Pymetrozine; Pesticide Tolerance

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

[Federal Register: December 27, 2001 (Volume 66, Number 248)]
[Rules and Regulations]
[Page 66786-66794]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de01-25]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301180; FRL-6804-1]
RIN 2070-AB78

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-
pyridinylmethylene) amino]
in or on cotton seed, undelinted at 0.3
parts per million (ppm); cotton gin byproducts at 2.0 ppm; fruiting
vegetables at 0.2 ppm; cucurbit vegetables at 0.1 ppm; leafy vegetables
(except Brassica) at 0.6 ppm; head and stem Brassica vegetables at 0.5
ppm; leafy Brassica and turnip greens at 0.25 ppm; hops (dried) at 6.0
ppm; and pecans at 0.02 ppm. Syngenta Crop Protection requested these
tolerances under the Federal Food, Drug, and Cosmetic Act, as amended
by the Food Quality Protection Act of 1996.

DATES: This regulation is effective December 27, 2001. Objections and
requests for hearings, identified by docket control number OPP-301180,
must be received by EPA on or before February 25, 2002.

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-301180 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; and 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 Potentially
Categories NAICS 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 theFederal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html , a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301180. 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 July 19, 2001 (66 FR 37677-37681 (FRL-
6793-9), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.

[[Page 66787]]

346a as amended by the Food Quality Protection Act of 1996 (FQPA)
(Public Law 104-170) announcing the filing of a pesticide petition (PP)
for tolerance by, Syngenta Crop Protection of Greensboro, North
Carolina 27419. This notice included a summary of the petition prepared
by Syngenta, 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 cotton seed, undelinted at 0.4 ppm; cotton gin
byproducts at 3.0 ppm; fruiting vegetables at 0.2 ppm; cucurbit
vegetables at 0.1 ppm; leafy vegetables (except Brassica) at 6.0 ppm;
head and stem Brassica vegetables at 2.0 ppm; leafy Brassica greens at
5.0 ppm; hops (dried) at 5.0 ppm; and pecans 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 in or on cotton
seed, undelinted at 0.3 ppm; cotton gin byproducts at 2.0 ppm; fruiting
vegetables at 0.2 ppm; cucurbit vegetables at 0.1 ppm; leafy vegetables
(except Brassica) at 0.6 ppm; head and stem Brassica vegetables at 0.5
ppm; leafy Brassica and turnip greens at 0.25 ppm; hops (dried) at 6.0
ppm; and pecans at 0.02 ppm. EPA's assessment of 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 toxic effects caused by pymetrozine are
discussed in this unit and 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

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
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a
million). Under certain specific circumstances, MOE calculations will
be used for the carcinogenic risk assessment. In this non-linear
approach, a ``point of departure'' is identified below which
carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOE_cancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for pymetrozine used for human
risk assessment was discussed in a previous Federal Register notice of
September 29, 1999 (64 FR 52438-52450) (FRL-6385-6).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Prior to this Rule,
the Agency had established tolerances for pymetrozine in or on corm and
tuberous vegetables (Crop Subgroup 1-C) at 0.02 ppm, cucurbit
vegetables (Crop Group 8) at 0.05 ppm, and fruiting vegetables (Crop
Group 9) at 0.05 ppm (40 CFR 180.556). This Rule establishes new
tolerances for residues of pymetrozine in or on a variety of raw
agricultural commodities: cotton seed, undelinted at 0.3 ppm; cotton
gin byproducts at 2.0 ppm; fruiting vegetables at 0.2 ppm;

[[Page 66788]]

cucurbit vegetables at 0.1 ppm; leafy vegetables (except Brassica) at
0.6 ppm; head and stem Brassica vegetables at 0.5 ppm; leafy Brassica
and turnip greens at 0.25 ppm; hops (dried) at 6.0 ppm; and pecans at
0.02 ppm. Risk assessments were conducted by EPA to assess dietary
exposures from pymetrozine 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 Dietary Exposure Evaluation Model
(DEEM analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments. 100% of the crop were treated, and
the residue levels were assumed to be at the tolerance level.
Using these conservative assumptions, the acute dietary (food only)
exposure to pymetrozine from all existing and proposed uses (tuberous
and corm, fruiting, and cucurbit vegetables; cotton seed (undelinted);
cotton gin byproducts; hops, dried; leafy vegetables (except Brassica);
head and stem Brassica vegetables; leafy Brassica greens; turnip
greens; and pecans will be below EPA's level of concern (100% of the
acute Population-Adjusted Dose (aPAD)) and will not occupy more than
5.9% of the aPAD for any population subgroup, including those of
infants and children. For the maximum-exposed subgroup, the
95th percentile of exposure (Females 13-50 years old) is
predicted to be 5.9% of the aPAD. Due to pymetrozine's lower acute
endpoint for females 13-50 years old (0.033 mg/kg) versus that of other
population subgroups (0.14 mg/kg for infants and children), the
percentage of the aPAD occupied for females 13-50 years old (5.9%) is
higher than that estimated for children 1-6 years old. For an exposure
analysis based on the assumptions that 100% of the crop is treated and
residues are at the tolerance level, EPA considers exposure at the
95th percentile of exposure to be a reasonable estimate of
high end of exposure. Even at the 99th percentile of
exposure, the acute risk is well below EPA's level of concern.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments. The chronic analysis was a Tier 3 analysis. See
Table 1 below. It was necessary to use both projected percent of crop
treated (%CT) estimates and anticipated residues in the chronic
analysis because when %CT alone was used, one population subgroup
exceeded the Agency's level of concern.
The Tier 3 DEEM chronic analysis indicates that exposure
to pymetrozine from tuberous and corm, fruiting, and cucurbit
vegetables; cotton seed (undelinted); cotton gin byproducts; hops,
dried; leafy vegetables (except Brassica); head and stem Brassica
vegetables; leafy Brassica greens; turnip greens; and pecans will
occupy less than 3.4% of the 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.

Table 1.--Results of Chronic Dietary Exposure Analysis
------------------------------------------------------------------------
cPAD (mg/kg/ Exposure
Subgroup day) (mg/kg/day) % cPAD
------------------------------------------------------------------------
U.S. Population (total) 0.0038 0.000034 <1
------------------------------------------------------------------------
All Infants (1 year old) 0.0013 0.000018 1.4
------------------------------------------------------------------------
Children 1-6 years old 0.0013 0.000045 3.4
------------------------------------------------------------------------
Children 7-12 years old 0.0013 0.000040 3.1
------------------------------------------------------------------------
Females 13-50 0.0013 0.000029 2.2
------------------------------------------------------------------------
Males 13-19 0.0038 0.000024 <1
------------------------------------------------------------------------
Males 20+ years old 0.0038 0.000034 <1
------------------------------------------------------------------------
Seniors 55+ 0.0038 0.000036 <1
------------------------------------------------------------------------

iii. Cancer. The Agency's level of concern for cancer exposure is 1
x 10-6. The lifetime risk of developing cancer from
pymetrozine exposure is determined for the U.S. population (total)
only. The estimated exposure to pymetrozine is 0.000034 mg/kg/day.
Applying the Q1₁* of 0.0119 (mg/kg/
day)-1 to the exposure value results in a cancer
risk estimate of 4.0 x 10-7. Therefore, the lifetime risk to
the U.S. population of developing cancer from dietary exposure to
pymetrozine is below EPA's level of concern.
iv. 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

[[Page 66789]]

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 registrant provided projected percent crop treated data for
pymetrozine, and the Agency revised them, as shown in the following
Table 2.

Table 2.--Projected Percent Crop Treated Estimates
------------------------------------------------------------------------
Crop %CT
------------------------------------------------------------------------
Broccoli 25
------------------------------------------------------------------------
Cabbage 12.2
------------------------------------------------------------------------
Cantaloupes 25
------------------------------------------------------------------------
Celery 25
------------------------------------------------------------------------
Cotton 6
------------------------------------------------------------------------
Cucumbers 10
------------------------------------------------------------------------
Head Lettuce 25
------------------------------------------------------------------------
Leaf Lettuce 25
------------------------------------------------------------------------
Peppers 8
------------------------------------------------------------------------
Potatoes 20
------------------------------------------------------------------------
Pumpkins 10
------------------------------------------------------------------------
Spinach 16.4
------------------------------------------------------------------------
Squash (winter and summer) 8
------------------------------------------------------------------------
Tomatoes 12
------------------------------------------------------------------------
Watermelons 20
------------------------------------------------------------------------

The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, for new and existing uses, the
Agency received estimates from Syngenta based upon its analysis of the
marketing data that compared all of the potential major pesticides for
cost, efficacy, and demand. EPA received these figures and performed
its own independent analysis. The Agency examined the registrant's data
and assumptions for all these factors. Based on the information that
the registrant has provided, together with in-house data and
information from outside contacts if necessary, the Agency agreed with
the company's estimate of projected PCT for many crops. For some crops,
the Agency revised the company's estimates upward.
For existing uses, 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 values for the percentage of the food
treated, as shown in Table 2 of this preamble, are reasonable and are
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 pymetrozine
may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for pymetrozine 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 pymetrozine.
The Agency uses FIRST (FQPA Index Reservoir Screening Tool) or
PRZM/EXAMS (Pesticide Root Zone/Exposure Analysis Modeling System)
program to predict pesticide concentrations in surface water; and SCI-
GROW (Screening Concentration In GROund Water version 1.0) program to
predict pesticide concentrations in groundwater.
The 'FIRST' program is a tier I screening model recently developed
by EPA. It is used as a coarse screen for estimation of pesticide
concentrations based on index agricultural watershed-drinking water
reservoir or index reservoir (IR) scenario and percent cropped area
(CPA). The FIRST model produces both a peak value (acute) and an annual
average (chronic) pesticide concentration, or Estimated Environmental
Concentrations (EECs). If the FIRST EECs are within 10% of a DWLOC,
EFED will move to the next tier and perform a PRZM/EXAMS assessment.
The PRZM/EXAMS is a tier II model that provides an upper-bound
estimate of a pesticide's concentration in a 1 hectare pond resulting
from surface water runoff from a 10 hectare field, and is used to
refine EECs generate by the lower tier FIRST model. As with FIRST,
PRZM/EXAMS incorporates an index reservoir environment and includes a
percent crop area factor as an adjustment to account for the maximum
percent crop coverage within a watershed or drainage basin. However,
this tier II model also uses NOAA climatological (rainfall) data for a
36-year period that allows for more realistic runoff events. PRZM/EXAMS
produces maximum and annual concentrations for each of the 36 years for
which there is rainfall data.
The Agency modeled six different scenarios, using the maximum
application rate allowed for each crop: cotton, cucurbits, tomatoes,
cabbage, pecans; and hops. The surface water concentrations for these
crops were estimated using the Pesticide Root Zone Model (PRZM version
3.12) (Carsel et al., 1998) coupled with the Exposure Analysis Modeling
System ( EXAMS version 2.97.5) (Burns, 1997) adjusted with the
appropriate (or default) percent cropped area (PCA) factor. The PCA
factor reflects the maximum percentage of a basin planted in the
agricultural crop being considered in the risk

[[Page 66790]]

assessment. EPA adapted a PCA factor of 0.20 for cotton. However, PCA
factors are not available for cucurbits, tomatoes, cabbage, pecans, or
hops, and a default value of 0.87 was used. This may result in an
overestimation of the surface water concentrations for these crops
compared to the cotton crop. The pecan scenario gives the highest
estimated surface water concentrations, mainly due to a high level of
rainfall in the areas where pecans are grown (sometimes as high as
three times the level of other crops considered in this assessment)
especially during the summer season. The peak (acute) EEC is 5.23 ppb
and the average annual (chronic) EEC is 1.58 ppb.
PRZM is used to simulate pesticide transport as a result of runoff
and erosion from an agricultural field. EXAMS estimates environmental
fate and transport of pesticides in a receiving water body. For human
health risk assessment, simulations were done using the Index Reservoir
scenario with the consideration of a PCA factor. Weather and
agricultural practices are simulated over 36 years so that the 10-year
exceedance probability at the site can be estimated.
The SCI-GROW screening model was also developed by EPA, and is a
regression model based upon actual groundwater monitoring data
collected for the registration of a number of pesticides. The current
version of SCI-GROW appears to provide a realistic estimate of
pesticide concentrations in shallow, highly vulnerable ground water
sites (i.e., sites with sandy soils and depth to ground water of 10 to
20 feet) for use in both chronic and acute ground water estimates.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to pymetrozine they are further
discussed in the aggregate risk sections below.
Based on the FIRST, SCI-GROW, and PRZM/EXAMS models the EECs of
pymetrozine for acute exposures are estimated to be 5.23 parts per
billion (ppb) for surface water and < 0.02 ppb for ground water. The
EECs for chronic exposures are estimated to be 1.58 ppb for surface
water and < 0.02 ppb for ground water. See Tables 3 and 4 below.

Table 3.--Acute Drinking Water Levels of Comparison for Aggregated Exposures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum Water SCI-GROW PRZM/EXAMS DWLOC\*\
Scenario/Population Subgroup aPAD mg/kg/ Food Exposure, Exposure, mg/kg/ (groundwater) (surface µg/
day mg/kg/day day ppb water) ppb L
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.42 0.002119 0.41788 0.02 5.23 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (<1 year old) 0.14 0.001404 0.13860 0.02 5.23 1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 yrs) 0.14 0.003517 0.13648 0.02 5.23 1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 7-12 years old 0.14 0.002615 0.13739 0.02 5.23 1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-50 0.033 0.001939 0.031061 0.02 5.23 930
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males 13-19 0.42 0.001722 0.41828 0.02 5.23 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males 20+ years old 0.42 0.001807 0.41819 0.02 5.23 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seniors 55+ 0.42 0.002035 0.41797 0.02 5.23 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\ DWLOC = Maximum Water Exposure (mg/kg/day) 1000 µg/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 5.23 µg/L.

Table 4. Chronic Drinking Water Levels of Comparison for Aggregated Exposures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum Water SCI-GROW PRZM/EXAMS DWLOC\*\
Scenario/Population Subgroup cPAD mg/kg/ Food Exposure, Exposure, mg/kg/ (groundwater) (surface µg/
day mg/kg/day day ppb water) ppb L
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.0038 0.000034 0.003766 0.02 1.58 130
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (<1 year old) 0.0013 0.000018 0.001282 0.02 1.58 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.0013 0.000045 0.001255 0.02 1.58 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 7-12 years 0.0013 0.000040 0.001260 0.02 1.58 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-50 0.0013 0.000029 0.001271 0.02 1.58 38
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 66791]]

Males 13-19 0.0038 0.000024 0.003776 0.02 1.58 130
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males 20+ years old 0.0038 0.000034 0.003766 0.02 1.58 130
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seniors 55+ 0.0038 0.000036 0.003764 0.02 1.58 130
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\ DWLOC = Maximum Water Exposure (mg/kg/day) 1,000 µg/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 chronic and cancer EEC is 1.58 µg/L.

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). Since the current
proposed uses do not result in additional residential exposure, the
Agency's earlier evaluation of approved residential uses, found in the
Federal Register of August 9, 2000 (65 FR 48626-48634), will not be
repeated here.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
Based on the information available to EPA, 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. Safety Factor for Infants and Children

1. 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.
2. Conclusion. There is a complete toxicity database for
pymetrozine and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children could be
reduced to 3. The FQPA factor is reduced after assessing the potential
for additional sensitivity of infants and children to residues of
pymetrozine in the following studies: developmental toxicity studies in
rabbit and rat and two-generation reproduction study in the rat. There
was no evidence of increased susceptibility in these studies. The FQPA
safety factor was not reduced to one due to the need for a
developmental neurotoxicity study.

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, the Office of Pesticide Programs (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. The Tier 1 exposure estimates provided by the acute
dietary analysis are based on the assumption that tolerance-level
residues are present in/on all commodities on which pymetrozine will be
used and that 100% of these commodities are treated. The exposure
estimates are therefore conservative ones. As shown in Table 3 of this
preamble the acute EECs for pymetrozine are below EPA's level of
concern. That is, they are below the DWLOC values calculated for the
various population subgroups. Thus, residues of pymetrozine in food and

[[Page 66792]]

drinking water do not exceed the EPA's level of concern (100% of the
aPAD) for acute aggregate exposure for any of the population subgroups.
Based on its assumptions and underlying data, this risk assessment is
considered confident, very conservative, and highly protective of human
health.
2. Chronic risk. The Tier 3 exposure estimates provided by the
chronic dietary analysis are based on anticipated residues and
projected percent crop treated data. Anticipated residues (average
field trial values) were calculated for the crops. The resulting
exposure estimates are therefore refined ones. The chronic EECs for
pymetrozine are below the Agency's level of concern. That is, as shown
in Table 4 of this preamble, they are below the DWLOC values calculated
for the various population subgroups. Thus, residues of pymetrozine in
food and drinking water do not exceed the Agency's level of concern
(100% of the cPAD) for chronic aggregate exposure for any of the
population subgroups.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). In aggregating short-
term risk, the Agency considered background average dietary exposure
and short-term, non-dietary oral exposure. Non-dietary oral exposure
may occur with toddlers as hand-to-mouth transfer of residues from
ornamental plants or incidental ingestion of treated ornamental plants
and/or surrounding soil. The highest estimated exposure via these
routes is 0.0046 mg/kg/day which results from hand-to-mouth transfer of
residues. Combining this exposure with the chronic dietary exposure
estimate of 0.000045 mg/kg/day results in an aggregate exposure of
0.0046 mg/kg/day. In the absence of a short-term oral endpoint, EPA has
used the acute dietary endpoint for infants and children (125 mg/kg/
day) to estimate aggregate short-term risk. Note that this endpoint is
based on a LOAEL and therefore has a 300-fold uncertainty factor
associated with it. Combining the exposure estimate with the
toxicological endpoint gives an MOE of 27,000. For this scenario, the
Agency would be concerned with an MOE of less than 900; thus, this
exposure is below EPA's level of concern. Aggregated short-term
exposure results in a DWLOC of 1,400 ppb. This value is in excess of
the peak EEC of 5.23 ppb for pymetrozine. Therefore, the short-term
aggregate risk is below the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). There are no
intermediate-term residential exposure scenarios for pymetrozine based
on the current uses. Therefore, aggregate intermediate-term risks do
not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. As with the chronic
dietary exposure analysis, the cancer risk assessment is also based on
a Tier 3 estimate of dietary exposure. The cancer aggregate risk
consists of chronic dietary exposure as well as non-occupational
exposure resulting from pruning and planting treated ornamental plants.
The sum of the food and residential exposure is 0.000034 (food) +
0.0000012 (residential) = 3.5 x 10-5 mg/kg/day.
Assuming a cancer risk limit of 1 x 10-6, the
cancer dose of concern is 8.4 x 10-5 mg/kg/day
(0.000001/Q₁* = 0.000001/0.0119). As 3.5 x
10-5 mg/kg/day is less than 8.4 x
10-5 mg/kg/day, the aggregate food and
residential exposure is below the level of concern. With respect to
drinking water, the cancer DWLOC is calculated to be 1.7 ppb. The
highest EEC for any of the crops in these petitions is 1.6 ppb
(pecans). As a result, the aggregate cancer risk resulting from use of
pymetrozine is below the Agency's level of concern.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to pymetrozine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The Agency's Analytical Chemistry Laboratory has validated an
enforcement methodology for pymetrozine (Syngenta Analytical Method AG-
643A). It will be available to enforce the tolerance expression. The
method may be requested from: Francis D. Griffith, Jr., Analytical
Chemistry Branch, BEAD (7503C), 702 mapes Rd., Ft. George Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
griffin.francis@epa.gov.

B. 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, dried (10 ppm) and potatoes (0.02 ppm). The
European Union is currently evaluating a proposed tolerance of 5 ppm on
hops, dried. There are proposed tolerances in Canada for tuberous and
corm vegetables at 0.02 ppm, fruiting vegetables at 0.2 ppm, head and
stem Brassica vegetables at 2.0 ppm, leafy Brassica vegetables at 5.0
ppm, leafy vegetables at 6.0 ppm, pecans at 0.02 ppm, hops (dried) at
5.0 ppm, citrus at 0.2 ppm, and cucurbits at 0.1 ppm. At this time,
international harmonization of residue levels is not an issue.

C. Conditions

The Agency imposed the following conditions on pymetrozine at the
time of the original Notices of Registration in the fall of 1999:
1. Storage stability (due December 2000).
2. Corrosion characteristics (due December 2000).
3. Acute estuarine/marine toxicity in shrimp (due October 2000)
4. Photodegradation on soil, 161-3, (due October 2000).
5. Developmental neurotoxicity Study, 870-6300 or 83-6, (due
October 2001).
6. Avian reproduction (mallard), 71-4(b), (due October 2001).
7. Drinking water monitoring (originally due October 2002 but the
requirement was no longer applicable after Cancer Q* was changed).

V. Conclusion

Therefore, the tolerances are established for residues of
pymetrozine in or on cotton seed, undelinted at 0.3 ppm; cotton gin
byproducts at 2.0 ppm; fruiting vegetables at 0.2 ppm; cucurbit
vegetables at 0.1 ppm; leafy vegetables (except Brassica) at 0.6 ppm;
head and stem Brassica vegetables at 0.5 ppm; leafy Brassica and turnip
greens at 0.25 ppm, hops (dried) at 6.0 ppm; and pecans at 0.02 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

[[Page 66793]]

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-301180 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
25, 2002.
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-301180, 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 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). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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 special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other 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

[[Page 66794]]

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). For these same reasons, the Agency has
determined that this rule does not have any tribal implications as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.
Policies that have tribal implications is defined in the Executive
Order to include regulations that have substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes. This
rule will not have substantial direct effects on tribal governments, on
the relationship between the Federal government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

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 17, 2001.
Peter Caulkins,
Acting 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), 346(a) and 371.

2. Section 180.556 is amended by revising paragraph (a) 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 of
the use of pymetrozine on these raw agricultural commodities.

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Brassica, head and stem, subgroup (Crop Subgroup 5-A)...... 0.5
Brassica, leafy greens, subgroup (Crop Subgroup 5-B)....... 0.25
Cotton gin byproducts...................................... 2.0
Cotton, undelinted seed.................................... 0.3
Hops, dried cones.......................................... 6.0
Pecans..................................................... 0.02
Turnip, greens............................................. 0.25
Vegetable, fruiting, group (Crop Group 8).................. 0.2
Vegetable, cucurbit, group (Crop Group 9).................. 0.1
Vegetable, leafy, execpt brassica, group (Crop Group 4).... 0.6
Vegetable, tuberous and corm, subgroup (Crop Subgroup 1-C). 0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-31801 Filed 12-26-01; 8:45 am]
BILLING CODE 6560-50-S

Pymetrozine; Pesticide Tolerance

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