Tembotrione; Pesticide Tolerance, 55078-55085 [E7-19230]
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Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Rules and Regulations
Commodity
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Wheat, forage .................
Wheat, grain ...................
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(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E7–19219 Filed 9–27–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0072; FRL–8148–2]
Tembotrione; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
rwilkins on PROD1PC63 with RULES
I. General Information
This regulation establishes
tolerances for combined residues of
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione and its metabolite
(M5); 2-[2-chloro-4-(methylsulfonyl)-3[(2,2,2-trifluoroethoxy)methyl]benzoyl]4,6-dihydroxy-1,3-cyclohexanedione in
or on corn (field, sweet and pop) and
livestock commodities. Bayer
CropScience requested those tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 28, 2007. Objections and
requests for hearings must be received
on or before November 27, 2007, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006-0072. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
SUMMARY:
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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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Eugene Wilson, Registration Division,
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305-6103; e-mail address:
wilson.eugene@epa.gov.
SUPPLEMENTARY 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 those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide 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.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006-0072 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
as required by 40 CFR part 178 on or
before November 27, 2007.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2006-0072, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
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II. Petition for Tolerance
In the Federal Register of April 26,
2006 (71 FR 24690 - 24692) (FRL–80636), EPA issued a notice pursuant to
section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing
of a pesticide petition (PP 5F7009) by
Bayer CropScience, 2 TW Alexander
Drive, P.O. Box 12014, RTP, NC 27709.
The petition requested that 40 CFR part
180 be amended by establishing a
tolerance for combined residues of the
herbicide AE 0172747 (tembotrione), 2[2-chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione, and metabolite (M5),
AE 1417268 (2-[2-chloro-4(methylsulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-4,6-dihydroxy1,3-cyclohexanedione (expressed as
tembotrione equivalents in or on corn,
field, grain at 0.02 ppm; corn, field,
forage at 0.5 ppm; corn, field, stover at
0.5 ppm; corn, sweet, kernel plus cob
with husks removed at 0.03 ppm; corn,
sweet, forage at 1.0 ppm; corn sweet,
stover at 1.0 ppm; popcorn, grain at 0.01
ppm; Popcorn, stover, 0.25 ppm; cattle,
liver at 0.5 ppm; cattle, meat
byproducts, except liver at 0.07 ppm;
goat, liver at 0.5 ppm; goat, kidney at
0.07 ppm; Hog Liver at 0.5; Hog, Kidney
at 0.07 ppm, sheep, kidney at 0.07 ppm;
sheep, meat byproducts at 0.5 ppm ;
horse, kidney at 0.07 ppm; horse, meat
byproducts at 0.5 ppm. There were no
comments received in response to the
notice of filing.
Based on the aggregate exposure from
food and feed commodities resulting
from the use-patterns proposed in the
petition, the proposed tolerances were
revised to account for both tembotrione
and its metabolite M5, expressed as
tembotrione equilivants. The aggregate
risk assessment is discussed in Unit III,
below. The reasons for these changes are
also explained in Unit V.
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III. Aggregate Risk Assessment and
Determination of Safety
For tembotrione, aggregate exposure
risk assessments were performed for the
following scenarios: acute aggregate
exposure (food and drinking water), and
chronic aggregate exposure (food and
drinking water). Short- and
intermediate-term assessments were not
performed because there are no
registered or proposed residential nonfood uses. The chronic Reference Dose
(cRfD) will be protective of cancer and
non-cancer effects, because tembotrione
is classified as ‘‘Suggestive Evidence of
Carcinogenicity’’ and EPA’s Cancer
Assessment Review Committee (CARC )
recommended that a separate
quantification of cancer risks is not
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required, while noting that the
progression of non-neoplastic related
lesions in rats was biologically plausible
by non-genotoxic modes of action for
the corneal tumors.
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....’’ These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerance for combined residues of
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy]methyl]benzoyl]-1,3-cyclo
hexanedione and metabolite (M5), 2-[2chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-4,6dihydroxy-1,3-cyclohexanedione, in or
on corn, field, grain at 0.02 ppm; corn,
field, forage at 0.60 ppm; corn, field,
stover at 0.45 ppm; corn, sweet, kernel
plus cob with husks removed at 0.04
ppm; corn, sweet, forage at 1.0 ppm;
corn, sweet, stover at 1.2 ppm; corn,
pop, grain at 0.02 ppm; corn, pop, stover
at 0.35 ppm; cattle, liver at 0.40 ppm;
cattle, meat byproducts, except liver
0.07 ppm; goat, liver at 0.40 ppm; goat,
meat byproducts, except liver at 0.07
ppm; horse, liver at 0.40 ppm; horse,
meat byproducts except liver at 0.07
ppm; sheep, liver at 0.40 ppm; sheep,
meat byproducts, except liver at 0.07
ppm; poultry, liver at 0.07 ppm. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance follows.
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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 adverse effects caused
by tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov. The referenced
document is available in the docket
established by this action, which is
described under ADDRESSES, and is
identified as EPA–HQ–OPP–2006–0072
in that docket.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which no adverse effects are observed
(the NOAEL) in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the lowest dose
at which adverse effects of concern are
identified (the LOAEL) is sometimes
used for risk assessment. Uncertainty/
safety factors (UFs) are used in
conjunction with the LOC to take into
account 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. Safety is assessed for acute
and chronic risks by comparing
aggregate exposure to the pesticide to
the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-,
and long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the margin of
exposure (MOE) called for by the
product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
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considered non-threshold. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
A summary of the toxicological
endpoints for tembotrione, 2-[2-chloro4-(methylsulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione used for human risk
assessment is shown in Table 1 of this
unit.
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TEMBOTRIONE, 2-[2-CHLORO-4-(METHYLSULFONYL)3-[(2,2,2-TRIFLUOROETHOXY)METHYL]BENZOYL]-1,3-CYCLOHEXANEDIONE FOR USE IN HUMAN RISK ASSESSMENT
Dose Used in Risk Assessment,
Interspecies and Intraspecies and
any Traditional FQPA, SF
Special FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Acute dietary (General population including infants and
children) and Females 13 to
49
LOAEL = 0.8 (mg/kg/day)
SF = 1000
UFA = 10X
UFH = 10X
FQPA SF = 10X(includes UFL =
10X)
Acute reference dose (RfD) =
0.0008 mg/kg
Special FQPA SF = 1
aPAD = acute RfD ÷ Special
FQPA SF = 0.0008 mg/kg
Developmental
Neurotoxicity
Study: Offspring NOAEL was
not
established.Offspring
LOAEL = 0.8 mg/kg/day
based on decreased acoustic
startle response on PND 60
(males),
and
brain
morphometric changes on
PND 75 (males and females).
Chronic dietary(All populations)
NOAEL= .04 mg/kg/day
SF = 100
UFA = 10X
UFH = 10X
FQPA SF = 1X
Chronic RfD = 0.0004 mg/kg/day
Special FQPA SF = 1
cPAD = chronic RfD Special
FQPA SF = 0.0004 mg/kg/day
Chronic/Carcinogenicity
Study
LOAEL = 0.79 mg/kg/day
based on neovascularization
and edema of the cornea and
snow flake-like corneal opacity, unilateral or bilateral keratitis of the eye, decreased
mean body weight and mean
body-weight gain, increased
total cholesterol, higher ketone
levels and lower pH values,
higher protein levels, increased kidney weight, kidney
to body weight and kidney to
brain weight ratios, chronic
nephropathy and atrophy of
the sciatic nerve.
Short-term dermal (1 to 30 days)
(Residential)
Oral study LOAEL= 0.8 mg/kg/day
UFA = 10X
UFH = 10X
FQPA SF = 10X (includes UFL =
10X) (dermal absorption rate = 15
%)
LOC for MOE =1000
Developmental
neurotoxicity
Study Offspring NOAEL was
not
established.Offspring
LOAEL = 0.8 mg/kg/day
based on decreased acoustic
startle response on PND 60
(males),
and
brain
morphometric changes on
PND 75 (males and females).
Intermediate-term dermal (1 to 6
months) (Residential)
Oral study LOAEL= 0.8 mg/kg/day
UFA = 10X
UFH = 10X
FQPA SF = 10X (includes UFL =
10X) (dermal absorption rate = 15
%)
LOC for MOE = 1000 (Residential)
Developmental
neurotoxicity
Study Offspring NOAEL was
not
established.Offspring
LOAEL = 0.8 mg/kg/day
based on decreased acoustic
startle response on PND 60
(males),
and
brain
morphometric changes on
PND 75 (males and females).
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Exposure/Scenario
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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TEMBOTRIONE, 2-[2-CHLORO-4-(METHYLSULFONYL)3-[(2,2,2-TRIFLUOROETHOXY)METHYL]BENZOYL]-1,3-CYCLOHEXANEDIONE FOR USE IN HUMAN RISK ASSESSMENT—
Continued
Dose Used in Risk Assessment,
Interspecies and Intraspecies and
any Traditional FQPA, SF
Special FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Long-term dermal (>6 months to
lifetime) (Residential)
Oral study NOAEL= 0.04 mg/kg/day
UFA = 10X
UFH = 10X
FQPA SF = 1X (dermal absorption
rate = 15 % when appropriate)
LOC for MOE = 100 (Residential)
Chronic/Carcinogenicity
Study
LOAEL = 0.79 mg/kg/day
based on neovascularization
and edema of the cornea and
snow flake-like corneal opacity, unilateral or bilateral keratitis of the eye, decreased
mean body weight and mean
body-weight gain, increased
total cholesterol, higher ketone
levels and lower pH values,
higher protein levels, increased kidney weight, kidney
to body weight and kidney to
brain weight ratios, chronic
nephropathy and atrophy of
the sciatic nerve.
Short-term inhalation (1 to 30
days) (Residential)
Oral study LOAEL= 0.8
UFL = 10X) (inhalation absorption
rate = 100%)
LOC for MOE = 1000 (Residential)
Developmental
neurotoxicity
Study Offspring NOAEL was
not
established.
Offspring
LOAEL = 0.8 mg/kg/day
based on decreased acoustic
startle response on PND 60
(males),
and
brain
morphometric changes on
PND 75 (males and females).
Intermediate-term inhalation (1
to 6 months) (Residential)
Oral study LOAEL= 0.8 mg/kg/day
UFA = 10X
UFH = 10X
FQPA SF = 10X (includes UFL =
10X) (inhalation absorption rate =
100%)
LOC for MOE = 1000 (Residential)
Developmental
neurotoxicity
Study] Offspring NOAEL was
not
established.Offspring
LOAEL = 0.8 mg/kg/day
based on decreased acoustic
startle response on PND 60
(males),
and
brain
morphometric changes on
PND 75 (males and females).
Long-term inhalation (>6
months) (Residential)
Oral study NOAEL= 0.04 mg/kg/day
UFH = 10X
FQPA SF = 1X (inhalation absorption rate = 100%)
LOC for MOE = 100 Residential
Chronic/Carcinogenicity
Study
LOAEL = 0.79 mg/kg/day
based on neovascularization
and edema of the cornea and
snow flake-like corneal opacity, unilateral or bilateral keratitis of the eye, decreased
mean body weight and mean
body-weight gain, increased
total cholesterol, higher ketone
levels and lower pH values,
higher protein levels, increased kidney weight, kidney
to body weight and kidney to
brain weight ratios, chronic
nephropathy and atrophy of
the sciatic nerve.
Cancer (Oral, dermal, inhalation)
Classification: ‘‘Suggestive Evidence of Carcinogenic Potential’’ based on the observance of squamous cell
carcinomas in a rat carcinogenicity study. Quantification of cancer risk is not required.
Exposure/Scenario
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UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of
the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. MOE = margin of exposure. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to tembotrione, 2-[2-chloro-4-
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(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione, EPA considered
exposure under the petitioned-for
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tolerances. EPA assessed dietary
exposures from tembotrione, 2-[2chloro-4-(methylsulfonyl)-3-[(2,2,2-tri
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fluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
Effects were identified in the
toxicological studies for tembotrione, 2[2-chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione; therefore, a
quantitative acute dietary exposure
assessment was necessary. The acute
analysis assumed 100% crop treated
(CT), Dietary Exposure Evaluation
Model (DEEM(TM)) 7.81 default
processing factors, and tolerance-level
residues for all foods. For drinking
water, the entire distribution of
estimated daily exposure values from
the Pesticide Root Zone ModelingExposure Evaluation Analysis Modeling
System (PRZM-EXAMS) run was
incorporated in the acute probabilistic
exposure analyses. The resulting acute
dietary (food + water) risk estimates
were <32% of the aPAD for the general
U.S. population and <77% of the aPAD
for all infants (<1 year old, the most
highly-exposed population subgroup) at
the 95th percentile; less than HED’s
LOC (100% aPAD). Even though the
entire distribution of estimated daily
drinking water exposure values was
incorporated, this analysis is still
conservative since tolerance-level
residues, DEEM(TM) 7.81 default
processing factors, and 100% CT were
assumed. Also, the distribution of
estimated daily drinking water exposure
still assumes 100% CT and the
maximum application rate.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA, 1994–1996, and 1998
Continuing Survey of Food Intake by
Individuals. As to residue levels in food,
EPA assumed all foods for which there
are proposed tolerances were treated
and contain tolerance-level residues. A
conservative chronic dietary assessment
assuming tolerance-level residues,
DEEM(TM) 7.81 default processing
factors, and 100% CT was also
conducted. The highest estimate of
chronic surface water exposure (1.05
parts per billion (ppb)) was used for
drinking water in this analysis.
iii. Cancer. There was only suggestive
evidence of carcinogenic potential based
on the observance of squamous cell
carcinomas in a rat carcinogenicity
study. Quantification of cancer risk is
not required. Dietary cancer risk
concerns due to long-term consumption
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of tembotrione residues are adequately
addressed by the chronic exposure
analysis using the cPAD.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione 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 environmental fate characteristics of
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione. Further, information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and
Screening Concentration in Ground
Water (SCI-GROW) models, the
estimated environmental concentrations
(EECs) of tembotrione, 2-[2-chloro-4(methylsulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione for acute exposures
are estimated to be 5.84 parts per billion
(ppb) for surface water and 0.0139 ppb
for ground water. The EECs for chronic
exposures are estimated to be 1.05 ppb
for surface water and 0.0139 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 5.84 ppb was
used to access the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 1.05 ppb was used to access the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Tembotrione, 2-[2-chloro-4(methylsulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione is not registered for
use on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
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‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Tembotrione, belongs to a class of
herbicides (including mesotrione,
pyrasulfotole, isoxaflutole and
topramezone) that inhibit the liver
enzyme 4-hydroxyphenylpyruvate
dioxygenase (HPPD). As discussed
above, EPA has concluded that the
ocular effects caused by these herbicides
has limited relevance to humans.
Nonetheless, as a worst case scenario,
EPA has assessed aggregate exposure to
tembotrione based on ocular effects in
rats. For similar reasons, a semiquantitative screening cumulative
assessment was conducted using the rat
ocular effects and 100% crop treated
information. The results of this
screening analysis did not indicate a
concern. In the future, assessments of
HPPD-inhibiting herbicides will
consider more appropriate models and
cross species extrapolation methods.
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 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 (‘‘10X’’) tenfold margin of
safety for infants and children in the
case of threshold effects to account for
pre- and post-natal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor. 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 FQPA safety
factor value based on the use of
traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There is evidence of increased
susceptibility in rabbit and rat fetuses to
in utero exposure to tembotrione
compared to the doses for the effects
found in maternal animals. In a
developmental toxicity study in rabbits,
the NOAEL of 1 milligram per kilogram
of body weight per day (mg/kg bw/day)
was based on decreased growth and/or
delayed development of the skeleton
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and increased incidences of skeletal
variations and anomalies in fetuses seen
at a LOAEL of 10 mg/kg/day. This
LOAEL is ten-fold lower than the dose
resulting in maternal toxicity (100 mg/
kg/day, few or no feces, late abortion,
decreased body weight and food
consumption). In a rat developmental
toxicity study, increased skeletal
variations (e.g., delayed ossifications)
and other fetal effects (decreased fetal
body weights and an increased number
of runts) occurred at a dose of 25 mg/
kg/day (the lowest dose tested), which
is lower than the 125 mg/kg bw dose
that caused marginal maternal toxicity
(decreased body-weight gains and food
consumption). In a rat developmental
neurotoxicity study (DNT), decreased
post-weaning body weight (males),
decreased acoustic startle response and
brain morphometric changes were seen
in rat fetuses at a dose of 0.8 mg/kg/day
(the lowest dose tested) which was
lower than the dose of 16.3 mg/kg/day
at which maternal toxicity occurred
(cornel opacity during lactation).
Although, these studies provide
evidence of increased susceptibility
following pre- and post-natal exposures,
the concern for increased susceptibility
is low for several reasons. First, a well
characterized NOAEL (with a sufficient
margin from the LOAEL) protecting
fetuses has been established in the
rabbit prenatal study. Also, the prenatal
developmental NOAELs or LOAELs for
both the rabbit and rat studies are
approximately 12 to 30-fold higher than
the LOAEL used for the acute RfD.
Although there were some marginal
effects reported in the offspring in the
rat 2-generation reproduction study at
1.4 mg/kg/day (the lowest dose tested),
these parameters (ocular, decreased
absolute brain weight, preputial
separation) were also evaluated at the
lower dose in the rat DNT study but
were not found at the low dose tested
(0.8 mg/kg/day). Therefore, a NOAEL
has been identified for these effects.
Other effects indicative of neurotoxicity
(altered brain morphometrics, decrease
in auditory startle response) were seen
in the rat developmental neurotoxicity
study at the lowest dose tested. The
response for brain morphometrics seen
at termination is considered to be
marginal or equivocal since the changes
were small and no clear dose response
was observed. The decreased acoustic
startle response was not found in young
pups (post-natal day 22) but only
observed in adult rats (post-natal day
60) and was statistically significant at
the mid and high dose but not at the
lowest dose tested.
3. Conclusion. Given the abovedescribed data on pre- and post-natal
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effects, the only significant uncertainty
concerns the acute RfD due to the
failure to identify a NOAEL for the brain
morphometric alterations found in the
rat DNT. The LOAEL in the DNT is
lower than the NOAEL and the LOAEL
from the rabbit and rat developmental
studies, and thus is the lowest dose
reflective of potential acute effects.
Because of the uncertainty as to the
NOAEL for the acute effects (brain
morphometric alterations) seen at 0.8
mg/kg/day in the DNT, EPA has
retained the additional 10X FQPA safety
factor in calculating the acute RfD. This
is a conservative step given the
equivocal nature of the brain
morphometric alterations seen at the
LOAEL in the DNT.
EPA has determined that reliable data
show that it would be safe for infants
and children to reduce the FQPA safety
factor to 1X for assessing chronic risk.
That decision is based on the following
findings:
i. For the reasons described in Unit
III.D.2., the toxicity database for
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione is adequate to assess
chronic risk.
ii. Despite evidence of sensitivity in
pre- and post-natal studies, as detailed
in Unit III.D.2., the chronic RfD based
on an adult animal study (chronic rat
study) is considered to be protective of
the chronic offspring toxicity found in
the rat DNT and 2-generation
reproduction studies. The 2-generation
reproduction study did not identify a
NOAEL for the chronic effects seen on
brain weight and preputial separation
but a NOAEL can be characterized from
the DNT, as discussed above, at 0.8 mg/
kg/day. The NOAEL used to set the
chronic RfD is 20-fold lower than this
0.8 mg/kg/day dose and is not based on
an effect as to which the data have
raised sensitivity concerns. Similarly,
the chronic rat study and the NOAEL
from that study are protective of the
chronic effects seen in the DNT study
and the other chronic effects found in
the 2-generation reproduction study.
The endpoints of concern for the
chronic RfD are based on ocular
toxicity, body weight decreases, kidney
toxicity, and changes in the clinical
chemistry parameters. Target organ
toxicity such as ocular toxicity, kidney
toxicity, body weight changes and
nervous system effects were assessed in
the young through pre- and post-natal
exposure to tembotrione in the 2generation reproduction study and the
DNT study. In those studies, these
effects were observed at higher doses in
the young than in the adults in the
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chronic rat study. Therefore, the chronic
RfD is considered to be protective of
effects in the young. As noted, the
NOAEL (0.04 mg/kg/day) selected for
the chronic RfD is 20-fold lower than
the dose at which developmental and
neurological effects were observed in
any study; it is also 20-fold lower than
the NOAEL for other chronic effects
seen in the young.
iii. There are no residual uncertainties
identified in the exposure data bases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues of tembotrione,
2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione.
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the aPAD
and cPAD. The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. For linear cancer risks,
EPA calculates the probability of
additional cancer cases given aggregate
exposure. Short-, intermediate-, and
long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the MOE called for
by the product of all applicable UFs is
not exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3-cyclo
hexanedione will occupy 77% of the
aPAD for the population group (infants
(<1 year old) receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to tembotrione, 2-[2chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione from food and water
will utilize 48% of the cPAD for the
population group (children 3 to 5 years
old). There are no residential uses for
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione that result in chronic
residential exposure to tembotrione, 2[2-chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
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Tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione 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 does not exceed
the Agency’s level of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3-cyclo
hexanedione 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 does not exceed the
Agency’s level of concern.
5. Aggregate cancer risk for U.S.
population. Dietary cancer risk concerns
due to long-term consumption of
tembotrione residues are adequately
addressed by the chronic exposure
analysis using the cPAD.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to tembotrione,
2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-1,3cyclohexanedione residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An Adequate enforcement
methodology, liquid chromatography/
mass spectroscopy (LC/MS/MS) method
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.
rwilkins on PROD1PC63 with RULES
B. International Residue Limits
There is neither a Codex proposal, nor
Canadian or Mexican limits for residues
of tembotrione and its metabolites in or
on crops or livestock commodities.
C. Response to Comments
There were no comments received on
the Notice of Filing of the pesticide
petition.
V. Conclusion
Therefore, the tolerance is established
for combined residues or residues of
tembotrione, 2-[2-chloro-4-(methyl
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sulfonyl)-3-[(2,2,2-(trifluoro
ethoxy)methyl]benzoyl]-1,3cyclohexanedione, metabolite; 2-[2chloro-4-(methylsulfonyl)-3-[(2,2,2trifluorethoxy)methyl]benzoyl]-4,6dihydroxycyclohexanedione, in or on
corn, field, grain at 0.02 ppm; corn,
field, forage at 0.60 ppm; corn, field,
stover at 0.45 ppm; corn, sweet, kernel
plus cob with husks removed at 0.04
ppm; corn, sweet, forage at 1.0 ppm;
corn sweet, stover at 1.2 ppm; corn, pop,
grain at 0.02 ppm; corn, pop, stover at
0.35 ppm; cattle, liver at 0.40 ppm;
cattle, meat byproducts, except liver
0.07 ppm; goat, liver at 0.40 ppm; goat,
meat byproducts, except liver at 0.07
ppm; horse, liver at 0.40 ppm; horse,
meat byproducts except liver at 0.07
ppm; sheep, liver at 0.40 ppm; sheep,
meat byproducts, except liver at 0.07
ppm; poultry, liver at 0.07 ppm.
VI. 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, 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) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
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Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
to this rule. In addition, This rule does
not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: September 23, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
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I
2. Section 180.634 is added to subpart
C to read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§180.634 Tembotrione; tolerances for
residues.
Centers for Medicare & Medicaid
Services
(a) General. Tolerances are
established for residues of the herbicide,
tembotrione, 2-[2-chloro-4-(methyl
sulfonyl)-3-[(2,2,2-trifluoro
ethoxy)methyl]benzoyl]-1,3-cyclo
hexanedione and its metabolite 2-[2chloro-4-(methylsulfonyl)-3-[(2,2,2trifluoroethoxy)methyl]benzoyl]-4,6dihydroxycyclohexane-1,3-dione in or
on the following commodities:
[CMS–1545–CN]
Commodity
Parts per million
Cattle, liver ............................
Cattle, meat byproducts, except 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, liver .............................
Goat, meat byproducts, except liver ............................
Horse, liver ...........................
Horse, meat byproducts, except liver ............................
Poultry, liver ..........................
Sheep, liver ...........................
Sheep, meat byproducts, except liver ............................
0.40
0.07
0.60
0.02
0.45
0.02
0.35
1.0
0.04
1.2
0.40
42 CFR Part 409
RIN 0938–AM46
Medicare Program; Prospective
Payment System and Consolidated
Billing for Skilled Nursing Facilities;
Corrections
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correction notice.
AGENCY:
SUMMARY: This document corrects
technical errors that appeared in the
August 3, 2007 Federal Register,
entitled ‘‘Medicare Program; Prospective
Payment System and Consolidated
Billing for Skilled Nursing Facilities for
FY 2008; Final Rule.’’
DATES: Effective Date: This correction is
effective October 1, 2007.
FOR FURTHER INFORMATION CONTACT: Bill
Ullman, (410) 786–5667.
SUPPLEMENTARY INFORMATION:
rwilkins on PROD1PC63 with RULES
I. Background
FR Doc. 07–3784 of August 3, 2007
(72 FR 43412) contained technical errors
that this notice serves to identify and
0.07
correct. The first involves the
0.07
construction of the 2004 skilled nursing
0.40
facility (SNF) market basket update. In
0.07 the SNF prospective payment system
(PPS) proposed rule for fiscal year (FY)
2008 (72 FR 25552, May 4, 2007), we
(b) Section 18 emergency exemptions. proposed to discontinue the previous,
[Reserved]
1997-based market basket’s use of the
Producer Price Index (PPI) for Industrial
(c) Tolerances with regional
Chemicals, in favor of using a blended
registrations. [Reserved]
PPI composed of the PPIs for soap and
(d) Indirect or inadvertent residues.
other detergent manufacturing (North
[Reserved]
American Industrial Classification
[FR Doc. E7–19230 Filed 9–27–07; 8:45 am]
System (NAICS) 325611), polish and
BILLING CODE 6560–50–S
other sanitation good manufacturing
(NAICS 325612), and all other
miscellaneous chemical product and
preparation manufacturing (NAICS
325998) in the 2004-based market
basket, which we believed would better
reflect SNF purchasing patterns. In the
FY 2008 SNF PPS final rule, we
finalized this proposal ‘‘* * * to revise
the market basket to reflect more
appropriate, industry-specific price
proxies (such as the blended
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18:21 Sep 27, 2007
0.07
0.40
Jkt 211001
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55085
compensation and chemical price
proxies)’’ (72 FR 43426, 43436).
However, in performing the actual
calculations in the final rule, we
inadvertently proxied the chemicals
cost weight by the PPI for Industrial
Chemicals rather than by the
appropriate blended chemical price
proxy. We note that this error did not
affect the final market basket update
factor of 3.3 percent, but did affect the
labor-related share. The corrected laborrelated share is 70.249, which is slightly
higher than the 70.152 figure published
in the FY 2008 SNF PPS final rule.
Accordingly, in this notice, we are
republishing corrected versions of
Tables 6, 7, 10, 13, and 14 (as well as
revising the corresponding portions of
the final rule’s preamble text) in order
to reflect the final, corrected laborrelated share.
In addition, we have determined that
in the process of developing the most
recent hospital wage index, two
inpatient hospital providers with wage
data that belonged in the Hartford–West
Hartford–East Hartford, CT core-based
statistical area (CBSA) were
inadvertently included in rural
Connecticut instead. Accordingly, in
Table 8, we are revising the wage index
value for CBSA Code 25540 (Hartford–
West Hartford–East Hartford, CT) from
1.0937 to the corrected value of 1.0930.
Similarly, in Table 9, we are revising the
wage index value for CBSA Code 7
(rural Connecticut) from 1.1283 to the
corrected value of 1.1711. As we are
revising only a single entry in each of
these two tables, we are not
republishing Tables 8 and 9 in their
entirety in this notice; however, we note
that the corrected versions of both tables
are available online on the SNF PPS
Web site, at https://www.cms.hhs.gov/
SNFPPS/04_WageIndex.asp. Moreover,
we note that the corrected version of
Table 14 that we are republishing in this
notice also reflects these corrected
values. We are also correcting a
typographical error in the final rule’s
version of that table, which had
inadvertently displayed the wage data
update for rural New England
incorrectly as a negative value.
II. Correction of Errors
In FR Doc. 07–3784 (72 FR 43412),
make the following corrections:
1. On page 43421, Table 6 is corrected
to read as follows:
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]]>Agencies
[Federal Register Volume 72, Number 188 (Friday, September 28, 2007)]
[Rules and Regulations]
[Pages 55078-55085]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19230]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0072; FRL-8148-2]
Tembotrione; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione and its metabolite
(M5); 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-4,6-dihydroxy-1,3-cyclohexanedione in
or on corn (field, sweet and pop) and livestock commodities. Bayer
CropScience requested those tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 28, 2007. Objections and
requests for hearings must be received on or before November 27, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0072. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., 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 in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Eugene Wilson, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-6103; e-mail address: wilson.eugene@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 those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide 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?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0072 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 as required by 40 CFR part 178 on or
before November 27, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0072, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
[[Page 55079]]
II. Petition for Tolerance
In the Federal Register of April 26, 2006 (71 FR 24690 - 24692)
(FRL-8063-6), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 5F7009) by Bayer CropScience, 2 TW Alexander Drive, P.O.
Box 12014, RTP, NC 27709. The petition requested that 40 CFR part 180
be amended by establishing a tolerance for combined residues of the
herbicide AE 0172747 (tembotrione), 2-[2-chloro-4-(methylsulfonyl)-3-
[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione, and
metabolite (M5), AE 1417268 (2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-4,6-dihydroxy-1,3-cyclohexanedione
(expressed as tembotrione equivalents in or on corn, field, grain at
0.02 ppm; corn, field, forage at 0.5 ppm; corn, field, stover at 0.5
ppm; corn, sweet, kernel plus cob with husks removed at 0.03 ppm; corn,
sweet, forage at 1.0 ppm; corn sweet, stover at 1.0 ppm; popcorn, grain
at 0.01 ppm; Popcorn, stover, 0.25 ppm; cattle, liver at 0.5 ppm;
cattle, meat byproducts, except liver at 0.07 ppm; goat, liver at 0.5
ppm; goat, kidney at 0.07 ppm; Hog Liver at 0.5; Hog, Kidney at 0.07
ppm, sheep, kidney at 0.07 ppm; sheep, meat byproducts at 0.5 ppm ;
horse, kidney at 0.07 ppm; horse, meat byproducts at 0.5 ppm. There
were no comments received in response to the notice of filing.
Based on the aggregate exposure from food and feed commodities
resulting from the use-patterns proposed in the petition, the proposed
tolerances were revised to account for both tembotrione and its
metabolite M5, expressed as tembotrione equilivants. The aggregate risk
assessment is discussed in Unit III, below. The reasons for these
changes are also explained in Unit V.
III. Aggregate Risk Assessment and Determination of Safety
For tembotrione, aggregate exposure risk assessments were performed
for the following scenarios: acute aggregate exposure (food and
drinking water), and chronic aggregate exposure (food and drinking
water). Short- and intermediate-term assessments were not performed
because there are no registered or proposed residential non-food uses.
The chronic Reference Dose (cRfD) will be protective of cancer and non-
cancer effects, because tembotrione is classified as ``Suggestive
Evidence of Carcinogenicity'' and EPA's Cancer Assessment Review
Committee (CARC ) recommended that a separate quantification of cancer
risks is not required, while noting that the progression of non-
neoplastic related lesions in rats was biologically plausible by non-
genotoxic modes of action for the corneal tumors.
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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for combined residues of tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-
[(2,2,2-trifluoroethoxy]methyl]benzoyl]-1,3-cyclohexanedione and
metabolite (M5), 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-4,6-dihydroxy-1,3-cyclohexanedione, in
or on corn, field, grain at 0.02 ppm; corn, field, forage at 0.60 ppm;
corn, field, stover at 0.45 ppm; corn, sweet, kernel plus cob with
husks removed at 0.04 ppm; corn, sweet, forage at 1.0 ppm; corn, sweet,
stover at 1.2 ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at
0.35 ppm; cattle, liver at 0.40 ppm; cattle, meat byproducts, except
liver 0.07 ppm; goat, liver at 0.40 ppm; goat, meat byproducts, except
liver at 0.07 ppm; horse, liver at 0.40 ppm; horse, meat byproducts
except liver at 0.07 ppm; sheep, liver at 0.40 ppm; sheep, meat
byproducts, except liver at 0.07 ppm; poultry, liver at 0.07 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by tembotrione, 2-[2-chloro-4-
(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-
cyclohexanedione as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies can be found at https://www.regulations.gov. The
referenced document is available in the docket established by this
action, which is described under ADDRESSES, and is identified as EPA-
HQ-OPP-2006-0072 in that docket.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are
[[Page 55080]]
considered non-threshold. For more information on the general
principles EPA uses in risk characterization and a complete description
of the risk assessment process, see https://www.epa.gov/fedrgstr/EPA-
PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for tembotrione, 2-[2-
chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-
1,3-cyclohexanedione used for human risk assessment is shown in Table 1
of this unit.
Table 1.--Summary of Toxicological Dose and Endpoints for tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione 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 FQPA, SF
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population LOAEL = 0.8 (mg/kg/day) Special FQPA SF = 1 Developmental
including infants and children) and SF = 1000.............. aPAD = acute RfD / Neurotoxicity Study:
Females 13 to 49 UFA = 10X.............. Special FQPA SF = Offspring NOAEL was
UFH = 10X.............. 0.0008 mg/kg. not
FQPA SF = 10X(includes established.Offspring
UFL = 10X). LOAEL = 0.8 mg/kg/day
Acute reference dose based on decreased
(RfD) = 0.0008 mg/kg. acoustic startle
response on PND 60
(males), and brain
morphometric changes
on PND 75 (males and
females).
----------------------------------------------------------------------------------------------------------------
Chronic dietary(All populations) NOAEL= .04 mg/kg/day Special FQPA SF = 1 Chronic/Carcinogenicity
SF = 100............... cPAD = chronic RfD Study LOAEL = 0.79 mg/
UFA = 10X.............. Special FQPA SF = kg/day based on
UFH = 10X.............. 0.0004 mg/kg/day. neovascularization and
FQPA SF = 1X........... edema of the cornea
Chronic RfD = 0.0004 mg/ and snow flake-like
kg/day. corneal opacity,
unilateral or
bilateral keratitis of
the eye, decreased
mean body weight and
mean body-weight gain,
increased total
cholesterol, higher
ketone levels and
lower pH values,
higher protein levels,
increased kidney
weight, kidney to body
weight and kidney to
brain weight ratios,
chronic nephropathy
and atrophy of the
sciatic nerve.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days) Oral study LOAEL= 0.8 LOC for MOE =1000 Developmental
(Residential) mg/kg/day neurotoxicity Study
UFA = 10X.............. Offspring NOAEL was
UFH = 10X.............. not
FQPA SF = 10X (includes established.Offspring
UFL = 10X) (dermal LOAEL = 0.8 mg/kg/day
absorption rate = 15 based on decreased
%). acoustic startle
response on PND 60
(males), and brain
morphometric changes
on PND 75 (males and
females).
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 to 6 Oral study LOAEL= 0.8 LOC for MOE = 1000 Developmental
months) (Residential) mg/kg/day (Residential) neurotoxicity Study
UFA = 10X.............. Offspring NOAEL was
UFH = 10X.............. not
FQPA SF = 10X (includes established.Offspring
UFL = 10X) (dermal LOAEL = 0.8 mg/kg/day
absorption rate = 15 based on decreased
%). acoustic startle
response on PND 60
(males), and brain
morphometric changes
on PND 75 (males and
females).
----------------------------------------------------------------------------------------------------------------
[[Page 55081]]
Long-term dermal (>6 months to Oral study NOAEL= 0.04 LOC for MOE = 100 Chronic/Carcinogenicity
lifetime) (Residential) mg/kg/day (Residential) Study LOAEL = 0.79 mg/
UFA = 10X.............. kg/day based on
UFH = 10X.............. neovascularization and
FQPA SF = 1X (dermal edema of the cornea
absorption rate = 15 % and snow flake-like
when appropriate). corneal opacity,
unilateral or
bilateral keratitis of
the eye, decreased
mean body weight and
mean body-weight gain,
increased total
cholesterol, higher
ketone levels and
lower pH values,
higher protein levels,
increased kidney
weight, kidney to body
weight and kidney to
brain weight ratios,
chronic nephropathy
and atrophy of the
sciatic nerve.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days) Oral study LOAEL= 0.8 LOC for MOE = 1000 Developmental
(Residential) UFL = 10X) (inhalation (Residential) neurotoxicity Study
absorption rate = Offspring NOAEL was
100%). not established.
Offspring LOAEL = 0.8
mg/kg/day based on
decreased acoustic
startle response on
PND 60 (males), and
brain morphometric
changes on PND 75
(males and females).
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 to 6 Oral study LOAEL= 0.8 LOC for MOE = 1000 Developmental
months) (Residential) mg/kg/day (Residential) neurotoxicity Study]
UFA = 10X.............. Offspring NOAEL was
UFH = 10X.............. not
FQPA SF = 10X (includes established.Offspring
UFL = 10X) (inhalation LOAEL = 0.8 mg/kg/day
absorption rate = based on decreased
100%). acoustic startle
response on PND 60
(males), and brain
morphometric changes
on PND 75 (males and
females).
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (>6 months) Oral study NOAEL= 0.04 LOC for MOE = 100 Chronic/Carcinogenicity
(Residential) mg/kg/day Residential Study LOAEL = 0.79 mg/
UFH = 10X............. kg/day based on
FQPA SF = 1X neovascularization and
(inhalation absorption edema of the cornea
rate = 100%). and snow flake-like
corneal opacity,
unilateral or
bilateral keratitis of
the eye, decreased
mean body weight and
mean body-weight gain,
increased total
cholesterol, higher
ketone levels and
lower pH values,
higher protein levels,
increased kidney
weight, kidney to body
weight and kidney to
brain weight ratios,
chronic nephropathy
and atrophy of the
sciatic nerve.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Suggestive Evidence of Carcinogenic Potential'' based
on the observance of squamous cell carcinomas in a rat carcinogenicity
study. Quantification of cancer risk is not required.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.
MOE = margin of exposure. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione, EPA considered
exposure under the petitioned-for tolerances. EPA assessed dietary
exposures from tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
tri
[[Page 55082]]
fluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Effects were identified in the toxicological studies for
tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione; therefore, a
quantitative acute dietary exposure assessment was necessary. The acute
analysis assumed 100% crop treated (CT), Dietary Exposure Evaluation
Model (DEEM(TM)) 7.81 default processing factors, and
tolerance-level residues for all foods. For drinking water, the entire
distribution of estimated daily exposure values from the Pesticide Root
Zone Modeling-Exposure Evaluation Analysis Modeling System (PRZM-EXAMS)
run was incorporated in the acute probabilistic exposure analyses. The
resulting acute dietary (food + water) risk estimates were <32% of the
aPAD for the general U.S. population and <77% of the aPAD for all
infants (<1 year old, the most highly-exposed population subgroup) at
the 95th percentile; less than HED's LOC (100% aPAD). Even though the
entire distribution of estimated daily drinking water exposure values
was incorporated, this analysis is still conservative since tolerance-
level residues, DEEM(TM) 7.81 default processing factors,
and 100% CT were assumed. Also, the distribution of estimated daily
drinking water exposure still assumes 100% CT and the maximum
application rate.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA, 1994-1996,
and 1998 Continuing Survey of Food Intake by Individuals. As to residue
levels in food, EPA assumed all foods for which there are proposed
tolerances were treated and contain tolerance-level residues. A
conservative chronic dietary assessment assuming tolerance-level
residues, DEEM(TM) 7.81 default processing factors, and 100%
CT was also conducted. The highest estimate of chronic surface water
exposure (1.05 parts per billion (ppb)) was used for drinking water in
this analysis.
iii. Cancer. There was only suggestive evidence of carcinogenic
potential based on the observance of squamous cell carcinomas in a rat
carcinogenicity study. Quantification of cancer risk is not required.
Dietary cancer risk concerns due to long-term consumption of
tembotrione residues are adequately addressed by the chronic exposure
analysis using the cPAD.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for tembotrione, 2-[2-chloro-4-
(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-
cyclohexanedione 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 environmental fate characteristics of tembotrione, 2-[2-chloro-
4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-
cyclohexanedione. Further, information regarding EPA drinking water
models used in pesticide exposure assessment can be found at https://
www.epa.gov/oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and Screening Concentration in Ground Water
(SCI-GROW) models, the estimated environmental concentrations (EECs) of
tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione for acute
exposures are estimated to be 5.84 parts per billion (ppb) for surface
water and 0.0139 ppb for ground water. The EECs for chronic exposures
are estimated to be 1.05 ppb for surface water and 0.0139 ppb for
ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 5.84 ppb was used to
access the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 1.05 ppb was used to
access the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione is not registered
for use on any sites that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Tembotrione, belongs to a class of herbicides (including
mesotrione, pyrasulfotole, isoxaflutole and topramezone) that inhibit
the liver enzyme 4-hydroxyphenylpyruvate dioxygenase (HPPD). As
discussed above, EPA has concluded that the ocular effects caused by
these herbicides has limited relevance to humans. Nonetheless, as a
worst case scenario, EPA has assessed aggregate exposure to tembotrione
based on ocular effects in rats. For similar reasons, a semi-
quantitative screening cumulative assessment was conducted using the
rat ocular effects and 100% crop treated information. The results of
this screening analysis did not indicate a concern. In the future,
assessments of HPPD-inhibiting herbicides will consider more
appropriate models and cross species extrapolation methods.
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 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 (``10X'') tenfold margin of safety for infants and children
in the case of threshold effects to account for pre- and post-natal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor. 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 FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is evidence of
increased susceptibility in rabbit and rat fetuses to in utero exposure
to tembotrione compared to the doses for the effects found in maternal
animals. In a developmental toxicity study in rabbits, the NOAEL of 1
milligram per kilogram of body weight per day (mg/kg bw/day) was based
on decreased growth and/or delayed development of the skeleton
[[Page 55083]]
and increased incidences of skeletal variations and anomalies in
fetuses seen at a LOAEL of 10 mg/kg/day. This LOAEL is ten-fold lower
than the dose resulting in maternal toxicity (100 mg/kg/day, few or no
feces, late abortion, decreased body weight and food consumption). In a
rat developmental toxicity study, increased skeletal variations (e.g.,
delayed ossifications) and other fetal effects (decreased fetal body
weights and an increased number of runts) occurred at a dose of 25 mg/
kg/day (the lowest dose tested), which is lower than the 125 mg/kg bw
dose that caused marginal maternal toxicity (decreased body-weight
gains and food consumption). In a rat developmental neurotoxicity study
(DNT), decreased post-weaning body weight (males), decreased acoustic
startle response and brain morphometric changes were seen in rat
fetuses at a dose of 0.8 mg/kg/day (the lowest dose tested) which was
lower than the dose of 16.3 mg/kg/day at which maternal toxicity
occurred (cornel opacity during lactation).
Although, these studies provide evidence of increased
susceptibility following pre- and post-natal exposures, the concern for
increased susceptibility is low for several reasons. First, a well
characterized NOAEL (with a sufficient margin from the LOAEL)
protecting fetuses has been established in the rabbit prenatal study.
Also, the prenatal developmental NOAELs or LOAELs for both the rabbit
and rat studies are approximately 12 to 30-fold higher than the LOAEL
used for the acute RfD. Although there were some marginal effects
reported in the offspring in the rat 2-generation reproduction study at
1.4 mg/kg/day (the lowest dose tested), these parameters (ocular,
decreased absolute brain weight, preputial separation) were also
evaluated at the lower dose in the rat DNT study but were not found at
the low dose tested (0.8 mg/kg/day). Therefore, a NOAEL has been
identified for these effects. Other effects indicative of neurotoxicity
(altered brain morphometrics, decrease in auditory startle response)
were seen in the rat developmental neurotoxicity study at the lowest
dose tested. The response for brain morphometrics seen at termination
is considered to be marginal or equivocal since the changes were small
and no clear dose response was observed. The decreased acoustic startle
response was not found in young pups (post-natal day 22) but only
observed in adult rats (post-natal day 60) and was statistically
significant at the mid and high dose but not at the lowest dose tested.
3. Conclusion. Given the above-described data on pre- and post-
natal effects, the only significant uncertainty concerns the acute RfD
due to the failure to identify a NOAEL for the brain morphometric
alterations found in the rat DNT. The LOAEL in the DNT is lower than
the NOAEL and the LOAEL from the rabbit and rat developmental studies,
and thus is the lowest dose reflective of potential acute effects.
Because of the uncertainty as to the NOAEL for the acute effects (brain
morphometric alterations) seen at 0.8 mg/kg/day in the DNT, EPA has
retained the additional 10X FQPA safety factor in calculating the acute
RfD. This is a conservative step given the equivocal nature of the
brain morphometric alterations seen at the LOAEL in the DNT.
EPA has determined that reliable data show that it would be safe
for infants and children to reduce the FQPA safety factor to 1X for
assessing chronic risk. That decision is based on the following
findings:
i. For the reasons described in Unit III.D.2., the toxicity
database for tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione is adequate to
assess chronic risk.
ii. Despite evidence of sensitivity in pre- and post-natal studies,
as detailed in Unit III.D.2., the chronic RfD based on an adult animal
study (chronic rat study) is considered to be protective of the chronic
offspring toxicity found in the rat DNT and 2-generation reproduction
studies. The 2-generation reproduction study did not identify a NOAEL
for the chronic effects seen on brain weight and preputial separation
but a NOAEL can be characterized from the DNT, as discussed above, at
0.8 mg/kg/day. The NOAEL used to set the chronic RfD is 20-fold lower
than this 0.8 mg/kg/day dose and is not based on an effect as to which
the data have raised sensitivity concerns. Similarly, the chronic rat
study and the NOAEL from that study are protective of the chronic
effects seen in the DNT study and the other chronic effects found in
the 2-generation reproduction study. The endpoints of concern for the
chronic RfD are based on ocular toxicity, body weight decreases, kidney
toxicity, and changes in the clinical chemistry parameters. Target
organ toxicity such as ocular toxicity, kidney toxicity, body weight
changes and nervous system effects were assessed in the young through
pre- and post-natal exposure to tembotrione in the 2-generation
reproduction study and the DNT study. In those studies, these effects
were observed at higher doses in the young than in the adults in the
chronic rat study. Therefore, the chronic RfD is considered to be
protective of effects in the young. As noted, the NOAEL (0.04 mg/kg/
day) selected for the chronic RfD is 20-fold lower than the dose at
which developmental and neurological effects were observed in any
study; it is also 20-fold lower than the NOAEL for other chronic
effects seen in the young.
iii. There are no residual uncertainties identified in the exposure
data bases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues of tembotrione, 2-[2-chloro-4-
(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-
cyclohexanedione.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione will occupy 77% of
the aPAD for the population group (infants (<1 year old) receiving the
greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione from food and
water will utilize 48% of the cPAD for the population group (children 3
to 5 years old). There are no residential uses for tembotrione, 2-[2-
chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-
1,3-cyclohexanedione that result in chronic residential exposure to
tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
[[Page 55084]]
Tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione 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 does not exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione 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 does not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Dietary cancer risk
concerns due to long-term consumption of tembotrione residues are
adequately addressed by the chronic exposure analysis using the cPAD.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An Adequate enforcement methodology, liquid chromatography/mass
spectroscopy (LC/MS/MS) method 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 is neither a Codex proposal, nor Canadian or Mexican limits
for residues of tembotrione and its metabolites in or on crops or
livestock commodities.
C. Response to Comments
There were no comments received on the Notice of Filing of the
pesticide petition.
V. Conclusion
Therefore, the tolerance is established for combined residues or
residues of tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
(trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione, metabolite; 2-
[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluorethoxy)methyl]benzoyl]-
4,6-dihydroxycyclohexanedione, in or on corn, field, grain at 0.02 ppm;
corn, field, forage at 0.60 ppm; corn, field, stover at 0.45 ppm; corn,
sweet, kernel plus cob with husks removed at 0.04 ppm; corn, sweet,
forage at 1.0 ppm; corn sweet, stover at 1.2 ppm; corn, pop, grain at
0.02 ppm; corn, pop, stover at 0.35 ppm; cattle, liver at 0.40 ppm;
cattle, meat byproducts, except liver 0.07 ppm; goat, liver at 0.40
ppm; goat, meat byproducts, except liver at 0.07 ppm; horse, liver at
0.40 ppm; horse, meat byproducts except liver at 0.07 ppm; sheep, liver
at 0.40 ppm; sheep, meat byproducts, except liver at 0.07 ppm; poultry,
liver at 0.07 ppm.
VI. 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, 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) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). 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., 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).
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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 23, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
[[Page 55085]]
0
2. Section 180.634 is added to subpart C to read as follows:
Sec. 180.634 Tembotrione; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide, tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione and its metabolite
2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-4,6-dihydroxycyclohexane-1,3-dione in
or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, liver........................................... 0.40
Cattle, meat byproducts, except liver................... 0.07
Corn, field, forage..................................... 0.60
Corn, field, grain...................................... 0.02
Corn, field, stover..................................... 0.45
Corn, pop, grain........................................ 0.02
Corn, pop, stover....................................... 0.35
Corn, sweet, forage..................................... 1.0
Corn, sweet, kernel plus cob with husks removed......... 0.04
Corn, sweet, stover..................................... 1.2
Goat, liver............................................. 0.40
Goat, meat byproducts, except liver..................... 0.07
Horse, liver............................................ 0.40
Horse, meat byproducts, except liver.................... 0.07
Poultry, liver.......................................... 0.07
Sheep, liver............................................ 0.40
Sheep, meat byproducts, except liver.................... 0.07
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E7-19230 Filed 9-27-07; 8:45 am]
BILLING CODE 6560-50-S
