Aminopyralid; Pesticide Tolerance, 46419-46428 [05-15523]
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Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 26, 2005.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended
as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.612 is added to read as
follows:
I
§ 180.612 Topramezone; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of the herbicide
topramezone, [3-(4,5-dihydro-3isoxazolyl)-2-methyl-4(methylsulfonyl)phenyl](5-hydroxy-1methyl-1H-pyrazol-4-yl)methanone, in
or on the following raw agricultural
commodities:
Parts per
million
Commodity
Cattle, kidney ............................
Cattle, liver ................................
Corn, field, forage .....................
Corn, field, grain .......................
Corn, field, stover .....................
Corn, pop, grain ........................
Corn, pop, stover ......................
Corn, sweet, forage ..................
Corn, sweet, kernel plus cob
with husks removed ..............
Corn, sweet, stover ..................
Goat, kidney .............................
Goat, liver .................................
Horse, kidney ............................
Horse, liver ...............................
Sheep, kidney ...........................
Sheep, liver ...............................
0.05
0.15
0.05
0.01
0.05
0.01
0.05
0.05
0.01
0.05
0.05
0.15
0.05
0.15
0.05
0.15
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
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(d) Indirect or inadvertent residues.
[Reserved]
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[FR Doc. 05–15604 Filed 8–9–05; 8:45 am]
DC 20460–0001; telephone number:
(703) 305–6224; e-mail address:
miller.joanne@epa.gov.
BILLING CODE 6560–50–S
SUPPLEMENTARY INFORMATION:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2004–0139; FRL–7724–8]
Aminopyralid; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for free and conjugated
residues of aminopyralid in or on grass
and wheat commodities; and residues of
aminopyralid in or meat; fat and meat
byproducts, excluding kidney; of cattle,
goat, and sheep, and milk. Dow
AgroSciences, LLC 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
August 10, 2005. Objections and
requests for hearings must be received
on or before October 11, 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–2004–
0139. 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
publicly available, i.e., Confidential
Business Information (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:
JoanneMiller, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
PO 00000
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A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
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 (http:/
/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 on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines athttps://www.epa.gpo/
opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of June 2, 2004
(69 FR 31106–31110) (FRL–7359–3),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
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346a(d)(3), announcing the filing of a
pesticide petition (PP 4F6827,
incorrectly stated as 7F4851) by Dow
AgroSciences, LLC, 9330 Zionsville Rd.,
Indianapolis, IN 46268. The petition
requested that 40 CFR part 180 be
amended by establishing a tolerance for
combined residues of the herbicide
aminopyralid (XDE-750): 4-amino-3,6dichloropyridine-2-carboxylic acid and
its glucose conjugate, expressed as total
parent in or on grass forage at 25 parts
per million (ppm), grass hay at 65 ppm,
wheat forage at 2 ppm, wheat hay at 4
ppm, wheat grain at 0.05 ppm, wheat
straw at 0.5 ppm, wheat bran at 0.1
ppm, wheat middlings at 0.02 ppm,
wheat shorts at 0.05 ppm, wheat flour
at 0.01 ppm, wheat germ at 0.02 ppm,
wheat aspirated grain fractions at 0.5
ppm. Tolerances of the parent,
aminopyralid (free) were also proposed
for milk at 0.02 ppm, cream at 0.02
ppm, edible animal tissues except
kidney at 0.05 ppm, and kidney at 1.0
ppm. That notice included a summary
of the petition prepared by Dow
AgroSciences, LLC, the registrant.
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, for a tolerance for free and
conjugated residues; of aminopyralid in
or on grass, forage at 25 ppm; grass, hay
at 50 ppm; aspirated grain fractions at
0.2 ppm; wheat, bran at 0.1 ppm; wheat
, forage at 2.0 ppm; wheat, grain at 0.04
ppm; wheat, hay at 4.0 ppm; wheat,
straw at 0.25 ppm; and for a tolerance
for residues of aminopyralid per se in or
on cattle, fat at 0.02 ppm; cattle, meat
at 0.02 ppm; cattle, meat byproducts,
except kidney at 0.02 ppm; cattle,
kidney at 0.3 ppm; goat, fat at 0.02 ppm;
goat, meat at 0.02 ppm; goat, meat
byproducts, except kidney at 0.02 ppm;
goat, kidney at 0.3 ppm; horse, fat at
0.02 ppm; horse, meat at 0.02 ppm;
horse, meat byproducts, except kidney
at 0.02 ppm; horse, kidney at 0.3 ppm;
sheep, fat at 0.02 ppm; sheep, meat at
0.02 ppm; sheep, meat byproducts,
except kidney at 0.02 ppm;
sheep,kidney at 0.3 ppm; and milk at
0.03 ppm. EPA’s assessment of
exposures and risks associatedwith
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 aminopyralid 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.
Studies were performed using
aminopyralid technical acid (XDE-750)
and a formulation (GF-871) consisting of
triisopropanolamine salt of
aminopyralid (XDE-750 TIPA). Doses
(Table 1 and Table 2 of this unit) are
expressed as acid equivalents for all
studies regardless of the material
administered to test animals.
TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY
Guideline
No.
Study type
Results
870.3100
2001 13–Week feeding—rat
(XDE-750) with 4 week recovery period
NOAEL = 500 milligrams/kilogram/day (mg/kg/day) for males (M) and 1,000 mg/kg/day for
females (F)
LOAEL M = 1,000 mg/kg/day based on hyperplasia of mucosal epithelium of the ileum and
cecum.
F = not determined
870.3100
2004 13–Week feeding—rat
(GF-871)
NOAEL = 520 mg/kg/day
LOAEL = mg/kg/day: not determined
870.3100
2001 13–Week feeding—mouse
(XDE-750)
NOAEL = 1,000 mg/kg/day
LOAEL = mg/kg/day: not determined
870.3200
2002 28–Day dermal—rat
(XDE-750)
Systemic:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Dermal:
NOAEL = M= 100 mg/kg/day
F = 1,000 mg/kg/day
LOAEL = M = 500 mg/kg/day, based on histopathological changes (slight epidermal
hyperplasia
F= not determined
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46421
TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued
Guideline
No.
Study type
Results
870.3150
2002 13–Week feeding—dog
(XDE-750)
NOAEL = M = 282 mg/kg/day
F = 232 mg/kg/day
LOAEL = M = 1,070 mg/kg/day
F = 929 mg/kg/day, based on stomach histopathology (slight diffuse hyperplasia and hypertrophy of the mucosal epithelium)
870.3700
2002 Developmental tox—rabbit
(XDE-750)
Maternal:
NOAEL = 250 mg/kg/day
LOAEL = 500 mg/kg/day, based on decrease in body weight (GD 7–10), decreased food
consumption, incoordinated gait (23/26), and ulcers and erosions of the stomach.
Developmental:
NOAEL = 500 mg/kg/day
LOAEL = (mg/kg/day) not determined
870.3700
2004 Developmental tox—rabbit
(GF-871)
Maternal:
NOAEL = 104 mg/kg/day
LOAEL = 260 mg/kg/day, based on severe inanition and body weight loss, decreased fecal
output, and mild incoordinated gait
Developmental:
NOAEL = 260 mg/kg/day
LOAEL = 520 mg/kg/day, based on decreased fetal body weight.
870.3700
2001 Developmental tox—rat
(XDE-750)
Maternal:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Developmental:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
870.3700
2004 Developmental tox—rat
(GF-871)
Maternal:
NOAEL = 520 mg/kg/day
LOAEL = mg/kg/day, not determined
Developmental:
NOAEL = 520 mg/kg/day
LOAEL = (mg/kg/day) not determined
870.3800
2003 2–Generation
tion—rat
(XDE-750)
Parental/Systemic:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Reproductive:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Offspring:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined.
870.4100
2003 1–Year feeding—dogs
(XDE-750)
NOAEL = M = 99 mg/kg/day
F = 93 mg/kg/day
LOAEL = M = 967 mg/kg/day
F = 1038 mg/kg/day, based on thickening of stomach mucosa (F), and stomach
histopathology in all animals (slight diffuse hyperplasia and hypertrophy of the mucosa epithelium, slight lymphoid hyperplasia of the gastric mucosa and very slight/slight chronic
mucosal inflammation).
870.4200
2003
18–Month
genicity—mice
(XDE-750)
NOAEL = M = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
870.4300
2004 2–Year carcinogenicity—
rats
(XDE-750)
NOAEL = 50 mg/kg/day
LOAEL = 500 mg/kg/day based on cecal enlargement, slight mucosal hyperplasia (M) and
slightly decreased body weights.
870.5100
2004 Bacterial reverse mutation
assay
(XDE-750)
Negative
870.5100
2004 Bacterial reverse mutation
assay
(GF-871)
XDETIPA
Negative
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TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued
Guideline
No.
Study type
Results
870.5300
2004 In vitro mammalian cell
gene mutation test
Negative
870.5300
2004 In vitro mammalian cell
gene mutation test
(GF-871)
Negative
870.5375
2004 In vitro mammalian cell
chromosome aberration test
(XDE-750)
XDE induced chromosome aberations, but only at cytotoxic concentrations, the clastogenic
response was induced secondary to toxicity.
870.5375
2004 In vitro Mammalian cell
chromosome aberration test
(GF-871)
Negative
870.5395
2002 Mammalian erythrocyte
micronucleus test (XDE-750)
Negative
870.5395
2004 Mammalian erythrocyte
micronucleus test (GF-871)
Negative
870.6200
Acute neurotoxicity
battery
(XDE-750)
NOAEL = 1,000 mg/kg/day
LOAEL = 2,000 mg/kg/day based on fecal soiling in M and urine soiling in F.
870.6200
Chronic neurotoxicity—rat (XDE750)
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined.
870.7485
2004 Metabolism and
macokinetics—rat
(XDE-750)
Recovery after 168 hrs: 96% in low dose (urine–50%, feces– 43%, tissues–0.1%, cage
wash–3%), 95% in high dose (urine–41%, feces–43%, tissues–1%, caged wash– 10%),
and 95% in the repeated low dose (urine–59%, feces– 33%, tissues–0.1%, cage wash–
3%). XDE-750 represented ≥96% of administered dose (AD) in urine and 100% AD in
feces. Three unknown components (≥4%) found in urine were also found in dose formulations.
Non-guideline
Triisopropanolamine Salt, Dissociation and Metabolism in
Maile Fischer 344—rats
(XDE-750)
screening
phar-
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
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14C-XDE-750
and 14C-XDE-750-TIPA, when administered orally to rats, were bioequivalent
in terms of absorption, distribution, metabolism, and excretion of the amino-dichloropicolinate portion of the molecule(s)
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
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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
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
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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
46423
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 aminopyralid used for
human risk assessment is shown in
Table 2 of this unit:
TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CHEMICAL FOR USE IN HUMAN RISK ASSESSMENTS
Exposure scenario
Dose used in risk assessment, UF
Special FQPA SF and level
of concern for risk assessment
Acute dietary
(General population, including
infants and children)
Study and toxicological effects
No appropriate toxicological endpoint attributable to a single exposure was identified in
the available toxicology studies.
Chronic dietary
(All populations)
NOAEL= 50 mg/kg/day
UF= 100
Chronic RfD=0.5 mg/kg/day
cPAD= cRfd/FQPA SF
cPAD= 0.5 mg/kg/day
Chronic toxicity/carcinogenicity study
LOAEL= 500mg/kg/daybased on cecal enlargement, slight mucosal hyperplasia in males and
slightly decreased body weights.
Incidental oral
Short-term (1-30 days)
NOAEL= 104 mg /kg/day
Residential LOC for MOE =
100
Occupational LOC for MOE
= 100
Developmental rabbit study (GF-871)
LOAEL=260 mg/kg/daybased on severe inanition (exhaustion due to lack of food) and body
weight loss, decreased fecal output, and mild
incoordinated gait.
Incidental oral
Intermediate-term (1–6 months)
NOAEL = 104 mg /kg/day
Residential LOC for MOE =
100
Occupational LOC for MOE
= 100
Developmental rabbit study (GF-871)
LOAEL=260 mg/kg/day based on severe inanition (exhaustion due to lack of food) and body
weight loss, decreased fecal output, and mild
incoordinated gait.
Dermal
Short-term (1–30 days)
N/A
N/A
No endpoint identified for this group.
No absorption study available.
No systemic toxicity seen at the limit dose
(1,000 mg/kg/day) in the 28–day dermal toxicity study in rats.
Dermal
Intermediate-term (1–6 months)
N/A
N/A
No endpoint identified for this group.
No absorption study available.
No systemic toxicity seen at the limit dose
(1,000 mg/kg/day) in the 28–day dermal toxicity study in rats.
Dermal
Long-term (> 6 months)
N/A
N/A
No endpoint identified for this group.
No absorption study available.
No systemic toxicity seen at the limit dose
(1,000 mg/kg/day) in the 28–day dermal toxicity study in rats.
Inhalation
Short-term (1–30 days)
NOAEL = 104 mg /kg/day
Residential LOC for MOE =
100
Occupational LOC for MOE
= 100
Developmental rabbit study (GF-871)
LOAEL = 260 mg/kg/day based on severe inanition (loss of vitality due to lack of food) and
body weight loss, decreased fecal output, and
mild incoordinated gait.
Inhalation
Intermediate-term (1–6 months)
NOAEL = 104 mg /kg/day
Residential LOC for MOE =
100
Occupational LOC for MOE
= 100
Developmental rabbit study (GF-871)
LOAEL=260 mg/kg/day based on severe inanition (loss of vitality due to lack of food) and
body weight loss, decreased fecal output, and
mild incoordinated gait.
Inhalation
Long-term (> 6 months)
N/A
N/A
N/A
Cancer
(Oral, dermal, inhalation)
Classification: There was no treatment related increase in tumor incidence when compared to control. This
chemical is not likely to be a carcinogen.
LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, N/A = Not Applicable
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Currently, no tolerances have
been established for the residues of
aminopyralid, in or on any raw
agricultural commodity. Risk
assessments were conducted by EPA to
assess dietary exposures from
aminopyralid 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. An endpoint of
concern attributable to a single dose of
aminopyralid was not identified.
Therefore, an acute dietary exposure
assessment was not conducted.
ii. Chronic exposure. In conducting
the chronic dietary risk assessment EPA
used the LifelineTM Model Version 2.0
software which incorporates food
consumption data as reported by
respondents in the USDA 1994–1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments. This
risk assessment assumed that 100%
crop treated for all food and feed
commodities and tolerance level
residues.
The dietary exposure was based on
residues of aminopyralid in or on grass
and wheat commodities treated with
formulations of its
triisopropanolammonium (TIPA) salt
and potential drinking water exposure.
Total dietary exposures for the U.S.
population and all subpopulations were
less than 0.0013 mg/kg/day.
iii. Cancer. Aminopyralid is classified
as ‘‘not likely to be carcinogenic to
humans’’ based on the lack of evidence
for carcinogenicity in mice and rats.
Therefore, a quantitative cancer
exposure assessment was not
conducted.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide chemicals that have
been measured in food. If EPA relies on
such information, EPA must pursuant to
section 408(f)(1) of FFDCA require that
data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. Following the initial data
submission, EPA is authorized to
require similar data on a time frame it
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deems appropriate. For the present
action, EPA did not rely on anticipated
residues or PCT information.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
aminopyralid in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
aminopyralid.
The Agency uses the Generic
Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate
pesticide concentrations in surface
water and the Screening Concentration
in Ground Water Modeling System (SCIGROW), which predicts pesticide
concentrations in ground water. In
general, EPA will use GENEEC (a tier 1
model) before using PRZM/EXAMS (a
tier 2 model) for a screening-level
assessment for surface water. The
GENEEC model is a subset of the PRZM/
EXAMS model that uses a specific highend runoff scenario for pesticides.
GENEEC incorporates a farm pond
scenario, while PRZM/EXAMS
incorporate an index reservoir
environment in place of the previous
pond scenario. The PRZM/EXAMS
model includes 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.
Aminopyralid is relatively persistent
in the environment at relevant pH’s and
temperatures. It is rapidly
photodegraded in water under favorable
light conditions. Laboratory studies
found a half-life of 0.6 day. In addition
to carbon dioxide, there were two major
degradates, oxamic acid and malonamic
acid, other degradates were at least four
different 2 and 3 carbon acid amides.
Photodegradation is expected to be a
significant route of dissipation for
aminopyralid in the environment in
clear shallow surface water.
Aminopyralid photogradades
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moderately slowly on soil, with half-life
of 72.2 days in one study.
Aminopyralid is mobile in soils and
generally is not expected to bind to
aquatic sediments. Based on
resultsreported in terrestrial field
dissipation studies, aminopyralid
appears to be non-persistent in the field.
No majordegradates were identified.
Since the models used are considered
to be screening tools in the risk
assessment process, the Agency
estimated environmental concentrations
(EECs), which are the model estimates
of a pesticide’s concentration in water.
Estimated drinking water concentration
(EDWC) derived from these models are
used to quantify drinking water
exposure and risk as a %RfD or %PAD.
Based on the PRZM/EXAMS model,
the EECs of aminopyralid for chronic
exposures are estimated to be 1.937
parts per billion (ppb) for surface water
and 0.630 ppb for ground water. The
chronic estimated water concentrations
derived from surface water modeling
results were significantly higher than
the modeled ground water
concentrations, and therefore protective
of potential exposures via ground water
sources of drinking water when
incorporated into aggregate exposure
estimates. The aminopyralid EEC’s were
incorporated into LifeLineTM Model
Version 2.0 to determine aggregate
pesticide exposures from pesticide
residues in the diet.
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).Aminopyralid has no pending
applications to register any use on
residential sites; however, use of
aminopyralid is requested on
campgrounds and other natural
recreation areas. Such use could result
in post-application incidental oral
exposures for infants and children.
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.’’
Aminopyralid is a pyridinecarboxylic
acids as are the pesticides picloram and
clopyralid. Although these pesticides
share a common herbicidal mode-ofaction (auxinic growth regulation), this
auxinic growth process in plants is not
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present in mammals. No common mode
of mammalian toxicity has been
identified for auxinic herbicides. An
evaluation of the mammalian toxicology
databases of all three active ingredients
for target organ toxicities indicates that
there is no evidence that the same toxic
effect occurs in or at the same organ or
tissue by essentially the same sequence
of major biochemical events.
For the purposes of this tolerance
action, therefore, EPA has not assumed
that aminopyralid 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 Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative/.
D. Safety Factor for Infants and
Children
1.In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for pre-natal
and post-natal 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 UFs (safety) in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Pre-natal and post-natal sensitivity.
There is no evidence of increased
qualitative or quantitative susceptibility
of the fetuses in the rat or rabbit
developmental toxicity studies (XDE750 and GF-871) or in a 2-generation
reproduction study (rat) after exposure
to aminopyralid. The toxicology
database is complete with respect to
pre- and post-natal toxicity. Therefore,
EPA has no residual uncertainty
regarding this finding.
In an acute neurotoxicity study in rats
with XDE-750, there were no treatment-
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related effects on the Functional
Observational Battery (FOB), motor
activity, or neuropathological
observations. Clinical observations of
rats in the 2,000 mg/kg/day group
revealed a higher incidence of fecal
soiling in males and urine soiling in
females compared to the controls.
However, these effects were transient
(most resolving within 3–4 days of
treatment) and without gross or
neuropathologic changes. In addition, a
chronic neurotoxicity study in rats did
not demonstrate effects that would
suggest neurotoxicity. In developmental
toxicity studies in rabbits with
aminopyralid (XDE-750 and GF-871)
incoordinated gait was observed in
males and females in the mid- and highdose groups. However this finding was
transient, with complete reversal within
2 hours post-dosing. Incoordinated gait
was not observed in any of the other
toxicity studies reviewed. A
developmental neurotoxicity study
(DNT) is not recommended based on
these studies.
3. Conclusion. There is a complete
toxicity database for aminopyralid and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures.The
FQPA SF was reduced to 1X, based
upon the following: As mentioned
above, there is no quantitative or
qualitative evidence of increased
susceptibility of rat and rabbit fetuses to
in utero exposure to aminopyralid in
developmental toxicity studies. There is
no quantitative or qualitative evidence
of increased susceptibility to
aminopyralid following pre-/post-natal
exposure in a 2-generation reproduction
study. In addition, there is no concern
for developmental neurotoxicity
resulting from exposure to
aminopyralid, and a developmental
neurotoxicity study is not required.
Furthermore, the chronic dietary food
exposure assessment assumes 100%
crops treated for all commodities. The
dietary drinking water assessment
utilizes water concentration values
generated by model and associated
modeling parameters which are
designed to provide conservative, health
protective, high-end estimates of water
concentrations which will not likely be
exceeded. Finally, for the proposed uses
for aminopyralid which result in
recreational exposure; default
assumptions, that result in high-end
estimates of exposure, were used.
E. Aggregate Risks and Determination of
Safety
The Agency currently has two ways to
estimate total aggregate exposure to a
pesticide from food, drinking water, and
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46425
residential uses. First, a screening
assessment can be used, in which the
Agency calculates drinking water levels
of comparison (DWLOCs) which are
used as a point of comparison against
EECs. The DWLOC values are not
regulatory standards for drinking water,
but are theoretical upper limits on a
pesticide’s concentration in drinking
water in light of total aggregate exposure
to a pesticide in food and residential
uses. In calculating a DWLOC, the
Agency determines how much of the
acceptable exposure (i.e., the PAD) is
available for exposure through drinking
water [e.g., allowable chronic water
exposure (mg/kg/day) = cPAD - (average
food + residential exposure)]. This
allowable exposure through drinking
water is used to calculate a DWLOC.
A DWLOC will vary depending on the
toxic endpoint, drinking water
consumption, and body weights. Default
body weights and consumption values
as used by the EPA’s Office of Water are
used to calculate DWLOCs: 2 liter (L)/
70 kg (adult male), 2L/60 kg (adult
female), and 1L/10 kg (child). Different
populations will have different
DWLOCs. Generally, a DWLOC is
calculated for each type of risk
assessment used: Acute, short-term,
intermediate-term, chronic, and cancer.
When EECs for surface water and
ground water are less than the
calculated DWLOCs, OPP concludes
with reasonable certainty that exposures
to the pesticide in drinking water (when
considered along with other sources of
exposure for which OPP has reliable
data) would not result in unacceptable
levels of aggregate human health risk at
this time. Because OPP considers the
aggregate risk resulting from multiple
exposure pathways associated with a
pesticide’s uses, levels of comparison in
drinking water may vary as those uses
change. When new uses are added OPP
reassesses the potential impacts of
residues of the pesticide in drinking
water as a part of the aggregate risk
assessment process.
More recently the Agency has used
another approach to estimate aggregate
exposure through food, residential and
drinking water pathways. In this
approach, modeled surface and ground
water EECs are directly incorporated
into the dietary exposure analysis, along
with food. This provides a more realistic
estimate of exposure because actual
body weights and water consumption
from the CSFII are used. The combined
food and water exposures are then
added to estimated exposure from
residential sources to calculate aggregate
risks. The resulting exposure and risk
estimates are still considered to be high
end, due to the assumptions used in
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developing drinking water modeling
inputs.
1. Acute risk. An endpoint of concern
attributable to a single dose was not
identified. Therefore, no acute risk is
expected.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to aminopyralid from food
plus drinking water will utilize <1% of
the cPAD for the U.S. population, <1%
of the cPAD for children 1–2 years old
, and <1% of the cPAD for children 6–
12 years old. There are no residential
uses for aminopyralid that result in
chronic residential exposure to
aminopyralid.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Although there will not be any
residential uses for aminopyralid, Dow
AgroSciences, LLC has pending
applications for use-sites: Campgrounds
and recreational areas. EPA has
completed short-term risk assessment
for these use-sites. The risk assessment
was for the potential post-application
exposure of infants and children, based
on hand-to-mouth transfer of residues
and ingestion of aminopyralidcontaminated grass and soil. Postapplication inhalation exposure is not
expected to occur. For the risk
assessment of these incidental
exposures, the NOAEL of 104 mg/kg/
day found in the rabbit development
study, was used. The combined
exposures from food and drinking water
and these incidental exposures were
used to estimate short-term aggregate
risk for infants and children. The Table
3 of this unit gives the EPA’s short-term
exposure and risk estimates for
aminopyralid, resulting from potential
exposures from food, drinking water
and the recreational uses of
aminopyralid.
TABLE 3.—SHORT-TERM AGGREGATE EXPOSURE AND RISK ESTIMATES FOR AMINOPYRALID
Population subgroup
Exposure, mg/kg/day
NOAEL, mg/
kg/day
Aggregate MOE
Dietary
Total non-dietary
Total aggregate
All infants (< 1
year)
104
0.00052
0.0021
0.00262
40,000
Children 1–2 years
104
0.00120
0.0021
0.00330
32,000
Children 3–5 years
104
0.00088
0.0021
0.00298
35,000
Children 6–12
years
104
0.00052
0.0021
0.00262
40,000
The EPA acknowledges that the
aggregate exposure and risk estimates
for infants and children are likely
overestimates and the coincidence of
such exposures will not be common.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Aminopyralid has no pending
registration for any sites that would
result in intermediate-term exposure.
While there is potential short-term
exposure from the campgrounds and
recreation area uses, there are no
potential intermediate-term (30–180
days) exposures.
5. Aggregate cancer risk for U.S.
population. Aminopyralid has not been
shown to be carcinogenic. Therefore,
aminopyralid is not expected to pose a
cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to
aminopyralid residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
liquid chromotography and positive ion
electrospray tandem spectrometry with
limits of quantitation of 0.01 ppm, is
available to enforce the tolerance
expression. 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.
B. International Residue Limits
There are currently no established
Codex, Canadian, or Mexican maximum
residue limits for aminopyralid.
C. Conditions
Dow AgroScience, LLC must submit
storage stability data for grass forage and
hay reflecting up to approximately 15
months of frozen storage.
D. Public Comments
One comment was received. B.
Sachau objected to the proposed
tolerance because of the amounts of
pesticides already consumed and
carried by the American population.
The commenter also claimed that tests
conducted with animals have absolutely
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no validity and are cruel to the
testanimals. EPA has responded to B.
Sachau’s generalized comments on
numerous previous occasions. (See the
Federal Register of January 7, 2005 (70
FR 1349–1354) (FRL–7691–4) and the
Federal Register of October 29, 2004 (69
FR 63083–63096) (FRL–7681–9)).
V. Conclusion
Therefore, the tolerances are
established for residues of
aminopyralid, free and conjugated
residues, in or on aspirated grain
fractions at 0.2 ppm; grass, forage at 25
ppm; grass, hay at 50 ppm; wheat bran
at 0.1 ppm; wheat , forage at 2.0 ppm;
wheat, grain at 0.04 ppm; wheat, hay at
4.0 ppm; wheat, straw at 0.25 ppm; and
tolerances are established for residues of
aminopyralid in or on cattle, fat at 0.02
ppm; cattle, meat at 0.02 ppm; cattle,
meat byproducts, except kidney at 0.02
ppm; cattle, kidney at 0.3 ppm; goat, fat
at 0.02 ppm; goat, meat at 0.02 ppm;
goat, meat byproducts, except kidney at
0.02 ppm; goat, kidney at 0.3 ppm;
horse, fat at 0.02 ppm; horse, meat at
0.02 ppm; horse, meat byproducts,
except kidney at 0.02 ppm; horse,
kidney at 0.3 ppm; milk at 0.03 ppm;
sheep, fat at 0.02 ppm; sheep, meat at
0.02 ppm; sheep, meat byproducts,
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except kidney at 0.02 ppm; and sheep,
kidney at 0.3 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–2004–0139 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 October 11, 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 on which a hearing is
requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
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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–2004–0139 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 in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
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46427
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
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
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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
Dated: July 27, 2005.
James Jones,
Director, Office of Pesticide Programs.
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 05–15523 Filed 8–9–05; 8:45 am]
I
Therefore, 40 CFR chapter I is
amended as follows:
BILLING CODE 6560–50–S
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.610 is added to subpart
C to read as follows:
I
§ 180.610 Aminopyralid; tolerances for
residues.
(a ) General. (1) Tolerances are
established for free and conjugated
residues of the herbicide, aminopyralid
(2-pyridine carboxylic acid, 4-amino3,6-dichloro-) calculated as
aminopyralid in or on:
Commodity
Parts per million
Grass, forage ........
Grass, hay ............
Wheat, bran ..........
Wheat, forage .......
Wheat, grain .........
Wheat, hay ...........
Wheat, straw .........
Aspirated grain
fractions .............
25
50
0.1
2.0
0.04
4.0
0.25
0.2
(2) Tolerances are established for
residues of the herbicide aminopyralid
in or on:
Commodity
Parts per million
List of Subjects in 40 CFR Part 180
Cattle, fat ..............
Cattle, meat ..........
Cattle, meat byproducts, excluding kidney ..........
Cattle, kidney ........
Goat, fat ................
Goat, meat ............
Goat, meat byproducts, excluding
kidney ................
Goat, kidney .........
Horse, fat ..............
Horse, meat ..........
Horse, meat byproducts, excluding kidney ..........
Horse, kidney ........
Milk .......................
Sheep, fat .............
Sheep, meat .........
Sheep, meat byproducts, excluding kidney ..........
Sheep, kidney .......
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
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).
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[OPP–2005–0141; FRL–7728–1]
2-amino-4,5-dihydro-6-methyl-4-propyls-triazolo(1,5-alpha)pyrimidin-5-one
(PP796); Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation amends the
established exemption from the
requirement of a tolerance under 40 CFR
180.1065 for 2-amino-4,5-dihydro-6methyl-4-propyl-s-triazolo(1,5alpha)pyrimidin-5-one, which is also
known as ‘‘PP796’’, by increasing the
amount that can be used to not more
than 0.3 percent in formulation of
paraquat dichloride. Syngenta Crop
Protection submitted a pesticide
petition ((PP) 5E6929) requesting this
amendment.
This regulation is effective
August 10, 2005. Objections and
requests for hearings must be received
on or before October 11, 2005.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit III. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number OPP–2005–
0141. 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
publicly available, i.e., Confidential
Business Information (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.
DATES:
E:\FR\FM\10AUR1.SGM
10AUR1
]]>Agencies
[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Rules and Regulations]
[Pages 46419-46428]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15523]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0139; FRL-7724-8]
Aminopyralid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for free and conjugated
residues of aminopyralid in or on grass and wheat commodities; and
residues of aminopyralid in or meat; fat and meat byproducts, excluding
kidney; of cattle, goat, and sheep, and milk. Dow AgroSciences, LLC
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 August 10, 2005. Objections and
requests for hearings must be received on or before October 11, 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-2004-0139. 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., Confidential Business Information (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: JoanneMiller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6224; e-mail address: miller.joanne@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 on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttps://www.epa.gpo/opptsfrs/home/
guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of June 2, 2004 (69 FR 31106-31110) (FRL-
7359-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C.
[[Page 46420]]
346a(d)(3), announcing the filing of a pesticide petition (PP 4F6827,
incorrectly stated as 7F4851) by Dow AgroSciences, LLC, 9330 Zionsville
Rd., Indianapolis, IN 46268. The petition requested that 40 CFR part
180 be amended by establishing a tolerance for combined residues of the
herbicide aminopyralid (XDE-750): 4-amino-3,6-dichloropyridine-2-
carboxylic acid and its glucose conjugate, expressed as total parent in
or on grass forage at 25 parts per million (ppm), grass hay at 65 ppm,
wheat forage at 2 ppm, wheat hay at 4 ppm, wheat grain at 0.05 ppm,
wheat straw at 0.5 ppm, wheat bran at 0.1 ppm, wheat middlings at 0.02
ppm, wheat shorts at 0.05 ppm, wheat flour at 0.01 ppm, wheat germ at
0.02 ppm, wheat aspirated grain fractions at 0.5 ppm. Tolerances of the
parent, aminopyralid (free) were also proposed for milk at 0.02 ppm,
cream at 0.02 ppm, edible animal tissues except kidney at 0.05 ppm, and
kidney at 1.0 ppm. That notice included a summary of the petition
prepared by Dow AgroSciences, LLC, the registrant.
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, for a tolerance for free and conjugated residues;
of aminopyralid in or on grass, forage at 25 ppm; grass, hay at 50 ppm;
aspirated grain fractions at 0.2 ppm; wheat, bran at 0.1 ppm; wheat ,
forage at 2.0 ppm; wheat, grain at 0.04 ppm; wheat, hay at 4.0 ppm;
wheat, straw at 0.25 ppm; and for a tolerance for residues of
aminopyralid per se in or on cattle, fat at 0.02 ppm; cattle, meat at
0.02 ppm; cattle, meat byproducts, except kidney at 0.02 ppm; cattle,
kidney at 0.3 ppm; goat, fat at 0.02 ppm; goat, meat at 0.02 ppm; goat,
meat byproducts, except kidney at 0.02 ppm; goat, kidney at 0.3 ppm;
horse, fat at 0.02 ppm; horse, meat at 0.02 ppm; horse, meat
byproducts, except kidney at 0.02 ppm; horse, kidney at 0.3 ppm; sheep,
fat at 0.02 ppm; sheep, meat at 0.02 ppm; sheep, meat byproducts,
except kidney at 0.02 ppm; sheep,kidney at 0.3 ppm; and milk at 0.03
ppm. EPA's assessment of exposures and risks associatedwith
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 aminopyralid 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.
Studies were performed using aminopyralid technical acid (XDE-750)
and a formulation (GF-871) consisting of triisopropanolamine salt of
aminopyralid (XDE-750 TIPA). Doses (Table 1 and Table 2 of this unit)
are expressed as acid equivalents for all studies regardless of the
material administered to test animals.
Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study type Results
----------------------------------------------------------------------------------------------------------------
870.3100 2001 13-Week feeding--rat NOAEL = 500 milligrams/kilogram/day (mg/kg/
(XDE-750) with 4 week day) for males (M) and 1,000 mg/kg/day for
recovery period females (F)
LOAEL M = 1,000 mg/kg/day based on
hyperplasia of mucosal epithelium of the
ileum and cecum.
F = not determined
----------------------------------------
870.3100 2004 13-Week feeding--rat NOAEL = 520 mg/kg/day
(GF-871)................. LOAEL = mg/kg/day: not determined
----------------------------------------
870.3100 2001 13-Week feeding-- NOAEL = 1,000 mg/kg/day
mouse LOAEL = mg/kg/day: not determined
(XDE-750)................
----------------------------------------
870.3200 2002 28-Day dermal--rat Systemic:
(XDE-750)................ NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Dermal:
NOAEL = M= 100 mg/kg/day
F = 1,000 mg/kg/day
LOAEL = M = 500 mg/kg/day, based on
histopathological changes (slight epidermal
hyperplasia
F= not determined
----------------------------------------
[[Page 46421]]
870.3150 2002 13-Week feeding--dog NOAEL = M = 282 mg/kg/day
(XDE-750)................ F = 232 mg/kg/day
LOAEL = M = 1,070 mg/kg/day
F = 929 mg/kg/day, based on stomach
histopathology (slight diffuse hyperplasia
and hypertrophy of the mucosal epithelium)
----------------------------------------
870.3700 2002 Developmental tox-- Maternal:
rabbit NOAEL = 250 mg/kg/day
(XDE-750)................ LOAEL = 500 mg/kg/day, based on decrease in
body weight (GD 7-10), decreased food
consumption, incoordinated gait (23/26),
and ulcers and erosions of the stomach.
Developmental:
NOAEL = 500 mg/kg/day
LOAEL = (mg/kg/day) not determined
----------------------------------------
870.3700 2004 Developmental tox-- Maternal:
rabbit NOAEL = 104 mg/kg/day
(GF-871)................. LOAEL = 260 mg/kg/day, based on severe
inanition and body weight loss, decreased
fecal output, and mild incoordinated gait
Developmental:
NOAEL = 260 mg/kg/day
LOAEL = 520 mg/kg/day, based on decreased
fetal body weight.
----------------------------------------
870.3700 2001 Developmental tox-- Maternal:
rat NOAEL = 1,000 mg/kg/day
(XDE-750)................ LOAEL = (mg/kg/day) not determined
Developmental:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
----------------------------------------
870.3700 2004 Developmental tox-- Maternal:
rat NOAEL = 520 mg/kg/day
(GF-871)................. LOAEL = mg/kg/day, not determined
Developmental:
NOAEL = 520 mg/kg/day
LOAEL = (mg/kg/day) not determined
----------------------------------------
870.3800 2003 2-Generation Parental/Systemic:
reproduction--rat NOAEL = 1,000 mg/kg/day
(XDE-750)................ LOAEL = (mg/kg/day) not determined
Reproductive:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined
Offspring:
NOAEL = 1,000 mg/kg/day
LOAEL = (mg/kg/day) not determined.
----------------------------------------
870.4100 2003 1-Year feeding--dogs NOAEL = M = 99 mg/kg/day
(XDE-750)................ F = 93 mg/kg/day
LOAEL = M = 967 mg/kg/day
F = 1038 mg/kg/day, based on thickening of
stomach mucosa (F), and stomach
histopathology in all animals (slight
diffuse hyperplasia and hypertrophy of the
mucosa epithelium, slight lymphoid
hyperplasia of the gastric mucosa and very
slight/slight chronic mucosal
inflammation).
----------------------------------------
870.4200 2003 18-Month NOAEL = M = 1,000 mg/kg/day
carcinogenicity--mice LOAEL = (mg/kg/day) not determined
(XDE-750)................
----------------------------------------
870.4300 2004 2-Year NOAEL = 50 mg/kg/day
carcinogenicity--rats LOAEL = 500 mg/kg/day based on cecal
(XDE-750)................ enlargement, slight mucosal hyperplasia (M)
and slightly decreased body weights.
----------------------------------------
870.5100 2004 Bacterial reverse Negative
mutation assay
(XDE-750)................
----------------------------------------
870.5100 2004 Bacterial reverse Negative
mutation assay
(GF-871).................
XDETIPA..................
----------------------------------------
[[Page 46422]]
870.5300 2004 In vitro mammalian Negative
cell gene mutation test
----------------------------------------
870.5300 2004 In vitro mammalian Negative
cell gene mutation test
(GF-871).................
----------------------------------------
870.5375 2004 In vitro mammalian XDE induced chromosome aberations, but only
cell chromosome at cytotoxic concentrations, the
aberration test clastogenic response was induced secondary
(XDE-750)................ to toxicity.
----------------------------------------
870.5375 2004 In vitro Mammalian Negative
cell chromosome
aberration test
(GF-871).................
----------------------------------------
870.5395 2002 Mammalian Negative
erythrocyte micronucleus
test (XDE-750)
----------------------------------------
870.5395 2004 Mammalian Negative
erythrocyte micronucleus
test (GF-871)
----------------------------------------
870.6200 Acute neurotoxicity NOAEL = 1,000 mg/kg/day
screening battery LOAEL = 2,000 mg/kg/day based on fecal
(XDE-750)................ soiling in M and urine soiling in F.
----------------------------------------
870.6200 Chronic neurotoxicity-- NOAEL = 1,000 mg/kg/day
rat (XDE-750) LOAEL = (mg/kg/day) not determined.
----------------------------------------
870.7485 2004 Metabolism and Recovery after 168 hrs: 96% in low dose
pharmacokinetics--rat (urine-50%, feces- 43%, tissues-0.1%, cage
(XDE-750)................ wash-3%), 95% in high dose (urine-41%,
feces-43%, tissues-1%, caged wash- 10%),
and 95% in the repeated low dose (urine-
59%, feces- 33%, tissues-0.1%, cage wash-
3%). XDE-750 represented >=96% of
administered dose (AD) in urine and 100% AD
in feces. Three unknown components (>=4%)
found in urine were also found in dose
formulations.
----------------------------------------
Non-guideline Triisopropanolamine \14\C-XDE-750 and \14\C-XDE-750-TIPA, when
Salt, Dissociation and administered orally to rats, were
Metabolism in Maile bioequivalent in terms of absorption,
Fischer 344--rats distribution, metabolism, and excretion of
(XDE-750)................ the amino-dichloro-picolinate portion of
the molecule(s)
----------------------------------------------------------------------------------------------------------------
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 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
[[Page 46423]]
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 aminopyralid used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Doses and Endpoints for Chemical for Use in Human Risk Assessments
----------------------------------------------------------------------------------------------------------------
Special FQPA SF and
Exposure scenario Dose used in risk level of concern for Study and toxicological
assessment, UF risk assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary No appropriate
(General population, including toxicological endpoint
infants and children). attributable to a
single exposure was
identified in the
available toxicology
studies.
--------------------------------------
Chronic dietary NOAEL= 50 mg/kg/day cPAD= cRfd/FQPA SF Chronic toxicity/
(All populations).................... UF= 100............... cPAD= 0.5 mg/kg/day... carcinogenicity study
Chronic RfD=0.5 mg/kg/ LOAEL= 500mg/kg/
day. daybased on cecal
enlargement, slight
mucosal hyperplasia in
males and slightly
decreased body
weights.
--------------------------------------
Incidental oral NOAEL= 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Short-term (1[dash]30 days)......... = 100 study (GF-871)
Occupational LOC for LOAEL=260 mg/kg/
MOE = 100. daybased on severe
inanition (exhaustion
due to lack of food)
and body weight loss,
decreased fecal
output, and mild
incoordinated gait.
--------------------------------------
Incidental oral NOAEL = 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Intermediate-term (1-6 months)....... = 100 study (GF-871)
Occupational LOC for LOAEL=260 mg/kg/day
MOE = 100. based on severe
inanition (exhaustion
due to lack of food)
and body weight loss,
decreased fecal
output, and mild
incoordinated gait.
--------------------------------------
Dermal N/A N/A No endpoint identified
Short-term (1-30 days).............. for this group.
No absorption study
available.
No systemic toxicity
seen at the limit dose
(1,000 mg/kg/day) in
the 28-day dermal
toxicity study in
rats.
--------------------------------------
Dermal N/A N/A No endpoint identified
Intermediate-term (1-6 months)...... for this group.
No absorption study
available.
No systemic toxicity
seen at the limit dose
(1,000 mg/kg/day) in
the 28-day dermal
toxicity study in
rats.
--------------------------------------
Dermal N/A N/A No endpoint identified
Long-term (> 6 months).............. for this group.
No absorption study
available.
No systemic toxicity
seen at the limit dose
(1,000 mg/kg/day) in
the 28-day dermal
toxicity study in
rats.
--------------------------------------
Inhalation NOAEL = 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Short-term (1-30 days)............... = 100 study (GF-871)
Occupational LOC for LOAEL = 260 mg/kg/day
MOE = 100. based on severe
inanition (loss of
vitality due to lack
of food) and body
weight loss, decreased
fecal output, and mild
incoordinated gait.
--------------------------------------
Inhalation NOAEL = 104 mg /kg/day Residential LOC for MOE Developmental rabbit
Intermediate-term (1-6 months)....... = 100 study (GF-871)
Occupational LOC for LOAEL=260 mg/kg/day
MOE = 100. based on severe
inanition (loss of
vitality due to lack
of food) and body
weight loss, decreased
fecal output, and mild
incoordinated gait.
--------------------------------------
Inhalation N/A N/A N/A
Long-term (> 6 months)..............
--------------------------------------
Cancer Classification: There was no treatment related increase in tumor
(Oral, dermal, inhalation)........... incidence when compared to control. This chemical is not likely to be a
carcinogen.
----------------------------------------------------------------------------------------------------------------
LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD =
reference dose, MOE = margin of exposure, LOC = level of concern, N/A = Not Applicable
[[Page 46424]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Currently, no
tolerances have been established for the residues of aminopyralid, in
or on any raw agricultural commodity. Risk assessments were conducted
by EPA to assess dietary exposures from aminopyralid 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. An endpoint of concern attributable to a single dose
of aminopyralid was not identified. Therefore, an acute dietary
exposure assessment was not conducted.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Lifeline\TM\ Model Version 2.0 software which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments. This risk assessment assumed that 100% crop treated for
all food and feed commodities and tolerance level residues.
The dietary exposure was based on residues of aminopyralid in or on
grass and wheat commodities treated with formulations of its
triisopropanolammonium (TIPA) salt and potential drinking water
exposure. Total dietary exposures for the U.S. population and all
subpopulations were less than 0.0013 mg/kg/day.
iii. Cancer. Aminopyralid is classified as ``not likely to be
carcinogenic to humans'' based on the lack of evidence for
carcinogenicity in mice and rats. Therefore, a quantitative cancer
exposure assessment was not conducted.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) of FFDCA require that data be provided 5 years
after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. For the
present action, EPA did not rely on anticipated residues or PCT
information.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for aminopyralid in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of aminopyralid.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and the Screening Concentration in Ground Water Modeling System
(SCI-GROW), which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes 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.
Aminopyralid is relatively persistent in the environment at
relevant pH's and temperatures. It is rapidly photodegraded in water
under favorable light conditions. Laboratory studies found a half-life
of 0.6 day. In addition to carbon dioxide, there were two major
degradates, oxamic acid and malonamic acid, other degradates were at
least four different 2 and 3 carbon acid amides. Photodegradation is
expected to be a significant route of dissipation for aminopyralid in
the environment in clear shallow surface water. Aminopyralid
photogradades moderately slowly on soil, with half-life of 72.2 days in
one study.
Aminopyralid is mobile in soils and generally is not expected to
bind to aquatic sediments. Based on resultsreported in terrestrial
field dissipation studies, aminopyralid appears to be non-persistent in
the field. No majordegradates were identified.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency estimated environmental
concentrations (EECs), which are the model estimates of a pesticide's
concentration in water. Estimated drinking water concentration (EDWC)
derived from these models are used to quantify drinking water exposure
and risk as a %RfD or %PAD.
Based on the PRZM/EXAMS model, the EECs of aminopyralid for chronic
exposures are estimated to be 1.937 parts per billion (ppb) for surface
water and 0.630 ppb for ground water. The chronic estimated water
concentrations derived from surface water modeling results were
significantly higher than the modeled ground water concentrations, and
therefore protective of potential exposures via ground water sources of
drinking water when incorporated into aggregate exposure estimates. The
aminopyralid EEC's were incorporated into LifeLine\TM\ Model Version
2.0 to determine aggregate pesticide exposures from pesticide residues
in the diet.
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).Aminopyralid has no
pending applications to register any use on residential sites; however,
use of aminopyralid is requested on campgrounds and other natural
recreation areas. Such use could result in post-application incidental
oral exposures for infants and children.
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.''
Aminopyralid is a pyridinecarboxylic acids as are the pesticides
picloram and clopyralid. Although these pesticides share a common
herbicidal mode-of-action (auxinic growth regulation), this auxinic
growth process in plants is not
[[Page 46425]]
present in mammals. No common mode of mammalian toxicity has been
identified for auxinic herbicides. An evaluation of the mammalian
toxicology databases of all three active ingredients for target organ
toxicities indicates that there is no evidence that the same toxic
effect occurs in or at the same organ or tissue by essentially the same
sequence of major biochemical events.
For the purposes of this tolerance action, therefore, EPA has not
assumed that aminopyralid 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 Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at https://
www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for pre-natal and post-natal
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 UFs (safety) in calculating a dose level
that poses no appreciable risk to humans. In applying this provision,
EPA either retains the default value of 10X when reliable data do not
support the choice of a different factor, or, if reliable data are
available, EPA uses a different additional safety factor value based on
the use of traditional uncertainty factors and/or special FQPA safety
factors, as appropriate.
2. Pre-natal and post-natal sensitivity. There is no evidence of
increased qualitative or quantitative susceptibility of the fetuses in
the rat or rabbit developmental toxicity studies (XDE-750 and GF-871)
or in a 2-generation reproduction study (rat) after exposure to
aminopyralid. The toxicology database is complete with respect to pre-
and post-natal toxicity. Therefore, EPA has no residual uncertainty
regarding this finding.
In an acute neurotoxicity study in rats with XDE-750, there were no
treatment-related effects on the Functional Observational Battery
(FOB), motor activity, or neuropathological observations. Clinical
observations of rats in the 2,000 mg/kg/day group revealed a higher
incidence of fecal soiling in males and urine soiling in females
compared to the controls. However, these effects were transient (most
resolving within 3-4 days of treatment) and without gross or
neuropathologic changes. In addition, a chronic neurotoxicity study in
rats did not demonstrate effects that would suggest neurotoxicity. In
developmental toxicity studies in rabbits with aminopyralid (XDE-750
and GF-871) incoordinated gait was observed in males and females in the
mid- and high-dose groups. However this finding was transient, with
complete reversal within 2 hours post-dosing. Incoordinated gait was
not observed in any of the other toxicity studies reviewed. A
developmental neurotoxicity study (DNT) is not recommended based on
these studies.
3. Conclusion. There is a complete toxicity database for
aminopyralid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures.The FQPA SF was
reduced to 1X, based upon the following: As mentioned above, there is
no quantitative or qualitative evidence of increased susceptibility of
rat and rabbit fetuses to in utero exposure to aminopyralid in
developmental toxicity studies. There is no quantitative or qualitative
evidence of increased susceptibility to aminopyralid following pre-/
post-natal exposure in a 2-generation reproduction study. In addition,
there is no concern for developmental neurotoxicity resulting from
exposure to aminopyralid, and a developmental neurotoxicity study is
not required. Furthermore, the chronic dietary food exposure assessment
assumes 100% crops treated for all commodities. The dietary drinking
water assessment utilizes water concentration values generated by model
and associated modeling parameters which are designed to provide
conservative, health protective, high-end estimates of water
concentrations which will not likely be exceeded. Finally, for the
proposed uses for aminopyralid which result in recreational exposure;
default assumptions, that result in high-end estimates of exposure,
were used.
E. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against EECs. The DWLOC values are not
regulatory standards for drinking water, but are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. When new
uses are added OPP reassesses the potential impacts of residues of the
pesticide in drinking water as a part of the aggregate risk assessment
process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EECs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in
[[Page 46426]]
developing drinking water modeling inputs.
1. Acute risk. An endpoint of concern attributable to a single dose
was not identified. Therefore, no acute risk is expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
aminopyralid from food plus drinking water will utilize <1% of the cPAD
for the U.S. population, <1% of the cPAD for children 1-2 years old ,
and <1% of the cPAD for children 6-12 years old. There are no
residential uses for aminopyralid that result in chronic residential
exposure to aminopyralid.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Although there will not be any residential uses for aminopyralid,
Dow AgroSciences, LLC has pending applications for use-sites:
Campgrounds and recreational areas. EPA has completed short-term risk
assessment for these use-sites. The risk assessment was for the
potential post-application exposure of infants and children, based on
hand-to-mouth transfer of residues and ingestion of aminopyralid-
contaminated grass and soil. Post-application inhalation exposure is
not expected to occur. For the risk assessment of these incidental
exposures, the NOAEL of 104 mg/kg/day found in the rabbit development
study, was used. The combined exposures from food and drinking water
and these incidental exposures were used to estimate short-term
aggregate risk for infants and children. The Table 3 of this unit gives
the EPA's short-term exposure and risk estimates for aminopyralid,
resulting from potential exposures from food, drinking water and the
recreational uses of aminopyralid.
Table 3.--Short-Term Aggregate Exposure and Risk Estimates for Aminopyralid
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure, mg/kg/day
Population subgroup NOAEL, mg/kg/day ------------------------------------------------------------ Aggregate MOE
Dietary Total non-dietary Total aggregate
-------------------------------------------------------------------------------------------------------------------------------------
All infants (< 1 year) 104 0.00052 0.0021 0.00262 40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years 104 0.00120 0.0021 0.00330 32,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years 104 0.00088 0.0021 0.00298 35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years 104 0.00052 0.0021 0.00262 40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
The EPA acknowledges that the aggregate exposure and risk estimates
for infants and children are likely overestimates and the coincidence
of such exposures will not be common.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Aminopyralid has no pending registration for any sites that would
result in intermediate-term exposure. While there is potential short-
term exposure from the campgrounds and recreation area uses, there are
no potential intermediate-term (30-180 days) exposures.
5. Aggregate cancer risk for U.S. population. Aminopyralid has not
been shown to be carcinogenic. Therefore, aminopyralid is not expected
to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to aminopyralid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, liquid chromotography and
positive ion electrospray tandem spectrometry with limits of
quantitation of 0.01 ppm, is available to enforce the tolerance
expression. 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.
B. International Residue Limits
There are currently no established Codex, Canadian, or Mexican
maximum residue limits for aminopyralid.
C. Conditions
Dow AgroScience, LLC must submit storage stability data for grass
forage and hay reflecting up to approximately 15 months of frozen
storage.
D. Public Comments
One comment was received. B. Sachau objected to the proposed
tolerance because of the amounts of pesticides already consumed and
carried by the American population. The commenter also claimed that
tests conducted with animals have absolutely no validity and are cruel
to the testanimals. EPA has responded to B. Sachau's generalized
comments on numerous previous occasions. (See the Federal Register of
January 7, 2005 (70 FR 1349-1354) (FRL-7691-4) and the Federal Register
of October 29, 2004 (69 FR 63083-63096) (FRL-7681-9)).
V. Conclusion
Therefore, the tolerances are established for residues of
aminopyralid, free and conjugated residues, in or on aspirated grain
fractions at 0.2 ppm; grass, forage at 25 ppm; grass, hay at 50 ppm;
wheat bran at 0.1 ppm; wheat , forage at 2.0 ppm; wheat, grain at 0.04
ppm; wheat, hay at 4.0 ppm; wheat, straw at 0.25 ppm; and tolerances
are established for residues of aminopyralid in or on cattle, fat at
0.02 ppm; cattle, meat at 0.02 ppm; cattle, meat byproducts, except
kidney at 0.02 ppm; cattle, kidney at 0.3 ppm; goat, fat at 0.02 ppm;
goat, meat at 0.02 ppm; goat, meat byproducts, except kidney at 0.02
ppm; goat, kidney at 0.3 ppm; horse, fat at 0.02 ppm; horse, meat at
0.02 ppm; horse, meat byproducts, except kidney at 0.02 ppm; horse,
kidney at 0.3 ppm; milk at 0.03 ppm; sheep, fat at 0.02 ppm; sheep,
meat at 0.02 ppm; sheep, meat byproducts,
[[Page 46427]]
except kidney at 0.02 ppm; and sheep, kidney at 0.3 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-2004-0139 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 October
11, 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 on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ 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-2004-0139 to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues in the manner sought by
the requestor would be adequate to justify the action requested (40 CFR
178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance u
