[Federal Register Volume 64, Number 188 (Wednesday, September 29, 1999)]
[Rules and Regulations]
[Pages 52438-52450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25313]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300929; FRL-6385-6]
RIN 2070-AB78


Pymetrozine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a permanent tolerance for 
pymetrozine [1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-
pyridinylmethylene) amino]] in or on tuberous and corm vegetables 
(Subgroup 1-C), at 0.02 parts per million (ppm). Novartis Crop 
Protection, Inc. of Greensboro, North Carolina 27419, requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by 
the Food Quality Protection Act of 1996.

DATES: This regulation is effective September 29, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300929, 
must be received by EPA on or before November 29, 1999.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each

[[Page 52439]]

method as provided in Unit VI. of the ``SUPPLEMENTARY INFORMATION'' 
section. To ensure proper receipt by EPA, your objections and hearing 
requests must identify docket control number OPP-300929 in the subject 
line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Dan Peacock, Registration 
Division (7504C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 305-5407; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

 I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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'' 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-300929. 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 (CM #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. 
Persons wishing to review copies of the actual studies summarized in 
this document need to file a Freedom of Information (FOI) request with 
Ms. Jeralean Green, Freedom of Information Office (1105), 401 M St., 
Washington, DC 20460. Specify the MRID number of each study needed. The 
FOI telephone number is (202) 260-4048.

II. Background and Statutory Findings

    In the Federal Register of May 20, 1998 (63 FR 27723) (FRL-5773-2), 
EPA issued a notice pursuant to section 408 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality 
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide petition (PP) for tolerance by 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 
pymetrozine and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a tolerance for residues of 
pymetrozine on tuberous and corm vegetables (Subgroup 1-C), at 0.02 
ppm. EPA's assessment of the exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by pymetrozine are 
discussed in this unit.
    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. This section summarizes the 
results of

[[Page 52440]]

the subchronic and chronic toxicity, metabolism, and dermal penetration 
studies in animals.
    i. Subchronic toxicity. A subchronic feeding study in rats (MRID 
No. 44024939, Guideline 82-1a), using 98% pymetrozine, exposed animals 
for 3 months at dose levels of 0, 50, 500 or 5,000 ppm. These dose 
levels correspond to 0, 3.42, 32.5 or 360 milligrams/kilograms/day (mg/
kg/day) in males and 0, 3.63, 33.9 or 370 mg/kg/day for females. At 
5,000 ppm, body weight was decreased. Food and water consumption also 
decreased. After 14 weeks, the numbers of white blood cells increased 
(leucocytosis) 42% in males and 73% in females. After the 4-week 
recovery period, the numbers of white blood cells were still elevated 
6% in males and 35% in females. The lowest observable adverse effect 
level (LOAEL) is 5,000 ppm (360 mg/kg/day) based primarily 
on body weight and liver effects. The no observable adverse effect 
level (NOAEL) is 500 ppm (32.5 mg/kg/day).
    A subchronic feeding study in beagle dogs (MRID No. 44572201, 
Guideline 82-1), using 98% pymetrozine, exposed animals for 13 weeks 
(4/sex/dose) at dose levels of 0, 100, 500 or 2,500 ppm. These dose 
levels corresponded to 0, 3.12, 14, or 54 mg/kg/day for either sex. 
Mean relative liver weights were increased at all dose levels. At 500 
ppm, both absolute (17% males and 18% females) and relative (19% males 
and 17% female) liver weights were increased. In addition, skeletal 
muscle myopathy (disease) in 1/4 males and 2/4 females, liver pathology 
(bile duct proliferation in both sexes and hepatocyte necrosis in 
females), and lymphohistocytic infiltration (several organs) increased. 
At 2,500 ppm, there was one death attributable to anemia. Decreases in 
red blood cell (RBC) parameters and increases in bilirubin were 
observed at this dose level as well, which are also indicative of 
anemia. Body weight was decreased in males (24%) and females (30%). 
Additional pathology was found in the thymus (atrophy and decrease in 
weight), heart (inflammation and decrease in weight), testis (decrease 
in spermatogenesis and weight) and uterus (atrophy). The LOAEL is 500 
ppm (14 mg/kg/day) based on liver effects, skeletal muscle 
atrophy, liver pathology and lymphohistocytic infiltration. The NOAEL 
is 100 ppm (3.12 mg/kg/day). Slight liver weight changes at 
100 ppm were not considered in the LOAEL.
    A subchronic feeding study in the mouse (MRID No. 44024938, 
Guideline 82-1c), using 98% pymetrozine and designed to determine the 
dose levels for the definitive carcinogenicity study, exposed mice for 
3 months at 0, 1,000, 3,000 or 7,000 ppm. Mean relative liver weights 
were increased in the low (10.5%), mid (26%) and high (57%) dose males 
and in the low (12%, not significant), mid (33%) and high (54%) dose 
females. The liver also showed increases in centrilobular hypertrophy 
of hepatocytes (swelling of liver cells) with a dose response of 0, 3, 
7 and 10 in males and 0, 2, 5, and 10 in females for four dose levels. 
The liver also was indicated as having ``slight centrilobular 
perivascular-like aggregates of lymphocytes'' in all dose groups except 
the control and demonstrated a marked dose response with treatment. 
Necrosis of the liver was also increased in a dose related manner. 
Relative spleen weight was also increased at 3,000 ppm (21% in males 
and 19% in females) and 7,000 ppm (53% in males and 16% in females) and 
was accompanied by splenic extramedullary hematopoiesis above 
background. Thus, the liver and blood forming system were indicated as 
target organs for pymetrozine. Body weight at termination was decreased 
(17%) in males in the high dose group but was actually slightly 
increased (7%, not significant) in females.
    A 28-day dermal toxicity study in the rat (MRID No. 44024942, 
Guideline No. 82-2), using 98% pymetrozine, exposed animals at 0, 10, 
100 or 1,000 mg/kg/day for 6 hours/day, 5 days/week for 4 weeks. The 
agent was suspended in distilled water and was applied directly to 
clipped skin using an occlusive dressing. No treatment-related clinical 
signs or signs of local irritation were observed. Hematology and 
clinical biochemistry performed on the test animals revealed no 
treatment-related effects. Macroscopic and microscopic examination of 
internal organs and the application site revealed no treatment-related 
findings. The NOAEL for both systemic effects and dermal irritation is 
1,000 mg/kg/day, the highest dose tested (HDT). The LOAEL is greater 
than 1,000 mg/kg/day.
    ii. Chronic toxicity. A chronic feeding study in beagle dogs (MRID 
No. 44024943, Guideline 83-1), using 98% pymetrozine, exposed animals 
for 12 months at 0, 20, 200 and 1,000 ppm (corresponding to 
approximately 0, 0.57, 5.33 or 27.8 mg/kg/day in both sexes). At 200 
ppm, there were increases in mean absolute (11%) and relative (17%) 
liver weights in males. At 1,000 ppm, mean absolute (6%) and relative 
(11%) liver weights were higher in both males and females (absolute 
(18%) and relative (6%)). In addition, in males, there was also 
increased inflammatory cell infiltration in the liver (4/6 vs 2/6 in 
the control group); and myopathy (2/6 vs 0/6 in the control group) in 
the small and large intestine. Anemia was apparent in two females. The 
LOAEL is 1,000 ppm (27.8 mg/kg/day), based primarily on myopathy 
(muscle disease) and presence of anemia (reduction in red blood cells). 
The NOAEL is 200 ppm (5.33 mg/kg/day). Similar findings in the dog 
subchronic study (MRID No. 44572201) regarding anemia and liver 
pathology support the conclusions of this study.
    An 18-month definitive carcinogenicity study in mice (MRID No. 
44024944, OPPTS No. 870.4200 or Guideline No. 83-2), using 98% 
pymetrozine, exposed animals (50/sex/dose group) for 18 months at 0, 
10, 100, 2,000 or 5,000 ppm. These dose levels correspond to 
approximately 0, 1.2, 12, 250 and 675 mg/kg/day pymetrozine in either 
sex. At 2,000 ppm, relative liver weight increased in males (36%) and 
females (17%), with hepatocyte hypertrophy occurring in most affected 
animals. Hemosiderosis (increase in storage of insoluble form of iron) 
and extramedullary hematopoiesis (red blood cell formation) were also 
increased. Relative liver weight was increased by 78% in males and by 
62% in females. The systemic LOAEL was 2,000 ppm (250 mg/
kg/day) based on increases in liver weight as well as hepatocyte 
hypertrophy and hemosiderosis. The NOAEL is 100 ppm (12 mg/
kg/day). Liver tumors were associated with the higher doses (2,000 and 
5,000 ppm) of pymetrozine exposure with 5, 5, 5, 9 and 23 (males) and 
0, 0, 0, 0 and 4 (females) hepatocellular carcinomas and 4, 5, 5, 1 and 
14 hepatocellular ``benign adenoma'' in females for the control, 10, 
100, 2,000 and 5,000 ppm dose groups, respectively. Males did not show 
increases in adenomas. The increases in liver weight and presence of 
hypertrophy and hematopoieses may imply that the high dose was 
excessive for meaningful carcinogenicity evaluation.
    A combined chronic feeding/carcinogenicity study in the rat (MRID 
No. 44024951, Guideline No. 83-5, using 98% pymetrozine, exposed 
animals for 12 and 24 months. Five groups of 80/sex were dosed at 0, 
10, 100, 1,000 or 3,000 ppm in the diet, corresponding to 0, 0.377, 
3.76, 38.52 or 123.4 mg/kg/day for males and 0, 0.454, 4.48, 46.26 or 
148.3 mg/kg/day for females. Ten/sex/group were sacrificed at 12 
months. Fifty/sex/group were reserved for carcinogenicity assessment 
after dosing for a scheduled 24 months. For the control, 10, 100, 1,000 
and 3,000 ppm dietary groups (based on 60/sex),

[[Page 52441]]

hepatocellular hypertrophy was present with the following total 
incidence: for males, 0, 1, 5, 22 and 37 and for females, 2, 1, 0, 12 
and 40. At the 1 year interim sacrifice, the incidence in males was 0, 
0, 4, 10 and 10 (out of 10/group). Thus indicating in males that the 
100 ppm dose is an effect level for induction of hepatocellular 
hypertrophy. At 1,000 ppm, body weight and gain were reduced (i.e., at 
4 weeks males 6% and females 12%, p < 0.05 less gain) and relative 
liver (26%, p < 0.05), spleen (24%, p < 0.05) and kidney (14%, not 
significant) weights were increased in males at week 53. At 3,000 ppm, 
the magnitude of the effects at 1,000 ppm was increased and, in 
addition, female liver, spleen, kidney, brain and ovary as well as male 
brain and testis relative weights increased. The uterus showed 
increased dilation. The systemic LOAEL is 100 ppm (3.76 mg/kg/day) 
based on hepatocellular hypertrophy in males. The NOAEL is 10 ppm 
(0.377 mg/kg/day). In females, the systemic LOAEL is 1,000 ppm (46.26 
mg/kg/day) and the NOAEL is 100 ppm (4.48 mg/kg/day) based on 
hepatocellular hypertrophy and reduced body weight and body weight 
gain. This study was considered positive for induction of liver tumors 
(benign hepatoma) at 1,000 and 3,000 ppm in females. The presence of 
hepatocellular hypertrophy at 1,000 and 3,000 ppm and decreased body 
weight at 3,000 ppm may provide a basis for determining that the dose 
levels associated with liver tumors were excessive.
    3. Neurotoxicity. An acute neurotoxicity study in the rat (MRID No. 
44411317, Guideline 81-8) exposed animals in groups of 10/sex at dose 
levels of 0, 125, 500 or 2,000 mg/kg/day. The LOAEL is 125 mg/kg based 
on decreases in body temperature, function observation battery (FOB) 
changes, and decreased motor activity (in males) related to decreased 
activity. The NOAEL is < 125 mg/kg/day.
    A 13-week subchronic neurotoxicity study in the rat (MRID No. 
44411318, Guideline No. 82-7) exposed groups of 10 animals/sex at dose 
levels of 0, 500, 1,000 or 3,000 ppm. Systemic effects of treatment 
were evident at 3,000 ppm only and were limited to decreased body 
weight gain (10-18% in males and 7-10% in females). At this dose, 
indications of neurotoxicity were limited to stereotypy (repetition of 
senseless movements) in males (3/10 affected at week 4 and 1/10 
affected at weeks 8 and 13). There were also indications of tiptoe gait 
or walking on toes in females at all intervals but only statistically 
significant at week 13. The LOAEL is 3,000 ppm (equivalent to a mean of 
201 mg/kg/day for males and 224 mg/kg/day in females) based on 
decreased weight and stereotypy in males as well as tiptoe gait in 
females. The NOAEL is 1,000 ppm (equivalent to a mean of 68 mg/kg/day 
in males and 81 mg/kg/day for females).
    4. Developmental toxicity. A developmental study in the rat (MRID 
No. 44024948, OPPTS No. 870.3700 or Guideline No. 83-3a), using 98% 
pymetrozine, exposed groups of 24 animals in a 0.5% w/w aqueous 
solution of sodium carboxymethylcellulose at either 0, 30, 100 or 300 
mg/kg/day by oral gavage from gestation days 6 through 15, inclusive. 
Maternal systemic toxicity was seen as reduced body weights gains in 
the 100 and 300 mg/kg/day dose groups during the dosing period 
(gestation days 6-16), the dosing period plus post-dosing period 
(gestation days 6-21 for 300 mg/kg/day) and the corrected body weight 
gain for the dosing period plus post-dosing period (statistically 
significant for both 100 and 300 mg/kg/day). There was reduced food 
consumption in the same groups during the dosing period. The maternal 
toxicity NOAEL was 30 mg/kg/day and the maternal toxicity LOAEL was 100 
mg/kg/day based on reduced body weight gains and food consumption. 
Developmental toxicity was observed as an increase in skeletal 
observations at 300 mg/kg/day including dumbbell-shaped thoracic 
vertebral centers, absent ossification of metatarsal #1, shortened rib 
#13, absent ossification of the proximal phalanx of anterior digit #5, 
absent ossification of the proximal phalanx of posterior digit #2, #3 
and #4, and absent and poor ossification of the proximal phalanx of 
posterior digit #5. The developmental toxicity NOAEL was 100 mg/kg/day 
and the developmental toxicity LOAEL was 300 mg/kg/day based on 
increased incidence of skeletal anomalies.
    A developmental study in the rabbit (MRID No. 44024949, OPPTS No. 
870.3700 or Guideline No. 83-3b), using 98% pymetrozine, exposed groups 
of 20 animals in a 0.5% w/w aqueous solution of sodium 
carboxymethylcellulose at either 0, 10, 75 or 125 mg/kg/day by oral 
gavage from gestation days 7 through 19, inclusive. Maternal systemic 
toxicity was seen as reduced body weight gains in the 75 and 125 mg/kg/
day dose groups. There was also reduced food consumption in the mid and 
high dose groups. There was reduced food efficiency noted in the mid 
and high dose groups during all periods except for predosing (gestation 
days 0-7). At 125 mg/kg/day, two dams died and one aborted the entire 
litter during the dosing period. (Note: these observations were also 
noted in the rangefinding study). The maternal toxicity NOAEL was 10 
mg/kg/day and the maternal toxicity LOAEL was 75 mg/kg/day based on 
reduced body weight gains and food consumption/efficiency. 
Developmental toxicity was observed as an increase in additional 13th 
ribs in the 75 and 125 mg/kg/day dose groups and an increase in 
skeletal observations at 125 mg/kg/day seen as fused sternebrae #2 & 3, 
#3 & 4 and #4 & 5, additional caudal vertebral centers, poor 
ossification of metacarpal #1, poor ossification of the talus of the 
hind limb, and poor ossification of the anterior digit #5 medial 
phalanx. Also, there was reduced litter size, increased resorptions and 
increased post-implantation loss in the 125 mg/kg/day dose group. The 
developmental toxicity NOAEL was 10 mg/kg/day and the developmental 
toxicity LOAEL was 75 mg/kg/day based on increased incidence of 
skeletal anomalies.
    5. Reproductive toxicity. A multigeneration reproduction study in 
the rat (MRID No. 44024950, OPPTS No. 870.3800 or Guideline No. 83-4), 
using 98% pymetrozine, exposed groups of 30 animals at 0, 20, 200 or 
2,000 ppm in the diet for two successive generations. Parental systemic 
toxicity included minimal hepatocellular hypertrophy in 5/30 200 ppm F0 
males, 27/30 2,000 ppm F0 males and 2/30 2,000 ppm F0 females, in 
addition to minimal to moderate hyperplasia of lymphatic follicles of 
splenic white pulp in 25/30 2,000 ppm F0 females. The F1 animals had 
minimal hepatocellular hypertrophy in 2/30 200 ppm males, 26/30 2,000 
ppm males and 10/30 2,000 ppm females, in addition to minimal to 
moderate hypertrophy of the basophilic cells in the adenohypophysis in 
17/30 2,000 ppm males, compared to 7/30, 8/30, 7/30 for the control, 20 
ppm and 200 ppm groups, respectively. Further, there were increased 
absolute and relative spleen and liver weights in the F0 and F1 2000 
ppm animals plus decreased absolute and relative thymus weights in the 
2,000 ppm F1 animals. The investigators concluded that the liver was 
the target organ in both sexes in both generations; in addition, the 
spleen was the target organ in F0 females, whereas the pituitary gland 
was affected in F1 males. Systemic toxicity to the paternal animals 
included reduced body weights, reduced body weight gains, and reduced 
food consumption. Systemic toxicity to F1 groups, included reduced body 
weights, reduced body weight gains, and reduced food consumption. The 
parental (paternal/

[[Page 52442]]

maternal) systemic toxicity NOAEL was 20 ppm (1.4-1.7 mg/kg/day for 
males and 1.6-1.8 mg/kg/day for females) and the parental (paternal/
maternal) systemic toxicity LOAEL = 200 ppm (13.9-17.0 mg/kg/day for 
males and 16.0-18.1 mg/kg/day for females) based on liver effects in 
the F0 and F1 males. The reproductive toxicity NOAEL is equal to or 
greater than 2,000 ppm (136.9-179.0 mg/kg/day for males and 151.6-186.5 
mg/kg/day for females) and the reproductive toxicity LOAEL is greater 
than 2,000 ppm (136.9-179.0 mg/kg/day for males and 151.6-186.5 mg/kg/
day for females), since no reproductive effects were noted at the 
highest dose tested. The offspring systemic/developmental toxicity 
NOAEL was 200 ppm (13.9-17.0 mg/kg/day for males and 16.0-18.1 mg/kg/
day for females) and the offspring systemic/developmental toxicity 
LOAEL was 2,000 ppm (136.9-179.0 mg/kg/day for males and 151.6-186.5 
mg/kg/day for females) based on decreased pup weight and delay in eye 
opening in both F1 and F2 litters.
    6. Mutagenicity. A reverse gene mutation assay in bacteria (MRID 
No. 44024952, Guideline No. 84-2), using 98% pymetrozine, exposed 
cultures of Salmonella typhimurium histidine-deficient (his-) mutant 
strains TA98, TA100, TA1535 and TA1537, and the Escherichia coli 
tryptophan-deficient (try-) strain WP2 uvrA in triplicate to five 
concentrations ranging from 312.5 to 5,000 g/plate, in the 
presence or absence of a mammalian metabolic activation system (S9 plus 
cofactors) derived from the microsomal fraction (S9) of livers from 
adult male RAI rats pretreated with Aroclor 1254. In neither the 
initial nor confirmatory trial were any increased incidences of his+ or 
try+ colonies found, compared to solvent control values, in contrast to 
the strongly positive responses in all mutagen-treated cultures. 
Therefore, in this in vitro test, pymetrozine is considered negative 
for reverse gene mutation in these strains of bacteria.
    A mammalian cell forward gene mutation assay in cultures of Chinese 
hamster lung (V79) cells (MRID No. 44024954, Guideline No. 84-2), using 
98% pymetrozine, exposed cultures in duplicate at four concentrations 
ranging from 5.21 to 333.3 g/mL, for 21 hours in the absence 
of a mammalian metabolic activation system or for 5 hours followed by 
16 hours in test article-free tissue culture medium in the presence of 
activation provided by the microsomal fraction (S9) of livers from 
adult male RAI rats pretreated with Aroclor 1254. Cultures were 
negative for the induction of forward gene mutation at the HGPRT locus 
in this test system.
    A mammalian cell cytogenetics (chromosome aberrations) assay in 
Chinese hamster ovary (CHO) cells (MRID No. 44024953, Guideline No. 84-
2), using 98% pymetrozine, exposed cultures at eight concentrations 
ranging from 2.58 to 330 g/mL for 18 hours in the absence of 
mammalian metabolic activation or for 3 hours in the presence of S9 
activation (S9 microsomal fraction of livers from adult male rats 
pretreated with Aroclor 1254, plus co-factors) followed by recovery in 
treatment-free medium for 15 hours. Cultures were not clastogenic; at 
none of the concentrations nor harvest times was the incidence of 
structural chromosome aberrations reported to exceed either the 
concurrent or historical control values.
    A micronucleus test in mice (MRID No. 44024955, Guideline 84-2), 
using 98% pymetrozine, exposed groups of 8 animals/sex orally by gavage 
in two series of trials: (1) Three groups at a single maximum tolerated 
dose (MTD) of 4,000 mg/kg and (2) three groups at single doses of 
1,000, 2,000 and 4,000. No statistically significant increases over 
controls were found in MPCE in any group at any sacrifice time. In 
addition, no effects of treatment were calculated in PCE/NCE ratios at 
any time or dose point. CPA-treated positive control animals responded 
with highly significant increased MPCE.
    An unscheduled DNA synthesis assay in primary rat hepatocyte cells 
(MRID No. 44024956, Guideline No. 84-2), using 98% pymetrozine, exposed 
cultures in two trials in dimethylsulfoxide (DMSO) at six 
concentrations ranging from 2.78 to 300 g/mL for 16-18 hours 
in the presence of tritiated thymidine. In this genotoxicity 
mutagenicity test, there was no evidence that the treatment induced 
unscheduled DNA synthesis, as determined by radioactive tracer 
procedures (nuclear silver grain counts).
    7. Absorption, distribution and metabolism. A metabolism study in 
rats (MRID No. 44024957, Guideline 85-1), using radiolabeled 
pymetrozine, exposed animals orally or intravenously in groups of 5 
animals/sex to evaluate absorption and excretion. Within the first 24 
hours post-dosing, the urine from all orally-dosed groups contained 
from 52.0% to 73.5% of the administered radioactivity. The intravenous 
treated rats also had comparable 24-hour urine levels which were 63.6% 
and 68.3% of the administered dose in males and females, respectively. 
At study termination (7 days post-dosing), the recovered radioactivity 
in urine (56.3-80.3%), expired air (0.2-1.4%), tissues (0.3-3.8%), 
feces (15.4-38.9%), and cage washes (0.2-0.7%) accounted for a total 
recovery of 91-100.7% of the administered dose in all groups. The 
relatively high urinary level of unchanged test material suggests 
metabolic saturation at the high dose of 100 mg/kg.
    A metabolism study in female rats (MRID No. 44517720, OPPTS No. 
870.7485, Guideline No. 85-1), using radiolabled pymetrozine, exposed 
animals orally to a single low dose (0.5 mg/kg) or a high dose (100 mg/
kg). Irrespective of the label site, the time to maximum blood 
concentrations (tmax) were attained at 1 hour (0.1 ppm for both labels) 
and at 8 hours (41 ppm for triazine and 52 ppm for pyridine) following 
low and high oral dosing, respectively. While the peak blood levels 
were dependent on the dose but independent of the labeling site, the 
pyridine label was more persistent than the triazine label. At all time 
points and irrespective of the dose or labeling site, tissue residue 
levels (ppm) were highest in the kidneys and liver. For the low/high 
doses, the peak kidney levels were 0.6/75 ppm (triazine) and 0.6/101 
ppm (pyridine), while the peak liver levels were 0.4/59 ppm (triazine) 
and 0.5/176 ppm (pyridine). Of all tissues (with the exception of the 
GI tract), the skeletal muscle had the highest percent of the 
administered dose (both labels) accounting for 7 to 8% of the low dose 
at 1 hour and for 19 to 21% of the high dose at 8 hours. The calculated 
half life times (t\1/2\) for the triazine residue depletion from all 
the tissues ranged from 2.9 to 4.8 hours (low dose) and from 1.9 to 3.5 
hours (high dose) and for the pyridine radiolabel depletion, from 31.7 
to 110.3 hours (low dose) and from 2.5 to 13.9 hours (high dose).
    Absorption was lower at the high dose representing nearly 82% of 
the administered dose for both radiolabels. Irrespective of the 
labeling site, the biliary excretion was higher at the low dose than at 
the high dose. The total 48-hour excretion, including cage wash, was 
higher at both dose levels for the triazine label (low dose/ high dose: 
103%/95%) than the pyridine label (low dose/high dose: 85%/81%). These 
results confirm other findings (above) that of the two moieties, 
pyridine is more persistent than triazine.
    8. Dermal absorption. A dermal absorption study in male rats (MRID 
No. 44024958, Guideline No. 85-3), using 98.1-99.5% radiolabeled 
pymetrozine, exposed 24 male animals in 0.5% carboxy-methyl cellulose 
aqueous suspension at dose levels of 0.084, 0.503, or 4.69 mg/rat 
(0.0067, 0.0402, or

[[Page 52443]]

0.375 mg/cm2). After blood collection, four rats/dose were 
killed for assessment of dermal absorption after 0.5, 1, 2, 4, 10, and 
24 hours of exposure. Urine and feces were also collected at the time 
of killing. After 24 hours of exposure, dermal absorption of CGA-215944 
was minimal (0.05%, 0.01%, and <0.005% for the low, mid, and high dose 
groups, respectively). For all dose groups, the majority of the dose 
(81.4-100.0%) was not absorbed and was recovered in the skin wash. For 
all dose groups, adsorption to skin from the test site (0.18-8.84%) 
accounted for the next largest proportion of the dose and only trace 
amounts (0.05%) of radioactivity were excreted in the urine 
and feces. Within each dose group, radioactivity remaining in/on the 
skin after washing did not seem to increase with the duration of 
exposure; likewise, absorption (measured as amount excreted plus amount 
retained in the body) did not seem to increase over time.
    9. Special studies. A cell proliferation study in young adult male 
mice (MRID No. 44024923), using 97.4% pymetrozine, exposed 15 groups of 
animals in a basal diet as follows: (i) Two groups at dietary 
concentrations of 0 and 5,000 ppm for 4 days (corresponding to intakes 
of 0 and 891.6 mg/kg/day); (ii) six groups at concentrations of 0, 10, 
100, 500, 2,000 and 5,000 ppm for 14 days (intakes of 0, 1.6, 15.6, 
83.9, 323.4 and 876.7 mg/kg/day); (iii) six groups at concentrations of 
0, 10, 100, 500, 2,000 and 5,000 ppm for 42 days (intakes of 0, 1.6, 
13.3, 70.7, 299.9 and 767.1 mg/kg/day); and (iv) a single group at a 
concentration of 5,000 ppm for 14 days (intake of 1,006 mg/kg/day), 
followed by a recovery period of 28 days, in order to test for 
reversibility of any treatment-related changes. No clinical signs of 
toxicity were observed in any group throughout the treatment and/or 
recovery periods. Absolute and relative liver weights were slightly 
increased at 4-days treatment with 5,000 ppm, but significantly so 
after 14 and 42 days at this high concentration as well as 2,000 ppm, 
indicating hypertrophy. Absolute and relative liver weights returned to 
control levels in the 14-day treatment/28 day recovery animals. 
Significant decreases in the mean number of total nuclei were recorded 
at 2,000 ppm (16% ) and at 5,000 ppm (17-18% ) 
after 14 and 42 days. These findings, in conjunction with evidence that 
the enlarged hepatocytes at 5,000 ppm (14 and 42 days) often contained 
vacuoles, slight focal single cell necrosis and PCNA+ inflammatory cell 
infiltration that occurred at a higher frequency in the livers of mice 
at 5,000 ppm (14 and 42 days) than in the vehicle control liver 
samples, indicate that the test material induced a cytotoxic effect on 
the target organ. Immunohistochemical staining of liver sections 
revealed significant increases in PCNA values in both 2,000 and 5,000 
ppm groups at all time points. Cell proliferation effects were 
reversible in animals treated at 5,000 ppm for 14 days followed by a 
28-day recovery. Thus, these results show that the observed 
hepatomegaly in mouse liver at the 2,000 and 5,000 ppm treatment levels 
was the combined result of hypertrophy and hyperplasia. Accordingly, 
the LOAEL is 2,000 ppm, based on increased liver weight, reduced total 
hepatocytes, microscopic evidence of necrosis and significant increases 
in the LI for cell proliferation; the NOAEL is 500 ppm level. Overall, 
the findings of this study offer support for the hypothesis that the 
increased incidence of hepatocellular carcinomas in a previous 18-month 
carcinogenicity study in mice was due to (reversible) replicative DNA 
synthesis, with a threshold effect at a NOAEL = 500 ppm.
    A special study in male rats (MRID No. 44517723), using 97.8% 
pymetrozine and conducted to evaluate possible mechanisms for liver 
tumor formulation, exposed 6 groups of 16 animals in diets containing 
0, 25, 50, 100 or 1,000 ppm for 18 weeks. Assessments were limited to 
cage side observations for clinical signs, body weight and food plus 
water consumption. Pathology was limited to organ assessment of the 
liver and thyroid for weight and macroscopic and histopathological 
lesions but also included a special assessment for the 
immunohistological evaluation of the glutathione S-transferase 
placental from positive hepatocyte (GST-P) foci, a foci induced by the 
presence of the initiators. Pymetrozine produced its expected increase 
in liver and thyroid weight but did not increase the GST-P foci thus 
was not considered positive for a promotional effect of proliferative 
lesions in the liver. Pymetrozine was associated with an increase (p < 
0.05) in follicular cell adenomas only in the 100 ppm dose group but 
there was no associated increase in thyroid hyperplasia or similar 
effect at 1,000 ppm. Overall, it could not be concluded that 
pymetrozine resulted in promotion of proliferative lesions in either 
the rat liver or thyroid at dose levels up to and including 1,000 ppm.

B. Toxicological Endpoints

    1. Acute dietary toxicity -- i. Females 13 years and older. The 
Agency selected a NOAEL of 10 mg/kg/day from the rabbit developmental 
study (MRID No. 44024949) for the acute dietary endpoint, based on 
reduced body weight gains and reduced food consumption and efficiency 
in mothers and an increased incidence of skeletal anomalies in pups at 
the LOAEL of 75 mg/kg/day. The selection of the rabbit developmental 
toxicity study is comparable to the rat developmental toxicity study, 
which had a maternal NOAEL and LOAEL of 30 and 100 mg/kg/day, 
respectively.
    ii. Acute dietary toxicity (General Population and Infants and 
Children). The Agency selected the LOAEL of 125 mg/kg (lowest dose 
tested) from the acute rat neurotoxicity study (MRID No. 44411317) for 
the acute dietary endpoint for the general population, including 
infants and children, based on decreased body temperature, decreased 
motor activity, and FOB parameters associated with decreased activity.
    2. Short- and intermediate-term toxicity. For dermal exposure, the 
Agency selected a NOAEL of 1,000 mg/kg/day from a 28-day dermal 
toxicity in the rat (MRID No. 44024942) because there were no effects 
at the highest dose tested. Based on these results, the Agency did not 
perform a short- or intermediate-term dermal risk assessments.
    For short-term (1-7 days) inhalation exposure, the Agency selected 
(in the absence of an inhalation study) an oral NOAEL of 10 mg/kg/day 
from a developmental study in the rabbit (MRID No. 44024949), based on 
reduced body weight gains and food consumption and efficiency in 
mothers and an increased incidence of skeletal anomalies in pups at the 
LOAEL of 75 mg/kg/day.
    For intermediate (7 days to several months) inhalation exposure, 
the Agency selected (in the absence of an inhalation study) an oral 
NOAEL of 10 ppm (0.377 mg/kg/day) from a chronic feeding study in the 
rat (MRID No. 44024951), based on hepatocellular (liver) hypertrophy in 
males at an LOAEL of 100 ppm (3.76 mg/kg/day).
    3. Chronic toxicity. For chronic dietary exposure, EPA has selected 
an oral NOAEL of 10 ppm (0.377 mg/kg/day) from a chronic feeding study 
in the rat (MRID No. 44024951), based on hepatocellular (liver) 
hypertrophy in males at an LOAEL of 100 ppm (3.76 mg/kg/day).
    4. Carcinogenicity. EPA has classified pymetrozine as a``likely 
human carcinogen'' and recommended that quantification of risk be 
estimated for combined (benign hepatomas and/or carcinomas) liver 
tumors in male and

[[Page 52444]]

female mice and female rats. EPA selected a unit risk, Q1*, of 2.05 x 
10-1 (mg/kg/day)-1 for quantification of the 
cancer risk and has determined the cancer dose to be 0.0000049 mg/kg/
day. The Agency reviewed ``mechanism of action'' studies, but these 
were insufficient to affect the classification of carcinogenicity.
    5. Dermal penetration. The dermal penetration study (MRID No. 
44024958) in rats indicated that the amount of pymetrozine capable of 
penetrating the skin is very small (no more than 0.28%). However, 
because the EPA concluded that the study may have underestimated the 
actual amount of dermal penetration, the Agency has used a dermal 
penetration value of 1% in risk assessments.
    6. Long-term (several months to life-time) dermal and inhalation 
endpoints. The current use pattern does not indicate a concern for 
long-term dermal or inhalation exposure potential.
    7. Safety (uncertainty) factors, including FQPA safety factor. The 
Agency will use the above NOAELs and LOAELs levels to assess the risks 
of using pymetrozine to the general population and certain subgroups of 
the general population. However, the Agency first modifies these values 
numerically, downward, by dividing the NOAEL dose by one or more safety 
factors. These safety factors may represent the uncertainty of the 
individual variation among animals for all studies (10 fold safety or 
uncertainty factor), of using animal studies to assess human risk for 
all studies (10 fold safety factor); and of using a LOAEL in place of a 
NOAEL to estimate the risk (3 fold safety factor).
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA determines that a 
different margin of safety will be safe for infants and children. As 
noted, EPA has added an additional three-fold factor to the acute 
dietary risk assessment for infants and children due to the lack of a 
NOAEL in the critical study. An additional 3-fold factor is also needed 
due to the uncertainty resulting from the data gap for the 
developmental neurotoxicity study in rats. This latter safety factor is 
applicable to the following subgroup populations: Females 13-50; 
infants, children (1-6 years), and children (7-12 years) for all risk 
assessment scenarios for acute and chronic dietary and residential 
scenarios. No greater additional factor is needed because:
     There was no evidence of developmental effects being 
produced in fetuses at lower doses as compared to maternal animals nor 
was there evidence of an increase in severity of effects at or below 
maternally toxic doses following in utero exposure in the prenatal 
developmental toxicity studies in rats and rabbits.
     In the prenatal/postnatal 2-generation reproduction study 
in rats, there was no evidence of enhanced susceptibility in pups when 
compared to parental animals (i.e., effects noted in offspring occurred 
at maternally toxic doses or higher).
     There was no evidence of abnormalities in the development 
of the fetal nervous system in the prenatal/postnatal studies submitted 
to the Agency.
     Adequate actual data, surrogate data, and/or modeling 
outputs are available to satisfactorily assess food exposure and to 
provide a screening level drinking water exposure assessment.
    i. Acute dietary toxicity (females 13 years and older). The Agency 
divided the NOAEL dose of 10 mg/kg/day from the rabbit developmental 
study (MRID No. 44024949) by 300 (10 for individual variation x 10 for 
species variation x 3 for lack of a developmental neurotoxicity study) 
to calculate an acute population-adjusted dose (aPAD) of 0.033 mg/kg 
for females 13 years or older.
    ii. Acute dietary toxicity (general population and infants and 
children). The Agency divided the LOAEL dose of 125 mg/kg from the 
acute neurotoxicity study (MRID No. 44411317) by 300 (3 for lack of a 
NOAEL x 10 for individual variation x 10 for species variation) to 
calculate an aPAD of 0.42 mg/kg for the general population (300-fold 
FQPA safety factor) and by dividing by an additional 3-fold FQPA safety 
factor for lack of a developmental neurotoxicity study to calculate an 
aPAD of 0.14 mg/kg for infants and children (900-fold safety factor).
    iii.  Chronic toxicity. EPA divided the NOAEL dose of 0.377 mg/kg/
day from a chronic feeding study in the rat (MRID No. 44024951) by 100 
(10 for individual variation x 10 for species variation) to calculate a 
chronic population-adjusted dose (cPAD) of 0.0038 mg/kg/day for the 
general population by dividing by a additional 3-fold FQPA safety 
factor to calculate a cPAD of 0.0013 mg/kg/day for females 13 years and 
older and for infants and children.

C. Exposures and Risks

    1. Proposed uses. Pymetrozine is a new insecticide of the pyridine 
azomethine type. Pymetrozine is proposed for the control of 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.
    Pymetrozine is proposed for use on tuberous and corm vegetables 
(Subgroup 1-C) and tobacco under FulfillTM and ornamental 
plants under RelayTM. Currently, there are no requested 
homeowner applications for pymetrozine. However; post-application 
(residential) exposure could occur due to contact with treated 
ornamental plants. As both FulfillTM and RelayTM, 
pymetrozine is formulated as a water-dispersible granule containing 50% 
active ingredient.
    FulfillTM 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 pound (lb) 
active ingredient per acre (ai/acre). 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 FulfillTM specifies a 
restricted-entry interval of 12 hours.
    RelayTM is to be broadcast-applied to ornamentals at a 
rate not to exceed 10 oz./acre/application. Multiple applications may 
be made on a 7- to 14-day interval. For indoor use, the yearly 
application rate is not to exceed 100 oz./acre/year; for outdoor use, 
the maximum rate is 48 oz./acre/year.
    The above uses result in food and feed, drinking water, and non-
dietary (residential) exposures as outlined below (2-4).
    2. From food and feed uses. This rule establishes the first 
tolerance for pymetrozine.
    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

[[Page 52445]]

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 only tuberous and corm vegetables. This was based on 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. 
Based on the number of existing alternatives, the PCT could be much 
lower. However, the market is looking for rotational alternatives to 
prevent the buildup of resistance and to replace organophosphate (OP) 
insecticides threatened by FQPA. 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 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 Dietary Exposure Evaluation Model (DEEMTM) 
analysis indicates that acute dietary (food only) exposure to 
pymetrozine from all in the original petition (tuberous and corm, 
fruiting, and curcubits) will be below EPA's level of concern (100% of 
the 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 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 DEEMTM chronic 
analysis indicates that exposure to pymetrozine from tuberous and corm 
vegetables (Subgroup 1-C), cucurbits and fruiting vegetables will 
occupy less than 74% of the cPAD for children ages 1-6 (the most highly 
exposed population subgroup). Chronic dietary risk to all other 
subgroups is less than that of children ages 1-6. See Table 1 below.

           Table 1. Chronic Dietary (Food Only) Tier 1 Exposure and Risk Estimates for Pymetrozine Use
----------------------------------------------------------------------------------------------------------------
         Population Subgroup               cPAD, mg/kg/dayb       Exposure, mg/kg/day            % cPADc
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)a.............                   0.0038                 0.000455                       12
Hispanics............................                   0.0038                 0.000496                       13
Children 1-6 yrs.....................                   0.0013                 0.000958                       74
Females 13-19 (not pregnant or                          0.0013                  000.480                       37
 nursing)............................
Males 13-19 yrs......................                   0.0038                 0.000500                       13
 
----------------------------------------------------------------------------------------------------------------
aPopulation subgroups shown include the U.S. general population and the maximally exposed subpopulation of
  adults, infants and children, and women of child-bearing age.
bcPAD values incorporate the different FQPA Safety Factors for the various population subgroups.
c% cPAD = Exposure (mg/kg/day)  cPAD (mg/kg/day) 100.



    iii. Cancer exposure and risk. The Agency used a Tier 3 
DEEMTM analysis for cancer risk estimates to the U.S. 
population. Based on use of pymetrozine on tuberous and corm vegetables 
only, the food only cancer risk is 1.7 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 (<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

[[Page 52446]]

Environmental Estimated Concentrations (EECs) for pymetrozine in ground 
water. SCI-GROW is a regression model based on actual ground water 
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/acre (hops), 
SCI-GROW estimates the concentration of pymetrozine in ground water 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 Estimated Environmental Concentrations (EECs) in 
surface water. The standard PRZM-EXAMS runoff modeling scenario is 
based on a 10 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 m2/m3. 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 2 applications of pymetrozine on sweet potato, 
each at 0.176 lb ai/acre, PRZM- EXAMS estimates acute (peak) EEC of 
pymetrozine in surface water to be 1.85 g/L and estimates the 
chronic (36-year mean) EEC of pymetrozine in surface water to be 0.222 
g/L.
    The EEC's for surface water (1.85 g/L and 0.222 
g/L) are higher than those for ground water (0.015 g/
L). Therefore, surface water EEC's will be used to: (1) Estimate actual 
concentrations of pymetrozine in water and (2) to compare those 
conentrations 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. 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 DWLOC's for acute and chronic exposure.

                                          Table 2. Drinking Water Levels of Comparison for Aggregated Exposures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Population-Adjusted                              Maximum Water Exposure
            Scenario/Population Subgroupa                 Dose, mg/kg/day        Exposure mg/kg/dayb           mg/kg/day           DWLOC g/Lc
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Exposure                                                                                                                                 [EEC=1.9]
U.S. Population.....................................                     0.42                 0.001980                 0.418020                    15000
Hispanic............................................                     0.42                 0.002285                 0.417715                    15000
Children (1-6 yrs)..................................                     0.14                 0.004556                 0.135444                     1400
Females (13-19, not pregnant or nursing)............                    0.033                0.0021 39                 0.030861                      930
Males (13-19 yrs)...................................                     0.42                 0.002052                 0.417948                    15000
Short-termd Exposure
Toddlers............................................                    0.033                  0.00097                 0.032030                      320
Chronic Exposure                                                                                                                              [EEC=0.22]
U.S. Population.....................................                   0.0038                 0.000455                 0.003345                      120
Hispanic............................................                  0.00380                 0.000496                 0.003304                      120
Children (1-6 yrs)..................................                   0.0013                 0.000958                 0.000342                      3.4
Females (13-19, not pregnant or nursing)............                   0.0013                 0.000480                 0.000820                       25
Males (13-19).......................................                   0.0038                 0.000500                 0.003300                      120
--------------------------------------------------------------------------------------------------------------------------------------------------------
aPopulation 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.
bExposure 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.
cDWLOC = 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 1.9 g/L, the chronic and cancer EEC is
  0.22 g/L.
dFor 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 (1.9 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 (0.22 g/L); thus, drinking 
water is not expected to be a significant contributor towards this type 
of exposure.
    iii. Cancer exposure and risk. Preliminary analysis suggested that 
drinking water may be a significant contributor towards cancer risk. 
Therefore, the Agency did an aggregate quantitative risk assessment 
which is discussed in section D3 of this unit.
    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, RelayTM, 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, EPA used its Standard Operating Procedures (SOPs) for 
Residential

[[Page 52447]]

Exposure Assessment (Draft, December 18, 1997) to estimate post-
application exposure. This SOP does not include a scenario for 
ornamentals, landscapes and groundcover. Therefore, this assessment 
used the garden plants scenarios to determine post-application 
exposures.
    The post-application 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), and (3) incidental non-
dietary ingestion of soil from pesticide-treated areas (660,000). The 
following assumptions were used for estimating post-application for the 
three post-application scenarios.
    Hand-to-mouth transfer (incidental non-dietary ingestion)
    -Maximum application rate of 0.3125 lbs ai/A as specified on the 
label
    -20% 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)
    -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


    Accidental Ingestion of Plant Material
    -According to the HED SOP for Residential Exposure, exposure via 
this route is considered negligible


    Accidential Ingestion of Soil
    -Maximum application rate of 0.3125 lbs ai per acre as specified 
on the label
    -20% 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 cm of soil is 1cm
    -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 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 post-
application 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. 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 post-
application 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 expectance = 70 years.
     Cancer Q* (mg/kg/day) = 2.05 x 10-1.

    The cancer risk estimate for this post-application exposure is 2.4 
x 10-7 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 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 post-application 
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.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    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's level of concern for the 
following reasons. As indicated in Table 2, the Tier 1 
DEEMTM analysis indicates that acute dietary (food only) 
exposure to pymetrozine from fruiting vegetables, cucurbits, and 
tuberous and corm

[[Page 52448]]

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 
(15000 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 
DEEMTM analysis indicates that chronic dietary (food only) 
exposure to pymetrozine will utilize less than 12% (0.000455/0.0038) of 
the 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 (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 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 tuberous and corm 
vegetables (Subgroup 1-C), EPA based its cancer risk assessment on a 
Tier 3 estimate of dietary exposure, which incorporates anticipated 
residues for pymetrozine and an estimate that 20% of the crops will be 
treated. At this level of refinement, EPA's estimate of food exposure 
and cancer risk were 0.0000008 mg/kg/day and 1.7 x10-7. 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.
    EPA does not generally use surface water modeling values for 
quantitative risk assessment. However, due to the statistical 
uncertainties regarding the significance of cancer risks, which are 
near 1 x 10-6, EPA has calculated the cancer risk resulting 
from 0.22 g/L in drinking water to be 1.3 x 10-6. 
The aggregate cancer risk is thus 1.7 x 10-6 (1.7 x 
10-7 for food, 1.3 x 10-6, for water, and 2.4 x 
10-7 for post-application residential exposure).
    4. Determination of safety. EPA believes that the total risk 
estimate for pymetrozine from food, drinking water, and residential 
exposures of 1.7 x 10-6 generally represents a negligible 
risk, as EPA has traditionally applied that concept. EPA has commonly 
referred to a negligible risk as one that is in the range of 1 in 1 
million (1 x 10-6). Quantitative cancer risk assessment is 
not a precise science. There are a significant number of uncertainties 
in both the toxicology used to derive the cancer potency of a substance 
and in the data used to measure and calculate exposure. The Agency does 
not attach great significance to numerical estimates for carcinogenic 
risk that differ by less than a factor of 2. However, as a condition of 
product registration, the Agency will require the registrant to submit 
monitoring data. These data are expected to confirm that the actual 
concentration of pymetrozine in drinking water is less than the level 
of concern for all sub-populations and endpoints.

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 (section A. of this unit) 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 prenatal and postnatal toxicity and 
the completeness of the data base 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 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 interspecies and 
intraspecies 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. A discussion of 
these considerations may be found in B7 of this unit.
    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 DEEMTM analysis indicates that 
acute dietary (food only) exposure to pymetrozine from tuberous and 
corm vegetables (Subgroup 1-C), fruiting vegetables and curcubits 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 the 
previous table, the Tier 1 DEEMTM 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 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.
    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  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).

[[Page 52449]]

    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

    The are no established European (CODEX), Canadian, or Mexican 
Maximum Residue Limits (MRLs) 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 label has been revised to include only the following sites: 
Tuberous and corm vegetables (Subgroup 1-C) and tobacco. The label also 
includes a plant back restriction of not less than 120 days for all 
leafy and root crops, and not less than 365 days for all other crops.

F. Pre-harvest Intervals

    The pre-harvest interval for pymetrozine on the tuberous and corm 
vegetables (Subgroup 1-C) is 14 days.

V. Conclusion

    Therefore, the tolerance is established for residues of pymetrozine 
per se in tuberous and corm vegetables (Subgroup 1-C), at 0.02 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. 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-300929 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 November 
29, 1999.
    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, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. 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 by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 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. of 
this preamble, you should also send a copy of your request to the PIRIB 
for its inclusion in the official record that is described in Unit 
I.B.2. of this preamble. Mail your copies, identified by docket number 
OPP-300929, 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

[[Page 52450]]

person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. of this preamble. 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 section 408(d) of the 
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). 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 prior consultation with State, local, and tribal 
government officials as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993) and Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), or special 
consideration of environmental justice related issues 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 require OMB review in accordance with Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 12612, 
entitled Federalism (52 FR 41685, October 30, 1987). This action 
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 the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. 346a(b)(4). 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). In addition, 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.

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 rule in the  Federal Register. This 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: September 23, 1999.

Susan B. Hazen,
Acting Director, 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 added 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.

 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Corm and Tuberous Vegetables      0.02                None
 Subgroup 1-C.
------------------------------------------------------------------------


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

[FR Doc. 99-25313 Filed 9-28-99; 8:45 am]
BILLING CODE 6560-50-F