Carfentrazone-ethyl; Pesticide Tolerance, 9217-9222 [E8-3111]
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Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
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).
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).
IX. 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
List of Subjects in 40 CFR Part 180
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0193; FRL–8349–4]
Carfentrazone-ethyl; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of carfentrazoneethyl, (ethyl-alpha-2-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzene propanoate) and the
metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzenepropanoic acid) in or on
barley, bran at 0.80 ppm; barley, flour at
0.80 ppm; grain, aspirated grain
fractions at 1.8 ppm; grain, cereal, group
15 (except rice grain and sorghum grain)
at 0.10 ppm; grain, cereal, stover at 0.80
ppm; grain, cereal, straw at 3.0 ppm;
hog, fat at 0.10 ppm; hog, meat at 0.10
ppm; hog, meat byproducts at 0.10 ppm;
millet, flour at 0.80 ppm; oat, flour at
0.80 ppm; poultry, meat byproducts at
0.10 ppm; rice, grain at 1.3 ppm; rice,
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. In section 180.910 the table is
amended by adding alphabetically the
following inert ingredients to read as
follows:
I
§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from
the requirement of a tolerance.
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Therefore, 40 CFR chapter I is
amended as follows:
I
Limits
BILLING CODE 6560–50–S
15:54 Feb 19, 2008
1. The authority citation for part 180
continues to read as follows:
I
Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
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d-Alpha tocopherol (CAS Reg. No. 9–02–9 ...........................
d-Alpha tocopheryl acetate (CAS Reg. No. 58–95–7) ...........
dl-Alpha tocopherol (CAS Reg. No.10191–41–0) ...................
dl-Alpha tocopheryl acetate (CAS Reg. No. 7695–91–2) .......
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Vitamin E (CAS Reg. No. 1406–18–4) ...................................
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PART 180—[AMENDED]
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Inert ingredients
[FR Doc. E8–3127 Filed 2–19–08; 8:45 am]
9217
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hulls at 3.5 ppm; rye, bran at 0.80 ppm;
rye, flour at 0.80 ppm; sorghum, grain
at 0.25 ppm; soybean, seed at 0.10 ppm;
sugarcane at 0.15 ppm; wheat, bran at
0.80 ppm; wheat, flour at 0.80 ppm;
wheat, germ at 0.80 ppm; wheat,
middlings at 0.80 ppm; and wheat,
shorts at 0.80 ppm. FMC Corporation
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective
February 20, 2008. Objections and
requests for hearings must be received
on or before April 21, 2008, 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–2007–0193. 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.
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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:
Joanne I. Miller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6224; e-mail address:
miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
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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–2007–0193 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 April 21, 2008.
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
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15:54 Feb 19, 2008
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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–2007–0193 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 June 27,
2007 (72 FR 35240) (FRL–8133–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6F7145) by FMC
Corporation, 1735 Market Street,
Philadelphia, PA 19103. The petition
requested that 40 CFR 180.515 be
amended by establishing a tolerance for
residues of the herbicide carfentrazoneethyl, (ethyl-alpha-2-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzene propanoate) and the
metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzenepropanoic acid) in or on
barley, bran at 0.80 ppm; barley, flour at
0.80 ppm; grain, aspirated grain
fractions at 1.8 ppm; grain, cereal, group
15 (except rice grain and sorghum grain)
at 0.10 ppm; grain, cereal, stover at 0.80
ppm; grain, cereal, straw at 3.0 ppm;
hog, fat at 0.10 ppm; hog, meat at 0.10
ppm; hog, meat byproducts at 0.10 ppm;
millet, flour at 0.80 ppm; oat, flour at
0.80 ppm; poultry, meat byproducts at
0.10 ppm; rice, grain at 1.3 ppm; rice,
hulls at 3.5 ppm; rye, bran at 0.80 ppm;
rye, flour at 0.80 ppm; sorghum, grain
at 0.25 ppm; soybean, seed at 0.10 ppm;
sugarcane at 0.15 ppm; wheat, bran at
0.80 ppm; wheat, flour at 0.80 ppm;
wheat, germ at 0.80 ppm; wheat,
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middlings at 0.80 ppm; and wheat,
shorts at 0.80 ppm. 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 section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerance for carfentrzone-ethyl. EPA’s
assessment of exposures and risks
associated with establishing the
petitioned-for tolerances 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. Carfentrazoneethyl has low acute oral, dermal, and
inhalation toxicity (Toxicity Category 34). It is non-irritating to skin and
minimally irritating to eyes. It is not a
skin sensitizer. The subchronic toxicity
studies in rats, mice, and dogs
demonstrated that the primary effects of
carfentrazone-ethyl were on
hermatology parameters (decreased
mean corpuscular hemoglobin: MCH,
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mean corpuscular volume: MCV),
urinary porphyrin excretion (increased),
liver weights (increased), and
histopathology. The chronic toxicity
studies in rats and dogs demonstrated
increased urinary porphyrin and
microscopic examination showed
hepatoxicity in rats and mice.
Fluorescence microscopy on liver
sections also revealed red fluorescent
granules consistent with porphryin
deposits in rats and mice. In
carcinogenicity studies in mice and rats,
there was no indication of increased
incidence of neoplasms and
spontaneous tumor formation at the
doses tested. The results of the 2–
generation reproduction and
developmental toxicity studies
indicated that carfentrazone-ethyl is not
a developmental or reproductive
toxicant. The acute and subchronic
neurotoxicity studies showed that
carfentrazone-ethyl is not neurotoxic.
The mutagenic test battery
demonstrated that carfentrazone-ethyl is
not mutagenic. Specific information on
the studies received and the nature of
the adverse effects caused by
carfentrazone-ethyl as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in the final rule published
in the Federal Register of August 9,
2000 (65 FR 48621–48623) (FRL–6597–
7).
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
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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
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 carfentrazone-ethyl used
for human risk assessment can be found
at https://www.regulations.gov in the
document titled ‘‘Human Heath Risk
Assessment’’ at page 9 in docket ID
number EPA–HQ–OPP–2007–0193.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to carfentrazone-ethyl, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing carfentrazone-ethyl tolerances
in (40 CFR 180.515). EPA assessed
dietary exposures from carfentrazoneethyl 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. Carfentrazone-ethyl is
classified as ‘‘not likely’’ a human
carcinogen and therefore an exposure
assessment for assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residues or PCT
information in the dietary assessment
for carfentrazone-ethyl. The acute and
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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
carfentrazone-ethyl 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
carfentrazone-ethyl. 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 Ground Water (SCIGROW) models, the estimated
environmental concentrations (EECs) of
carfentrazone-ethyl for acute exposures
are estimated to be 34.3 parts per billion
(ppb) for surface water and 13.4 ppb for
ground water. The EECs for chronic
exposures are estimated to be 19.0 ppb
for surface water and 13.4 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 34.3 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 19.0 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).
Carfentrazone-ethyl is currently
registered for the following residential
non-dietary sites: Ornamental lawns and
turf (application by commercial
operators only). Residential exposure is
also anticipated from aquatic
applications of carfentrazone-ethyl. The
risk assessment was conducted using
the following residential exposure
assumptions: Exposures to toddlers in
the residential lawn setting would be
higher than that encountered by
toddlers in an institutional setting, such
as in schools and parks. It was
anticipated that herbicide application to
homeowner lawns is a seasonal event,
thus, only short-term post-application
residential exposures were conducted.
A swimmer exposure assessment was
conducted based on the aquatic
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application. The swimmer assessment
estimates exposures from oral
(ingestion) and inhalation routes.
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
carfentrazone-ethyl and any other
substances and carfentrazone-ethyl 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
carfentrazone-ethyl 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 was no indication of increased
susceptibility of rats or rabbits to in
utero and/or postnatal exposure to
carfentrazone-ethyl. There is no
uncertainty for prenatal and/or
postnatal toxicity.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
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decision is based on the following
findings:
i. The toxicity database for
carfentrazone-ethyl is complete.
ii. There is no indication that
carfentrazone-ethyl is a neurotoxic
chemical and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
carfentrazone-ethyl results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. Conservative
ground and surface water modeling
estimates were used. Similarly
conservative Residential Standard
Operating Procedures were used to
assess post-application exposure to
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by carfentrazone-ethyl.
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
carfentrazone-ethyl will occupy 1% 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 carfentrazone-ethyl
from food and water will utilize 89% of
the cPAD for the population group
(children 1-2 years old) receiving the
greatest exposure. Based on the use
pattern, chronic residential exposure to
residues of carfentrazone-ethyl is not
expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
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exposure to food and water (considered
to be a background exposure level).
Carfentrazone-ethyl is currently
registered for uses that could result in
short-term residential exposure and the
Agency has determined that it is
appropriate to aggregate chronic food
and water and short-term exposures for
carfentrazone-ethyl.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of:
General U.S. population = 54,000;
infants < 1 year old = 30,000; children
1-2 years old = 18,000; children 3-5
years old = 23,000; children 6-12 years
old = 37,000; youth 13-19 years old =
60,000; adults 20-49 yeas old = 69,000;
adults >50 years old = 73,000; and
females 13-49 years old = 71,000. None
of these MOEs show risks 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). Residential exposure is
not expected to occur over the
intermediate-term. Therefore, the
aggregate risk is the sum of the risk from
food and water.
5. Aggregate cancer risk for U.S.
population. Carfentrazone-ethyl 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
carfentrazone-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
There is a practical method for
detecting and measuring levels of
carfentrazone-ethyl and its metabolites
in or on food with a limit of detection
that allows monitoring of food with
residues at or above the levels set in
these tolerances. The analytical method
involves separate analyses for parent
and its metabolite. The parent is
analyzed by gas chromatography (GC)/
electron capture detection (ECD). The
metabolite is derivatized with boron
trifluoride and acetic anhydride for
analysis by GC/mass spectrometry
detection (MSD) using selective ion
monitoring. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
E:\FR\FM\20FER1.SGM
20FER1
Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
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 carfentrazone-ethyl on any
crops at this time.
sroberts on PROD1PC70 with RULES
V. Conclusion
Therfore the tolerance is established
for residues of carfentrazone-ethyl,
(ethyl-alpha-2-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzene propanoate) and the
metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzenepropanoic acid) in or on
barley, bran at 0.80 ppm; barley, flour at
0.80 ppm; grain, aspirated grain
fractions at 1.8 ppm; grain, cereal, group
15 (except rice grain and sorghum grain)
at 0.10 ppm; grain, cereal, stover at 0.80
ppm; grain, cereal, straw at 3.0 ppm;
hog, fat at 0.10 ppm; hog, meat at 0.10
ppm; hog, meat byproducts at 0.10 ppm;
millet, flour at 0.80 ppm; oat, flour at
0.80 ppm; poultry, meat byproducts at
0.10 ppm; rice, grain at 1.3 ppm; rice,
hulls at 3.5 ppm; rye, bran at 0.80 ppm;
rye, flour at 0.80 ppm; sorghum, grain
at 0.25 ppm; soybean, seed at 0.10 ppm;
sugarcane at 0.15 ppm; wheat, bran at
0.80 ppm; wheat, flour at 0.80 ppm;
wheat, germ at 0.80 ppm; wheat,
middlings at 0.80 ppm; and wheat,
shorts at 0.80 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
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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).
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
9221
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, 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.
2. Section 180.515 is amending the
table in paragraph (a) as follows:
a. By placing the entry ‘‘Sorghum,
forage’’ before the entry ‘‘Sorghum,
sweet.’’
b. By revising the entries for
‘‘Soybean, seed’’ and ‘‘Sugarcane’’, and
c. By alphabetically adding the other
commodities to read as follows:
I
§ 180.515 Carfentrazone-ethyl; tolerances
for residues.
(a) * * *
Commodity
*
*
Parts per million
*
*
*
Barley, bran ....................
Barley, flour ....................
*
*
*
*
*
Grain, aspirated grain
fractions .......................
*
*
*
*
*
Grain, cereal, group 15
(except rice grain and
sorghum grain) ............
Grain, cereal, stover .......
Grain, cereal, straw ........
*
*
*
0.80
0.80
1.8
0.10
0.80
3.0
*
*
Hog, fat ...........................
Hog, meat .......................
Hog, meat byproducts ....
*
*
*
*
Millet, flour ......................
*
*
*
*
*
Oat, flour .........................
*
*
*
*
*
Poultry, meat byproducts
*
*
*
*
*
Rice, grain ......................
Rice, hulls .......................
*
*
*
Rye, bran ........................
Rye, flour ........................
E:\FR\FM\20FER1.SGM
20FER1
0.10
0.10 ppm
0.10
*
0.80
0.80
0.10
1.3
3.5
*
*
0.80
0.80
9222
Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
40 CFR Part 180
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: Erik
Kraft, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9358; e-mail address:
kraft.erik @epa.gov.
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPP–2007–0030; FRL–8349–7]
I. General Information
Mesotrione; Pesticide Tolerance
A. Does this Action Apply to Me?
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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.
Commodity
*
*
Parts per million
*
*
Sorghum, grain ...............
*
*
*
*
*
Soybean, seed ................
*
*
*
*
*
Sugarcane ......................
*
*
*
*
*
Wheat,
Wheat,
Wheat,
Wheat,
Wheat,
*
*
0.25
0.10
0.15
bran ....................
flour ....................
germ ...................
middlings ............
shorts .................
*
*
*
0.80
0.80
0.80
0.80
0.80
*
[FR Doc. E8–3111 Filed 2–19–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of mesotrione in
or on asparagus, grass grown for seed,
oats, okra, rhubarb, grain sorghum,
sweet sorghum, and sugarcane.
Syngenta Crop Protection requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 20, 2008. Objections and
requests for hearings must be received
on or before April 21, 2008, 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–2007–0030. 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
VerDate Aug<31>2005
15:54 Feb 19, 2008
Jkt 214001
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
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–2007–0030 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 April 21, 2008.
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–2007–0030, 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.
E:\FR\FM\20FER1.SGM
20FER1
Agencies
[Federal Register Volume 73, Number 34 (Wednesday, February 20, 2008)]
[Rules and Regulations]
[Pages 9217-9222]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3111]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0193; FRL-8349-4]
Carfentrazone-ethyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzene
propanoate) and the metabolite carfentrazone-chloropropionic acid
(alpha, 2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid) in or on barley,
bran at 0.80 ppm; barley, flour at 0.80 ppm; grain, aspirated grain
fractions at 1.8 ppm; grain, cereal, group 15 (except rice grain and
sorghum grain) at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain,
cereal, straw at 3.0 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm;
hog, meat byproducts at 0.10 ppm; millet, flour at 0.80 ppm; oat, flour
at 0.80 ppm; poultry, meat byproducts at 0.10 ppm; rice, grain at 1.3
ppm; rice, hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80
ppm; sorghum, grain at 0.25 ppm; soybean, seed at 0.10 ppm; sugarcane
at 0.15 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat,
germ at 0.80 ppm; wheat, middlings at 0.80 ppm; and wheat, shorts at
0.80 ppm. FMC Corporation requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 20, 2008. Objections and
requests for hearings must be received on or before April 21, 2008, 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-2007-0193. 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: Joanne I. Miller, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address:
miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse,
[[Page 9218]]
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-2007-0193 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 April 21, 2008.
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-2007-0193 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 June 27, 2007 (72 FR 35240) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7145) by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103.
The petition requested that 40 CFR 180.515 be amended by establishing a
tolerance for residues of the herbicide carfentrazone-ethyl, (ethyl-
alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzene propanoate) and the metabolite
carfentrazone-chloropropionic acid (alpha, 2-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoic acid) in or on barley, bran at 0.80 ppm; barley,
flour at 0.80 ppm; grain, aspirated grain fractions at 1.8 ppm; grain,
cereal, group 15 (except rice grain and sorghum grain) at 0.10 ppm;
grain, cereal, stover at 0.80 ppm; grain, cereal, straw at 3.0 ppm;
hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; hog, meat byproducts at
0.10 ppm; millet, flour at 0.80 ppm; oat, flour at 0.80 ppm; poultry,
meat byproducts at 0.10 ppm; rice, grain at 1.3 ppm; rice, hulls at 3.5
ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 ppm; sorghum, grain at
0.25 ppm; soybean, seed at 0.10 ppm; sugarcane at 0.15 ppm; wheat, bran
at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, germ at 0.80 ppm; wheat,
middlings at 0.80 ppm; and wheat, shorts at 0.80 ppm. 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerance for carfentrzone-ethyl. EPA's assessment of exposures and
risks associated with establishing the petitioned-for tolerances
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. Carfentrazone-ethyl has low acute oral, dermal, and
inhalation toxicity (Toxicity Category 3-4). It is non-irritating to
skin and minimally irritating to eyes. It is not a skin sensitizer. The
subchronic toxicity studies in rats, mice, and dogs demonstrated that
the primary effects of carfentrazone-ethyl were on hermatology
parameters (decreased mean corpuscular hemoglobin: MCH,
[[Page 9219]]
mean corpuscular volume: MCV), urinary porphyrin excretion (increased),
liver weights (increased), and histopathology. The chronic toxicity
studies in rats and dogs demonstrated increased urinary porphyrin and
microscopic examination showed hepatoxicity in rats and mice.
Fluorescence microscopy on liver sections also revealed red fluorescent
granules consistent with porphryin deposits in rats and mice. In
carcinogenicity studies in mice and rats, there was no indication of
increased incidence of neoplasms and spontaneous tumor formation at the
doses tested. The results of the 2-generation reproduction and
developmental toxicity studies indicated that carfentrazone-ethyl is
not a developmental or reproductive toxicant. The acute and subchronic
neurotoxicity studies showed that carfentrazone-ethyl is not
neurotoxic. The mutagenic test battery demonstrated that carfentrazone-
ethyl is not mutagenic. Specific information on the studies received
and the nature of the adverse effects caused by carfentrazone-ethyl as
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in the final rule published in the Federal Register of August
9, 2000 (65 FR 48621-48623) (FRL-6597-7).
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 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 carfentrazone-ethyl
used for human risk assessment can be found at https://
www.regulations.gov in the document titled ``Human Heath Risk
Assessment'' at page 9 in docket ID number EPA-HQ-OPP-2007-0193.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to carfentrazone-ethyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing carfentrazone-ethyl
tolerances in (40 CFR 180.515). EPA assessed dietary exposures from
carfentrazone-ethyl 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. Carfentrazone-ethyl is classified as ``not likely'' a
human carcinogen and therefore an exposure assessment for assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residues or PCT information in the dietary
assessment for carfentrazone-ethyl. The acute and 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 carfentrazone-ethyl 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 carfentrazone-ethyl. 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 Ground Water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of carfentrazone-ethyl
for acute exposures are estimated to be 34.3 parts per billion (ppb)
for surface water and 13.4 ppb for ground water. The EECs for chronic
exposures are estimated to be 19.0 ppb for surface water and 13.4 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 34.3 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 19.0 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).
Carfentrazone-ethyl is currently registered for the following
residential non-dietary sites: Ornamental lawns and turf (application
by commercial operators only). Residential exposure is also anticipated
from aquatic applications of carfentrazone-ethyl. The risk assessment
was conducted using the following residential exposure assumptions:
Exposures to toddlers in the residential lawn setting would be higher
than that encountered by toddlers in an institutional setting, such as
in schools and parks. It was anticipated that herbicide application to
homeowner lawns is a seasonal event, thus, only short-term post-
application residential exposures were conducted. A swimmer exposure
assessment was conducted based on the aquatic
[[Page 9220]]
application. The swimmer assessment estimates exposures from oral
(ingestion) and inhalation routes.
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 carfentrazone-ethyl and
any other substances and carfentrazone-ethyl 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
carfentrazone-ethyl 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 was no indication of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to carfentrazone-ethyl. There is no uncertainty for
prenatal and/or postnatal toxicity.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for carfentrazone-ethyl is complete.
ii. There is no indication that carfentrazone-ethyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that carfentrazone-ethyl results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. Conservative ground and
surface water modeling estimates were used. Similarly conservative
Residential Standard Operating Procedures were used to assess post-
application exposure to children as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by carfentrazone-ethyl.
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 carfentrazone-ethyl will occupy 1% 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
carfentrazone-ethyl from food and water will utilize 89% of the cPAD
for the population group (children 1-2 years old) receiving the
greatest exposure. Based on the use pattern, chronic residential
exposure to residues of carfentrazone-ethyl is not expected.
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).
Carfentrazone-ethyl is currently registered for uses that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and short-
term exposures for carfentrazone-ethyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of: General U.S.
population = 54,000; infants < 1 year old = 30,000; children 1-2 years
old = 18,000; children 3-5 years old = 23,000; children 6-12 years old
= 37,000; youth 13-19 years old = 60,000; adults 20-49 yeas old =
69,000; adults >50 years old = 73,000; and females 13-49 years old =
71,000. None of these MOEs show risks 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). Residential
exposure is not expected to occur over the intermediate-term.
Therefore, the aggregate risk is the sum of the risk from food and
water.
5. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl
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 carfentrazone-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
There is a practical method for detecting and measuring levels of
carfentrazone-ethyl and its metabolites in or on food with a limit of
detection that allows monitoring of food with residues at or above the
levels set in these tolerances. The analytical method involves separate
analyses for parent and its metabolite. The parent is analyzed by gas
chromatography (GC)/electron capture detection (ECD). The metabolite is
derivatized with boron trifluoride and acetic anhydride for analysis by
GC/mass spectrometry detection (MSD) using selective ion monitoring.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone
[[Page 9221]]
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 carfentrazone-ethyl on any crops at this time.
V. Conclusion
Therfore the tolerance is established for residues of
carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzene
propanoate) and the metabolite carfentrazone-chloropropionic acid
(alpha, 2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid) in or on barley,
bran at 0.80 ppm; barley, flour at 0.80 ppm; grain, aspirated grain
fractions at 1.8 ppm; grain, cereal, group 15 (except rice grain and
sorghum grain) at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain,
cereal, straw at 3.0 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm;
hog, meat byproducts at 0.10 ppm; millet, flour at 0.80 ppm; oat, flour
at 0.80 ppm; poultry, meat byproducts at 0.10 ppm; rice, grain at 1.3
ppm; rice, hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80
ppm; sorghum, grain at 0.25 ppm; soybean, seed at 0.10 ppm; sugarcane
at 0.15 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat,
germ at 0.80 ppm; wheat, middlings at 0.80 ppm; and wheat, shorts at
0.80 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: February 6, 2008.
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 180.515 is amending the table in paragraph (a) as follows:
a. By placing the entry ``Sorghum, forage'' before the entry
``Sorghum, sweet.''
b. By revising the entries for ``Soybean, seed'' and ``Sugarcane'',
and
c. By alphabetically adding the other commodities to read as
follows:
Sec. 180.515 Carfentrazone-ethyl; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Barley, bran......................................... 0.80
Barley, flour........................................ 0.80
* * * * *
Grain, aspirated grain fractions..................... 1.8
* * * * *
Grain, cereal, group 15 (except rice grain and 0.10
sorghum grain)......................................
Grain, cereal, stover................................ 0.80
Grain, cereal, straw................................. 3.0
* * * * *
Hog, fat............................................. 0.10
Hog, meat............................................ 0.10 ppm
Hog, meat byproducts................................. 0.10
* * * * *
Millet, flour........................................ 0.80
* * * * *
Oat, flour........................................... 0.80
* * * * *
Poultry, meat byproducts............................. 0.10
* * * * *
Rice, grain.......................................... 1.3
Rice, hulls.......................................... 3.5
* * * * *
Rye, bran............................................ 0.80
Rye, flour........................................... 0.80
[[Page 9222]]
* * * * *
Sorghum, grain....................................... 0.25
* * * * *
Soybean, seed........................................ 0.10
* * * * *
Sugarcane............................................ 0.15
* * * * *
Wheat, bran.......................................... 0.80
Wheat, flour......................................... 0.80
Wheat, germ.......................................... 0.80
Wheat, middlings..................................... 0.80
Wheat, shorts........................................ 0.80
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-3111 Filed 2-19-08; 8:45 am]
BILLING CODE 6560-50-S