Topramezone; Pesticide Tolerances, 46410-46419 [05-15604]
Download as PDF
<![CDATA[
46410
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
Indian Tribal Governments
This rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have a substantial
direct effect on one or more Indian
tribes, 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.
Energy Effects
We have analyzed this rule under
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use. We have
determined that it is not a ‘‘significant
energy action’’ under that order because
it is not a ‘‘significant regulatory action’’
under Executive Order 12866 and is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy. The Administrator of the Office
of Information and Regulatory Affairs
has not designated it as a significant
energy action. Therefore, it does not
require a Statement of Energy Effects
under Executive Order 13211.
Technical Standards
The National Technology Transfer
and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use
voluntary consensus standards in their
regulatory activities unless the agency
provides Congress, through the Office of
Management and Budget, with an
explanation of why using these
standards would be inconsistent with
applicable law or otherwise impractical.
Voluntary consensus standards are
technical standards (e.g., specifications
of materials, performance, design, or
operation; test methods; sampling
procedures; and related management
systems practices) that are developed or
adopted by voluntary consensus
standards bodies.
This rule does not use technical
standards. Therefore, we did not
consider the use of voluntary consensus
standards.
Environment
We have analyzed this rule under
Commandant Instruction M16475.lD,
which guides the Coast Guard in
complying with the National
Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321–4370f), and
have made a preliminary determination
that there are no factors in this case that
would limit the use of a categorical
exclusion under section 2.B.2 of the
Instruction. Therefore we believe this
rule should be categorically excluded,
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
under figure 2–1, paragraph 34 (g) from
further environmental documentation.
This temporary rule establishes a
regulated navigation area and as such is
covered by this paragraph.
A final ‘‘Environmental Analysis
Check List’’ and a final ‘‘Categorical
Exclusion Determination’’ are available
in the docket where indicated under
ADDRESSES. Comments on this section
will be considered before we make the
final decision on whether the rule
should be categorically excluded from
further environmental review.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and record keeping
requirements, Security measures,
Waterways.
I For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
I
Authority: 33 U.S.C. 1226, 1231; 46 U.S.C.
Chapter 701; 50 U.S.C. 191, 195; 33 CFR
1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L.
107–295, 116 Stat. 2064; Department of
Homeland Security Delegation No. 0170.1.
2. Add § 165.T09.102 to read as
follows:
I
§ 165.T09.102 Temporary Regulated
Navigation Area between mile markers
296.1 and 296.7 of the Chicago Sanitary and
Ship Canal located near Romeoville, IL.
(a) Location. The following is a
Regulated Navigation Area: All waters
of the Chicago Sanitary and Ship Canal,
Romeoville, IL beginning at the north
side of Romeo Road Bridge Mile Marker
296.1, and ending at the south side of
the Aerial Pipeline Mile Marker 296.7.
(b) Effective period: This rule is
effective from 12 p.m. (local) June 30,
2005 through 12 p.m. (local) December
31, 2005.
(c) Regulations. (1) The general
regulations contained in 33 CFR 165.13
apply.
(2) All vessels are prohibited from
loitering in the regulated navigation
area. Vessels may enter this section of
the waterway with the sole purpose of
transiting to the other side, and must
maintain headway throughout the
transit. All personnel on open decks
must wear a Coast Guard approved Type
I personal flotation device while in the
regulated navigation area until
subsequent field testing determines the
waters in this area do not pose
significant risk to human life. Vessels
may not moor or lay up on the right or
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
left descending banks. Towboats may
not make or break tows. Vessels may not
pass (meet or overtake) in the regulated
navigation area and must make a
SECURITE call when approaching the
barrier to announce intentions and work
out passing arrangements on either side.
Commercial tows transiting the barrier
must be made up with wire rope to
ensure electrical connectivity between
all segments of the tow.
(3) All persons and vessels shall
comply with this rule and any
additional instructions of the Ninth
Coast Guard District Commander, or his
designated representative.
Dated: June 30, 2005.
R.J. Papp, Jr.,
Rear Admiral, U.S. Coast Guard, Commander,
Ninth Coast Guard District.
[FR Doc. 05–15781 Filed 8–9–05; 8:45 am]
BILLING CODE 4910–15–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0156; FRL–7726–9]
Topramezone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of topramezone
in or on field corn, pop corn, sweet
corn, kidney, and liver. BASF
Corporation requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA).
DATES: This regulation is effective
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–2005–
0156. 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., 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
E:\FR\FM\10AUR1.SGM
10AUR1
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
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: Joanne I.
Miller, 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 (http:/
/www.epa.gov/edocket/), you may
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of June 11,
2003 (68 FR 34950) (FRL–7310–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 3F6568) by BASF
Corporation, P.O. Box 13528, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.612 be
amended by establishing tolerances for
residues of the herbicide topramezone,
[3-(4,5-dihydro-isoxazol-3-yl)-4methanesulfonyl-2-methylphenyl)-(5hydroxyl-1-methyl-1H-pyrazol-4yl)methanone, in or on corn, field,
forage; corn, field, grain; corn, field,
stover; corn, pop, grain; corn, pop,
stover; corn, sweet, forage; corn, sweet,
kernal plus cob with husks removed;
corn, sweet, stover; cattle, kidney; cattle,
liver; goat, kidney; goat, liver; hog,
kidney; hog, liver; horse, kidney; horse,
liver; sheep, kidney; and sheep, liver at
0.05; 0.01; 0.05; 0.01; 0.05; 0.05; 0.01;
0.05; 0.02; 0.70; 0.20; 0.70; 0.20; 0.70;
0.20; 0.70; 0.20; and 0.70 parts per
million (ppm), respectively. That notice
included a summary of the petition
prepared by BASF Corporation, the
registrant. There were no comments
received in response to the notice of
filing.
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
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
46411
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 residues of
topramezone on cattle, kidney at 0.05
ppm; cattle, liver at 0.15 ppm; corn,
field, forage at 0.05 ppm; corn, field,
grain at 0.01 ppm; corn, field, stover at
0.05 ppm; corn, pop, grain at 0.01 ppm;
corn, pop, stover at 0.05 ppm; corn,
sweet, forage at 0.05 ppm; corn, sweet,
kernal plus cob with husks removed at
0.01 ppm; corn, sweet, stover at 0.05
ppm; goat, kidney at 0.05 ppm; goat,
liver at 0.15 ppm; horse, kidney at 0.05
ppm; horse, liver at 0.15 ppm; sheep,
kidney at 0.05 ppm; and sheep, liver at
0.15 ppm, respectively.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
topramezone 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 .
E:\FR\FM\10AUR1.SGM
10AUR1
46412
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY
Guideline No.
Study Type
Results
870.3100
90-Day oral toxicity--rodents (rat)
NOAEL = 1.1 milligrams/kilogram/day (mg/kg/day) males (M) and 2.1 mg/kg/day females (F)
LOAEL = 2.1 mg/kg/day for males based on diffuse degeneration in the pancreas
and was not established for females
870.3100
90-Day oral toxicity--rodents (mouse)
NOAEL = 2,289/3,010 mg/kg/day (M/F)
LOAEL = was not established
870.3150
90-Day oral toxicity--nonrodents (dog)
NOAEL = 535/1,712 mg/kg/day (M/F)
LOAEL = 1,511 mg/kg/day for males based on decreased body-weight gain, impaired food efficiency, and inflammation of the urinary bladder and was not established for females
870.3200
28-Day dermal toxicity
(rat)
NOAEL = 100/300 mg/kg/day (M/F)
LOAEL = 300 mg/kg/day males based on thyroid follicular cell hypertrophy and
1,000 mg/kg/day females based on thyroid follicular cell hypertrophy
870.3700
Prenatal developmental-rodents (rat)
Maternal NOAEL = not established
Maternal LOAEL = 100 mg/kg/day based on decreased body-weight gains
Developmental NOAEL = not established
Developmental LOAEL = 100 mg/kg/day based on decreased fetal body weight and
increased incidences of skeletal variation
870.3700
Prenatal developmental-nonrodents (rabbit)
Maternal NOAEL = not established
Maternal LOAEL = 0.5 mg/kg/day based on increased serum tyrosine level
Developmental NOAEL = 0.5 mg/kg/day
Developmental LOAEL = 5 mg/kg/day based on alterations in skeletal ossification
sites and increased number of pairs of ribs
870.3700
Prenatal developmental-nonrodents (rabbit)
Maternal NOAEL = not established
Maternal LOAEL = 1.5 mg/kg/day based on increased serum tyrosine level
Developmental NOAEL = not established
Developmental LOAEL = 1.5 mg/kg/day based on an increased incidence of absent
kidney and ureter and increased incidences of supernumerary thoracic vertebrae
and supernumerary 13th rib
870.3700
Prenatal developmental-nonrodents (rabbit)
Maternal NOAEL = 5.0 mg/kg/day
Maternal LOAEL = was not established
Developmental NOAEL = not established
Developmental LOAEL = 1.5 mg/kg/day for N33 and N17/CFR 1–2 based on increased presence of supernumerary thoracic vertebrae and supernumerary 13th
rib. No effect was observed for N17/CFR 3 at 0.5 mg/kg/day (the only dose tested)
870.3700
Prenatal developmental-nonrodents (rabbit)
Maternal NOAEL = 450 mg/kg/day
Maternal LOAEL = not established
Developmental NOAEL = not established
Developmental LOAEL = 5 mg/kg/day based on visceral findings (fluid-filled abdomen, pale liver, and dark content of the stomach and intestines) and alterations in
skeletal development (i.e. incomplete ossification of the vertebrae and talus, and
supernumerary thoracic vertebrae and 13th rib)
870.3700
Prenatal developmental-nonrodents (rabbit)
Maternal NOAEL = 150 mg/kg/day
Maternal LOAEL = 450 mg/kg/day based on decreased body-weight, body-weight
gains, food consumption, and increased incidences of abortion and lack of defecation
Developmental NOAEL = not established
Developmental LOAEL = 50 mg/kg/day based on decreased fetal weight and increased incidence of visceral malformations, and skeletal malformations, variations, and unclassified abnormalities
870.3700
Prenatal developmental-nonrodents (rabbit)
Maternal NOAEL = 450 mg/kg/day
Maternal LOAEL = not established
Developmental NOAEL = 0.5 mg/kg/day
Developmental LOAEL = 5 mg/kg/day based on increased presence of 27 pre-sacral
vertebrae and increased an incidence of full supernumerary 13th rib
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
E:\FR\FM\10AUR1.SGM
10AUR1
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
46413
TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued
Guideline No.
Study Type
Results
870.3700
Prenatal developmental-nonrodents (rabbit)
Maternal NOAEL = 450 mg/kg/day
Maternal LOAEL = not established
Developmental NOAEL = not established
Developmental LOAEL = 50 mg/kg/day based on an increased incidence of extra
sternebral ossification sites and supernumerary 13th rib
870.3700
Prenatal developmental-nonrodents (mouse)
Maternal NOAEL = not established
Maternal LOAEL = 30 mg/kg/day based on increased serum tyrosine level
Developmental NOAEL = 1,000 mg/kg/day
Developmental LOAEL = not established
870.3800
Reproduction and fertility
effects (rat)
Parental/Systemic NOAEL = 0.4/0.5 mg/kg/day (M/F)
Parental/Systemic LOAEL = 4.2/4.6 mg/kg/day (M/F) based on decreased bodyweight, body-weight gain in males, increased thyroid and kidney weights of both
sexes, and microscopic findings in eyes, kidney, and thyroid of both sexes
Reproductive NOAEL = 426.8/471.9 mg/kg/day (M/F)
Reproductive LOAEL = not established
Offspring NOAEL = 0.4/0.5 mg/kg/day (M/F)
Offspring LOAEL = 4.2/4.6 mg/kg/day (M/F) based on decreased pup weight and
weight gain in F2 male and female pups and increased time to preputial separation in the F1 males
870.4100
Chronic toxicity--rodents
(rat)
NOAEL = 0.4/0.5 mg/kg/day (M/F)
LOAEL = 3.9/5.3 mg/kg/day (M/F) based on corneal opacity and pannus and chronic
keratitis in both sexes, and thyroid hypertrophy in males
870.4100
Chronic toxicity--dogs
NOAEL = 2.9/15.4 (M/F) mg/kg/day
LOAEL = 15.3 mg/kg/day (M) based on increased incidence of thyroid C-cell
hyperplasia and 92 mg/kg/day (F) based on decreased body-weight, body-weight
gain, and food efficiency
870.4200
Carcinogenicity--rats
NOAEL = 0.4/0.5 mg/kg/day (M/F)
LOAEL = 3.6/4.7 mg/kg/day (M/F) based on increased incidences of corneal opacity,
decreased body-weight and body-weight gains (males only) and histopathological
evaluations in the thyroids, pancreas, and eyes of both sexes
Neoplastic pathology showed increased incidences of follicular cell adenomas in the
thyroid glands of both sexes
870.4300
Carcinogenicity--mice
NOAEL = not established
LOAEL = 19/26 mg/kg/day (M/F) based on decreased body-weight and body-weight
gains in males
No evidence of carcinogenicity
870.5100
Gene mutation
No indication of a mutagenic response in any strain at any level up to cytotoxic concentrations either with or without S9 activation
870.5100
Gene mutation
Based on these considerations, it was concluded that there was confirmed evidence
of a mutagenic response in S. typhimurium TA98 in the nonactivated portion of
both the plate incorporation and preincubation assays. The effect was, however,
observed at high concentrations (≥ 3,000 µg/plate-plate incorporation and ≥ 2,500
µg/plate-preincubation). It was further concluded that the mutagenic effect was
likely due to impurities in the test article because: 1) The response was seen at
high concentrations including and exceeding the limit dose, 2) bacterial gene mutation assays conducted with other lots of the test material were negative up to
the limit dose (see Master Record Identification (MRID) Nos. 45902225 through
45902227, and 3) the active ingredient (a.i.) used in the current study has the lowest percentage of purity (95.8% versus 97.7 to 99.3% a.i. for the other lots)
870.5300
In vitro mammalian cell
gene mutation
No indication that topramezone induced a mutagenic response, either in the presence of absence of S9 activation
870.5375
In vitro mammalian chromosome aberration
Topramezone-induced a clastogenic response in the presence of S9 activation with
significant effects recorded only at an insoluble limit concentration
870.5395
In vivo mouse bone morrow micronucleus
No evidence that topramezone was clastogenic or aneugenic
870.5550
Unscheduled DNA synthesis (UDS)
No evidence that topramezone-induced UDS, as determined by radioactive tracer
procedures (nuclear silver grain counts) at any concentration tested
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
E:\FR\FM\10AUR1.SGM
10AUR1
46414
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued
Guideline No.
Study Type
Results
870.6200
Acute neurotoxicity
screening battery (rat)
NOAEL= 2,000 mg/kg/day, no neurotoxicity observed
870.6200
Subchronic neurotoxicity
(rat)
No neurotoxicity observed
Systemic NOAEL = not established
LOAEL = 4.2/5/0 mg/kg/day (M/F) based on elevated levels of granular casts and
transitional epithelial cells in the urinary sediment of the males, increased
incidences of corneal clouding in females, minimal diffuse degeneration of the
pancreas (both sexes), and slight to moderate flaky colloid in the thyroid of the
males
870.6300
Developmental
neurotoxicity (rat)
Maternal NOAEL = not established
Maternal LOAEL = 8 mg/kg/day based on corneal opacities
Offspring NOAEL = not established
Offspring LOAEL = 8 mg/kg/day based on decreased auditory startle reflex response
870.7485
Metabolism and pharmacokinetics
Absorption of [14C]-topramezone following a single oral dose was rapid but limited,
with the highest plasma concentrations observed at 1 hour (first time point measured). Oral absorption is estimated to be approximately 20% of the administered
dose. The majority of the dose was recovered within 48 hours in the feces (73–
91% dose) and urine (8–29% dose)
870.7600
Dermal penetration
The majority of the applied dose for each group was not absorbed (91.0–98.3%
dose), with the greatest amount of the non-absorbed material being recovered
from the skin wash (90.8–96.0% dose). Absorbed radioactivity was low and accounted for 0.16–2.60% of the dose for all groups for all exposures
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, 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
uncertainty factors 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
uncertainty factors used prior to FQPA
passage to account for database
deficiencies. These traditional
uncertainty factors have been
incorporated by the FQPA into the
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
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
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of
exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify
carcinogenic risk. The Q* approach
assumes that any amount of exposure
will lead to some degree of cancer risk.
A Q* is calculated and used to estimate
risk which represents a probability of
occurrence of additional cancer cases
(e.g., risk). An example of how such a
probability risk is expressed would be to
describe the risk as one in one hundred
thousand (1 X 10-5), one in a million (1
X 10-6), or one in ten million (1 X 10-7).
Under certain specific circumstances,
MOE calculations will be used for the
carcinogenic risk assessment. In this
non-linear approach, a ‘‘point of
departure’’ in 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 topramezone used for
human risk assessment is shown in
Table 2. of this unit:
E:\FR\FM\10AUR1.SGM
10AUR1
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
46415
TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TOPRAMEZONE FOR USE IN HUMAN RISK
ASSESSMENT
Exposure Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
Level of Concern for Risk
Assessment
Study and Toxicological Effects
Acute Dietary (Females 13–50
years of age)
NOAEL = 0.5 mg/kg/day
UF = 100
Acute RfD = 0.005 mg/kg/day
Special FQPA SF = 1X
aPAD = acute RfD ÷ Special FQPA SF = 0.005
mg/kg/day
Developmental Toxicity Study in Rabbits
LOAEL = 5 mg/kg/day based on alterations in
skeletal ossification sites and increased
number of pairs of ribs
Acute Dietary (General population including infants and
children)
An endpoint of concern for the general population attributable to a single dose was not identified in the hazard database
Chronic Dietary (All populations)
NOAEL= 0.4 mg/kg/day
UF = 100
Chronic RfD = 0.004 mg/kg/
day
Cancer (oral, dermal, inhalation)
In accordance with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29, 2005), EPA classified topramezone as ‘‘not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.’’ EPA determined that quantification of human cancer risk is not required since the
NOAEL (0.4 mg/kg/day) for non-cancer risk assessment is not expected to alter thyroid hormone homeostasis nor result in thyroid tumor formation
Topramezone inhibits the 4hydroxyphenylpyruvate dioxygenase (4HPPD) enzyme in the metabolism of
tyrosine. Inhibition of this enzyme
results in increased serum tyrosine
levels and eventually in adverse effects
in the animal with increased incidences
of corneal opacity, decreased bodyweight, and body-weight gains. The
petitioner conducted eight rabbit studies
to determine the NOAEL for increased
serum tyrosine levels as well as
determine the NOAELs for systemic
maternal and fetal developmental
toxicity endpoints that are not based on
tyrosine measurements.
There are well established NOAELs
and LOAELs for the standard endpoints
for maternal and developmental toxicity
in rabbits. Currently, it is not known
what level of inhibition of the 4-HPPD
enzyme results in an adverse effect.
Therefore, the observation of enzyme
inhibition in the absence of systemic
toxicity in maternal animals or soft
tissue or skeletal alterations in pups/
offspring are being considered to be a
biomarker of exposure, not an adverse
effect. None of the data in the submitted
studies permit a determination of the
percentage of increased tyrosine levels
that result in detrimental or adverse
effects.
The lowest maternal LOAEL observed
in the numerous rabbit developmental
toxicity studies was 0.5 mg/kg/day. It is
not clear, however, that this value is
actually a LOAEL because it is based on
increased serum tyrosine levels. In this
study it could not be determined what
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
Special FQPA SF = 1X
cPAD = chronic RfD ÷
Special FQPA SF =
0.004 mg/kg/day
dose would not induce increased serum
tyrosine levels. In fact, in no study
could a ‘‘no effect’’ level be determined
for increased serum tyrosine levels in
dams. However, a maternal NOAEL of 5
mg/kg/day was observed in another
study based on systemic toxicity; in this
study tyrosine measurements were not
performed. This study has the lowest
maternal NOAEL for systemic toxicity
among the eight rabbit developmental
toxicity studies. Tyrosine levels were
not measured for fetuses in any of the
rabbit developmental studies. There was
a clear developmental toxicity NOAEL
of 0.5 mg/kg/day, based on skeletal
variations observed at 5 mg/kg/day.
The acute RfD for females 13–49 years
of age is based on a NOAEL of 0.5 mg/
kg/day for alterations in skeletal
ossification sites in rabbits. The chronic
RfD is based on the NOAEL of 0.4 mg/
kg/day in the carcinogenicity study in
rats. In this study the LOAEL was based
on increased incidence of corneal
opacities, decrease in body weight gain,
liver, pancreas, and thyroid effects seen
at 3.6 mg/kg/day.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. No tolerances have been
established (40 CFR 180.612) previously
for the residues of topramezone. Risk
assessments were conducted by EPA to
assess dietary exposures from
topramezone in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
Carcinogenicity Study in Rats
LOAEL = 3.6 mg/kg/day based on increased
incidences of corneal opacity, decreased
body-weight and body-weight gains in males
and histopathological evaluations in the thyroid, pancreas, and eyes of both sexes
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one-day or
single exposure.
In conducting the acute dietary risk
assessment EPA used the Dietary
Exposure Evaluation Model software
with the Food Commodity Intake
Database (DEEM-FCIDTM), which
incorporates food consumption data as
reported by respondents in the United
States Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII), and
accumulated exposure to the chemical
for each commodity. The following
assumptions were made for the acute
exposure assessments: For the acute
analyses, tolerance-level residues were
assumed for all food commodities with
proposed topramezone tolerances, and it
was assumed that all of the crops
included in the analysis were treated.
Percent crop treated (PCT) and/or
anticipated residues were not used in
the acute risk assessment.
ii. Chronic exposure. In conducting
the chronic dietary risk assessment EPA
used the Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEMFCIDTM), 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
E:\FR\FM\10AUR1.SGM
10AUR1
46416
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
the chronic exposure assessments: For
the chronic analyses, tolerance-level
residues were assumed for all food
commodities with current or proposed
topramezone tolerances, and it was
assumed that all of the crops included
in the analysis were treated. PCT and/
or anticipated residues were not used in
the chronic risk assessment.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
topramezone 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
topramezone.
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 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 screeninglevel 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.
Since the models used are considered
to be screening tools in the risk
assessment process, the Agency does
not use estimated environmental
concentrations (EECs), which are the
model estimates of a pesticide’s
concentration in water. EECs derived
from these models are used to quantify
drinking water exposure and risk as a
%RfD or %PAD.
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
Based on the PRZM/EXAMS and SCIGROW models, the EECs of
topramezone for acute exposures are
estimated to be 0.77 parts per billion
(ppb) for surface water and 0.0671 ppb
for ground water. The EECs for chronic
exposures are estimated to be 0.14 ppb
for surface water and 0.0671 ppb for
ground water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Topramezone is not registered for use
on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
topramezone and any other substances
and topramezone does not appear to
produce a toxic metabolite produced by
other substances. However, EPA is
aware of other herbicides that inhibit
the 4-HPPD enzyme (i.e. mesotrione and
isoxaflutole). Topramezone, isoxaflutole
and mesotrione are known to cause
tyrosinemia. To ensure that the
potential cumulative effects from these
pesticides are not of concern EPA
examined three factors:
• The extent to which the uses of
these pesticides overlap.
• The exposure assumptions used in
the risk assessments for each of the
pesticides.
• The risk characterization for each
pesticide.
As explained Unit III.C.4.i.,ii., and iii.,
this analysis suggests both that the
individual risk characterizations for
each pesticide are highly overstated and
that cumulative exposure to these
pesticides, even if they are later
determined to share a common
mechanism, is unlikely to pose a risk of
concern.
i. Pesticide uses. Topramezone,
mesotrione, and isoxaflutole are broadspectrum herbicides used to control
grassy and broadleaf weeds in corn (the
mesotrione label does not list grasses on
the label). All three active ingredients
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
are in the phenylpyrazolyl ketone class
of chemicals and share the same mode
of herbicidal action. They inhibit the 4HPPD enzyme and thereby impair
caroteniod biosynthesis in the
chlorophyll synthesis pathway, leading
to the breakdown in chloroplasts.
Therefore no more than one of these
active ingredients would be applied to
the same field in the same growing
season. Topramezone is used postemergent, mesotrione is used pre- and
post-emergent, and isoxaflutole is used
pre-plant and pre-emergent. The current
PCT information for field corn indicates
a 5–10% PCT for isoxaflutole and 10–
15% PCT for mesotrione. Sweet corn
PCT is < 2.5 for both chemicals.
Maximum PCT projections for
topramezone on field corn and sweet
corn, made by assuming that it will
surely not overtake the current leader(s)
among herbicides on those crops (i.e.
atrazine), are 68 and 60, respectively.
ii. Exposure assumptions. Highlyconservative assumptions were used for
the aggregate (food + water) risk
assessments for each individual
assessment. First, it was assumed that
100% of the corn crop was treated with
all three of the pesticides. Second, each
of the exposure assessments assumed all
corn in the diet would have residues
present at the tolerance level. In fact,
residue data indicates that very low
levels of residues were detected in the
grain for all three pesticides.
iii. Risk characterization. Even with
the highly-conservative assumptions,
the individual aggregate risk for each of
the active ingredients is as follows:
• The topramezone chronic dietary
risk estimates (food + water) were < 1%
of the cPAD for the U.S. population and
1.2% of the cPAD for the most highly
exposed population subgroup (children
3–5 years old).
• The mesotrione chronic dietary risk
estimates (food + water) were 15% of
the cPAD for the U.S. population and
45% of the cPAD for the most highlyexposed population subgroup (all
infants (< 1 year old)).
• The chronic dietary risk estimates
(food + water) for residues of the 4HPPD inhibitors (isoxaflutole + RPA
202248) were 18% of the cPAD for the
U.S. population and 40% of the cPAD
for the most highly-exposed population
subgroup (children 3–5 years old).
In fact, even if one were to calculate
the chronic dietary risk for all three
herbicides by combining the individual
exposures and using the most sensitive
endpoint, the risk would not exceed the
level of concern. These pesticides do
not share a common acute adverse
effect.
E:\FR\FM\10AUR1.SGM
10AUR1
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
Accordingly, because the use patterns,
exposure assumptions, and risk
characterizations for the three pesticides
do not suggest that any potential
cumulative effect would be at a level of
concern, EPA concludes it has
adequately considered the potential
cumulative effects of topramezone and
the pesticides for which it may possibly
share a common mechanism of toxicity.
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 prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Increased sensitivity of the young.
There is a potential of increased
quantitative susceptibility following in
utero and/or pre-/post-natal exposure in
the developmental toxicity and
developmental neurotoxicity studies in
rats because a NOAEL for parental or
offspring systemic toxicity was not
established. However, the current
NOAEL of 0.5 mg/kg/day for an acute
RfD would provide a 200-fold lower
dose based on the most sensitive
endpoint. In a developmental
neurotoxicity (DNT) study in rats,
decreased auditory startle reflex was
seen at the LOAEL of 8 mg/kg/day in the
presence of maternal toxicity manifested
as corneal opacity. Therefore, the
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
susceptibility in this study could not be
assessed. However, the NOAEL for the
chronic RfD is 0.4 mg/kg/day based on
the most critical tyrosine-mediated
effects which is 20-fold lower than the
LOAEL for the DNT study. There is no
evidence of increased susceptibility
following pre-/post-natal exposure to
rats in the two-generation reproduction
study.
3. Conclusion. There is a complete
toxicity data base for topramezone and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures.
Although there is the potential for
increased quantitative sensitivity in the
young from exposure to topramezone,
the RfDs selected for evaluating the
safety of exposure provide a wide
margin of safety for the effects seen in
the young. Accordingly, the additional
10X factor for the protection of infants
and children is removed.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and drinking water
to topramezone will occupy 1.4 % of the
aPAD for females 13 years and older.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to topramezone from food
and drinking water will utilize 0.6 % of
the cPAD for the U.S. population, 0.9 %
of the cPAD for all infants (< 1 year old),
and 1.2 % of the cPAD for children 3–
5 years old.
Topramezone is not registered for use
on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which do not exceed
the Agency’s level of concern.
3. 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 topramezone
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A proposed enforcement methodology
(liquid chromatography (LC)/mass
spectrometry (MS)) 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; email address: residuemethods@epa.gov.
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
46417
B. International Residue Limits
There are currently no established
Codex, Canadian, or Mexican maximum
residue limits (MRLs) for topramezone.
V. Conclusion
Therefore, the tolerance is established
for residues of topramezone, [3-(4,5dihydro-3-isoxazolyl)-2-methyl-4(methylsulfonyl)phenyl](5-hydroxy-1methyl-1H-pyrazol-4-yl)methanone, in
or on cattle, kidney at 0.05 ppm; cattle,
liver at 0.15 ppm; corn, field, forage at
0.05 ppm; corn, field, grain at 0.01 ppm;
corn, field, stover at 0.05 ppm; corn,
pop, grain at 0.01 ppm; corn, pop, stover
at 0.05 ppm; corn, sweet, forage at 0.05
ppm; corn, sweet, kernal plus cob with
husks removed at 0.01 ppm; corn,
sweet, stover at 0.05 ppm; goat, kidney
at 0.05 ppm; goat, liver at 0.15 ppm;
horse, kidney at 0.05 ppm; horse, liver
at 0.15 ppm; sheep, kidney at 0.05 ppm;
and sheep, liver at 0.15 ppm,
respectively.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to FFDCA
by FQPA, EPA will continue to use
those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
section 408(g) of FFDCA provides
essentially the same process for persons
to ‘‘object’’ to a regulation for an
exemption from the requirement of a
tolerance issued by EPA under new
section 408(d) of FFDCA, as was
provided in the old sections 408 and
409 of FFDCA. However, the period for
filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP–2005–0156 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
E:\FR\FM\10AUR1.SGM
10AUR1
46418
Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / Rules and Regulations
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issue(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit VI.A., you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
OPP–2005–0156, 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:
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issue(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risk (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
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
E:\FR\FM\10AUR1.SGM
10AUR1
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]
VerDate jul<14>2003
13:34 Aug 09, 2005
Jkt 205001
(d) Indirect or inadvertent residues.
[Reserved]
46419
[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
Frm 00017
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\10AUR1.SGM
10AUR1
]]>Agencies
[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Rules and Regulations]
[Pages 46410-46419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15604]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0156; FRL-7726-9]
Topramezone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
topramezone in or on field corn, pop corn, sweet corn, kidney, and
liver. BASF Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
DATES: This regulation is effective 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-2005-0156. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either
[[Page 46411]]
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: Joanne I. Miller, 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 at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at https://www.epa.gpo/opptsfrs/home/
guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of June 11, 2003 (68 FR 34950) (FRL-7310-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3F6568) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.612 be amended by
establishing tolerances for residues of the herbicide topramezone, [3-
(4,5-dihydro-isoxazol-3-yl)-4-methanesulfonyl-2-methylphenyl)-(5-
hydroxyl-1-methyl-1H-pyrazol-4-yl)methanone, in or on corn, field,
forage; corn, field, grain; corn, field, stover; corn, pop, grain;
corn, pop, stover; corn, sweet, forage; corn, sweet, kernal plus cob
with husks removed; corn, sweet, stover; cattle, kidney; cattle, liver;
goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney;
horse, liver; sheep, kidney; and sheep, liver at 0.05; 0.01; 0.05;
0.01; 0.05; 0.05; 0.01; 0.05; 0.02; 0.70; 0.20; 0.70; 0.20; 0.70; 0.20;
0.70; 0.20; and 0.70 parts per million (ppm), respectively. That notice
included a summary of the petition prepared by BASF Corporation, the
registrant. There were no comments received in response to the notice
of filing.
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 residues of topramezone on
cattle, kidney at 0.05 ppm; cattle, liver at 0.15 ppm; corn, field,
forage at 0.05 ppm; corn, field, grain at 0.01 ppm; corn, field, stover
at 0.05 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.05
ppm; corn, sweet, forage at 0.05 ppm; corn, sweet, kernal plus cob with
husks removed at 0.01 ppm; corn, sweet, stover at 0.05 ppm; goat,
kidney at 0.05 ppm; goat, liver at 0.15 ppm; horse, kidney at 0.05 ppm;
horse, liver at 0.15 ppm; sheep, kidney at 0.05 ppm; and sheep, liver
at 0.15 ppm, respectively.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by topramezone 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 .
[[Page 46412]]
Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity-- NOAEL = 1.1 milligrams/kilogram/day (mg/kg/
rodents (rat) day) males (M) and 2.1 mg/kg/day females
(F)
LOAEL = 2.1 mg/kg/day for males based on
diffuse degeneration in the pancreas and
was not established for females
----------------------------------------
870.3100 90-Day oral toxicity-- NOAEL = 2,289/3,010 mg/kg/day (M/F)
rodents (mouse) LOAEL = was not established
----------------------------------------
870.3150 90-Day oral toxicity-- NOAEL = 535/1,712 mg/kg/day (M/F)
nonrodents (dog) LOAEL = 1,511 mg/kg/day for males based on
decreased body-weight gain, impaired food
efficiency, and inflammation of the
urinary bladder and was not established
for females
----------------------------------------
870.3200 28-Day dermal toxicity NOAEL = 100/300 mg/kg/day (M/F)
(rat) LOAEL = 300 mg/kg/day males based on
thyroid follicular cell hypertrophy and
1,000 mg/kg/day females based on thyroid
follicular cell hypertrophy
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = not established
rodents (rat) Maternal LOAEL = 100 mg/kg/day based on
decreased body-weight gains
Developmental NOAEL = not established
Developmental LOAEL = 100 mg/kg/day based
on decreased fetal body weight and
increased incidences of skeletal variation
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = not established
nonrodents (rabbit) Maternal LOAEL = 0.5 mg/kg/day based on
increased serum tyrosine level
Developmental NOAEL = 0.5 mg/kg/day
Developmental LOAEL = 5 mg/kg/day based on
alterations in skeletal ossification sites
and increased number of pairs of ribs
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = not established
nonrodents (rabbit) Maternal LOAEL = 1.5 mg/kg/day based on
increased serum tyrosine level
Developmental NOAEL = not established
Developmental LOAEL = 1.5 mg/kg/day based
on an increased incidence of absent kidney
and ureter and increased incidences of
supernumerary thoracic vertebrae and
supernumerary 13\th\ rib
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 5.0 mg/kg/day
nonrodents (rabbit) Maternal LOAEL = was not established
Developmental NOAEL = not established
Developmental LOAEL = 1.5 mg/kg/day for N33
and N17/CFR 1-2 based on increased
presence of supernumerary thoracic
vertebrae and supernumerary 13\th\ rib. No
effect was observed for N17/CFR 3 at 0.5
mg/kg/day (the only dose tested)
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 450 mg/kg/day
nonrodents (rabbit) Maternal LOAEL = not established
Developmental NOAEL = not established
Developmental LOAEL = 5 mg/kg/day based on
visceral findings (fluid-filled abdomen,
pale liver, and dark content of the
stomach and intestines) and alterations in
skeletal development (i.e. incomplete
ossification of the vertebrae and talus,
and supernumerary thoracic vertebrae and
13\th\ rib)
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 150 mg/kg/day
nonrodents (rabbit) Maternal LOAEL = 450 mg/kg/day based on
decreased body-weight, body-weight gains,
food consumption, and increased incidences
of abortion and lack of defecation
Developmental NOAEL = not established
Developmental LOAEL = 50 mg/kg/day based on
decreased fetal weight and increased
incidence of visceral malformations, and
skeletal malformations, variations, and
unclassified abnormalities
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 450 mg/kg/day
nonrodents (rabbit) Maternal LOAEL = not established
Developmental NOAEL = 0.5 mg/kg/day
Developmental LOAEL = 5 mg/kg/day based on
increased presence of 27 pre-sacral
vertebrae and increased an incidence of
full supernumerary 13\th\ rib
----------------------------------------------------------------------------------------------------------------
[[Page 46413]]
870.3700 Prenatal developmental-- Maternal NOAEL = 450 mg/kg/day
nonrodents (rabbit) Maternal LOAEL = not established
Developmental NOAEL = not established
Developmental LOAEL = 50 mg/kg/day based on
an increased incidence of extra sternebral
ossification sites and supernumerary
13\th\ rib
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = not established
nonrodents (mouse) Maternal LOAEL = 30 mg/kg/day based on
increased serum tyrosine level
Developmental NOAEL = 1,000 mg/kg/day
Developmental LOAEL = not established
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL = 0.4/0.5 mg/kg/day
effects (rat) (M/F)
Parental/Systemic LOAEL = 4.2/4.6 mg/kg/day
(M/F) based on decreased body-weight, body-
weight gain in males, increased thyroid
and kidney weights of both sexes, and
microscopic findings in eyes, kidney, and
thyroid of both sexes
Reproductive NOAEL = 426.8/471.9 mg/kg/day
(M/F)
Reproductive LOAEL = not established
Offspring NOAEL = 0.4/0.5 mg/kg/day (M/F)
Offspring LOAEL = 4.2/4.6 mg/kg/day (M/F)
based on decreased pup weight and weight
gain in F2 male and female pups and
increased time to preputial separation in
the F1 males
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity--rodents NOAEL = 0.4/0.5 mg/kg/day (M/F)
(rat) LOAEL = 3.9/5.3 mg/kg/day (M/F) based on
corneal opacity and pannus and chronic
keratitis in both sexes, and thyroid
hypertrophy in males
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity--dogs NOAEL = 2.9/15.4 (M/F) mg/kg/day
LOAEL = 15.3 mg/kg/day (M) based on
increased incidence of thyroid C-cell
hyperplasia and 92 mg/kg/day (F) based on
decreased body-weight, body-weight gain,
and food efficiency
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity--rats NOAEL = 0.4/0.5 mg/kg/day (M/F)
LOAEL = 3.6/4.7 mg/kg/day (M/F) based on
increased incidences of corneal opacity,
decreased body-weight and body-weight
gains (males only) and histopathological
evaluations in the thyroids, pancreas, and
eyes of both sexes
Neoplastic pathology showed increased
incidences of follicular cell adenomas in
the thyroid glands of both sexes
----------------------------------------------------------------------------------------------------------------
870.4300 Carcinogenicity--mice NOAEL = not established
LOAEL = 19/26 mg/kg/day (M/F) based on
decreased body-weight and body-weight
gains in males
No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100 Gene mutation No indication of a mutagenic response in
any strain at any level up to cytotoxic
concentrations either with or without S9
activation
----------------------------------------------------------------------------------------------------------------
870.5100 Gene mutation Based on these considerations, it was
concluded that there was confirmed
evidence of a mutagenic response in S.
typhimurium TA98 in the nonactivated
portion of both the plate incorporation
and preincubation assays. The effect was,
however, observed at high concentrations
(>= 3,000 [mu]g/plate-plate incorporation
and >= 2,500 [mu]g/plate-preincubation).
It was further concluded that the
mutagenic effect was likely due to
impurities in the test article because: 1)
The response was seen at high
concentrations including and exceeding the
limit dose, 2) bacterial gene mutation
assays conducted with other lots of the
test material were negative up to the
limit dose (see Master Record
Identification (MRID) Nos. 45902225
through 45902227, and 3) the active
ingredient (a.i.) used in the current
study has the lowest percentage of purity
(95.8% versus 97.7 to 99.3% a.i. for the
other lots)
----------------------------------------------------------------------------------------------------------------
870.5300 In vitro mammalian cell No indication that topramezone induced a
gene mutation mutagenic response, either in the presence
of absence of S9 activation
----------------------------------------------------------------------------------------------------------------
870.5375 In vitro mammalian Topramezone-induced a clastogenic response
chromosome aberration in the presence of S9 activation with
significant effects recorded only at an
insoluble limit concentration
----------------------------------------------------------------------------------------------------------------
870.5395 In vivo mouse bone morrow No evidence that topramezone was
micronucleus clastogenic or aneugenic
----------------------------------------------------------------------------------------------------------------
870.5550 Unscheduled DNA synthesis No evidence that topramezone-induced UDS,
(UDS) as determined by radioactive tracer
procedures (nuclear silver grain counts)
at any concentration tested
----------------------------------------------------------------------------------------------------------------
[[Page 46414]]
870.6200 Acute neurotoxicity NOAEL= 2,000 mg/kg/day, no neurotoxicity
screening battery (rat) observed
----------------------------------------------------------------------------------------------------------------
870.6200 Subchronic neurotoxicity No neurotoxicity observed
(rat) Systemic NOAEL = not established
LOAEL = 4.2/5/0 mg/kg/day (M/F) based on
elevated levels of granular casts and
transitional epithelial cells in the
urinary sediment of the males, increased
incidences of corneal clouding in females,
minimal diffuse degeneration of the
pancreas (both sexes), and slight to
moderate flaky colloid in the thyroid of
the males
----------------------------------------------------------------------------------------------------------------
870.6300 Developmental Maternal NOAEL = not established
neurotoxicity (rat) Maternal LOAEL = 8 mg/kg/day based on
corneal opacities
Offspring NOAEL = not established
Offspring LOAEL = 8 mg/kg/day based on
decreased auditory startle reflex response
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and Absorption of [\14\C]-topramezone following
pharmacokinetics a single oral dose was rapid but limited,
with the highest plasma concentrations
observed at 1 hour (first time point
measured). Oral absorption is estimated to
be approximately 20% of the administered
dose. The majority of the dose was
recovered within 48 hours in the feces (73-
91% dose) and urine (8-29% dose)
----------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration The majority of the applied dose for each
group was not absorbed (91.0-98.3% dose),
with the greatest amount of the non-
absorbed material being recovered from the
skin wash (90.8-96.0% dose). Absorbed
radioactivity was low and accounted for
0.16-2.60% of the dose for all groups for
all exposures
----------------------------------------------------------------------------------------------------------------
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, 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 uncertainty factors 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 uncertainty factors 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 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'' in
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 topramezone used for
human risk assessment is shown in Table 2. of this unit:
[[Page 46415]]
Table 2.--Summary of Toxicological Dose and Endpoints for Topramezone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of NOAEL = 0.5 mg/kg/day Special FQPA SF = 1X Developmental Toxicity
age) UF = 100............... aPAD = acute RfD / Study in Rabbits
Acute RfD = 0.005 mg/kg/ Special FQPA SF = LOAEL = 5 mg/kg/day
day. 0.005 mg/kg/day. based on alterations
in skeletal
ossification sites and
increased number of
pairs of ribs
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population An endpoint of concern for the general population attributable to a
including infants and children) single dose was not identified in the hazard database
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 0.4 mg/kg/day Special FQPA SF = 1X Carcinogenicity Study
UF = 100............... cPAD = chronic RfD / in Rats
Chronic RfD = 0.004 mg/ Special FQPA SF = LOAEL = 3.6 mg/kg/day
kg/day. 0.004 mg/kg/day. based on increased
incidences of corneal
opacity, decreased
body-weight and body-
weight gains in males
and histopathological
evaluations in the
thyroid, pancreas, and
eyes of both sexes
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) In accordance with the EPA Final Guidelines for Carcinogen Risk
Assessment (March 29, 2005), EPA classified topramezone as ``not likely
to be carcinogenic to humans at doses that do not alter rat thyroid
hormone homeostasis.'' EPA determined that quantification of human
cancer risk is not required since the NOAEL (0.4 mg/kg/day) for non-
cancer risk assessment is not expected to alter thyroid hormone
homeostasis nor result in thyroid tumor formation
----------------------------------------------------------------------------------------------------------------
Topramezone inhibits the 4-hydroxyphenylpyruvate dioxygenase (4-
HPPD) enzyme in the metabolism of tyrosine. Inhibition of this enzyme
results in increased serum tyrosine levels and eventually in adverse
effects in the animal with increased incidences of corneal opacity,
decreased body-weight, and body-weight gains. The petitioner conducted
eight rabbit studies to determine the NOAEL for increased serum
tyrosine levels as well as determine the NOAELs for systemic maternal
and fetal developmental toxicity endpoints that are not based on
tyrosine measurements.
There are well established NOAELs and LOAELs for the standard
endpoints for maternal and developmental toxicity in rabbits.
Currently, it is not known what level of inhibition of the 4-HPPD
enzyme results in an adverse effect. Therefore, the observation of
enzyme inhibition in the absence of systemic toxicity in maternal
animals or soft tissue or skeletal alterations in pups/offspring are
being considered to be a biomarker of exposure, not an adverse effect.
None of the data in the submitted studies permit a determination of the
percentage of increased tyrosine levels that result in detrimental or
adverse effects.
The lowest maternal LOAEL observed in the numerous rabbit
developmental toxicity studies was 0.5 mg/kg/day. It is not clear,
however, that this value is actually a LOAEL because it is based on
increased serum tyrosine levels. In this study it could not be
determined what dose would not induce increased serum tyrosine levels.
In fact, in no study could a ``no effect'' level be determined for
increased serum tyrosine levels in dams. However, a maternal NOAEL of 5
mg/kg/day was observed in another study based on systemic toxicity; in
this study tyrosine measurements were not performed. This study has the
lowest maternal NOAEL for systemic toxicity among the eight rabbit
developmental toxicity studies. Tyrosine levels were not measured for
fetuses in any of the rabbit developmental studies. There was a clear
developmental toxicity NOAEL of 0.5 mg/kg/day, based on skeletal
variations observed at 5 mg/kg/day.
The acute RfD for females 13-49 years of age is based on a NOAEL of
0.5 mg/kg/day for alterations in skeletal ossification sites in
rabbits. The chronic RfD is based on the NOAEL of 0.4 mg/kg/day in the
carcinogenicity study in rats. In this study the LOAEL was based on
increased incidence of corneal opacities, decrease in body weight gain,
liver, pancreas, and thyroid effects seen at 3.6 mg/kg/day.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. No tolerances have
been established (40 CFR 180.612) previously for the residues of
topramezone. Risk assessments were conducted by EPA to assess dietary
exposures from topramezone in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\), which incorporates food consumption
data as reported by respondents in the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII), and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the acute exposure assessments: For the acute analyses, tolerance-level
residues were assumed for all food commodities with proposed
topramezone tolerances, and it was assumed that all of the crops
included in the analysis were treated. Percent crop treated (PCT) and/
or anticipated residues were not used in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the 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
[[Page 46416]]
the chronic exposure assessments: For the chronic analyses, tolerance-
level residues were assumed for all food commodities with current or
proposed topramezone tolerances, and it was assumed that all of the
crops included in the analysis were treated. PCT and/or anticipated
residues were not used in the chronic risk assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for topramezone 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 topramezone.
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 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.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
topramezone for acute exposures are estimated to be 0.77 parts per
billion (ppb) for surface water and 0.0671 ppb for ground water. The
EECs for chronic exposures are estimated to be 0.14 ppb for surface
water and 0.0671 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Topramezone is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to topramezone and any other
substances and topramezone does not appear to produce a toxic
metabolite produced by other substances. However, EPA is aware of other
herbicides that inhibit the 4-HPPD enzyme (i.e. mesotrione and
isoxaflutole). Topramezone, isoxaflutole and mesotrione are known to
cause tyrosinemia. To ensure that the potential cumulative effects from
these pesticides are not of concern EPA examined three factors:
The extent to which the uses of these pesticides overlap.
The exposure assumptions used in the risk assessments for
each of the pesticides.
The risk characterization for each pesticide.
As explained Unit III.C.4.i.,ii., and iii., this analysis suggests
both that the individual risk characterizations for each pesticide are
highly overstated and that cumulative exposure to these pesticides,
even if they are later determined to share a common mechanism, is
unlikely to pose a risk of concern.
i. Pesticide uses. Topramezone, mesotrione, and isoxaflutole are
broad-spectrum herbicides used to control grassy and broadleaf weeds in
corn (the mesotrione label does not list grasses on the label). All
three active ingredients are in the phenylpyrazolyl ketone class of
chemicals and share the same mode of herbicidal action. They inhibit
the 4-HPPD enzyme and thereby impair caroteniod biosynthesis in the
chlorophyll synthesis pathway, leading to the breakdown in
chloroplasts. Therefore no more than one of these active ingredients
would be applied to the same field in the same growing season.
Topramezone is used post-emergent, mesotrione is used pre- and post-
emergent, and isoxaflutole is used pre-plant and pre-emergent. The
current PCT information for field corn indicates a 5-10% PCT for
isoxaflutole and 10-15% PCT for mesotrione. Sweet corn PCT is < 2.5 for
both chemicals. Maximum PCT projections for topramezone on field corn
and sweet corn, made by assuming that it will surely not overtake the
current leader(s) among herbicides on those crops (i.e. atrazine), are
68 and 60, respectively.
ii. Exposure assumptions. Highly-conservative assumptions were used
for the aggregate (food + water) risk assessments for each individual
assessment. First, it was assumed that 100% of the corn crop was
treated with all three of the pesticides. Second, each of the exposure
assessments assumed all corn in the diet would have residues present at
the tolerance level. In fact, residue data indicates that very low
levels of residues were detected in the grain for all three pesticides.
iii. Risk characterization. Even with the highly-conservative
assumptions, the individual aggregate risk for each of the active
ingredients is as follows:
The topramezone chronic dietary risk estimates (food +
water) were < 1% of the cPAD for the U.S. population and 1.2% of the
cPAD for the most highly exposed population subgroup (children 3-5
years old).
The mesotrione chronic dietary risk estimates (food +
water) were 15% of the cPAD for the U.S. population and 45% of the cPAD
for the most highly-exposed population subgroup (all infants (< 1 year
old)).
The chronic dietary risk estimates (food + water) for
residues of the 4-HPPD inhibitors (isoxaflutole + RPA 202248) were 18%
of the cPAD for the U.S. population and 40% of the cPAD for the most
highly-exposed population subgroup (children 3-5 years old).
In fact, even if one were to calculate the chronic dietary risk for
all three herbicides by combining the individual exposures and using
the most sensitive endpoint, the risk would not exceed the level of
concern. These pesticides do not share a common acute adverse effect.
[[Page 46417]]
Accordingly, because the use patterns, exposure assumptions, and
risk characterizations for the three pesticides do not suggest that any
potential cumulative effect would be at a level of concern, EPA
concludes it has adequately considered the potential cumulative effects
of topramezone and the pesticides for which it may possibly share a
common mechanism of toxicity.
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 prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Increased sensitivity of the young. There is a potential of
increased quantitative susceptibility following in utero and/or pre-/
post-natal exposure in the developmental toxicity and developmental
neurotoxicity studies in rats because a NOAEL for parental or offspring
systemic toxicity was not established. However, the current NOAEL of
0.5 mg/kg/day for an acute RfD would provide a 200-fold lower dose
based on the most sensitive endpoint. In a developmental neurotoxicity
(DNT) study in rats, decreased auditory startle reflex was seen at the
LOAEL of 8 mg/kg/day in the presence of maternal toxicity manifested as
corneal opacity. Therefore, the susceptibility in this study could not
be assessed. However, the NOAEL for the chronic RfD is 0.4 mg/kg/day
based on the most critical tyrosine-mediated effects which is 20-fold
lower than the LOAEL for the DNT study. There is no evidence of
increased susceptibility following pre-/post-natal exposure to rats in
the two-generation reproduction study.
3. Conclusion. There is a complete toxicity data base for
topramezone and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Although there
is the potential for increased quantitative sensitivity in the young
from exposure to topramezone, the RfDs selected for evaluating the
safety of exposure provide a wide margin of safety for the effects seen
in the young. Accordingly, the additional 10X factor for the protection
of infants and children is removed.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and
drinking water to topramezone will occupy 1.4 % of the aPAD for females
13 years and older.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
topramezone from food and drinking water will utilize 0.6 % of the cPAD
for the U.S. population, 0.9 % of the cPAD for all infants (< 1 year
old), and 1.2 % of the cPAD for children 3-5 years old.
Topramezone is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
3. 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 topramezone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A proposed enforcement methodology (liquid chromatography (LC)/mass
spectrometry (MS)) 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 (MRLs) for topramezone.
V. Conclusion
Therefore, the tolerance is established for residues of
topramezone, [3-(4,5-dihydro-3-isoxazolyl)-2-methyl-4-
(methylsulfonyl)phenyl](5-hydroxy-1-methyl-1H-pyrazol-4-yl)methanone,
in or on cattle, kidney at 0.05 ppm; cattle, liver at 0.15 ppm; corn,
field, forage at 0.05 ppm; corn, field, grain at 0.01 ppm; corn, field,
stover at 0.05 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at
0.05 ppm; corn, sweet, forage at 0.05 ppm; corn, sweet, kernal plus cob
with husks removed at 0.01 ppm; corn, sweet, stover at 0.05 ppm; goat,
kidney at 0.05 ppm; goat, liver at 0.15 ppm; horse, kidney at 0.05 ppm;
horse, liver at 0.15 ppm; sheep, kidney at 0.05 ppm; and sheep, liver
at 0.15 ppm, respectively.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0156 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
[[Page 46418]]
grounds for the objections (40 CFR 178.25). If a hearing is requested,
the objections must include a statement of the factual issue(s) on
which a hearing is requested, the requestor's contentions on such
issues, and a summary of any evidence relied upon by the objector (40
CFR 178.27). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as CBI. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2. A copy
of the information that does not contain CBI must be submitted for
inclusion in the public record. Information not marked confidential may
be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 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-2005-0156, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted
