[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Rules and Regulations]
[Pages 48626-48634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20117]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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


Pymetrozine; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

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

[[Page 48627]]

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

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

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

FOR FURTHER INFORMATION CONTACT:  By mail: Daniel Peacock, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5407; e-mail address: [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
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

     1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
     2. In person. The Agency has established an official record for 
this action under docket control number OPP-301033. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

     In the Federal Register of May 20, 1998 (63 FR 27723-27727) (FRL-
5773-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a, as amended by the FQPA (Public Law 104-170) announcing the 
filing of a pesticide petition (PP) for tolerance by Novartis Crop 
Protection, Inc. of Greensboro, NC 27419. This notice included a 
summary of the petition prepared by Novartis Crop Protection, the 
registrant. There were no comments received in response to the notice 
of filing.
     The petition requested that 40 CFR 180.556 be amended by 
establishing a tolerance for residues of the insecticide pymetrozine 
1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) 
amino], in or on hops at 5 ppm, fruiting vegetables at 0.05 ppm, and 
cucurbits and potatoes at 0.02 ppm.
     Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
     EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

     Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of pymetrozine, 1,2,4-triazin-
3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) amino] on 
cucurbit vegetables (Crop Group 8) at 0.05 parts per million (ppm) and 
fruiting vegetables at 0.05 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

     EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the

[[Page 48628]]

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

B. Toxicological Endpoints

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

C. Exposures and Risks

     1. Current and proposed uses. Pymetrozine is an insecticide of the 
pyridine azomethine type and was first registered in 1999. Pymetrozine 
controls aphids and suppression of whiteflies in a variety of crops. 
The mode of action of pymetrozine has not been precisely determined 
biochemically; physiologically, it appears to act by preventing these 
insects from inserting their stylus into the plant tissue.
     Currently, EPA has registered pymetrozine for use on tuberous and 
corm vegetables (Subgroup 1-C) and tobacco under Fulfill (EPA 
Reg. No. 100-912) and ornamental plants under Endeavor (EPA 
Reg. No. 100-913). There are no homeowner applications for pymetrozine. 
However; postapplication (residential) exposure could occur due to 
contact with treated ornamental plants. For both Fulfill and 
Endeavor , pymetrozine is formulated as a water-dispersible 
granule containing 50% active ingredient.
     Fulfill may be applied by either ground or aerial 
broadcast equipment, in a minimum of 10 gallons of water per acre; 
chemigation is not permitted. Pymetrozine is applied to the foliage of 
affected plants where it is quickly absorbed. Potato and tobacco crops 
may be treated up to twice, each at a maximum rate of 0.09 lb active 
ingredient/acre (ai/A). The maximum seasonal use rate is 0.17 lb ai/
acre. The retreatment and pre-harvest intervals are 7 and 14 days, 
respectively. The label for Fulfill specifies a restricted-
entry interval of 12 hours.
     Endeavor may be broadcast-applied to ornamentals at a 
rate not to exceed 10 ounce/acre/application (oz./A/application). 
Multiple applications may be made on a 7- to14-day interval. For indoor 
use, the yearly application rate is not to exceed 100 oz./A/year; for 
outdoor use, the maximum rate is 48 oz./A/year.
     Novartis Crop Protection has proposed that the use of pymetrozine 
be expanded on the Fulfill label to included cucurbit and 
fruiting vegetables. The rates, number of applications, pre-harvest 
intervals, and restricted-entry interval will remain the same for these 
additional uses.
     2. From food and feed uses. This Rule establishes two new 
tolerances for pymetrozine: in or on cucurbit vegetables (Crop Group 8) 
at 0.05 parts per million (ppm) and fruiting vegetables (Crop Group 9) 
at 0.05 ppm.
     Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
     Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of crop treated (PCT) for assessing chronic dietary risk 
only if the Agency can make the following findings: That the data used 
are reliable and provide a valid basis to show what percentage of the 
food derived from such crop is likely to contain such pesticide 
residue; that the exposure estimate does not underestimate exposure for 
any significant subpopulation group; and if data are available on 
pesticide use and food consumption in a particular area, the exposure 
estimate does not understate exposure for the population in such area. 
In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by section 408(b)(2)(F), EPA may require registrants 
to submit data on PCT.
     Most of the dietary risk assessments performed on pymetrozine used 
a Tier 1 approach for fruiting vegetables, cucurbits, and potatoes, 
crops originally requested in the petition. That is, the Agency assumed 
100% crop treated and tolerance level residues. For carcinogenicity 
risk assessment, the Agency used a Tier 3 chronic dietary exposure 
analysis for fruiting, cucurbit, and tuberous and corm vegetables. This 
was based on 6-20% of the crop treated and an anticipated residue of 
0.0046 ppm to refine the cancer risk. Novartis supplied this estimate 
of PCT to the Agency. The Agency reviewed Novartis' estimate and found 
it reasonable.
     The Agency believes that the three conditions, discussed in 
section 408 (b)(2)(F) in this unit concerning the Agency's 
responsibilities in assessing chronic dietary risk findings, have been 
met. EPA finds that the PCT information is reliable and has a valid 
basis. Before the petitioner can increase production of product for 
treatment of greater than 340,000 acres (20% of 1,700,000 total acres 
for fruiting, cucurbit, and the tuberous and corm subgroup), permission 
from the Agency must be obtained. The regional consumption information 
and consumption information for significant subpopulations is taken 
into account through EPA's computer-based model for evaluating the 
exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available information on the consumption of food in a 
particular area.
     i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure.
     The Tier 1 DEEM analysis indicates that acute dietary 
(food only) exposure to pymetrozine from all existing and proposed uses 
(tuberous and corm, fruiting, and cucurbit vegetables) will be below 
EPA's level of concern (100% of the acute Population-Adjusted Dose 
(aPAD)) and will not occupy more than 7% of the aPAD for any population 
subgroup, including those of infants and children. For the maximum 
exposed subgroup, the 95th percentile of exposure (children ages 1-6 
years) is

[[Page 48629]]

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

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

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

[[Page 48630]]



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

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

[[Page 48631]]

duration of exposure) and some central tendency (i.e., transfer 
coefficient, surface area, hand-to-mouth activity, and body weight) 
assumptions and are considered to be representative of high-end 
exposures. The uncertainties associated with this assessment stem from 
the use of an assumed amount of pesticide available from gardens, and 
assumptions regarding dissipation, transfer of chemical residues, and 
hand-to-mouth activity. The estimated exposures are believed to be 
reasonable high-end estimates based on observations from chemical-
specific field studies and professional judgement.
     EPA determined that the FQPA Safety Factor to protect infants and 
children should be reduced to 3x and that the factor should apply to 
female (13-50 years), infant, and children population subgroups for all 
risk assessments. Thus, the levels of concern for these postapplication 
exposure scenarios are MOEs that are less than 100 for adult 
populations and less than 300 for female (13-50), infant, and children 
populations.
     i. Chronic exposure and risk. Based on the proposed uses of 
pymetrozine, EPA does not believe there will be chronic non-
occupational exposure to this insecticide.
     ii. Cancer exposure and risk. The EPA has estimated the lifetime 
average daily dose for non-occupational exposure resulting from prining 
and planting treated ornamental plants is 0.0000012 mg/kg/day.
     A quantitative cancer risk assessment was performed for 
postapplication non-occupational exposure to treated ornamentals (e.g., 
a home garden). Exposures were estimated using EPA's default activity 
scenarios, transfer coefficients and input parameters as follows: The 
fraction of active ingredient retained on foliage is assumed to be 20% 
(0.2) on day zero (= percent dislodgeable foliar residue, DFR, after 
initial treatment). This fraction is assumed to further dissipate at 
the rate of 10% (0.1) per day on following days. These are EPA's 
default values for exposure.
     An application rate of 0.3125 lbs ai/acre (electrostatic 
spray, pulsfog and low volume systems) was used to represent the worst 
case scenario.
     Transfer coefficient of 4,500 was used to represent 
heaviest day of activity (planting, transplanting, and pruning) for 
contact with treated ornamental plants
     Assumed homeowner worked 0.67 hours per day (Residential 
SOP for Gardening)
     Assumed homeowner worked a total of 2 days per year 
performing heaviest activities (planting, pruning) at time points 
shortly after pymetrozine application
     Assumed homeowner would be exposed for 50 years of their 
life
     Dermal absorption = 1%
     Body weight = 70 kg
     Life expectancy = 70 years
     Cancer Q\*\ (mg/kg/day) = 1.19  x 10-2
     The cancer risk estimate for this postapplication exposure is 1.4 
x  10-8 and does not exceed EPA's level of concern (in the 
range of 1  x  10-6) for the general population.
     iii. Short- and intermediate-term exposure and risk. EPA did not 
calculate margins of exposure (MOEs) for adults since there are no 
short-term dermal exposure scenarios. However, short-term oral 
exposures and risks were calculated for toddlers. For toddlers, the 
MOEs for short-term postapplication exposure scenarios are 770,000 and 
660,000 for hand-to-mouth and soil ingestion scenarios. These values 
are all greater than either of the threshold values; thus, short-term 
risks are below the Agency's level of concern.
     5. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
     According to our information, there are no other pesticides that 
have a common mechanism of toxicity with pymetrozine. Unlike other 
pesticides for which EPA has followed a cumulative risk approach based 
on a common mechanism of toxicity, pymetrozine does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
pymetrozine has a common mechanism of toxicity with other substances. 
For information regarding EPA's efforts to determine which chemicals 
have a common mechanism of toxicity and to evaluate the cumulative 
effects of such chemicals, see the final rule for Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

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

[[Page 48632]]

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

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

     1. Safety factor for infants and children--i.In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of pymetrozine, EPA considered data from 
developmental toxicity studies in rabbit, an acute neurotoxicity study 
in the rat, and a chronic feeding study in the rat. See the 
Toxicological Profile (Unit III.A) for a discussion of these tests.
     FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard uncertainty factor (usually 100 for combined inter- 
and intra-species variability) and the additional 3-fold MOE/
uncertainty factors, as described above, when EPA has a complete data 
base under existing guidelines and when the severity of the effect in 
infants or children or the potency or unusual toxic properties of a 
compound do not raise concerns regarding the adequacy of these safety 
factors.
     ii. Conclusion. EPA considered the available data and determined 
that the 10-fold FQPA factor could be reduced to 3.
     2. Acute risk. The risk from aggregate acute exposure from food 
and drinking water from pymetrozine is below EPA level of concern for 
the following reasons. The Tier 1 Dietary Exposure Evaluation Model 
(DEEM) analysis indicates that acute dietary (food only) 
exposure to pymetrozine from tuberous and corm vegetables (Subgroup 1-
C), fruiting vegetables and cucurbits will occupy less than 4% 
(0.004556/0.14) of the aPAD for children (1 to 6 years old), which is 
below EPA's level of concern of 100% of the aPAD. In addition, for 
drinking water, the DWLOC value (1,400 g/L) for children (1 to 
6 years old) is greatly in excess of the modeled acute EEC values (1.9 
g/L); thus, drinking water is not expected to be a significant 
contributor towards this type of exposure.
     3. Chronic risk. Using the residue concentration exposure 
assumptions described in this unit, the risk from aggregate chronic 
exposure from food and drinking water from pymetrozine is below EPA's 
level of concern for the following reasons. As indicated in Table 1 
above, the Tier 1 DEEM analysis indicates that chronic dietary (food 
only) exposure to pymetrozine will utilize less than 74% (0.000958/
0.0013) of the cPAD for children (1 to 6 years old). EPA generally has 
no concern for exposures below 100% of the cPAD because the cPAD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. In 
addition, for drinking water, the DWLOC value (3.4 g/L) for 
children (1 to 6 years old) exceeds the modeled chronic EEC values 
(0.222 g/L); thus, drinking water is not expected to be a 
significant contributor towards this type of exposure. Despite the 
potential for exposure from food, drinking water and non-dietary, non-
occupational exposure, EPA does not expect the aggregate chronic 
exposure to exceed 100% of the cPAD.
    4. Short-term risk. In aggregating short-term risk, EPA considered 
background average dietary exposure and short-term, non-dietary oral 
exposure. Non-dietary oral exposure may occur as hand-to-mouth transfer 
of residues from ornamental plants or incidental ingestion of 
surrounding soil. The lowest short-term MOE value is for toddlers. 
Combining this MOE (660,000) with that from dietary exposure (Short-
term oral NOAEL/chronic dietary exposure = 10/0.00096  
10,000) results in an aggregate MOE of  (approximately 
equal) 10,000. As this value is greater than 300, the short-term 
aggregate risk is below the Agency's level of concern. Aggregated 
short-term exposure results in a DWLOC of 320 g/L. This value 
is in excess of the peak EEC for pymetrozine (1.9 g/L; see 
Table 2).
     5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty of no harm to infants 
and children from aggregate exposure to pymetrozine residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

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

B. Analytical Enforcement Methodology

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

C. Magnitude of Residues

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

D. International Residue Limits

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

E. Rotational Crop Restrictions

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

F. Pre-harvest Intervals

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

V. Conclusion

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

VI. Objections and Hearing Requests

     Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a

[[Page 48633]]

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

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

     You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301033 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before October 
10, 2000.
     1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
     Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Room M3708, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
     2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission be labeling it ``Tolerance Petition Fees.''
     EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
     If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
     3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket number OPP-301033, to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person or 
by courier, bring a copy to the location of the PRIB described in Unit 
I.B.2. You may also send an electronic copy of your request via e-mail 
to: [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 file format or ASCII file format. Do not 
include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

     A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

     This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require OMB review or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the

[[Page 48634]]

Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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


    Dated: August 1, 2000.

  James Jones,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

 PART 180--[AMENDED]

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

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


    2. Section 180.556 is revised to read as follows:


Sec. 180.556  Pymetrozine; tolerances for residues.

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


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

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

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