[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Rules and Regulations]
[Page 51738-51743]
[DOCID:fr05se08-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0366; FRL-8377-6]

Pyraflufen-ethyl; Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes permanent tolerances for residues
of pyraflufen-ethyl in or on grass, forage, group 17; and grass, hay,
group 17; establishes time-limited tolerances for milk; cattle, meat
byproducts; goat, meat byproducts; horse, meat byproducts and sheep,
meat byproducts, and revises the existing tolerances for soybean,
forage; soybean, hay; wheat, forage and wheat, hay. Nichino America,
Inc. requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA). The time-limited tolerances expire on October 15,
2012.

DATES: This regulation is effective September 5, 2008. Objections and
requests for hearings must be received on or before November 4, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0366. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
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: Joanne I. Miller, 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:
     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 provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing

Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0366 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before November 4, 2008
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0366, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg., 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is<PHONE_NUMBER>.

II. Petition for Tolerances

    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7190) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be
amended by establishing tolerances for residues of the herbicide,
pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate; and its acid
metabolite, E-1, 2-chloro-5-4-chloro-5-difluoromethoxy-(1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the
parent in or on food commodities: Soybeans, forage at 0.05 parts per
million (ppm); soybean, hay at 0.10 ppm; grass, forage, crop group 17
at 1.0 ppm; and grass, hay, crop group 17 at 1.2 ppm.
    In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367-
3), EPA issued a second notice pursuant to section 408(d)(3) of FFDCA,
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7190) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be
amended by establishing new tolerances for residues of the herbicide,
pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid
metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the
parent, in or on food commodities grass, forage, group 17 at 1.0 ppm;
grass, hay, group 17 at 1.4 ppm; milk at 0.02 ppm; cattle, meat
byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat
byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm, and by
revising existing tolerances for residues of the herbicide, pyraflufen-
ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid metabolite, E-1, 2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid, expressed in terms of the parent, in or on
food commodities soybean, seed to 0.05 ppm; soybean, hay to 0.10 ppm;
wheat, forage to 0.02 ppm; and wheat, hay to 0.01 ppm.These notices
referenced a summary of the petition prepared by Nichino America, Inc.,
the registrant, which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notices of filing. Tolerances for milk at 0.02 ppm; cattle, meat
byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat
byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm expire
on October 15, 2012. A time limitation been imposed because of the
requirement for a cattle feeding study conducted to determine residues
of the E-9 metabolite in milk and cattle tissues.

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 the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure for the petitioned-for tolerances for residues of pyraflufen-
ethyl and its metabolite expressed in terms of the parent on grass,
forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm; milk at
0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat byproducts at
0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, meat
byproducts at 0.02 ppm, and by revising existing tolerances for
soybean, forage to 0.05 ppm; soybean, hay to 0.10 ppm; wheat, forage to
0.02 ppm; and wheat, hay to 0.01 ppm. EPA's assessment of exposures and
risks associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by

pyraflufen-ethyl as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies.
    Pyraflufen-ethyl has low to moderate toxicity from acute exposure
and it is not a dermal sensitizer. The liver, kidney, and possibly the
hematopoietic system are the target organs for pyraflufen-ethyl in the
rat and/or the mouse. There is no evidence of increased sensitivity to
the young in developmental and reproductive studies with pyraflufen-
ethyl. Pyraflufen-ethyl was not shown to be mutagenic in a battery of
tests. Pyraflufen-ethyl was classified as ``Likely to be carcinogenic
to humans'' based on male mouse hepatocellular adenomas, carcinomas
and/or hepatoblastomas (combined) observed in the mouse carcinogenicity
study.
    Specific information on the studies received and the nature of the
toxic effects caused by pyraflufen-ethyl 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 Pyraflufen-ethyl: Human Health Risk
Assessment for Pyraflufen-ethyl: Proposed New Use on Pasture and
Rangeland Grasses (PP 7F7190) and Amendment to Allow Early Season
Postemergence Broadcast Uses to Corn (excluding sweet corn), Soybeans
and Wheat at page 13 in docket ID number EPA-HQ-OPP-2007-0366.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs/
safety factors) are used in conjunction with the POD to take into
account uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. Safety is
assessed for acute and chronic dietary risks by comparing aggregate
food and water exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and chronic-term risks are evaluated
by comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
    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
greater than that 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 pyraflufen-ethyl used
for human risk assessment can be found at http://www.regulations.gov in
document Pyraflufen-ethyl: Human Health Risk Assessment for Pyraflufen-
ethyl: Proposed New Use on Pasture and Rangeland Grasses
(PP7F7190) and Amendment to Allow Early Season Postemergence
Broadcast Uses to Corn (excluding sweet corn), Soybeans and Wheat at
page 13 in docket ID number EPA-HQ-OPP-2007-0366. Also, a summary of
the toxicological endpoints for pyraflufen-ethyl used for human risk
assessment is discussed in Unit III.B. of the final rule published in
the Federal Register of April 30, 2003 (68 FR 23046) (FRL-7300-9).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraflufen-ethyl, EPA considered exposure from the
petitioned-for tolerances as well as all existing pyraflufen-ethyl
tolerances in 40 CFR 180.585. EPA assessed dietary exposures from
pyraflufen-ethyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
pyraflufen-ethyl; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys of Food Intake by Individuals (CSFII). As
to residue levels in food, the following assumptions were made for the
chronic exposure assessments: 100 percent crop treated (PCT) and
tolerance-level residues for pyraflufen-ethyl on all treated crops
except corn, cottonseed, potato, soybean and wheat for which one half
of the combined Levels of Quantification (LOQs) for the parent and the
metabolite were used since all field trial data were less than the LOQ.
    iii. Cancer. For the cancer dietary exposure assessment EPA used
the food consumption data from the USDA 1994-1996 and 1998 Continuing
Surveys of Food Intake by Individuals (CSFII). As to residue levels in
food, the following assumptions were made for the chronic exposure
assessments: 100 percent crop treated (PCT) and tolerance-level
residues for pyraflufen-ethyl on all treated crops except corn,
cottonseed, potato, soybean and wheat for which one-half of the
combined LOQs for the parent and the metabolite were used since all
field trial data were less than the LOQ.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyraflufen-ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of pyraflufen-ethyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of pyraflufen-ethyl for
acute exposures are estimated to be 1,247 parts per trillion (ppt) for
surface water and 1.8 ppt for ground water. Chronic exposures for
cancer assessments are estimated to be 281 ppt for surface water and
1.8 ppt for ground water
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 281 ppt 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).

     Pyraflufen-ethyl is currently registered on the following
residential non-dietary sites that could result in residential
exposures: airports, nurseries, ornamental turf, golf courses,
roadsides, railroads, non-crop land, and uncultivated agricultural
areas. The risk assessment was conducted using the following
residential exposure assumptions: adults and children may be exposed to
residues of pyraflufen-ethyl through short-term post-application
contact with treated areas which may include residential/recreational
areas.
    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 pyraflufen-ethyl to share a common mechanism of
toxicity with any other substances, and pyraflufen-ethyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
pyraflufen-ethyl 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. There is no evidence of
increased susceptibility of rat or rabbit fetuses following in utero
exposure in the developmental studies with pyraflufen-ethyl. There is
no evidence of increased susceptibility of young rats in the
reproduction study with pyraflufen-ethyl. EPA concluded there are no
residual uncertainties for pre- and/or postnatal exposure.
    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 pyraflufen-ethyl is complete.
    ii. There is no indication that pyraflufen-ethyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that pyraflufen-ethyl results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% of the crop treated and a conservative estimate of residues in
food. EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to pyraflufen-ethyl in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by pyraflufen-ethyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
pyraflufen-ethyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyraflufen-ethyl from food and water will utilize less than 1% of the
cPAD for all population groups. Based on the explanation in Unit
III.C.3., regarding residential use patterns, chronic residential
exposure to residues of pyraflufen-ethyl is not expected.
    3. Short-term risk. Pyraflufen-ethyl is currently registered for
use(s) that could result in short-term residential exposure and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to pyraflufen-ethyl.
    Short-term aggregate exposure takes into account short-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). A short-term risk
aggregate assessment was not performed for adults because no handler
exposure is expected and post-application inhalation exposure is
expected to be negligible (and there are no dermal endpoints of
concern). A short-term aggregate risk assessment was performed for
infants and children because there is a potential for oral post-
application exposure resulting from contact with treated areas which
may include residential/recreational areas. Short-term aggregate
exposure takes into account residential exposure plus chronic exposure
to food and water. Short term aggregate risk is based on children's
incidental oral exposure (from residential post-application treatment)
and dietary exposure (food and drinking water). The anticipated
exposure level for children, 1-2 years (the highest exposed population)
is below EPA's level of concern, with a Margin of Exposure (MOE)
greater than 60,000.
    4. Intermediate-term risk.
     Intermediate-term aggregate exposure takes into account
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Pyraflufen-ethyl is not registered for any use patterns that would
result in intermediate-term residential exposure. No residential
handler exposure is expected and post-application inhalation exposure
is expected to be negligible. Post-application exposure to infants and
children over the intermediate term duration (1 to 6) months is not
likely based on the use pattern. Therefore, the intermediate-

term aggregate risk is the sum of the risk from exposure to pyraflufen-
ethyl through food and water, which has already been addressed, and
will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. The aggregate cancer
risk assessment for the general population takes into account exposure
estimates form dietary consumption of pyraflufen-ethyl from food,
residential, and drink water sources. Exposures from residential uses
are based on the lifetime average daily dose and assume an exposure
period of 5 days per year and 50 years of exposure in a lifetime (70
years). Average food plus water source dietary exposure was used.
Estimated cancer risk for the U.S. population includes infants and
children. The aggregate cancer risk estimate for pyraflufen-ethyl is
2.9 x 10-6. This risk estimate is based, in part, on the
conservative assumption that 100% of all crops for which pyraflufen-
ethyl is registered or proposed for registration are treated.
Additional refinement using Percent Crop Treated estimates would result
in a lower estimate of cancer risk.
    EPA generally considers cancer risks in the range of 1 in 1 million
(1 x 10-6) or less to be negligible. The precision which can
be assumed for cancer risk estimates is best described by rounding to
the nearest integral order of magnitude on the log scale; for example,
risks falling between 3.16 x 10-7 and 3.16 x 10-6
are expressed as risks in the range of 1 x 10-6. Considering
the precision with which cancer hazard can be estimated, the
conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark LOC of the range of 1 x 10-6 until
the calculated risk exceeds approximately 3 x 10-6. Since
the calculated cancer risk for pyraflufen-ethyl does not exceed this
level, estimated cancer risk is considered to be negligible.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to pyraflufen-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography and Mass
Spectrometry (GC/MS)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no established Codex, Canadian or Mexican
maximum residue limits, for residues of pyraflufen-ethyl in/on grass,
milk, meat byproducts, soybean and wheat.

V. Conclusion

    Therefore, permanent tolerances are established for residues of
pyraflufen-ethyl and its metabolite expressed in terms of the parent on
grass, forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm.
Time-limited tolerances are established for milk at 0.02 ppm; cattle,
meat byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse,
meat byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm.
Existing tolerances are revised for soybean, forage to 0.05 ppm;
soybean, hay to 0.10 ppm; wheat, forage to 0.02 ppm; and wheat, hay to
0.01 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, 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: August 25, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.585 is amended by revising paragraph (a) to read as
follows:

Sec.  180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-
difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate, and
its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms
of the parent in or on the following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Cattle, meat byproducts.......................         0.02     10/15/12
Corn, field, forage...........................         0.01         None
Corn, field, grain............................         0.01         None
Corn, field, stover...........................         0.01         None
Cotton, gin byproducts........................          1.5         None
Cotton, undelinted seed.......................         0.04         None
Goat, meat byproducts.........................         0.02     10/15/12
Grass, forage, group 17.......................          1.0         None
Grass, hay, group 17..........................          1.4         None
Horse, meat byproducts........................         0.02     10/15/12
Milk..........................................         0.02     10/15/12
Potato........................................         0.02         None
Sheep, meat byproducts........................         0.02     10/15/12
Soybean, forage...............................         0.05         None
Soybean, hay..................................         0.10         None
Soybean, seed.................................         0.01         None
Wheat, forage.................................         0.02         None
Wheat, grain..................................         0.01         None
Wheat, hay....................................         0.01         None
Wheat, straw..................................         0.01         None
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-20515 Filed 9-4-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: September 25, 2006 (Volume 71, Number 185)]
[Notices]
[Page 55811-55812]
[DOCID:fr25se06-52]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 15c3-4; SEC File No. 270-441; OMB Control No. 3235-0497.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Rule 15c3-4 (17 CFR 240.15c3-4) (the ``Rule'') under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (the ``Exchange Act'')
requires certain broker-dealers that are registered with the Commission
as OTC Derivatives Dealers to establish, document, and maintain a
system of internal risk management controls. The Rule sets forth the
basic elements for an OTC Derivatives Dealer to consider and include
when establishing, documenting, and reviewing its internal risk
management control system, which are designed to, among other things,
ensure the integrity of an OTC Derivatives Dealer's risk measurement,
monitoring, and management process, to clarify accountability at the
appropriate organizational level, and to define the permitted scope of
the dealer's activities and level of risk. The Rule also requires that
management of an OTC Derivatives Dealer must periodically review, in
accordance with written procedures, the OTC Derivatives Dealer's
business activities for consistency with its risk management
guidelines.
    The staff estimates that that the average amount of time an OTC
Derivatives Dealer will spend implementing its risk management control
system is 2,000 hours and that, on average, an OTC Derivatives Dealer
will spend approximately 200 hours each year reviewing and updating its
risk management control system. Currently, five firms are registered
with the Commission as an OTC Derivatives Dealer. The staff estimates
that approximately one additional OTC Derivatives Dealer may become
registered within the next three years. Accordingly, the staff
estimates the total hour burden for six OTC Derivatives Dealers to be
1,200 hours annually.
    The staff believes that the cost of complying with Rule 15c3-4 will
be approximately $205 per hour.\1\ This per hour cost is based upon an
annual average hourly salary for a compliance manager who would be
responsible for ensuring compliance with the requirements of Rule 15c3-
4. The total annual cost for all affected OTC Derivatives Dealers is
estimated to be $246,000, based on 1,200 hours at $205 per hour.
---------------------------------------------------------------------------

    \1\ Based on the average annual salary for a Compliance Manager
based inside New York City of about $69,000, as reflected in SIA
Management and Professional Earnings for 2005, modified to account
for an 1,800-hour work-year and multiplied by 5.35 to account for
bonuses, firm size, employee benefits and overhead.
---------------------------------------------------------------------------

    The records required to be made by OTC Derivatives Dealers pursuant
to the Rule and the results of the periodic reviews conducted under
paragraph (d) of Rule 15c3-4 must be preserved under Rule 17a-4 of the
Exchange Act (17 CFR 240.17a-4) for a period of not less than three
years, the first two years in an accessible place. The Commission will
not generally publish or make available to any person notice or reports
received pursuant to the Rule. The statutory basis for the Commission's
refusal to disclose such information to the public is the exemption
contained in Section (b)(4) of the Freedom of Information Act, 5 U.S.C.
552, which essentially provides that the requirement of public
dissemination does not apply to commercial or financial information
which is privileged or confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to (i) the Desk Officer for the SEC,
Desk Officer for the Securities and Exchange Commission, Office of
Information and Regulatory Affairs, Office of Management and Budget,
Room 10102, New Executive Office Building, Washington, DC 20503 or by
sending an e-mail to<EMAIL_ADDRESS>

and (ii) R. Corey Booth, Director/Chief Information Officer, Securities
and Exchange Commission, c/o Shirley Martinson, 6432 General Green Way,
Alexandria, Virginia 22312 or send an e-mail to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: September 18, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. 06-8136 Filed 9-22-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Notices]
[Page 27554-27555]
[DOCID:fr16my07-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4784-074]

DaimlerChrysler Financial Services Americas LLC, Teton Power
Funding, LLC and Topsham Hydro Partners Limited Partnership Topsham
Hydroelectric Generating Facility Trust No. 1; Notice of Application
for Transfer of License and Soliciting Comments, Motions To Intervene,
and Protests

May 9, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Partial Transfer of License.
    b. Project No.: 4784-074.
    c. Date Filed: April 26, 2007.
    d. Applicants: DaimlerChrysler Financial Services Americas LLC,
Teton Power Funding, LLC, and Topsham Hydro Partners Limited
Partnership (Transferor) and Topsham Hydroelectric Generating Facility
Trust No. 1 (Transferee).

    e. Name and Location of Project: The Pejepscot Project is located
on the Androscoggin River, in Sagadahoc, Cumberland, and Androscoggin
Counties, Maine.
    f. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    g. Applicant Contacts: For Transferor: DaimlerChrysler Financial
Services Americas LLC, 27777 Inkster Road, Farmington Hills, MI 48334-
5326, Attn: Marco DeSanto, Esq.,<PHONE_NUMBER>. For Transferee:
Topsham Hydroelectric Generating Facility Trust No. 1, c/o U.S. Bank,
National Association, 300 Delaware Avenue, 9th Floor, Wilmington, DE
19801, Attn: Nicole Poole,<PHONE_NUMBER>.
    h. FERC Contact: Etta L. Foster<PHONE_NUMBER>.
    i. Deadline for filing comments, protests, and motions to
intervene: May 23, 2007.
    All documents (original and eight copies) should be filed with
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper, see 18 CFR 385.2001 (a) (1) (iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-4784-074) on any comments, protests, or motions filed. The
Commission's Rules of Practice and Procedure require all intervenors
filing a document with the Commission to serve a copy of that document
on each person in the official service list for the project. Further,
if an intervenor files comments or documents with the Commission
relating to the merits of an issue that may affect the responsibilities
of a particular resource agency, they must also serve a copy of the
documents on that resource agency.
    j. Description of Application: Applicants request approval, under
section 8 of the Federal Power Act, of a transfer of license for the
Pejepscot Project No. 4784 from DaimlerChrysler Financial Services
Americas LLC to Topsham Hydroelectric Generating Facility Trust No. 1.
    k. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``e-Library'' link. Enter the project

number excluding the last three digits (P-4784) in the docket number
field to access the document. For online assistance, contact
<EMAIL_ADDRESS>or call toll-free<PHONE_NUMBER>, for TTY,

call<PHONE_NUMBER>. A copy is also available for inspection and
reproduction at the addresses in item g.
    l. Individual desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    m. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    n. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', OR
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    o. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be assumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-9356 Filed 5-15-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59207-59208]
[FR Doc No: 2015-24881]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75983; File No. SR-ICEEU-2015-013]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Approving Proposed Rule Change Relating to CDS End-of-Day Price
Discovery Policy

September 25, 2015.

I. Introduction

    On July 24, 2015, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
amend its end-of-day price discovery policies and procedures for credit
default swap (``CDS'') contracts to incorporate certain enhancements
(SR-ICEEU-2015-013). The proposed rule change was published for comment
in the Federal Register on August 12, 2015.\3\ The Commission did not
receive comments on the proposed rule change. The Commission is
approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-75624 (Aug. 6, 2015),
80 FR 48369 (Aug. 12, 2015) (SR-ICEEU-2015-013).
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    ICE Clear Europe has proposed to amend its CDS End-of-Day Price
Discovery Policy (the ``EOD Price Discovery Policy'') to make certain
enhancements to the end-of-day submission and firm trade process for
CDS contracts. ICE Clear Europe also proposed to adopt a new Price
Submission Disciplinary Framework (the ``Disciplinary Framework'') that
addresses missed price submissions by Clearing Members for CDS
contracts. ICE Clear Europe did not otherwise propose to change its
Clearing Rules or Procedures in connection with these amendments.
    As described by ICE Clear Europe, under the EOD Price Discovery
Policy, ICE Clear Europe currently utilizes a ``cross and lock''
algorithm as part of its CDS price discovery process. Under this
algorithm, standardized bids and offers derived from Clearing Member
submissions are matched by sorting them from highest to lowest and
lowest to highest levels, respectively. This sorting process pairs the
Clearing Member submitting the highest bid price with the Clearing
Member submitting the lowest offer price, the Clearing Member
submitting the second highest bid price with the Clearing Member
submitting the second-lowest offer price, and so on. The algorithm then
identifies crossed and/or locked markets. Crossed markets are the
Clearing Member pairs generated by the sorting and ranking process for
which the bid price of one Clearing Member is above the offer price of
the matched Clearing Member. The algorithm identifies locked markets,
where the bid and the offer are equal, in a similar fashion.
    According to ICE Clear Europe, whenever there are crossed and/or
locked matched markets, the algorithm applies a set of rules designed
to identify standardized submissions that are ``obvious errors.'' The
algorithm sets a high bid threshold equal to the preliminary end-of-day
(``EOD'') level plus one bid-offer width (``BOW''), and a low offer
threshold equal to the preliminary EOD level minus one BOW. The
algorithm considers a Clearing Member's standardized submission to be
an ``obvious error'' if the bid is higher than the high bid threshold,
or the offer is lower than the low offer threshold.
    Clearing Member pairs identified by the algorithm as crossed or
locked markets may be required from time to time, under the EOD Price
Discovery Policy, to enter into cleared CDS trades with each other
(``Firm Trades''). Currently, ICE Clear Europe excludes standardized
submissions it identifies as obvious errors from potential Firm Trades
and does not use these submissions in its determination of published
EOD levels.
    ICE Clear Europe has proposed to impose certain consequences under
the Firm Trade methodology for Clearing Members providing price
discovery submissions deemed to be obvious errors. ICE Clear Europe has
represented that, as revised, the process for determining potential
Firm Trades will now include all standardized submissions, including
those classified as obvious errors (and as a result submissions that
are obvious errors may result in Firm Trades). However, obvious errors
will not be used in the calculation of the final EOD level, as under
the current framework. Thus, ICE Clear Europe has represented that it
will effectively execute its current EOD algorithm twice: initially in
the same way it does today (eliminating obvious errors) to generate the
final EOD levels, and again, without excluding obvious errors, to
generate Firm Trades and related reversing transactions.\4\
---------------------------------------------------------------------------

    \4\ A reversing transaction is a second cleared transaction with
identical attributes to the initial Firm Trade, but with the buyer
and seller counterparties reversed, and at that day's EOD price
rather than the initial Firm Trade price.
---------------------------------------------------------------------------

    To limit the potential exposure created through Firm Trades that
include a bid or offer from an obvious error submission, ICE Clear
Europe has represented that it will adjust Firm Trade prices, where
appropriate, to fall within a predefined band on either side of the EOD
price such that the potential profit or loss (``P/L'') realized by
unwinding the trade at the EOD level is capped.
    To prevent Clearing Members from receiving Firm Trades with large
P/L impact in certain index instruments that are less actively traded,
and for which it is therefore more difficult and/or more expensive to
manage the associated risk, ICE Clear Europe has represented that it
will automatically generate reversing transactions at the end-of-day
price level for specific index CDS instruments (i.e., for specific
combinations of index/sub-index and series determined by the ICE Clear
Europe risk department in consultation with the trading advisory
committee). Currently, reversing transactions are only available for
eligible single name CDS instruments.
    ICE Clear Europe has also proposed revising the EOD Price Discovery
Policy to remove the option for Clearing Members to provide end-of-day
price submissions for single name CDS instruments in terms of spread
and associated recovery rate. Under the revised approach, Clearing
Members will be required to provide price submissions (or equivalent
``points upfront'' submissions) for all single name CDS instruments.
Clearing

Members may provide a recovery rate, which ICE Clear Europe will use
for purposes of its own analysis. Accordingly, ICE Clear Europe will no
longer need to convert spread submissions for single name instruments
into a price level for purposes of the EOD price determination process.
Various conforming changes will be made throughout the policy as a
result.
    ICE Clear Europe has also proposed to implement a new Disciplinary
Framework, which addresses failures by a Clearing Member to provide
required EOD price submissions for CDS Contracts in which they hold
cleared open interest with ICE Clear Europe (``Missed Submissions'').
For purposes of the Disciplinary Framework, obvious errors (as
described above) with respect to CDX index CDS contracts will also be
treated as Missed Submissions (since such instruments are not subject
to Firm Trade requirements). ICE Clear Europe has represented that it
will impose a cash assessment on Clearing Members for each Missed
Submission, generally ranging from $1,000 to $4,000, depending on
whether the Missed Submission related to an index or single-name,
whether it occurred on an announced firm trade date and whether the
related contract is actively traded. For single name CDS contracts, the
framework will also specify an aggregate daily maximum assessment per
Clearing Member for multiple Missed Submissions and a daily maximum
assessment per Clearing Member per risk sub-factor.
    As part of a new summary assessment process, ICE Clear Europe has
represented that it will determine on a monthly basis whether a
Clearing Member has any Missed Submissions and provide the Clearing
Member a notice of assessment with details of such Missed Submissions.
The notice of assessment will include information about the date, type,
quantity and assessment amount for the relevant Missed Submission(s).
The Disciplinary Framework will also provide a procedure for a Clearing
Member to dispute a notice of assessment. ICE Clear Europe has
represented that a Clearing Member will have fifteen days from the
notice of assessment to dispute the notice or seek to have it waived or
rescinded. ICE Clear Europe has represented that it may grant a waiver
of an assessment for certain specified reasons. A conditional waiver
may be granted for the first instance of a Missed Submission for a
particular instrument, provided that the Clearing Member does not have
another Missed Submission in that instrument within 90 days. ICE Clear
Europe has represented that it may grant an unconditional waiver where
Missed Submissions result from extraordinary circumstances outside of
the Clearing Member's control, such as market-wide disruptions. ICE
Clear Europe has represented the imposition of a cash assessment on a
Clearing Member does not preclude ICE Clear Europe from taking any
other disciplinary action against a Clearing Member under the Rules and
Procedures, including for persistent failures to meet the requirements
of the EOD Price Discovery Policy.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \5\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if the
Commission finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such self-regulatory organization. Section 17A(b)(3)(F)
of the Act \6\ requires, among other things, that the rules of a
clearing agency are designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts, and transactions and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2)(C).
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission finds that ICE Clear Europe's proposed revisions to
its EOD Price Discovery Policy and its proposed new Disciplinary
Framework are consistent with the requirements of Section 17A of the
Act \7\ and rules thereunder applicable to ICE Clear Europe. The
proposed revisions are intended to enhance ICE Clear Europe's price
discovery process by including all price submissions (including those
classified as obvious errors) in the process of determining Firm
Trades, thereby strengthening the incentives for Clearing Members to
provide accurate end-of-day price submissions. In addition, the
proposed rule change would adjust the trading prices of Firm Trades
that include a bid or offer classified as an obvious error to fall
within a predefined range on either side of the EOD price, thereby
limiting Clearing Members' potential P/L exposure to obvious errors
from the risk management perspective, while holding them accountable
for their price submissions. The proposed rule change would also assist
Clearing Members in unwinding Firm Trades in certain less actively
traded index products by automatically generating reversing trades at
the EOD level. Finally, the proposed rule change further incentivizes
accurate price submissions by imposing financial consequences on
Clearing Members for Missed Submissions, through cash assessments under
the new Disciplinary Framework. The Disciplinary Framework is intended
to further enhance compliance with the EOD Price Discovery Policy and
provides Clearing Members with notice and a mechanism to dispute any
Missed Submissions or seek a waiver of any assessments.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    The Commission therefore believes that the proposal is designed to
promote the prompt and accurate clearance and settlement of securities
transactions and derivative agreements, contracts and transactions
cleared by ICE Clear Europe and, in general, to protect investors and
the public interest, consistent with Section 17A(b)(3)(F) of the
Act.\8\ The Commission further believes that the proposed Disciplinary
Framework is designed to subject participants to appropriate discipline
for violation of ICE Clear Europe's end-of-day price submission
requirements, consistent with section 17A(b)(3)(G) of the Act.\9\
Finally, the Commission believes that the proposed Disciplinary
Framework provides a fair procedure with respect to the disciplining of
participants, consistent with section 17A(b)(3)(H) of the Act.\10\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78q-1(b)(3)(F).
    \9\ 15 U.S.C. 78q-1(b)(3)(G).
    \10\ 15 U.S.C. 78q-1(b)(3)(H).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act \11\ and
the rules and regulations thereunder.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-ICEEU-2015-013), is
approved.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).
    \13\ In approving the proposed rule change, the Commission
considered the proposed rule change's impact on efficiency,
competition and capital formation. 15 U.S.C. 78c(f).

For the Commission, by the Division of Trading and Markets, pursuant
to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-24881 Filed 9-30-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 47034-47035]
[FR Doc No: 2019-19288]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Aviation Rulemaking Advisory Committee (ARAC)
meeting.

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

SUMMARY: This notice announces a meeting of the ARAC.

DATES: The meeting will be held on Thursday, September 19, 2019, from
1:00 p.m. to 3:00 p.m. Eastern Standard Time.
    Requests for accommodations to a disability must be received by
Friday, September 6, 2019.
    Requests to speak during the meeting must submit a written copy of
their remarks to the Designated Federal Officer (DFO) by Friday,
September 6, 2019.
    Requests to submit written materials to be reviewed during the
meeting must be received no later than Friday, September 6, 2019.

ADDRESSES: The meeting will be held at the Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591.
Copies of the meeting minutes will be available on the FAA Committee
website at https://www.faa.gov/regulations_policies/rulemaking/committees/documents/. Any committee related request should be sent to
the person listed in the following section.

FOR FURTHER INFORMATION CONTACT: Lakisha Pearson, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Also, visit the FAA Committee website at https://www.faa.gov/regulations_policies/rulemaking/committees/documents/.

SUPPLEMENTARY INFORMATION:

I. Background

    The ARAC was created under the Federal Advisory Committee Act
(FACA), in accordance with Title 5 of the United States Code (5 U.S.C.
App. 2) to provide advice and recommendations to the FAA concerning
rulemaking activities, such as aircraft operations, airman and air
agency certification, airworthiness standards and certification,
airports, maintenance, noise, and training.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 Status Report from the FAA
 Status Updates:
    [cir] Active Working Groups
    [cir] Transport Airplane and Engine (TAE) Subcommittee
 Recommendation Reports
 Any Other Business

    A final agenda will be posted on the FAA Committee website at
https://www.faa.gov/regulations_policies/rulemaking/committees/documents/ at least one week in advance of the meeting.

III. Public Participation

    The meeting will be open to the public on a first-come, first
served basis, as space is limited. Please confirm your attendance with
the person listed in the FOR FURTHER INFORMATION CONTACT section no
later than September 6, 2019. Please provide the following information:
Full legal name, country of citizenship, and name of your industry
association, or applicable affiliation. If you are attending as a
public citizen, please indicate so.
    For persons participating by telephone, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section by email or phone
for the teleconference call-in number and passcode. Callers are
responsible for paying long-distance charges.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    There will be 15 minutes allotted for oral comments from members of
the public joining the meeting. To accommodate as many speakers as
possible, the time for each commenter may be limited. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration, as well as the name, address, and
organizational affiliation of the proposed speaker. If the number of
registrants requesting to make statements is greater than can be
reasonably accommodated during the meeting, the FAA Office of
Rulemaking may conduct a lottery to determine the speakers. Speakers
are requested to submit a written copy of their prepared remarks for
inclusion in the meeting records and for circulation to ARAC members.
All prepared remarks submitted on time will be accepted and considered
as part of the record. Any member of the public may present a written
statement to the committee at any time.
    The public may present written statements to the Aviation
Rulemaking Advisory Committee by providing 25 copies to the Designated
Federal Officer, or by bringing the copies to the meeting.

    Issued in Washington, DC, on September 3, 2019.
Brandon Roberts,
Acting Executive Director, Office of Rulemaking.
[FR Doc. 2019-19288 Filed 9-4-19; 8:45 am]
 BILLING CODE 4910-13-P


June 9, 2021

Mr. Daryl Z. Miller, Station General Manager
<EMAIL_ADDRESS>Homer City Generation , L.P.
1750 Power Plant Road
Homer City, PA 15748

Re:	Title V Operating Permit 32-00055 Modification Application
      Homer City Generation, L.P.
      Homer City Generating Station
      Units 1, 2, & 3 RACT II Compliance
	Black Lick and Center Townships, Indiana County
	APS # 941736, Auth #1350294, PF # 262713

Dear Mr. Miller,

The Department of Environmental Protection (DEP) has reviewed the above referenced operating permit significant modification application (Homer City Generating Station TV-32-00055) and has identified the following technical deficiencies.  This information is required pursuant to 25 Pa. Code §127.541.

 The following data should be supplied for all hours during the years 2017 to 2020 in an electronic format, preferably in an excel spreadsheet. This data should be given in hourly increments in a form that it can easily be added to the publicly available CAMD data (sample attached).

          The hourly exhaust temperature at the inlet to the SCR for each unit

          The hourly ammonia injection rate

 Please provide SCR operations and maintenance manual. If you wish to keep certain information confidential, please see the Confidential Business Information (CBI) Procedure, below.

      Confidential Business Information (CBI) Procedure

      Any CBI claims must be addressed at the time of submittal.  Please be aware that DEP has a specific procedure for deciding confidentiality requests from source owners made under Section 13.2 of the Air Pollution Control Act (APCA), 35 P.S. Section 4013.2.  This procedure requires that source owners submit their request in writing to DEP.  The request must specifically designate which items of information the source owner wishes DEP to treat confidentially, along with a reason why those items should be treated in this manner.  The word "confidential" on a page or plan sheet submitted to DEP has no validity by itself.  Each item must be identified, and justification presented per Section 13.2 of the APCA for why it warrants confidential treatment.

             Pursuant to Section 13.2 of the APCA, information can generally qualify for confidential treatment if it is not emission data and if disclosure of the information would divulge production or sales figures or methods, or would divulge a unique process or production, or would otherwise adversely affect competitive position by revealing trade secrets.

             In order to request confidential treatment for information in any document, you must submit a redacted version of the relevant document with the confidential information blacked out (and thus suitable for public disclosure), along with a letter of request containing a table identifying the page and line number of each redaction, along with a justification for each redacted item as to why it should be deemed confidential under the specific criteria allowed under Section 13.2 of the APCA.  Please see the Example Confidential Information Log to use as a guide when submitting your confidentiality justifications.

             DEP's final decision on any CBI request will be sent to you in writing, along with a notice of appeal rights in the event the request is denied.  Please be aware that if you do not provide adequate justification for each redacted item such that it meets one of the specific criteria for confidential treatment under Section 13.2 of the APCA, your request may be denied.

Example Confidential Information Log

Page # in Document
Description
Basis for Confidential Treatment as Identified in the Pennsylvania Air Pollution Control Act,
35 P.S. § 4013.2

You must submit a response fully addressing the significant technical deficiencies set forth above within 15 business days of receipt of this letter or the Department may deny the application.

If you believe that any of the stated deficiencies is not significant, instead of submitting a response to that deficiency, you have the option of asking the Department to make a decision based on the information with regard to the subject matter of that deficiency that you have already made available.  If you choose this option with regard to any deficiency, you should explain and justify how your current submission satisfies that deficiency.  Please keep in mind that if you fail to respond, your application may be denied.

Should you have any questions regarding the identified deficiencies, please contact me at<EMAIL_ADDRESS>or David Balog at<PHONE_NUMBER> or<EMAIL_ADDRESS>and refer to TV-32-00055 to discuss your concerns or to schedule a meeting.  The meeting must be scheduled within the 15-day period allotted for your reply, unless otherwise extended by the Department.  You may also follow your application through the review process via eFACTS on the Web at:  http//www.ahs2.dep.state.pa.us/eFactsWeb/default.aspx.

Sincerely,

/s/ Sheri L. Guerrieri

Sheri L. Guerrieri, P.E.
Air Quality Engineer
Air Quality Program

cc:  	AQ/Facilities/Permits/32-00055
	Harrisburg


"King, Heidi R."<EMAIL_ADDRESS> 03/06/2008 10:31 AM

To

Margaret Morrison/RTP/USEPA/US@EPA, Dave Mckee/RTP/USEPA/US@EPA, Harvey Richmond/RTP/USEPA/US@EPA, John Hannon/DC/USEPA/US@EPA, John Langstaff/RTP/USEPA/US@EPA, Karen Martin/RTP/USEPA/US@EPA, Lea Anderson/DC/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA, Susan Stone/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

cc

Subject

RE: 3/6/08 - FYI - #1 - Ozone NAAQS Comments from Heidi King, OMB

Thanks Margaret,

I've requested that this be addressed.

heidi

-----Original Message-----

From<EMAIL_ADDRESS> <EMAIL_ADDRESS> Sent: Thursday, March 06, 2008 10:27 AM

To<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Cc: King, Heidi R.

Subject: 3/6/08 - FYI - #1 - Ozone NAAQS Comments from Heidi King, OMB

(See attached file: OMB Comments  # 1   3-6-08.pdf)

Heidi, can you reset the fax machine to reflect the correct date/time?

Thanks.

Margaret Morrison (MC C504-02)

US EPA/OAQPS/HEID/IO

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>


Lydia Wegman/ RTP/ USEPA/ US 06/ 14/ 2005 07: 10 PM To afraas@ omb. eop. gov, aflynn@ omb. eop. gov, Todd Hawes/ RTP/ USEPA/ US@ EPA cc Joe Paisie/ RTP/ USEPA/ US@ EPA, Kathy Kaufman/ RTP/ USEPA/ US@ EPA, wehrum. bill@ epa. gov Subject Re: TSD for 23 CALPUFF runs Art and Amy

I wanted to let you know that we have not fully reviewed this yet. Todd plans to do so this evening and it is possible that we may make some small changes after he is done. But the basic document should not change.

Lydia Todd Hawes/ RTP/ USEPA/ US 06/ 14/ 2005 07: 05 PM To afraas@ omb. eop. gov cc Lydia Wegman/ RTP/ USEPA/ US@ EPA, Joe Paisie/ RTP/ USEPA/ US, Kathy Kaufman/ RTP/ USEPA/ US@ EPA Subject TSD for 23 CALPUFF runs Art  This document, which is has two appendices, will be merged into one document for the final submittal. Nothing will change, however.

[


[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Notices]
[Page 16921-16922]
[DOCID:fr31mr08-122]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2005-20331]
RIN 2105-AD48

Request for Public Comments and Office of Management and Budget
(OMB) Approval of an Existing Information Collection (2105-0552)

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
described below has been forwarded to OMB for extension of the
currently approved collection. The ICR describes the nature of the
information collection and its expected burden. The Federal Register
notice with a 60-day comment period soliciting comments on the
following collection of information was published on October 10, 2007
(72 FR 57631). The purpose of this notice is to allow the public an
additional 30 days from the date of this notice to submit comments on
our application to renew ICR 2105-0552, Reports by Carriers on
Incidents Involving Animals During Air Transport. The current
information collection request approved by OMB expires on March 31,
2008.

DATES: Comments on this notice must be received by April 30, 2008.

ADDRESSES: You may file comments identified by the docket number DOT-
OST-2005-20331 by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave., SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Ave., SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: You must include the agency name and docket number
DOT-OST-2005-20331 or the Regulatory Identification Number (RIN) for
the rulemaking at the beginning of your comment. All comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received in any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc). You may review DOT's
complete Privacy Act statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78), or you may visit http://
DocketsInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to the street
address listed above. Follow the online instructions for accessing the
docket.

FOR FURTHER INFORMATION CONTACT: Blane A. Workie, Office of the
Assistant General Counsel for Aviation Enforcement and Proceedings,
U.S. Department of Transportation, 1200 New Jersey Ave., SE.,
Washington, DC 20590,<PHONE_NUMBER>,<PHONE_NUMBER> (fax),
<EMAIL_ADDRESS>(e-mail).

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law No. 104-13, Sec. 2, 109 Stat. 163 (1995) (codified as
revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5
CFR part 1320, require Federal agencies to issue two notices seeking
public comment on information collection activities before OMB may
approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5,
1320.8(d)(1), 1320.12. On October 10, 2007, OST published a 60-day
notice in the Federal Register soliciting comment on ICRs for which the
agency was seeking OMB approval. 72 FR 57631. OST received no comments
after issuing this notice. Accordingly, DOT announces that these
information collection activities have been re-evaluated and certified
under 5 CFR 1320.5(a) and forwarded to OMB for review and approval
pursuant to 5 CFR 1320.12(c).
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30-day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44978, 44983, Aug. 29, 1995. Therefore, respondents
should submit their respective

comments to OMB within 30 days of publication of this notice to best
ensure their having full effect. 5 CFR 1320.12(c); see also 60 FR
44978, 44983, Aug. 29, 1995.
    The summary below describes the nature of the information
collection requirement (ICR) and the expected burden.
    Title: Reports by Carriers on Incidents Involving Animals During
Air Transport.
    OMB Control Number: 2105-0552.
    Type of Request: Extension without change of a previously approved
collection.
    Abstract: The requested extension of the approved control number
covers the information collection request (ICR) OMB No. 2105-0552,
``Reports by Carriers on Incidents Involving Animals During Air
Transport,'' which the Department of Transportation codified at 14 CFR
234.13. Section 234.13, which implements Section 710 of the Wendell H.
Ford Aviation Investment and Reform Act for the 21st Century (AIR-21)
[i.e., Public Law 106-810], requires U.S. air carriers that provide
scheduled service to submit a monthly report on any incidents involving
the loss, injury or death of an animal during air transport to the
Department's Aviation Consumer Protection Division (ACPD). ``Animal''
is defined in the rule as any warm or cold blooded animal which, at the
time of transportation, is being kept as a pet in a family household in
the United States. The information gathered from the airline reports is
published in DOT's Air Travel Consumer Report to provide the public
with a valuable tool to use in choosing which air carrier to travel
with when traveling with a pet.
    Respondents: Air carriers that transport pets.
    Estimated Number of Respondents: 30.
    Frequency: 12 reports per year for each respondent
    Estimated Annual Burden on Each Respondent: 12 hours a year for
each respondent [time to prepare and submit each report (1 hour)
multiplied by frequency (12)].
    Estimated Total Burden on Respondents: 360 hours [Respondents (30)
x Estimated Annual Burden on Each Respondent (12 hours per year)].
    Comments are Invited on: (a) Whether the collection of information
is necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility; (b) the accuracy of the Department's estimate of the burden of
the proposed information collection; (c) ways to enhance the quality,
utility and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology. As noted earlier, OST published a Federal
Register notice with a 60-day comment period for this ICR on Wednesday,
October 10, 2007. The purpose of this notice is to allow the public an
additional 30 days from the date of this notice to submit comments. A
comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Issued in Washington, DC, on March 25, 2008.
Samuel Podberesky,
Assistant General Counsel for Aviation Enforcement and Proceedings,
U.S. Department of Transportation.
[FR Doc. E8-6591 Filed 3-28-08; 8:45 am]

BILLING CODE 4910-9X-P