[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Rules and Regulations]
[Page 9217-9222]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe08-20]
-----------------------------------------------------------------------
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 http://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 http://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 http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://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 http://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: http://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 http://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 http://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 http://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 http://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