Tepraloxydim; Pesticide Tolerance, 54584-54588 [E7-18850]
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54584
Federal Register / Vol. 72, No. 186 / Wednesday, September 26, 2007 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.249 is revised to read
as follows:
I
§ 180.249 Alachlor; tolerances for
residues.
(a) General. Tolerances are
established for combined residues of
alachlor (2-chloro-2’,6’-diethyl-N(methoxymethyl)acetanilide) and its
metabolites which can be converted to
2,6-diethylaniline (DEA) or 2-ethyl-6-(1hydroxyethyl)aniline (1-HEEA) upon
basic hydrolysis, calculated as alachlor
in or on the following raw agricultural
commodities.
Commodity
Parts per
million
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Beans, dry ................................
Beans, succulent lima ..............
Cattle, fat ..................................
Cattle, meat byproducts ...........
Cattle, meat ..............................
Corn, field, forage .....................
Corn, field, grain .......................
Corn, field, pop .........................
Corn, field, stover .....................
Corn, pop, stover ......................
Corn, sweet (K+CWHR) ...........
Corn, sweet, stover ..................
Cotton, gin byproducts .............
Cotton, undelinted seed ...........
Cowpea, forage ........................
Cowpea, hay .............................
Egg ...........................................
Goat, fat ....................................
Goat, meat byproducts .............
Goat, meat ................................
Hog, fat .....................................
Hog meat byproducts ...............
Hog, meat .................................
Horse, fat ..................................
Horse, meat byproducts ...........
Horse, meat ..............................
Milk ...........................................
Peanut ......................................
Poultry, fat ................................
Poultry, meat byproducts ..........
Poultry, meat ............................
Sheep, fat .................................
Sheep, meat byproducts ..........
Sheep, meat .............................
Sorghum grain, forage ..............
Sorghum, grain, grain ...............
Sorghum, grain, stover .............
Soybeans, seed ........................
Sunflower, meal ........................
Sunflower, seed ........................
0.1
0.1
0.02
0.02
0.02
2.0
0.2
0.2
2.0
2.0
0.05
2.0
0.7
0.03
5.0
5.0
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.5
0.02
0.02
0.02
0.02
0.02
0.02
2.0
0.1
1.0
1.0
3.4
2.5
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
Tolerances are established for indirect
or inadvertent residues of alachlor (2chloro-2’,6’-diethyl-N(methoxymethyl)acetanilide) and its
metabolites which can be converted to
2,6-diethylaniline (DEA) or 2-ethyl-6-(1hydroxyethyl)aniline (1-HEEA) upon
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basic hydrolysis, calculated as alachlor,
in or on the following raw agricultural
commodities when present therein as a
result of the application of alachlor to
the growing crops in paragraph (a) of
this section:
Parts per
million
Commodity
Animal feed, nongrass, group
18, forage ..............................
Animal feed, nongrass, group
18, hay ..................................
Grain, cereal, forage, and
straw, group 16 except corn,
sorghum, rice, straw .............
Grain, cereal, forage, fodder
and straw, group 16 except
corn, sorghum, rice, forage ...
Grain, cereal, forage, fodder,
and straw, group 16 except
for corn, sorghum, rice, hay ..
Grain, cereal, group 15 except
corn, sorghum, rice ...............
1.4
1.2
0.8
0.6
0.8
0.05
[FR Doc. E7–18967 Filed 9–25–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2007–0145; FRL–8148–1]
Tepraloxydim; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of tepraloxydim
in or on imported flax, seed; lentil, seed;
and pea, dry seed. BASF requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 26, 2007. Objections and
requests for hearings must be received
on or before November 26, 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–2007–0145. 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
PO 00000
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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: Jim
Tompkins, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5697; e-mail address:
tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
Sfmt 4700
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to 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
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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–2007–0145 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 26, 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–2007–0145, 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
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deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of May 9, 2007
(72 FR 26372) (FRL–8121–5), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6E7046) by BASF,
26 Davis Drive, Research Triangle Park,
NC 27709. The petition requested that
40 CFR 180.573 be amended by
establishing a tolerance for residues of
the herbicide tepraloxdydim (2-[1[[[(2E)-3-chloro-2propenyl]oxy]imino]propyl]-3-hydroxy5-(tetrahydro-2H-pyran-4-yl)-2cyclohexen-1-one) and its metabolites
convertible to GP (3-(tetrahydropyran-4yl)pentane-1,5-dioic acid) and OH-GP
(3-hydroxy-3-(tetrahydropyran-4yl)pentane-1,5-dioic acid), calculated as
tepraloxydim, in or on imported flax,
seed; lentil, seed; and pea, dry, seed at
0.10 parts per million (ppm). That
notice referenced a summary of the
petition prepared by BASF, the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
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
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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 residues of tepraloxydim
on imported flax, seed; lentil, seed; and
pea, dry, seed at 0.10 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 tepraloxydim 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 document 3 (pages 44-47)
in docket ID number EPA–HQ–OPP–
2007–0145 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 Point of Departure
(POD) 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 POD by all applicable UFs.
Short-, intermediate-, and long-term
risks are evaluated by comparing
aggregate exposure to the POD to ensure
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that the LOC 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
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 tepraloxydim used for
human risk assessment can be found at
https://www.regulations.gov in document
3 (pages 22-23) in docket ID number
EPA–HQ–OPP–2007–0145.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to tepraloxydim, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing tepraloxydim tolerances in (40
CFR 180.573). EPA assessed dietary
exposures from tepraloxydim 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.
In estimating acute dietary exposure,
EPA used food consumption
information from the U.S. Department of
Agriculture (USDA) 1994–1996 and
1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As
to residue levels in food, EPA assumed
all foods for which there are tolerances
were treated and contain tolerance-level
residues.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
assumed all foods for which there are
tolerances were treated and contain
tolerance-level residues.
iii. Cancer. Tepraloxydim is classified
as ‘‘Data are inadequate for an
assessment of human carcinogenic
potential’’, because there was some
evidence of liver tumors in female rats
at the high dose in the carcinogenicity
phase of the study, but not in the
chronic phase of the study. Female mice
developed liver tumors at an excessively
toxic dose. Male mice had nonneoplastic liver changes similar to or
exceeding those seen in female mice at
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the same dose, though there was no
increase in liver tumor incidences.
Tepraloxydim was not mutagenic in a
battery of assays. Considering all of this
evidence, tepraloxydim is not expected
to pose a cancer risk for humans, and a
quantitative cancer risk assessment was
not conducted.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residues or PCT
information in the dietary assessment
for tepraloxydim. The acute and chronic
dietary exposure analyses were based on
tolerance level residues and 100 PCT
assumptions.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
tepraloxydim 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
tepraloxydim. 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 First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Groundwater (SCIGROW) models, the estimated
environmental concentrations (EECs) of
tepraloxydim for acute exposures are
estimated to be 1.4 parts per billion
(ppb) for surface water and 0.002 ppb
for ground water. The EECs for chronic
exposures are estimated to be 0.7 ppb
for surface water and 0.002 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 1.4 ppb was used
to assess the contribution to drinking
water. For chronic dietary risk
assessment, the water concentration of
value 0.7 ppb was used to assess 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).
Tepraloxydim 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
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to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to and
any other substances and tepraloxydim
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has not
assumed that tepraloxydim has a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see 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
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. 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 were qualitative and quantitative
prenatal susceptibility in the rat
developmental toxicity study. The
developmental findings with a NOAEL
of 40 milligrams/kilograms/day (mg/kg/
day) were well characterized and
included increased developmental
sensitivity in the form of reduced fetal
body weights, retarded ossification
indicative of delayed maturation and
the presence of hydroureter at 120 mg/
kg/day (developmental LOAEL). Rare
malformations (dilation of both heart
ventricles and filiform tail) were also
detected at the high dose of 360 mg/kg/
day. The maternal toxicity NOAEL/
LOAEL of 120/360 mg/kg/day was based
on reduced body weight gain and food
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consumption. There was no evidence of
increased susceptibility following
prenatal exposure to rabbits, nor was
there evidence of increased
susceptibility following prenatal and/or
postnatal exposure to rats (in the rat
reproduction and fertility effects study).
The degree of concern is low for the
increased susceptibility seen the
developmental study in rats (prenatal
exposure) since a clear NOAEL/LOAEL
was established for developmental
toxicity, and since the endpoints of
concern were used for the most
sensitive population of concern
(Females 13-49). There is no uncertainty
for prenatal and/or postnatal toxicity.
3. Conclusion. The 10X FQPA safety
factor was retained for assessing the
acute dietary risk to the general
population (including infants and
children), due to the lack of a NOAEL
in the acute neurotoxicity study. The
10X FQPA safety factor was reduced to
1X for assessing the acute dietary risk to
females (13-49 years of age) and for
assessing the chronic dietary risk to all
populations based on the following
conclusions.
i. The toxicity database for
tepraloxydim is complete.
ii. While there are indications that
tepraloxydim is neurotoxic at doses far
higher than those currently being used
for the acute and chronic dietary risk
assessments, the two generation
reproduction study showed no clinical
signs indicative of neurotoxicity in the
parental animals or offspring, nor was
there evidence for increased
susceptibility. The Agency concluded
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. There are no residual concerns
regarding increased sensitivity in the
young. There were no qualitative or
quantitative prenatal or postnatal
susceptibility issues in the
developmental toxicity study in rabbits
and 2–generation reproduction toxicity
study in rats. Although increased
sensitivity was seen in the
developmental rat study, the degree of
concern is low as to this finding because
a clear NOAEL/LOAEL was established
for developmental toxicity, and the
endpoints of concern were used for
assessing risk to the most sensitive
population of concern (Females 13-49).
iv. The dietary food exposure
assessment was performed based on
100%CT and tolerance-level residues.
Conservative ground water and surface
water modeling estimates were used.
The drinking water assessment utilized
values generated by models and
associated modeling parameters which
are designed to provide conservative,
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health protective, high-end estimates of
water concentrations. These
assessments will not underestimate the
exposure and risks posed by
tepraloxydim.
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 the LOC to ensure that the
Margin of exposure 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
tepraloxydim will occupy 2% of the
aPAD for the population group (children
1-2 years 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 tepraloxydim from food
and water will utilize 10% of the cPAD
for the population group (children 1-2
years old) receiving the greatest
exposure.
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).
Tepraloxydim 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). Tepraloxydim is not
registered for use on any sites that
would result in residential exposure.
Therefore, the aggregate risk is the sum
of the risk from food and water, which
do not exceed the Agency’s level of
concern.
5. Aggregate cancer risk for U.S.
population. Tepraloxydim is not
expected to pose a cancer risk for
humans.
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
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54587
population or to infants and children
from aggregate exposure to
tepraloxydim residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
is available to enforce the tolerance
expression. The analytical method
involves extraction, concentration,
precipitation, centrifugation/filtration,
oxidation, partition, and clean-up.
Samples are then analyzed by GC-MS
(selected ion monitoring). The LOQ is
0.05 ppm for each analyte.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
No Codex maximum residue limits
(MRLs) have been established for
residues of tepraloxydim on any crops
at this time.
V. Conclusion
Therefore, the tolerance is established
for residues tepraloxdydim (2-[1-[[[(2E)3-chloro-2-propenyl]oxy]imino]propyl]3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)2-cyclohexen-1-one) and its metabolites
convertible to GP (3-(tetrahydropyran-4yl)pentane-1,5-dioic acid) and OH-GP
(3-hydroxy-3-(tetrahydropyran-4yl)pentane-1,5-dioic acid), calculated as
tepraloxydim, in or on flax, seed; lentil,
seed; and pea, dry, seed at 0.10 parts per
million (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
E:\FR\FM\26SER1.SGM
26SER1
54588
Federal Register / Vol. 72, No. 186 / Wednesday, September 26, 2007 / Rules and Regulations
rmajette on PROD1PC64 with RULES
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).
VerDate Aug<31>2005
15:42 Sep 25, 2007
Jkt 211001
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date.
DATES: Effective Dates: The effective
Dated: September 13, 2007.
date of each community’s scheduled
Lois Rossi,
suspension is the third date (‘‘Susp.’’)
Director, Registration Division, Office of
listed in the third column of the
Pesticide Programs.
following tables.
I Therefore, 40 CFR chapter I is
ADDRESSES: If you want to determine
amended as follows:
whether a particular community was
suspended on the suspension date,
PART 180—[AMENDED]
contact the appropriate FEMA Regional
Office.
I 1. The authority citation for part 180
FOR FURTHER INFORMATION CONTACT:
continues to read as follows:
David Stearrett, Mitigation Directorate,
Authority: 21 U.S.C. 321(q), 346a and 371.
Federal Emergency Management
I 2. Section 180.573 is amended by
Agency, 500 C Street, SW., Washington,
alphabetically adding the following
DC 20472, (202) 646–2953.
commodities to the table in paragraph
SUPPLEMENTARY INFORMATION: The NFIP
(a)(1) to read as follows:
enables property owners to purchase
flood insurance which is generally not
§ 180.573 Tepraloxydim; tolerances for
otherwise available. In return,
residues.
communities agree to adopt and
(a) General. (1) * * *
administer local floodplain management
aimed at protecting lives and new
Parts per
Commodity
million
construction from future flooding.
Section 1315 of the National Flood
*
*
*
*
*
Insurance Act of 1968, as amended, 42
Flax, seed .................................
0.10
Lentil, seed ...............................
0.10 U.S.C. 4022, prohibits flood insurance
Pea, dry, seed ..........................
0.10 coverage as authorized under the NFIP,
42 U.S.C. 4001 et seq.; unless an
*
*
*
*
*
appropriate public body adopts
adequate floodplain management
*
*
*
*
*
measures with effective enforcement
[FR Doc. E7–18850 Filed 9–25–07; 8:45 am]
measures. The communities listed in
BILLING CODE 6560–50–S
this document no longer meet that
statutory requirement for compliance
with program regulations, 44 CFR part
DEPARTMENT OF HOMELAND
59. Accordingly, the communities will
SECURITY
be suspended on the effective date in
the third column. As of that date, flood
Federal Emergency Management
insurance will no longer be available in
Agency
the community. However, some of these
communities may adopt and submit the
44 CFR Part 64
required documentation of legally
[Docket No. FEMA–7991]
enforceable floodplain management
measures after this rule is published but
Suspension of Community Eligibility
prior to the actual suspension date.
These communities will not be
AGENCY: Federal Emergency
suspended and will continue their
Management Agency, DHS.
eligibility for the sale of insurance. A
ACTION: Final rule.
notice withdrawing the suspension of
SUMMARY: This rule identifies
the communities will be published in
communities, where the sale of flood
the Federal Register.
insurance has been authorized under
In addition, FEMA has identified the
the National Flood Insurance Program
Special Flood Hazard Areas (SFHAs) in
(NFIP), that are scheduled for
these communities by publishing a
suspension on the effective dates listed
Flood Insurance Rate Map (FIRM). The
within this rule because of
date of the FIRM, if one has been
noncompliance with the floodplain
published, is indicated in the fourth
management requirements of the
column of the table. No direct Federal
program. If the Federal Emergency
financial assistance (except assistance
Management Agency (FEMA) receives
pursuant to the Robert T. Stafford
documentation that the community has
Disaster Relief and Emergency
adopted the required floodplain
Assistance Act not in connection with a
PO 00000
Frm 00070
Fmt 4700
Sfmt 4700
E:\FR\FM\26SER1.SGM
26SER1
]]>Agencies
[Federal Register Volume 72, Number 186 (Wednesday, September 26, 2007)]
[Rules and Regulations]
[Pages 54584-54588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18850]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0145; FRL-8148-1]
Tepraloxydim; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
tepraloxydim in or on imported flax, seed; lentil, seed; and pea, dry
seed. BASF requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective September 26, 2007. Objections and
requests for hearings must be received on or before November 26, 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-2007-0145. 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: Jim Tompkins, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to 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
[[Page 54585]]
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-2007-0145 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 26, 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-2007-0145, 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.
II. Petition for Tolerance
In the Federal Register of May 9, 2007 (72 FR 26372) (FRL-8121-5),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 6E7046)
by BASF, 26 Davis Drive, Research Triangle Park, NC 27709. The petition
requested that 40 CFR 180.573 be amended by establishing a tolerance
for residues of the herbicide tepraloxdydim (2-[1-[[[(2E)-3-chloro-2-
propenyl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-
cyclohexen-1-one) and its metabolites convertible to GP (3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as
tepraloxydim, in or on imported flax, seed; lentil, seed; and pea, dry,
seed at 0.10 parts per million (ppm). That notice referenced a summary
of the petition prepared by BASF, the registrant, which is available to
the public in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
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 residues of tepraloxydim on imported flax, seed; lentil, seed; and
pea, dry, seed at 0.10 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 tepraloxydim 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 document 3 (pages 44-47) in docket ID number EPA-HQ-OPP-
2007-0145 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 Point of Departure (POD) 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 POD by all applicable UFs. Short-, intermediate-, and
long-term risks are evaluated by comparing aggregate exposure to the
POD to ensure
[[Page 54586]]
that the LOC 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 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 tepraloxydim used for
human risk assessment can be found at https://www.regulations.gov in
document 3 (pages 22-23) in docket ID number EPA-HQ-OPP-2007-0145.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tepraloxydim, EPA considered exposure under the petitioned-
for tolerances as well as all existing tepraloxydim tolerances in (40
CFR 180.573). EPA assessed dietary exposures from tepraloxydim 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.
In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances were treated and contain tolerance-level residues.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for
which there are tolerances were treated and contain tolerance-level
residues.
iii. Cancer. Tepraloxydim is classified as ``Data are inadequate
for an assessment of human carcinogenic potential'', because there was
some evidence of liver tumors in female rats at the high dose in the
carcinogenicity phase of the study, but not in the chronic phase of the
study. Female mice developed liver tumors at an excessively toxic dose.
Male mice had non-neoplastic liver changes similar to or exceeding
those seen in female mice at the same dose, though there was no
increase in liver tumor incidences. Tepraloxydim was not mutagenic in a
battery of assays. Considering all of this evidence, tepraloxydim is
not expected to pose a cancer risk for humans, and a quantitative
cancer risk assessment was not conducted.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residues or PCT information in the dietary
assessment for tepraloxydim. The acute and chronic dietary exposure
analyses were based on tolerance level residues and 100 PCT
assumptions.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for tepraloxydim 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 tepraloxydim. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Groundwater (SCI-GROW) models, the estimated
environmental concentrations (EECs) of tepraloxydim for acute exposures
are estimated to be 1.4 parts per billion (ppb) for surface water and
0.002 ppb for ground water. The EECs for chronic exposures are
estimated to be 0.7 ppb for surface water and 0.002 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 1.4 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.7 ppb was used to assess
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).
Tepraloxydim is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to and any other substances
and tepraloxydim does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that tepraloxydim has a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
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 prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. 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 were qualitative and
quantitative prenatal susceptibility in the rat developmental toxicity
study. The developmental findings with a NOAEL of 40 milligrams/
kilograms/day (mg/kg/day) were well characterized and included
increased developmental sensitivity in the form of reduced fetal body
weights, retarded ossification indicative of delayed maturation and the
presence of hydroureter at 120 mg/kg/day (developmental LOAEL). Rare
malformations (dilation of both heart ventricles and filiform tail)
were also detected at the high dose of 360 mg/kg/day. The maternal
toxicity NOAEL/LOAEL of 120/360 mg/kg/day was based on reduced body
weight gain and food
[[Page 54587]]
consumption. There was no evidence of increased susceptibility
following prenatal exposure to rabbits, nor was there evidence of
increased susceptibility following prenatal and/or postnatal exposure
to rats (in the rat reproduction and fertility effects study). The
degree of concern is low for the increased susceptibility seen the
developmental study in rats (prenatal exposure) since a clear NOAEL/
LOAEL was established for developmental toxicity, and since the
endpoints of concern were used for the most sensitive population of
concern (Females 13-49). There is no uncertainty for prenatal and/or
postnatal toxicity.
3. Conclusion. The 10X FQPA safety factor was retained for
assessing the acute dietary risk to the general population (including
infants and children), due to the lack of a NOAEL in the acute
neurotoxicity study. The 10X FQPA safety factor was reduced to 1X for
assessing the acute dietary risk to females (13-49 years of age) and
for assessing the chronic dietary risk to all populations based on the
following conclusions.
i. The toxicity database for tepraloxydim is complete.
ii. While there are indications that tepraloxydim is neurotoxic at
doses far higher than those currently being used for the acute and
chronic dietary risk assessments, the two generation reproduction study
showed no clinical signs indicative of neurotoxicity in the parental
animals or offspring, nor was there evidence for increased
susceptibility. The Agency concluded there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. There are no residual concerns regarding increased sensitivity
in the young. There were no qualitative or quantitative prenatal or
postnatal susceptibility issues in the developmental toxicity study in
rabbits and 2-generation reproduction toxicity study in rats. Although
increased sensitivity was seen in the developmental rat study, the
degree of concern is low as to this finding because a clear NOAEL/LOAEL
was established for developmental toxicity, and the endpoints of
concern were used for assessing risk to the most sensitive population
of concern (Females 13-49).
iv. The dietary food exposure assessment was performed based on
100%CT and tolerance-level residues. Conservative ground water and
surface water modeling estimates were used. The drinking water
assessment utilized values generated by models and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. These
assessments will not underestimate the exposure and risks posed by
tepraloxydim.
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 the LOC to ensure that the Margin
of exposure 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 tepraloxydim will occupy 2% of the aPAD for the population group
(children 1-2 years 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
tepraloxydim from food and water will utilize 10% of the cPAD for the
population group (children 1-2 years old) receiving the greatest
exposure.
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). Tepraloxydim 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). Tepraloxydim
is not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Tepraloxydim is not
expected to pose a cancer risk for humans.
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 tepraloxydim residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The analytical method involves extraction,
concentration, precipitation, centrifugation/filtration, oxidation,
partition, and clean-up. Samples are then analyzed by GC-MS (selected
ion monitoring). The LOQ is 0.05 ppm for each analyte.
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
No Codex maximum residue limits (MRLs) have been established for
residues of tepraloxydim on any crops at this time.
V. Conclusion
Therefore, the tolerance is established for residues tepraloxdydim
(2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-hydroxy-5-
(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one) and its metabolites
convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and
OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid),
calculated as tepraloxydim, in or on flax, seed; lentil, seed; and pea,
dry, seed at 0.10 parts per million (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
[[Page 54588]]
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 13, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.573 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(1) to read as follows:
Sec. 180.573 Tepraloxydim; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Flax, seed................................................. 0.10
Lentil, seed............................................... 0.10
Pea, dry, seed............................................. 0.10
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-18850 Filed 9-25-07; 8:45 am]
BILLING CODE 6560-50-S
