[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Rules and Regulations]
[Pages 43292-43298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14598]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0106; FRL-7724-5]


Pymetrozine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
pymetrozine in or on asparagus. Interregional Research Project Number 4 
(IR-4) requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA).

DATES: This regulation is effective July 27, 2005. Objections and 
requests for hearings must be received on or before September 26, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0106. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers, and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers, greenhouse, nursery, and floriculture workers; 
ranchers, pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers, greenhouse, nursery, and 
floriculture workers; residential users.
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of June 9, 2004 (69 FR 32346) (FRL-7360-2), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 2E6467) 
by IR-4, 681 US Highway 1 South, North Brunswick, NJ 08902-
3390. The petition requested that 40 CFR 180.556 be amended by 
establishing a tolerance for residues of the insecticide pymetrozine, 
[4,5-dihydro-6-methyl-4-[(E)-(3-pyridinylmethylene)amino]-1,2,4-
triazin-3(2H)-one], in or on asparagus at 0.02 parts per million (ppm). 
The petition was subsequently amended to establish a tolerance of 0.04 
ppm. That notice included a summary of the

[[Page 43293]]

petition prepared by Syngenta, the registrant. There were no comments 
received in response to the notice of filing.
    Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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) of FFDCA, for a tolerance for residues of pymetrozine on 
asparagus at 0.04 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, as 
well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed are discussed in the Federal Register of December 27, 2001 (66 
FR 66786) (FRL-6804-1).

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 intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    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 an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, 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 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). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-5, one in a million (1 X 10-6), or one in ten 
million (1 X 10-7)). 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 is shown in the Table of this unit:

[[Page 43294]]



          Summary of Toxicological Dose and Endpoints for Pymetrozine for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49 years of  NOAEL = 10 mg/kg/day     Special FQPA SF = 1X     Rabbit development
 age)                                  UF = 1,000.............  aPAD = acute RfD/         study
                                       Acute RfD = 0.01 mg/kg/   Special FQPA SF = 0.01  LOAEL = 75 mg/kg/day
                                        day.                     mg/kg/day.               based on reduced body
                                                                                          weight gain, food
                                                                                          consumption and feed
                                                                                          efficiency. Also,
                                                                                          increased incidence of
                                                                                          skeletal anomalies in
                                                                                          pups.
-----------------------------------------------------------------------------------------
Acute dietary (General population      LOAEL = 125 mg/kg/day    Special FQPA SF = 1X     Rat acute neurotoxicity
 including infants and children)       UF = 1,000.............  aPAD = acute RfD/         study
                                       Acute RfD = 0.125 mg/kg/  Special FQPA SF =       LOAEL = 125 mg/kg/day
                                        day.                     0.125 mg/kg/day.         based on decreased
                                                                                          body temperature,
                                                                                          decreased motor
                                                                                          activity and FOB
                                                                                          parameters associated
                                                                                          with decreased
                                                                                          activity.
-----------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 0.377 mg/kg/kg/   Special FQPA SF = 1X     Rat chronic feeding
                                        day                     cPAD = chronic RfD/       study
                                       UF = 100...............   Special FQPA SF =       LOAEL = 3.76 mg/kg/day
                                       Chronic RfD = 0.0038 mg/  0.0038 mg/kg/day.        based on liver
                                        kg/day.                                           hypertrophy pathology
                                                                                          supported by chronic
                                                                                          feeding and multi-
                                                                                          generation
                                                                                          reproduction studies
                                                                                          and dog sub-chronic
                                                                                          and chronic studies.
-----------------------------------------------------------------------------------------
Cancer                                    Cancer Classification: ``Likely to be carcinogen to humans'' (Q* of
                                                                    0.0119 mg/kg/day)
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food, and drinking water. Tolerances have 
been established (40 CFR 180.556) for the residues of pymetrozine, in 
or on a variety of raw agricultural commodities. In conducting the 
acute and chronic dietary risk assessments, EPA used the LifeLine\TM\ 
Model software. This LifeLine assessment was conducted using the same 
consumption data as the DEEM-FCID\TM\ (CSFII, 1994-1996 and 1998). 
LifeLine\TM\ models the individual's dietary exposures over a season by 
selecting a new CSFII diary each day from a set of similar individuals. 
Lifeline organizes groups, or ``bins,'' of CSFII diaries based on the 
respondents' age and the season during which the food diary was 
recorded. Both age and season were found to be the critical 
determinants of dietary patterns.
    Modeled estimates of drinking water concentrations were directly 
entered into the exposure model (LifeLine\TM\ ) to assess the 
contribution from drinking water. 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 1-day or 
single exposure. The following assumptions were made for the acute 
exposure assessment: A Tier 1 analysis was utilized; which assumes 
tolerance-level residues of pymetrozine per se in/on all commodities 
(along with additional residues, calculated and summed with the parent 
compound to account for plant metabolites), and also assumes 100 
percent crop treated (PCT). Actual PCT and/or anticipated residues were 
not used. Aggregate acute food and water exposure was determined by 
including modeled estimates of drinking water concentrations in the 
dietary model. The Agency used the acute water concentration (16.3 ppb) 
derived from surface water modeling results, which was significantly 
higher than the modeled ground water concentration, and therefore 
protective of potential exposures via ground water sources of drinking 
water.
    ii. Chronic exposure. The following assumptions were made for the 
chronic exposure assessment: A Tier 3 analysis was utilized; tolerance-
level residues of pymetrozine (plus metabolites) and 100 PCT were 
assumed for asparagus. For all other commodities, anticipated residues 
were derived from average crop field trial residue values, and PCT data 
were taken from prior risk assessments. Actual PCT and/or anticipated 
residues were used. Aggregate chronic food and water exposure was 
determined by including modeled estimates of drinking water 
concentrations in the dietary model. The Agency used the chronic water 
concentration (10.1 ppb) derived from surface water modeling results, 
which was significantly higher than the modeled ground water 
concentration, and therefore protective of potential exposures via 
ground water sources of drinking water.
    iii. Cancer. The following assumptions (identical to those for the 
chronic exposure assessment) were made for the cancer exposure 
assessment: A Tier 3 analysis was utilized; tolerance-level residues of 
pymetrozine (plus metabolites) and 100 PCT were assumed for asparagus. 
For all other commodities, anticipated residues were derived from 
average crop field trial residue values, and PCT data for existing uses 
were taken from prior risk assessments. Actual PCT and/or anticipated 
residues were used. Aggregate cancer food and water exposure was 
determined by including modeled estimates of drinking water 
concentrations in the dietary model. The Agency used the average water 
concentration (6.0 ppb) derived from surface water modeling results, 
which was significantly higher than the modeled ground water 
concentration, and therefore protective of potential exposures via 
ground water sources of drinking water.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA 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, pursuant 
to section 408(f)(1), 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. For the present action, EPA will 
issue such Data Call-

[[Page 43295]]

Ins for information relating to anticipated residues as are required by 
FFDCA section 408(b)(2)(E) and authorized under FFDCA section 
408(f)(1). Such Data Call-Ins will be required to be submitted no later 
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows:
    Cucumbers 10%; squash (winter and summer) 8%; cantaloupes 25%; 
pumpkins 10%; watermelons 20%; potatoes 20%; cotton 6%; tomatoes 12%; 
peppers 8%; spinach 16%; leaf lettuce 25%; head lettuce 25%; celery 
25%; cabbage 12%; and broccoli 25%.
    The Agency believes that the three conditions listed in Unit 
III.B., have been met. With respect to Condition 1, PCT estimates are 
derived from Federal and private market survey data, which are reliable 
and have a valid basis. EPA uses an average PCT for chronic dietary 
exposure estimates. The average PCT figure is derived by combining 
available federal, state, and private market survey data, averaging by 
year, averaging across all years, and rounding up to the nearest 
multiple of five. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which 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 used Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in 
surface water and Screening Concentrations in Ground water (SCI-GROW), 
which predicts pesticide concentrations in ground water. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water.
    Pymetrozine is not generally considered to be persistent. It tends 
to break down relatively quickly in the environment through a variety 
of degradation mechanisms such as acidic hydrolysis, aqueous 
photolysis, and soil photolysis. In aerobic soils, it exhibits a strong 
bi-phasic degradation pattern consisting of a rapid initial breakdown 
of the available pymetrozine, followed by a much slower degradation 
process which could be possibly due to the strong binding of this 
chemical to the soil matrix. Approximately 35% of the pymetrozine and 
40% of the pymetrozine plus CGA-359009 remained at the end of the 
aerobic soil metabolism studies. Furthermore, based on its high soil/
water partitioning coefficients, pymetrozine is expected to have a low 
potential to leach. Laboratory studies conducted to assess the mobility 
of pymetrozine on a variety of soils classify this chemical as a ``low 
mobility to no mobility'' chemical.
    Fifteen degradates were observed in laboratory studies. Because 
CGA-359009 is structurally similar to the parent, the Agency concluded 
that CGA-359009 should be included in the drinking water assessment in 
addition to the parent. CGA-359009 is expected to be more mobile than 
the parent due to the addition of the hydroxyl group and therefore more 
likely to reach to drinking water.
    Based on the PRZM/EXAMS model, the estimated environmental 
concentrations (EECs) of pymetrozine for acute, chronic, and cancer 
exposures are estimated to be 16.3 parts per billion (ppb), 10.1 ppb 
and 6.0 ppb for surface water respectively. Based on the SCI-GROW 
model, the EEC of pymetrozine for the acute and chronic exposure is 
estimated to be 0.038 ppb for ground water. The acute, chronic, and 
cancer estimated water concentrations derived from surface water 
modeling results were significantly higher than the modeled ground 
water concentrations, and therefore protective of potential exposures 
via ground water sources of drinking water when incorporated into 
aggregate exposure estimates. The pymetrozine EEC's were incorporated 
into LifeLine version 2.0 to determine aggregate pesticide exposures 
from pesticide residues in the diet.
    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).
    Fulfill[reg] is the pymetrozine pesticide product for 
use on ornamentals. Application of this product must be by a licensed 
pesticide applicator. Currently, there are no applications for 
registration of a homeowner use of pymetrozine. EPA believes that there 
is a low likelihood of adults and children engaging in activities in 
and/or around treated or landscaped areas and/or ornamentals that could 
lead to any meaningful exposure. As a result, dermal and oral post-
application exposures are expected to be negligible.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to

[[Page 43296]]

pymetrozine and any other substances, and 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 policy statements released by EPA's 
Office of Pesticide Programs concerning common mechanism determinations 
and procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA 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 based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Based on the results of the 
developmental and reproduction studies, there is no indication of 
increased sensitivity in rats or rabbits to in utero and/or postnatal 
exposure to pymetrozine.
    3. Conclusion. Due to the lack of a required developmental 
neurotoxicity study, EPA is retaining the additional 10X FQPA safety 
factor for the protection of infants and children. Evaluation of the 
pymetrozine database indicates that the DNT has the potential to lower 
regulatory endpoints for pymetrozine and therefore the 10X factor is 
being retained.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated environmental concentrations 
(EECs). The DWLOC values are not regulatory standards for drinking 
water, but 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 EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA 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. When new 
uses are added EPA reassesses the potential impacts of residues of the 
pesticide in drinking water as a part of the aggregate risk assessment 
process.
    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface and ground water EECs are 
directly incorporated into the dietary exposure analysis, along with 
food. This provides a more realistic estimate of exposure because 
actual body weights and water consumption from the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs.
    There are no existing or proposed uses for pymetrozine that would 
result in residential non-dietary exposure, therefore aggregate acute, 
chronic and cancer risks are based solely on exposure from food and 
water, which are as follows:
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to pymetrozine will occupy 2.3% of the aPAD for the U.S. population, 
31% of the aPAD for females 13 years and older, 2.5% of the aPAD for 
all infants < 1 years old, and 3.4% of the aPAD for children 1-2 years 
old. EPA does not expect the aggregate exposure to exceed 100% of the 
aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pymetrozine from food will utilize 5.1% of the cPAD for the U.S. 
population, 16% of the cPAD for all infants < 1 year old, and 8.9% of 
the cPAD for children 1-2 years old. There are no residential uses for 
pymetrozine that result in chronic residential exposure to pymetrozine. 
EPA does not expect the aggregate exposure to exceed 100% of the cPAD.
    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). Pymetrozine is not 
registered for use on any sites that would result in significant 
residential exposure. Although postapplication non-occupational 
exposure could occur as a result of contact with treated ornamental 
plants, EPA believes that there is a low likelihood of adults and 
children engaging in activities in and/or around treated or landscaped 
areas and/or ornamentals that could lead to any meaningful exposure. As 
a result, dermal and oral post-application exposures are expected to be 
negligible.
    4. Aggregate cancer risk or U.S. population. Under the reasonable 
certainty of no harm standard in FFDCA section 408(b)(2)(A)(ii), cancer 
risks must be no greater than negligible. EPA has consistently 
interpreted negligible cancer risks to be risks within the range of an 
increased cancer risk of 1 in 1 million (1 X 10-6). Risks as 
high as 3 in

[[Page 43297]]

1 million have been considered to be within this risk range. The 
estimated chronic cancer exposure of the general U.S. population to 
pymetrozine is 0.000137 mg/kg/day. Applying the Q1* of 0.0119 (mg/kg/
day)-1 to the exposure value results in a cancer risk 
estimate of 1.6 x 10-6, which is within the negligible risk 
range of 1 x 10-6. The exposure value of 0.000137 mg/kg/day, 
although somewhat refined, is a high-end estimate. Use of food 
monitoring data, if available, would likely result in a significant 
reduction in the exposure estimate since residues would be from actual 
pymetrozine use patterns and not from trials designed to maximize 
residues for tolerance-setting purposes. It is EPA's experience that 
monitoring data from sources such as the USDA's Pesticide Data Program 
show that residues in foods are significantly less than those produced 
from field trials. In addition, default processing factors were used 
with no adjustments made to account for consumer practices such as 
washing and peeling. Based on those factors, the Agency is confident 
that actual dietary exposure to pymetrozine in food and drinking water 
will be much less than our estimate of 0.000137 mg/kg/day and that the 
actual cancer risk will be correspondingly lower than 1 X 
10-6.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to pymetrozine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The HPLC/UV methods, AG-643A and AG-647, are adequate for 
collecting data on residues of pymetrozine and GS-23199, respectively, 
in/on the following commodities: Undelinted cottonseed, cotton gin 
byproducts, cottonseed processed commodities, broccoli, cabbage (with 
and without wrapper leaves), celery, hops (green and dried cones), 
lettuces, mustard greens, spinach, pecans, cucurbits, and fruiting 
vegetables. The validated limit of quantitation (LOQ) is 0.02 ppm for 
each analysis in each matrix with the exception of pymetrozine in dried 
hops cones. The Agency's Analytical Chemistry Branch (ACB) validated 
Method AG-643A on tomatoes, hops, and cottonseed. This method is 
considered adequate for enforcement purposes on plant commodities.
    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are no MRLs or Codex limits for pymetrozine on asparagus.

V. Conclusion

    Therefore, the tolerance is established for residues of 
pymetrozine, [4,5-dihydro-6-methyl-4-[(E)-(3-pyridinylmethylene)amino]-
1,2,4-triazin-3(2H)-one], in or on asparagus at 0.04 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA 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) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. 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 ID number OPP-2005-0106 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 September 
26, 2005.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. 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) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0106, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. 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

[[Page 43298]]

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. Statutory and Executive Order Reviews

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

    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: July 18, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.556 is amended by alphabetically adding the commodity to 
the table in paragraph (a) to read as follows:


Sec.  180.556  Pymetrozine; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Asparagus............................................               0.04
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-14598 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S