Pinoxaden; Pesticide Tolerance, 43313-43322 [05-14896]
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[FR Doc. 05–14887 Filed 7–26–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0184; FRL–7725–5]
Pinoxaden; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for combined residues of
pinoxaden in or on barley and wheat.
Syngenta Crop Protection, Inc.,
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective July
27, 2005. Objections and requests for
hearings must be received on or before
September 26, 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–
0184. All documents in the docket are
listed in the EDOCKET index at http:/
/www.epa.gov/edocket/. Although listed
in the index, some information is not
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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: Jim
Tompkins, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5697; e-mail address:
tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
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.
I. General Information
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://
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.
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Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations
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 November
19, 2004 (69 FR 67731) (FRL–7686–5),
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 4F6817) by
Syngenta Crop Protection, Inc., P.O. Box
18300, Greensboro, NC 27419–8300.
The petition requested that 40 CFR part
180 be amended by establishing a
tolerance for combined residues of the
herbicide pinoxaden, 8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate, in or on
wheat, grain at 0.70 parts per million
(ppm), wheat, forage at 3.0 ppm, wheat,
hay at 1.75 ppm, wheat, straw at 1.5
ppm, barley, grain at 0.70 ppm, barley,
hay at 1.25 ppm, and barley, straw at
0.60 ppm. That notice included a
summary of the petition prepared by
Syngenta Crop Protection, Inc., the
registrant. There were no comments
received in response to the notice of
filing.
Based on the Agency’s review the
tolerances for pinoxaden are being
revised to reflect the CAS chemical
name. Additionally, the Agency’s
review of the residue chemistry data
indicated that the tolerance levels
needed to be raised as follows: Wheat,
forage to 3.5 ppm; wheat, grain to 1.3
ppm; wheat, hay to 2.0 ppm; barley,
grain to 0.9 ppm; barley, hay to 1.5 ppm;
and barley, straw to 1.0 ppm. Finally,
EPA concluded that tolerances were
needed on barley, bran; cattle, fat; cattle,
meat; cattle, meat byproducts; egg; milk;
poultry, fat; poultry, meat; poultry, meat
byproducts; and wheat, bran. The
registrant did not propose tolerances for
meat, milk, poultry, and egg (MMPE)
commodities since feeding studies
resulted in residues less than limit of
quantitation (LOQ). However, the
Agency determined that tolerances are
needed on MMPE since the feeding
studies were not conducted at ≥ 10X
and the livestock metabolism studies
indicated that residues are concentrated
in some livestock tissues (liver and
kidney). The tolerances for pinoxaden
will be as follows:
1. The combined residues of the
herbicide pinoxaden (8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its
metabolites 8-(2,6-diethyl-4-methylphenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2),
and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5]
oxadiazepine-7,9-dione (M4), and 4(7,9-dioxo-hexahydro-pyrazolo[1,2-d]
[1,4,5]oxadiazepin-8-yl)-3,5-diethylbenzoic acid (M6), calculated as
pinoxaden in/on barley, bran at 1.6
ppm; barley, grain at 0.9 ppm; barley,
hay at 1.5 ppm; barley, straw at 1.0
ppm; egg at 0.06 ppm; poultry, fat at
0.06 ppm; poultry, meat at 0.06 ppm;
poultry, meat byproducts at 0.06 ppm;
wheat, bran at 3.0 ppm; wheat, forage at
3.5 ppm; wheat, grain at 1.3 ppm;
wheat, hay at 2.0 ppm; and wheat, straw
at 1.5 ppm.
2. The combined residues of
pinoxaden,(8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its
metabolites 8-(2,6-diethyl-4-methylphenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2),
and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5]
oxadiazepine-7,9-dione (M4), calculated
as pinoxaden, in/on cattle, fat at 0.04
ppm; cattle, meat at 0.04 ppm; cattle,
meat byproducts at 0.04 ppm; and milk
at 0.02 ppm.
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 the final rule on
Bifenthrin Pesticide Tolerances (62 FR
62961, November 26,1997) (FRL–5754–
7).
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA.
EPA’s assessment of exposures and
risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. The nature of the
toxic effects caused by pinoxaden are
discussed in Table 1 of this unit as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies reviewed.
TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY
Guideline
No.
870.3100
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Study Type
Results
90–Day oral toxicity—rat-gavage
NOAEL = 300/100 Male/Female (M/F) milligrams/kilogram/day (mg/kg/day)
LOAEL = 300 mg/kg/day based on increased water consumption and urinary volume in females. A LOAEL was not observed in males
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TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued
Guideline
No.
Study Type
Results
870.3100
90–Day oral toxicity—rat-diet
NOAEL = 466/537 (M/F) mg/kg/day
LOAEL = 900/965 (M/F) mg/kg/day based on decreased body weight and body weight gain
and increased incidence of renal lesions in both sexes; decreased food consumption and
increased water consumption in males; and increased urine volume in females
870.3100
13-Week oral toxicity—mice-gavage
NOAEL = 700 mg/kg/day
LOAEL = 1,000 mg/kg/day based on increased incidence of piloerection and decreased
body weight gain in both sexes, and increased incidence of renal tubular basophilia in
males
870.3100
90–Day oral toxicity—mice-diet
NOAEL = 365 mg/kg/day in males. NOAEL not observed in females.
LOAEL = 708.2/165.9 (M/F) mg/kg/day based on decreased body weight and body weight
gain in females, and decreased food efficiency in males
870.3150
90–Day
oral
rodents
NOAEL = 100 mg/kg/day
LOAEL = 250 mg/kg/day based on clinical signs of toxicity fluid feces, (vomit, pale and thin
appearance, decreased activity, dehydration, cold to touch, and regurgitation in both
sexes, and mucus in feces in the males) and decreased body weights, body weight gains,
and food consumption in both sexes
870.3200
28–Day dermal toxicity
870.3700
Prenatal developmental
icity—rabbit
870.3700
Prenatal developmental—rat
Maternal:
NOAEL = 30 mg/kg/day
LOAEL = 300 mg/kg/day based on decreased body weight gains and food consumption
Developmental:
NOAEL = 30 mg/kg/day
LOAEL = 300 mg/kg/day based on delays in skeletal ossification in the skull and hind digits
870.3800
Reproduction and fertility effects
Parental:
NOAEL = 250 mg/kg/day
LOAEL = 500 mg/kg/day based on increased water consumption, renal tubular atrophy, and
chronic nephropathy in both sexes, and increased incidence of renal pelvic dilatation in
the males
Reproductive:
NOAEL = 500 mg/kg/day
LOAEL = was not observed
Offspring:
NOAEL = 250 mg/kg/day
LOAEL = 500 mg/kg/day based on decreased body weights and body weight gains in the F1
pups, and decreased body weights in the F2 males
870.4100
Chronic toxicity—dogs
NOAEL = 125 mg/kg/day
LOAEL = was not observed
870.4200
Carcinogenicity—mice-diet
NOAEL = 216.5/181.2 (M/F) mg/kg/day
LOAEL = was not observed
870.4200
Carcinogenicity—mice-gavage
Study could not be interpreted due to gavage errors and lung involvement.
870.4300
Chronic
toxicity/Carcinogenicity—rats-gavage
NOAEL = 100 mg/kg/day
LOAEL = 250 mg/kg/day based on mortality, clinical signs, and increased serum urea and
creatinine in males, and decreased body weights and body weight gains, increased water
consumption and incidence of urinalysis findings, kidney surface granulation, and microscopic renal lesions in both sexes
870.5100
In vitro bacterial gene mutation
S. typhimurium/E. coli
No marked increases in the number of revertants were observed at any concentration in any
strain in either trial. [negative]
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toxicity—non-
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NOAEL = 1,000 mg/kg/day (limit dose)
LOAEL = was not observed
tox-
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Maternal:
NOAEL = 30 mg/kg/day
LOAEL = 100 mg/kg/day based on increased mortality, abortion, clinical signs of toxicity, and
decreased body weights, body weight gains and food consumption
Developmental:
NOAEL = 30 mg/kg/day
LOAEL = 100 mg/kg/day based on increased incidence of complete early litter resorption
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TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued
Guideline
No.
Study Type
Results
870.5300
In vitro mammalian gene mutation (L5178YTK+/-)
No reproducible substantial (≥ 2x solvent controls) and/or concentration-dependent increases
in mutant colonies per 106 cells were observed at any dose level in the presence or absence of S9. [negative]
870.5375
In vitro mammalian cytogenetics
in V79 Chinese Hamster lung
fibroblasts (2001)
Although there was not a clear dose-response and several of the increases in percent aberrant cells were within the historical control range (0.0–4.0%), there was sufficient reproducible evidence of a positive mutagenic effect in the presence and absence of S9. [positive]
870.5375
In vitro mammalian cytogenetics
in V79 Chinese Hamster lung
fibroblasts (2002)
There was an increase in the percent aberrant cells that exceeded the historical control
range with/without S9 metabolic activation. [positive]
870.5395
In vivo mammalian cytogenetics
micronucleus—mice
There were no marked increases observed in mean net nuclear grains (NNG) or percent
cells in repair (NNG≥ 5) at 2 or 16 hours post-dosing compared to controls. [negative]
870.5550
Unscheduled DNA synthesis
(UDS) in mammalian cells
(2001)
There were no marked increases observed in the mean grains per nucleus or mean NNG in
either trial. Negative for increased UDS up to limit dose. [negative]
870.5550
UDS in mammalian cells (2002)
There were no marked Increases observed in mean NNG or percent cells in repair (NNG≥5)
at 2 or 16 hours post-dosing compared to controls. [negative]
870.6200
Acute neurotoxicity screening
battery in rats-gavage
NOAEL = 2,000 mg/kg/day
LOAEL = was not determined
870.6200
Subchronic neurotoxicity screening battery in rats-gavage
NOAEL = 500 mg/kg/day
LOAEL = was not determined
870.7485
Metabolism—rat
Approximately 90% of the orally gavaged dose was absorbed from the gastrointestinal tract.
Approximately, 90% of the absorbed dose was excreted in the urine and feces in 72 hours
and excretion was nearly complete in 7 days. Excretion in the urine ranged from 59–78%
and in feces 20–25%. Tissue distribution data indicated no significant accumulation in the
body. Billiary excretion study did not indicate enterohepatic circulation. No parent compound was detected in the urine, feces or bile. Major metabolite in the urine and feces
was the hydrolysis product M2. Major metabolites in the urine were M2 (65%–85%) and
M4 (5–13%) and in the feces 50%–70%) and M4 (25%–35%) depending up on the dose.
There were no sex related differences in the absorption, distribution, excretion or qualitative profile of the metabolites.
870.7600
In vivo dermal penetration—rat
Low dose = 4%, 14%, 18% at 4, 10, 24 hours
Mid dose = 1%, 2%, 4% at 4, 10, 24 hours
High dose = 17%, 30%, 36% at 4, 10, 24 hours
B. Toxicological Endpoints
The dose at which no adverse effects
are observed (the 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 lowest
dose at which adverse effects of concern
are identified (the LOAEL) 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. An UF of 100 is
routinely used, 10X to account for
interspecies differences and 10X for
intraspecies differences.
Three other types of safety or UFs
may be used: ‘‘Traditional uncertainty
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factors;’’ the ‘‘special FQPA safety
factor;’’ and the ‘‘default FQPA safety
factor.’’ By the term ‘‘traditional
uncertainty factor,’’ EPA is referring to
those additional UFs used prior to
FQPA passage to account for database
deficiencies. These traditional
uncertainty factors have been
incorporated by the FQPA into the
additional safety factor for the
protection of infants and children. The
term ‘‘special FQPA safety factor’’ refers
to those safety factors that are deemed
necessary for the protection of infants
and children primarily as a result of the
FQPA. The ‘‘default FQPA safety factor’’
is the additional 10X safety factor that
is mandated by the statute unless it is
decided that there are reliable data to
choose a different additional factor
(potentially a traditional uncertainty
factor or a special FQPA safety factor).
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For dietary risk assessment (other
than cancer) the Agency uses the UF to
calculate an acute or chronic reference
dose (acute RfD or chronic RfD) where
the RfD is equal to the NOAEL divided
by an UF of 100 to account for
interspecies and intraspecies differences
and any traditional uncertainty factors
deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or
the default FQPA safety factor is used,
this additional factor is applied to the
RfD by dividing the RfD by such
additional factor. The acute or chronic
Population Adjusted Dose (aPAD or
cPAD) is a modification of the RfD to
accommodate this type of safety factor.
For non-dietary risk assessments
(other than cancer) the UF is used to
determine the LOC. For example, when
100 is the appropriate UF (10X to
account for interspecies differences and
10X for intraspecies differences) the
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LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of
exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify
carcinogenic risk. The Q* approach
assumes that any amount of exposure
will lead to some degree of cancer risk.
A Q* is calculated and used to estimate
risk which represents a probability of
occurrence of additional cancer cases
(e.g., risk). An example of how such a
probability risk is expressed would be to
describe the risk as one in one hundred
thousand (1 X 10-5), one in a million (1
X 10-6), or one in ten million (1 X 10-7).
Under certain specific circumstances,
MOE calculations will be used for the
carcinogenic risk assessment. In this
non-linear approach, a ‘‘point of
departure’’ is identified below which
carcinogenic effects are not expected.
43317
The point of departure is typically a
NOAEL based on an endpoint related to
cancer effects though it may be a
different value derived from the dose
response curve. To estimate risk, a ratio
of the point of departure to exposure
(MOEcancer = point of departure/
exposures) is calculated.
A summary of the toxicological
endpoints for pinoxaden used for
human risk assessment is shown in
Table 2 of this unit:
TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PINOXADEN 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
Study and toxicological effects
Acute dietary
(Females 13–49 years of age)
NOAEL = 30 mg/kg/day
UF = 100
Acute RfD = 0.30 mg/kg/day
Special FQPA SF = 1X
aPAD = acute RfD/ Special
FQPA SF = 0.30 mg/kg/
day
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on increased
incidence of complete early litter resorption.
Acute dietary
(General population including
infants and children)
N/A
N/A
An endpoint of concern attributable to a singledose effect was not identified in the database.
Chronic dietary
(All populations)
NOAEL= 30 mg/kg/day
UF = 100
Chronic RfD = 0.30 mg/kg/
day
Special FQPA SF = 1X
cPAD = chronic RfD/Special FQPA SF = 0.30 mg/
kg/day
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Incidental Oral
Short-term (1–30 days)
NOAEL = 30 mg/kg/day
LOC for MOE = 100 (Residential includes FQPA
SF)
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Incidental Oral
Intermediate-term (1–6 months)
NOAEL = 30 mg/kg/day
LOC for MOE = 100 (Residential includes FQPA
SF)
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Dermal
Short-term (1–30 days)
NOAEL = 30 mg/kg/day
(Dermal absorption rate =
40%)
LOC for MOE = 100 (Residential includes FQPA
SF)
LOC for MOE (occupational) = 100
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Dermal
Intermediate-term (1– months)
NOAEL = 30 mg/kg/day
(Dermal absorption rate =
40%)
LOC for MOE = 100 (Residential includes FQPA
SF)
LOC for MOE (occupational) = 100
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Dermal
Long-term (> 6 months)
NOAEL = 30 mg/kg/day
(Dermal absorption rate =
40%)
LOC for MOE = 100 (Residential includes FQPA
SF)
LOC for MOE (occupational) = 100
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Exposure scenario
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TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PINOXADEN FOR USE IN HUMAN RISK
ASSESSMENT—Continued
Dose used in risk assessment, interspecies and
intraspecies and any Traditional UF
Special FQPA SF and level
of concern for risk assessment
Study and toxicological effects
Short-term inhalation
(1 to 30 days)
NOAEL = 30 mg/kg/day
(inhalation absorption rate =
100%)
LOC for MOE = 100 (Residential includes FQPA
SF)
LOC for MOE (occupational) = 100
Developmental toxicity-rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Intermediate-term inhalation
(1–6 months)
NOAEL = 30 mg/kg/day
(inhalation absorption rate =
100%)
LOC for MOE = 100 (Residential includes FQPA
SF)
LOC for MOE (occupational)= 100
Developmental toxicity-rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Long-term inhalation
(> 6 months)
NOAEL = 30 mg/kg/day
(inhalation absorption rate =
100%)
LOC for MOE = 100 (Residential includes FQPA
SF)
LOC for MOE (occupational) = 100
Developmental toxicity—rabbit
LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs
of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains,
and food consumption.
Exposure scenario
Cancer
(Oral, dermal, inhalation)
Not likely to pose a cancer risk.
Although an acceptable cancer study
in rats was submitted, the dietary cancer
study in the mouse was found to be
unacceptable due to the failure to test at
high enough doses. Nonetheless, based
on the following weight-of-evidence, a
repeat carcinogenicity study in mice is
not required at this time:
• No evidence of carcinogenicity was
observed in an acceptable/guideline
carcinogenicity study in rats.
• The gavage carcinogenicity study in
mice was conducted at doses as high as
750 mg/kg/day. No tumors were
observed in other organs except
adenomas/carcinomas in the lungs.
However, the interpretation of the
adenomas/carcinomas in the lungs was
confounded by the gavage errors that
may have introduced the dosing
solution in to the trachea and lungs, and
perhaps leading to lung tumors and
excessive mortality.
• No tumors were seen in the mouse
dietary carcinogenicity study, however,
the dosing was considered to be
inadequate due to the lack of significant
systemic toxicity at doses up to 181.2
mg/kg/day (the study, performed under
the Organization for Economic
Cooperation and Development (OECD)
and EPA guidelines, was terminated
early for humanitarian reasons due to
excessive decreases in body weight gain
in the high-dose animals).
• In the 90–day feeding study in
mice, pinoxaden was tested up to 7,000
ppm (1,311 mg/kg/day; limit dose), and
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did not produce any tumors or severe
toxicity.
• Pinoxaden was considered to be
non-mutagenic.
This evidence convinces EPA that
repeating the dietary mouse cancer
study is unlikely to provide additional
useful information for the risk
assessment, and that pinoxaden is not
likely to pose a cancer risk.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. No Tolerances have been
established (40 CFR part 180) previously
for the combined residues of pinoxaden
on any commodities. Risk assessments
were conducted by EPA to assess
dietary exposures from pinoxaden in
food as follows:
i. Acute exposure. Acute dietary risk
assessments are performed for a fooduse 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.
In conducting the acute dietary risk
assessment EPA used the Dietary
Exposure Evaluation Model software
with the Food Commodity Intake
Database (DEEM-FCIDTM), 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
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commodity. The following assumptions
were made for the acute exposure
assessments: For the acute analyses,
tolerance-level residues were assumed
for all food commodities with
recommended pinoxaden tolerances,
and it was assumed that all of the crops
included in the analysis were treated.
Percent crop treated (PCT) and
anticipated residues were not used in
the acute risk assessment.
ii. Chronic exposure. In conducting
the chronic dietary risk assessment EPA
used the DEEM-FCIDTM, which
incorporates food consumption data as
reported by respondents in the USDA
1994 –1996 and 1998 CSFII, and
accumulated exposure to the chemical
for each commodity. The following
assumptions were made for the chronic
exposure assessments: For the chronic
analyses, tolerance-level residues were
assumed for all food commodities with
recommended pinoxaden tolerances,
and it was assumed that all of the crops
included in the analysis were treated.
The PCT and the anticipated residues
were not used in the chronic risk
assessment.
iii. Cancer. Because EPA concluded
that pinoxaden is not likely to pose a
cancer risk, a cancer exposure
assessment was not conducted.
2. Dietary exposure from drinking
water. Pinoxaden has never been
registered in the United States so
drinking water concentration estimates
are made by reliance on simulation or
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modeling taking into account data on
the physical characteristics of
pinoxaden.
The Agency uses the FQPA Index
Reservoir Screening Tool (FIRST) or the
Pesticide Root Zone Model/Exposure
Analysis Modeling System (PRZM/
EXAMS), to produce estimates of
pesticide concentrations in an index
reservoir. The Screening Concentration
in Ground Water (SCI-GROW) model is
used to predict pesticide concentrations
in shallow ground water. For a
screening-level assessment for surface
water EPA will use FIRST (a tier 1
model) before using PRZM/EXAMS (a
tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that
uses a specific high-end runoff scenario
for pesticides. Both FIRST and PRZM/
EXAMS incorporate an index reservoir
environment, and both models include
a percent crop area factor as an
adjustment to account for the maximum
percent crop coverage within a
watershed or drainage basin.
None of these models include
consideration of the impact processing
(mixing, dilution, or treatment) of raw
water for distribution as drinking water
would likely have on the removal of
pesticides from the source water. The
primary use of these models by the
Agency at this stage is to provide a
screen for sorting out pesticides for
which it is unlikely that drinking water
concentrations would exceed human
health levels of concern.
Since the models used are considered
to be screening tools in the risk
assessment process, the Agency does
not use estimated environmental
concentrations (EECs), which are the
model estimates of a pesticide’s
concentration in water. EECs derived
from these models are used to quantify
drinking water exposure and risk as a
%RfD or %PAD.
To better evaluate aggregate risk
associated with exposure through food
and drinking water, OPP is no longer
comparing EECs generated by water
quality models with Drinking Water
Levels of Comparison (DWLOC).
Instead, OPP is now directly
incorporating the actual water quality
model output concentrations into the
risk assessment. This method of
incorporating water concentrations into
our aggregate assessments relies on
actual CSFII-reported drinking water
consumptions and more appropriately
reflects the full distribution of drinking
water concentrations. This is further
discussed in the aggregate risk section
in Unit III.E.
Based on the PRZM/EXAMS and SCIGROW models, the EECs of pinoxaden
for acute exposures are estimated to be
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0.76 parts per billion (ppb) for surface
water (90th percentile annual daily
maximum) and 0.13 ppb for ground
water. The EECs for chronic exposures
are estimated to be 0.47 ppb for surface
water (90th percentile annual mean) and
0.13 ppb for ground 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). Pinoxaden
is not registered for use on any sites that
would result in residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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 pinoxaden and any
other substances and pinoxaden does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
pinoxaden 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
released by EPA’s OPP 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 ten-fold 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 database 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
(safety) factors in calculating a dose
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43319
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
uncertainty factors and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There are no concerns and no residual
uncertainties with regard to pre- and/or
postnatal toxicity based on the
following reasons:
• There is no evidence of qualitative
and/or quantitative evidence of
increased susceptibility of rat and rabbit
fetuses to in utero exposure to
pinoxaden.
• There is no evidence of increased
qualitative and/or quantitative evidence
of increased susceptibility to pinoxaden
following prenatal exposure in a 2generation reproduction study in rats.
• There is no evidence of increased
susceptibility to pinoxaden following
prenatal exposure in a 2-generation
reproduction study in rats.
3. Conclusion. There is a complete
toxicity database for pinoxaden and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures.
Additionally, the data show no concerns
for pre- or postnatal sensitivity.
Accordingly, EPA concludes that it is
safe for infants and children to remove
the additional 10X FQPA safety factor.
E. Aggregate Risks and Determination of
Safety
For pinoxaden, no residential uses are
proposed. Therefore, aggregate risk will
consist of exposure from food and
drinking water sources. Acute and
chronic aggregate risks were calculated.
To better evaluate aggregate risk
associated with exposure through food
and drinking water, OPP is no longer
comparing EECs generated by water
quality models with DWLOC. Instead,
OPP is now directly incorporating the
actual water quality model output
concentrations into the risk assessment.
This method of incorporating water
concentrations into our aggregate
assessments relies on actual CSFIIreported drinking water consumptions
and more appropriately reflects the full
distribution of drinking water
concentrations.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food to pinoxaden will
occupy 1.5 % of the aPAD for females
13–49 years old. Drinking water was
incorporated directly into the dietary
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assessment using the annual peak
concentration for surface water
generated by the PRZM-EXAMS model
as a high-end estimate (0.76 ppb; 90th
percentile annual daily maximum), and
therefore the aggregate exposure for food
and water for females 13–49 is 1.5% of
the aPAD.
An endpoint of concern attributable to
a single-dose effect was not identified in
the database for the general population,
therefore, the only acute risk that
pinoxaden poses is as a result of
prenatal exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to pinoxaden from food
will utilize 0.9 % of the cPAD for the
U.S. general population, and 2.1 % of
the cPAD for children 1–2 years old, the
highest exposed population subgroup.
Drinking water was incorporated
directly into the dietary assessment
using the annual mean concentration for
surface water generated by the PRZMEXAMS model as a high-end estimate
(0.47 ppb; 90th percentile annual mean),
and therefore the aggregate exposure for
food and water is 0.9% of the cPAD for
the general population, and 2.1% of the
cPAD for children 1–2 years old. There
are no residential uses for pinoxaden
that result in chronic residential
exposure to pinoxaden.
3. Aggregate cancer risk for U.S.
population. As explained in Unit III.B.,
EPA has concluded that exposure to
pinoxaden is not likely to pose a cancer
risk. Therefore, an aggregate cancer risk
assessment was not conducted.
4. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result from aggregate
exposure to residues of pinoxaden and
its metabolites.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(117–01) high performance liquid
chromatography-mass spectrometry
(HPLC-MS/MS) is available to enforce
the tolerance expression for the
combined residues of pinoxaden and
M2 (as M2), and residues of M4 and M6
for plants. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
The proposed enforcement
methodology (T001530–03) for livestock
is adequate for the determination of two
major pinoxaden metabolites, M4 and
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M6. Based on its similarities to the plant
enforcement method, the Agency
expects that the proposed livestock
method will be adequate for
quantification of pinoxaden and M2.
B. International Residue Limits
U.S. tolerances for pinoxaden have
been harmonized with Canada on the
following commodities: Barley, bran at
1.6 ppm; barley, grain at 0.9 ppm; cattle,
fat at 0.04 ppm; cattle, meat at 0.04
ppm; cattle, meat byproduct at 0.04
ppm; egg at 0.06 ppm; milk at 0.02 ppm;
poultry, fat at 0.06 ppm; poultry, meat
at 0.06 ppm; poultry, meat byproduct at
0.06 ppm; wheat, bran at 3.0 ppm; and
wheat, grain at 1.3 ppm.
In addition to the harmonized
tolerances, the United States has
established tolerances on the following
commodities: Barley, hay at 1.5 ppm;
barley, straw at 1.0 ppm; wheat, forage
at 3.5 ppm; wheat, hay at 2.0 ppm; and
wheat, straw at 1.5 ppm.
C. Conditions
The following are confirmatory data
required as conditions of registration:
1. Additional storage stability data for
wheat and barley processed fractions.
2. Additional validation data for
pinoxaden and M2 residues in livestock
commodities (ruminant and poultry).
V. Conclusion
Therefore, tolerances are established
for:
1. The combined residues of
pinoxaden (8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its
metabolites 8-(2,6-diethyl-4-methylphenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2),
and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5]
oxadiazepine-7,9-dione (M4), and 4(7,9-dioxo-hexahydro-pyrazolo[1,2-d]
[1,4,5]oxadiazepin-8-yl)-3,5-diethylbenzoic acid (M6), calculated as
pinoxaden in/on barley, bran at 1.6
ppm; barley, grain at 0.9 ppm; barley,
hay at 1.5 ppm; barley, straw at 1.0
ppm; egg at 0.06 ppm; poultry, fat at
0.06 ppm; poultry, meat at 0.06 ppm;
poultry, meat byproducts at 0.06 ppm;
wheat, bran at 3.0 ppm; wheat, forage at
3.5 ppm; wheat, grain at 1.3 ppm;
wheat, hay at 2.0 ppm; and wheat, straw
at 1.5 ppm.
2. The combined residues of
pinoxaden,(8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its
metabolites 8-(2,6-diethyl-4-methyl-
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phenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2),
and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5]
oxadiazepine-7,9-dione (M4), calculated
as pinoxaden, in/on cattle, fat at 0.04
ppm; cattle, meat at 0.04 ppm; cattle,
meat byproducts at 0.04 ppm; and milk
at 0.02 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–2005–0184 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 September 26, 2005.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issues(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
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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–2005–0184, 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.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
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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 tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
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
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43321
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.
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).
E:\FR\FM\27JYR1.SGM
27JYR1
43322
Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations
oxadiazepine-7,9-dione, calculated as
pinoxaden, in/on the following
commodities:
Reference Information Center, Portals II,
445 Twelfth Street, SW., Room CY–
Environmental protection,
A257, Washington, DC 20554. The
Administrative practice and procedure,
complete text of this decision may also
Agricultural commodities, Pesticides
Parts per
be purchased from the Commission’s
Commodity
and pests, Reporting and recordkeeping
million
duplicating contractor, Best Copy and
requirements.
Printing, Inc., 445 12th Street, SW.,
Cattle, fat ..................................
0.04
Dated: July 18, 2005.
Cattle, meat ..............................
0.04 Room CY–B402, Washington, DC 20054,
James Jones,
Cattle, meat byproducts ...........
0.04 telephone 1–800–378–3160 or https://
Milk ...........................................
0.02 www.BCPIWEB.com. The Declaratory
Director, Office of Pesticide Programs.
Ruling is also available on the FCC’s
I Therefore, 40 CFR chapter I is
(b) Section 18 emergency exemptions. Web site at https://hraunfoss.fcc.gov/
amended as follows:
edocs_public/attachmatch/FCC–05–
[Reserved]
123A1.doc or https://hraunfoss.fcc.gov/
(c) Tolerances with regional
PART 180—[AMENDED]
edocs_public/attachmatch/FCC–05–
registrations. [Reserved]
123A1.pdf. The Commission will send a
I 1. The authority citation for part 180
(d) Indirect or inadvertent residues.
copy of this Declaratory Ruling in a
continues to read as follows:
[Reserved]
report to be sent to Congress and the
Authority: 21 U.S.C. 321(q), 346a and 371.
[FR Doc. 05–14896 Filed 7–26–05; 8:45 am]
Government Accountability Office
I 2. Section 180.611 is added to read as
BILLING CODE 6560–50–S
pursuant to the Congressional Review
follows:
Act, see 5 U.S.C. 801(a)(1)(A).
1. CSEA establishes a mechanism to
§ 180.611 Pinoxaden; tolerances for
FEDERAL COMMUNICATIONS
use spectrum auction proceeds to
residues.
COMMISSION
reimburse Federal agencies operating on
(a) General. (1) Tolerances are
‘‘eligible frequencies’’ (the 216–220
established for the combined residues of 47 CFR Part 1
MHz, 1432–1435 MHz, 1710–1755 MHz,
pinoxaden (8-(2,6-diethyl-4and 2385–2390 MHz bands, and certain
methylphenyl)-1,2,4,5-tetrahydro-7-oxo- [WT Docket No. 05–211; FCC 05–123]
other frequency bands) that may be
7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9Implementation of the Commercial
reallocated from Federal to non-Federal
yl 2,2-dimethylpropanoate), and its
Spectrum Enhancement Act
use, for the cost of relocating operations.
metabolites 8-(2,6-diethyl-4-methylCSEA requires that the ‘‘total cash
phenyl)-tetrahydro-pyrazolo[1,2AGENCY: Federal Communications
proceeds’’ from any auction of eligible
d][1,4,5]oxadiazepine-7,9-dione (M2),
Commission.
frequencies equal at least 110 percent of
and free and conjugated forms of 8-(2,6- ACTION: Declaratory ruling.
estimated relocation costs of eligible
diethyl-4-hydroxymethyl-phenyl)Federal entities. CSEA prohibits the
tetrahydro-pyrazolo[1,2-d][1,4,5]
SUMMARY: In order to implement the
Commission from concluding any
oxadiazepine-7,9-dione (M4), and 4auction revenue requirement in
auction of eligible frequencies that falls
(7,9-dioxo-hexahydro-pyrazolo[1,2-d]
Commercial Spectrum Enhancement
short of this revenue requirement. CSEA
[1,4,5]oxadiazepin-8-yl)-3,5-diethylAct (CSEA) for any auction of
requires the Commission, if it is unable
benzoic acid (M6), calculated as
frequencies subject to CSEA, the
to conclude an auction for this reason,
pinoxaden, in/on the following
Commission interprets the meaning of
to cancel the auction, return any
commodities:
the term ‘‘total cash proceeds’’ as used
deposits from participating bidders held
in CSEA to mean winning bids net of
in escrow, and absolve such bidders
Parts per
any applicable bidding credit discounts. from any obligation to bid in any
Commodity
million
subsequent reauction of the spectrum.
DATES: Effective August 26, 2005.
2. In order to implement CSEA’s
Barley, bran ..............................
1.6 ADDRESSES: Federal Communications
Barley, grain .............................
0.9
revenue requirement, the Commission
Commission, 445 Twelfth Street, SW.,
Barley, hay ................................
1.5
must determine the meaning of the term
Barley, straw .............................
1.0 Washington, DC 20554. People with
‘‘total cash proceeds’’ as used in the
Egg ...........................................
0.06 Disabilities: Contact the FCC to request
statute. For the following reasons, the
materials in accessible formats (Braille,
Poultry, fat ................................
0.06
Commission interprets ‘‘total cash
Poultry, meat ............................
0.06 large print, electronics files, audio
proceeds’’ for purposes of CSEA to
Poultry, meat byproducts ..........
0.06 format, etc.) by e-mail at
mean winning bids net of any
Wheat, bran ..............................
3.0 FCC504@fcc.gov or call the Consumer &
applicable bidding credit discounts.
Wheat, forage ...........................
3.5 Governmental Affairs Bureau at 202–
Under the Commission’s competitive
Wheat, grain .............................
1.3 418–0531 (voice), 202–418–7365 (TTY).
bidding rules, winning bids in an
Wheat, hay ...............................
2.0
Wheat, straw .............................
1.5 FOR FURTHER INFORMATION CONTACT:
auction do not necessarily translate into
Audrey Bashkin or Gary Michaels,
amounts actually owed by bidders. The
Auctions and Spectrum Access
(2) For the combined residues of
discrepancy between gross and net
Division, Wireless Telecommunications winning bid amounts arises from the
pinoxaden, 8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo- Bureau, (202) 418–0660.
award of bidding credits—i.e., discounts
7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9- SUPPLEMENTARY INFORMATION: This is a
on gross winning bids—to eligible
yl 2,2-dimethylpropanoate), and its
synopsis of the Commission’s
designated entities, new entrants into
metabolites M2, 8-(2,6-diethyl-4-methyl- Declaratory Ruling in WT Docket No.
the broadcast marketplace, and winning
phenyl)-tetrahydro-pyrazolo[1,205–211 adopted June 9, 2005, and
bidders that undertake to serve
d][1,4,5]oxadiazepine-7,9-dione, and
released June 14, 2005. The full text of
previously underserved tribal lands. In
free and conjugated forms of M4, 8-(2,6- this Commission decision is available
this context, the plain language of the
diethyl-4-hydroxymethyl-phenyl)for inspection and copying during
statute appears to refer to an auction’s
tetrahydro-pyrazolo[1,2-d][1,4,5]
regular business hours at the FCC’s
net winning bids rather than gross
List of Subjects in 40 CFR Part 180
VerDate jul<14>2003
18:34 Jul 26, 2005
Jkt 205001
PO 00000
Frm 00064
Fmt 4700
Sfmt 4700
E:\FR\FM\27JYR1.SGM
27JYR1
]]>Agencies
[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Rules and Regulations]
[Pages 43313-43322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14896]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0184; FRL-7725-5]
Pinoxaden; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
of pinoxaden in or on barley and wheat. Syngenta Crop Protection, Inc.,
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective July 27, 2005. Objections and
requests for hearings must be received on or before September 26, 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-2005-0184. 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: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: tompkins.jim@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; 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://
[[Page 43314]]
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 November 19, 2004 (69 FR 67731) (FRL-
7686-5), 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
4F6817) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR part 180 be amended
by establishing a tolerance for combined residues of the herbicide
pinoxaden, 8-(2,6-diethyl-4-methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-
pyrazolo[1,2-d][1,4,5] oxadiazepin-9-yl 2,2-dimethylpropanoate, in or
on wheat, grain at 0.70 parts per million (ppm), wheat, forage at 3.0
ppm, wheat, hay at 1.75 ppm, wheat, straw at 1.5 ppm, barley, grain at
0.70 ppm, barley, hay at 1.25 ppm, and barley, straw at 0.60 ppm. That
notice included a summary of the petition prepared by Syngenta Crop
Protection, Inc., the registrant. There were no comments received in
response to the notice of filing.
Based on the Agency's review the tolerances for pinoxaden are being
revised to reflect the CAS chemical name. Additionally, the Agency's
review of the residue chemistry data indicated that the tolerance
levels needed to be raised as follows: Wheat, forage to 3.5 ppm; wheat,
grain to 1.3 ppm; wheat, hay to 2.0 ppm; barley, grain to 0.9 ppm;
barley, hay to 1.5 ppm; and barley, straw to 1.0 ppm. Finally, EPA
concluded that tolerances were needed on barley, bran; cattle, fat;
cattle, meat; cattle, meat byproducts; egg; milk; poultry, fat;
poultry, meat; poultry, meat byproducts; and wheat, bran. The
registrant did not propose tolerances for meat, milk, poultry, and egg
(MMPE) commodities since feeding studies resulted in residues less than
limit of quantitation (LOQ). However, the Agency determined that
tolerances are needed on MMPE since the feeding studies were not
conducted at >= 10X and the livestock metabolism studies indicated that
residues are concentrated in some livestock tissues (liver and kidney).
The tolerances for pinoxaden will be as follows:
1. The combined residues of the herbicide pinoxaden (8-(2,6-
diethyl-4-methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-
d][1,4,5] oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites
8-(2,6-diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-
d][1,4,5]oxadiazepine-7,9-dione (M2), and free and conjugated forms of
8-(2,6-diethyl-4-hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-
d][1,4,5] oxadiazepine-7,9-dione (M4), and 4-(7,9-dioxo-hexahydro-
pyrazolo[1,2-d] [1,4,5]oxadiazepin-8-yl)-3,5-diethyl-benzoic acid (M6),
calculated as pinoxaden in/on barley, bran at 1.6 ppm; barley, grain at
0.9 ppm; barley, hay at 1.5 ppm; barley, straw at 1.0 ppm; egg at 0.06
ppm; poultry, fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat
byproducts at 0.06 ppm; wheat, bran at 3.0 ppm; wheat, forage at 3.5
ppm; wheat, grain at 1.3 ppm; wheat, hay at 2.0 ppm; and wheat, straw
at 1.5 ppm.
2. The combined residues of pinoxaden,(8-(2,6-diethyl-4-
methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5]
oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-
diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-
7,9-dione (M2), and free and conjugated forms of 8-(2,6-diethyl-4-
hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-
7,9-dione (M4), calculated as pinoxaden, in/on cattle, fat at 0.04 ppm;
cattle, meat at 0.04 ppm; cattle, meat byproducts at 0.04 ppm; and milk
at 0.02 ppm.
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 the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26,1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA.
EPA's assessment of exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by pinoxaden are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity--rat- NOAEL = 300/100 Male/Female (M/F) milligrams/
gavage kilogram/day (mg/kg/day)
LOAEL = 300 mg/kg/day based on increased
water consumption and urinary volume in
females. A LOAEL was not observed in males
----------------------------------------
[[Page 43315]]
870.3100 90-Day oral toxicity--rat- NOAEL = 466/537 (M/F) mg/kg/day
diet LOAEL = 900/965 (M/F) mg/kg/day based on
decreased body weight and body weight gain
and increased incidence of renal lesions in
both sexes; decreased food consumption and
increased water consumption in males; and
increased urine volume in females
----------------------------------------
870.3100 13-Week oral toxicity-- NOAEL = 700 mg/kg/day
mice-gavage LOAEL = 1,000 mg/kg/day based on increased
incidence of piloerection and decreased
body weight gain in both sexes, and
increased incidence of renal tubular
basophilia in males
----------------------------------------
870.3100 90-Day oral toxicity-- NOAEL = 365 mg/kg/day in males. NOAEL not
mice-diet observed in females.
LOAEL = 708.2/165.9 (M/F) mg/kg/day based on
decreased body weight and body weight gain
in females, and decreased food efficiency
in males
----------------------------------------
870.3150 90-Day oral toxicity-- NOAEL = 100 mg/kg/day
nonrodents LOAEL = 250 mg/kg/day based on clinical
signs of toxicity fluid feces, (vomit, pale
and thin appearance, decreased activity,
dehydration, cold to touch, and
regurgitation in both sexes, and mucus in
feces in the males) and decreased body
weights, body weight gains, and food
consumption in both sexes
----------------------------------------
870.3200 28-Day dermal toxicity NOAEL = 1,000 mg/kg/day (limit dose)
LOAEL = was not observed
----------------------------------------
870.3700 Prenatal developmental Maternal:
toxicity--rabbit NOAEL = 30 mg/kg/day
LOAEL = 100 mg/kg/day based on increased
mortality, abortion, clinical signs of
toxicity, and decreased body weights, body
weight gains and food consumption
Developmental:
NOAEL = 30 mg/kg/day
LOAEL = 100 mg/kg/day based on increased
incidence of complete early litter
resorption
----------------------------------------
870.3700 Prenatal developmental-- Maternal:
rat NOAEL = 30 mg/kg/day
LOAEL = 300 mg/kg/day based on decreased
body weight gains and food consumption
Developmental:
NOAEL = 30 mg/kg/day
LOAEL = 300 mg/kg/day based on delays in
skeletal ossification in the skull and hind
digits
----------------------------------------
870.3800 Reproduction and Parental:
fertility effects NOAEL = 250 mg/kg/day
LOAEL = 500 mg/kg/day based on increased
water consumption, renal tubular atrophy,
and chronic nephropathy in both sexes, and
increased incidence of renal pelvic
dilatation in the males
Reproductive:
NOAEL = 500 mg/kg/day
LOAEL = was not observed
Offspring:
NOAEL = 250 mg/kg/day
LOAEL = 500 mg/kg/day based on decreased
body weights and body weight gains in the
F1 pups, and decreased body weights in the
F2 males
----------------------------------------
870.4100 Chronic toxicity--dogs NOAEL = 125 mg/kg/day
LOAEL = was not observed
----------------------------------------
870.4200 Carcinogenicity--mice- NOAEL = 216.5/181.2 (M/F) mg/kg/day
diet LOAEL = was not observed
----------------------------------------
870.4200 Carcinogenicity--mice- Study could not be interpreted due to gavage
gavage errors and lung involvement.
----------------------------------------
870.4300 Chronic toxicity/ NOAEL = 100 mg/kg/day
Carcinogenicity--rats- LOAEL = 250 mg/kg/day based on mortality,
gavage clinical signs, and increased serum urea
and creatinine in males, and decreased body
weights and body weight gains, increased
water consumption and incidence of
urinalysis findings, kidney surface
granulation, and microscopic renal lesions
in both sexes
----------------------------------------
870.5100 In vitro bacterial gene No marked increases in the number of
mutation S. typhimurium/ revertants were observed at any
E. coli concentration in any strain in either
trial. [negative]
----------------------------------------
[[Page 43316]]
870.5300 In vitro mammalian gene No reproducible substantial (>= 2x solvent
mutation (L5178YTK\+\/-) controls) and/or concentration-dependent
increases in mutant colonies per 10\6\
cells were observed at any dose level in
the presence or absence of S9. [negative]
----------------------------------------
870.5375 In vitro mammalian Although there was not a clear dose-response
cytogenetics in V79 and several of the increases in percent
Chinese Hamster lung aberrant cells were within the historical
fibroblasts (2001) control range (0.0-4.0%), there was
sufficient reproducible evidence of a
positive mutagenic effect in the presence
and absence of S9. [positive]
----------------------------------------
870.5375 In vitro mammalian There was an increase in the percent
cytogenetics in V79 aberrant cells that exceeded the historical
Chinese Hamster lung control range with/without S9 metabolic
fibroblasts (2002) activation. [positive]
----------------------------------------
870.5395 In vivo mammalian There were no marked increases observed in
cytogenetics mean net nuclear grains (NNG) or percent
micronucleus--mice cells in repair (NNG>= 5) at 2 or 16 hours
post-dosing compared to controls.
[negative]
----------------------------------------
870.5550 Unscheduled DNA synthesis There were no marked increases observed in
(UDS) in mammalian cells the mean grains per nucleus or mean NNG in
(2001) either trial. Negative for increased UDS up
to limit dose. [negative]
----------------------------------------
870.5550 UDS in mammalian cells There were no marked Increases observed in
(2002) mean NNG or percent cells in repair
(NNG>=5) at 2 or 16 hours post-dosing
compared to controls. [negative]
----------------------------------------
870.6200 Acute neurotoxicity NOAEL = 2,000 mg/kg/day
screening battery in LOAEL = was not determined
rats-gavage
----------------------------------------
870.6200 Subchronic neurotoxicity NOAEL = 500 mg/kg/day
screening battery in LOAEL = was not determined
rats-gavage
----------------------------------------
870.7485 Metabolism--rat Approximately 90% of the orally gavaged dose
was absorbed from the gastrointestinal
tract. Approximately, 90% of the absorbed
dose was excreted in the urine and feces in
72 hours and excretion was nearly complete
in 7 days. Excretion in the urine ranged
from 59-78% and in feces 20-25%. Tissue
distribution data indicated no significant
accumulation in the body. Billiary
excretion study did not indicate
enterohepatic circulation. No parent
compound was detected in the urine, feces
or bile. Major metabolite in the urine and
feces was the hydrolysis product M2. Major
metabolites in the urine were M2 (65%-85%)
and M4 (5-13%) and in the feces 50%-70%)
and M4 (25%-35%) depending up on the dose.
There were no sex related differences in
the absorption, distribution, excretion or
qualitative profile of the metabolites.
----------------------------------------
870.7600 In vivo dermal Low dose = 4%, 14%, 18% at 4, 10, 24 hours
penetration--rat Mid dose = 1%, 2%, 4% at 4, 10, 24 hours
High dose = 17%, 30%, 36% at 4, 10, 24
hours
----------------------------------------------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the 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 lowest dose at which adverse effects of concern are
identified (the LOAEL) 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. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or UFs may be used: ``Traditional
uncertainty factors;'' the ``special FQPA safety factor;'' and the
``default FQPA safety factor.'' By the term ``traditional uncertainty
factor,'' EPA is referring to those additional UFs used prior to FQPA
passage to account for database deficiencies. These traditional
uncertainty factors have been incorporated by the FQPA into the
additional safety factor for the protection of infants and children.
The term ``special FQPA safety factor'' refers to those safety factors
that are deemed necessary for the protection of infants and children
primarily as a result of the FQPA. The ``default FQPA safety factor''
is the additional 10X safety factor that is mandated by the statute
unless it is decided that there are reliable data to choose a different
additional factor (potentially a traditional uncertainty factor or a
special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the
[[Page 43317]]
LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin
of exposure (MOE) = NOAEL/exposure) is calculated and compared to the
LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for pinoxaden used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Pinoxaden 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 NOAEL = 30 mg/kg/day Special FQPA SF = 1X Developmental toxicity--
(Females 13-49 years of age)......... UF = 100............... aPAD = acute RfD/ rabbit
Acute RfD = 0.30 mg/kg/ Special FQPA SF = 0.30 LOAEL = 100 mg/kg/day
day. mg/kg/day. based on increased
incidence of complete
early litter
resorption.
--------------------------------------
Acute dietary N/A N/A An endpoint of concern
(General population including infants attributable to a
and children). single-dose effect was
not identified in the
database.
--------------------------------------
Chronic dietary NOAEL= 30 mg/kg/day Special FQPA SF = 1X Developmental toxicity--
(All populations).................... UF = 100............... cPAD = chronic RfD/ rabbit
Chronic RfD = 0.30 mg/ Special FQPA SF = 0.30 LOAEL = 100 mg/kg/day
kg/day. mg/kg/day. based on morbid
condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Incidental Oral NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity--
Short-term (1-30 days)............... (Residential includes rabbit
FQPA SF) LOAEL = 100 mg/kg/day
based on morbid
condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Incidental Oral NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity--
Intermediate-term (1-6 months)...... (Residential includes rabbit
FQPA SF) LOAEL = 100 mg/kg/day
based on morbid
condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Dermal NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity--
Short-term (1-30 days)............... (Dermal absorption rate (Residential includes rabbit
= 40%). FQPA SF) LOAEL = 100 mg/kg/day
LOC for MOE based on morbid
(occupational) = 100. condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Dermal NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity--
Intermediate-term (1- months)........ (Dermal absorption rate (Residential includes rabbit
= 40%). FQPA SF) LOAEL = 100 mg/kg/day
LOC for MOE based on morbid
(occupational) = 100. condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Dermal NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity--
Long-term (> 6 months)............... (Dermal absorption rate (Residential includes rabbit
= 40%). FQPA SF) LOAEL = 100 mg/kg/day
LOC for MOE based on morbid
(occupational) = 100. condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
[[Page 43318]]
Short-term inhalation NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity-
(1 to 30 days)....................... (inhalation absorption (Residential includes rabbit
rate = 100%). FQPA SF) LOAEL = 100 mg/kg/day
LOC for MOE based on morbid
(occupational) = 100. condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Intermediate-term inhalation NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity-
(1-6 months)......................... (inhalation absorption (Residential includes rabbit
rate = 100%). FQPA SF) LOAEL = 100 mg/kg/day
LOC for MOE based on morbid
(occupational)= 100. condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Long-term inhalation NOAEL = 30 mg/kg/day LOC for MOE = 100 Developmental toxicity--
(> 6 months)......................... (inhalation absorption (Residential includes rabbit
rate = 100%). FQPA SF) LOAEL = 100 mg/kg/day
LOC for MOE based on morbid
(occupational) = 100. condition in one
rabbit (mortality),
clinical signs of
toxicity in a morbid
rabbit, abortion,
decreased body
weights, body weight
gains, and food
consumption.
--------------------------------------
Cancer Not likely to pose a cancer risk.
(Oral, dermal, inhalation)...........
----------------------------------------------------------------------------------------------------------------
Although an acceptable cancer study in rats was submitted, the
dietary cancer study in the mouse was found to be unacceptable due to
the failure to test at high enough doses. Nonetheless, based on the
following weight-of-evidence, a repeat carcinogenicity study in mice is
not required at this time:
No evidence of carcinogenicity was observed in an
acceptable/guideline carcinogenicity study in rats.
The gavage carcinogenicity study in mice was conducted at
doses as high as 750 mg/kg/day. No tumors were observed in other organs
except adenomas/carcinomas in the lungs. However, the interpretation of
the adenomas/carcinomas in the lungs was confounded by the gavage
errors that may have introduced the dosing solution in to the trachea
and lungs, and perhaps leading to lung tumors and excessive mortality.
No tumors were seen in the mouse dietary carcinogenicity
study, however, the dosing was considered to be inadequate due to the
lack of significant systemic toxicity at doses up to 181.2 mg/kg/day
(the study, performed under the Organization for Economic Cooperation
and Development (OECD) and EPA guidelines, was terminated early for
humanitarian reasons due to excessive decreases in body weight gain in
the high-dose animals).
In the 90-day feeding study in mice, pinoxaden was tested
up to 7,000 ppm (1,311 mg/kg/day; limit dose), and did not produce any
tumors or severe toxicity.
Pinoxaden was considered to be non-mutagenic.
This evidence convinces EPA that repeating the dietary mouse cancer
study is unlikely to provide additional useful information for the risk
assessment, and that pinoxaden is not likely to pose a cancer risk.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. No Tolerances have
been established (40 CFR part 180) previously for the combined residues
of pinoxaden on any commodities. Risk assessments were conducted by EPA
to assess dietary exposures from pinoxaden in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide, if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\), 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 acute
exposure assessments: For the acute analyses, tolerance-level residues
were assumed for all food commodities with recommended pinoxaden
tolerances, and it was assumed that all of the crops included in the
analysis were treated. Percent crop treated (PCT) and anticipated
residues were not used in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994 -1996 and
1998 CSFII, and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: For the chronic analyses, tolerance-level residues were
assumed for all food commodities with recommended pinoxaden tolerances,
and it was assumed that all of the crops included in the analysis were
treated. The PCT and the anticipated residues were not used in the
chronic risk assessment.
iii. Cancer. Because EPA concluded that pinoxaden is not likely to
pose a cancer risk, a cancer exposure assessment was not conducted.
2. Dietary exposure from drinking water. Pinoxaden has never been
registered in the United States so drinking water concentration
estimates are made by reliance on simulation or
[[Page 43319]]
modeling taking into account data on the physical characteristics of
pinoxaden.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentration in Ground Water (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water EPA will use FIRST
(a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
To better evaluate aggregate risk associated with exposure through
food and drinking water, OPP is no longer comparing EECs generated by
water quality models with Drinking Water Levels of Comparison (DWLOC).
Instead, OPP is now directly incorporating the actual water quality
model output concentrations into the risk assessment. This method of
incorporating water concentrations into our aggregate assessments
relies on actual CSFII-reported drinking water consumptions and more
appropriately reflects the full distribution of drinking water
concentrations. This is further discussed in the aggregate risk section
in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of pinoxaden
for acute exposures are estimated to be 0.76 parts per billion (ppb)
for surface water (90\th\ percentile annual daily maximum) and 0.13 ppb
for ground water. The EECs for chronic exposures are estimated to be
0.47 ppb for surface water (90th percentile annual mean) and 0.13 ppb
for ground 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). Pinoxaden is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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 pinoxaden and any other substances and pinoxaden does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that pinoxaden 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
released by EPA's OPP 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 ten-fold 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 database 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 (safety) factors 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 uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There are no concerns and no
residual uncertainties with regard to pre- and/or postnatal toxicity
based on the following reasons:
There is no evidence of qualitative and/or quantitative
evidence of increased susceptibility of rat and rabbit fetuses to in
utero exposure to pinoxaden.
There is no evidence of increased qualitative and/or
quantitative evidence of increased susceptibility to pinoxaden
following prenatal exposure in a 2-generation reproduction study in
rats.
There is no evidence of increased susceptibility to
pinoxaden following prenatal exposure in a 2-generation reproduction
study in rats.
3. Conclusion. There is a complete toxicity database for pinoxaden
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. Additionally, the data
show no concerns for pre- or postnatal sensitivity. Accordingly, EPA
concludes that it is safe for infants and children to remove the
additional 10X FQPA safety factor.
E. Aggregate Risks and Determination of Safety
For pinoxaden, no residential uses are proposed. Therefore,
aggregate risk will consist of exposure from food and drinking water
sources. Acute and chronic aggregate risks were calculated.
To better evaluate aggregate risk associated with exposure through
food and drinking water, OPP is no longer comparing EECs generated by
water quality models with DWLOC. Instead, OPP is now directly
incorporating the actual water quality model output concentrations into
the risk assessment. This method of incorporating water concentrations
into our aggregate assessments relies on actual CSFII-reported drinking
water consumptions and more appropriately reflects the full
distribution of drinking water concentrations.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
pinoxaden will occupy 1.5 % of the aPAD for females 13-49 years old.
Drinking water was incorporated directly into the dietary
[[Page 43320]]
assessment using the annual peak concentration for surface water
generated by the PRZM-EXAMS model as a high-end estimate (0.76 ppb;
90\th\ percentile annual daily maximum), and therefore the aggregate
exposure for food and water for females 13-49 is 1.5% of the aPAD.
An endpoint of concern attributable to a single-dose effect was not
identified in the database for the general population, therefore, the
only acute risk that pinoxaden poses is as a result of prenatal
exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to pinoxaden
from food will utilize 0.9 % of the cPAD for the U.S. general
population, and 2.1 % of the cPAD for children 1-2 years old, the
highest exposed population subgroup. Drinking water was incorporated
directly into the dietary assessment using the annual mean
concentration for surface water generated by the PRZM-EXAMS model as a
high-end estimate (0.47 ppb; 90\th\ percentile annual mean), and
therefore the aggregate exposure for food and water is 0.9% of the cPAD
for the general population, and 2.1% of the cPAD for children 1-2 years
old. There are no residential uses for pinoxaden that result in chronic
residential exposure to pinoxaden.
3. Aggregate cancer risk for U.S. population. As explained in Unit
III.B., EPA has concluded that exposure to pinoxaden is not likely to
pose a cancer risk. Therefore, an aggregate cancer risk assessment was
not conducted.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to residues of pinoxaden and its metabolites.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (117-01) high performance liquid
chromatography-mass spectrometry (HPLC-MS/MS) is available to enforce
the tolerance expression for the combined residues of pinoxaden and M2
(as M2), and residues of M4 and M6 for plants. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
The proposed enforcement methodology (T001530-03) for livestock is
adequate for the determination of two major pinoxaden metabolites, M4
and M6. Based on its similarities to the plant enforcement method, the
Agency expects that the proposed livestock method will be adequate for
quantification of pinoxaden and M2.
B. International Residue Limits
U.S. tolerances for pinoxaden have been harmonized with Canada on
the following commodities: Barley, bran at 1.6 ppm; barley, grain at
0.9 ppm; cattle, fat at 0.04 ppm; cattle, meat at 0.04 ppm; cattle,
meat byproduct at 0.04 ppm; egg at 0.06 ppm; milk at 0.02 ppm; poultry,
fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat byproduct at
0.06 ppm; wheat, bran at 3.0 ppm; and wheat, grain at 1.3 ppm.
In addition to the harmonized tolerances, the United States has
established tolerances on the following commodities: Barley, hay at 1.5
ppm; barley, straw at 1.0 ppm; wheat, forage at 3.5 ppm; wheat, hay at
2.0 ppm; and wheat, straw at 1.5 ppm.
C. Conditions
The following are confirmatory data required as conditions of
registration:
1. Additional storage stability data for wheat and barley processed
fractions.
2. Additional validation data for pinoxaden and M2 residues in
livestock commodities (ruminant and poultry).
V. Conclusion
Therefore, tolerances are established for:
1. The combined residues of pinoxaden (8-(2,6-diethyl-4-
methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5]
oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-
diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-
7,9-dione (M2), and free and conjugated forms of 8-(2,6-diethyl-4-
hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-
7,9-dione (M4), and 4-(7,9-dioxo-hexahydro-pyrazolo[1,2-d]
[1,4,5]oxadiazepin-8-yl)-3,5-diethyl-benzoic acid (M6), calculated as
pinoxaden in/on barley, bran at 1.6 ppm; barley, grain at 0.9 ppm;
barley, hay at 1.5 ppm; barley, straw at 1.0 ppm; egg at 0.06 ppm;
poultry, fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat
byproducts at 0.06 ppm; wheat, bran at 3.0 ppm; wheat, forage at 3.5
ppm; wheat, grain at 1.3 ppm; wheat, hay at 2.0 ppm; and wheat, straw
at 1.5 ppm.
2. The combined residues of pinoxaden,(8-(2,6-diethyl-4-
methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5]
oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-
diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-
7,9-dione (M2), and free and conjugated forms of 8-(2,6-diethyl-4-
hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-
7,9-dione (M4), calculated as pinoxaden, in/on cattle, fat at 0.04 ppm;
cattle, meat at 0.04 ppm; cattle, meat byproducts at 0.04 ppm; and milk
at 0.02 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-2005-0184 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 September
26, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information
