[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.
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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: tavano.joseph@epa.gov.
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
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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:
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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: furlow.calvin@epa.gov.
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="">tompkins.jim@epa.gov,
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: docket@epa.gov. 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
