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avermectin (Agri-Mek, Affirm) Pesticide Tolerance 12/00


ENVIRONMENTAL PROTECTION AGENCY


40 CFR Part 180


[OPP-301082; FRL-6755-9]
RIN 2070-78AB



Avermectin B1; Pesticide Tolerance


AGENCY: Environmental Protection Agency (EPA).


ACTION: Final rule.


-----------------------------------------------------------------------


SUMMARY: This regulation establishes a tolerance for combined residues
of avermectin B1 and its delta-8,9-isomer in or on celeriac
(roots and tops) at 0.05 parts per million (ppm). The Interregional
Research Project Number 4 (IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996.


DATES: This regulation is effective December 21, 2000. Objections and
requests for hearings, identified by docket control number OPP-301082,
must be received by EPA on or before February 20, 2001.


ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI.. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301082 in the
subject line on the first page of your response.


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


SUPPLEMENTARY INFORMATION:


I. General Information


A. Does this Action Apply to Me?


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


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


[[Page 80354]]


    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/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301082. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.


II. Background and Statutory Findings


    In the Federal Register of September 27, 2000 (65 FR 58081) (FRL-
6746-4), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP 0E6118) for tolerance
by IR-4, 681 U.S. Highway #1 South, North Brunswick, New Jersey 08902-
3390. This notice included a summary of the petition prepared by
Novartis Crop Protection, Inc., the registrant. There were no comments
received in response to the notice of filing.
    The petitions requested that 40 CFR 180.449 be amended by
establishing tolerances for combined residues of the insecticide
avermectin B1, (a mixture of avermectins containing greater
than or equal to 80% avermectin B1a (5-O-demethyl avermectin
A1a) and less than or equal to 20% avermectin B1b
(5-O-demethyl-25-de(1- methylpropyl)-25-(1-methylethyl) avermectin
A1a)) and its delta-8,9-isomer, in or on celeriac roots and
tops at 0.05 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).


III. Aggregate Risk Assessment and Determination of Safety


    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for combined residues of avermectin
B1 and its delta-8,9-isomer on celeriac roots and tops at
0.05 ppm. EPA's assessment of exposures and risks associated with
establishing the tolerances follows.


A. Toxicological Profile


    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by avermectin
B1 are discussed in Unit III A of the Final Rule on
Avermectin Pesticide Tolerance published in the Federal Register on
September 7, 1999 (FRL 6380-7).


B. Toxicological Endpoints


    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolatin from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the 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.


[[Page 80355]]


    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for avermectin B1 used for human risk assessment
is as follows:
    A summary of the toxicological endpoints for avermectin
B1 used for human risk assessment is shown in the following
Table 1:


    Table 1.--Summary of Toxicological Dose and Endpoints for Avermectin B1 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 U.S. population          NOAEL = 0.25 mg/kg/day   FQPA SF = 1 aPAD =       Chronic toxicity--dog
                                        UF = 100 Acute RfD = acute RfD FQPA SF =      LOAEL = 0.50 mg/kg/day
                                        0.0025 mg/kg/day 0.0025 mg/kg/day         based on dilated
pupils seen at week 1
of dosing.
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13+ years of     NOAEL = 0.25 mg/kg/day   FQPA SF = 10 aPAD =      Chronic toxicity--dog
 age, and infants and children          UF = 100 Acute RfD = acute RfD FQPA SF =      LOAEL = 0.50 mg/kg/day
                                        0.0025 mg/kg/day 0.00025 mg/kg/day        based on dilated
pupils seen at week 1
of dosing.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary U.S. population        NOAEL= 0.12 mg/kg/day    FQPA SF = 1 cPAD =       2-generation
                                        UF = 100 Chronic RfD = chronic RfD FQPA SF =    reproduction--rat
                                        0.0012 mg/kg/day 0.0012 mg/kg/day         LOAEL = 0.40 mg/kg/day
based on based on
decreased pup weight
and viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary females 13+ years of   NOAEL = 0.12 mg/kg/day   FQPA SF = 10 cPAD =      2-generation
 age, and infants and children          UF = 100 Chronic RfD = chronic RfD FQPA SF =    reproduction--rat
                                        0.0012 mg/kg/day 0.00012 mg/kg/day        LOAEL = 0.40 mg/kg/day
based on based on
decreased pup weight
and viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days)        oral study NOAEL = 0.25  LOC for MOE = 1,000      chronic toxicity--dog
 (Residential)                          mg/kg/day (dermal (Residential)            LOAEL = 0.50 mg/kg/day
                                        absorption rate = 1%) based on dilated
pupils at week 1 of
dosing
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to    oral study NOAEL = 0.25  LOC for MOE = 1,000      chronic toxicity--dog
 several months) (Residential)          mg/kg/day(dermal (Residential)            LOAEL = 0.50 mg/kg/day
                                        absorption rate = 1% based on dilated
pupils at week 1 of
dosing
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    oral study NOAEL= 0.12   LOC for MOE = 1,000      2-generation
 lifetime) (Residential)                mg/kg/day (dermal (Residential)            reproduction--rat
                                        absorption rate = 1% LOAEL = 0.40 mg/kg/day
                                        when appropriate) based on based on
decreased pup weight
and viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)    oral study NOAEL = 0.25  LOC for MOE = 1,000      chronic toxicity--dog
 (Residential)                          mg/kg/day (inhalation (Residential)            LOAEL = 0.50 mg/kg/day
                                        absorption rate = based on dilated
                                        100%) pupils at week 1 of
dosing
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week   oral study NOAEL = 0.25  LOC for MOE = 1,000      chronic toxicity--dog
 to several months) (Residential)       mg/kg/day (inhalation (Residential)            LOAEL = 0.50 mg/kg/day
                                        absorption rate = based on dilated
                                        100%) pupils at week 1 of
dosing
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   oral study NOAEL = 0.12  LOC for MOE = 1,000      2-generation
 to lifetime) (Residential)             mg/kg/day (inhalation (Residential)            reproduction--rat
                                        absorption rate = LOAEL = 0.40 mg/kg/day
                                        100%) based on based on
decreased pup weight
and viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Not Applicable Cancer Group E--absence  Rodent carcinogenicity
                                                                 of significant tumor     study--was negative
increases in two         carcinogens.
adequate rodent
carcinogenicity
                                                                 studies.
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.


[[Page 80356]]


C. Exposure Assessment


    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.449) for the combined residues of avermectin
B1 and its delta-8,9-isomer, in or on a variety of raw
agricultural commodities including apples, almonds, citrus, cottonseed,
grapes, hops, peppers, potatoes, cattle meat and meat by-products and
milk. Risk assessments were conducted by EPA to assess dietary
exposures from avermectin B1 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. The following assumptions were made for the acute
exposure assessments: The acute dietary exposure assessment was
conducted using probabilistic Monte Carlo'' modeling incorporating
anticipated residue and percent of crop treated refinements to
calculate the Anticipated Residue Contribution (ARC). Residue Data
Files (RDF) and percent crop treated were used on all but a few low
consumption food items. Reduction factors for fractionation and
processing were utilized for citrus and pome fruit. Monitoring data
were not used for mixed/blended commodities. EPA was able to further
refine the acute dietary estimate from food by using updated PCT data,
resetting the processing factor for dried potatoes to 1 which reflects
the non-concentration of avermectin B1 in potato processed
commodities, correcting the residue files above to use one half the
level of detection or one half the level of quantification, where
appropriate, and using the average field trial residue level and
previously established processing factors for blended commodities. In
addition, the analysis included residues in pear juice for which no
data has been previously required. Since all other juices show
reductions in avermectin B1 residues from the raw
agricultural commodity, EPA used the reduction factor for apples in the
analysis.
    ii. Chronic exposure.In conducting this chronic dietary (food only)
risk assessment, EPA used anticipated residues and percent crop-treated
data for many crops. This chronic dietary (food only) exposure should
be viewed as a highly refined risk estimate; further refinement using
additional percent crop-treated values would not result in a
significantly lower dietary exposure estimate. Thus, in making a safety
determination for this tolerance, EPA is taking into account this
refined chronic exposure assessment.
    iii. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used percent crop treated (PCT) information as follows:
For each crop in the dietary (food only) model the following percent
crop treated values were used for the acute and chronic analyses
(respectively): almond 100%, 100%; apple 6.1%, 1.9%; avocado 100%,
100%; basil 100%, 100%; cantaloupe 5%, 1.3%; celeriac 100%, 100%;
celery 60%, 49%; citrus, other 43%, 32%; cotton 4.8%, 3.2%; cucumber
100%, 31%; grapefruit, juice and peel 60.9%, 46%; grapefruit, peeled
fruit 43%, 46%; grape 14%, 14%; hops 100%, 84%; lemon, juice and peel
34.4%, 17%; lemon, peeled fruit 43%, 17%; head lettuce 28%, 22%; lime,
juice and peel 63.2%, 32%; lime, peeled fruit 43%, 32%; melons 5%,
1.3%; orange, juice and peel 36.3%, 28%; orange, peeled fruit 43%, 28%;
pear 75%, 56%; peppers 15%, 6.3%; potato 5%, 0.3%; spinach 18%, 8.9%;
squash 100%, 31%; strawberry 47%, 42%; tangelo 43%, 57%; tangerine,
juice 74.3%, 53%; tangerine, fresh 43%, 53%; tomato 8%, 3.7%; walnut
100%, 100%; watermelon 5%, 1.3%. For fresh, peeled citrus a weighted
average (43%) was calculated pooling all types of citrus; this value
was used in the analysis of chronic dietary exposure from citrus.
    The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which avermectin
B1 may be applied in a particular area.
    2. Dietary exposure from drinking water. Avermectin B1
is moderately persistent and non-mobile. It is not expected to reach
surface or ground


[[Page 80357]]


water in significant quantities. It is stable to hydrolysis at pH 5, 7,
and 9. It is also moderately persistent in aerobic soil (topsoil) with
half-lives of 37-131 days. The major pathways of avermectin
B1 dissipation are binding to soil and sediment, degradation
in aerobic soil, and photolysis in water. In shallow, well-mixed
surface water with no suspended sediments, avermectin B1
degraded rapidly with a photodegradation half-life of 3 days. However,
in most surface waters, suspended sediments and lack of mixing would
decrease the rate of photodegradation significantly. In water,
avermectin B1 residues would be tightly bound to sediment,
reducing aqueous concentrations. There are no Maximum Contaminant
Levels (MCL) or Health Advisories (HA) established for avermectin
B1 residues in drinking water.
    The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
avermectin B1 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 avermectin
B1.
    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 groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    EPA decided to rely on the strawberry model to assess aggregate
risk since strawberries were considered a higher exposure scenario
(four applications per season allowed for strawberries). However, EPA
noted that the certainty of the concentrations estimated for
strawberries is low, due to uncertainty on the amount of runoff from
plant beds covered in plastic mulch and uncertainty on the amount of
degradation of avermectin B1 on black plastic compared to
soil. In order to refine the model in the future, the Agency has
required the registrant, as a condition of product registration, to
conduct additional tests on the effects of plastic mulch on surface
water pesticide concentrations.
    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 avermectin B1
they are further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated
environmental concentrations (EECs) of avermectin B1 for
acute exposures are estimated to be [0.88] parts per billion (ppb) for
surface water and 0.0015 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.57 ppb for surface water and 0.002 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).
    Avermectin B1 is currently registered for use on the
following residential non-dietary sites: residential lawns for fire ant
control, and residential indoor crack and crevice for cockroaches.
Registered uses may result in short-term to intermediate exposures.
However, based on current use patterns, chronic exposure to avermectin
B1 is not expected. The risk assessment was conducted using
the following residential exposure assumptions:
    i. Short and intermediate exposure--residential lawn applications.
For exposure of residential applicators, three scenarios were used: (a)
granular bait dispersed by hand, (b) belly grinder-granular open pour-
mixer/loader/applicator and (c) push type granular.
    For postapplication exposure from treated lawns, EPA default
assumptions such as dermal transfer coefficient (TC), exposure time
(ET), hand surface area (SA), ingestion frequency (FQ), residue
dissipation, and ingestion rates were used. These defaults estimated
postapplication exposure to children and adults from treated lawns. The
application rate (AR) used for this assessment is based on the label
for Affirm Fire Ant Insecticide (0.011% avermectin B1). The
label recommends a broadcast application rate on lawns of 1 lb of
product/acre, the maximum rate for all registered lawn uses.
    ii. Short and intermediate exposure--residential indoor crack and
crevice uses. For residential applicators, exposure and risk estimates
for homeowners applying crack and crevice baits were estimated using
the EPA DRAFT Standard Operating Procedure (SOP) for Residential
Exposure Assessments (12/18/97). The amount of active ingredient (ai)
handled was based on the assumption that one 30 gram package of
Whitmire Avert Prescription Bait Prescription Treatment 310 (0.05% ai)
would be applied in a day. The unit exposure from the EPA default
wettable powder, open mixing and loading scenarios was used as a
surrogate for estimating dermal and inhalation exposure to residential
applicators.
    For estimating postapplication exposure from indoor treatment, two
postapplication exposure studies were conducted with crack and crevice
products containing avermectin B1: (1) Evaluation of Avert
Prescription Treatment 310 Residual Study in Air, Food and on Surfaces,
dated November 8, 1990 and (2) Evaluation of Indoor Exposure to a Crack
and Crevice Application of Whitmire Avert Crack and Crevice
Prescription Treatment 310 and Prescription TC 93A Bait, dated October
27, 1995 (see Unit III.C. of the Final Rule on Avermectin Pesticide
Tolerance published in the Federal Register on September 7, 1999 (FRL
6380-7)).
    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


[[Page 80358]]


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 avermectin B1 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,
avermectin B1 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 avermectin B1
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the final rule for Bifenthrin Pesticide Tolerances
(62 FR 62961, November 26, 1997).


D. Safety Factor for Infants and Children


    1. 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 margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. There was evidence of
increased susceptibility to the offspring following prenatal and
postnatal exposure to avermectin B1 in the 2-generation
reproduction study in rats.
    iii. Conclusion. There is a complete toxicity data base for
avermectin B1 and exposure data are complete or are
estimated based on data that reasonably accounts for potential
exposures. The Agency is retaining the 10-fold safety factor for
increased susceptibility of infants and children for this pesticide and
is applying it to females 13+, infants, and children population
subgroups for acute, chronic, and residential exposure.
    The 10X Safety Factor is being retained because: (1) There was
evidence of increased susceptibility to the offspring following pre-
and postnatal exposure to avermectin B1 in the 2-generation
reproduction study in rats. (2) There is evidence of neurotoxicity
manifested as clinical signs of neurotoxicity in mice, rats, and dogs
in developmental, reproduction, chronic and/or carcinogenicity studies
in mice, rats and/or dogs. (3) There is concern for Structure Activity
Relationship: Avermectin induced cleft palate in fetal rats, and cleft
palate and clubbed forefoot in fetal rabbits. (4) EPA determined that a
developmental neurotoxicity study in rats is required for avermectin
B1. This study could provide additional information on
potential increased susceptibility, effects on the development of the
fetal nervous system, as well as the functional development of the
young. (5) There is concern for post-application exposure to infants
and children in treated areas, including incidental hand-to-mouth
ingestion of the pesticide.


E. Aggregate Risks and Determination of Safety


    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
avermectin will occupy 4% of the aPAD for the U.S. population, 37% of
the aPAD for females 13 years and older nursing, 47% of the aPAD for
non-nursing infants and 70% of the aPAD for children 1-6 years. In
addition, there is potential for acute dietary exposure to avermectin
in drinking water. After calculating DWLOCs and comparing them to the
EECs for surface and ground water, the acute exposure for aggregate
risk slightly exceeds the aPAD for children 1-6 years old. However EPA
believes that acute exposure to avermectin from drinking water will not
pose an unacceptable risk to human health. Neither surface nor ground
water models used by EPA were designed specifically for estimating
concentrations in drinking water. There are significant uncertainties
in both the toxicology used to derive the DWLOC and the exposure
estimate from the PRZM-EXAMS model. EPA has compensated for these
uncertainties by using reasonable high-end assumptions. Given this
approach, the Agency does not attach great significance to such a small
difference. However, EPA may do additional analyses and, as a condition
of product registration, the Agency has required the registrant to
submit (1) data on the effects of plastic mulch on surface water
pesticide concentrations and (2) data characterizing the effectiveness
of various types of drinking water treatment on removing avermectin.
These data are expected to confirm that the actual concentration of
avermectin in drinking water is less than the level of concern for all
sub-populations, as shown in the following Table 2:


[[Page 80359]]


                     Table 2.--Aggregate Risk Assessment for Acute Exposure to Avermectin B1
----------------------------------------------------------------------------------------------------------------
Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg) (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       0.0025 4         0.88       0.0015           84
Children 1-6 years old                               0.00025 70         0.88       0.0015         0.74
Females 13+ nursing                                  0.00025 37         0.88       0.0015          4.7
----------------------------------------------------------------------------------------------------------------


    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
avermectin B1 from food will utilize less than 1% of the
cPAD for the U.S. population, 17% of the cPAD for non-nursing infants
and 13% of the cPAD for children 1-6 years old. Based the use pattern,
chronic residential exposure to residues of avermectin B1 is
not expected. In addition, there is potential for chronic dietary
exposure to avermectin B1 in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:


             Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Avermectin B1
----------------------------------------------------------------------------------------------------------------
Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       0.0012 <1         0.57        0.002           42
Infant, non-nursing                                  0.00012 17         0.57        0.002            1
Female 13+, nursing                                  0.00012 6         0.57        0.002            3
----------------------------------------------------------------------------------------------------------------


    3. Short-and intermediate-term risk.. Short- and intermediate term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Avermectin B1 is currently registered for use that could
result in short- and intermediate term residential exposure and the
Agency has determined that it is appropriate to aggregate chronic food
and water and short-and intermediate term exposures for avermectin
B1.
    Short- and intermediate-term total MOEs (dermal + inhalation) are
greater than 1,000 and therefore exceeds EPA's level of concern.
    A margin of exposure (MOE) of 1,000 or greater is required for the
most sensitive subgroups. All lawn postapplication MOEs exceeded this
value and therefore is not of concern to EPA. The dermal short- and
intermediate-term MOEs for adults and children are 83,000 and 86,000,
respectively. The oral hand-to-mouth short- and intermediate-term MOEs
for children are 14,000 and 6,500, respectively. The oral incidental
ingestion short- and intermediate-term MOEs for children are 610,000
and 290,000, respectively.
    The short- and intermediate-term MOEs for dermal and inhalation
exposure are each 12 million, exceeds EPA's level of concern.
    The short- and intermediate-term dermal MOE for children's
postapplication dermal is 78,000. The short- and intermediate-term oral
MOE for children's postapplication oral hand-to-mouth is 12,000. The
short- and intermediate-term inhalation MOE for children's
postapplication inhalation is 2,400.
    The risk from children's post application exposure to crack and
crevice products containing avermectin B1 does not exceed
EPA's level of concern. Avert Prescription Treatment 310 is a dust
formulation that is intended for the application to crack and crevices
only. Other formulations for similar crack and crevice products (i.e.,
gels, granulars, pressurized liquids, etc.) will have less migration
from the treated area and are expected to result in lower risk from
dermal, oral, and inhalation postapplication exposure.
    Using the exposure assumptions described in this unit for short-
and intermediate term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of dermal,
inhalation, and oral exposures. These aggregate MOEs do not exceed the
Agency's level of concern for aggregate exposure to food and
residential uses. In addition, short-and intermediate term DWLOCs were
calculated and compared to the EECs for chronic exposure of avermectin
B1 in ground and surface water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect short-and intermediate term aggregate exposure to exceed the
Agency's level of concern as shown in Table 4.
    Short-intermediate-term aggregate exposure takes into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).


            Table 4.--Aggregate Risk Assessment for Short-Intermediate-Term Exposure to Avermectin B1
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE Food + Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential) (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       1,7000 100         0.57      0.00023           87
Infants and children                                    1400 100         0.57     0.000077         0.77
----------------------------------------------------------------------------------------------------------------


[[Page 80360]]


    4. Aggregate cancer risk for U.S. population. EPA classified
avermectin B1 as a Cancer Group E (evidence of non-
carcinogenicity for humans) chemical based on the absence of
significant tumor increases in two adequate rodent carcinogenicity
studies.
    5. 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 avermectin B1 residues.


IV. Other Considerations


A. Analytical Enforcement Methodology


    Adequate enforcement methodology is available to enforce the
tolerance expression. Separate analytical methods were employed to
quantify residues in celeriac roots and tops: The method used for roots
was a modified version of HPLC Fluorescence Determination for
Avermectin B1 and its Delta 8,9 Isomer in Raw Whole Potatoes
(Method No. 936-92-4, 25 July 1992). Celeriac tops were analyzed using
HPLC Fluorescence Determination for Avermectin B1 and its
Delta 8,9 Isomer in/on Fruits and Vegetables: Commodity - Stone Fruit
(Method No. M-073, 15 November 1996). The methods 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:
furlow.calvin@epa.gov.


B. International Residue Limits


    There are no Codex, Canadian, or Mexican Maximum Residue Limits
(MRL) for avermectin B1 on celeriac. Therefore,
international harmonization is not an issue for the action.


V. Conclusion


    Therefore, the tolerance is established for combined residues of
avermectin B1 and its delta-8,9-isomer in or on celeriac
roots and tops at 0.05 ppm.


VI. Objections and Hearing Requests


    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.


A. What Do I Need to Do to File an Objection or Request a Hearing?


    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301082 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 February
20, 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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301082, 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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.


B. When Will the Agency Grant a Request for a Hearing?


    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual


[[Page 80361]]


issues(s) in the manner sought by the requestor would be adequate to
justify the action requested (40 CFR 178.32).


VII. Regulatory Assessment Requirements


    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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 petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).


VIII. Submission to Congress and the Comptroller General


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


List of Subjects in 40 CFR Part 180


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


    Dated: December 7, 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 180.449 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:


Sec. 180.449   Avermectin B1 and its delta-8,9-isomer;
tolerances for residues.


    (a) * * *


[[Page 80362]]


----------------------------------------------------------------------------------------------------------------
                      Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
        *                  *                  *                  * *                  *
Celeriac, roots...................................... 0.05
Celeriac, tops....................................... 0.05
        *                  *                  *                  * *                  *
----------------------------------------------------------------------------------------------------------------


* * * * *


[FR Doc. 00-32569 Filed 12-20-00; 8:45 am]
BILLING CODE 6560-50-S