[Federal Register: June 20, 2007 (Volume 72, Number 118)]
[Rules and Regulations]
[Page 33901-33907]
[DOCID:fr20jn07-23]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0178; FRL-8132-9]

Lactofen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a regional tolerance for residues
of lactofen in or on vegetables, fruiting, group 08, and okra.
Interregional Research Group Number 4 (IR-4)

requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective June 20, 2007. Objections and
requests for hearings must be received on or before August 20, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0178. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, 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-2006-0178 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before August 20, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0178, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 12, 2006 (71 FR 18744) (FRL-7773-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5E6930) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.432 be amended by
establishing a tolerance for residues of the herbicide, lactofen, (1-
(carboethoxy) ethyl 5-2-chloro-4-(trifluoromethyl) phenoxy-2-
nitrobenzoate), in or on vegetable, fruiting, and okra at 0.01 parts
per million (ppm). That notice referenced a summary of the petition
prepared by Valent U.S.A. Corporation, the registrant, which is
available to the public in the docket, http://www.regulations.gov.

There were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the 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 the
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. . . .'' These provisions were added to the
FFDCA by the Food Quality Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors
specified in section 408(b)(2)(D) of the FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned for
tolerance for residues of lactofen in/on vegetables, fruiting, group
08, at 0.02 ppm and okra at 0.02 ppm . EPA's assessment of exposures
and risks associated with establishing the tolerance 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. Specific information on the studies received and the nature
of the adverse effects caused by lactofen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in support
documents to this action under Docket ID number EPA-HQ-OPP-2006-0178.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which NOAEL in the toxicology study identified
as appropriate for use in risk assessment. However, if a NOAEL cannot
be determined, the LOAEL doseof concern are identified is sometimes
used for risk assessment. Uncertainty/safety factors (UF) are used in
conjunction with the LOC to take into account uncertainties inherent in
the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. Safety is assessed for acute and chronic risks by
comparing aggregate exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the LOC by all applicable
uncertainty/safety factors. Short-term, intermediate-term, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of exposure (MOE) called for by the product of
all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for lactofen used for
human risk assessment can be found at http://www.regulations.gov in document

``Lactofen: Human Health Risk Assessment for Proposed Uses of Fruiting
Vegetables and Okra'' at page number 13 in docket ID number EPA-HQ-OPP-
2006-0178. To locate this information on the Regulation.gov website
follow these steps:
     Select ``Advanced Search'', then ``Docket Search.''
     In the ``Docket ID number'' field type the docket number
in the following format - ''OPP-year-docket number'' e.g., OPP-2005-
9999).
     Click the ``Submit'' button.
     Click on the docket to open.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to lactofen, EPA considered exposure under the petitioned-for
tolerances as well as all existing lactofen tolerances in (40 CFR 180.
432). Exposure assessment also considered exposures as a result of
acifluorfen, an environmental degrade of lactofen.
    EPA assessed dietary exposures from lactofen 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.
    The Agency did not identify an endpoint for an acute dietary
exposure assessment for the general population due to the lack of
toxicological effects of concern attributable to a single exposure
(dose) in studies available in the data base including oral
developmental toxicity studies in rats and rabbits. An acute dietary
exposure assessment was conducted for the population subgroup, female
ages 13-49, only. In estimating acute dietary exposure, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM, Version 2.03), which
incorporates consumption data from United States Department of
Agriculture (USDA) Continuing Surveys of Food Intakes by Individuals
(CSFII), 1994-1996 and 1998. As to residue levels in food, EPA assumed
all foods for which there are proposed or existing tolerances were
treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM/FCIDTM, Version 2.03, which
incorporates food consumption data from USDA's 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII).
The chronic dietary analysis assumed all crops for which there are
proposed or existing tolerances were treated and contain tolerance-
level residues.
    iii. Cancer. Lactofen has been classified as ``not likely'' to be
carcinogenic in humans because of available data on lactofen support
activation of the peroxisome proliferator activated receptor alpha
(PPAR[alpha]) as the mode of action which induced liver tumors in
rodents. While the proposed mode of action for liver tumors in rodent
is qualitatively possible in humans, it is quantitatively implausible
and unlikely to take place in humans based on quantitative species
toxicodynamic differences in PPAR[alpha] activation. The quantification
of risk is not required.
    iv. Exposure assessment for acifluorfen. Lactofen degrades in the
environment to acifluorfen. Sodium acifluorfen is a registered
agricultural pesticide. Accordingly, an aggregate assessment for
acifluorfen exposure resulting from both use of lactofen and sodium
acifluorfen was also conducted. As to residue levels of acifluorfen in
food from use of sodium acifluorfen, EPA assumed all foods for which
there are tolerances were treated and contain tolerance level residues.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient

monitoring data to complete a comprehensive dietary exposure analysis
and risk assessment for lactofen in drinking water. Because the Agency
does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
lactofen. 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 drinking water assessment of lactofen is complicated by the
fact that lactofen has a major degradate in common with another
registered herbicide, sodium acifluorfen. Lactofen and sodium
acifluorfen also have common use sites. The Agency considered the
contribution of acifluorfen as an environmental degradate of lactofen
and from sodium acifluorfen in the aggregate assessment. The drinking
water residues used in the dietary risk assessment were incorporated
directly into this dietary exposure from drinking water assessment.
Therefore, EPA estimated drinking water concentrations for both
lactofen and acifluorfen from lactofen applications. Water residues
were incorporated into DEEM-FCID as the food categories ``water,
direct, all sources'' and ``water, indirect, all sources.''
    The Tier 2 surface water estimated drinking water concentrations
(EDWCs) and estimated environmental concentrations (EECs) for lactofen
and acifluorfen were generated with standard Florida pepper and Florida
tomato cropping scenarios using EPA's pesticide root zone model (PRZM3)
and EXAMS. PRZM simulates pesticide fate and transport as a result of
leaching, direct spray drift, runoff and erosion from an agricultural
field and EXAMS estimates environmental fate and transport of
pesticides in surface water body for a 30-year period (1961-1990). The
EDWCs and EECs assessment for surface water uses single or multiple
sites which typically represent a high-end exposure scenario from
pesticide use on a particular cropped or non-cropped site. Ground-water
concentrations were estimated using the Tier 1 screening model
screening concentration in ground water (SCI-GROW). The models and its
description are available at EPA internet site: http://www.epa.gov/oppefed1/models/water/
.

    Based on the PRZM3/EXAMS model, the EDWCs in surface water
(lactofen and the acifluorfen derived from lactofen) for acute
exposures are estimated to be 1.48 parts per billion (ppb) and 22.5 ppb
for lactofen and acifluorfen, respectively, and for chronic exposures
0.044 ppb and 3.9 ppb for lactofen and acifluorfen, respectively. By
comparison, the EDWC for chronic exposure for acifluorfen derived from
sodium acifluorfen use on soybeans is 3.3 ppb.
    For ground water, the SCI-GROW estimates of lactofen and
acifluorfen EDWCs from application of lactofen for both acute and
chronic exposures are 0.006 ppb lactofen and 2.0 ppb acifluorfen. By
comparison, the SCI-GROW estimate of acifluofren EDWCs in ground water
from applications of sodium acifluorfen is 3.67 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the lactofen acute dietary
risk assessment, the water concentration value of 1.48 ppb was used to
assess the contribution to drinking water. For the lactofen chronic
dietary risk assessment, the water concentration of value 0.044 ppb was
used to assess the contribution to drinking water. For the acifluorfen
acute dietary risk assessment, the water concentration value of 22.5
ppb was used to assess the contribution to drinking water. For the
acifluorfen chronic dietary risk assessment, the water concentration of
value 3.9 ppb was used to assess the contribution to drinking water.
Acifluorfen from lactofen and sodium acifluorfen were not combined
because they are not expected to be used in the same area.
    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).
    There are no products containing lactofen as an active ingredient
that are registered for use in a residential or other non-occupational
setting. No residential exposure assessment is required.
    Residential exposures to the environmental degradate acifluorfen
may occur as a result of the use of sodium acifluorfen, which has
registered residential spot treatment uses. The only scenario for
residential exposure is a short-term spot treatment. Due to the
frequency, duration and location of residential spot treatment
applications, the Agency considered exposure to adults applying sodium
acifluorfen and does not anticipate post-application dermal exposures.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Lactofen is a member of the diphenyl ether chemical family. The
common toxicity that these compounds share is induction of liver
effects (liver hypertrophy, increase in liver weight, tumors). Members
of this class have been shown to induce rodent liver effects /tumors
through the activation of the PPAR[alpha]. It should be noted that
liver hypertrophy and increases in liver weight are part of the range
of morphological changes that result from chemically-mediated effects
on the PPAR[alpha] receptor and hepatocarcinogenesis. Although
PPAR[alpha] agonists can induce liver rodent tumors, the potential for
PPAR[alpha] agonists to induce liver tumors in other species, including
humans, appears to be unlikely. This is because evidence shows that
these other species are quantitatively less sensitive to the effects of
PPAR[alpha] agonism due to toxicodynamic differences between the human
and rodent nuclear PPAR[alpha] receptor. Thus, while this mode of
action for liver tumors in rodent is qualitatively possible in humans,
it is quantitatively implausible and unlikely to take place in humans.
Accordingly, although members of the diphenyl ether family as well as
other classes of compounds may share a common hepatocarcinogenic mode
of action, cumulative exposure to PPAR[alpha] agonists is unlikely to
induce liver carcinogenesis in humans.
    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
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional (10X) tenfold 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 data base 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. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional FQPA safety factor value based on the use of
traditional uncertainty/safety factors and/or special FQPA safety
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Although there is
qualitative evidence of increased susceptibility in the prenatal
developmental studies in rats and rabbits, the Agency did not identify
any residual uncertainties after establishing toxicity endpoints and
traditional uncertainty factors to be used in the risk assessment of
lactofen. The degree of concern for prenatal and postnatal toxicity is
low.
    3. Conclusion. Several factors weighed in favor of the conclusion
that no additional safety factor is needed to protect the safety of
infants and children.
     There are no outstanding data gaps for developmental
toxicity or reproductive toxicity studies;
     There are no residual uncertainties regarding prenatal and
postnatal toxicity; and
     There are no residual uncertainties regarding the exposure
of infants and children to lactofen.
    Nonetheless, EPA determined that an additional safety factor was
needed to address the lack of a NOAEL in the rabbit developmental
study. Although sufficient reliable information has been submitted on
developmental effects of lactofen in rabbits, no NOAEL was identified
in one of the two rabbit developmental studies submitted. The endpoints
of concern identified in available studies are: Decreased live young/
litter, increased embryonic death/litter, and increased incidence of
post-implantation loss. These effects were noted at all dose levels (5,
15, 50 mg/kg/day) thus a NOAEL was not established. Consequently, a
LOAEL to NOAEL factor is appropriate and the risk assessment applies a
3X uncertainty factor. A FQPA uncertainty factor of infants and
children and will be used for the LOAEL to NOAEL extrapolation. The 3X
factor is considered to be protective because the incidence of the
effects at the lowest dose tested was only marginally higher than the
historical controls.
    For sodium acifluorfen, the available toxicology database provides
sufficient information for selecting various toxicity endpoints and
doses for assessing the risks. The Agency evaluated the hazard and
exposure data for sodium acifluorfen and recommended retaining the
safety factor at 10X due to the data gap for the developmental
neurotoxicity study in rats. In accordance with the current EPA policy,
the 10x factor will be applied to all exposure durations.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability
of additional cancer cases given aggregate exposure. Short-term,
intermediate-term, and long-term risks are evaluated by comparing
aggregate exposure to the LOC to ensure that the margin of exposure
(MOE) called for by the product of all applicable uncertainty/safety
factors is not exceeded.
    1. Acute risk. Acute (1-day) exposures to lactofen may result from
consuming treated food and drinking water. No endpoints were identified
for the general population so the only assessment was conducted for
females ages 13-49. The results of the acute aggregate assessment for
lactofen for food and drinking water show that all exposures are below
the level of concern, with the lactofen assessments at less than 1% of
the aPAD.
    The acute aggregate assessment for acifluorfen includes food
exposure from tolerance level residues (from sodium acifluorfen
applications) and water exposures of acifluorfen as an environmental
degradate of lactofen. No acute endpoints were identified for the
general population so the only assessment was conducted for females
ages 13-49. All exposures are below the level of concern, with the
acifluorfen assessments at 6% of the aPAD.
    Both the lactofen and acifluorfen assessments are likely to be
overestimates of risk because they assume all of the crops (for which
there are registered uses) consumed in the U.S. are treated and bear
tolerance-level residues.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to lactofen
from food and water will utilize < 1% of the cPAD for all the population
subgroups. There are no residential uses for lactofen that result in
chronic residential exposure to lactofen.
    The results of the long-term aggregate assessment for acifluorfen
show that for food and drinking water, all exposures are below the
level of concern. The most highly exposed subgroup in the acifluorfen
assessment at 37% of the cPAD was infants, less than 1-year old.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
     Lactofen is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water.
    An aggregate assessment was conducted for exposure to acifluorfen.
Registered residential uses of sodium acifluorfen include spot
treatments only. The short term endpoint selected applies to females
ages 13-49, but is protective of all populations. The acifluorfen
aggregate assessment for this exposure duration includes the average
food exposure assuming tolerance level residues, average water exposure
(acifluorfen as an environmental degradate of lactofen), and
residential handler exposures. The MOE for the aggregate assessment is
16,000, which exceeds the target MOE of 1,000. Therefore, the
acifluorfen short term aggregate risks are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    An intermediate-term assessment is not required for lactofen as
there are no residential uses of lactofen.
    Intermediate-term exposure is not expected for acifluorfen because
residential uses of sodium acifluorfen are limited to spot treatments
that do not include broadcast application to lawns.
    5. Aggregate cancer risk for U.S. population. For the reasons
discussed in Unit III.C.1.iii. the chronic aggregate assessments are
protective of the carcinogenic effects for both lactofen and
acifluorfen.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to lactofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Acceptable gas chromatography with electron capture detection (GC/
ECD) methods are available in the Pesticide Analytical Manual (PAM)
Vol. II for the enforcement of tolerances of lactofen and metabolites
in plant commodities. A modified version of Method B is listed in the
EPA Index of Pesticide Analytical Methods under lactofen. Samples from
the pepper and tomato field trials were analyzed using established GC/
ECD enforcement methods or modified versions of established enforcement
methods. The validated limits of quantitation (LOQs) were 0.01 ppm for
peppers and 0.02 ppm from all other trials. The methods are adequate
for data collection based on acceptable method validation and
concurrent recovery data.

B. International Residue Limits

    There are no established or proposed Codex, Canadian, or Mexican
maximum residue limits (MRLs) for lactofen in any crops. Therefore,
there are no international compatibility issues with respect to U.S.
tolerances.

V. Conclusion

    Therefore, the regional tolerance is established for residues of
[the herbicide lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2- nitrobenzoate, in or on the following raw
agricultural commodities: Vegetables, fruiting, group 8 at 0.02 ppm,
and okra at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, this rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 7, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.432 is amended by adding text to paragraph (c) to read
as follows:

Sec.  180.432  Lactofen; tolerances for residues.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in 180.1(n) are established for
residues of the herbicide, lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-
4-(trifluoromethyl)phenoxy]-2- nitrobenzoate, in or on the following
food commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Okra...........................................                     0.02
------------------------------------------------------------------------
Vegetables, fruiting, group 08.................                     0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-11797 Filed 6-19-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Pages 12833-12836]
[FR Doc No: 2018-05902]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82901; File Nos. SR-LCH SA-2017-012 and SR-LCH SA-2017-
013]

Self-Regulatory Organizations; LCH SA; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove Proposed Rule
Changes Related to LCH SA's Recovery and Wind Down Plans

March 19, 2018.

I. Introduction

    On November 30, 2017, Banque Centrale de Compensation, which
conducts business under the name LCH SA (``LCH SA''), filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change (LCH SA-2017-012)
to adopt a recovery plan (the ``RP''). The proposed rule change was
published for comment in the Federal Register on December 19, 2017.\3\
On December 7, 2017, LCH SA filed with the Commission a proposed rule
change (LCH SA-2017-013) to adopt a wind down plan (``WDP'').\4\ The
proposed rule change was published for comment in the Federal Register
on December 19, 2017.\5\ On January 23, 2018, the Commission designated
a longer period for Commission action on both proposed rule changes.\6\
To date, the Commission has not received any comments on the proposed
rule changes. The Commission is publishing this order to institute
proceedings pursuant to Section 19(b)(2)(B) \7\ of the Act to determine
whether to approve or disapprove the proposed rule changes.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-82316 (Dec. 13,
2017), 82 FR 60246 (Dec. 19, 2017) (SR-LCH-SA-2017-012) (``Notice
012'').
    \4\ Capitalized terms used in this order but not defined herein
have the same meanings specified in LCH SA's rules.
    \5\ Securities Exchange Act Release No. 34-82317 (Dec. 13,
2017), 82 FR 60238 (Dec. 19, 2017) (SR-LCH SA-2017-013) (``Notice
013'').
    \6\ Securities Exchange Act Release No. 34-82570 (Jan. 23,
2018), 83 FR 4088 (Jan. 29, 2018) and Securities Exchange Act
Release No. 34-82571 (Jan. 23, 2018), 83 FR 4081 (Jan. 29, 2018).
    \7\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Institution of proceedings does not indicate that the Commission
has reached any conclusions with respect to the proposed rule changes,
nor does it mean that the Commission will ultimately disapprove the
proposed rule changes. Rather, as discussed below, the Commission seeks
additional input on the proposed rule changes and issues presented by
the proposed rule changes.

II. Description of the Proposed Rule Changes \8\
---------------------------------------------------------------------------

    \8\ The descriptions of the proposed rule changes are
substantially excerpted from Notice 012 and Notice 013.
---------------------------------------------------------------------------

    As a ``covered clearing agency,'' \9\ LCH SA is required to, among
other things, ``establish, implement, maintain and enforce written
policies and procedures reasonably designed to . . . maintain a sound
risk management framework for comprehensively managing legal, credit,
liquidity, operational, general business, investment, custody, and
other risks that arise in or are borne by the covered clearing agency,
which . . . includes plans for the recovery and orderly wind-down of
the covered clearing agency necessitated by credit losses, liquidity
shortfalls, losses from general business risk, or any other losses.''
\10\ The Commission has previously clarified that it believes that such
recovery and wind-down plans are ``rules'' within the meaning of
Exchange Act section 19(b) and Rule 19b-4 because such plans would
constitute changes to a stated policy, practice or interpretation of a
covered clearing agency.\11\ Accordingly, a covered clearing agency,
such as LCH SA, must file its RP and WDP with the Commission.
---------------------------------------------------------------------------

    \9\ The term ``covered clearing agency'' is defined in SEC Rule
17Ad-22(a)(5), 17 CFR 240.17Ad-22(a)(5).
    \10\ 17 CFR 240.17Ad-22(e)(3)(ii).
    \11\ Standards for Covered Clearing Agencies, Securities
Exchange Act Release No. 34-78961 (Sep. 28, 2016), 81 FR 70786,
70809 (Oct. 13, 2016).
---------------------------------------------------------------------------

A. The RP (LCH SA-2017-012)

    The Commission has previously explained that the term ``recovery''
refers to action taken to allow a financial company that is non-viable
as a going concern or insolvent to sustain its critical operations and
services.\12\ To that end, LCH SA's RP seeks to maintain the continuity
of critical services in times of extreme stress and to facilitate the
recovery of LCH SA from such stress. In particular, the RP describes
(i) the scenarios and triggers for initiating recovery measures; (ii)
various recovery tools used in such recovery; and (iii) the governance
framework for managing the

RP. Each of those aspects of the RP are discussed in more detail below.
---------------------------------------------------------------------------

    \12\ Id. at 70808, n. 251.
---------------------------------------------------------------------------

    The scenarios that could necessitate the implementation of the RP
include the default of one or more clearing members, liquidity
shortfalls as a result of the default of an investment counterparty of
LCH SA or any other investment losses resulting from changes in the
market value on the investments, a loss resulting from an event which
impacts the critical services provided by LCH SA (e.g., failure in the
provision of service by a third party), loss of critical contracts with
exchanges, or the operational or financial failure of a financial
market infrastructure such as an allied clearing house or trade
repository.\13\
---------------------------------------------------------------------------

    \13\ See Notice 012, 82 FR at 60247.
---------------------------------------------------------------------------

    The default management process is used to re-establish a matched
book and return to business as usual and therefore LCH SA considers it
to be a recovery tool.\14\ When pre-funded resources, such as
defaulter's margin, defaulter's default fund contributions, LCH SA's
capital, and non-defaulters' default fund contributions, are no longer
available to meet obligations due to member and non-member losses, the
RP lists various measures or tools that LCH SA can use to return to
business as usual.\15\ The RP is organized to discuss each tool by the
nature of the loss (e.g., clearing member default losses, liquidity
shortfalls, operational, business, and investment risks). The RP also
discusses the sequence in which these tools would be used and the
relative strength of each.\16\
---------------------------------------------------------------------------

    \14\ Id.
    \15\ Id.
    \16\ Id. at 60249-60250.
---------------------------------------------------------------------------

    When pre-funded resources have been exhausted after a clearing
member default, LCH SA can call a default fund assessment up to a cap,
request voluntary payments from all non-defaulting members, and
effectuate service closure.\17\ In the event such tools are unavailable
certain other business as usual tools, such as default fund additional
margin, may enable LCH SA to collect additional resources.
---------------------------------------------------------------------------

    \17\ Id. at 60249.
---------------------------------------------------------------------------

    In the event of a liquidity shortfall, LCH SA may use its central
bank credit line to deposit securities received on behalf of defaulting
clearing members and obtain liquidity.\18\ Other potential tools to
manage a liquidity stress situation are limits with respect to illiquid
collateral, the application of increased haircuts on certain types of
collateral to incentivize the use of more liquid collateral, or
specific liquidity margins.\19\ LCH SA could also defer funding for the
settlement platform for a limited period of time but views this as a
tool of last resort.\20\
---------------------------------------------------------------------------

    \18\ Id.
    \19\ Id.
    \20\ Id.
---------------------------------------------------------------------------

    For most investment, business, and operational losses, LCH SA can
allocate its capital surplus against losses.\21\ Further down the list
of preferable recovery tools for non-clearing member defaults are the
abilities to raise capital or utilize insurance meant to cover a
specific operational risk event.\22\ For any disruption or loss of key
third-party service provider, LCH SA would be able to exercise several
contractual rights and maintains exit plans which are intended to
safeguard the continuity of services.\23\
---------------------------------------------------------------------------

    \21\ Id.
    \22\ See Notice 012, 82 FR at 60249.
    \23\ Id. at 60250.
---------------------------------------------------------------------------

    The RP discusses the governance surrounding its creation,
invocation, and operation.\24\ LCH SA relies upon its existing
governance forums for both the creation and on-going monitoring and
operation of the RP. Specifically, the LCH SA Management Committee is
responsible for the preparation of the RP and the monitoring and
implementation of the recovery tools set forth in the RP.\25\ The LCH
SA Risk Committee reviews and makes a recommendation to the Board, who
ultimately has the power to approve the RP.\26\ However, before
submission to the LCH SA Risk Committee, the RP is reviewed and
validated by the Executive Risk Committee of LCH Group.\27\
---------------------------------------------------------------------------

    \24\ Id.
    \25\ Id.
    \26\ Id.
    \27\ Id.
---------------------------------------------------------------------------

    The Default Management Group is responsible for the management of
clearing member defaults while all critical decisions are escalated and
submitted to the LCH SA Default Crisis Management Team (``DCMT'').\28\
The triggering of recovery measures is subject to discussion in the
DCMT and approval by the LCH SA CEO.\29\
---------------------------------------------------------------------------

    \28\ Id.
    \29\ Id.
---------------------------------------------------------------------------

    The management of non-clearing member events will vary based on the
nature of the event.\30\ For example, investment losses and liquidity
shortfalls are managed by the departments responsible for controlling
such risks within the parameters set by the Board.\31\ Similarly,
operational risks are managed by each business line in accordance with
the operational risk policy approved by the Board.\32\ Business risk is
managed by individual business lines, with a second line challenge
performed by the risk and finance departments to verify if sufficient
capital buffers are available for the applicable business risks.\33\
Matters are escalated to the Management Committee when the RP is
triggered and the LCH SA Board will approve implementation of the
RP.\34\
---------------------------------------------------------------------------

    \30\ Id.
    \31\ Id.
    \32\ Id.
    \33\ Id.
    \34\ Id.
---------------------------------------------------------------------------

B. The WDP (LCH SA-2017-013)

    In the event a recovery is not successful, LCH SA would invoke its
WDP to wind down its operations to full service closure in an orderly
manner, thereby minimizing the disruption to clearing members, market
participants, and the broader financial system. The WDP would be
triggered after a determination by the LCH SA Board that all the
recovery tools have been exhausted and have failed to return LCH SA to
business as usual.\35\ A voluntary wind-down not precipitated by these
extreme events would not be considered.\36\ The WDP would set forth
clear mechanisms for the transfer of LCH SA's membership and business,
and would be designed to facilitate continued access to critical
services and to minimize market impact.\37\
---------------------------------------------------------------------------

    \35\ Notice 013, 82 FR at 60239.
    \36\ Id.
    \37\ Id. at 60239-60240.
---------------------------------------------------------------------------

    The decision to wind down would be taken by the Board and
ultimately the shareholders' meeting, upon advice of the Executive Risk
Committee and Local Management Committee (``LMC'').\38\ The
implementation of the WDP would be monitored by the LCH SA LMC or
Default Crisis Management Team, the executive committee in charge of
the coordination of defaults.\39\ All relevant regulatory authorities
would be consulted before such a decision is taken, and the French
Autorit[eacute] de Contr[ocirc]le Prudentiel et de Resolution would
have to approve such a decision, unless all clearing services have
already been closed.\40\ These authorities would then be kept regularly
informed of the plan's implementation.\41\ Any decision to wind-down
while in resolution would be taken by the relevant governing resolution
authority.\42\
---------------------------------------------------------------------------

    \38\ Id. at 60239.
    \39\ Id.
    \40\ Id.
    \41\ Id.
    \42\ Id.
---------------------------------------------------------------------------

    The WDP assumes that LCH SA's businesses would be wound down until
full closure and that the closure of

various business lines could occur at different times, with some
business functions significantly scaled down or even closed by the time
the decision to wind-down is officially made.\43\ The WDP also states
that LCH SA would publish written notice to the clearing members that a
wind-down event has occurred and potential dates by which transactions
will no longer be accepted for clearing.\44\ In a non-default situation
or in a situation where the corresponding business line is still
active, LCH SA would attempt to give clearing members the maximum time
necessary to clear transactions in the normal course, close-out
positions, and switch to another central counterparty.\45\
---------------------------------------------------------------------------

    \43\ Id.
    \44\ Id. at 60239-60240.
    \45\ Id. at 60240.
---------------------------------------------------------------------------

    The WDP also provides detail about the closure of supporting
functions. For instance, the treasury function would close once all
clearing services have ceased and monies are paid by LCH SA and its
members.\46\ Any other supporting operational, information technology,
or risk functions would be kept active until all positions are
closed.\47\ Further, once the WDP is implemented, LCH SA would deposit
remaining cash in central bank accounts or invest the cash in
instruments with maturities no longer than same-day repos.\48\ The WDP
further notes that LCH SA's contractual agreements with third-party
service providers, such as information technology or venue providers,
contain wind-down provisions that permit LCH SA to exit the agreements
under particular conditions.\49\ Finally, the WDP provides citations to
its various clearing services' rule book provisions giving a legal
basis for the actions taken to effectuate the plan.\50\
---------------------------------------------------------------------------

    \46\ Id.
    \47\ Id.
    \48\ Id.
    \49\ Id.
    \50\ Id.
---------------------------------------------------------------------------

III. Proceedings To Determine Whether To Approve or Disapprove the
Proposed Rule Changes and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act to determine whether the proposed rule changes
should be approved or disapproved.\51\ Institution of proceedings is
appropriate at this time in view of the legal and policy issues raised
by the proposed rule changes. As noted above, institution of
proceedings does not indicate that the Commission has reached any
conclusions with respect to any of the issues involved. Rather, the
Commission seeks and encourages interested persons to comment on the
proposed rule changes and provide arguments to support the Commission's
analysis as to whether to approve or disapprove the proposals.
---------------------------------------------------------------------------

    \51\ 15 U.S.C. 78s(b)(2)(B) (providing that proceedings to
determine whether to disapprove a proposed rule change must be
concluded within 180 days of the date of publication of notice of
the filing of the proposed rule change. The time for conclusion of
the proceedings may be extended for up to an additional 60 days if
the Commission finds good cause for such extension and publishes its
reasons for so finding or if the self-regulatory organization
consents to the extension).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\52\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of, and input from, commenters with respect to the proposed
rule changes' consistency with the Act \53\ and the rules thereunder,
including the following provisions:
---------------------------------------------------------------------------

    \52\ 15 U.S.C. 78s(b)(2)(B).
    \53\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

     Section 17A(b)(3)(F) of the Act, which requires that the
rules of a clearing agency be designed to, among other things, assure
the safeguarding of securities and funds which are in the custody or
control of the clearing agency for which it is responsible; \54\
---------------------------------------------------------------------------

    \54\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

     Rule 17Ad-22(e)(2) under the Act, which requires that a
covered clearing agency establish, implement, maintain, and enforce
written policies and procedures reasonably designed to provide for
governance arrangements that are clear and transparent and support the
public interest requirements in Section 17A of the Act applicable to
clearing agencies, and the objectives of owners and participants; \55\
---------------------------------------------------------------------------

    \55\ 17 CFR 240.17Ad-22(e)(2).
---------------------------------------------------------------------------

     Rule 17Ad-22(e)(3)(ii) under the Act, which requires that
covered clearing agencies, among other things, ``establish, implement,
maintain and enforce written policies and procedures reasonably
designed to . . . maintain a sound risk management framework for
comprehensively managing legal, credit, liquidity, operational, general
business, investment, custody, and other risks that arise in or are
borne by the covered clearing agency, which . . . includes plans for
the recovery and orderly wind-down of the covered clearing agency
necessitated by credit losses, liquidity shortfalls, losses from
general business risk, or any other losses;'' and
     Rules 17Ad-22(e)(15)(i)-(ii),\56\ which require LCH SA to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to determine the amount of liquid net
assets funded by equity based upon its general business risk profile
and the length of time required to achieve a recovery or orderly wind-
down, as appropriate, of its critical operations and services if such
action is taken and to establish, implement, maintain and enforce
written policies and procedures reasonably designed to provide for
holding liquid net assets funded by equity equal to the greater of
either six months of its current operating expenses or the amount
determined by the board of directors to be sufficient to ensure a
recovery or orderly wind-down of critical operations and services of
the covered clearing agency, as contemplated by the plans established
under Rule 17Ad-22(e)(3)(ii).\57\
---------------------------------------------------------------------------

    \56\ 17 CFR 240.17Ad-22(e)(15)(i)-(ii).
    \57\ 17 CFR 240.17Ad-22(e)(3)(ii).
---------------------------------------------------------------------------

IV. Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues raised by the proposed rule changes. In particular, the
Commission invites the written views of interested persons concerning
whether the proposed rule changes are inconsistent with Section
17A(b)(3)(F) of the Act \58\ and Rules 17Ad-22(e)(2),\59\ 17Ad-
22(e)(3)(ii),\60\ and 17Ad-22(e)(15)(i)-(ii),\61\ under the Act, or any
other provision of the Act or rules and regulations thereunder.
---------------------------------------------------------------------------

    \58\ 15 U.S.C. 78q-1(b)(3)(F).
    \59\ 17 CFR 240.17Ad-22(e)(2).
    \60\ 17 CFR 240.17Ad-22(e)(3)(ii).
    \61\ 17 CFR 240.17Ad-22(e)(15)(i)-(ii).
---------------------------------------------------------------------------

    Although there do not appear to be any issues relevant to approval
or disapproval that would be facilitated by an oral presentation of
views, data, and arguments, the Commission will consider, pursuant to
Rule 19b-4, any request for an opportunity to make an oral
presentation.\62\
---------------------------------------------------------------------------

    \62\ Section 19(b)(2) of the Act, as amended by the Securities
Acts Amendments of 1975, Public Law 94-29, 89 Stat. 97 (1975),
grants the Commission flexibility to determine what type of
proceeding--either oral or notice and opportunity for written
comments--is appropriate for consideration of a particular proposal
by a self-regulatory organization. See Securities Acts Amendments of
1975, Report of the Senate Committee on Banking, Housing and Urban
Affairs to Accompany S. 249, S. Rep. No. 75, 94th Cong., 1st Sess.
30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposed rule changes should be
approved or disapproved on or before April 13, 2018. Any person who
wishes to file a rebuttal to any other person's

submission must file that rebuttal on or before April 27, 2018.
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 email to [email protected]. Please include
File Number SR-LCH SA-2017-012 and SR-LCH SA-2017-013 on the subject
line.

Paper Comments

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

All submissions should refer to SR-LCH SA-2017-012 and SR-LCH SA-2017-
013. These file numbers should be included on the subject line if email
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 website (http://www.sec.gov/rules/sro.shtml). Copies of the submissions, all subsequent amendments,
all written statements with respect to the proposed rule changes that
are filed with the Commission, and all written communications relating
to the proposed rule changes 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 website
viewing and printing in the Commission's Public Reference Room, 100 F
Street NE, Washington, DC 20549, on official business days between the
hours of 10:00 a.m. and 3:00 p.m. Copies of the filings also will be
available for inspection and copying at the principal office of LCH SA
and on LCH SA's website at http://www.lch.com/asset-classes/cdsclear.
All comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-LCH SA-2017-012 and
SR-LCH SA-2017-013 and should be submitted on or before April 13, 2018.
If comments are received, any rebuttal comments should be submitted on
or before April 27, 2018.
---------------------------------------------------------------------------

    \63\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\63\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-05902 Filed 3-22-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33267-33268]
[FR Doc No: 2021-13298]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2146-111; Project No. 82-000; Project No. 618-000]

Alabama Power Company, Notice of Availability of The Draft
Supplemental Environmental Impact Statement for The Coosa River
Hydroelectric Project

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for a single new license for three currently
separately licensed projects and has prepared a draft supplemental
environmental impact statement (SEIS).\1\ The single new operating
license would combine the Coosa Hydroelectric Project (FERC No. 2146),
which consists of the Weiss, H. Neely Henry, Logan Martin, Lay, and
Bouldin developments, the Mitchell Dam Hydroelectric Project (FERC No.
82), and the Jordan Dam Hydroelectric Project (FERC No. 618) as one
960.9-megawatt (MW) project, the Coosa River Hydroelectric Project
(Coosa River Project) No. 2146. The projects are located on the Coosa
River, in the states of Alabama and Georgia, and occupy about 508.31
acres of federal land administered by the U.S. Bureau of Land
Management and 5.75 acres of federal land administered by the U.S. Army
Corps of Engineers.
---------------------------------------------------------------------------

    \1\ On July 16, 2020, the Council on Environmental Quality (CEQ)
issued a final rule, Update to the Regulations Implementing the
Procedural Provisions of the National Environmental Policy Act
(Final Rule, 85 FR 43304), which was effective as of September 14,
2020; however, the NEPA review of this project was in process at
that time and was prepared pursuant to CEQ's 1978 NEPA regulations.
---------------------------------------------------------------------------

    The draft SEIS has been prepared to address the July 6, 2018
opinion issued by the United States Court of Appeals for the District
of Columbia (court) regarding the Commission's environmental review of
the Coosa River Project, and supplements the final environmental
assessment (FEA), issued December 31, 2009, for the project. The draft
SEIS focuses on the following issues identified by the court as needing
further analysis and expands upon the analysis contained within the FEA
for these issues: (1) Dissolved oxygen; (2) fish entrainment and
turbine mortality; (3) federally listed threatened and endangered
species; and (4) cumulative effects. The draft SEIS describes staff's
analysis of the applicant's proposal and the alternatives for
relicensing the project. The draft SEIS documents the views of
governmental agencies, non-governmental organizations, affected Indian
tribes, the public, the license applicant, and Commission staff.
    The Commission provides all interested persons with an opportunity
to view and/or print the draft SEIS via the internet through the
Commission's Home Page (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. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), in a Presidential
proclamation issued on March 13, 2020. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866)
208-3676, or for TTY,<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    Due to concerns with large gatherings related to COVID-19, we do
not intend to conduct public meetings for the

purpose of receiving comments on the draft SEIS. Instead, we are
soliciting written comments, which must be filed within 60 days of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments using the Commission's eFiling system at https://www.ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support. In lieu
of electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-2146-111.
    Anyone may intervene in this proceeding based on this draft SEIS
(18 CFR 380.10). You must file your request to intervene as specified
above.\2\ You do not need intervenor status to have your comments
considered.
---------------------------------------------------------------------------

    \2\ Interventions may also be filed electronically via the
internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    For further information, please contact Aaron Liberty at (202) 502-
6862 or at<EMAIL_ADDRESS>
    Dated: June 17, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-13298 Filed 6-23-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67046-67047]
[FR Doc No: 2022-24112]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0776]

Studying Multiple Versions of a Cellular or Gene Therapy Product
in an Early-Phase Clinical Trial; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Studying Multiple
Versions of a Cellular or Gene Therapy Product in an Early-Phase
Clinical Trial; Guidance for Industry.'' The guidance document provides
recommendations to sponsors interested in studying multiple versions of
a cellular or gene therapy product in an early phase clinical trial for
a single disease. Sponsors have expressed interest in gathering
preliminary evidence of safety and activity using multiple versions of
a cellular or gene therapy product in a single clinical trial, where
each version of the product is distinct and is generally submitted to
FDA in a separate investigational new drug application (IND). The
guidance provides recommendations for conducting such studies,
including how to organize and structure the INDs, submit new
information, and report adverse events. The guidance announced in this
notice finalizes the draft guidance of the same title dated September
2021.

DATES: The announcement of the guidance is published in the Federal
Register on November 7, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0776 for ``Studying Multiple Versions of a Cellular or Gene
Therapy Product in an Early-Phase Clinical Trial; Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the

claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica Gillum, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Studying Multiple Versions of a Cellular or Gene Therapy Product in
an Early-Phase Clinical Trial; Guidance for Industry.'' The guidance
document provides recommendations to sponsors interested in studying
multiple versions of a cellular or gene therapy product in an early
phase clinical trial for a single disease. Sponsors have expressed
interest in gathering preliminary evidence of safety and activity using
multiple versions of a cellular or gene therapy product in a single
clinical trial, where each version of the product is distinct and is
generally submitted to FDA in a separate IND. The objective of these
early phase clinical studies is to guide which version(s) of the
product to pursue for further development in later phase studies. Thus,
these studies are not intended to provide primary evidence of
effectiveness to support a marketing application and generally are not
adequately powered to demonstrate a statistically significant
difference in efficacy between the study arms. The guidance provides
recommendations for conducting such studies, including how to organize
and structure the INDs, submit new information, and report adverse
events.
    In the Federal Register of September 30, 2021 (86 FR 54207), FDA
announced the availability of the draft guidance entitled ``Studying
Multiple Versions of a Cellular or Gene Therapy Product in an Early
Phase Clinical Trial.'' FDA received several comments on the draft
guidance and those comments were considered as the guidance was
finalized. Changes to the guidance include clarifying how to continue
the umbrella trial after a study arm has been closed and adding
examples of changes that result in multiple versions of a cellular or
gene therapy product. In addition, editorial changes were made to
improve clarity. The guidance announced in this notice finalizes the
draft guidance of the same title dated September 2021.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Studying Multiple Versions of a Cellular
or Gene Therapy Product in an Early-Phase Clinical Trial.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 and Form FDA 1572 have been approved
under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24112 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P