[Federal Register Volume 75, Number 91 (Wednesday, May 12, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11301]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Clethodim; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
clethodim in or on the raw agricultural commodity artichoke, globe;
bushberry subgroup 13-07B; caneberry subgroup 13-07A; and peach. This
regulation additionally removes the existing tolerances on lettuce leaf
and spinach, as they are covered by the leafy greens subgroup 4A and
removes the tolerance for flax seed at 0.50 ppm because there is one
for flax seed at 0.6 ppm. The Interregional Research Project Number 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective May 12, 2010. Objections and
requests for hearings must be received on or before July 12, 2010, 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-2009-0307. All documents in the
docket are listed in the docket index available at http://www.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)
FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: email@example.com.
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).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0307 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 12, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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-2009-0307, 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 Facility'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 10, 2009 (74 FR 27538) (FRL-8417-
7), 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
8E7505) by IR-4 Project Headquarters, Rutgers, The State University of
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.458 be amended by establishing
tolerances for combined residues of the herbicide clethodim, ((E)-()-2-
hydroxy-2-cyclohexen-1-one) and its metabolites containing the 5-(2-
(ethylthio)propyl]cyclohexen-3-one and the 5-[2-(ethylthio)propyl]-5-
hydroxycyclohexen-3-one moieties and their sulfoxides and sulfones,
expressed as clethodim, in or on the raw agricultural commodity
artichoke, globe at 1.3 parts per million (ppm), bushberry subgroup 13-
07B at 3.0 ppm, caneberry subgroup 13-07A at 0.30 ppm and peach at 0.20
ppm. That notice referenced a summary of the petition prepared by
Valent U.S.A. Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the bushberry subgroup 13-07B tolerance from 3.0 ppm to 0.20
ppm and the globe artichoke tolerance from 1.3 ppm to 1.2 ppm. The
reason for these changes is explained in Unit IV.C.
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. . .
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 clethodim including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with clethodim
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. Clethodim has a low order of acute toxicity via oral, dermal
and inhalation routes of exposure. Clethodim produces mild ocular
irritation and moderate skin irritation. It is not a dermal sensitizer.
The subchronic and chronic toxicity data show that clethodim produces
consistent effects in the liver characterized by increased liver
weights and centrilobular hepatic hypertrophy in rats, mice, and dogs.
Decreased body weight is also a consistent finding. Treatment related
increase in tumor incidence is not observed in rat and mouse
carcinogenicity studies. Clethodim is not genotoxic. The data
demonstrate no reproductive effect in rats and no developmental effects
in rabbits. No effects were seen in offspring of the 2-generation
study. In the rat developmental toxicity study, reduced fetal weights
and increased incidence of reduced ossification were seen in the
fetuses at the maternal toxic dose level.
The data show no increase in susceptibility in the young.
Specific information on the studies received and the nature of the
adverse effects caused by clethodim as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov on pages 45-50 of the document titled ``Clethodim
Human Health Risk Assessment for Proposed Uses on Caneberry Subgroup
13-07A, Bushberry Subgroup 13-07B, Peach, and Globe Artichoke'' in
docket ID number EPA-HQ-OPP-2009-0307.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for clethodim used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Clethodim for Use in Human Health Risk Assessment
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
Acute dietary N/A N/A None Selected.
(All Populations).................. There were no effects
observed in oral
toxicity studies in
rats and rabbits that
could be attributable
to a single dose
a dose and endpoint
were not selected for
this exposure scenario.
Chronic dietary NOAEL= 1.0 mg/kg/day Chronic RfD = 0.01 mg/ Chronic Toxicity-Dog (1-
(All populations)................... UFA = 10x.............. kg/day year).
UFH = 10x.............. cPAD = 0.01 mg/kg/day.. Alterations in
FQPA SF = 1x........... hematology and clinical
and increased absolute
and relative liver
weights observed at the
LOAEL of 75 mg/kg/day.
Cancer Classification: ``Not likely to be Carcinogenic to Humans'' based on
(Oral, dermal, inhalation).......... feeding studies in rats and mice.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clethodim, EPA considered exposure under the petitioned-for
tolerances as well as all existing clethodim tolerances in 40 CFR
180.458. EPA assessed dietary exposures from clethodim in food as
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.
No such effects were identified in the toxicological studies for
clethodim; therefore, a quantitative acute dietary exposure assessment
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. The chronic dietary (food and drinking water) exposure
assessment is partially refined, i.e., based on the assumption of
tolerance-level residues for most commodities and average percent crop
treated information for some crops. An anticipated residue (AR) value
was used for succulent snap bean.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that clethodim is classified as ``Not Likely to be
Carcinogenic to Humans.'' Therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to section 408(f)(1) of FFDCA that data be provided 5 years
after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by section 408(b)(2)(E) of FFDCA and authorized under
section 408(f)(1) of FFDCA. Data will be required to be submitted no
later than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food
derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require
registrants to submit data on PCT.
The Agency estimated the percent crop treated for existing uses as
Beets 1%, Broccoli 10%, Cabbage 1%, Cantaloupes 1%, Carrots 10%,
Celery 5%, Cotton 1%, Cucumbers 1%, Dry beans 5%, Lettuce 1%, Onions
10%, Peanuts 5%, Potatoes 5%, Pumpkins 5%, Soybeans 5%, Squash 5%,
Strawberries 1%, Sugar beets 45%, Sunflowers 20%, Sweet potatoes 1%,
Tomatoes 1%, Watermelons 5%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which clethodim may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for clethodim in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clethodim. 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 drinking water concentrations (EDWCs) of clethodim for
chronic exposures for non-cancer assessments are 13.0 ppb for surface
water and 9.8 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 13.0 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).
Clethodim is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found clethodim to share a common mechanism of toxicity
with any other substances, and clethodim does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that clethodim does not
have 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(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of fetuses as compared to maternal animals
following in utero and/or postnatal exposure to clethodim in the
developmental toxicity studies in rats or rabbits, and no increased
sensitivity in pups as compared to adults in the 2-generation rat
reproduction toxicity study. There are no residual uncertainties
concerning prenatal and postnatal toxicity and no neurotoxicity
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
i. Except for the new requirements of an immunotoxicity study and
an acute and subchronic neurotoxicity battery, the available toxicity
database for clethodim is sufficient and the exposure data are complete
or are estimated based on data that reasonably account for potential
exposures. In the absence of the immunotoxicity and acute and
subchronic neurotoxicity studies, the available toxicity data for
clethodim have been thoroughly examined for any information which
suggests a potential for neurotoxicity or immunotoxicity.
The analysis did not reveal such information and the Agency does not
believe that conducting these studies will result in a NOAEL less than
the currently selected NOAELs for risk assessment. Therefore, a
database uncertainty factor (UFdb) is not needed to account
for the lack of these studies.
ii. There is no evidence of susceptibility following in utero and/
or postnatal exposure in the developmental toxicity studies in rats or
rabbits, and in the 2-generation rat reproduction study. There are no
residual uncertainties concerning prenatal and postnatal toxicity.
iii. There is no evidence that clethodim is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iv. There are no residual uncertainties identified in the exposure
data base. The chronic dietary food exposure assessment utilized
tolerance level residues for most commodities and incorporated average
PCT data for some commodities. There is no potential for residential
exposure. The dietary (food and drinking water) exposure assessment
will not underestimate the potential exposure for infants, children,
and/or women of childbearing age.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
clethodim is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clethodim from food and drinking water will utilize 79% of the cPAD for
all infants <1 year old, the population group receiving the greatest
exposure. There are no residential uses for clethodim.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
A short-term adverse effect was identified; however, clethodim is
not registered for any use patterns that would result in short-term
residential exposure. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-term risk), no
further assessment of short-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short-term risk for
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and drinking water (considered to be a background
An intermediate-term adverse effect was identified; however,
clethodim is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, clethodim is not expected to pose a cancer risk to 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 clethodim residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate plant analytical methods are available for tolerance
enforcement. Method RM-26B-2 (a gas chromatography method with flame
photometric detection in the sulfur mode (GC/FPD-S) and the
confirmatory method RM-26D-2 (a high performance liquid chromatography
method with ultraviolet detection (HPLC/UV) have been forwarded to FDA
as enforcement methods for publication in the Pesticides Analytical
Manual, Volume II (PAM II). Method RM-26B-2 has undergone a successful
validation in an EPA laboratory. Method RM-26B-2 and Method RM-26B-3 (a
modification of Method RM-26B-2) determine the combined residues of
clethodim and its metabolites containing the 2-cyclohexen-1-one moiety
determined as the dimethyl esters of clethodim sulfoxide and 5-OH
clethodim sulfone (DME and DME-OH, respectively) and reported as
A modification of Method RM-26B-3 (GC/FPD-S) was used for
quantitation of clethodim residues in/on blueberry, caneberry, peach
and globe artichoke samples from the submitted field trials. The method
is adequate for data collection based on validation data.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs)/tolerances established at this time for residues of clethodim in
or on the commodities receiving tolerances in this document. However,
Agriculture and Agri-Food Canada (AAFC) and IR-4 developed residue
field trial data for blueberry jointly and submitted these data to the
Pest Management Regulatory Agency (PMRA) and EPA. Both PMRA and EPA
will be establishing MRLs for bushberry subgroup 13-07B at the same
C. Revisions to Petitioned-For Tolerances
The globe artichoke tolerance is a reduction from the proposed 1.3
ppm to 1.2 ppm based on the tolerance spreadsheet summary of clethodim
field trial data under the Guidance for Setting Pesticide Tolerances
Based on Field Trial Data SOP.
The recommended bushberry subgroup 13-07B tolerance is a reduction
from the proposed 3.0 ppm to 0.20 ppm. The 0.20 ppm recommended
tolerance is based on the lowest level of method validation and
excludes the lowbush blueberry data since the lowbush blueberry data
were obtained by over-the-top foliar spray instead of
according to the proposed use of spray directed at the base of the
plants and only one study was submitted on low-growing berries.
The paragraph and table in (a)(2) is being removed because the
tolerances in this section have expired.
The tolerances for lettuce leaf and spinach are being removed in
paragraph (a)(3) as they are covered by the leafy greens subgroup 4A.
The tolerance for flax seed at 0.50 ppm is being removed in
paragraph (a)(3) because there is one for flax seed at 0.6 ppm.
Therefore, tolerances are established for residues of clethodim,
including its metabolites and degradates, in or on the raw agricultural
commodities artichoke, globe at 1.2 ppm, bushberry subgroup 13-07B at
0.20 ppm, caneberry subgroup 13-07A at 0.30 ppm and peach at 0.20 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition,
this final 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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: May 4, 2010.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.458 is amended as follows:
i. Remove paragraph (a)(2);
ii. Redesignate paragraph (a)(3) as (a)(2);
iii. Alphabetically add the commodities to newly designated paragraph
iv. Redesignate paragraph (a)(4) as (a)(3);
v. Remove the existing tolerances on lettuce leaf, and spinach in newly
designated paragraph (a)(2);
vi. Remove the tolerance for flax seed at 0.50 ppm in newly designated
The amendments read as follows:
Sec. 180.458 Clethodim; tolerances for residues.
(a) General. * * *
(2) Tolerances are established for the combined residues of the
herbicide clethodim [(E)-()-2-[1-[[(3-chloro-2-
cyclohexen-1-one] and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones,
expressed as clethodim tolerance residues for the following
Commodity Parts per million
* * * * *
Artichoke, globe..................................... 1.2
* * * * *
Bushberry subgroup 13-07B............................ 0.20
Caneberry subgroup 13-07A............................ 0.30
* * * * *
* * * * *
* * * * *
[FR Doc. 2010-11301 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S