[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
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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 None
age
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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