (M/F)(HDT), the effects 
observed at the LOAEL in both males and females were slightly increased 
in severity. In addition, decreased body weight, increased food 
consumption, and increased serum GGT levels were observed in males and 
decreased body weights, increased food consumption, increased serum 
urea nitrogen levels, increased serum creatinine levels and decreased 
kidney weights were observed in females. The NOAEL for neonatal 
toxicity was 38/45 mg/kg/day (M/F) and the LOAEL was 406/477 mg/kg/day 
(M/F). At the LOAEL of 406/477 mg/kg/day, treatment-related decreased 
pup body weights were observed in F1 pups on postnatal days 
14 and 21 and in F2 pups on postnatal days 7, 14 and 21. At 
the next higher dose level of 1,814/2,043 mg/kg/day (M/F) (HDT), the 
decreased pup body weights were increased in severity. In addition, an 
increased mortality was observed among the post weaning F1 
pups selected to be F1 parents (possibly due to the small size of the 
pups at weaning, which was 30% less than controls).
     The results in this reproduction study are equivocal with respect 
to evaluating the possibility of increased susceptibility of pups, as 
compared to adults, to fenhexamid. On the basis of NOAELs/LOAELs, no 
increased susceptibility of pups to fenhexamid was demonstrated in this 
study. However, the severity of the effects observed in the pups may 
have been greater than that observed in the adults at the same dose 
levels. In addition, several other toxicological considerations, 
including possibly increased intake of test material in pups resulting 
from intake in both milk and diet during the lactation period and 
possibly decreased levels of UDP-glucuronyltransferase enzyme in pups 
(a normally occurring phenomenon in rat pups) resulting in decreased 
metabolism or ``detoxification'' of test material, contributed to the 
uncertainty of the determination.
    iv. Prenatal and postnatal sensitivity. The available Agency 
Guideline studies indicate no increased susceptibility of rat or rabbit 
fetuses to in utero exposure to fenhexamid. In the prenatal 
developmental toxicity study in rats, no evidence of developmental 
toxicity was seen even at the highest dose tested. In the prenatal 
developmental toxicity study in rabbits, developmental toxicity was 
seen only in the presence of maternal toxicity.
     In the 2-generation reproduction study in rats, quantitatively 
(i.e., based on NOAELs/LOAELs in parental animals versus offspring), 
there was no evidence of increased susceptibility of the pups. 
Qualitatively, however, there was evidence of increased susceptibility 
based on the comparative severity of effects at the LOAEL (406 mg/kg/
day): Parental toxicity was characterized as alterations in clinical 
chemistry parameters and decreased organ weights without collaborative 
histopathology; while offspring toxicity was manifested as 
significantly decreased pup body weights in both generations during the 
lactation period (on lactation days 7, 14, and 21 in the F2 
generation and lactation days 14 and 21 in the F1 generation 
offspring)
    v. Conclusion. The Agency has determined that a safety factor is 
required for fenhexamid because qualitatively, there was evidence of 
increased susceptibility based on the comparative severity of effects 
in the 2-generation reproduction study in rats. The effects on pups 
were of concern because:
    1. Significant pup body weight decreases were observed in both the 
F1 and the F2 generations.
    2. The pup body weight decreases in the F2 generation 
were observed during early lactation (lactation day 7 through day 21) 
when the pups are exposed to the test material primarily through the 
mother's milk.
    3. The pup body weight decreases in the F1 generation 
were observed during late lactation (lactation days 14 through 21) when 
the pups are exposed to the test material through the mother's milk and 
through the feed.
    4. In the metabolism study on fenhexamid, glucuronidation of 
fenhexamid was clearly demonstrated to be the single major route of 
metabolism, detoxification and excretion of fenhexamid in adult male 
and female Wistar rats. The demonstrated poor glucuronidation capacity 
of rat pups between days 7 and 21 (in a referenced study) indicates a 
possibly increased sensitivity of pups and serves to support a concern 
for neonatal toxicity.
     However, the Agency has reduced the FQPA safety factor to 3x 
because:
    1. The toxicology data base is complete for the assessment of the 
effects of fenhexamid following in utero and/or postnatal exposure.
     2. There is no indication of increased susceptibility of rat or 
rabbit fetuses to in utero exposure in the prenatal developmental 
toxicity studies with fenhexamid.
    3. The increased susceptibility demonstrated in the 2-generation 
reproduction study was only qualitative (not quantitative) evidence and 
was observed only in the presence of parental toxicity.
    4. The qualitative offspring effect was limited to decreased body 
weight and no other adverse effects (e.g., decreased pup survival, 
behavioral alterations, etc) were observed.
    5. Adequate data are available or conservative modeling assumptions 
are used to assess dietary food and drinking water exposure.
    6. There are currently no residential uses for fenhexamid.

[[Page 69881]]

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 U.S. EPA Office of Water are used to calculate 
DWLOCs: 2 Liter(L)/70 kilogram (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 fenhexamid 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 
fenhexamid on drinking water as a part of the aggregate risk assessment 
process.
    1. Acute risk. 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. No acute dietary endpoint has been identified. 
Therefore, no risk assessment was conducted for acute dietary 
exposures.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenhexamid from food will utilize 7% of the cPAD for the U.S. 
population, 65% of the cPAD for all infants, less than 1 year old and 
16% of the cPAD for children, 1-6 years old, the subpopulation of 
children at greatest exposure. There are no residential uses for 
fenhexamid that result in chronic residential exposure to fenhexamid. 
In addition, despite the potential for chronic dietary exposure to 
fenhexamid in drinking water, after calculating DWLOCs and comparing 
them to conservative model estimated environmental concentrations of 
fenhexamid 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 Fenhexamid
----------------------------------------------------------------------------------------------------------------
                                                                                           Ground
       Population Subgroup        cPAD mg/kg/day    % cPAD (Food)    Surface Water EEC   Water EEC     Chronic
                                                                           (ppb)           (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                            0.057                  7                4.8       0.0007        1,900
----------------------------------------------------------------------------------------------------------------
Children, 1-6 years                        0.057                 16                4.8       0.0007          480
----------------------------------------------------------------------------------------------------------------
All infants, < 1 year                      0.057                 65                4.8       0.0007          190
----------------------------------------------------------------------------------------------------------------

    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). Fenhexamid is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is 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). Fenhexamid is not registered for use on any sites that would 
result in residential exposure. 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. The Agency has 
classified Fenhexamid as a ``not likely'' carcinogen. Therefore, no 
risk assessment was conducted to assess cancer concerns.
    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 fenhexamid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

     Bayer AG Method 00362, a high performance liquid chromatography 
method with electrochemical detection, is the enforcement method for 
fenhexamid residues in plant commodities. A copy of the method has been 
sent to FDA for publication in the Pesticide Analytical Manual (PAM), 
Volume II, as a Roman numeral method. In the interim, it may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

     There are no Codex or Mexican MRL tolerances established for 
fenhexamid and no Canadian MRL on pears..

VI. Conclusion

    Therefore, the tolerance is established for residues of fenhexamid, 
(N-2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide), in 
or on pears at 15 ppm.

[[Page 69882]]

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-301075 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 January 
22, 2001.
     1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
     Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
     2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
     EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
     3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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-301075, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 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 (58 FR 51735, October 4, 1993). 
This final rule does not contain any information collections subject to 
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501  
et seq., or impose any enforceable duty or contain any unfunded mandate 
as described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or require OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 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

[[Page 69883]]

U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4).

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: November 8, 2000.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.553 is amended by revising paragraph (b) to read as 
follows:


Sec. 180.553  Fenhexamid; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the residues of the fungicide fenhexamid, (N-2,3-
dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide), in 
connection with use of the pesticide under section 18 emergency 
exemptions granted by EPA. The tolerances will expire on the dates 
specified in the following table:

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Pears                             15................  12/31/02
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-29770 Filed 11-20-00; 8:45 am]
BILLING CODE 6560-50-S