[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Rules and Regulations]
[Pages 56681-56689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27398]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300917; FRL-6381-3]
RIN 2070-AB78


Pyriproxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
pyriproxyfen in or on citrus fruits, fruiting vegetables (except 
cucurbits), tree nuts, almond hulls, citrus oil and citrus pulp, dried. 
Valent USA Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996.

DATES: This regulation is effective October 21, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300917, 
must be received by EPA on or before December 20, 1999.

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'' section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-300917 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph Tavano, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 305-6411; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

 I. General Information

A. Does this Action Apply to Me?

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

 
------------------------------------------------------------------------
                                                 Examples of Potentially
              Categories                 NAICS      Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------


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

[[Page 56682]]

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-300917. 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.

II. Background and Statutory Findings

    In the Federal Register of October 6, 1998 (63 FR 53656) (FRL-6033-
8), 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 8F5022) for a tolerance by 
Valent USA Corporation, 1333 N. California Blvd., Walnut Creek, CA 
94596. This notice included a summary of the petition prepared by 
Valent USA Corporation, the registrant. There were no comments received 
in response to the notice of filing.
    The petition requested that 40 CFR 180.510 be amended by 
establishing a tolerance for residues of the insecticide, pyriproxyfen, 
in or on almond hulls at 2.0 parts per million (ppm) citrus fruits 
(crop group 10) at 0.3 ppm; fruiting vegetables (crop group 8) at 0.1 
ppm; tree nuts (crop group 14) at 0.02 ppm; and in the processed 
commodities citrus oil at 20 ppm and dried citrus pulp at 1.5. 
Pyriproxyfen is a reduced risk pesticide and controls California red 
scale, black scale brown soft scale, citrus whitefly, citrus leafminer 
and citrus black fly on citrus; immature sweet potato/silverleaf 
whitefly on peppers and tomatoes; codling moth and navel orangeworm on 
walnuts and San Jose scale and peach twig borer on almonds.
    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 pyriproxyfen on almond hulls 
at 2.0 ppm; citrus fruits at 0.3 ppm; fruiting vegetables (except 
cucurbits) at 0.2 ppm; tree nuts at 0.02 ppm; and in the processed 
commodities citrus oil at 20 ppm and dried citrus pulp at 2.0 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 toxic effects caused by pyriproxyfen are 
discussed in this unit.
    1. Acute toxicity. Acute toxicity studies with technical 
pyriproxyfen: Oral LD50 in the rat is >5,000 milligrams/
kilograms (mg/kg) for males and females - Toxicity Category IV; dermal 
LD50 in the rabbit at >2, 000 mg/kg - Toxicity Category IV; 
inhalation LC50 in the rat is >1.3 mg/L (highest dose 
attainable) - Toxicity Category III; primary eye irritation in the 
rabbit (mild irritatant) - Toxicity Category III; primary dermal 
irritation in the rabbit (not an irritant: non-irritating to the skin 
under conditions of test))- Toxicity Category IV. Pyriproxyfen is not a 
sensitizer.
    2. Subchronic toxicity-- i. In the subchronic feeding study in 
rats, the no observed adversed effect level (NOAEL) was 27.68 mg/kg/
day. The lowest oberved adversed effect level (LOAEL) was 141.28 mg/kg/
day, based upon higher mean total cholesteral and phospholipids, 
decreased mean red blood cells (RBCs), hematocrit and hemoglobin counts 
and increased relative liver weight.
    ii. In the subchronic feeding study in dogs, the NOAEL was 100 mg/
kg/day and the LOAEL was 300 mg/kg/day. The effects were based on 
increased absolute and relative liver weight in males and 
hepatocellular hypertrophy in females. These findings were also 
observed at 1,000 mg/kg/day and may represent adaptive changes at both 
300 mg/kg/day and the limit dose of 1,000 mg/kg/day.
    iii. In a 21-day dermal study in rats, the NOAEL for systemic 
effects was >1,000 mg/kg/day (limit dose). The LOAEL for systemic 
effects was not established in this study. No dermal or systemic 
toxicity was observed at any dose tested.
    3. Chronic toxicity/carcinogenicity --i. In a 1-year chronic 
feeding study in dogs, the NOAEL was 100 mg/kg/day. The LOAEL was 300 
mg/kg/day based on decreased weight gain, increased absolute and 
relative liver weight, mild

[[Page 56683]]

anemia, increased cholesterol and triglycerides.
    ii. In the oncogenicity study in mice, the NOAEL and LOAEL for 
systemic toxicity in males are 600 ppm and 3,000 ppm, respectively, 
based on renal lesions in males. The technical grade test material was 
given to male and female CD-1 mice in diet for 18 months at 0, 120, 
600, or 3,000 ppm. No statistically significant increase in tumor 
incidence relative to controls were observed in either sex at any does 
up to 3,000 ppm highest dose tested (HDT).
    iii. In the chronic feeding/oncogenicity study in rats, the NOAEL 
(systemic) was 35.1 mg/kg/day and the LOAEL (systemic) was 182.7 mg/kg/
day. The technical grade test material was administered to male and 
female Sprague-Dawley rats in diet for 24 months at 0, 120, 600, or 
3,000 ppm. A decrease of 16.9% in body weight gain in females at 3,000 
ppm (182.7 mg/kg/day) was basis for the systemic LOAEL.
    4. Developmental toxicity --i. In the developmental study in 
rabbits, the maternal NOAEL/LOAEL for maternal toxicity were 100 and 
300 mg/kg/day based on premature delivery/abortions, soft stools, 
emaciation, decreased activity and bradypnea. The developmental NOAEL 
was determined to be 300 mg/kg/day and developmental LOAEL was 
determined to be undetermined; no dose related anomalies occurred in 
the four remaining litters studied at 1,000 mg/kg/day.
    ii. In the developmental study in rats, a maternal NOAEL/LOAEL were 
determined to be 100 mg/kg/day and 300 mg/kg/day, respectively. These 
findings were based on increased incidences in mortality and clinical 
signs at 1,000 mg/kg/day with decreased in food consumption, body 
weight, and body weight gain together with increases in water 
consumption at 300 and 1,000 mg/kg/day. The developmental NOAEL/LOAEL 
were 100 mg/kg/day and 300 mg/kg/day based on the increase of skeletal 
variations at 300 mg/kg/day and above.
    5. Reproductive toxicity. In a 2-generation reproduction study in 
rats, the systemic NOAEL was 1,000 ppm (87 mg/kg/day). The LOAEL for 
systemic toxicity was 5,000 ppm (453 mg/kg/day). Effects were based on 
decreased body weight, weight gain and food consumption in both sexes 
and both generations, and increased liver weights in both sexes 
associated with liver and kidney histopathology in males. The 
reproductive NOAEL was 5,000 ppm. A reproductive LOAEL was not 
established.
    6. Mutagenicity. Studies on gene mutation and other genotoxic 
effects: In a Gene Mutation Assay (Ames Test)/Reverse Mutation, finding 
were determined as negative for induction of gene mutation measured as 
the reversion to histine protrophy of five S.typhimurium strains and 
E.Coli WP2 uvra at doses from 10 to 5,000 g/plate with and 
without S-9 activation. The highest does was insoluble. A Gene Mutation 
assay in Mammalian Cells was found to be negative for mutagencity in 
CHO (Chinese hamster ovary) V79 cells with and without metabolic 
activation up to cytotoxic doses (300 g/milliliter (mL). In a 
Structural Chromosomal Aberration Assay in vivo, findings proved 
nonclastogenic in CHO cells both with and without S-9 activation up to 
cytotoxic doses (300 g/mL). In other Genotoxicity Assays, an 
increase in unscheduled DNA synthesis was not induced both with and 
without activation in HeLa cells exposed up to insoluble doses ranging 
to 6.4 g/mL (without activation) and 51.2 g/mL (with 
activation).
    7. Metabolism. The results of the metabolism studies are as 
follows: Acceptable rats were orally dosed with 14C-labeled 
pyriproxyfen at 2 or 1,000 mg/kg and at repeated oral doses (14 daily 
doses) of unlabeled pyriproxyfen at 2 mg/kg followed by administration 
of a single oral dose of labeled pyriproxyfen at 2 mg/kg. Most 
radioactivity was excreted in the feces (81-92%) and urine (5-12%) over 
a 7-day collection period. Expired air was not detected. Tissue 
radioactivity levels were very low (less than 0.3%) except for fat. 
Examination of urine, feces, liver, kidney, bile and blood metabolites 
yielded numerous (>20) identified metabolites when compared to 
synthetic standards. The major biotransformation reactions of 
pyriproxyfen include: (i) Oxidation of the 4' - position of the 
terminal phenyl group; (ii) Oxidation at the 5' - position of pyridine; 
(iii) Cleavage of the ether linkage and conjugation of the resultant 
phenols with sulfuric acid.
    8. Neurotoxicity. Neurotoxicity has not been observed in any of the 
acute, subchronic, chronic, developmental or reproductive studies 
performed with pyriproxyfen.

B. Toxicological Endpoints

    1. Acute toxicity. An acute dietary dose and endpoint was not 
identified in the data base. The Agency concludes that there is a 
reasonable certainty of no harm from acute dietary exposure.
    2. Short-term and intermediate-term toxicity. Doses and endpoints 
were not identified for short-term and intermediate-term dermal and 
inhalation exposure. The Agency concludes that there are reasonable 
certainties of no harm from these exposures.
    3. Chronic toxicity. EPA has established the Reference Dose (RfD) 
for pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine at 
0.35 mg/kg/day. This RfD is based on a NOAEL of 35.1 mg/kg/day and an 
uncertainty factor (UF) of 100. The NOAEL was established from the 
combined chronic feeding/oncogenicity study in rats where the the LOAEL 
was 3,000 ppm, based on a 16.9% decrease in body weight gain in females 
when compared to controls.
    The chronic Population Adjusted Dose (cPAD) is a modification of 
the chronic RfD to accommodate the FQPA Safety Factor. The cPAD is 
equal to the chronic RfD divided by the FQPA Safety Factor. The FQPA 
Safety Factor was reduced from 10x to 1x for the reasons explained 
below. Therefore, the cPAD is identical to the chronic RfD. Reducing 
10x factor to 1x is supported by the following factors.
    i. Developmental studies showed no increased sensitivity in fetuses 
as compared to maternal animals following in utero exposures in rats 
and rabbits.
    ii. A 2-generation reproduction toxicity study in rats showed no 
increased sensitivity in pups as compared to adults.
    iii. The toxicology data base is complete and there are no data 
gaps.
    4. Carcinogenicity. Pyriproxyfen is classified as Category E: not 
carcinogenic in two acceptable animal studies.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.510) for the residues of pyriproxyfen, in or on a variety of 
raw agricultural commodities. In today's action, tolerances will be 
established for the residues of pyriproxyfen in or on the raw 
agriculural commodities almond hulls at 2.0 ppm citrus fruits at 0.3 
ppm; fruiting vegetables (except cucurbits) at 0.2 ppm; tree nuts at 
0.02 ppm; and in the processed commodities citrus oil at 20 ppm and 
dried citrus pulp at 2.0 ppm. Risk assessments were conducted by EPA to 
assess dietary exposures as follows:
    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. No acute dietary endpoint and dose was 
identified in the toxicology data base for

[[Page 56684]]

pyriproxyfen; therefore, the Agency concludes that there is a 
reasonable certainty of no harm from acute dietary exposure.
    ii. Chronic exposure and risk. The Dietary Exposure Evaluation 
Model (DEEM) analysis for pyriproxyfen was performed in order to 
provide an estimate of the dietary exposure and associated risk 
resulting from the existing tolerances and the recommended tolerance 
levels for citrus fruits, fruiting vegetables (except cucurbits), and 
tree nuts. The DEEM analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1989-92 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity.
    This chronic dietary exposure analysis from food sources was 
conducted using the chronic population adjusted dose (cPAD) of 0.35 mg/
kg/day.
    In conducting this chronic dietary risk assessment, EPA has made 
very conservative assumptions: 100% of all crops having pyriproxyfen 
tolerances will contain pyriproxyfen residues and those residues will 
be at the level of the established (or recommended) tolerance. 
Moreover, rather than making use of experimentally-determined 
processing factors, only DEEM default processing factors were used. 
This results in an overestimate of human dietary exposure. Thus, in 
making a safety determination for this tolerance, EPA is taking into 
account this conservative exposure assessment.
    DEEM analysis including all the appropriate pyriproxyfen tolerances 
results in Total Exposures that are equivalent to the following 
percentages of the cPAD:

 
------------------------------------------------------------------------
                                                            Total
                                                          Exposure    %
                        Subgroups                          (mg/kg/  cPAD
                                                            day)
------------------------------------------------------------------------
U.S. Population (48 contiguous states)..................  0.001411   0.4
Children (1-6 years)....................................  0.003876   1.1
Non-hispanic other than black or white..................  0.001852   0.5
Hispanics...............................................  0.001592   0.5
Females (13+/nursing)...................................  0.001660   0.5
------------------------------------------------------------------------


    The subgroups listed above are: (1) The U.S. population (48 
contiguous states); (2) those for infants and children; and (3) the 
other subgroups for which the percentage of the cPAD occupied is 
greater than that occupied by the subgroup U.S. population (48 
contiguous states).

    2. From drinking water --i. Acute exposure and risk. Because no 
acute dietary endpoint was determined, the Agency concludes that there 
is a reasonable certainty of no harm from acute exposure from drinking 
water.
    ii. Chronic exposure and risk. Following EPA's Interim Guidance for 
Conducting Drinking Water Exposure and Risk Assessments issued on 
October 15, 1998, the PRZM/EXAMS model and the SCI-GROW model were run 
to produce estimates of pyriproxyfen concentrations in surface and 
ground water, respectively. The primary use of these models is to 
provide a coarse screen for sorting out pesticides for which EPA has a 
high degree of confidence that the true levels of the pesticide in 
drinking water will be less than the human health drinking water levels 
of comparison (DWLOCs). A human health DWLOC is the concentration of a 
pesticide in drinking water which would result in unacceptable 
aggregate risk, after having already factored in all food exposures and 
other non-occupational exposures for which EPA has reliable data.
    DWLOCchronic = chronic water exposure (mg/kg/day) x 
(body weight) / consumption (L) x 10-3 mg/g where 
chronic water exposure (mg/kg/day) = [cPAD - (chronic food + 
residential exposure) (mg/kg/day)]

    The DWLOCchronic is the concentration in drinking water 
as part of the aggregate chronic exposure that results in a negligible 
cancer risk. The Agency's default body weights and consumption values 
used to calculate DWLOCs are as follows: 70 kg/2L (adult male), 60 kg/
2L (adult female), and 10 kg/1L (child).
    The results are summarized in the following table:

                      DWLOC Values Calculated for Pyriproxyfen Based on a Chronic Scenario
----------------------------------------------------------------------------------------------------------------
                                                                                 Chronic Scenario\1\
                                                                    --------------------------------------------
                                                                                                        PRZM-
                        Population Subgroup                          cPAD     DWLOC       SCI-GROW     EXAMS\2\
                                                                      mg/  g/     EEC in       EEC in
                                                                      kg/       L       g/  g/
                                                                      day                    L            L
----------------------------------------------------------------------------------------------------------------
U.S. Population....................................................  0.35      12,000      0.006         0.11
Children (1-6 yrs).................................................  0.35       3,500      0.006         0.11
----------------------------------------------------------------------------------------------------------------
\1\ DEEM TMRCs in mg/kg/day: U.S. Population = 0.001411, Children (1-6 years) = 0.003876. The average potential
  dose rate from residential use of pet collars is 0.00058 and 0.000081 mg/kg/day for children and U.S.
  population, respectively (see Table 4.1).
\2\ Using the 1-year average EEC for pyriproxyfen in surface water calculated using the citrus fruit application
  rate.


    For chronic (non-cancer) exposure to pyriproxyfen in surface and 
ground water, the drinking water levels of concern are 12,000 
g/L for U.S. Population and 3,500 g/L for children 
(1-6 years). Estimated average concentrations of pyriproxyfen in 
surface and ground water are 0.11 parts per billion (ppb) and 0.006 
ppb, respectively. The estimated average concentrations of pyriproxyfen 
in surface and ground water are less than EPA's level of concern for 
pyriproxyfen in drinking water as a contribution to chronic aggregate 
exposure. Therefore, taking into account present uses and uses proposed 
in this action, EPA concludes with reasonable certainty that residues 
of pyriproxyfen in drinking water (when considered along with other 
sources of exposure for which EPA has reliable data) would not result 
in unacceptable levels of aggregate human health risk at this time.
    3. From non-dietary exposure. Pyriproxyfen is currently registered 
for use on residential non-food sites. Pyriproxyfen is the active 
ingredient in many registered residential (indoor, non-food) products 
for flea and tick control. Formulations include foggers, aerosol 
sprays, emulsifiable concentrates, and impregnated materials (pet 
collars).
    i. Acute exposure and risk. Because no acute toxicological endpoint 
was determined, the Agency concludes that there is a reasonable 
certainty of no harm from acute exposure.
    ii. Chronic exposure and risk. Chronic residential post-application 
exposure and risk assessments were conducted to estimate the potential 
risks from pet collar uses.

[[Page 56685]]

    The risk assessment was conducted using the following assumptions: 
application rate of 0.58 mg ai/day (product label), average body weight 
for a 1 - 6 year old child of 10 kg, the active ingredient dissipates 
uniformly through 365 days (the label instruct to change collar once a 
year), 1% of the active ingredient is available for dermal and 
inhalation exposure per day (assumption from Draft EPA Standard 
Operating Procedures (SOPs) for Residential Exposure Assessments, 
December 18, 1998). The assessment also assumes an absorption rate of 
100%. This is a conservative assumption since the dermal absorption was 
estimated to be 10%.


 Residential Exposure and Risk Assessment Exposure & Risk Assessment for
                      Homeowner Use of Pet Collars
------------------------------------------------------------------------
                                                     Average
                                                    Potential
                                       Application     Dose     Chronic
         Population Subgroup           Rate\1\ mg/   Rate\2\      Term
                                           day       (mg/kg/     MOE\3\
                                                       day)
------------------------------------------------------------------------
Children.............................      0.58      0.00058      61,000
Adults...............................      0.58      0.000081   430,000
------------------------------------------------------------------------
\1\ Product label: Reg. No. 2382-149 (0.5% pyriproxyfen, ovisterilant
  pet collar). Application rate = 42 gm collar x 0.5% a.i./collar x
  1,000 mg/1 gm x 1/365 days. Collar to be replaced once a year.
\2\ Potential Dose Rate (PDR) = Application rate x fraction of ai
  available for exposure (1%) x absorption rate (100%) x 1/(10 or 71.8
  kg bw for children or adults, respectively).
\3\ Dermal and Inhalation NOAEL = 35.1 mg/kg/day; MOE = NOAEL/Exposure;
  Adequate MOE = 100.


    The estimated chronic term MOE was 61,000 for children, and 430,000 
for adults. The risk estimates indicate that potential risks from pet 
collar uses do not exceed the Agency's level of concern.
    iii. Short- and intermediate-term exposure and risk. Toxicological 
endpoints of concern were not identified for short- and intermediate-
term exposures.The Agency concludes that there is a reasonable 
certainty of no harm from short and intermediate exposure.
    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.''
    EPA does not have, at this time, available data to determine 
whether pyriproxyfen has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
pyriproxyfen 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 pyriproxyfen 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. An acute dietary dose and endpoint was not 
identified. Thus the risk from acute aggregate exposure is considered 
to be negligible.
    2. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has calculated that the maximum percentage of the 
cPAD that will be utilized by dietary (food) exposure to residues of 
pyriproxyfen is 1.1% for children (1 - 6 years). Chronic residential 
exposure to pyriproxyfen from pet collars is estimated to increase 
total pyriproxyfen exposure of infants and children only marginally. 
Despite the potential for dietary exposure to pyriproxyfen in drinking 
water, EPA does not expect the aggregate dietary exposure to exceed 
100% of the cPAD.
    EPA bases this determination on a comparison of estimated 
concentrations of pyriproxyfen in surface and ground water to levels of 
concern for pyriproxyfen in drinking water. The estimates of 
pyriproxyfen in surface and ground water are derived from water quality 
models that use conservative assumptions regarding the pesticide 
transport from the point of application to surface and ground water. 
Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with the pesticide's uses, levels of 
concern in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impact of 
pyriproxyfen in food and drinking water as part of the aggregate 
chronic risk assessment process.
    Taking into account the completeness and reliability of the 
toxicity data and this conservative exposure assessment, EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from chronic aggregate exposure to pyriproxyfen 
residues.
    3. Short- and intermediate-term risk. Due to the lack of 
significant toxicological effects observed, the risk from short and 
intermediate exposure is considered to be negligible.
    Short- and intermediate-term aggregate exposure takes into account 
chronic dietary food and water (considered to be a background exposure 
level) plus indoor and outdoor residential exposure.
    4. Aggregate cancer risk for U.S. population. Pyriproxyfen is 
classified as Category E: not carcinogenic in two acceptable animal 
studies.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to 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 pyriproxyfen, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    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 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 
interspecies and intraspecies variability) and not the additional 
tenfold MOE/uncertainty factor 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

[[Page 56686]]

raise concerns regarding the adequacy of the standard MOE/safety 
factor.
    ii. Developmental toxicity studies. In the rat developmental study, 
the developmental NOAEL was 100 mg/kg/day and the maternal NOAEL was 
100 mg/kg/day. Therefore, there was no prenatal developmental toxicity 
in the presence of maternal toxicity. Similarly in rabbits, the 
prenatal developmental NOAEL was 300 mg/kg/day and the maternal NOAEL 
was 300 mg/kg/day. Therefore, prenatally exposed fetuses were not more 
sensitive to the effects of pyriproxyfen than maternal animals.
    iii. Reproductive toxicity study. In the rat reproduction study, 
the parental NOAEL of 1,000 ppm was identical to the pup NOAEL of 1,000 
ppm (and decreased body weight was seen in both pup and parental 
animals). This finding demonstrates that there are no extra 
sensitivities with respect to prenatal and postnatal toxicity between 
adult and infant animals.
    iv. Prenatal and postnatal sensitivity. The oral perinatal and 
prenatal data demonstrated no indication of increased sensitivity of 
rats or rabbits to in utero and postnatal exposure to pyriproxyfen.
    v. Conclusion. The 10x factor for infants and children (as required 
by FQPA) was reduced to 1x, since there was no special sensitivity for 
infants and children and the data base are complete. For chronic 
dietary risk assessment, a UF of 100 is adequate for protection from 
exposure to pyriproxyfen.
    2. Acute risk. An acute dietary dose and endpoint was not 
identified. Thus the risk from acute aggregate exposure is considered 
to be negligible.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to pyriproxyfen from 
food will utilize 1.1% of the cPAD for infants and children. 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. Despite the potential for exposure to pyriproxyfen in drinking 
water and from non-dietary, non-occupational exposure, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD.
    4. Short- or intermediate-term risk. Short-term and intermediate-
term dermal and inhalation risks are judged to be negligible due to the 
lack of significant toxicological effects observed.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants is understood. Acceptable 
metabolism studies using 14C-labeled pyriproxyfen (phenyl 
and pyridyl rings) have been performed in/on apples, cotton and 
tomatoes. Metabolism of pyriproxyfen in apples proceeds through 
hydroxylation and cleavage of the phenoxy ether linkage. Primary 
metabolites formed are further metabolized to more polar products by 
oxidation or conjugation reactions. Similar metabolic pathways were 
observed for the metabolism of pyriproxyfen in cotton and tomatoes.
    Accordingly, EPA has determined that there are no pyriproxyfen 
metabolites of toxicological or regulatory concern in plants. Thus, 
tolerances based on the parent only are appropriate.
    1. Poultry. There are no poultry feed items associated with citrus, 
fruiting vegetables, or tree nuts. Therefore, no secondary residues are 
expected to occur in poultry eggs, fat, meat, and meat byproducts as a 
result of the proposed uses on citrus, fruiting vegetables, and tree 
nuts.
    2. Ruminants. Valent submitted data from studies investigating the 
metabolism of (Ph-14C uniformly ring labeled) and (Py-
14C in pyridine ring 2 and 6 positions) pyriproxyfen in 
lactating goats. Two goats were fed 10 ppm of Ph-14C 
pyriproxyfen daily for 5 days, while two other goats were fed 10 ppm of 
Py-14C pyriproxyfen daily for 5 days, with 1 control goat. 
Urine, feces and milk samples were obtained twice daily. After 
sacrifice at 6 hours after last dose, samples of blood, heart, kidneys, 
liver, loin muscle, rear leg muscle, omental and perirenal fat, 
gastrointestinal tract and contents were collected for 14C 
analysis.
    The majority (62-76%) of the 14C-pyriproxyfen ingested 
by goats was excreted in urine and feces, with residue levels in feces 
being higher than in urine. Approximately 25 to 32% of the administered 
14C-pyriproxyfen was found in goat tissues, with the large 
majority located in the gastrointestinal tract. These studies show that 
metabolism of phenyl-14C pyriproxyfen in goats proceeds 
through hydroxylation of the phenoxyphenyl and pyridyl rings, sulfation 
of the 4'- OH phenoxyphenyl moiety, and cleavage of the ether linkage. 
Metabolism of pyridyl-14C pyriproxyfen in goats proceeds 
through hydroxylation of the phenoxyphenyl and pyridyl rings, sulfation 
of the 4'-OH phenoxyphenyl moiety, cleavage of the ether linkage and 
oxidation of the side chain. EPA concludes that the nature of the 
residue in ruminants is adequately understood.
    EPA determined that the residues of concern in animals are 
pyriproxyfen and the free and sulfate forms of 4'-OH-PYR.

B. Analytical Enforcement Methodology

    Residue analytical method RM-33P-2 (cotton) underwent validation in 
EPA laboratories and is suitable to gather residue data and to enforce 
tolerances.
    For data collection and tolerance enforcement in fruits, Valent has 
proposed use of Method RM-33P-1-3, ``Determination of Pyriproxyfen and 
4'-OH-Pyriproxyfen Residues in Apples, Pear, and Citrus Fruit.'' This 
method was successfully validated by an independent laboratory on the 
first try. The mean percent pyriproxyfen recoveries were 79.4 
 1.6% and 84.9  4.7% on apples and oranges, 
respectively. This method differs significantly from the method used to 
analyze cotton seed. Accordingly, method RM-33P-1-3 underwent 
validation in EPA laboratories and is suitable to gather residue data 
and to enforce tolerances. As described previously, this method also 
underwent successful radiovalidation using apple pomace samples. Thus, 
Valent has adequately demonstrated the extraction efficiency of this 
analytical method.
    For data collection and tolerance enforcement in nutmeats, Valent 
has proposed use of Method RM-33N-2. This method is largely similar to 
Method RM-33P-1-3; thus, no independent laboratory validation was 
conducted for this method. However, method RM-33N-2 underwent 
validation in EPA laboratories and is suitable to gather residue data 
and to enforce tolerances. Method RM-33H was also validated in EPA 
laboratories and found suitable to gather residue data and enforce 
tolerances in almond hulls.
    For data collection and tolerance enforcement in fruiting 
vegetables, Valent has proposed use of Method RM-33P-9. This method is 
largely similar to Method RM-33P-1-3; thus, no independent laboratory 
validation was conducted for this method. However, method RM-33P-9 
underwent validation in EPA laboratories and is suitable to gather 
residue data and to enforce tolerances.
    Valent submitted data from a study performed by Corning Hazleton 
Inc. describing the testing of pyriproxyfen through the Food and Drug 
Administration (FDA) Multiresidue

[[Page 56687]]

Methods Protocols A, C, D, E, and F found in the Pesticide Analytical 
Manual Volume I (PAM I), Appendix II. This study showed that 
pyriproxyfen was recovered from fortified apple and cotton samples 
through protocols A, C, D, E, and F. The metabolite PYPAC was tested 
with protocols A, B, C, and D. The multiresidue methods will serve as 
confirmatory methods for residues of pyriproxyfen. The multiresidue 
recovery data were sent to the FDA for inclusion in PAM I.
    These methods 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 submitted field trial data on citrus fruits are adequate. 
Geographic representation of field trials on grapefruit, lemons, and 
oranges conformed to OPPTS Series 860 guidelines and an adequate number 
of samples were analyzed. Residues of pyriproxyfen were <0.01-0.24 ppm 
in/on 52 samples of oranges, lemons, and grapefruits treated at 1x. The 
available data support the proposed tolerance of 0.3 ppm for residues 
of pyriproxyfen in/on citrus fruit.
    The submitted field trial data on fruiting vegetables are adequate. 
Geographic representation of field trials on peppers and tomatoes 
conformed to OPPTS Series 860 guidelines and an adequate number of 
samples was analyzed. An adequate variety of commercially important 
peppers and tomatoes were included in the study. Residues of 
pyriproxyfen were <0.01-0.06 ppm in/on 46 samples of tomato and peppers 
treated at 1x; one sample bore pyriproxyfen residues at 0.105 ppm. The 
available data support a tolerance level of 0.20 ppm for residues of 
pyriproxyfen in/on fruiting vegetables.
    Valent provided data from a total of 10 field trials in support of 
the tree nut group tolerance, 6 on almonds submitted with this 
petition, and 4 on walnuts that were previously reviewed. Valent 
requested that these data be used in lieu of the required 5 almond and 
5 pecan field trials required for a tree nut group tolerance.
    Due to the low toxicity of pyriproxyfen (no acute dietary, cancer, 
or short- or intermediate-term dermal or inhalation endpoints were 
identified), relatively high chronic RfD (0.35 mg/kg/day), removal of 
the FQPA safety factor, its low use rates, and the rapid incorporation 
of pyriproxyfen metabolites into the general carbon pool after 
metabolism, EPA is willing to agree to this modified data set for 
pyriproxyfen only. The Agency emphasizes that the general non-systemic 
nature of pyriproxyfen combined with the specific almond and walnut 
data showing that pyriproxyfen residues do not readily translocate from 
the nut shell into the nutmeat provide some confidence that finite 
pyriproxyfen residues should not be found in pecan nutmeat since almond 
shells are generally considered more porous than pecan shells.
    The available data support the proposed tolerance of 2.0 ppm for 
residues of pyriproxyfen in/on almond hulls, and the proposed tolerance 
of 0.02 ppm for residues of pyriproxyfen in the tree nut crop group.
    In conjunction with the residue study on oranges, Valent submitted 
data depicting residues of pyriproxyfen and 4'-OH-PYR in orange 
commodities processed from oranges bearing measurable residues.
    The submitted orange processing study is adequate and indicates 
that residues of pyriproxyfen do not concentrate in juice, but 
concentrate by 74.6x in citrus oil and 6.4x in dried pulp. Based upon 
these concentration factors and the HAFT residues in/on oranges of 0.22 
ppm, the proposed tolerances for pyriproxyfen residues in citrus oil 
and in dried pulp were 20.0 and 1.5 ppm, respectively. The citrus oil 
tolerance is appropriate; however, adverse effects disclosure (FIFRA 
section 6(a)(2)) data from California indicates that a citrus dried 
pulp tolerance of 2.0 ppm is needed.
    Valent submitted data depicting the potential for concentration of 
pyriproxyfen residues in the processed commodities of tomatoes. This 
tomato processing study is adequate. Pyriproxyfen residues were 0.04 
ppm in whole tomatoes, 0.02 ppm in paste, and <0.01 ppm in puree. As 
there was no concentration, separate tolerances for tomato paste and 
puree are not required.
    There are no processed commodities associated with tree nuts and 
therefore no tolerances for processed commodities are required.
    An adequate cattle feeding study has been previously reviewed and 
EPA concluded that tolerances would not be required for residues of 
pyriproxyfen in animal commodities provided that no additional uses on 
livestock feed items are proposed. The maximum theoretical dietary 
burden (MTDB) for beef and dairy cattle was calculated at 1.69 and 1.29 
ppm, respectively, using estimated tolerances for almond hulls (2.0 
ppm), apple wet pomace (0.8 ppm), dried citrus pulp (1.0 ppm), 
cottonseed (0.05 ppm) and cotton gin byproducts (2.0 ppm).
    Based on the data submitted with the current petition, the 
calculated MTDB (Table 3.2) for beef and dairy cattle has increased 
slightly to 1.91 and 1.51 ppm, respectively, based on a more 
appropriate tolerance of 2.0 ppm for pyriproxyfen residues in dried 
citrus pulp. This adjustment does not significantly affect the maximum 
expected dietary burden of pyriproxyfen residues for livestock.
    There are no poultry feed items associated with this petition. 
Therefore, no additional secondary residues are expected to occur in 
poultry eggs, fat, meat, and meat byproducts as a result of the 
proposed uses. In conjunction with the petition for use on cotton, EPA 
concluded that secondary residues in poultry and eggs are unlikely in 
light of the poultry metabolism study results.

                         Maximum Theoretical Dietary Burdens for Beef and Dairy Cattle.
----------------------------------------------------------------------------------------------------------------
                                                                                     Beef Cattle    Dairy Cattle
                                                              Tolerance    % Dry   -----------------------------
                          Feed Item                             (ppm)    Matter\1\  % of  Burden,  % of  Burden,
                                                                                    Diet    ppm    Diet    ppm
----------------------------------------------------------------------------------------------------------------
Apple pomace, wet...........................................    0.8\2\       40       40    0.80     20    0.40
Cotton gin byproducts.......................................    2.0\3\       90       20    0.44     20    0.44
Citrus, pulp................................................    2.0          91       20    0.44     20    0.44
Almond hulls................................................    2.0          90       10    0.22     10    0.22
 

[[Page 56688]]

 
Cotton seed.................................................    0.05\3\      88       10    0.01     25    0.01
                                                                                   -----------------------------
    TOTAL...................................................                         100    1.91     95    1.51
----------------------------------------------------------------------------------------------------------------
\1\From Residue Chemistry Test Guidelines (OPPTS 860.1000, Table 1).
\2\Based on apple residue data.
\3\Based on cotton residue data.


    Typically, tolerances are required on all animal commodities having 
detectable residue levels at a 10x dosing rate or below. For the 
computed MTDB of 1.69 ppm in beef cattle, this would include the 3 and 
9 ppm dosing levels. The only commodity having detectable pyriproxyfen 
residues at these levels was fat: 0.01 - 0.03 ppm. Since the MTDB 
calculation is based on a nutritionally unbalanced diet and includes 
contributions from some animal feed items that are used only 
regionally, EPA will not require the establishment of pyriproxyfen 
tolerances in fat at this time. However, should future new uses include 
additional animal feed items, tolerances on animal commodities will be 
needed.

D. International Residue Limits

     There are no CODEX, Canadian, or Mexican tolerances for 
pyriproxyfen residues in/on citrus fruits, fruiting vegetables, or the 
tree nut crop groups. Therefore, international harmonization is not an 
issue at this time.

E. Rotational Crop Restrictions

    The Agency has determined that rotational crop studies are not 
required for uses of pesticides on the citrus fruits or tree nut crop 
groups. An adequate confined rotational crop study was conducted in 
support of the cotton tolerance previously issued. Based on a 30-day 
plantback interval and a treatment rate of 0.18 lb ai/A, no 
pyriproxyfen residues above 0.01 ppm were found in any of the following 
crop matrices: lettuce leaf; radish tops and roots; and wheat grain, 
forage, straw and chaff. Accordingly, EPA concludes that a 30-day 
plantback interval is needed for fruiting vegetables when treated with 
pyriproxyfen as directed.

V. Conclusion

    Therefore, tolerances are established for residues of pyriproxyfen 
in citrus fruits, fruiting vegetables (except cucurbits), tree nuts, 
almond hulls, citrus oil and dried citrus pulp at 0.30, 0.20, 0.02, 
2.0, 20, and 2.0 ppm respectively.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the 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-300917 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 December 
20, 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

[[Page 56689]]

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-300917, 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 PIRIB described in Unit I.B.2. of this preamble. You 
may also send an electronic copy of your request via e-mail to: opp-
[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 5.1/6.1 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 tolerances 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 tolerances 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.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. In Sec. 180.510, by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec. 180.510  Pyriproxyfen; tolerances for residues.

    (a) General.   *    *    *

 
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Almond hulls..............................  2.0
 
                          *    *    *    *    *
Citrus fruits.............................  0.3
Citrus oil................................  20
Citrus pulp, dried........................  2.0
 
                          *    *    *    *    *
Fruiting vegetables (except cucurbits)....  0.2
 
                          *    *    *    *    *
Tree nuts.................................  0.02
 
                          *    *    *    *    *
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-27398 Filed 10-20-99; 8:45 am]
BILLING CODE 6560-50-F