Pymetrozine; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 9, 2000 (Volume 65, Number 154)]
[Rules and Regulations]
[Page 48626-48634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au00-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301033; FRL-6599-2]
RIN 2070-AB78

Pymetrozine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-
pyridinylmethylene)amino] in or on cucurbit vegetables (Crop Group 8)
at 0.05 parts per million (ppm) and fruiting vegetables (Crop Group 9)
at 0.05 ppm. Novartis Crop Protection, Inc. of Greensboro, NC 27419
requested this

[[Page 48627]]

tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 9, 2000. Objections and
requests for hearings, identified by docket control number OPP-301033,
must be received by EPA on or before October 10, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301033 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Daniel Peacock, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5407; e-mail address: peacock.dan@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
------------------------------------------------------------------------

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-301033. 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 May 20, 1998 (63 FR 27723-27727) (FRL-
5773-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, as amended by the FQPA (Public Law 104-170) announcing the
filing of a pesticide petition (PP) for tolerance by Novartis Crop
Protection, Inc. of Greensboro, NC 27419. This notice included a
summary of the petition prepared by Novartis Crop Protection, the
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.556 be amended by
establishing a tolerance for residues of the insecticide pymetrozine
1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene)
amino], in or on hops at 5 ppm, fruiting vegetables at 0.05 ppm, and
cucurbits and potatoes at 0.02 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 a tolerance for residues of pymetrozine, 1,2,4-triazin-
3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) amino] on
cucurbit vegetables (Crop Group 8) at 0.05 parts per million (ppm) and
fruiting vegetables at 0.05 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance 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

[[Page 48628]]

toxic effects caused by pymetrozine, 1,2,4-triazin-3(2H)-one,4,5-
dihydro-6-methyl-4-[(3-pyridinylmethylene) amino] are discussed in this
unit or in a previous Federal Register notice.
1. Acute toxicity. In general, technical pymetrozine has low acute
toxicity, being classified as Toxicity Category III for acute dermal
and primary eye irritation studies and Toxicity Category IV for acute
oral, acute inhalation and primary dermal studies. It is a slight
sensitizer.
2. Subchronic and chronic toxicity. EPA's September 29, 1999,
Federal Register notice (64 FR 52438-52450) (FRL-6385-6) summarized the
results of the subchronic and chronic toxicity, metabolism, and dermal
penetration studies in animals.

B. Toxicological Endpoints

EPA's September 29, 1999, Federal Register notice (64 FR 52438-
52450) (FRL-6385-6) discussed the toxicological endpoints in detail and
will not be repeated here.

C. Exposures and Risks

1. Current and proposed uses. Pymetrozine is an insecticide of the
pyridine azomethine type and was first registered in 1999. Pymetrozine
controls aphids and suppression of whiteflies in a variety of crops.
The mode of action of pymetrozine has not been precisely determined
biochemically; physiologically, it appears to act by preventing these
insects from inserting their stylus into the plant tissue.
Currently, EPA has registered pymetrozine for use on tuberous and
corm vegetables (Subgroup 1-C) and tobacco under Fulfill (EPA
Reg. No. 100-912) and ornamental plants under Endeavor (EPA
Reg. No. 100-913). There are no homeowner applications for pymetrozine.
However; postapplication (residential) exposure could occur due to
contact with treated ornamental plants. For both Fulfill and
Endeavor , pymetrozine is formulated as a water-dispersible
granule containing 50% active ingredient.
Fulfill may be applied by either ground or aerial
broadcast equipment, in a minimum of 10 gallons of water per acre;
chemigation is not permitted. Pymetrozine is applied to the foliage of
affected plants where it is quickly absorbed. Potato and tobacco crops
may be treated up to twice, each at a maximum rate of 0.09 lb active
ingredient/acre (ai/A). The maximum seasonal use rate is 0.17 lb ai/
acre. The retreatment and pre-harvest intervals are 7 and 14 days,
respectively. The label for Fulfill specifies a restricted-
entry interval of 12 hours.
Endeavor may be broadcast-applied to ornamentals at a
rate not to exceed 10 ounce/acre/application (oz./A/application).
Multiple applications may be made on a 7- to14-day interval. For indoor
use, the yearly application rate is not to exceed 100 oz./A/year; for
outdoor use, the maximum rate is 48 oz./A/year.
Novartis Crop Protection has proposed that the use of pymetrozine
be expanded on the Fulfill label to included cucurbit and
fruiting vegetables. The rates, number of applications, pre-harvest
intervals, and restricted-entry interval will remain the same for these
additional uses.
2. From food and feed uses. This Rule establishes two new
tolerances for pymetrozine: in or on cucurbit vegetables (Crop Group 8)
at 0.05 parts per million (ppm) and fruiting vegetables (Crop Group 9)
at 0.05 ppm.
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 crop treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: 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; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and 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 PCT as required by section 408(b)(2)(F), EPA may require registrants
to submit data on PCT.
Most of the dietary risk assessments performed on pymetrozine used
a Tier 1 approach for fruiting vegetables, cucurbits, and potatoes,
crops originally requested in the petition. That is, the Agency assumed
100% crop treated and tolerance level residues. For carcinogenicity
risk assessment, the Agency used a Tier 3 chronic dietary exposure
analysis for fruiting, cucurbit, and tuberous and corm vegetables. This
was based on 6-20% of the crop treated and an anticipated residue of
0.0046 ppm to refine the cancer risk. Novartis supplied this estimate
of PCT to the Agency. The Agency reviewed Novartis' estimate and found
it reasonable.
The Agency believes that the three conditions, discussed in
section 408 (b)(2)(F) in this unit concerning the Agency's
responsibilities in assessing chronic dietary risk findings, have been
met. EPA finds that the PCT information is reliable and has a valid
basis. Before the petitioner can increase production of product for
treatment of greater than 340,000 acres (20% of 1,700,000 total acres
for fruiting, cucurbit, and the tuberous and corm subgroup), permission
from the Agency must be obtained. The 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 consumption of food in a
particular area.
i. Acute exposure and 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 1-day or single exposure.
The Tier 1 DEEM analysis indicates that acute dietary
(food only) exposure to pymetrozine from all existing and proposed uses
(tuberous and corm, fruiting, and cucurbit vegetables) will be below
EPA's level of concern (100% of the acute Population-Adjusted Dose
(aPAD)) and will not occupy more than 7% of the aPAD for any population
subgroup, including those of infants and children. For the maximum
exposed subgroup, the 95th percentile of exposure (children ages 1-6
years) is

[[Page 48629]]

predicted to be 3.3% of the aPAD. Due to pymetrozine's lower acute
endpoint for females 13-50 years (0.033 mg/kg) versus that of other
population subgroups (0.14 mg/kg), the percentage of the aPAD occupied
for females 13-50 years (6.5%) is slightly higher than that estimated
for children 1-6 years. For a Tier 1 analysis, EPA considers exposure
at the 95th percentile of exposure. Even at the 99.9th percentile of
exposure, the acute risk is well below EPA's level of concern.
ii. Chronic exposure and risk. The Tier 1 DEEM chronic
analysis indicates that exposure to pymetrozine from tuberous and corm
vegetables, cucurbits, and fruiting vegetables will occupy less than
74% of the chronic Population-Adjusted Dose (cPAD) for children ages 1-
6 (the most highly exposed population subgroup). Chronic dietary risk
to all other subgroups is less than that of children ages 1-6. See
Table 1 below.

Table 1.--Chronic Dietary (Food Only) Tier 1 Exposure and Risk Estimates
for Pymetrozine Use on Cucurbit, Fruiting, and Tuberous and Corm
Vegetables
------------------------------------------------------------------------
cPAD, mg/kg/ Exposure,
Population Subgroup\1\ day\2\ mg/kg/day %cPAD\3\
------------------------------------------------------------------------
U.S. Population (total) 0.0038 0.000455 12
Hispanics 0.0038 0.000496 13
Children 1-6 yrs 0.0013 0.000958 74
Females 13-19 (not preg or 0.0013 0.48 37
nursing)
Males 13-19 yrs 0.0038 0.0005 13
------------------------------------------------------------------------
¹ Population subgroups shown include the U.S. general population and the
maximally exposed subpopulation of adults, infants and children, and
women of child-bearing age.
² cPAD values incorporate the different FQPA Safety Factors for the
various population subgroups
³ %cPAD = Exposure (mg/kg) cPAD (mg/kg)100.

iii. Cancer exposure and risk. The Agency used a Tier 3
DEEM analysis for cancer risk estimates to the U.S.
population. Based on use of pymetrozine on tuberous and corm
vegetables, fruiting vegetables, and cucurbits vegetables, the food
only cancer risk is 1 x 10^-7, which is below the Agency's
level of concern.
3. From drinking water. Pymetrozine is not persistent, breaking
down in the environment through a number of mechanisms and degradation
pathways including hydrolysis and aqueous and soil photolysis.
Laboratory studies indicate that pymetrozine is a ``low mobility'' to
``no mobility'' chemical with respect to leaching. The environmental
fate profile and application rates suggest that there should not be any
notable concerns in the areas of soil mobility and persistence for
pymetrozine resulting from its agriculture use to control aphids and
whiteflies. Based on the low application rate, the field dissipation
data, and the minimal concentrations relative to the parent (less than
10%, total), pymetrozine degradates should not enter ground and surface
water to any appreciable extent.
EPA used the Screening Concentration In GROund Water (SCI-GROW)
model to predict the Environmental Estimated Concentrations (EEC's) for
pymetrozine in ground water. SCI-GROW is a regression model based on
actual groundwater monitoring data. SCI-GROW appears to provide
realistic estimates of pesticide concentrations in shallow, highly
vulnerable ground water sites. Using the highest application rate of
0.187 lb ai/A (hops), SCI-GROW estimates the concentration of
pymetrozine in groundwater to be 0.015 g/L. As there is
relatively little temporal variation in ground water, this estimate can
be used for both acute and chronic exposure scenarios.
In addition, EPA used the Tier 2 GENeric Estimated Environmental
Concentration (GENEEC) and Pesticide Root Zone Model-EXAMS (PRZM-EXAMS)
model to obtain EEC's in surface water. The standard PRZM-EXAMS runoff
modeling scenario is based on a 10 hectares (ha) field draining into a
1 ha by 2 meter deep small water body. This scenario represents a
watershed drainage area: water volume ratio of 5 m\2\/m\3\. Each PRZM
modeling scenario represents a unique combination of climatic
conditions (e.g., rainfall), crop specific management practices, soil
specific properties, site specific hydrology, and pesticide specific
application and dissipation processes. Each PRZM simulation is
conducted for multiple years to provide a probabilistic exposure
characterization for a single site.
Based on the maximum use pattern for any of the requested crops
(hops at 0.56 lb ai/A/season), the GENEEC-estimated 56-day surface
water EEC is 2.29 g/L. Actual chronic surface water
concentrations are likely to be less than this estimated 56-day
average. Because the DWLOC exceeds the chronic EEC, the Agency believes
that the aggregate risk from exposure to pymetrozine due to the
proposed uses on tuberous and corm, fruiting, and cucurbit vegetables
is not likely to exceed our level of concern. The DWLOCs for acute,
short-term, and chronic exposure have not changed from those detailed
in the risk assessment; all remain greater than the Tier 1 EEC values.
The EEC's for surface water (2.29 g/L) are higher than
those for groundwater (0.015 g/L). Therefore, surface water
EEC's will be used:
(1) To estimate actual concentrations of pymetrozine in water.
(2) To compare those concentrations with the Drinking Water Levels
of Comparison (DWLOCs) in g/L.
DWLOCs are acceptable concentrations of pymetrozine in drinking water
as theoretical upper limits in light of total aggregate exposure to
that pesticide from food, water, and residential uses. The EPA
calculates each DWLOC by subtracting the food and residential exposures
(if appropriate) from the PAD or Cancer Dose and by converting this
resulting dose, called the Maximum Water Exposure (in mg/kg/day), into
a concentration of pymetrozine in water expressed in g/L. Only
pymetrozine was included in the drinking water assessment on the basis
that the metabolites would not be found in drinking water. Table 2
shows the Drinking Water Levels of Comparison (DWLOC's) for acute,
chronic, and cancer exposure.

[[Page 48630]]

Table 2.--Drinking Water Levels of Comparison for Aggregated Exposures
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Population-
Scenario/Population Subgroup\a\ Adjusted Dose, mg/ Exposure mg/kg/ Maximum Water DWLOC g/
kg/day day\b\ Exposure mg/kg/day L\c\
----------------------------------------------------------------------------------------------------------------
Acute Exposure EEC = 4.0
U.S. Population 0.42 0.002 0.41802 15000
Hispanic 0.42 0.0023 0.417715 15000
Children (1-6 yrs) 0.14 0.0046 0.135444 1400
Females (13-19, not pregnant or 0.033 0.0021 0.030861 930
nursing)
Males (13-19 yrs) 0.42 0.0021 0.417948 15000
Short-term Exposure\d\
Toddlers 0.033 0.001 0.03203 320
Chronic Exposure EEC = 2.29
U.S. Population 0.0038 0 0.003345 2.6
Hispanic 0.00380 0 0.003304 120
Children (1-6 yrs) 0.0013 0.001 0.000342 3.4
Females (13-19, not pregnant or 0.0013 0 0.00082 25
nursing)
Males (13-19) 0.0038 0.001 0.0033 120
----------------------------------------------------------------------------------------------------------------
^a Population subgroups shown include the U.S. general population and the maximally exposed subpopulation of
adults, infants and children, and women of child-bearing age for each exposure scenario.
^b Exposure is the sum of dietary and non-dietary exposure. For the case of pymetrozine, only the short-term and
cancer DWLOC have a non-dietary component. See section 5.4 for clarification.
^c DWLOC = Maximum Water Exposure (mg/kg/day) 1,000 g/mg body weight (70 kg general population/males 13+
60 kg females 13+, 10 kg infants and children) Water Consumption (2 L/day adults, 1 L/day infants and
children). The acute EEC is 4.0 g/L, the chronic and cancer EEC is 2.29 g/L.
^d For short-term exposure, the short-term oral NOAEL was converted to a PAD by applying the 100x and 3x safety
factors. Chronic food exposure for children ages 1-6 was used to estimate background food exposure.

i. Acute exposure and risk. For acute aggregate exposure
scenarios, the DWLOC values (930-15,000 g/L) are all in excess
of the modeled acute EEC values (4.0 g/L); thus, drinking
water is not expected to be a significant contributor towards this type
of exposure.
ii. Chronic exposure and risk. For chronic (non-cancer) aggregate
exposure scenarios, the DWLOC values (3.4-120 g/L) are all in
excess of the modeled EEC values (2.29 g/L); thus, drinking
water is not expected to be a significant contributor towards this type
of exposure.
iii. Cancer exposure and risk. For cancer aggregate exposure
scenarios, the DWLOC value of 2.6 g/L is in excess of the
modeled EEC values (2.29 g/L). EPA has calculated the cancer
risk resulting from 2.29 g/L in drinking water, a dose of
0000654 mg/kg/day, to be 6.54 x 10^-7. Thus, drinking water
alone does not exceed EPA's level of concern (in the range of 1 x
10^-6) and is not expected to be a significant contributor
towards cancer risk.
4. From non-dietary exposure. As currently proposed, pymetrozine
could be used on the following residential non-food sites: ornamentals
(landscape, ground-covers, interiorscapes); home nurseries, non-bearing
orchards, and greenhouses. The end-use product, Endeavor, may
not be applied by homeowners, but post-application exposure could
occur. There are no intermediate-term exposure scenarios for which a
risk assessment is required. Short-term exposures are not applicable
for adults but are applicable for toddlers.
Since there was no chemical specific data to determine
dislodgeable residues, the EPA used its Standard Operating Procedures
(SOPs) for Residential Exposure Assessment (Draft, December 18, 1997)
to estimate postapplication exposure. This Standard Operating Procedure
(SOP) does not include a scenario for ornamentals, landscapes and
groundcover. Therefore, this assessment used the garden plants
scenarios to determine postapplication exposures.
The postapplication scenarios and associated Margins of Exposure
(MOEs) included:
(1) Incidental non-dietary hand-to-mouth transfer of pesticide
residues (770,000).
(2) Incidental non-dietary ingestion of pesticide-treated plants
(not significant).
(3) Incidental non-dietary ingestion of soil from pesticide-treated
areas (660,000).
The following assumptions were used for estimating postapplication
for the three post-application scenarios.
(a) Hand-to-mouth transfer (incidental non-dietary ingestion).
Maximum application rate of 0.3125 lbs ai per acre as
specified on the label
Twenty percent of the application rate are available on
the foliage as dislodgeable residue
Exposure is assessed on the same day the pesticide is
applied
Medium surface area of both hands is 350 cm²
for a toddler (age 3 yrs old)
Mean rate of hand-to-mouth activity is 1.56 events/hr
Duration of exposure was assumed to be 0.18 hrs/day (10
mins) for toddlers
A body weight of 15 kg was assumed for toddlers
Short term NOAEL = 10 mg/kg/day (acute dietary);
Hand-to-mouth exposure is not considered an intermediate-
term exposure scenario
(b) Accidental ingestion of plant material.
According to the HED SOP for Residential Exposure,
exposure via this route is considered negligible.
(c) Accidental ingestion of soil.
Maximum application rate of 0.3125 lbs ai per acre as
specified on the label
Twenty percnt; of the application rate are available on
the foliage as dislodgeable residue
Exposure is assessed on the same day the pesticide is
applied
The fraction of ai available in uppermost centimeter of
soil is 1 cm
The assumed soil ingestion rate for children (ages 1-6
yrs) is 100 mg/day
A body weight of 15 kg was assumed for toddlers
Short term NOAEL = 10 mg/kg/day (acute dietary);
Exposure from soil ingestion is not considered an
intermediate-term exposure scenario.
These exposure estimates are based on upper-percentile (i.e.,
maximum application rate, available residues and

[[Page 48631]]

duration of exposure) and some central tendency (i.e., transfer
coefficient, surface area, hand-to-mouth activity, and body weight)
assumptions and are considered to be representative of high-end
exposures. The uncertainties associated with this assessment stem from
the use of an assumed amount of pesticide available from gardens, and
assumptions regarding dissipation, transfer of chemical residues, and
hand-to-mouth activity. The estimated exposures are believed to be
reasonable high-end estimates based on observations from chemical-
specific field studies and professional judgement.
EPA determined that the FQPA Safety Factor to protect infants and
children should be reduced to 3x and that the factor should apply to
female (13-50 years), infant, and children population subgroups for all
risk assessments. Thus, the levels of concern for these postapplication
exposure scenarios are MOEs that are less than 100 for adult
populations and less than 300 for female (13-50), infant, and children
populations.
i. Chronic exposure and risk. Based on the proposed uses of
pymetrozine, EPA does not believe there will be chronic non-
occupational exposure to this insecticide.
ii. Cancer exposure and risk. The EPA has estimated the lifetime
average daily dose for non-occupational exposure resulting from prining
and planting treated ornamental plants is 0.0000012 mg/kg/day.
A quantitative cancer risk assessment was performed for
postapplication non-occupational exposure to treated ornamentals (e.g.,
a home garden). Exposures were estimated using EPA's default activity
scenarios, transfer coefficients and input parameters as follows: The
fraction of active ingredient retained on foliage is assumed to be 20%
(0.2) on day zero (= percent dislodgeable foliar residue, DFR, after
initial treatment). This fraction is assumed to further dissipate at
the rate of 10% (0.1) per day on following days. These are EPA's
default values for exposure.
An application rate of 0.3125 lbs ai/acre (electrostatic
spray, pulsfog and low volume systems) was used to represent the worst
case scenario.
Transfer coefficient of 4,500 was used to represent
heaviest day of activity (planting, transplanting, and pruning) for
contact with treated ornamental plants
Assumed homeowner worked 0.67 hours per day (Residential
SOP for Gardening)
Assumed homeowner worked a total of 2 days per year
performing heaviest activities (planting, pruning) at time points
shortly after pymetrozine application
Assumed homeowner would be exposed for 50 years of their
life
Dermal absorption = 1%
Body weight = 70 kg
Life expectancy = 70 years
Cancer Q\*\ (mg/kg/day) = 1.19 x 10^-2
The cancer risk estimate for this postapplication exposure is 1.4
x 10^-8 and does not exceed EPA's level of concern (in the
range of 1 x 10^-6) for the general population.
iii. Short- and intermediate-term exposure and risk. EPA did not
calculate margins of exposure (MOEs) for adults since there are no
short-term dermal exposure scenarios. However, short-term oral
exposures and risks were calculated for toddlers. For toddlers, the
MOEs for short-term postapplication exposure scenarios are 770,000 and
660,000 for hand-to-mouth and soil ingestion scenarios. These values
are all greater than either of the threshold values; thus, short-term
risks are below the Agency's level of concern.
5. 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.''
According to our information, there are no other pesticides that
have a common mechanism of toxicity with pymetrozine. Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, pymetrozine 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
pymetrozine 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. Aggregate Risks and Determination of Safety for U.S. Population

1. Acute risk. The risk from aggregate acute exposure from food
and drinking water from pymetrozine is below EPA level of concern for
the following reasons. As indicated in Table 2, the Tier 1 Dietary
Exposure Evaluation Model (DEEM) analysis indicates that
acute dietary (food only) exposure to pymetrozine from fruiting
vegetables, cucurbits, and tuberous and corm vegetables (Subgroup 1-C)
will occupy less than 1/2% (0.001980/0.42) of the aPAD for the U.S.
population, which is below EPA's level of concern of 100% of the aPAD.
In addition, for drinking water, the DWLOC value (15,000 g/L)
for the U.S. population is greatly in excess of the modeled acute EEC
value (1.9 g/L); thus, drinking water is not expected to be a
significant contributor towards this type of exposure.
2. Chronic risk. As indicated in Table 1, the Tier 1 DEEM analysis
indicates that chronic dietary (food only) exposure to pymetrozine will
utilize less than 12% (0.000455/0.0038) of the chronic Population-
Adjusted Dose (cPAD) for the U.S. population. EPA generally has no
concern for exposures below 100% of the cPAD because the cPAD
represents the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health. In
addition, for drinking water, the DWLOC value (120 g/L) for
the U.S. Population is greatly in excess of the modeled EEC values
(2.29 g/L); thus, drinking water is not expected to be a
significant contributor towards this type of exposure. Despite the
potential for exposure in the diet, drinking water, and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate
chronic exposure to exceed 100% of the cPAD.
3. Aggregate cancer risk for U.S. population. For fruiting
vegetables, cucurbits, and tuberous and corm vegetables, EPA based its
cancer risk assessment on a Tier 3 estimate of dietary exposure, which
incorporates anticipated residues (0.0046 ppm) for pymetrozine and an
estimate for percent crop treated. At this level of refinement, EPA's
estimates of food exposure and cancer risk were 0.000008 mg/kg/day and
1 x 10^-7) (in the range of 1 x 10^-6. The EPA
also calculated a lifetime average daily dose of 0.0000012 mg/kg/day
for non-occupational exposure resulting from pruning and planting
treated ornamental plants, resulting in a cancer risk from this type of
exposure of 0.143 x 10^-7). For drinking water, the cancer
dose was 0.0000654 mg/kg/day, and the cancer risk was 8 x
10^-7).
The aggregate cancer risk for all exposures, even including water
is 0.9 x 10^-6) , which is below the Agency's level of
concern.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate

[[Page 48632]]

exposure to pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-
[(3-pyridinylmethylene) amino] residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

1. Safety factor for infants and children--i.In general. In
assessing the potential for additional sensitivity of infants and
children to residues of pymetrozine, EPA considered data from
developmental toxicity studies in rabbit, an acute neurotoxicity study
in the rat, and a chronic feeding study in the rat. See the
Toxicological Profile (Unit III.A) for a discussion of these tests.
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 pre-and post-natal toxicity and the
completeness of the database 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. EPA believes that reliable data support
using the standard uncertainty factor (usually 100 for combined inter-
and intra-species variability) and the additional 3-fold MOE/
uncertainty factors, as described above, when EPA has a complete data
base under existing guidelines and when the severity of the effect in
infants or children or the potency or unusual toxic properties of a
compound do not raise concerns regarding the adequacy of these safety
factors.
ii. Conclusion. EPA considered the available data and determined
that the 10-fold FQPA factor could be reduced to 3.
2. Acute risk. The risk from aggregate acute exposure from food
and drinking water from pymetrozine is below EPA level of concern for
the following reasons. The Tier 1 Dietary Exposure Evaluation Model
(DEEM) analysis indicates that acute dietary (food only)
exposure to pymetrozine from tuberous and corm vegetables (Subgroup 1-
C), fruiting vegetables and cucurbits will occupy less than 4%
(0.004556/0.14) of the aPAD for children (1 to 6 years old), which is
below EPA's level of concern of 100% of the aPAD. In addition, for
drinking water, the DWLOC value (1,400 g/L) for children (1 to
6 years old) is greatly in excess of the modeled acute EEC values (1.9
g/L); thus, drinking water is not expected to be a significant
contributor towards this type of exposure.
3. Chronic risk. Using the residue concentration exposure
assumptions described in this unit, the risk from aggregate chronic
exposure from food and drinking water from pymetrozine is below EPA's
level of concern for the following reasons. As indicated in Table 1
above, the Tier 1 DEEM analysis indicates that chronic dietary (food
only) exposure to pymetrozine will utilize less than 74% (0.000958/
0.0013) of the cPAD for children (1 to 6 years old). EPA generally has
no concern for exposures below 100% of the cPAD because the cPAD
represents the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health. In
addition, for drinking water, the DWLOC value (3.4 g/L) for
children (1 to 6 years old) exceeds the modeled chronic EEC values
(0.222 g/L); thus, drinking water is not expected to be a
significant contributor towards this type of exposure. Despite the
potential for exposure from food, drinking water and non-dietary, non-
occupational exposure, EPA does not expect the aggregate chronic
exposure to exceed 100% of the cPAD.
4. Short-term risk. In aggregating short-term risk, EPA considered
background average dietary exposure and short-term, non-dietary oral
exposure. Non-dietary oral exposure may occur as hand-to-mouth transfer
of residues from ornamental plants or incidental ingestion of
surrounding soil. The lowest short-term MOE value is for toddlers.
Combining this MOE (660,000) with that from dietary exposure (Short-
term oral NOAEL/chronic dietary exposure = 10/0.00096
10,000) results in an aggregate MOE of (approximately
equal) 10,000. As this value is greater than 300, the short-term
aggregate risk is below the Agency's level of concern. Aggregated
short-term exposure results in a DWLOC of 320 g/L. This value
is in excess of the peak EEC for pymetrozine (1.9 g/L; see
Table 2).
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty of no harm to infants
and children from aggregate exposure to pymetrozine residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

Data concerning the metabolism of pymetrozine in plants and
animals have been previously submitted. The nature of residues in
plants and animals is adequately understood. The tolerance expression
is for pymetrozine per se. The residues of concern for risk assessment
are pymetrozine; the plant metabolites GS-23199 [6-methyl-1,2,4-
triazin-3,5 (2H,4H)-dione], CGA-215525 [4-amino-4,5-dihydro-6-methyl-
1,2,4-triazin-3(2H)-one], CGA-249257 [4,5-dihydro-6-methyl-1,2,4-
triazin-3(2H)-one], CGA-294849 [4-amino-6-methyl-1,2,4-triazin-
3,5(2H,4H)-dione]; and the ruminant metabolite CGA-313124 [4,5-dihydro-
6-hydroxymethyl-4-[(3-pyndynyl methylene)amino]-1,2,4-triazin-3(2H)-
one] (free acid conjugated).

B. Analytical Enforcement Methodology

Adequate enforcement methodology for pymetrozine (Novartis
Analytical Method AG-643) is currently being validated. Following
validation, it will be available to enforce the tolerance expression.
At that time the method may be requested from: Calvin Furlow, PIRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703)
305-5229; e-mail address: furlow.calvin@epa.gov.

C. Magnitude of Residues

The crop field trial data support the proposed tolerances for
residues of ``pymetrozine, per se.''

D. International Residue Limits

There are no established European (CODEX), Canadian, or Mexican
Maximum Residue Limits (MRL's) for pymetrozine. There are provisional
MRLs in Germany for hops (10 ppm) and potatoes (0.02 ppm). The European
Union is currently evaluating a proposed tolerance of 5 ppm on hops. At
this time, international harmonization of residue levels is not an
issue.

E. Rotational Crop Restrictions

The Fulfill label reads as follows: ``The rotational
(plantback) restrictions for Fulfill are 30-days for all crops.''

F. Pre-harvest Intervals

The pre-harvest interval for pymetrozine on the tuberous and corm,
fruiting, and cucurbit vegetables is 14 days.

V. Conclusion

Therefore, EPA is establishing tolerances for residues of
pymetrozine per se in cucurbit vegetables (Crop Group 8) at 0.05 ppm
and fruiting vegetables (Crop Group 9) 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

[[Page 48633]]

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-301033 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 October
10, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Room M3708, 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 be 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, 401 M St., SW., 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, 401 M St., SW.,
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 PIRB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket number OPP-301033, to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person or
by courier, bring a copy to the location of the PRIB 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 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

[[Page 48634]]

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 record
keeping requirements.

Dated: August 1, 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 180.556 is revised to read as follows:

Sec. 180.556 Pymetrozine; tolerances for residues.

(a) General. Tolerances are established for residues of the
insecticide pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-
[(3-pyridinylmethylene) amino] in or on the following raw agricultural
commodities. The tolerance level for each commodity is expressed in
terms of the parent insecticide only, which serves as an indicator or
the use of pymetrozine on these raw agricultural commodities.

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Tuberous and Corm Vegetables (Crop Group 1- 0.02
C)
Cucurbit Vegetables (Crop Group 8) 0.05
Fruiting Vegetables (Crop Group 9) 0.05
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-20117 Filed 8-8-00; 8:45 a.m.]
BILLING CODE 6560-50-S

Pymetrozine; Pesticide Tolerance

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