[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Rules and Regulations]
[Pages 71523-71528]
[FR Doc No: 2013-28640]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0429; FRL-9902-15]

Quinclorac; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
quinclorac in or on rapeseed, subgroup 20A. BASF Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective November 29, 2013. Objections and
requests for hearings must be received on or before January 28, 2014,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0429, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2012-0429 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
January 28, 2014. 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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0429, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at  http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8035) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR
180.463 be amended by establishing tolerances for residues of the
herbicide quinclorac (3,7-dichloro-8-quinolinecarboxylic acid), in or
on rapeseed, subgroup 20A at 1.0 parts per million (ppm). That document
referenced a summary of the petition prepared by BASF 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.
    EPA has revised this tolerance level based on analysis of the
residue field trial data using the Organization for Economic Co-
operation and Development (OECD) tolerance calculation procedures. The
reason for this change is explained in Unit IV.D.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for quinclorac including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with quinclorac 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.
    Quinclorac has low acute toxicity by oral, inhalation, and dermal
routes of exposure. It is minimally irritating to the eye and non-
irritating to the skin. Quinclorac is a skin sensitizer.
    Subchronic toxicity includes, decreased body weight gains,
increased water intake, increased liver enzymes, and focal chronic
interstitial nephritis (rats). Chronic toxic effects include body
weight decrement, increase in kidney, and liver weights, and hydropic
degeneration of the kidneys (dogs). At high doses, chronic toxicity
also includes increased incidences of pancreatic acinar cell
hyperplasia, and adenomas (rats). Neurotoxic effects were not observed
in any of the acute, subchronic and chronic studies with quinclorac.
    There was no increased qualitative or quantitative fetal or
offspring susceptibility in the prenatal developmental or postnatal
reproduction studies. Developmental toxicity in the rabbit consisted of
increased resorptions, post-implantation loss, decreased number of live
fetuses, and reduced fetal body weight. These effects occurred at much
higher doses than the maternal effects of decreased food consumption,
and increased water consumption, and decreased body weight gain. In the
rat, no developmental toxicity was observed at the highest dose tested
(HDT) (438 milligrams/kilogram/day (mg/kg/day)). In the 2-generation
reproduction study, parental toxicity and offspring toxicity occurred
at the same dose. Parental toxicity consisted of reduced body weight in
both sexes during premating and lactation periods. Offspring toxicity
consisted of decreased pup weight, developmental delays and a possible
marginal effect on pup viability. No reproductive toxicity occurred at
the HDT (480 mg/kg/day).
    There are no mutagenicity concerns. Quinclorac is not mutagenic in
bacterial assays and does not cause unscheduled DNA damage in primary
rat hepatocytes. There is also no evidence of a genotoxic response in
whole animal test systems (in vivo mouse bone marrow micronucleus
assay). Quinclorac was negative in a mammalian cell in vitro
cytogenetic chromosomal aberration assay in Chinese hamster ovary cells
(CHO). Quinclorac produced an equivocal increase in the incidence of
one type of benign tumor (pancreatic acinar cell adenomas) in only one
sex of one species of animals (male Wistar rats). There was no evidence
of carcinogenicity in mice or female rats. Based on this limited
evidence of cancer, a quantification of cancer risk is not warranted
because the chronic reference dose (RfD) will adequately account for
all chronic effects, including carcinogenicity, likely to result from
exposure to quinclorac.
    Neurotoxic effects were not observed in any of the acute,
subchronic and chronic studies with quinclorac. Due to lack of evidence
of neurotoxic effects, the Agency has determined that no acute,
subchronic, or developmental neurotoxicity studies are required for
quinclorac.
    Specific information on the studies received and the nature of the
adverse effects caused by quinclorac 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 in document ``Quinclorac: Risk Assessment to
Support Permanent Tolerance for Rapeseed Subgroup 20A without U.S.
Registration'' in docket ID number EPA-HQ-OPP-2012-0429.

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 (LOC) 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 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 quinclorac used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Quinclorac for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary....................  NOAEL = 200 mg/kg/    Acute RfD = 2.0 mg/  Developmental toxicity study in
(Females 13-50 years of age).....   day.                  kg/day.              rabbits.
                                   UFA = 10x...........  aPAD = 2.0 mg/kg/    LOAEL = 600 mg/kg/day based on
                                   UFH = 10x...........   day.                 increased early resorptions and
                                   FQPA SF = 1x........                        postimplantation loss, decreased
                                                                               live fetuses, decreased fetal
                                                                               body weight. These fetal effects
                                                                               are presumed to occur after a
                                                                               single dose.
----------------------------------------------------------------------------------------------------------------
Acute dietary....................  None................  None...............  No acute dietary endpoint selected
(General population including                                                  based on the absence of an
 infants and children).                                                        appropriate endpoint attributed
                                                                               to a single dose.
----------------------------------------------------------------------------------------------------------------
Chronic dietary..................  NOAEL = 37.5 mg/kg/   Chronic RfD = 0.38   Carcinogenicity study in mice.
(All populations)................   day.                  mg/kg/day.          LOAEL = 150 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 0.38 mg/kg/    decreased body weight.
                                   UFH = 10x...........   day.
                                   FQPA SF = 1x........
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Incidental oral short-term.......  NOAEL =.............  LOC for MOE = 100..  Developmental toxicity study in
(1 to 30 days)...................  70 mg/kg/day........                        rabbits.
                                   UFA = 10x...........                       LOAEL = 200 mg/kg/day based on
                                   UFH = 10x...........                        decreased maternal body weight
                                   FQPA SF = 1x........                        gain, and food consumption, and
                                                                               increased water consumption.
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Dermal short-term................  None................  None...............  No adverse effects were seen in
(1 to 30 days)...................                                              dermal studies
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term.........  None................  None...............  Same
(1 to 6 months)..................
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  Residential LOC for  Developmental toxicity study in
 days).                             study.                MOE = 100.           rabbits.
and intermediate-term (1 to 6      NOAEL = 70 mg/kg/day                       Maternity toxicity LOAEL = 200 mg/
 months).                           (inhalation                                kg/day based on decreased
                                    absorption rate =                          maternal body weight gain and
                                    100%).                                     food consumption, and increased
                                   UFA = 10x...........                        water consumption.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation.......................  None................  None...............  Long-term inhalation exposure is
(1 to 6 months)..................                                              not anticipated under current use
                                                                               scenarios.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Quantification of risk using the chronic RfD will adequately account for all
                                    chronic effects, including carcinogenicity, which may result from exposure
                                    to quinclorac.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. Mg/kg/day = milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UFA = extrapolation from
  animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
  (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to quinclorac, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinclorac tolerances in 40 CFR
180.463. EPA assessed dietary exposures from quinclorac 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. Such effects were identified
for quinclorac. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, the acute dietary assessment assumes 100% crop treated (PCT)
along with tolerance or maximum residue level estimates for quinclorac
and its methyl ester metabolite. It used dietary exposure evaluation
model (DEEM) default processing factors and an empirical processing
factor for oil commodities of rapeseed subgroup 20A.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008,
NHANES/WWEIA. As to residue levels in food, the chronic dietary
assessment used the same residue levels, processing factors and 100 PCT
assumptions used in the acute dietary assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to quinclorac. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii.

    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for quinclorac. Tolerance or maximum residue levels for quinclorac and
its methyl ester metabolite and 100 PCT were assumed for all food
commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for quinclorac in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of quinclorac. 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 Tier I Rice Model, Version 1.0, the estimated drinking
water concentrations (EDWCs) of quinclorac for surface water are
estimated to be 511 parts per billion (ppb) for acute and chronic
exposures. Based on the screening concentration in ground water (SCI
GROW) model, the EDWCs for ground water are estimated to be 29 ppb for
acute and chronic exposures. Modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
For acute and chronic dietary risk assessments, the water concentration
value of 511 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). Quinclorac is
currently registered for the following uses that could result in
residential exposures: Turf grass and ornamentals. EPA assessed
residential exposure using the following assumptions: Short-term
inhalation exposures for residential handlers from mixing, loading, and
applying quinclorac to residential turf, and short-term postapplication
incidental oral exposures (hand-to-mouth activities) of children from
contact with treated turf. Intermediate-term exposures resulting from
adult handler and postapplication exposures were not assessed due to a
lack of a dermal POD. Incidental oral scenarios for children are
considered to be short-term only. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 quinclorac to share a common mechanism of
toxicity with any other substances, and quinclorac does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
quinclorac 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 Web site 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. The toxicology database for
quinclorac consists of developmental toxicity studies in rats and
rabbits and a 2-generation reproduction study in rats. There is no
indication of increased qualitative or quantitative susceptibility of
rats or rabbit fetuses to in utero and/or postnatal exposure in the
developmental and reproductive toxicity data.
    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
findings.
    i. The toxicity database for quinclorac is complete.
    ii. There is no indication that quinclorac 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 quinclorac 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 tolerance or maximum residue levels for residues of concern and
assumed 100 PCT. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to quinclorac
in drinking water. EPA used similarly conservative assumptions to
assess incidental oral exposures (hand-to-mouth activities) of toddlers
to quinclorac. These assessments will not underestimate the exposure
and risks posed by quinclorac.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to quinclorac and its methyl ester metabolite will occupy 1.6% of the
aPAD for females age 13 to 49 years old, the population group receiving
the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
quinclorac and its methyl ester metabolite from food and water will
utilize 8.9% of the cPAD for infants less than 1 year of age, the
population group receiving the greatest exposure. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of quinclorac is not expected.
    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).
    Quinclorac 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 exposure through food and water
with short-term residential exposures to quinclorac.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 2,100 for adults
and 1,600 for children 1 to 2 years old. Because EPA's LOC for
quinclorac is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
quinclorac 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
quinclorac.
    5. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., the cPAD is protective of all effects, including
carcinogenicity. Based on the chronic risk assessment described in Unit
III.E.2., there is no concern for any potential carcinogenic effects
from quinclorac.
    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 quinclorac residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology for quinclorac (liquid
chromatography with tandem mass spectrometric detection (LC/MS/MS)
method (BASF method D9708/1) and quinclorac methyl ester LC/MS/MS
method (BASF method D9806/02) are available to enforce the tolerance
expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for quinclorac.

C. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA is revising the
proposed tolerances in or on rapeseed subgroup 20A from 1.0 ppm to 1.5
ppm. The Agency revised this tolerance level based on analysis of the
residue field trial data using the Organization for Economic Co-
operation and Development (OECD) tolerance calculation procedures.
Additionally, the Agency determined that the tolerance expression for
proposed tolerance on rapeseed subgroup 20A should include quinclorac
methyl ester.
    The qualitative nature of quinclorac residues in plants was
considered adequately understood for the currently registered crops,
based upon the metabolism studies on rice, sorghum, and wheat.
Additional metabolism data were submitted for quinclorac on canola to
support use on rapeseed. This study showed a significant level of
quinclorac methyl ester. The qualitative nature of quinclorac residues
in livestock is also understood based upon the adequate goat and
poultry metabolism studies. In earlier risk assessments, EPA had
concluded that parent is the only residue of concern in both plant and
livestock commodities for purposes of the tolerance expression and risk
assessment. For the current action, because of the significant level of
quinclorac methyl ester found, the Agency concluded that the residue of
concern on canola is quinclorac and its methyl ester.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide
quinclorac, including its metabolites and degradates, in or on the
following commodity. Compliance with the tolerance levels specified in
this paragraph is to be determined by measuring only quinclorac, 3,7-
dichloro-8-quinolinecarboxylic acid, and its methyl ester, methyl-3,7-
dichloro-8-quinolinecarboxylate, calculated as the stoichiometric
equivalent of quinclorac, in or on rapeseed, subgroup 20A at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C.
1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: November 22, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.463:
0
a. Designate the text of paragraph (a) as paragraph (a)(1).
0
b. Add new paragraph (a)(2).
    The amendments read as follows:

Sec.  180.463  Quinclorac; tolerances for residues.

    (a) * * *
    (2) Tolerances are established for residues of the herbicide
quinclorac, including its metabolites and degradates, in or on the
commodity in the following table. Compliance with the tolerance levels
specified in this paragraph is to be determined by measuring only
quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, and its methyl
ester, methyl-3,7-dichloro-8-quinolinecarboxylate, calculated as the
stoichiometric equivalent of quinclorac, in or on the commodity.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Rapeseed, subgroup 20A \1\................                           1.5
------------------------------------------------------------------------
\1\ There are no U.S. Registrations.

* * * * *
[FR Doc. 2013-28640 Filed 11-27-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Notices]
[Pages 69615-69616]
[FR Doc No: 2020-24326]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC21-13-000.
    Applicants: SunE Beacon Site 2 LLC, SunE Beacon Site 5 LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of SunE Beacon Site 2 LLC, et al.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5025.
    Comments Due: 5 p.m. ET 11/17/20.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1276-012; ER10-1292-001; ER10-1287-011; ER10-
1303-001; ER10-1319-013; ER10-1353-013; ER18-1183-004; ER18-1184-004.
    Applicants: Consumers Energy Company, CMS Energy Resource
Management Company, Grayling Generation Station Limited Partnership,
CMS Generation Michigan Power, L.L.C., Dearborn Industrial Generation,
L.L.C., Delta Solar Power I, LLC, Delta Solar Power II, LLC.
    Description: Notice of Non-Material Change-In-Status of Consumer
Energy Company, et al.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5126.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER10-1285-011.
    Applicants: Craven County Wood Energy Limited Partnership.
    Description: Notice of Non-Material Change-In-Status of Craven
County Wood Energy Limited Partnership.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5132.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER10-2881-035; ER10-2882-036; ER10-2883-034; ER10-
2884-034; ER16-2509-005; ER17-2400-006; ER17-2401-006; ER17-2403-006;
ER17-2404-006.
    Applicants: Alabama Power Company, Southern Power Company,
Mississippi Power Co., Georgia Power Co., Rutherford Farm, LLC, SP
Butler Solar, LLC, SP Decatur Parkway Solar, LLC, SP Pawpaw Solar, LLC,
SP Sandhills Solar, LLC.
    Description: Amendment to June 30, 2020 Updated Market Power
Analysis for the Southeast Region of Alabama Power Company, et al.
    Filed Date: 10/22/20.
    Accession Number: 20201022-5177.
    Comments Due: 5 p.m. ET 11/12/20.

    Docket Numbers: ER18-1150-004.
    Applicants: Northwest Ohio Wind, LLC.
    Description: Notice of Non-Material Change-In-Status of Northwest
Ohio Wind, LLC.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5136.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER21-213-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: PSC-PTZLGN-LGIA-196-0.0.0-
Agrmt to be effective 10/15/2020.
    Filed Date: 10/26/20.
    Accession Number: 20201026-5139.
    Comments Due: 5 p.m. ET 11/16/20.

    Docket Numbers: ER21-214-000.
    Applicants: Baltimore Gas and Electric Company, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: BGE submits Revisions to PJM
Tariff, Attachment H-2A and H-2B to be effective 1/1/2021.
    Filed Date: 10/26/20.
    Accession Number: 20201026-5147.
    Comments Due: 5 p.m. ET 11/16/20.

    Docket Numbers: ER21-215-000.
    Applicants: Deseret Generation & Transmission Co-operative, Inc.
    Description: Sec.  205(d) Rate Filing: 2020 RIA Annual Update to be
effective 7/1/2020.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5036.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER21-216-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 5813; Queue No. AD2-072 to be effective 9/29/2020.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5052.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER21-217-000.
    Applicants: Citizens Sunrise Transmission LLC.
    Description: Compliance filing: Order No. 864 Compliance Filing to
be effective N/A.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5078.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER21-218-000.
    Applicants: Citizens Sycamore-Penasquitos Transmission LLC.
    Description: Compliance filing: Order No. 864 Compliance Filing to
be effective N/A.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5081.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER21-219-000.
    Applicants: Suncor Energy Marketing Inc.
    Description: Baseline eTariff Filing: Suncor Energy Marketing Inc.
MBR Tariff Filing to be effective 12/26/2020.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5086.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER21-220-000.
    Applicants: Citizens Sunrise Transmission LLC.
    Description: Sec.  205(d) Rate Filing: Request for Approval of
Amended Tariff to be effective 1/1/2021.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5129.
    Comments Due: 5 p.m. ET 11/17/20.

    Docket Numbers: ER21-221-000.
    Applicants: Citizens Sycamore-Penasquitos Transmission LLC.
    Description: Sec.  205(d) Rate Filing: Annual Operating Cost True-
Up Adjustment Informational to be effective 1/1/2021.
    Filed Date: 10/27/20.
    Accession Number: 20201027-5147.
    Comments Due: 5 p.m. ET 11/17/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 27, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-24326 Filed 11-2-20; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

DATE:		November 24, 2014

TO:		Carbon Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Region 7, EPA

SUBJECT:	October 9 2014, Meeting Regarding Proposed Carbon Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY

      Karl Brooks and Mark Smith of EPA gave a summary presentation on October 9, 2014, to the members of the Kansas City Chamber of Commerce.  The majority of the presentation centered on highlighting the four major building blocks in the Carbon Power Plan for Existing Power Plants. The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014.        ATTENDEES

EPA Region 7: Karl Brooks Becky Weber Mark Smith Josh Tapp Amy Bhesania

Other Attendees included members of Kansas City Chamber of Commerce- attendee list not available.


[Federal Register: December 23, 2008 (Volume 73, Number 247)]
[Notices]
[Page 78814-78816]
[DOCID:fr23de08-98]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0375] (formerly Docket No. 2004D-0555)

Guidance for Industry and Food and Drug Administration Staff;
``Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300''; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Labeling for Natural Rubber Latex Condoms Classified
Under 21 CFR 884.5300.'' This guidance document describes a means by
which male condoms made of natural rubber latex (latex condoms) may
comply with the requirement of special controls for class II devices.
FDA believes that the labeling recommendations contained in this
guidance, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of latex condoms without
spermicidal lubricant. In the Federal Register of November 10, 2008 (73
FR 66522), FDA published a final rule that amended the classification
regulation for condoms from class II (performance standards) to class
II (special controls) and designated this guidance document as the
special control for male condoms made of natural rubber latex
classified under that regulation.

DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR
884.5300'' to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for

information on electronic access to the guidance.
    Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Paul Tilton, Center for Devices and
Radiological Health (HFZ-332), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, Congress enacted Public Law 106-554, which
directed FDA to ``* * * reexamine existing condom labels'' and ``* * *
determine whether the labels are medically accurate regarding the
overall effectiveness or lack of effectiveness of condoms in preventing
sexually transmitted diseases, including [human papillomavirus].''
Under this mandate, FDA conducted a review of scientific information
and of existing latex condom labeling, and concluded that existing
latex condom labeling was medically accurate in presenting the
conclusion that, as an overall matter, condoms are effective in
reducing the risk of sexually transmitted infections (STIs). To help
consumers make appropriate choices for their particular needs, and
therefore to ensure the safe and effective use of latex condoms, FDA
issued a proposed rule to establish a labeling guidance as a special
control to address some additional, more nuanced information about
latex condoms and STIs, as well as to provide information about
contraception, and about appropriate directions and precautions for use
of latex condoms (the 2005 proposed rule) (70 FR 69102, November 14,
2005). The rule proposed to amend existing classification regulations
to designate a labeling guidance document entitled ``Class II Special
Controls Guidance Document: Labeling for Male Condoms Made of Natural
Rubber Latex'' as the special control for condoms made of natural
rubber latex (latex condoms), classified under Sec.  884.5300 (21 CFR
884.5300), and latex condoms with spermicidal lubricant containing
nonoxynol-9, classified under Sec.  884.5310 (21 CFR 884.5310). Also in
the Federal Register of November 14, 2005 (70 FR 69156), FDA announced
the availability of the draft guidance entitled ``Class II Special
Controls Guidance Document: Labeling for Male Condoms Made of Natural
Rubber Latex'' (the 2005 draft guidance). FDA invited interested
persons to comment on the 2005 proposed rule and 2005 draft guidance by
February 13, 2006.
    In response to FDA's requests for comments, more than 100
commenters submitted information and comments to the docket for the
2005 proposed rule and the docket for the 2005 draft guidance. Because
of the intertwined nature of the 2005 proposed rule and the 2005 draft
guidance, and because of the significant overlap in comments, FDA
considered all comments in preparing both the final rule and special
controls guidance. The analysis of comments is contained in the final
rule.
    In the Federal Register of November 10, 2008 (73 FR 66522), FDA
issued a final rule which amended the classification regulation for
condoms in Sec.  884.5300 and designated the guidance document entitled
``Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300,'' which is the
subject of this notice, as the special control for latex condoms
classified under that regulation. This guidance is based on the draft
guidance proposed as a special control in November 2005 entitled
``Class II Special Controls Guidance Document: Labeling for Male
Condoms Made of Natural Rubber Latex.'' FDA assigned a new title to the
final special control guidance document designated as a special control
by Sec.  884.5300 in order to avoid confusion with the 2005 draft
guidance, which remains available (but not for implementation) as the
proposed special control for latex condoms with spermicidal lubricant
(classified under Sec.  884.5310) in association with the proposal to
amend that classification regulation. FDA is continuing to study the
issues surrounding latex condoms with spermicidal lubricant and has not
yet issued a new final rule regarding those devices.

II. Significance of Special Controls Guidance Document

    FDA believes that adherence to the labeling recommendations
described in this guidance document, in addition to the general
controls, will provide reasonable assurance of the safety and
effectiveness of latex condoms classified under Sec.  884.5300. The
final rule establishing this guidance document as a special control
will be effective January 9, 2009. Following the effective date of the
final rule, latex condoms classified under Sec.  884.5300 must comply
with the requirement of special controls; manufacturers must address
the issues requiring special controls as identified in the guidance,
either by following the recommendations in the guidance or by some
other means that provides equivalent assurances of safety and
effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Labeling for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300,'' you may either send an e-mail request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number (1688) to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The new collections of information in this guidance were approved under
OMB control number 0910-0633.
    This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR part 807, subpart E, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 801, including those in 21 CFR 801.435,
referenced in the guidance, have been

approved under OMB control number 0910-0485. The latex allergy caution
required by 21 CFR 801.437 and referenced in the guidance does not
constitute a ``collection of information'' under the PRA. Rather, it is
a ``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public.'' (5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments or
submissions will be accepted by FDA only through FDMS at http://
www.regulations.gov.

    Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30586 Filed 12-22-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6630-6631]
[DOCID:fr12fe07-125]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55243; File No. SR-CBOE-2007-06]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Amend CBOE Rules Relating To CBOE's Determination To
Trade Options on the iShares Russell 2000 Index Fund (IWM) on the
Hybrid 2.0 Platform

February 5, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 12, 2007, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Exchange filed the proposal as a ``non-controversial'' proposed
rule change pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and
Rule 19b-4(f)(6) thereunder.\4\ The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to amend its rules relating to CBOE's determination
to trade options on the iShares Russell 2000 Index Fund (IWM) on the
Hybrid 2.0 Platform. The text of the proposed rule change is available
on CBOE's Web site (http://www.cboe.com), at the CBOE's Office of the

Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this rule change is to amend CBOE Rule 8.3 and Rule
8.4 in connection with CBOE's determination to trade options on the
iShares Russell 2000 Index Fund (IWM) on the Hybrid 2.0 Platform.\5\
IWM options currently have an appointment cost of .50. CBOE intends to
maintain that appointment cost when IWM options trade on the Hybrid 2.0
Platform. As a result, IWM options will be classified as an ``AA'' Tier
option class. CBOE intends to trade IWM options on the Hybrid 2.0
Platform beginning on January 16, 2007.
---------------------------------------------------------------------------

    \5\ CBOE Rule 1.1(aaa) defines Hybrid Trading System and Hybrid
2.0 Platform.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\6\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) of the
Act,\7\ which requires that the rules of an exchange be designed to
promote just and equitable principles of trade, to prevent fraudulent
and manipulative acts and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(iii) of the Act \8\ and subparagraph (f)(6) of Rule 19b-4
\9\ thereunder because it does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate; and the Exchange has given the Commission
written notice of its intention to file the proposed rule change at
least five business days prior to filing. At any time within 60 days of
the filing of such proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    Under Rule 19b-4(f)(6) of the Act, the proposal does not become
operative for 30 days after the date of its filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest.\10\ The Exchange has requested

that the Commission waive the 30-day operative date, so that the
proposal may take effect January 16, 2007. The Exchange believes that
the proposed rule change does not raise any new regulatory issues. The
Commission agrees and, consistent with the protection of investors and
the public interest, has determined to waive the 30-day operative date,
which renders the proposal effective on January 16, 2007.\11\
---------------------------------------------------------------------------

    \10\ Rule 19b-4(f)(6) also requires the self-regulatory
organization to give the Commission notice of its intention to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at leave five business days prior to the
date of filing the proposed rule change, or such shorter time
designated by the Commission. CBOE has satisfied the five day
prefiling requirement.
    \11\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-06 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-CBOE-2007-06. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of the CBOE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2007-06 and should be
submitted on or before March 5, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-2302 Filed 2-9-07; 8:45 am]

BILLING CODE 8010-01-P