Pyriproxyfen; Pesticide Tolerance, 55733-55740 [05-19059]
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
V. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
Agency promulgating the rule must
submit a rule report, which includes a
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copy of the rule, to each House of the
Congress and 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 the rule in
the Federal Register. This rule is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
55733
[FR Doc. 05–19056 Filed 9–22–05; 8:45 am]
legume, group 6; onion, dry bulb; grape;
strawberry; sapote, white; and citrus
hybrids. Interregional Research Project
Number 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
DATES: This regulation is effective
September 23, 2005. Objections and
requests for hearings must be received
on or before November 22, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under docket
identification (ID) number OPP–2005–
0246. All documents in the docket are
listed in the EDOCKET index at https://
www.epa.gov/edocket. Although listed
in the index, some information is not
publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Shaja R. Brothers, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
703–308–3194; e-mail address:
brothers.shaja@epa.gov.
BILLING 6560–50–S
SUPPLEMENTARY INFORMATION:
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 19, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
§ 180.910
[Amended]
2. Section 180.910 is amended by
removing, in the table, the following
entries: Casein; fish meal; soy protein,
isolated; and wheat, including flour,
bran, and starch.
I
§ 180.920
[Amended]
3. Section 180.920 is amended by
removing, in the table, the following
entry: Sodium caseinate.
I
§ 180.930
[Amended]
4. Section 180.930 is amended by
removing, in the table, the following
entries: Rhodamine B; soy protein,
isolated; and wheat shorts.
I
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0246; FRL–7737–8]
Pyriproxyfen; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of pyriproxyfen
in or on grass, forage, fodder, and hay,
group 17, forage; grass, forage, fodder,
and hay, group 17, hay; vegetable,
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A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
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greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET (https://
www.epa.gov/edocket/), you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines athttps://www.epa.gpo/
opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of August 17,
2005 (70 FR 48413) (FRL–7732–1, EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP 3E6596, 3E6750,
4E6866, 4E6865, and 3E6582) by IR-4,
681 US Highway #1 South, North
Brunswick, NJ 08902–3390. The
petitions requested that 40 CFR 180.510
be amended by establishing tolerances
for residues of the insecticide
pyriproxyfen, [2-[1-methyl-2-(4phenoxyphenoxy)ethoxy]pyridine, in or
on legume vegetables, crop subgroups
6a, 6b, and 6c at 0.2 part per million
(ppm) (PP 3E6596); onion, dry bulb at
0.05 ppm (PP 3E6750); grape at 2.5 ppm,
and raisin at 4.0 ppm (PP 4E6866);
strawberry at 0.3 ppm (PP 4E6865);
white sapote, and ugli fruit at 0.3 ppm
(PP 3E6582). The petition for onion, dry
bulb (PP 3E6750) was subsequently
amended from 0.05 ppm to 0.15 ppm.
The Agency has also determined a
separate tolerance for raisin is not
necessary. In addition, ugli fruit has
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been translated to citrus hybrids. No
comments were recived on the notice of
filing.
Additionally, in the Federal Register
of December 22, 2004 (69 FR 76724)
(FRL–7689–6), EPA issued a notice
pursuant to section 408(d)(3) of FFDCA,
21 U.S.C. 346a(d)(3), announcing the
filing of a pesticide petition (PP 4F6847)
by Valent USA Corporation, 1600
Riviera Ave., Suite 200, Walnut Creek,
California 94596–8025. The petition
requested that 40 CFR 180.510 be
amended by establishing tolerances for
residues of the insecticide pyriproxyfen,
[2-[1-methyl-2-(4phenoxyphenoxy)ethoxy]pyridine], in
or on grass forage and hay (crop group
17). The Agency has subsequently
amended the petition to establish
tolerances for grass, forage, fodder, and
hay, group 17, forage at 0.70 ppm
(previously requested at 0.5 ppm), and
grass, forage, fodder, and hay, group 17,
hay at 1.1 ppm (previously requested at
1.0 ppm). That notice included a
summary of the petitions prepared by
Valent USA Corporation], the registrant.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of FFDCA
and a complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/health/
human.htm
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III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of these
actions. EPA has sufficient data to
assess the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for tolerances for residues of
pyriproxyfen on vegetable, legume,
group 6 at 0.20 ppm; onion, dry bulb at
0.15 ppm; grape at 2.5 ppm; strawberry
at 0.30 ppm; white sapote at 0.30 ppm;
citrus hybrids at 0.30 ppm; grass, forage,
fodder, and hay, group 17, forage at 0.70
ppm; and grass, forage, fodder, and hay,
group 17, hay at 1.1 ppm. EPA’s
assessment of exposures and risks
associated with establishing these
tolerances follow.
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. Specific
information on the studies received and
the nature of the toxic effects caused by
pyriproxyfen as well as the no observed
adverse effect level (NOAEL) and the
lowest observed adverse effect level
(LOAEL) from the toxicity studies can
be found at https://www.epa.gov/
fedrgstr/EPA-PEST/2003/May/Day-14/
p12022.htm.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which NOAEL from the
toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the LOAEL
of concern identified is sometimes used
for risk assessment if no NOAEL was
achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
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cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases.
A summary of the toxicological
endpoints for pyriproxyfen used for
55735
human risk assessment is shown in the
following Table 1:
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PYRIPROXYFEN FOR USE IN HUMAN RISK
ASSESSMENT
Dose Used in Risk Assessment,
Interspecies and Intraspecies
and any Traditional UF
Special FQPA SF and Level of
Concern for Risk Assessment
Acute dietary (females 13–
50 years of age) and
general population
None
None
An appropriate endpoint attributable to a
single oral dose was not available in the
data base, including maternal toxicity in
the developmental toxicity studies
Chronic dietary (all populations)
NOAEL = 35.1 mg/kg/day
UF = 100
Chronic Reference Dose (cRfD)
= 0.35 mg/kg/day
Special FQPA SF = 1X
Chronic Population Adjusted
Dose (cPAD) = cRfD
Special FQPA SF = 0.35 mg/
kg/day
Subchronic toxicity and chronic toxicity
(feeding) - rat
LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results
Short-term incidental, oral
(1 to 30 days) (Residential)
Oral Maternal
NOAEL = 100 mg/kg/day
LOC for Margin of Exposure
(MOE) = 100 (Residential)
Rat developmental toxicity study
LOAEL = 300 mg/kg/day based on decreased body weight, body weight gain,
and food consumption, and increased
water consumption
Intermediate-term incidental, oral (1–6
months) (Residential)
Oral NOAEL = 35.1 mg/kg/day
LOC for MOE = 100 (Residential)
Subchronic toxicity and chronic toxicity
(feeding) - rat (co-critical)
LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results
Short-term, and intermediate-term dermal (1–
30 days and 1–6
months) (Occupational/
Residential)
None
None
Based on the systemic toxicity NOAEL of
1,000 mg/kg/day (limit dose) in the 21-day
dermal toxicity study in rats, quantification
of dermal risks is not required. In addition,
no developmental concern (toxicity) were
seen in either rats or rabbits
Long-term dermal (6
months to lifetime) (Occupational/Residential)
Dermal (or oral) study NOAEL =
35.1 mg/kg/day
LOC for MOE = 100 (Residential)
Subchronic toxicity and chronic toxicity
(feeding) - rat(co-critical)
LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results
Short-term, and intermediate-term dermal (1
to 30 days and 1–6
months)(Residential)
None
None
28-day inhalation toxicity - rats. Based on
the absence of significant toxicity at the
LOAEL of 1.0 mg/L (limit dose), the quantification of inhalation risks is not required.
In addition, no developmental concern
(toxicity) were seen in either rats or rabbits
Long-term dermal (6
months to lifetime) (Occupational/Residential)
Dermal oral study NOAEL = 35.1
mg/kg/day (inhalation absorption rate = 100%)
LOC for MOE = 100 (Residential)
Subchronic and chronic toxicity (feeding) rat (co-critial)
LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results
Cancer (oral, dermal, inhalation)
Cancer classification (‘‘Group E’’)
None
No evidence of carcinogenicity
Exposure/Scenario
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.510) for the
residues of pyriproxyfen, in or on the
following raw agricultural commodities:
Acerola at 0.10 part per million (ppm);
almond, hulls at 2.0 ppm; apple, wet
pomace at 0.8 ppm; atemoya at 0.20
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ppm; avocado at 1.0 ppm; biriba at 0.20
ppm; black sapote at 1.0 ppm; brassica,
head and stem, subgroup at 5A at 0.70
ppm; brassica, leafy greens, subgroup 5B
at 2.0 ppm; bushberry subgroup 13B at
1.0 ppm; canistel at 1.0 ppm; cherimoya
at 0.20 ppm; citrus, oil at 20 ppm;
citrus, dried pulp at 2.0 ppm; cotton, gin
byproducts at 2.0 ppm; cotton,
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Study and Toxicological Effects
undelinted seed at 0.05 ppm; custard
apple at 0.20 ppm; feijoa at 0.10 ppm;
fig at 0.30 ppm; fig, dried at 1.0 ppm;
fruit, citrus at 0.3 ppm; fruit, pome at
0.2 ppm; fruit, stone, group 12 at 1.0
ppm; guava at 0.10 ppm; ilama at 0.20
ppm; jaboticaba at 0.10 ppm; juneberry
at 1.0 ppm; lingonberry at 1.0 ppm;
logan at 0.30 ppm; lychee at 0.30 ppm;
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mamey sapote at 1.0 ppm; mango at 1.0
ppm; okra at 0.02 ppm; olive at 1.0 ppm;
olive, oil at 2.0 ppm; papaya at 1.0 ppm;
passionfruit at 0.10 ppm; pistachio at
0.02 ppm; pulasan at 0.30 ppm;
rambutan at 0.30 ppm; salal at 1.0 ppm;
sapodilla at 1.0 ppm; soursop at 0.20
ppm; spanish lime at 0.30 ppm; star
apple at 1.0 ppm; starfruit at 0.10 ppm;
sugar apple at 0.20 ppm; tree nut at 0.02
ppm; vegetable, cucurbit, group 9 at
0.10 ppm; vegetable, fruiting, group 8 at
0.2 ppm; walnut at 0.02 ppm; and wax
jambu at 0.10 ppm. Risk assessments
were conducted by EPA to assess
dietary exposures from pyriproxyfen in
food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and 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 such effects were
identified in the toxicological studies
for pyriproxyfen, therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the Dietary
Exposure Evaluation Model software
with the Food Commodity Intake
Database (DEEMTM/FCID), which
incorporates food consumption data as
reported by respondents in the U.S.
Department of Agriculture (USDA)
1994–1996, and 1998 nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated
exposure to the chemical for each
commodity. The following assumptions
were made for the chronic exposure
assessments: The Tier 1 chronic analysis
assumed 100% crop treated, DEEMTM
7.81 default processing factors and
tolerance-level residues for all
commodities. Percent crop treatedand/
or anticipated residues were not used.
iii. Cancer. The Agency classified
pyriproxyfen as a ‘‘Group E’’ chemical,
no evidence for carcinogenicity to
humans, based on the absence of
evidence of carcinogenicity in male and
female rats as well as in male and
female mice. Therefore, a cancer risk
assessment was not performed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
pyriproxyfen in drinking water. Because
the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
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pyriproxyfen. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on EPA’s Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and, Screening
Concentration in Ground Water (SCIGROW) models, the Estimated
Environmental Concentrations (EECs) of
pyriproxyfen for ground water
exposures are estimated to be 0.006
parts per billion (ppb) (acute and
chronic). Surface water exposures are
estimated to be 2.15 ppb (peak
concentration), and 0.40 ppb (long term
average).
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model
DEEMTM/FCID using long-term average
concentrations for surface water (0.40
ppb) to access the contribution to
drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Pyriproxyfen is currently registered
for use on the following residential nondietary sites: Residential products for
flea and tick control (home environment
and pet treatments), and ant and roach
control (indoor and outdoor
applications). Formulations include
carpet powders, foggers, aerosol sprays,
liquids (shampoos, sprays and pipettes
for pet treatments), granules, bait
(indoor and outdoor), and impregnated
materials (pet collars). Adults and
toddlers could potentially be exposed to
pyriproxyfen residues on treated
carpets, floors, upholstery, and pets;
however, since the Agency did not
select any short-term dermal or
inhalation endpoints, only a postapplication residential assessment was
conducted. Toddlers are anticipated to
have higher exposures than adults from
treated home environments and pets
due to their behavior patterns. The risk
assessment was conducted using the
following residential exposure
assumptions:
i. Hand-to-mouth: Short-term,
intermediate term, and long-term handto-mouth exposures to toddlers from
treated carpets, flooring (note the
efficacy of carpet powders is
approximately 365 days).
ii. Hand-to-mouth: Short-term and
intermediate-term hand-to-mouth
exposures to toddlers from petting
treated animals (shampoos, sprays, spoton treatments and collars). Long-term
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hand-to-mouth exposures to toddlers
from petting treated animals (pet collars;
note efficacy of pet collars up to 365
days).
iii. Dermal: Long-term dermal
exposures from treated carpets, flooring,
and pets (note that treated furniture is
included in the carpet/flooring
assessment).
iv. Ingestion of granules or bait by
toddlers (acute, episodic event).
v. Combined short-term and
intermediate-term hand-to-mouth
exposures (toddlers):
• Treated carpet (powder application)
and treated pet (collar/pet shampoo/pet
spray).
• Treated carpet (spray application)
and treated pet (collar/pet shampoo/pet
spray).
• Treated home environment (fogger
application) and treated pet (collar/pet
shampoo/pet spray).
vi. Combined long-term hand-tomouth and dermal exposures (toddlers):
• Dermal exposure from pet hugging.
• Dermal contact with treated carpet.
• Hand-to-mouth exposures from
treated carpets.
• Hand-to-mouth exposures from
treated pets.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the Federal
Food, Drug, and Cosmetic Act (FFDCA)
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
pyriproxyfen and any other substances
and pyriproxyfen does not appear to
produce a toxic metabolite produced by
other substances. EPA has also
evaluated comments submitted that
suggested there might be a common
mechanism among pyriproxyfen and
other named pesticides that cause brain
effects. EPA concluded that the
evidence did not support a finding of
common mechanism for pyriproxyfen
and the named pesticides. 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 policy statements
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released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at https://
www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty factors (UFs) (safety) in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
Based on the available data, there is no
quantitative and qualitative evidence of
increased susceptibility observed
following in utero pyriproxyfen
exposure to rats and rabbits or following
prenatal/postnatal exposure in the 2generation reproduction study.
3. Conclusion. There is a complete
toxicity data base for pyriproxyfen and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. EPA
determined the 10X safety factor for
infants and children should be reduced
to 1X. The FQPA safety factor was
reduced:
i. Due to the lack of evidence of
prenatal or postnatal extra sensitivity, or
increased susceptibility in
developmental studies (rats and rabbits),
and reproduction studies (rats).
ii. The lack of quantitative or
qualitative evidence of increased
susceptibility for rats and rabbits
identified in the guideline prenatal
developmental toxicity studies.
iii. The lack of evidence of
quantitative or qualitative increased
susceptibility in the two non-guideline
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studies that evaluated perinatal and
prenatal development.
iv. Offspring toxicity (decreased body
weight on pups during lactation days 14
to 21) in the reproduction toxicity study
occurred only in the presence of
decreases in body weight in parental
animals at the same dose level (i.e.,
comparable toxicity in adults and
offspring).
E. Aggregate Risks and Determination of
Safety
The Agency currently has two ways to
estimate total aggregate exposure to a
pesticide from food, drinking water, and
residential uses. First, a screening
assessment can be used, in which the
Agency calculates drinking water levels
of comparison (DWLOCs) which are
used as a point of comparison against
estimated environmental concentrations
(EECs). The DWLOC values are not
regulatory standards for drinking water,
but are theoretical upper limits on a
pesticide’s concentration in drinking
water in light of total aggregate exposure
to a pesticide in food and residential
uses. In calculating a DWLOC, the
Agency determines how much of the
acceptable exposure (i.e., the PAD) is
available for exposure through drinking
water e.g., allowable chronic water
exposure (mg/kg/day) = cPAD - (average
food + residential exposure). This
allowable exposure through drinking
water is used to calculate a DWLOC.
A DWLOC will vary depending on the
toxic endpoint, drinking water
consumption, and body weights. Default
body weights and consumption values
as used by EPA’s Office of Water are
used to calculate DWLOCs: 2 liter L/70
kg (adult male), 2L/60 kg (adult female),
and 1L/10 kg (child). Different
populations will have different
DWLOCs. Generally, a DWLOC is
calculated for each type of risk
assessment used: Acute, short-term,
intermediate-term, chronic, and cancer.
When EECs for surface water and
ground water are less than the
calculated DWOCs, EPA concluded with
reasonable certainty that exposures to
the pesticide in drinking water (when
considered along with other sources of
exposures for which EPA has reliable
data) would not result in unacceptable
levels of aggregate human health risk at
this time. Because EPA considers the
aggregate risk resulting from multiple
exposure pathways associated with a
pesticide’s uses, levels of comparison in
drinking water may vary as those uses
changes. When new uses are added EPA
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55737
reassesses the potential impacts of
residues of the pesticide in drinking
water as a part of the aggregate
assessment process.
More recently the Agency has used
another approach to estimate aggregate
exposure through food, residential and
drinking water pathways. In this
approach, modeled surface water and
ground water EECs are directly
incorporated into the dietary exposure
analysis, along with food. This provides
a more realistic estimate of exposure
because actual body weights and water
consumption from the CSFII are used.
The combined food and water exposures
are then added to estimated exposure
from residential sources to calculate
aggregate risks. The resulting exposure
and risk estimates are still considered to
be high end, due to the assumptions
used in developing drinking water
modeling inputs.
1. Acute risk. An acute aggregate
exposure analysis was not conducted
since no acute doses or endpoints were
selected for the general U.S. population
(including infants and children) or the
females 13–50 years old population
subgroup.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to pyriproxyfen from food
and water will utilize 3.2% of the cPAD
for the U.S. population, 4.4% of the
cPAD for all infants <1 year old, 9.9%
of the cPAD for children 1–2 years old,
and 2.4% of the cPAD for females 13–
49 years old.
Chronic aggregate exposure takes into
account chronic residential exposure
plus chronic exposure to food and
water. Pyriproxyfen is currently
registered for use that could result in
chronic residential exposure and the
Agency has determined that it is
appropriate to aggregate chronic food,
water, and residential exposures for
pyriproxyfen.
Using the exposure assumptions
described in this unit for chronic
exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of
3,200 for the U.S. population; 820 for all
infants <1 year old; 560 for children 1–
2 years old; and 4,700 for females 13–
49 years old. These aggregate MOEs do
not exceed the Agency’s level of
concern for aggregate exposure to food
and residential uses, as shown in the
following Table 2:
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations
TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO PYRIPROXYFEN
cPAD/mg/
kg/day
Population/Subgroup
%cPAD/
(Food)
Target MOE
Aggregate
MOE (food
+ water +
residential)
U.S. population
0.35
3.2
100
3200
All infants (<1 year old)
0.35
4.4
100
820
Children (1–2 years old)
0.35
9.9
100
560
Females (13–49 years old)
0.35
2.4
100
4700
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Pyriproxyfen is currently registered
for use that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for pyriproxyfen.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of
9,000 for the U.S. population; 1,600 for
all infants <1 year old; 1,200 for
children 1–2 years old; and 1,3000 for
females 13–49 years old. These
aggregate MOEs do not exceed the
Agency’s level of concern for aggregate
exposure to food and residential uses.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Pyriproxyfen is currently registered
for use(s) that could result in
intermediate-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic food
and water and intermediate-term
exposures for pyriproxyfen.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of
3,200 for the U.S. population; 560 for all
infants <1 year old, 430 for children 1–
2 years old, and 4,700 for females 13–
49 years old. These aggregate MOEs do
not exceed the Agency’s level of
concern for aggregate exposure to food
and residential uses.
5. Aggregate cancer risk for U.S.
population. A cancer aggregate risk
assessment was not performed since
pyriproxyfen has not been classified as
a potential carcinogen.
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6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to pyriproxyfen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
In conjunction with the crop field
trial studies, the petitioner submitted
adequate concurrent recovery data for a
gas chromatography/nitrogenphosphorus detector (GC/NPD) method
(RM-33P-1-3a or 9.66 V 1) used to
determine residues of pyriproxyfen in/
on the subject crops. The method has
undergone an adequate radiovalidation,
independent laboratory validation (ILV)
trial, petition method validation (PMV)
trial, and has been forwarded to the
Food and Drug Administration (FDA)
for inclusion in PAM Vol. II. The GC/
NPD method RM-33P-1-3a is adequate
for enforcement of the recommended
tolerance levels for residues of
pyriproxyfen per se in/on the subject
crops.
B. International Residue Limits
There are currently no established
Codex, Canadian, or Mexican maximum
residue limits (MRLs) for pyriproxyfen.
C. Response to Comments
Several comments were received from
a private citizen on objecting to
pesticide body load, IR-4 profiteering,
animal testing, establishing tolerances,
pesticide residues, and pesticide
exemptions.
The Agency has received these same
comments from this commenter of
numerous previous occasions. Refer to
the Federal Register of June 30, 2005
(70 FR 37686) (FRL–7718–3), January 7,
2005 (70 FR 1349) (FRL–7691–4), and
October 29, 2004 (69 FR 63083) (FRL–
7681–9) for the Agency’s response to
these objections.
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V. Conclusion
Therefore, tolerances are established
for residues of pyriproxyfen, [2-[1methyl-2-(4phenoxyphenoxy)ethoxy]pyridine], in
or on vegetable, legume, group 6 at 0.20
ppm; onion, dry bulb at 0.15 ppm; grape
at 2.5 ppm; strawberry at 0.30 ppm;
white sapote at 0.30 ppm; citrus hybrids
at 0.30 ppm; grass, forage,fodder, and
hay, group 17, forage at 0.70 ppm; and
grass, forage, fodder, and hay, group 17,
hay at 1.1 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to FFDCA
by FQPA, EPA will continue to use
those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
section 408(g) of FFDCA provides
essentially the same process for persons
to ‘‘object’’ to a regulation for an
exemption from the requirement of a
tolerance issued by EPA under new
section 408(d) of FFDCA, as was
provided in the old sections 408 and
409 of FFDCA. However, the period for
filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP–2005–0246 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before November 22, 2005.
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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 issue(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit VI.A., you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
OPP–2005–0246, to: Public Information
and Records Integrity Branch,
Information Resources and Services
Division (7502C), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001. In person
or by courier, bring a copy to the
location of the PIRIB described in
ADDRESSES. You may also send an
electronic copy of your request via email to: opp-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
6.1/8.0 or ASCII file format. Do not
include any CBI in your electronic copy.
You may also submit an electronic copy
of your request at many Federal
Depository Libraries.
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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
issue(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerances in this final rule, do not
require the issuance of a proposed rule,
PO 00000
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55739
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’‘‘Policies
that have federalism implications’’ is
defined in the Executive Order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
I
Dated: September 19, 2005
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
§ 180.510 Pyriproxyfen; tolerances for
residues.
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.510 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a) to read as follows:
(a) * * *
Therefore, 40 CFR chapter I is
amended as follows:
I
Commodity
Parts per million
*
*
*
*
*
Citrus hybrids ...................................................................................................................................................
*
*
*
*
*
Grape ...............................................................................................................................................................
Grass, forage, fodder, and hay, group 17, forage ..........................................................................................
Grass, forage, fodder, and hay, group 17, hay ...............................................................................................
*
*
*
*
*
Onion, dry bulb ................................................................................................................................................
*
*
*
*
*
Strawberry ........................................................................................................................................................
*
*
*
*
*
Vegetable, legume, group 6 ............................................................................................................................
*
*
*
*
*
White sapote ....................................................................................................................................................
*
*
*
*
*
*
*
*
*
*
[FR Doc. 05–19059 Filed 9–22–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0133; FRL–7738–7]
Fenpropathrin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of fenpropathrin
in or on bushberry subgroup 13B;
lingonberry; juneberry; salal; pea,
succulent; and vegetable, fruiting, group
8. Interregional Research Project
Number 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
DATES: This regulation is effective
September 23, 2005. Objections and
requests for hearings must be received
on or before November 22, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
VerDate Aug<31>2005
14:48 Sep 22, 2005
Jkt 205001
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number OPP–2005–
0133. All documents in the docket are
listed in the EDOCKET index at https://
www.epa.gov/edocket. Although listed
in the index, some information is not
publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Shaja R. Brothers, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
PO 00000
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0.30
2.5
0.70
1.1
0.15
0.30
0.20
0.30
(703) 308–3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
E:\FR\FM\23SER1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Rules and Regulations]
[Pages 55733-55740]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19059]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0246; FRL-7737-8]
Pyriproxyfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
pyriproxyfen in or on grass, forage, fodder, and hay, group 17, forage;
grass, forage, fodder, and hay, group 17, hay; vegetable, legume, group
6; onion, dry bulb; grape; strawberry; sapote, white; and citrus
hybrids. Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 23, 2005. Objections and
requests for hearings must be received on or before November 22, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2005-0246. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers;
[[Page 55734]]
greenhouse, nursery, and floriculture workers; ranchers; pesticide
applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttps://www.epa.gpo/opptsfrs/home/
guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of August 17, 2005 (70 FR 48413) (FRL-7732-
1, EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
3E6596, 3E6750, 4E6866, 4E6865, and 3E6582) by IR-4, 681 US Highway
1 South, North Brunswick, NJ 08902-3390. The petitions
requested that 40 CFR 180.510 be amended by establishing tolerances for
residues of the insecticide pyriproxyfen, [2-[1-methyl-2-(4-
phenoxyphenoxy)ethoxy]pyridine, in or on legume vegetables, crop
subgroups 6a, 6b, and 6c at 0.2 part per million (ppm) (PP 3E6596);
onion, dry bulb at 0.05 ppm (PP 3E6750); grape at 2.5 ppm, and raisin
at 4.0 ppm (PP 4E6866); strawberry at 0.3 ppm (PP 4E6865); white
sapote, and ugli fruit at 0.3 ppm (PP 3E6582). The petition for onion,
dry bulb (PP 3E6750) was subsequently amended from 0.05 ppm to 0.15
ppm. The Agency has also determined a separate tolerance for raisin is
not necessary. In addition, ugli fruit has been translated to citrus
hybrids. No comments were recived on the notice of filing.
Additionally, in the Federal Register of December 22, 2004 (69 FR
76724) (FRL-7689-6), EPA issued a notice pursuant to section 408(d)(3)
of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 4F6847) by Valent USA Corporation, 1600 Riviera Ave.,
Suite 200, Walnut Creek, California 94596-8025. The petition requested
that 40 CFR 180.510 be amended by establishing tolerances for residues
of the insecticide pyriproxyfen, [2-[1-methyl-2-(4-
phenoxyphenoxy)ethoxy]pyridine], in or on grass forage and hay (crop
group 17). The Agency has subsequently amended the petition to
establish tolerances for grass, forage, fodder, and hay, group 17,
forage at 0.70 ppm (previously requested at 0.5 ppm), and grass,
forage, fodder, and hay, group 17, hay at 1.1 ppm (previously requested
at 1.0 ppm). That notice included a summary of the petitions prepared
by Valent USA Corporation], the registrant. Comments were received on
the notice of filing. EPA's response to these comments is discussed in
Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
pesticides/health/human.htm
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
these actions. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for residues of pyriproxyfen on
vegetable, legume, group 6 at 0.20 ppm; onion, dry bulb at 0.15 ppm;
grape at 2.5 ppm; strawberry at 0.30 ppm; white sapote at 0.30 ppm;
citrus hybrids at 0.30 ppm; grass, forage, fodder, and hay, group 17,
forage at 0.70 ppm; and grass, forage, fodder, and hay, group 17, hay
at 1.1 ppm. EPA's assessment of exposures and risks associated with
establishing these tolerances follow.
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. Specific information on the studies received and the nature
of the toxic effects caused by pyriproxyfen as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies can be found at https://
www.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-14/p12022.htm.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
of concern identified is sometimes used for risk assessment if no NOAEL
was achieved in the toxicology study selected. An uncertainty factor
(UF) is applied to reflect uncertainties inherent in the extrapolation
from laboratory animal data to humans and in the variations in
sensitivity among members of the human population as well as other
unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of
[[Page 55735]]
cancer risk, estimates risk in terms of the probability of occurrence
of additional cancer cases.
A summary of the toxicological endpoints for pyriproxyfen used for
human risk assessment is shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of None None An appropriate endpoint
age) and general population attributable to a
single oral dose was
not available in the
data base, including
maternal toxicity in
the developmental
toxicity studies
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL = 35.1 mg/kg/day Special FQPA SF = 1X Subchronic toxicity and
UF = 100............... Chronic Population chronic toxicity
Chronic Reference Dose Adjusted Dose (cPAD) = (feeding) - rat
(cRfD) = 0.35 mg/kg/ cRfD. LOAEL = 141.28 mg/kg/
day. Special FQPA SF = 0.35 day based on decreased
mg/kg/day. body weight and
clinical pathology
results
----------------------------------------------------------------------------------------------------------------
Short-term incidental, oral (1 to 30 Oral Maternal LOC for Margin of Rat developmental
days) (Residential) NOAEL = 100 mg/kg/day.. Exposure (MOE) = 100 toxicity study
(Residential) LOAEL = 300 mg/kg/day
based on decreased
body weight, body
weight gain, and food
consumption, and
increased water
consumption
----------------------------------------------------------------------------------------------------------------
Intermediate-term incidental, oral (1- Oral NOAEL = 35.1 mg/kg/ LOC for MOE = 100 Subchronic toxicity and
6 months) (Residential) day (Residential) chronic toxicity
(feeding) - rat (co-
critical)
LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results
----------------------------------------------------------------------------------------------------------------
Short-term, and intermediate-term None None Based on the systemic
dermal (1-30 days and 1-6 months) toxicity NOAEL of
(Occupational/Residential) 1,000 mg/kg/day (limit
dose) in the 21-day
dermal toxicity study
in rats,
quantification of
dermal risks is not
required. In addition,
no developmental
concern (toxicity)
were seen in either
rats or rabbits
----------------------------------------------------------------------------------------------------------------
Long-term dermal (6 months to Dermal (or oral) study LOC for MOE = 100 Subchronic toxicity and
lifetime) (Occupational/Residential) NOAEL = 35.1 mg/kg/day (Residential) chronic toxicity
(feeding) - rat(co-
critical)
LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results
----------------------------------------------------------------------------------------------------------------
Short-term, and intermediate-term None None 28-day inhalation
dermal (1 to 30 days and 1-6 toxicity - rats. Based
months)(Residential) on the absence of
significant toxicity
at the LOAEL of 1.0 mg/
L (limit dose), the
quantification of
inhalation risks is
not required. In
addition, no
developmental concern
(toxicity) were seen
in either rats or
rabbits
----------------------------------------------------------------------------------------------------------------
Long-term dermal (6 months to Dermal oral study NOAEL LOC for MOE = 100 Subchronic and chronic
lifetime) (Occupational/Residential) = 35.1 mg/kg/day (Residential) toxicity (feeding) -
(inhalation absorption rat (co-critial)
rate = 100%) LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Cancer classification None No evidence of
(``Group E'') carcinogenicity
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.510) for the residues of pyriproxyfen, in or on
the following raw agricultural commodities: Acerola at 0.10 part per
million (ppm); almond, hulls at 2.0 ppm; apple, wet pomace at 0.8 ppm;
atemoya at 0.20 ppm; avocado at 1.0 ppm; biriba at 0.20 ppm; black
sapote at 1.0 ppm; brassica, head and stem, subgroup at 5A at 0.70 ppm;
brassica, leafy greens, subgroup 5B at 2.0 ppm; bushberry subgroup 13B
at 1.0 ppm; canistel at 1.0 ppm; cherimoya at 0.20 ppm; citrus, oil at
20 ppm; citrus, dried pulp at 2.0 ppm; cotton, gin byproducts at 2.0
ppm; cotton, undelinted seed at 0.05 ppm; custard apple at 0.20 ppm;
feijoa at 0.10 ppm; fig at 0.30 ppm; fig, dried at 1.0 ppm; fruit,
citrus at 0.3 ppm; fruit, pome at 0.2 ppm; fruit, stone, group 12 at
1.0 ppm; guava at 0.10 ppm; ilama at 0.20 ppm; jaboticaba at 0.10 ppm;
juneberry at 1.0 ppm; lingonberry at 1.0 ppm; logan at 0.30 ppm; lychee
at 0.30 ppm;
[[Page 55736]]
mamey sapote at 1.0 ppm; mango at 1.0 ppm; okra at 0.02 ppm; olive at
1.0 ppm; olive, oil at 2.0 ppm; papaya at 1.0 ppm; passionfruit at 0.10
ppm; pistachio at 0.02 ppm; pulasan at 0.30 ppm; rambutan at 0.30 ppm;
salal at 1.0 ppm; sapodilla at 1.0 ppm; soursop at 0.20 ppm; spanish
lime at 0.30 ppm; star apple at 1.0 ppm; starfruit at 0.10 ppm; sugar
apple at 0.20 ppm; tree nut at 0.02 ppm; vegetable, cucurbit, group 9
at 0.10 ppm; vegetable, fruiting, group 8 at 0.2 ppm; walnut at 0.02
ppm; and wax jambu at 0.10 ppm. Risk assessments were conducted by EPA
to assess dietary exposures from pyriproxyfen in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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 such effects were
identified in the toxicological studies for pyriproxyfen, therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEMTM/FCID), which
incorporates food consumption data as reported by respondents in the
U.S. Department of Agriculture (USDA) 1994-1996, and 1998 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: The Tier 1
chronic analysis assumed 100% crop treated, DEEMTM 7.81
default processing factors and tolerance-level residues for all
commodities. Percent crop treatedand/or anticipated residues were not
used.
iii. Cancer. The Agency classified pyriproxyfen as a ``Group E''
chemical, no evidence for carcinogenicity to humans, based on the
absence of evidence of carcinogenicity in male and female rats as well
as in male and female mice. Therefore, a cancer risk assessment was not
performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for pyriproxyfen in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of pyriproxyfen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on EPA's Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and, Screening Concentration in Ground Water (SCI-
GROW) models, the Estimated Environmental Concentrations (EECs) of
pyriproxyfen for ground water exposures are estimated to be 0.006 parts
per billion (ppb) (acute and chronic). Surface water exposures are
estimated to be 2.15 ppb (peak concentration), and 0.40 ppb (long term
average).
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model DEEMTM/FCID using
long-term average concentrations for surface water (0.40 ppb) to access
the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Pyriproxyfen is currently registered for use on the following
residential non-dietary sites: Residential products for flea and tick
control (home environment and pet treatments), and ant and roach
control (indoor and outdoor applications). Formulations include carpet
powders, foggers, aerosol sprays, liquids (shampoos, sprays and
pipettes for pet treatments), granules, bait (indoor and outdoor), and
impregnated materials (pet collars). Adults and toddlers could
potentially be exposed to pyriproxyfen residues on treated carpets,
floors, upholstery, and pets; however, since the Agency did not select
any short-term dermal or inhalation endpoints, only a post-application
residential assessment was conducted. Toddlers are anticipated to have
higher exposures than adults from treated home environments and pets
due to their behavior patterns. The risk assessment was conducted using
the following residential exposure assumptions:
i. Hand-to-mouth: Short-term, intermediate term, and long-term
hand-to-mouth exposures to toddlers from treated carpets, flooring
(note the efficacy of carpet powders is approximately 365 days).
ii. Hand-to-mouth: Short-term and intermediate-term hand-to-mouth
exposures to toddlers from petting treated animals (shampoos, sprays,
spot-on treatments and collars). Long-term hand-to-mouth exposures to
toddlers from petting treated animals (pet collars; note efficacy of
pet collars up to 365 days).
iii. Dermal: Long-term dermal exposures from treated carpets,
flooring, and pets (note that treated furniture is included in the
carpet/flooring assessment).
iv. Ingestion of granules or bait by toddlers (acute, episodic
event).
v. Combined short-term and intermediate-term hand-to-mouth
exposures (toddlers):
Treated carpet (powder application) and treated pet
(collar/pet shampoo/pet spray).
Treated carpet (spray application) and treated pet
(collar/pet shampoo/pet spray).
Treated home environment (fogger application) and treated
pet (collar/pet shampoo/pet spray).
vi. Combined long-term hand-to-mouth and dermal exposures
(toddlers):
Dermal exposure from pet hugging.
Dermal contact with treated carpet.
Hand-to-mouth exposures from treated carpets.
Hand-to-mouth exposures from treated pets.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the Federal Food, Drug, and
Cosmetic Act (FFDCA) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to pyriproxyfen and any other
substances and pyriproxyfen does not appear to produce a toxic
metabolite produced by other substances. EPA has also evaluated
comments submitted that suggested there might be a common mechanism
among pyriproxyfen and other named pesticides that cause brain effects.
EPA concluded that the evidence did not support a finding of common
mechanism for pyriproxyfen and the named pesticides. 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 policy statements
[[Page 55737]]
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at https://
www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty factors (UFs) (safety) in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. Based on the available data,
there is no quantitative and qualitative evidence of increased
susceptibility observed following in utero pyriproxyfen exposure to
rats and rabbits or following prenatal/postnatal exposure in the 2-
generation reproduction study.
3. Conclusion. There is a complete toxicity data base for
pyriproxyfen and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
the 10X safety factor for infants and children should be reduced to 1X.
The FQPA safety factor was reduced:
i. Due to the lack of evidence of prenatal or postnatal extra
sensitivity, or increased susceptibility in developmental studies (rats
and rabbits), and reproduction studies (rats).
ii. The lack of quantitative or qualitative evidence of increased
susceptibility for rats and rabbits identified in the guideline
prenatal developmental toxicity studies.
iii. The lack of evidence of quantitative or qualitative increased
susceptibility in the two non-guideline studies that evaluated
perinatal and prenatal development.
iv. Offspring toxicity (decreased body weight on pups during
lactation days 14 to 21) in the reproduction toxicity study occurred
only in the presence of decreases in body weight in parental animals at
the same dose level (i.e., comparable toxicity in adults and
offspring).
E. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated environmental concentrations
(EECs). The DWLOC values are not regulatory standards for drinking
water, but are theoretical upper limits on a pesticide's concentration
in drinking water in light of total aggregate exposure to a pesticide
in food and residential uses. In calculating a DWLOC, the Agency
determines how much of the acceptable exposure (i.e., the PAD) is
available for exposure through drinking water e.g., allowable chronic
water exposure (mg/kg/day) = cPAD - (average food + residential
exposure). This allowable exposure through drinking water is used to
calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by EPA's Office of Water are used to calculate DWLOCs: 2
liter L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Different populations will have different DWLOCs. Generally, a
DWLOC is calculated for each type of risk assessment used: Acute,
short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWOCs, EPA concluded with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposures for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses changes. When
new uses are added EPA reassesses the potential impacts of residues of
the pesticide in drinking water as a part of the aggregate assessment
process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water EECs
are directly incorporated into the dietary exposure analysis, along
with food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs.
1. Acute risk. An acute aggregate exposure analysis was not
conducted since no acute doses or endpoints were selected for the
general U.S. population (including infants and children) or the females
13-50 years old population subgroup.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pyriproxyfen from food and water will utilize 3.2% of the cPAD for the
U.S. population, 4.4% of the cPAD for all infants <1 year old, 9.9% of
the cPAD for children 1-2 years old, and 2.4% of the cPAD for females
13-49 years old.
Chronic aggregate exposure takes into account chronic residential
exposure plus chronic exposure to food and water. Pyriproxyfen is
currently registered for use that could result in chronic residential
exposure and the Agency has determined that it is appropriate to
aggregate chronic food, water, and residential exposures for
pyriproxyfen.
Using the exposure assumptions described in this unit for chronic
exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of 3,200 for the U.S.
population; 820 for all infants <1 year old; 560 for children 1-2 years
old; and 4,700 for females 13-49 years old. These aggregate MOEs do not
exceed the Agency's level of concern for aggregate exposure to food and
residential uses, as shown in the following Table 2:
[[Page 55738]]
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Aggregate
cPAD/mg/kg/ %cPAD/ MOE (food +
Population/Subgroup day (Food) Target MOE water +
residential)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.35 3.2 100 3200
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.35 4.4 100 820
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.35 9.9 100 560
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.35 2.4 100 4700
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Pyriproxyfen is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for pyriproxyfen.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of 9,000 for the U.S.
population; 1,600 for all infants <1 year old; 1,200 for children 1-2
years old; and 1,3000 for females 13-49 years old. These aggregate MOEs
do not exceed the Agency's level of concern for aggregate exposure to
food and residential uses.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyriproxyfen is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for pyriproxyfen.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs of 3,200 for
the U.S. population; 560 for all infants <1 year old, 430 for children
1-2 years old, and 4,700 for females 13-49 years old. These aggregate
MOEs do not exceed the Agency's level of concern for aggregate exposure
to food and residential uses.
5. Aggregate cancer risk for U.S. population. A cancer aggregate
risk assessment was not performed since pyriproxyfen has not been
classified as a potential carcinogen.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to pyriproxyfen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
In conjunction with the crop field trial studies, the petitioner
submitted adequate concurrent recovery data for a gas chromatography/
nitrogen-phosphorus detector (GC/NPD) method (RM-33P-1-3a or 9.66 V 1)
used to determine residues of pyriproxyfen in/on the subject crops. The
method has undergone an adequate radiovalidation, independent
laboratory validation (ILV) trial, petition method validation (PMV)
trial, and has been forwarded to the Food and Drug Administration (FDA)
for inclusion in PAM Vol. II. The GC/NPD method RM-33P-1-3a is adequate
for enforcement of the recommended tolerance levels for residues of
pyriproxyfen per se in/on the subject crops.
B. International Residue Limits
There are currently no established Codex, Canadian, or Mexican
maximum residue limits (MRLs) for pyriproxyfen.
C. Response to Comments
Several comments were received from a private citizen on objecting
to pesticide body load, IR-4 profiteering, animal testing, establishing
tolerances, pesticide residues, and pesticide exemptions.
The Agency has received these same comments from this commenter of
numerous previous occasions. Refer to the Federal Register of June 30,
2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70 FR 1349) (FRL-
7691-4), and October 29, 2004 (69 FR 63083) (FRL-7681-9) for the
Agency's response to these objections.
V. Conclusion
Therefore, tolerances are established for residues of pyriproxyfen,
[2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or on vegetable,
legume, group 6 at 0.20 ppm; onion, dry bulb at 0.15 ppm; grape at 2.5
ppm; strawberry at 0.30 ppm; white sapote at 0.30 ppm; citrus hybrids
at 0.30 ppm; grass, forage,fodder, and hay, group 17, forage at 0.70
ppm; and grass, forage, fodder, and hay, group 17, hay at 1.1 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0246 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
22, 2005.
[[Page 55739]]
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 issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0246, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-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 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.''``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
[[Page 55740]]
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 19, 2005
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.510 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Citrus hybrids...................... 0.30
* * * * *
Grape............................... 2.5
Grass, forage, fodder, and hay, 0.70
group 17, forage...................
Grass, forage, fodder, and hay, 1.1
group 17, hay......................
* * * * *
Onion, dry bulb..................... 0.15
* * * * *
Strawberry.......................... 0.30
* * * * *
Vegetable, legume, group 6.......... 0.20
* * * * *
White sapote........................ 0.30
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-19059 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S
