[Federal Register Volume 78, Number 61 (Friday, March 29, 2013)]
[Rules and Regulations]
[Pages 19130-19136]
[FR Doc No: 2013-07093]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0860; FRL-9378-6]

Clothianidin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
clothianidin in or on tea, dried and increases the tolerance level for
pepper to support a shorter pre-harvest interval (PHI). These
tolerances were requested by Interregional Research Project Number 4
(IR-4) and Valent U.S.A. Corporation, respectively, under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 29, 2013. Objections and
requests for hearings must be received on or before May 28, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0860, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0860 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
May 28, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2011-0860, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 8, 2011 (76 FR 76674) (FRL-
9328-8) and September 28, 2012 (77 FR 59578) (FRL-9364-6), EPA issued a
document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions ((PP) 1E7923 and 2F8008)
by IR-4, IR-4 Headquarters, 500 College Road East, Suite 201 W,
Princeton, NJ 08540 and Valent U.S.A. Corporation, P.O. Box 8025,
Walnut Creek, CA 94596, respectively. The petitions requested that 40
CFR 180.586 be amended by establishing tolerances for residues of the
insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-
methyl-2-nitroguanidine, in or on fruit, citrus, group 10-10; citrus,
dried pulp; pistachio; strawberry and tea, fresh at 0.60, 1.0, 0.01,
1.50 and 70 parts per million (ppm), respectively, 1E7923; and
vegetable, fruiting group 8-10, except pepper/eggplant, subgroup 8-10B;
and pepper/eggplant subgroup 8-10B at 0.20, and 0.7 ppm, respectively,
2F8008. In addition, PP 2F8008 requested that 40 CFR 180.586(a) be
amended by deleting the tolerance for residues of clothianidin in or on
the vegetable, fruiting group 8 at 0.2 ppm, upon approval of
vegetables, fruiting, group 8-10, except pepper/eggplant subgroup 8-10B
at 0.2 ppm; and replacing the tolerance for residues of clothianidin in
or on fruit, pome at 1.0 ppm with fruit, pome group 11-10 at 1.0 ppm
due to EPA expansion of the crop group. The above-mentioned Federal
Register documents referenced a summary of the petition prepared by
Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596, the
registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to this comment is discussed in Unit IV.C.
    At this time, EPA is only establishing tolerances for tea, dried
and is increasing the tolerance level for pepper to support PHI for an
existing registration. In addition, EPA is re-defining the crop group
tolerance expression ``vegetable, fruiting, group 8'' as ``vegetable,
fruiting, group 8, except pepper.'' EPA is not prepared to establish
tolerances for the remaining petitioned-for clothianidin tolerances
until the potential ecological and environmental risks can be assessed.
EPA will make a final determination on the other petitioned-for
tolerances at a later date. The reasons for these changes are explained
in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for clothianidin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with clothianidin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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.
    EPA considered the toxicity of clothianidin as well as several
metabolites and degradates in conducting this risk assessment. EPA
assumed that clothianidin's metabolites/degradates that are similar in
structure to clothianidin are toxicologically equivalent to
clothianidin with respect to the endpoints being used for risk
assessment.
    The available data indicate that there are no consistent target
organs in mammals; however, some effects noted in the liver,
hematopoietic system and kidney are similar to effects from other
neonicotinoid insecticides. In

subchronic oral studies, the dog seemed to be more sensitive to
clothianidin than the rat. In addition to decreases in body weight and
body weight gains observed in both animals, dogs also displayed
decreased white blood cells, albumin and total protein, as well as some
anemia. Long-term dietary administration of clothianidin did not result
in a wider spectrum of effects in the dog; in contrast, the chronic
feeding studies in rats showed additional effects in the liver, ovaries
and kidneys. In the mouse chronic oral study, increases in vocalization
and decreases in body weight and body weight gain were noted.
    Based on the lack of significant tumor increases in two adequate
rodent carcinogenicity studies, EPA has classified clothianidin as
``not likely to be carcinogenic to humans.'' A bone marrow micronucleus
assay in mice showed that clothianidin is neither clastogenic nor
aneugenic up to a toxic oral dose. Additionally, a study on the livers
of Wistar male mice showed no induction of unscheduled DNA synthesis up
to the limit dose; therefore, mutagenicity is not of concern.
    Clinical signs of neurotoxicity were exhibited in both rats
(decreased arousal, motor activity and locomotor activity) and mice
(decreased spontaneous motor activity, tremors and deep respirations)
in acute neurotoxicity studies following exposure by gavage; however,
no indications of neurotoxicity were observed following dietary
exposure in the subchronic neurotoxicity study in rats.
    There was no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses following in utero exposure to
clothianidin in developmental studies; however, increased quantitative
susceptibility of rat pups was seen in both the reproduction and
developmental neurotoxicity studies. In the rat reproduction study,
offspring toxicity (decreased body weight gains and absolute thymus
weights in pups, delayed sexual maturation and an increase in
stillbirths) was observed in the absence of maternal effects. In the
developmental neurotoxicity study in rats, offspring effects (decreased
body weights, body weight gains, motor activity and acoustic startle
response amplitude) were noted at doses lower than those resulting in
maternal toxicity.
    Decreased absolute and relative thymus and spleen weights were
observed in multiple studies; these studies showed possible evidence of
effects on the immune system. In addition, juvenile rats in the rat
reproduction study appeared to be more susceptible to these effects.
However, a guideline immunotoxicity study showed no evidence of
clothianidin-mediated immunotoxicity in adult rats and a developmental
immunotoxicity study demonstrated no increased susceptibility for
offspring with regard to immunotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by clothianidin 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: ``Clothianidin--Aggregate Human Health
Risk Assessment of New Uses on Strawberry, Pistachio, and Citrus; New
Tolerance for Tea; and Revised PHI and Tolerance for Pepper and
Eggplant (Crop Subgroup 8-10B),'' dated September 27, 2012 at page 32,
and additional information on pome fruit can be found in document:
``Clothianidin--Human Health Risk Assessment for Requested Foliar Uses
on Rice, Seed Treatment on Leafy Vegetables, Increased Application Rate
for Vegetables, and Expanded Uses on Fruiting Vegetables and Pome
Fruit,'' dated February 1, 2012, in docket ID number EPA-HQ-OPP-2011-
0860.

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 clothianidin used for
human risk assessment is discussed in Unit II of the final rule
published in the Federal Register of August 29, 2012 (77 FR 52246)
(FRL-9360-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clothianidin, EPA considered exposure for all of the
petitioned-for tolerances as well as all existing clothianidin
tolerances in 40 CFR 180.586. EPA assessed dietary exposures from
clothianidin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for clothianidin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA used maximum field trial values,
empirical processing factors and assumed 100 percent crop treated (PCT)
for all commodities. Clothianidin is a major metabolite of
thiamethoxam, and there are a number of crops for which uses of both
clothianidin and thiamethoxam have been registered. The labels for the
various end-use products containing these active ingredients prohibit
the application of both active ingredients to the same crop during a
growing cycle. Due to that restriction and the assumption of 100 PCT, a
single value reflecting the greatest clothianidin residue from either
active ingredient has been used for crops listed for use with both
active ingredients (versus combined estimates from clothianidin and
thiamethoxam). Generally, this assessment uses the established or
recommended clothianidin tolerance for crops having tolerances for both
compounds (the exception being low-growing berry, subgroup 13-07G,
which is based on observed clothianidin residues in thiamethoxam
strawberry field trials). For foods with thiamethoxam tolerances but
without clothianidin tolerances, maximum residues of clothianidin
observed in thiamethoxam field trials have been used in these
assessments. Foods falling

into this category include meats, meat by-products, artichoke, tropical
fruits, coffee, hop, mint, and rice.
    In relying on maximum field trial residues of clothianidin, EPA has
adjusted the field trial values upward to account for metabolites of
concern for leafy and root and tuber vegetables and for ruminants and
poultry. Details on these adjustments are provided in document:
``Clothianidin--Human Health Risk Assessment for Requested Foliar Uses
on Rice, Seed Treatment on Leafy Vegetables, Increased Application Rate
for Vegetables, and Expanded Uses on Fruiting Vegetables and Pome
Fruit,'' dated February 1, 2012, in docket ID number EPA-HQ-OPP-2011-
0860.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assessed chronic
dietary exposure using the same residue information and assumptions
regarding metabolites/degradates as in the acute exposure analysis.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that clothianidin 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 information. EPA used anticipated residue
(maximum field trial residues) in the dietary assessment for
clothianidin.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for clothianidin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clothianidin. 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.
    The Agency modeled estimated drinking water concentrations (EDWC)
of clothianidin in surface and groundwater using the Tier 1 Rice Model,
the Food Quality Protection Act (FQPA) Index Reservoir Screening Tool
(FIRST), and the Screening Concentrations in Groundwater model (SCI-
GROW). The Tier 1 Rice Model produced the greatest value of any of the
models used to predict EDWCs for acute and chronic exposures. The Tier
1 Rice Model EDWC of 72 parts per billion (ppb) was entered directly
into the dietary exposure model.
    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).
    Clothianidin is currently registered for the following uses that
could result in residential exposures: Turf, ornamental plants, and/or
indoor use to control bed bugs. EPA assessed residential exposure using
the following assumptions: Exposures may occur during application of
products containing clothianidin (handler exposure) as well as
following application (post-application exposure) and are expected to
be of short-term (1-30 days) duration.
    Adults were assessed for potential short-term dermal and inhalation
handler exposure from applying clothianidin to residential turf/home
lawns and for short-term post-application dermal exposure from contact
with treated residential and recreational turf home lawns and golf
courses. There is also potential for post-application dermal and
inhalation exposure for adults and children resulting from use of
clothianidin on residential turf, ornamentals (i.e., trees), and indoor
surfaces, as well as, potential for incidental oral post-application
exposure for children.
    Although there is potential for adult exposure resulting from both
applying the product and post-application activities, the Agency did
not combine exposure estimates from adult handler and post-application
activities because of the conservative assumptions and inputs within
each exposure scenario. The children's combined exposure includes only
the hand-to-mouth exposure for the incidental oral exposure component.
To include exposure from object-to-mouth and soil ingestion in addition
to hand-to-mouth would overestimate incidental oral exposures for
purposes of estimating combined residential exposure. Further, because
the level of concern for dermal exposures (MOEs less than 100) and
inhalation exposure (MOEs less than 1,000) are different, a total
aggregate risk index (ARI) approach was used instead of the MOE
approach. ARIs of greater than 1 indicate risks are not of concern.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Clothianidin is a member of the neonicotinoid class of pesticides
and is a metabolite of another neonicotinoid, thiamethoxam. Structural
similarities or common effects do not constitute a common mechanism of
toxicity. Evidence is needed to establish that the chemicals operate by
the same, or essentially the same sequence of major biochemical events.
Although clothianidin and thiamethoxam bind selectively to insect
nicotinic acetylcholine receptors (nAChR), the specific binding
site(s)/receptor(s) for clothianidin, thiamethoxam, and the other
neonicotinoids are unknown at this time. Additionally, the commonality
of the binding activity itself is uncertain, as preliminary evidence
suggests that clothianidin operates by direct competitive inhibition,
while thiamethoxam is a noncompetitive inhibitor. Furthermore, even if
future research shows that neonicotinoids share a common binding
activity to a specific site on insect nAChRs, there is not necessarily
a relationship between this pesticidal action and a mechanism of
toxicity in mammals. Structural variations between the insect and
mammalian nAChRs produce quantitative differences in the binding
affinity of the neonicotinoids towards these receptors, which, in turn,
confers the notably greater selective toxicity of this class towards
insects, including aphids and leafhoppers, compared to mammals. While
the insecticidal action of the neonicotinoids is neurotoxic, the most
sensitive regulatory endpoint for clothianidin is based on unrelated
effects in mammals, including changes in body and thymus weights,
delays in sexual maturation,

and stillbirths. Additionally, the most sensitive toxicological effect
in mammals differs across the neonicotinoids (such as testicular
tubular atrophy with thiamethoxam, and mineralized particles in thyroid
colloid with imidaclopid). Thus, there is currently no evidence to
indicate that neonicotinoids share common mechanisms of toxicity, and
EPA is not following a cumulative risk approach based on a common
mechanism of toxicity for the neonicotinoids. 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
the policy statements concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism released by OPP on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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 residual concern
for increased qualitative or quantitative susceptibility in the rat or
rabbit developmental toxicity studies. Since there is evidence of
increased quantitative susceptibility of the young following exposure
to clothianidin in the rat reproduction study and the DNT study, EPA
performed a degree of concern analysis to:
    i. Determine the level of concern for the effects observed when
considered in the context of all available toxicity data; and,
    ii. Identify any residual uncertainties after establishing toxicity
endpoints and traditional uncertainty factors to be used in the
clothianidin risk assessment.
    Considering the overall toxicity profile and the endpoints and
doses selected for the clothianidin risk assessment, EPA characterized
the degree of concern for the effects observed in the clothianidin 2-
generation reproduction and DNT studies as low, noting that there are
clear NOAELs for the offspring effects and regulatory doses were
selected to be protective of these effects. No other residual
uncertainties were identified with respect to susceptibility.
    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 in assessing risks from dermal and oral
exposure pathways. However, EPA does not have reliable data to support
reduction of the FQPA SF in assessing risks from the inhalation
exposure pathway and thus is retaining the 10X FQPA SF for these
assessments. That decision is based on the following findings:
    i. The toxicity database for clothianidin is complete with the
exception of a required 28-day inhalation study.
    ii. There are no residual concerns regarding potential prenatal and
postnatal toxicity in the young. A rat developmental neurotoxicity
study is available and shows evidence of increased quantitative
susceptibility of offspring. However, EPA considers the degree of
concern for the developmental neurotoxicity study to be low for
prenatal and postnatal toxicity because the NOAEL and LOAEL were well
characterized, and the doses and endpoints selected for risk assessment
are protective of the observed susceptibility. While the rat multi-
generation reproduction study showed evidence of increased quantitative
susceptibility of offspring compared to adults, the degree of concern
is low because the study NOAEL has been selected as the POD for risk
assessment purposes for relevant exposure routes and durations. In
addition, the potential immunotoxic effects observed in the study have
been further characterized with the submission of a developmental
immunotoxicity study that showed no evidence of susceptibility. As a
result, there are no concerns or residual uncertainties for pre- and
postnatal toxicity after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment for clothianidin.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including
maximum field trial residues, adjustment factors from metabolism data,
empirical processing factors, and 100 PCT for all commodities. The
exposure databases (dietary food, drinking water, and residential) are
complete. The risk assessment for each potential exposure scenario
includes all metabolites and/or degradates of concern and does not
underestimate potential exposure and risk for infants or children.
Additionally, EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
clothianidin 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 clothianidin.
    In conclusion, there are reliable data showing that, with the
exception of scenarios involving inhalation exposure, the risk to
infants and children can be safely assessed without an additional 10X
safety factor. However, in the absence of the required inhalation
toxicity study, EPA is retaining the 10X FQPA factor as a database
uncertainty factor for assessing inhalation exposure and risk only, for
both adults and children.

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 Population adjusted dose (aPAD) and chronic PAD (cPAD). For
linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to clothianidin will occupy 28% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clothianidin from food and water will utilize 28% of the cPAD for
children 1-2 years 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
clothianidin is not expected;

therefore, the chronic aggregate risk estimates are equivalent to the
dietary risk estimates and are below EPA's level of concern.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    For purposes of performing an aggregate assessment, the EPA
selected the worst-case adult and children exposure scenarios. The
treatment of tree trunks using a manually-pressurized handwand presents
the worst-case exposure estimate for adults, while the bed bug scenario
presents the worst-case exposure estimates for children 1 to <2 yrs
old.
    For short- and intermediate-term ``worst-case'' aggregate exposure
estimates, the ARI for adults is 6.5 and for children 1 to <2 years
old, the ARI is estimated at 1.2. ARI estimated values greater than 1.0
indicate risks are 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, clothianidin was classified as ``not likely to be carcinogenic
to humans,'' and 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 clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies, based on solvent extraction and
Liquid chromatography--mass spectrometry/mass spectrometry (LC-MS/MS)
separation, identification, and quantification, are available for plant
(Morse Method Meth 164--modified, RM-39C-1, or Bayer Method
00552) and livestock (Bayer Method 00624) matrices. The (LOQ) for
clothianidin in plant commodities is 0.01 ppm, except for wheat straw
(0.02 ppm), and the validated LOQs are 0.01 ppm in milk and 0.02 ppm in
animal tissues. Clothianidin and its major metabolites are not
adequately recovered using any of the United States Food and Drug
Administration (FDA) multiresidue methods.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for clothianidin in or on tea, fresh
at 0.7 ppm and fruiting vegetables other than cucurbits at 0.050 ppm.
The residue field trial submitted to support the U.S. tolerances
results in higher clothianidin residues than the maximum residue levels
established by Codex and therefore, the U.S. tolerances cannot be
harmonized with the Codex MRLs.

C. Response to Comments

    EPA received one comment on the notice of filing for petition,
1E7923, in which the commenter requested that EPA deny IR-4's petition
to establish a tolerance for residues of clothianidin on food crops
because it is toxic to humans.
    When new or amended tolerances are requested for the presence of
the residues of a pesticide and its toxicologically significant
metabolite(s) in food or feed, the Agency, as is required by section
408 of the FFDCA, estimates the risk of the potential exposure to these
residues by performing an aggregate risk assessment. As discussed in
Unit III, EPA's assessment for clothianidin concludes that there is a
reasonable certainty that no harm will result from exposure to
clothianidin residues of interest. Therefore, the tolerances
established by this action are found to be acceptable. The commenter
submitted no evidence or argument that addresses this statutory
finding.

D. Revisions to Petitioned-For Tolerances

    In this action EPA is only establishing tolerances for tea, dried
and pepper and will make a final determination on the remaining
petitioned for tolerances at a later date. Though EPA is able to make
the required safety finding under FFDCA and the human health risk
assessments support all of the petitioned-for uses, what must still be
considered for the additional uses to be registered in the United
States are potential ecological and environmental risks associated with
clothianidin. Therefore, at this time EPA is only prepared to establish
a tolerance on dried tea (without a U.S. registration; i.e., an
``import tolerance'') and to increase the tolerance on pepper to
support a shorter pre-harvest interval (PHI).
    EPA is still in the process of assessing the potential ecological
concerns identified with the additional exposures expected from the
registration of the proposed pome fruit group 11-10, pepper/eggplant
subgroup 8-10B, citrus fruit group 10-10, pistachio, and strawberry
uses. However, in order to support an effort to establish tolerances
for residues of pesticides on tea, to ensure a safe supply of tea for
the U.S. consumer, EPA has determined it will move forward with
establishing the tolerance for clothianidin on tea prior to finalizing
the decision on the remaining petitioned for uses. Additionally, there
is an existing tolerance for residues of clothianidin on fruiting
vegetable group 8 at 0.20 ppm and residue field trial data were
submitted for pepper to support a lower PHI which results in a
recommended higher tolerance. Though EPA is not prepared to allow the
expansion of the Fruiting Vegetable Group 8 at this time to include the
additional commodities in Pepper/eggplant Subgroup 8-10B, shortening
the PHI on pepper is not expected to result in any additional
environmental exposure. Therefore, the EPA has determined that it will
establish a higher tolerance for clothianidin on pepper in this action
and a final determination on the petition for the pepper/eggplant
subgroup 8-10B tolerance will be made at a later date.
    As to the tolerance levels, the proposed tea, fresh tolerance at 50
ppm will be established on tea, dried at 70 ppm. The commodity listing
is changed from tea, fresh to tea, dried to reflect the commodity from
which residue data were collected and to reflect the principal tea
commodity that is in the channels of trade. The value of the tolerance
is changed based on the

output from the Organisation for Economic Cooperation and Development
(OECD) calculation procedures. EPA is also establishing the separate
tolerance on pepper at 0.80 ppm which is different than the requested
tolerance at 0.7 ppm for pepper/eggplant subgroup 8-10B. EPA based the
0.80 tolerance level on the non-bell-pepper residue data and OECD
Calculation Procedures.
    Finally, to account for the establishment of a ``separate'' pepper
tolerance, EPA re-defined the existing crop group tolerance expression
``vegetable, fruiting, group 8'' as ``vegetable, fruiting, group 8,
except pepper''.

V. Conclusion

    Therefore, tolerances are established for residues of clothianidin,
(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in
or on tea, dried at 70 ppm, pepper at 0.80 ppm, and vegetable,
fruiting, group 8, except pepper at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 15, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.586 is amended in paragraph (a)(1) by revising the
commodity ``vegetable, fruiting, group 8'', by alphabetically adding
the commodities ``pepper'' and ``tea, dried'', and by adding footnote 1
to the table to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Pepper.....................................................         0.80

                                * * * * *
Tea, dried \1\.............................................           70

                                * * * * *
Vegetable, fruiting, group 8, except pepper................         0.20

                                * * * * *
------------------------------------------------------------------------
\1\ No U.S. registrations.

* * * * *
[FR Doc. 2013-07093 Filed 3-28-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 26, 2007 (Volume 72, Number 17)]
[Notices]
[Page 3892-3893]
[DOCID:fr26ja07-157]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55130; File No. SR-NASDAQ-2006-067]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change to Retroactively Reduce Fees
for Nasdaq's Risk Management Service

January 19, 2007.
    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 December 29, 2006, The NASDAQ Stock Market LLC (``Nasdaq'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by Nasdaq. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    Nasdaq proposes to make retroactive to November 1, 2006 recent
reductions in fees charged for the Nasdaq Risk Management Service
(``Service''). The text of the proposed rule change is available at
Nasdaq, http://www.nasdaq.com, and the Commission's Public Reference Room.

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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
    In SR-NASDAQ-2006-066,\3\ Nasdaq reduced the per trade fee for the
Service to $0.025, and capped the per month total Service fee per
clearing firm at $7,500. The instant proposed rule change seeks to make
those same fee and cap reductions retroactive to November 1, 2006.
Nasdaq believes that these fee reductions will ensure that Nasdaq's
charges for risk management services remain competitive with those of
providers of similar services.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 55131 (January 19,
2007).
---------------------------------------------------------------------------

2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\4\ in general, and with Section
6(b)(4) of the Act,\5\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which Nasdaq operates or controls.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml
); or

     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NASDAQ-2006-067 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-NASDAQ-2006-067. 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. Copies of such
filing also will be available for inspection and copying at the
principal office of Nasdaq. 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-NASDAQ-2006-067 and should be submitted on or before
February 16, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-1225 Filed 1-25-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44113-44114]
[FR Doc No: 2022-15841]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER22-2418-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-West Texas Solar
Project II 3rd A&R Generation Interconnection Agreement to be effective
6/22/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5129.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2419-000.
    Applicants: Lockhart Solar PV, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/18/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5130.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2420-000.
    Applicants: Lockhart Solar PV II, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/18/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5131.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2421-000.
    Applicants: SR DeSoto I, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 7/20/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5146.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2422-000.
    Applicants: SR Turkey Creek, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/18/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5148.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2423-000.
    Applicants: SR DeSoto I Lessee, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 7/20/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5149.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2424-000.
    Applicants: SR Bell Buckle, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/18/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5152.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2425-000.
    Applicants: SR Clay, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 7/20/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5153.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2426-000.
    Applicants: SR McKellar, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/18/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5155.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2427-000.
    Applicants: SR Cedar Springs, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 7/20/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5156.
    Comment Date: 5 pm ET 8/9/22.

    Docket Numbers: ER22-2428-000.
    Applicants: SR McKellar Lessee, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/18/2022.
    Filed Date: 7/19/22.
    Accession Number: 20220719-5157.
    Comment Date: 5 pm ET 8/9/22.

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

    Docket Numbers: ES22-53-000.
    Applicants: AEP Generating Company.
    Description: Application Under Section 204 of the Federal Power Act
for Authorization to Issue Securities of AEP Generating Company.
    Filed Date: 7/18/22.
    Accession Number: 20220718-5208.
    Comment Date: 5 pm ET 8/8/22.

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

    Docket Numbers: RR21-10-001.
    Applicants: North American Electric Reliability Corporation.
    Description: Compliance Filing of the North American Electric
Reliability Corporation In Response to the Order On the Rules of
Procedure Revisions to the Compliance Monitoring and Enforcement
Program.
    Filed Date: 7/18/22.
    Accession Number: 20220718-5218.
    Comment Date: 5 pm ET 8/8/22.

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

    Dated: July 19, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-15841 Filed 7-22-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 1, 2009 (Volume 74, Number 168)]
[Notices]
[Page 45268-45269]
[DOCID:fr01se09-113]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60569; File No. SR-BATS-2009-028]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
BATS Rule 11.9, Entitled ``Orders and Modifiers,'' and BATS Rule 11.13,
Entitled ``Order Execution.''

August 26, 2009.
    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 August 21, 2009, BATS Exchange, Inc. (``BATS'' or the
``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 by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) 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 from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange is proposing to amend BATS Rules 11.9, entitled
``Orders and Modifiers,'' and 11.13, entitled ``Order Execution,'' to
remove an order type (a ``BATS Only BOLT Order'') and processing method
(``BOLT Routing'') that each provide an optional display period through
which a marketable order is displayed to Exchange Users (and market
data recipients) for a brief period of time designated by the Exchange
prior to being routed, cancelled, or posted to the BATS Book.
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to remove language which
allows marketable orders to be displayed to Exchange Users (and market
data recipients) prior to being routed, cancelled, or posted to the
BATS Book. Specifically, the Exchange currently offers both an order
type and a pre-routing processing method that, after first seeking to
execute against the BATS Book, permit the order to be displayed as a
marketable order at the NBB for a sell order or the NBO for a buy order
to Exchange Users and market data recipients for a brief, variable
amount of time (not to exceed 500 milliseconds) for potential
execution.
2. Statutory Basis
    The rule change proposed in this submission is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\5\ Specifically, the
proposed change is consistent with Section 6(b)(5) of the Act,\6\
because it would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system, and, in general, protect investors and
the public interest.
---------------------------------------------------------------------------

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

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

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\9\
However, Rule 19b-4(f)(6)(iii) \10\ 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 Exchange requests this
waiver because it plans to stop supporting the order type and pre-
routing processing method that are being deleted through the proposal
as of September 1, 2009.\11\ Based on the foregoing, the Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest and hereby designates
the proposal operative on September 1, 2009.\12\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of 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. The Exchange has satisfied this requirement.
    \10\ Id.
    \11\ See SR-BATS-2009-028, Item 7.
    \12\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change the

Commission may summarily abrogate such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors or otherwise in furtherance
of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-BATS-2009-028 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-BATS-2009-028. 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, 100 F Street, NE.,
Washington, DC 20549, 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 BATS. 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 No. SR-BATS-2009-028 and should be
submitted on or before September 22, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-20988 Filed 8-31-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Page 59995]
[FR Doc No: 2016-20975]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-494-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of
Application

    Take notice that on August 16, 2016, Transcontinental Gas Pipe Line
Company, LLC (Transco), Post Office Box 1396, Houston, Texas 77251,
filed in Docket No. CP16-494-000, an application pursuant to section
7(c) of the Natural Gas Act and Part 157 of the Commission's
regulations requesting authorization of its Gulf Connector Expansion
Project (Project) consisting of three new compressor stations totaling
30,650 horsepower in Wharton, San Patricio and Victoria Counties,
Texas; a new interconnect with Cheniere Corpus Christi Pipeline, LLC's
pipeline facilities in San Patricio County, Texas; and piping and valve
modifications in Hardin and Wharton Counties, Texas to allow for bi-
directional flow and related appurtenant facilities. The Project would
cost approximately $167.4 million and would enable 475,000 dekatherms
per day of incremental firm natural gas transportation, all as more
fully set forth in the application which is on file with the Commission
and open to public inspection. This filing may be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding this Application should be directed to
Ingrid Germany, Rates & Regulatory, P.O. Box 1396, Houston, Texas
77251-1396, or call<PHONE_NUMBER>, or via eMail:
<EMAIL_ADDRESS>the toll-free Project telephone number
(866) 455-9103, or the Project Web site at www.williams.com/GulfConnector.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with he Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and ill not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link.
    Comment Date: September 15, 2016

    Dated: August 25, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-20975 Filed 8-30-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]
[Page 59533-59536]
[DOCID:fr18no09-38]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0851; FRL-8800-1]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

 AGENCY: Environmental Protection Agency (EPA).

 ACTION: Notice.

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SUMMARY: There will be a 4-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review Draft Framework and Case Studies on Atrazine, Human
Incidents, and the Agricultural Health Study: Incorporation of
Epidemiology and Human Incident Data into Human Health Risk Assessment.

DATES: The meeting will be held on February 2 - 5, 2010, from
approximately 8:30 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted
by January 19, 2010 and requests for oral comments be submitted by
January 26, 2010. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after January 19, 2010 should contact the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT. For additional instructions, see Unit I.C. of the
SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before November
30, 2009.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0851, 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>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0851. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT to obtain special instructions before
submitting your comments. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: 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., 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
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.

 FOR FURTHER INFORMATION CONTACT: Myrta R. Christian, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
 SUPPLEMENTARY INFORMATION:

 I. General Information

 A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.

 B. What Should I Consider as I Prepare My Comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     2. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

 C. How May I Participate in this Meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2009-0851 in the subject line
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than January
19, 2010, to provide FIFRA SAP the time necessary to consider and
review the written comments. Written comments are accepted until the
date of the meeting, but anyone submitting written comments after
January 19, 2010 should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments at the meeting
should bring 30 copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than January 26, 2010, in order to be included on the meeting
agenda. Requests to present oral comments will be accepted until the
date of the meeting and, to the extent that time permits, the Chair of
FIFRA SAP may permit the presentation of oral comments at the meeting
by interested persons who have not previously requested time. The
request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment (e.g., overhead
projector, 35mm projector, chalkboard). Oral comments before FIFRA SAP
are limited to approximately 5 minutes unless prior arrangements have
been made. In addition, each speaker should bring 30 copies of his or
her comments and presentation slides for distribution to the FIFRA SAP
at the meeting.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of FIFRA SAP
for this meeting. As part of a broader process for developing a pool of
candidates for each meeting, FIFRA SAP staff routinely solicits the
stakeholder community for nominations of prospective candidates for
service as ad hoc members of FIFRA SAP. Any interested person or
organization may nominate qualified individuals to be considered as
prospective candidates for a specific meeting. Individuals nominated
for this meeting should have expertise in one or more of the following
areas: Risk Assessment; Human Epidemiology (particularly occupational
and environmental epidemiology); Mode of Action Analysis (particularly
those with MOA framework experience); Human Relevance Framework;
Pharmacokinetics (particularly animal to human extrapolation); Exposure
Assessment of Pesticides (both residential & agricultural worker).
Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments on the scientific issues for this meeting.
Nominees should be identified by name, occupation, position, address,
and telephone number. Nominations should be provided to the DFO listed
under FOR FURTHER INFORMATION CONTACT on or before November 30, 2009.
The Agency will consider all nominations of prospective candidates for
this meeting that are received on or before this date. However, final
selection of ad hoc members for this meeting is a discretionary
function of the Agency.
    The selection of scientists to serve on FIFRA SAP is based on the
function of the panel and the expertise needed to address the Agency's
charge to the panel. No interested scientists shall be ineligible to
serve by reason of their membership on any other advisory committee to
a Federal department or agency or their employment by a Federal
department or agency except the EPA. Other factors considered during
the selection process include availability of the potential panel
member to fully participate in the panel's reviews, absence of any
conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of lack
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected

to serve on FIFRA SAP. Numerous qualified candidates are identified for
each panel. Therefore, selection decisions involve carefully weighing a
number of factors including the candidates' areas of expertise and
professional qualifications and achieving an overall balance of
different scientific perspectives on the panel. In order to have the
collective breadth of experience needed to address the Agency's charge
for this meeting, the Agency anticipates selecting approximately 10 ad
hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by the EPA in 5
CFR part 6401. In anticipation of this requirement, prospective
candidates for service on the FIFRA SAP will be asked to submit
confidential financial information which shall fully disclose, among
other financial interests, the candidate's employment, stocks and
bonds, and where applicable, sources of research support. The EPA will
evaluate the candidates financial disclosure form to assess whether
there are financial conflicts of interest, appearance of a lack of
impartiality or any prior involvement with the development of the
documents under consideration (including previous scientific peer
review) before the candidate is considered further for service on FIFRA
SAP. Those who are selected from the pool of prospective candidates
will be asked to attend the public meetings and to participate in the
discussion of key issues and assumptions at these meetings. In
addition, they will be asked to review and to help finalize the meeting
minutes. The list of FIFRA SAP members participating at this meeting
will be posted on the FIFRA SAP website at http://epa.gov/scipoly/sap
or may be obtained from the OPP Regulatory Public Docket at http://
www.regulations.gov.

 II. Background

 A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and
is structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. FIFRA SAP is a Federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act. FIFRA SAP is composed of a permanent
panel consisting of seven members who are appointed by the EPA
Administrator from nominees provided by the National Institutes of
Health and the National Science Foundation. FIFRA, as amended by FQPA,
established a Science Review Board consisting of at least 60 scientists
who are available to the SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, FIFRA SAP provides
comments, evaluations and recommendations to improve the effectiveness
and quality of analyses made by Agency scientists. Members of FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency.

 B. Public Meeting

    Data from epidemiology studies and human incident reports contain
valuable information about human exposure and response to pesticides.
This information can contribute to a weight of evidence analysis in the
characterization of human health risks. Epidemiology and incident data
do, however, pose challenges with respect to characterizing human
health risks. EPA is convening a meeting of the FIFRA Scientific
Advisory Panel (SAP) to discuss science issues related to using
epidemiology and human incident data in human health risk assessment.
The Office of Pesticide Programs (OPP) will solicit comment on a draft
framework for implementing such data into human health risk assessment
in addition to several case studies that illustrate scientific issues
to be addressed at the SAP meeting. OPP's draft framework describes a
weight of the evidence evaluation that uses the best available science
on mode of action, exposure, pharmacokinetics, animal and human data
from both in vivo and in vitro studies in addition to models such as
physiologically-based pharmacokinetic models when available. Three case
studies to be evaluated by the SAP are intended to illustrate the draft
framework and to highlight key science challenges with incorporating
epidemiology or human incident data into a risk assessment. The Agency
will solicit comment on the weight of the evidence approach for
evaluating and integrating the exposure, laboratory animal, and human
information.
    A case study on the evaluation of several epidemiology studies
concerning atrazine will be presented. These epidemiology studies are
either ecologic or retrospective cohort studies in design. OPP, in
collaboration with EPA's Office of Water and Office of Research and
Development (ORD), will solicit comment on the strengths and weaknesses
of these types of epidemiology studies in addition to advice on the
appropriate way to use such studies in the atrazine human health risk
assessment. This case study is also the first step in EPA's atrazine
science re-evaluation plan as described to the November 3, 2009 FIFRA
SAP previously (http://www.epa.gov/scipoly/sap/meetings/2009/
110309meeting.html).
    A case study is also included to illustrate an analysis of reported
human incident cases using diazinon; a pesticide that has historically
been used in residential settings.
    Additionally, a case study concerning the collaborative work by
scientists from OPP, ORD, and the National Cancer Institute (NCI) and
the National Institute of Environmental Health Sciences (NIEHS) on the
Agricultural Health Study (AHS) will be presented to: Compare the
exposure algorithms used by OPP and the AHS, and; consider temporal
relationships for multi-chemical exposure in the AHS. The purpose of
on-going work to compare the OPP and AHS exposure algorithms is to
better understand differences and similarities in the two approaches to
estimating worker exposure. Evaluation of temporal relationships for
multi-chemical exposure in the AHS will involve information on the
timing of uses and combined uses of pesticides, with particular
emphasis on pesticides which share the same mode of action. The Agency
will solicit advice on types of evaluations conducted to date and those
being proposed with the third case study.
    The FIFRA SAP's advice will provide the Agency with input on
approaches to integrate diverse types of experimental toxicology and
epidemiology data. The SAP input will be considered in characterizing
atrazine's human health risks which will be presented to the SAP in
September 2010.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc
members for this meeting), and the meeting agenda will be available by
early January. In addition, the Agency may provide additional
background documents as the materials become available. You may obtain
electronic copies of these documents, and certain other related
documents that might be available electronically, at http://
www.regulations.gov and the FIFRA

SAP homepage at http://www.epa.gov/scipoly/sap.
    FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted on the FIFRA SAP website or may be
obtained from the OPP Regulatory Public Docket at http://
www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: November 10, 2009.
Frank Sanders,
Director, Office of Science Coordination and Policy.

[FR Doc. E9-27671 Filed 11-17-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26615]
[DOCID:fr10my07-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-421-000]

Garden Banks Gas Pipeline, LLC; Notice of Proposed Changes in
FERC Gas Tariff

May 3, 2007.
    Take notice that on May 1, 2007, Garden Banks Gas Pipeline, LLC
(Garden Banks) tendered for filing as part of its FERC Gas Tariff,
Original Volume No. 1, the following tariff sheets, with an effective
date of June 1, 2007:

Second Revised Sheet No. 19
Second Revised Sheet No. 23
First Revised Sheet No. 23A
First Revised Sheet 23B
Third Revised Sheet No. 25
Second Revised Sheet No. 221
First Revised Sheet No. 226

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). Anyone
filing an intervention or protest must serve a copy of that document on
the Applicant. Anyone filing an intervention or protest on or before
the intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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 docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-8928 Filed 5-9-07; 8:45 am]

BILLING CODE 6717-01-P