[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Rules and Regulations]
[Page 40745-40751]
[DOCID:fr14jy10-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0801; FRL-8833-1]

Cyazofamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
cyazofamid in or on Brassica, head and stem, subgroup 5A; Brassica,
leafy greens, subgroup 5B; turnip, greens; spinach; and hop, dried
cones. Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 14, 2010. Objections and
requests for hearings must be received on or before September 13, 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-2009-0801. 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail 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.
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
INFORMATION CONTACT.

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.gpoaccess.gov/ecfr.

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-2009-0801 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
September 13, 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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0801, 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<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E7615) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.601 be amended by
establishing tolerances for residues of the fungicide cyazofamid, 4-
chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile, expressed as cyazofamid, in or on Brassica,
head and stem, subgroup 5A at 1.2 parts per million (ppm); Brassica,
leafy greens, subgroup 5B at 12.0 ppm; turnip, greens at 12.0 ppm;
spinach at 9.0 ppm; and hops at 10.0 ppm. That notice referenced a
summary of the petition prepared on behalf of IR-4 by ISK Biosciences,
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 the tolerance expression for all established
commodities to be consistent with current Agency policy. The reason for
this change 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 cyazofamid including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with cyazofamid
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.
    Cyazofamid has a low order of acute toxicity via the oral, dermal,
and inhalation routes of exposure. It produces minimal but reversible
eye irritation, is a slight dermal irritant, and is a weak dermal
sensitizer. In subchronic toxicity studies in rats, the kidney appeared
to be the primary target organ, with kidney effects including an
increased number of basophilic kidney tubules and mild increases in
urinary volume, pH, and protein. No adverse kidney effects were noted
in chronic toxicity studies in rats. There were no toxicity findings up
to the limit dose in a subchronic toxicity study in dogs; in the
chronic dog toxicity study, increased cysts in parathyroids were
observed in males at the highest dose tested (HDT).
    There were no maternal or developmental effects observed in the
prenatal developmental toxicity study in rabbits and no maternal,
reproductive, or offspring effects in the 2-generation reproductive
toxicity study in rats. There was evidence of increased susceptibility
following in utero exposure of rats in the prenatal developmental
toxicity study at the HDT; developmental effects, including an
increased incidence of bent ribs, were observed in the absence of
maternal toxicity.
    There was no evidence of neurotoxicity in any study in the exposure
database for cyazofamid. Skin lesions, which may be due to a systemic
allergy, were observed in male mice in a carcinogenicity study. There
was no evidence of carcinogenicity in the rat or mouse carcinogenicity
studies and no evidence that cyazofamid is mutagenic in several in vivo
and in vitro studies. Based on the results of these studies, EPA has
classified cyazofamid as ``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by cyazofamid 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: ``Cyazofamid. Human Health Risk
Assessment for Proposed Uses on Brassica (Cole) Leafy Vegetables Crop
Group 5, Turnip Greens, Spinach, and Hops,'' pp 34-38 in docket ID
number EPA-HQ-OPP-2009-0801.

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 cyazofamid used for
human risk assessment is shown in the following Table.

  Table 1.--Summary of Toxicological Doses and Endpoints for cyazofamid 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 (General population        No adverse effects were observed which could be attributed to a single
 including infants and children)                        dose exposure for the general population.
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 100 mg/kg/day    Acute RfD = 1.0 mg/kg/   Rat Prenatal
 age)                                  UFA = 10x..............   day                      Developmental Toxicity
                                       UFH = 10x..............  aPAD = 1.0 mg/kg/day...   Study
                                       FQPA SF = 1x...........                           LOAEL = 1,000 mg/kg/day
                                                                                based on developmental
                                                                                toxicity findings of
                                                                                increased incidence of
                                                                                bent ribs.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 94.8 mg/kg/day    Chronic RfD = 0.948 mg/  18-Month Mouse Oral
                                       UFA = 10x..............   kg/day                   Carcinogenicity Study
                                       UFH = 10x..............  cPAD = 0.948 mg/kg/day.   LOAEL = 985 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                skin lesions.
----------------------------------------------------------------------------------------------------------------
Incidental oral, short-term            NOAEL= 30 mg/kg/day      LOC for MOE = 100        90-day Rat Oral
(1 to 30 days) and intermediate-term   UFA = 10x..............                            Toxicity Study
 (1-6 months).                         UFH = 10x..............                           LOAEL = 295 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                number of basophilic
                                                                                tubules of the
                                                                                kidneys, increased
                                                                                urinary volume, pH,
                                                                                and protein.
----------------------------------------------------------------------------------------------------------------
Dermal, short-term (1 to 30 days) and  For Children: No toxicity was found at 1,000 mg/kg/day in a 28-day dermal
 intermediate-term (1-6 months)          toxicity study; therefore, in the absence of hazard identified for this
                                                 population, a dermal risk assessment is not necessary.
----------------------------------------------------------------------------------------------------------------

                                       For Adults: Dermal (or   LOC for MOE = 100        Rat Prenatal
                                        oral) study                                       Developmental Toxicity
                                       NOAEL = 100 mg/kg/day                              Study
                                        (dermal absorption                               LOAEL = 1,000 mg/kg/day
                                        rate = 37 %).                                     based on developmental
                                       UFA = 10x..............                            toxicity findings of
                                       UFH = 10x..............                            increased incidence of
                                       FQPA SF = 1x...........                            bent ribs.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)       Classification: ``Not likely to be carcinogenic to humans'' based on the
                                              absence of significant tumor increases in two adequate rodent
                                                                carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyazofamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyazofamid tolerances in 40 CFR
180.601. EPA assessed dietary exposures from cyazofamid 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. EPA identified such an
effect (increased incidence of bent ribs in the rat prenatal
developmental toxicity study) for the population subgroup females 13 to
49 years old; however, no such effect was identified for the general
population, including infants and children.
    In estimating acute dietary exposure for females 13 to 49 years
old, EPA used food consumption information from the United States
Department of Agriculture (USDA) 1994 to 1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed tolerance-level residues, Dietary Exposure
Evaluation Model (DEEM) default processing factors and 100 percent crop
treated (PCT) for all existing and proposed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994 to
1996 and 1998 CSFII. As to residue levels in food, EPA assumed
tolerance-level residues, DEEM default processing factors and 100 PCT
for all existing and proposed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that cyazofamid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for cyazofamid. Tolerance level residues and/or 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 cyazofamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyazofamid. 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.
    Available environmental fate studies suggest cyazofamid is not very
mobile and quickly degrades into a number of degradation products under
different environmental conditions. Among the three major degradates
for cyazofamid (CCIM, CCIM-AM and CTCA), the two terminal degradates
are CCIM and CTCA. The highest estimated drinking water concentrations
resulted from modeling which assumed application of 100% molar
conversion of the parent into the terminal degradate CTCA. EPA used
these estimates of CTCA in its dietary exposure assessments, a
conservative approach that likely overestimates the exposure
contribution from drinking water. Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling System (PRZM/EXAMS) model for surface
water and the Screening Concentration in Ground Water (SCI-GROW) model
for ground water, the estimated drinking water concentrations (EDWCs)
of CTCA for acute exposures are estimated to be 136 parts per billion
(ppb) for surface water and 2.18 ppb for ground water. Chronic
exposures for non-cancer assessments are estimated to be 133 ppb for
surface water and 2.18 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 136 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 133 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).
    Cyazofamid is currently registered for use on residential turf and
ornamentals and on professionally managed turf areas, such as golf
courses and college/professional sports fields. For the use of
cyazofamid on professionally managed turf areas, short-term and
intermediate-term postapplication dermal exposure was assessed for
adult and youth golfers and adult athletes. However, because it is
unlikely for an individual to experience a co-occurrence of activities
within a single day, the scenarios of golfing and/or using recreational
fields were not aggregated with the residential turf and ornamental
scenarios.
    For the use of cyazofamid on residential turf and ornamentals,
application by homeowners is

prohibited; therefore, residential handler exposure is not expected and
was not assessed. However, short-term and intermediate-term
postapplication exposure is possible for adults and children. Adults
were assessed for short-term and intermediate-term postapplication
dermal exposure from contact with treated turf and ornamentals. The
adult population of concern for dermal risk assessment is females of
childbearing age (13+), based on the developmental toxicity findings of
increased incidence of bent ribs; thus, the estimated risk for this
population is protective of all adult population subgroups. Children
were assessed for short-term and intermediate-term postapplication
incidental oral exposure to treated residential turf and ornamentals,
including hand-to-mouth activity, object-to-mouth activity, and soil
ingestion. No POD was identified for dermal exposures to treated turf
or ornamentals for children, since no toxicity was seen in the 28-day
dermal toxicity study at the HDT (1,000 mg/kg/day); therefore, dermal
postapplication exposure scenarios for children were not assessed.
    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 cyazofamid to share a common mechanism of
toxicity with any other substances, and cyazofamid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyazofamid 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 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 prenatal and postnatal
toxicology database for cyazofamid includes rat and rabbit
developmental toxicity studies and a 2-generation reproductive toxicity
study in rats. There was no indication of increased susceptibility, as
compared to adults, of rabbit fetuses to in utero exposure in a
developmental study or of rat pups in the 2-generation reproductive
toxicity study. There is evidence of increased quantitative
susceptibility following in utero exposure of rats to cyazofamid in the
prenatal developmental study; an increased incidence of bent ribs in
fetuses at the HDT was noted in the absence of maternal effects.
    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 cyazofamid is complete except for
immunotoxicity and subchronic neurotoxicity testing. Recent changes to
40 CFR part 158 make immunotoxicity testing (OSCPP Harmonized Guideline
870.7800) and subchronic neurotoxicity testing (OSCPP Harmonized
Guideline 158.500) required for pesticide registration; however, the
available data for cyazofamid do not show potential for immunotoxicity.
Further, there is no evidence of neurotoxicity in any study in the
toxicity database for cyazofamid. EPA does not believe that conducting
neurotoxicity and immunotoxicity studies will result in a NOAEL lower
than the regulatory dose for risk assessment. Consequently, the EPA
believes the existing data are sufficient for endpoint selection for
exposure/risk assessment scenarios and for evaluation of the
requirements under the FQPA, and an additional database uncertainty
factor does not need to be applied.
    ii. There is no indication that cyazofamid 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 cyazofamid results in increased
susceptibility in rabbits in the prenatal developmental study or in
young rats in the 2-generation reproductive toxicity study. Although
there is evidence of increased quantitative susceptibility in the
prenatal developmental study in rats, the Agency determined that
concern is low because:
    a. The developmental effect (increased bent ribs) is well
identified with a clear NOAEL and LOAEL.
    b. Increased bent ribs are considered a reversible variation rather
than a malformation.
    c. The effect was noted only at the limit dose of 1,000 mg/kg/day.
    d. This endpoint was used to establish the acute reference dose
(aRfD) for females 13-49.
    e. The overall toxicity profile indicates that cyazofamid is not a
very toxic compound.
    Therefore, there are no residual concerns regarding developmental
effects in the young.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to cyazofamid in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by cyazofamid.

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-term, intermediate-term 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 cyazofamid will occupy 1.2% of the aPAD for females 13 to 49 years
old, the population group of concern for acute effects. Cyazofamid is
not expected to pose an acute risk to the general population, including
infants and children.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyazofamid

from food and water will utilize 1.2% of the cPAD for infants less than
1 year old, 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 cyazofamid is not
expected.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Cyazofamid is
currently registered for uses that could result in short-term and
intermediate-term postapplication residential exposure to adults and
children. The Agency has determined that it is appropriate to aggregate
chronic exposure through food and water with short-term and
intermediate-term residential exposure to cyazofamid.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined
short-term and intermediate-term food, water, and residential exposures
(treated residential turf and ornamentals) aggregated result in MOEs of
1,000 for the general U.S. population, 1,400 for children 3 to 5 years
old, and 1,500 for children 6 to 12 years old. As the MOEs are greater
than 100 for all population subgroups, short-term and intermediate-term
aggregate exposure to cyazofamid is not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, cyazofamid is not expected to pose a cancer risk to humans.
    5. 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 cyazofamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical methodology is available to enforce the
proposed tolerances. Cyazofamid and the metabolite CCIM are completely
recovered (>80% recovery) using FDA's Multi-Residue Protocol D (without
cleanup). In addition, a high performance liquid chromatography/
ultraviolet detector (HPLC/UV) method is available for use as a single
analyte confirmatory method. These methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail 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 U.N. 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.
     There are currently no Codex or Canadian MRLs established for
residues of cyazofamid in or on commodities associated with this
petition.

C. Revisions to Petitioned-For Tolerances

    The EPA has revised the tolerance expression to clarify: 1. That,
as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of cyazofamid not specifically mentioned; 2.
That compliance with the specified tolerance levels is to be determined
by measuring only the specific compounds mentioned in the tolerance
expression.

V. Conclusion

    Therefore, tolerances are established for residues of cyazofamid,
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide, and its metabolite 4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile, calculated as the stoichiometric equivalent
of cyazofamid, in or on Brassica, head and stem, subgroup 5A at 1.2
ppm; Brassica, leafy greens, subgroup 5B at 12.0 ppm; turnip, greens at
12.0 ppm; spinach at 9.0 ppm; and hop, dried cones at 10.0 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 note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 1, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.601 is amended by:
    i. Revising the introductory text and alphabetically adding the
following commodities to the table in paragraph (a):
    ii. Revising the introductory text in paragraph (c) to read as
follows:

Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide cyazofamid, including its metabolites and degradates, in or
on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only the sum of 4-chloro-2-cyano-N,N-dimethyl-5-(4-
methylphenyl)-1H-imidazole-1-sulfonamide and its metabolite, 4-chloro-
5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, calculated as the
stoichiometric equivalent of cyazofamid, in or on the following
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.................                1.2
------------------------------------------------------------------------
Brassica, leafy greens, subgroup 5B..................               12.0
------------------------------------------------------------------------

                              * * * * * * *
Hop dried cones......................................               10.0
------------------------------------------------------------------------

                              * * * * * * *
Spinach..............................................                9.0
------------------------------------------------------------------------
Turnip, greens.......................................               12.0

                              * * * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registrations are established for residues of the fungicide
cyazofamid, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only the sum of 4-chloro-2-cyano-N,N-dimethyl-5-(4-
methylphenyl)-1H-imidazole-1-sulfonamide and its metabolite, 4-chloro-
5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, calculated as the
stoichiometric equivalent of cyazofamid, in or on the following
commodities:
* * * * *
[FR Doc. 2010-17025 Filed 7-13-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Notices]
[Pages 29866-29867]
[FR Doc No: 2019-13430]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0482]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Associated
With New Animal Drug Applications and Veterinary Master Files

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
25, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0032.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Reporting Associated With New Animal Drug Applications (NADA) and
Veterinary Master Files--21 CFR 514.1, 514.4, 514.5, 514.6, 514.8,
514.11, and 558.5

OMB Control Number 0910-0032--Extension

    Under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal
drug application (NADA) seeking our approval to legally market a new
animal drug. Section 512(b)(1) of the FD&C Act sets forth the
information required to be submitted in a NADA. Sections 514.1, 514.4,
514.6, 514.8, and 514.11 of our regulations (21 CFR 514.1, 514.4,
514.6, 514.8, and 514.11) further specify the information that the NADA
must contain. The application must include safety and effectiveness
data, proposed labeling, product manufacturing information, and where
necessary, complete information on food safety (including microbial
food safety) and any methods used to determine residues of drug
chemicals in edible tissue from food producing animals. FDA Guidance
for Industry #152 outlines a risk assessment approach for evaluating
the microbial food safety of antimicrobial new animal drugs. We request
that applicants utilize Form FDA 356V, as appropriate, to ensure
efficient and accurate processing of information to support new animal
drug approval.
    Under section 512(b)(3) of the FD&C Act, any person intending to
file a NADA or supplemental NADA or a request for an investigational
exemption under section 512(j) of the FD&C Act is entitled to one or
more conferences with us prior to making a submission. Section 514.5 of
our regulations (21 CFR 514.5) describes the procedures for requesting,
conducting, and documenting presubmission conferences. We have found
that these meetings have increased the efficiency of the drug
development and drug review processes. We encourage sponsors to submit
data for review at the most appropriate and productive times in the
drug development process. Rather than submitting all data for review as
part of a complete application, we have found that the submission of
data supporting discrete technical sections during the investigational
phase of the new animal drug is the most appropriate and productive.
This ``phased review'' of data submissions has created efficiencies for
both us and the animal pharmaceutical industry.
    Additionally, we have found that various uses of veterinary master
files have increased the efficiency of the drug development and drug
review processes for both us and the animal pharmaceutical industry. A
veterinary master file is a repository for submission to FDA's Center
for Veterinary Medicine of confidential detailed information about
facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more veterinary drugs. The
benefits of veterinary master files include confidential exchange of
information with FDA, a process for reporting information outside of a
NADA or an investigational new animal drug (INAD) file, as well as an
opportunity for increased communication with FDA during early stages of
product development. Respondents may choose to use veterinary master
files to provide and organize confidential detailed information to the
Agency. A holder of a veterinary master file may also authorize other
parties to reference information in the veterinary master file without
disclosing information in the file to those parties. Veterinary master
files can be used as repositories for information that can be
referenced in multiple submissions to the Agency, thus minimizing
paperwork burden. Veterinary master files are already used by the
animal pharmaceutical industry in support of information being
submitted for NADAs, abbreviated new animal drug applications (ANADAs),
INAD files, and generic investigational new animal drug (JINAD) files.
In previous information collection requests, we have included the time
necessary to compile and submit such information to veterinary master
files within the burden estimates provided for applications and amended
applications (for NADAs and INAD files) and abbreviated applications
and amended abbreviated applications (for ANADAs and JINAD files),
respectively. We are now combining the time necessary to compile and
submit such information to veterinary master files within the burden
estimates provided in this collection of information.
    We are also developing new approaches to permit more complex uses
of veterinary master files to facilitate the development of animal drug
products. We expect respondents will want to use veterinary master
files to submit information to us for review and consultation during
all phases of animal drug product development (including product
development that precedes the establishment of an INAD file or the
submission of a NADA). This information could include information about
processes, facilities, or articles used in the manufacturing,
processing,

packaging, and storing of veterinary drugs and drug substances.
Information submitted to FDA through a veterinary master file could
also include drug characterization, methods, protocols, or other
relevant information. In this request for OMB review, we seek approval
of an increased use of veterinary master files by respondents to submit
additional information to us for review and consultation during all
phases of animal drug product development (including product
development that precedes the establishment of an INAD file or the
submission of a NADA). To account for an expected increase in reporting
burden hours associated with the increased use of veterinary master
files by respondents, we are separately estimating in table 1, row 10,
the burden of the use of veterinary master files during all phases of
product development (including product development that precedes the
establishment of an INAD file or the submission of a NADA).
    Finally, Sec.  558.5(i) of our regulations (21 CFR 558.5(i))
describes the procedure for requesting a waiver of the labeling
requirements of Sec.  558.5(h) in the event that there is evidence to
indicate that it is unlikely a new animal drug would be used in the
manufacture of a liquid medicated feed.
    The reporting associated with NADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(1) of the FD&C Act. We use the information collected to
review the data, labeling, and manufacturing controls and procedures to
evaluate the safety and effectiveness of the proposed new animal drug.
    Description of Respondents: Respondents include persons developing,
manufacturing, and/or researching new animal drugs.
    In the Federal Register of February 15, 2019 (84 FR 4479), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
514.1 & 514.6; applications and              182            0.05               9             212           1,908
 amended applications...........
514.1(b)(8) and 514.8(c)(1) \2\;             182            0.10              18              90           1,620
 evidence to establish safety
 and effectiveness..............
514.5(b), (d), (f); requesting               182            0.49              89              50           4,450
 presubmission conferences......
514.8(b); manufacturing changes              182            1.40             255              35           8,925
 to an approved application.....
514.8(c)(1); labeling and other              182            0.05               9              71             639
 changes to an approved
 application....................
514.8(c)(2) & (3); labeling and              182            0.43              78              20           1,560
 other changes to an approved
 application....................
514.11; submission of data,                  182            0.09              16               1              16
 studies and other information..
558.5(i); requirements for                   182            0.01               2               5              10
 liquid medicated feed..........
Form FDA 356V...................             182            2.92             531               5           2,655
Use of veterinary master files                15               1              15              20             300
 during all phases of product
 development (including product
 development that precedes the
 establishment of an INAD file
 or the submission of an NADA)..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           1,022  ..............          22,083
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
  antimicrobial concerns as part of the overall pre-approval safety evaluation.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our previous
estimates. However, as discussed, we have separately estimated the
burden of the ``Use of veterinary master files during all phases of
product development (including product development that precedes the
establishment of an INAD file or the submission of an NADA)'' in table
1, line 10. We base our estimate of the total annual responses for the
use of veterinary master files on such uses initiated during calendar
year 2018. We base our estimate of the hours per response upon our
experience with the respondents' use of veterinary master files. We
estimate that the time it takes to compile information and submit it to
a veterinary master file will vary from 1 to 50 hours depending on the
complexity of the information; therefore, we are estimating on average
the burden per response to be 20 hours. Accordingly, our estimated
burden for the information collection reflects an overall increase of
124 hours and a corresponding increase of 14 responses.

    Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13430 Filed 6-24-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Notices]
[Page 51609-51610]
[DOCID:fr30au06-97]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2106--047-California]

Pacific Gas and Electric; Notice of Site Visit

(August 23, 2006).
    On September 19 and September 20, 2006, the Federal Energy
Regulatory Commission (Commission) Staff and Pacific Gas and Electric
Company, the applicant, will conduct an on-site visit of the McCloud-
Pit Project located on the McCloud and Pit Rivers in Shasta County,
California. Under the Integrated Licensing Process (ILP), the
Commission conducts its National Environmental Policy Act (NEPA)
scoping meeting within 90 days of the filing of the applicant's Notice
of Intent and Pre-Application Document. A site visit is typically held
in conjunction with that scoping meeting; however, scoping for this
project is currently planned for October 23 and 24, 2006 and access to
some project facilities may be limited by weather conditions. For this
reason, the Commission will host the site visit earlier in the process.
The Commission encourages all interested parties to participate in this
site visit to ensure a productive scoping meeting in October 2006.
    The site visit is open to the public and resource agencies.
Participants are responsible for their own transportation, but car
pooling is encouraged as much as possible. Some roads in upper
watershed locations are unpaved and may be in poor condition--4-wheel
drive is recommended, but not required. Also, portions of the tour may
require hiking steep trails in remote locations, so please plan
accordingly. Tour days may be long, so please bring food and water. A
tentative schedule is provided below (times given are in Pacific
Daylight Savings):

Tuesday, September 19, 2006

6:45 a.m. Individuals arrive at PG&E's Service Center, located at 20818
Black Ranch Road, Burney, CA 96013
8 a.m. Meet at McCloud Reservoir USFS Tarantula Gulch Boat Ramp
9 a.m. Ah-Di-Na Stream Gage (MC-1)
10 a.m. Star City
10:30 a.m. McCloud Dam (Top)
11 a.m. McCloud Dam (Bottom)
11:15 a.m. Stream GageMC-7
11:30 a.m. Hawkins Creek Pipe Crossing
12:30 a.m. Lunch at USFS Deadlum Campground
1:30 p.m. Hawkins Landing Campground & Boat Ramp
2 p.m. Iron Canyon Overflow
2:30 p.m. Iron Canyon Dam
3:30 p.m. Iron Canyon Pipe
4 p.m. James B. Black Surge Chamber
4:30 p.m. James B. Black Penstock

Wednesday, September 20, 2006

6:45 a.m. Individuals arrive at PG&E's Service Center, located at 20818
Black Ranch Road, Burney, CA 96013
8 a.m. James B. Black Powerhouse
10 a.m. Pit 6 Dam
10:30 a.m. Pit 6 Powerhouse
12 p.m. Lunch at Pit 7 Afterbay Dam
2 p.m. Pit 7 Dam
2:30 p.m. Pit 7 Powerhouse
3:30 p.m. Stream Gage PH-47

    Please direct any questions regarding the McCloud-Pit Hydroelectric
Project licensing to Emily Carter, FERC Team Leader, at<PHONE_NUMBER>
or<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
 [FR Doc. E6-14391 Filed 8-29-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 139 (Friday, July 21, 2017)]
[Proposed Rules]
[Pages 33833-33834]
[FR Doc No: 2017-15283]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0354; Airspace Docket No. 17-ACE-8]

Proposed Amendment of Class E Airspace, Seward, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify Class E airspace extending up
to 700 feet above the surface at Seward Municipal Airport, Seward, NE.,
to accommodate new standard instrument approach procedures for
instrument flight rules (IFR) operations at the airport. This action is
necessary due to the decommissioning of the Seward non directional
radio beacon (NDB), and cancellation of NDB approach, and would enhance
the safety and management of IFR operations at the airport.

DATES: Comments must be received on or before September 5, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone
(202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No.
FAA-2017-0354 and Airspace Docket No. 17-ACE-8, at the beginning of
your comments. You may also submit comments through the Internet at
http://www.regulations.gov. You may review the public docket containing
the proposal, any comments received, and any final disposition in
person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday
through Friday, except federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Walter Tweedy (prepare by Ron Laster),
Federal Aviation Administration, Operations Support Group, Central
Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone
(817) 222-5802.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace in Class E.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0354/
Airspace Docket No. 17-ACE-8.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A

report summarizing each substantive public contact with FAA personnel
concerned with this rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 700 feet above the surface within a 6.5-mile radius of
Seward Municipal Airport. The segments within 4 miles each side of the
166[deg] bearing from the Seward NDB extending from the 6.4-mile radius
to 14 miles southeast of the NDB, and within 4 miles each side of the
359[deg] bearing from the Seward NDB extending from the 6.4-mile radius
to 13 miles north of the NDB, would be modified due to the
decommissioning of the Seward NDB and cancellation of the NDB approach.
This action would enhance the safety and management of the standard
instrument approach procedures for IFR operations at the airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
feet or More Above the Surface of the Earth.

* * * * *

ACE NE E5 Seward, NE [Amended]

Seward Municipal Airport, NE
    (Lat. 40[deg]51'53'' N., long. 97[deg]06'33'' W.)

    The airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Seward Municipal Airport.

    Issued in Fort Worth, Texas, on July 11, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-15283 Filed 7-20-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: December 3, 2008 (Volume 73, Number 233)]
[Notices]
[Page 73640]
[DOCID:fr03de08-24]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-311-000]

LANXESS Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

November 26, 2008.
    This is a supplemental notice in the above-referenced proceeding of
LANXESS Energy, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 26, 2008.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-28685 Filed 12-2-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Rules and Regulations]
[Pages 37035-37036]
[FR Doc No: 2021-15072]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2020-F-1289]

Food Additives Permitted in Feed and Drinking Water of Animals;
Selenomethionine Hydroxy Analogue

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of
selenomethionine hydroxy analogue as a source of selenium in feed for
beef and dairy cattle. This action is in response to a food additive
petition filed by Adisseo France S.A.S.

DATES: This rule is effective July 14, 2021. See section V of this
document for further information on the filing of objections. Submit
either electronic or written objections and requests for a hearing on
the final rule by August 13, 2021.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before August
13, 2021. The https://www.regulations.gov electronic filing system will
accept objections until 11:59 p.m. Eastern Time at the end of August
13, 2021. Objections received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting objections. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your objection, that information will be
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-F-1289 for ``Food Additives Permitted in Feed and Drinking
Water

of Animals; Selenomethionine Hydroxy Analogue.'' Received objections,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies in total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of objections. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your objections and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper objections received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Chelsea Cerrito, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-221),
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of May 11, 2020 (85
FR 27692), FDA announced that we had filed a food additive petition
(animal use) (FAP 2312) submitted by Adisseo France S.A.S.; Immeuble
Antony Parc II, 10 Place du G[eacute]n[eacute]ral de Gaulle, 92160
Antony, France. The petition proposed that the regulations for food
additives permitted in feed and drinking water of animals be amended to
provide for the safe use of selenomethionine hydroxy analogue as a
source of selenium in feed for beef and dairy cattle.

II. Conclusion

    FDA concludes that the data establish the safety and utility of
selenomethionine hydroxy analogue as a source of selenium in feed for
beef and dairy cattle and that the food additive regulations should be
amended as set forth in this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h) (21 CFR 571.1(h)), the petition
and documents we considered and relied upon in reaching our decision to
approve the petition will be made available for public disclosure (see
FOR FURTHER INFORMATION CONTACT). As provided in Sec.  571.1(h), we
will delete from the documents any materials that are not available for
public disclosure.

IV. Analysis of Environmental Impact

    We have determined under 21 CFR 25.32(r) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may
file with the Dockets Management Staff (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
shall constitute a waiver of the right to a hearing on the objection.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, 21 CFR part 573 is amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS

0
1. The authority citation for part 573 continues to read as follows:

    Authority:  21 U.S.C. 321, 342, 348.

0
2. In Sec.  573.920, revise paragraphs (a)(6), (h)(2) and (3)
introductory text to read as follows:

Sec.  573.920  Selenium.

    (a) * * *
    (6) Paragraphs (b) through (h) of this section provide the
currently acceptable levels of selenium supplementation.
* * * * *
    (h) * * *
    (2) Selenium, as selenomethionine hydroxy analogue, is added to
feed as follows:
    (i) In complete feed for chickens, turkeys, swine, beef cattle, and
dairy cattle at a level not to exceed 0.3 ppm.
    (ii) In feed supplements for limit feeding for beef cattle at a
level not to exceed an intake of 3 milligrams per head per day.
    (iii) In salt-mineral mixtures for free-choice feeding for beef
cattle up to 120 parts per million in a mixture for free-choice feeding
at a rate not to exceed an intake of 3 milligrams per head per day.
    (3) To assure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act, the
label and labeling of selenomethionine hydroxy analogue in its packaged
form shall contain:
* * * * *

    Dated: July 7, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: July 12, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-15072 Filed 7-13-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 24, 2008 (Volume 73, Number 57)]
[Notices]
[Page 15546-15548]
[DOCID:fr24mr08-97]

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SECURITIES AND EXCHANGE COMMISSION

Release No. 34-57512; File No. SR-CBOE-2008-19]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change, as Modified by Amendment No. 1 Thereto, Relating to
Customer-to-Customer Immediate Crosses

March 17, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 4, 2008, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') 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 substantially by
CBOE. On March 14, 2008, CBOE submitted Amendment No. 1 to the proposed
rule change. CBOE filed the proposed rule change as a ``non-
controversial'' proposed rule change pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders it
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change, as
amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to amend its Automated Improvement Mechanism
(``AIM'') Rule to permit customer-to-customer orders to be entered
paired and to be crossed without any AIM auction exposure period. The
text of the proposed rule change is available at CBOE, the Commission's
Public Reference Room, and http://www.cboe.com.

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

    In its filing with the Commission, CBOE included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. CBOE 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
    CBOE proposes to amend Rule 6.74A to permit customer-to-customer
orders to be entered paired and to be crossed without any AIM auction
exposure period. Currently, CBOE Rules provide for a minimum exposure
time of three seconds for crossing orders on the Hybrid Trading System
(``Hybrid'') when an order entry firm (i) executes as principal against
orders it represents as agent, or (ii) executes orders it represents as
agent against orders solicited from members and non-member broker-
dealers to transact with such orders.\5\ However, the three second
exposure period is not applicable when crossing two orders that are
both for the accounts of non-broker-dealer customers. Thus, two non-
broker-dealer customer orders may be entered separately into Hybrid by
the same order entry firm to trade against each other without waiting
three seconds. To enhance and automate order entry firms' ability to
submit two contra-side customer orders, the Exchange is proposing to
introduce and to codify a new feature in its AIM Rule \6\ that the
Exchange refers to as a ``customer-to-customer immediate cross.''
---------------------------------------------------------------------------

    \5\ See CBOE Rule 6.45A, Priority and Allocation of Equity
Option Trades on the CBOE Hybrid System, Interpretations and
Policies .01 and .02, and Rule 6.45B, Priority and Allocation of
Trades in Index Options and Options on ETFs on the CBOE Hybrid
System.
    \6\ AIM is an automated auction mechanism through which a member
that represents agency orders may electronically execute an order it
represents as agent (``agency order'') against principal or
solicited interest. When the Exchange receives an agency order
properly designated for an AIM auction, a request for responses
(``RFR'') is initiated and, subject to certain exceptions delineated
in Rule 6.74A, the RFR lasts for a random time determined by the
system between three and five seconds. Once the AIM auction
concludes, the agency order is allocated at the best prices pursuant
to allocation procedures in the Rule. See CBOE Rule 6.74A.
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    When using the AIM customer-to-customer immediate cross feature,
the proposed rule will provide that an order entry firm (``Initiating
Member'') may enter an agency order for the account of a non-broker-
dealer customer in AIM, paired with a solicited order for the account
of a non-broker-dealer customer. Under the rule proposal, those paired
orders will be automatically executed without an exposure period so
long as the execution price: (i) Is in the applicable standard
increment (i.e., $0.10 for series quoted at or above $3, $0.05 for
series quotes below $3, $0.01 for series participating in the Penny
Pilot Program, and the applicable standard or $0.01 increment for
complex orders as designated pursuant to Rule 6.53C); (ii) will not
trade at the same price as any resting customer order; and (iii)
subject to certain exceptions, is not at a price that trades through
the national best bid or offer (``NBBO''). If the Exchange determines
on a class-by-class basis to (i) designate complex orders as eligible
for AIM customer-to-customer immediate crosses or (ii) permit orders of
500 or more contracts and that have a premium value of at least
$150,000 to be executed without considering prices that might be
available on other options exchanges, the NBBO condition shall not
apply to such orders and instead the execution price will not trade
through CBOE's best bid or offer (``BBO'').\7\ In addition, the
execution price must be in the applicable standard increment and will
not trade at the same price as any resting customer order. In the case
of a complex order, this means that the execution price will not trade
at the same price as any customer complex order resting in the CBOE's
electronic complex order book. To be eligible to use the customer-to-
customer immediate cross feature, the proposed rule will also provide
that the agency

order must be in a class designated by the Exchange as eligible for the
feature and within the designated order eligibility size parameters, as
such parameters are determined by the Exchange.
---------------------------------------------------------------------------

    \7\ See proposed paragraph .09(b) to CBOE Rule 6.74A.
---------------------------------------------------------------------------

    Lastly, the proposed rule will contain a cross-reference to
Interpretation and Policy .01 to CBOE Rules 6.45A and 6.45B.
Specifically, the proposed rule will note that Interpretation and
Policy .01 to CBOE Rules 6.45A and 6.45B prevent an order entry firm
from executing agency orders to increase its economic gain from trading
against the order without first giving other trading interests on the
Exchange an opportunity to either trade with the agency order or to
trade at the execution price when the member was already bidding or
offering on the book. However, as the proposed rule will also note, the
Exchange recognizes that it may be possible for a firm to establish a
relationship with a customer or other person to deny agency orders the
opportunity to interact on the Exchange and to realize similar economic
benefits as it would achieve by executing agency orders as principal.
Therefore, the proposed rule will provide that it would be a violation
of Interpretation and Policy .01 to Rule 6.45A or 6.45B, as applicable,
for a firm to circumvent Interpretation and Policy .01 to Rule 6.45A or
6.45B, as applicable, by providing an opportunity for (i) a customer
affiliated with the firm, or (ii) a customer with whom the firm has an
arrangement that allows the firm to realize similar economic benefits
from the transaction as the firm would achieve by executing agency
orders as principal, to regularly execute against agency orders handled
by the firm immediately upon their entry as AIM customer-to-customer
immediate crosses. The Exchange believes that this provision should
help prevent a firm from doing indirectly what it is prohibited from
doing directly as principal. This provision of CBOE's proposed rule is
substantially similar to a provision in ISE's Rules.\8\
---------------------------------------------------------------------------

    \8\ See Supplemental Material .01 to ISE Rule 717.
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) of the Act \9\ that an exchange have
rules that are designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest. In particular, the proposed rule change will provide
members with a more efficient means of executing their customer option
orders subject to the Exchange's existing requirements limiting
principal transactions, and will allow CBOE to effectively compete with
ISE.
---------------------------------------------------------------------------

    \9\ 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

    CBOE neither solicited nor received comments on the proposal.

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

    Because the foregoing proposed rule change 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, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\12\
However, Rule 19b-4(f)(6)(iii) \13\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because it will allow
customers to benefit from the proposed rule change without delay.\14\
The Commission hereby grants the Exchange's request and designates the
proposal as operative upon filing.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
CBOE has complied with this requirement.
    \13\ Id.
    \14\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the 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.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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 No. SR-CBOE-2008-19 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2008-19. 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 Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal office of
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-2008-19 and should be submitted on or before April 14, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-5795 Filed 3-21-08; 8:45 am]

BILLING CODE 8011-01-P