[Federal Register Volume 66, Number 248 (Thursday, December 27, 2001)]
[Rules and Regulations]
[Pages 66786-66794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31801]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301180; FRL-6804-1]
RIN 2070-AB78


Pymetrozine; Pesticide Tolerance

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: 
[email protected].

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 
(MOEcancer = 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   g/
                                                                      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 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 5.23 g/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   g/
                                                                      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 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 chronic and cancer EEC is 1.58 g/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: 
[email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 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