[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Rules and Regulations]
[Page 49364-49368]
[DOCID:fr23au06-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0216; FRL-8087-6]

Fenpyroximate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of fenpyroximate and its z-isomer in or on hop, dried cones; almond
hulls; nut, tree, group 14; pistachio; fruit, citrus, group 10; citrus,
dried pulp; citrus, oil; peppermint, tops; and spearmint, tops.
Interregional Project Number 4 (IR-4) requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 23, 2006. Objections and
requests for hearings must be received on or before October 23, 2006,
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-2006-0216. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

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

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

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0216 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 23, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0216, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of August 10, 2005 (70 FR 46444) (FRL-7729-
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
5E6943) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ
08902-3390. The petition requested that 40 CFR 180.566 be amended by
establishing tolerances for combined residues of the insecticide/
miticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]benzoate and its Z-
isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-
4-yl)methylene]amino]oxy] methyl]benzoate, in or on almond hulls at 1.8
parts per million (ppm); nut, tree, group 14 at 0.1 ppm; pistachio at
0.1 ppm; fruit, citrus, group 10; citrus at 0.4 ppm, fruit, citrus,
dried pulp at 2.5

ppm; citrus, oil at 15 ppm; hop at 4.5 ppm; peppermint, tops at 3.0
ppm; and spearmint, tops at 3.0 ppm. That notice included a summary of
the petition prepared by Nichino America, the registrant. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C. below.
    Following review of the residue chemistry data, EPA determined that
the commodity terms and tolerance levels should be revised to the
following: Almond, hulls at 3.0 ppm; hop, dried cones at 10 ppm ; nut,
tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; fruit, citrus, group
10 at 0.60 ppm; fruit, citrus, dried pulp revised to read citrus,
dried, pulp at 2.5 ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0
ppm; and spearmint, tops at 7.0 ppm.
    Time-limited tolerances for grape, wine and hop (currently revised
to hop, dried cones) have expired under 40 CFR 180.566(a)(1). Permanent
tolerances have been established for these commodities; therefore,
grape, wine and hop, dried cones will be added to 40 CFR 180.566(a)(2).
The petitioner for hop, dried cones has requested a domestic
registration; therefore, footnote 1 to the table in Sec.  180.566(a)(2)
which reads ``There are no U.S. registration on hops'' has been
removed. In addition, registrations for citrus fruits, hops, mint, tree
nuts (including pistachio) have been deemed as conditional and are
contingent upon submission of required additional data.
    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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of
fenpyroximate and its z-isomer on almond, hulls at 3.0 ppm; hop, dried
cones at 10 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10
ppm; fruit, citrus, group 10 at 0.60 ppm; citrus, dried, pulp at 2.5
ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0 ppm; and spearmint,
tops at 7.0 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerances follow.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by fenpyroximate 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
, Docket No. EPA-HQ-OPP-2004-0174-0001, pages 2-4.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect 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.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for fenpyroximate used for
human risk assessment is discussed at http://www.regulations.gov,

Docket No. EPA-HQ-OPP- 2005-0216-0001; pages 14-15.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established in 40 CFR 180.566(a)(2) for the combined residues of
fenpyroximate and its z-isomer, in or on a variety of raw agricultural
commodities. Risk assessments were conducted by EPA to assess dietary
exposures from fenpyroximate 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 one-day or single exposure.
     An unrefined, Tier I acute dietary-exposure assessment was
conducted for females 13 to 49 years old. The unrefined, Tier I acute
analyses assumed that fenpyroximate residues were present in all
commodities at tolerance levels and that 100% of all commodities
(registered and proposed uses) are treated. Adequate processing data on
apples, grapes, oranges and mint are available. Modified processing
factors based on these data were used for apple juice, pear juice,
grape juice, raisins, citrus juice (orange, grapefruit, lemon and lime)
and mint oils (peppermint and spearmint). The Dietary Exposure
Evaluation Model (DEEMTM) default processing factors were
used for all other processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Data base (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The

following assumptions were made for the chronic exposure assessments:
An unrefined, Tier I chronic dietary exposure assessment was conducted
for the general U.S. population, and various population subgroups. The
unrefined, Tier I chronic analyses assumed that fenpyroximate residues
were present in all commodities at tolerance levels and that 100% of
all commodities (registered and proposed uses) are treated. Adequate
processing data on apples, grapes, oranges and mint are available.
Modified processing factors based on these data were used for apple
juice, pear juice, grape juice, raisins, citrus juice (orange,
grapefruit, lemon and lime) and mint oils (peppermint and spearmint).
DEEM\TM\ default processing factors were used for all other processed
commodities.
    iii. Cancer. Fenpyroximate is classified as ``not likely to be a
human carcinogen.'' Therefore, a cancer dietary exposure assessment was
not performed.
    2. Dietary exposure from drinking water. The Agency determined in
addition to the parent compound (M-1), the M-3 metabolite should be
included in the drinking water assessment for fenpyroximate. Based on
the proposed application rates and the environmental fate properties of
fenpyroximate, some surface and ground water contamination may occur.
However, the risk of water contamination from parent compound is
relatively low, based on its high sorption potential. Unlike parent
compound, the sorption of the M-3 metabolite is much less, and it may
move into water resources more readily. Environmental fate data
indicate that parent and its Z-isomer are stable to photolysis in soil
and immobile in soil. Major degradates formed in the aqueous layer were
M-3 (50%), M-8 (36%), M-16 (4-hydroxymethylbenzoic acid, 58%) and M-11
(25 to 30%), and M-3 (>10%), M-11 (25 to 30%) and M8 (16 to 19%) in the
soil. However, data from a field dissipation study showed M3 (32%)
being the only significant degradate found in the field. Based on the
structural similarity between parent and M-3, the Agency concluded that
parent and M-3 be included in the risk assessment.
     Based on Tier II screening-level surface water modeling for
drinking water, the Agency estimated concentrations in surface water to
be used for acute, chronic non-cancer, and cancer exposure assessment.
Tier II surface water concentrations for parent fenpyroximate and M-3
were calculated using the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM-EXAMS). The acute, and chronic non-cancer
concentrations for GA pecan (highest exposure) are 12.9 and 1.8
microgram/liter, respectively. EPA used the Screening Concentration in
Ground Water model (SCI-GROW2) to estimate a groundwater concentration
of 0.059 parts per billion (ppb). These results for both surface water
and ground water are consistent with the fate and transport properties
of fenpyroximate.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID). For the acute
assessment, the peak concentration of 12.9 ppb was used to access the
contribution to drinking water; for the chronic assessment, the annual
mean value of 1.8 ppb was used to access the contribution to drinking
water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Fenpyroximate is not
registered for use on any sites that would result in residential
exposure.
    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.'' Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to fenpyroximate and any other substances and fenpyroximate
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that fenpyroximate has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see 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 Web site at
http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. 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 safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The rat and rabbit
developmental-toxicity studies were tested at doses that produced
minimal maternal toxicity at best. These doses were supported partly by
range finding data. The two generation reproductive-toxicity study
indicated that maternal (decreased body weight) and offspring toxicity
(decreased lactational weight gain) occurred at the same dose,
suggesting no evidence of sensitivity or susceptibility. Reproductive
parameters were not affected in this 2-generation reproduction study.
There are no neurotoxicity studies other than a negative delayed acute-
neurotoxicity study in the hen. There was no indication of
neurotoxicity present in any of the existing subchronic or chronic
toxicity studies. The toxicology data base is complete for FQPA
purposes and that there are no residual uncertainties for prenatal/
postnatal toxicity.
    3. Conclusion. There is a complete toxicity data base for
fenpyroximate and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children should be changed to 1X
for the following reasons:
    i. There are no concerns or residual uncertainties for prenatal or
postnatal toxicity.
    ii. The toxicological data base is complete for the assessment of
toxicity and susceptibility following prenatal and/or postnatal
exposures. No clinical

signs of neurotoxicity or neuropathology were observed in the data
base.
    iii. There are no residual concerns regarding completeness of the
exposure data base.
    iv. The dietary food exposure assessment is Tier I, screening
level, which is based on tolerance level residues and assumes 100% of
all crops will be treated with fenpyroximate. By using these screening-
level assessments, actual exposures/risks will not be underestimated.
    v. The dietary drinking water assessment utilizes water
concentration values generated by models and associated modeling
parameters which are designed to provide conservative, health-
protective, high-end estimates of water concentrations which will not
likely be exceeded.
    vi. There are currently no registered or proposed residential uses
of fenpyroximate.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An unrefined, acute dietary-exposure assessment was
conducted for females 13 to 49 years old. Since an effect of concern
attributable to a single dose in toxicity studies was not identified
for the general U.S. population, an acute dietary-exposure assessment
was not performed for this population. Using the exposure assumptions
discussed in this unit for acute exposure, the acute dietary exposure
from food and water to fenpyroximate will occupy 6.8% of the acute
population adjusted dose (aPAD) for females 13 years and older. EPA
does not expect the aggregate exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fenpyroximate from food and water will utilize 9.8% of the chronic
adjusted population dose (cPAD) for the U.S. population, 20% of the
cPAD for all infants <  1 year old, and 34% of the cPAD for children 1
to 2 years old. There are no residential uses for fenpyroximate that
result in chronic residential exposure to fenpyroximate. Therefore, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD.
    3. Aggregate cancer risk for U.S. population. Fenpyroximate has
been classified as not likely to be carcinogenic to humans. Therefore,
fenpryroximate is expected to pose at most a negligible cancer risk.
    4. 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, and to infants and children from aggregate
exposure to fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An enforcement method has been developed which involves extraction
of fenpyroximate from crops with acetone, filtration, partitioning and
cleanup, and analysis by gas chromatography using a nitrogen/
phosphorous detector. This method allows detection of residues at or
above the proposed tolerances. The method has undergone independent
laboratory validation.

B. International Residue Limits

    Codex maximum residue limits (MRLs) are established for residues of
fenpyroximate per se in/on apple, grapes, hops, oranges, and cattle
commodities. The Codex MRLs differ from the proposed and established
tolerances for all commodities except hops. Harmonization with the
other Codex MRLs is not possible because the U.S. tolerance expressions
include additional metabolites/isomers. There are currently no
established Canadian or Mexican MRLs.

C. Response to Comments

    Comments were received from a private citizen in Florham Park, New
Jersey. The comments were in response to the notice of filing published
in the Federal Register of August 10, 2005 (70 FR 46444) (FRL-7729-3).
The commenter opposes the establishment of any food tolerances (greater
than zero) and exemptions. However, under the existing legal framework
provided by section 408 of the FFDCA, EPA is authorized to establish
pesticide tolerances or exemptions where persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. The commenter also believes
IR-4 and Rutgers University are profiteering, and expressed concerns
about the Agency's partnership with IR-4. This comment was earlier
addressed in the Federal Register of June 30, 2005 (70 FR 37683) (FRL-
7718-3).

V. Conclusion

    Therefore, the tolerances are established for combined residues of
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl) methylene] amino]oxy]methyl]benzoate and its Z-isomer,
(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene] amino]oxy]methyl]benzoate, in or on almond, hulls at 3.0
ppm; hop, dried cones at 10 ppm; nut, tree, group 14 at 0.10 ppm;
pistachio at 0.10 ppm; fruit, citrus, group 10 at 0.60 ppm; citrus,
dried, pulp at 2.5 ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0
ppm; and spearmint, tops at 7.0 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 due to its lack of
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled

Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 11, 2006.
Donald R. Stubbs,
Acting 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 180.566 is amended by removing paragraph (a)(1), by
redesignating paragraph (a)(2) as paragraph (a)(1), by revising the
table in newly redesignated paragraph (a)(1), and by redesignating
paragraphs (a)(3) and (a)(4) as paragraphs (a)(2) and (a)(3),
respectively, to read as follows:

Sec.  180.566   Fenpyroximate; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................             3.0
Citrus, dried pulp......................................             2.5
Citrus, oil.............................................              10
Cotton, gin byproducts..................................              10
Cotton undelinted seed..................................            0.10
Fruit, citrus, group 10.................................            0.60
Fruit, pome, group 11...................................            0.40
Grape...................................................             1.0
Hop, dried cones........................................              10
Nut, tree, group 14.....................................            0.10
Peppermint, tops........................................             7.0
Pistachio...............................................            0.10
Spearmint, tops.........................................             7.0
------------------------------------------------------------------------

* * * * *

[FR Doc. E6-13761 Filed 8-22-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Notices]
[Page 45296]
[FR Doc No: 2020-16228]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2020-0047]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on June 12, 2020, the National
Railroad Passenger Corporation (Amtrak) petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR part
238, Passenger Equipment Safety Standards. FRA assigned the petition
Docket Number FRA-2020-0047.
    Amtrak requests relief from the requirements of 49 CFR 238.121,
Emergency communication, for a new fleet of Viewliner II sleeping cars.
Each new passenger car must be equipped with an intercom system at each
half end of the car that provides a means for passengers and
crewmembers to communicate by voice during an emergency. Amtrak's
Viewliner II cars are configured with two passenger emergency intercoms
(PEIs): one located in the hallway at the car's A-end and the other
inside the Americans with Disabilities Act (ADA) bedroom at the car's
B-end. Amtrak states that it believes this arrangement meets the
requirements for a PEI at each end of the car. However, because the PEI
on the B-end of the vehicle is located inside the ADA bedroom, which is
not readily accessible to all passengers on that car end, the PEI is
not compliant with the regulation.
    Amtrak explains it is working with Ultra-Tech Enterprises, the
current PEI vendor, to develop the scope of work and cost of
installation of a fully accessible PEI in each car's B-end hallway. The
modification will be made as the cars are delivered, and all cars are
expected to be delivered and modified within two years.
    However, Amtrak wishes to place the cars into service before the
modification is complete, as waiting will shorten the warranty period
of the vehicles, while still incurring costs to perform periodic
maintenance and delay Amtrak the opportunity to offer a new product
that may attract passengers during the current economic hardship. Until
the modification is complete, Amtrak proposes to install signage that
will inform passengers of the PEI locations.
    Amtrak also states that the current cars' configuration is similar
to the configuration of the Viewliner I equipment, which has operated
safely without an emergency two-way communication device, as it was
built before the current regulation went into effect.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. If any interested
parties desire an opportunity for oral comment and a public hearing,
they should notify FRA, in writing, before the end of the comment
period and specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, W12-140, Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by September 10, 2020 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its processes. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2020-16228 Filed 7-24-20; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Proposed Rules]
[Pages 37195-37198]
[FR Doc No: 2019-16320]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1986-0005; FRL-9997-61-Region 9]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Intel Corp. (Santa Clara III)
Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of intent.

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SUMMARY: The Environmental Protection Agency (EPA) Region 9 is issuing
a Notice of Intent to Delete the Intel Corp. (Santa Clara III)
Superfund Site (Site) located in Santa Clara, California, from the
National Priorities List (NPL) and requests public comments on this
proposed action. The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an appendix of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP). EPA and the
State of California, through the San Francisco Regional Water Quality
Control Board (RWQCB), have determined that all appropriate response
actions under CERCLA have been completed. However, this deletion does
not preclude future actions under Superfund.

DATES: Comments must be received by August 30, 2019.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1986-0005, by one of the following methods:
     http://www.regulations.gov Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. The EPA may publish any comment received
to its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or

multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
     Email: Project Manager<EMAIL_ADDRESS>or Community
Involvement Coordinator<EMAIL_ADDRESS>     Mail: Holly Hadlock (SFD-7-3), U.S. EPA, 75 Hawthorne
Street, San Francisco, CA 94105.
     Hand delivery: Superfund Records Center, U.S. EPA, 75
Hawthorne Street, San Francisco, California. Such deliveries are
accepted only during EPA's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
1986-0005. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be CBI or
other information whose disclosure is restricted by statute. Do not
submit information that you consider to be CBI or otherwise protected
through http://www.regulations.gov or email. The http://www.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 email comment
directly to EPA without going through http://www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public 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 http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statue. Certain other material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the
following repositories:
    Superfund Records Center, 75 Hawthorne Street Room 3110, San
Francisco, California, Hours: 8:00 a.m.-4:00 p.m.;<PHONE_NUMBER>
    Site Repository: Santa Clara City Library, 2635 Homestead Road,
Santa Clara, California. Call<PHONE_NUMBER> for hours of operation.

FOR FURTHER INFORMATION CONTACT: Holly Hadlock, Project Manager, U.S.
EPA, Region 9 (SFD-7-3), 75 Hawthorne Street, San Francisco, CA 94105,
(415) 972-3171, email: [email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents:

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Intended Site Deletion

I. Introduction

    EPA Region 9 announces its intent to delete the Intel Corp. (Santa
Clara III) Superfund Site from the National Priorities List (NPL) and
requests public comment on this proposed action. The NPL constitutes
Appendix B of 40 CFR part 300 which is the National Oil and Hazardous
Substances Pollution Contingency Plan (NCP), which EPA promulgated
pursuant to section 105 of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA) of 1980, as amended. EPA
maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment. Sites
on the NPL may be the subject of remedial actions financed by the
Hazardous Substance Superfund (Fund). As described in 40 CFR
300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible
for Fund-financed remedial actions if future conditions warrant such
actions.
    EPA will accept comments on the proposal to delete this Site for
thirty (30) days after publication of this document in the Federal
Register.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses procedures that EPA is using
for this action. Section IV discusses the Site and demonstrates how it
meets the deletion criteria.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the State, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. all appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. the remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) EPA consulted with the State before developing this Notice of
Intent to Delete;
    (2) EPA has provided the State 30 working days for review of this
notice prior to publication of it today;
    (3) In accordance with the criteria discussed above, EPA has
determined that no further response is appropriate;
    (4) The State of California, through the RWQCB, has concurred with
deletion of the Site from the NPL;
    (5) Concurrently with the publication of this Notice of Intent to
Delete in the Federal Register, a notice is being published in a local
newspaper, The Santa Clara Weekly. The newspaper notice announces the
30-day public comment period concerning the Notice of Intent to Delete
the Site from the NPL; and
    (6) EPA placed copies of documents supporting the proposed deletion
in the deletion docket and made these items available for public
inspection and copying at the Site information repositories identified
above.
    If comments on this document are received within the 30-day public
comment period, EPA will evaluate and respond appropriately to the
comments before making a final decision to delete. If necessary, EPA
will prepare a Responsiveness Summary to address any significant public
comments received. After the public comment period, if EPA determines
it is still appropriate to delete the Site, the Regional Administrator
will publish a final Notice of Deletion in the Federal Register. Public
notices, public submissions and copies of the Responsiveness Summary,
if prepared, will be made available to interested parties and in the
Site information repositories listed above.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any

individual's rights or obligations. Deletion of a site from the NPL
does not in any way alter EPA's right to take enforcement actions, as
appropriate. The NPL is designed primarily for informational purposes
and to assist EPA management. Section 300.425(e)(3) of the NCP states
that the deletion of a site from the NPL does not preclude eligibility
for future response actions, should future conditions warrant such
actions.

IV. Basis for Site Deletion

    The following information provides EPA's rationale for deleting the
Site from the NPL.

Site Background and History

    The Site (CERCLIS ID # CAT000612184) is located at 2880
Northwestern Parkway in the City of Santa Clara, Santa Clara County,
California, approximately six miles south of the San Francisco Bay. The
Site is approximately four acres in size. Intel Corporation (Intel)
performed quality control of chemicals and electrical testing of
semiconductors at the Site from 1976 to 2008. Volatile organic
compounds (VOCs), primarily trichloroethene (TCE), were detected in
shallow groundwater at the Site starting in 1982. Waste solvents were
managed in a drum storage area and acid neutralization system located
outdoors in the area of groundwater contamination and may have been the
source of the groundwater VOCs; however, no evidence of a source was
found in Site soil or soil gas. On October 15, 1984, the Site was
proposed for NPL listing (49 FR 40320). On June 10, 1986, EPA added the
Site to the NPL (51 FR 21072). Prior to the Site's listing on the NPL,
the acid neutralization system and drum storage area were removed and a
two-well groundwater extraction and treatment system (GWTS) was
installed and put into operation.

Ongoing Development

    The Site is zoned for light industrial use and is in an industrial
park, dominated by the electronics industry, particularly semiconductor
manufacturing. Since 2010, the Site has been owned by Vantage Data
Center as part of its 18-acre Santa Clara campus, which is under
redevelopment.

Remedial Investigation and Feasibility Study (RI/FS)

    The Remedial Investigation (RI) was completed in 1989 and included
investigation of groundwater, soil, and soil gas. Based on the RI, EPA
concluded that only VOCs in shallow (less than 30 feet deep)
groundwater required cleanup. By 1990 the only contaminant above
drinking water standards was TCE. Indoor air was sampled in 2010 and
EPA determined that there is no unacceptable risk of TCE vapor
intrusion.
    EPA completed the Feasibility Study (FS) in early 1990. The FS
evaluated four alternatives: (1) No further action; (2) continued
operation of the existing two-well GWTS, groundwater monitoring, and
implementation of a deed restriction; (3) cyclic operation of the
existing two-well GWTS, groundwater monitoring, and implementation of a
deed restriction; and (4) addition of a third extraction well and
cyclic operation of the expanded GWTS, groundwater monitoring, and
implementation of a deed restriction.

Selected Remedy

    The Record of Decision (ROD) was issued on September 20, 1990, and
Alternative 4 was the selected remedy. As described above, this remedy
included modifications to and continued operation of the existing GWTS
and implementation of a deed restriction for shallow groundwater use.
    The remedial action objectives for the remedy selected in the 1990
ROD was to restore the groundwater to maximum contaminant levels
(MCLs); prevent migration of contaminants in the groundwater; prevent
any exposure of the public to contaminated groundwater; and restore the
A-zone groundwater to drinking water quality. Although the 1990 ROD
listed MCL cleanup criteria for nine different VOCs, only TCE remained
above the MCL when the ROD was issued.
    A ROD Amendment was signed on September 7, 2010, modifying the
previously selected remedy for the Site, but leaving intact the 1990
ROD's RAO of restoring groundwater to its beneficial use as drinking
water. The amended remedy included the deed restriction already
recorded for the Site and monitored natural attenuation (MNA) to
achieve groundwater clean-up standards.

Response Actions

    The remedy selected in the 1990 ROD remedy was implemented in 1991.
By 1995 the GWTS was no longer effective at reducing groundwater TCE
concentrations and was shut down with RWQCB approval. In 2005, an in-
situ chemical oxidation (ISCO) pilot test was implemented, but it also
did not achieve the MCL in all wells. In January 2008, a new and
expanded deed restriction was recorded. In addition to restricting
extraction of groundwater, this new deed restriction included
specifications that no residences, hospitals, schools, or daycare
centers could be built at the Site and that no excavations greater than
three feet bgs were allowed without RWQCB approval. In 2016, a pilot
study using injected colloidal activated carbon was implemented for in
situ adsorption of the low (less than 10 micrograms per liter) and
localized (two monitoring wells) TCE concentrations above the MCL that
remained in shallow groundwater. Follow-up injections were conducted
near one of these two monitoring wells in 2017.

Cleanup Levels

    Following the 2016-2017 pilot study, groundwater monitoring was
conducted periodically in the two monitoring wells that previously had
groundwater TCE concentrations above the MCL. These groundwater
monitoring data were evaluated using EPA statistical tools for
assessing completion of groundwater restoration. EPA determined that
the RAO (i.e., groundwater restoration to drinking water standards) had
been attained at the Site based on: (1) TCE concentrations in these two
monitoring wells were below MCLs; (2) TCE concentrations in these two
monitoring wells were expected to remain below MCLs; and, (3)
groundwater VOCs in all other Site monitoring wells had been
consistently below MCLs for at least seven years.

Operation and Maintenance

    Under the MNA remedy, the operation, maintenance, and monitoring
included periodic groundwater monitoring and maintenance of the deed
restriction. The 2008 deed restriction was signed by Intel and the
RWQCB and was recorded with Santa Clara County by Intel. Because
cleanup is now complete at the Site, the deed restriction is being
terminated, groundwater monitoring has been discontinued, the
monitoring wells have been properly closed under Santa Clara Valley
Water District (SCVWD) permit, and monitoring and maintenance have been
discontinued.

Five-Year Reviews

    EPA conducts reviews every five years to determine if remedies are
functioning as intended and if they continue to be protective of human
health and the environment. EPA issued the Fifth Five-Year Review
Report on August 4, 2016, and concluded that the remedy at the Intel
Santa Clara 3 Site is protective of human health and the environment.
At that time, groundwater contamination had been reduced to below the
MCLs in all but a very limited

area, and any potential exposures were controlled through the deed
restriction. No future five-year reviews are needed because the MCL
cleanup goals have been attained throughout the Site, all monitoring
wells have been closed, and the deed restriction is being terminated.

Community Involvement

    EPA held community meetings before and during the Site cleanup,
most recently in 2009. EPA released a fact sheet shortly before
publication of this Notice informing the community of the proposal to
delete the surface soil portion of the Site from the NPL and how to
submit comments.

Determination That the Site Meets the Criteria for Deletion in the NCP

    EPA has followed all procedures required by 40 CFR 300.425(e),
Deletion from the NPL. EPA consulted with the State of California prior
to developing this Notice. EPA determined that the responsible party
has implemented all appropriate response actions required and that no
further response action for the Site is appropriate. EPA is publishing
a notice in a local newspaper, The Santa Clara Weekly, of its intent to
delete the Site and how to submit comments. EPA placed copies of
documents supporting the proposed deletion in the Site information
repositories; these documents are available for public inspection and
copying.
    The implemented groundwater remedy achieved the degree of cleanup
and protection specified in the ROD for the Site. The selected remedial
action objectives and associated cleanup levels for the groundwater are
consistent with agency policy and guidance. Based on information
currently available to EPA, no further Superfund response is needed to
protect human health and the environment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p.306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p.351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

Dated: July 23, 2019.
Michael B. Stoker
Regional Administrator, Region 9.
[FR Doc. 2019-16320 Filed 7-30-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Notices]
[Pages 17724-17725]
[FR Doc No: 2013-06639]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30427; File No. 812-14114]

Ivy Funds Variable Insurance Portfolios, et al.; Notice of
Application

March 15, 2013 .
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from rule 12d1-2(a)
under the Act.

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Summary of Application: Applicants request an order to permit open-end
management investment companies relying on rule 12d1-2 under the Act to
invest in certain financial instruments.

Applicants: Ivy Funds Variable Insurance Portfolios (the ``Trust''),
Waddell & Reed Investment Management Company (``WRIMCO''), and Waddell
& Reed, Inc. (``W&R'').

Filing Dates: The application was filed on January 18, 2013.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on April 9, 2013, and should be accompanied by proof of service on
applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Hearing requests should state the nature of the writer's
interest, the reason for the request, and the issues contested. Persons
who wish to be notified of a hearing may request notification by
writing to the Commission's Secretary.

ADDRESSES: Elizabeth M. Murphy, Secretary, Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants,
6300 Lamar Avenue, Overland Park, Kansas 66202-4200.

FOR FURTHER INFORMATION CONTACT: Bruce R. MacNeil, Senior Counsel, at
(202) 551-6817, or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Trust is a Delaware statutory trust registered under the Act
as an open-end management investment company. WRIMCO, a Kansas
corporation, is an investment adviser registered under the Investment
Advisers Act of 1940, as amended (the ``Advisers Act'') and serves as
investment adviser to the Trust. W&R is organized as a Delaware
corporation, and is a registered broker-dealer under the Securities
Exchange Act of 1934, as amended (``1934 Act''); W&R is the principal
underwriter of the Trust.
    2. Applicants request the exemption to the extent necessary to
permit any existing or future series of the Trust and any other
registered open-end management investment company or series thereof
that (i) is advised by WRIMCO or any person controlling, controlled by
or under common control with WRIMCO (any such adviser or WRIMCO, an
``Adviser''),\1\ (ii) is in the same group of investment companies, as
defined in section 12(d)(1)(G) of the Act, as the Trust and invests in
other registered open-end management investment companies in that same
group (``Underlying Funds'') in reliance on section 12(d)(1)(G) of the
Act; and (iii) is also eligible to invest in securities (as defined in
section 2(a)(36) of the Act) in reliance on rule 12d1-2 under the Act
(each a ``Fund of Funds''), to also invest, to the extent consistent
with its investment objectives, policies, strategies and limitations,
in financial

instruments that may not be securities within the meaning of section
2(a)(36) of the Act (``Other Investments'').\2\ Applicants also request
that the order exempt W&R and any entity, including any entity
controlled by or under common control with an Adviser, that in the
future acts as principal underwriter, or broker or dealer (if
registered under the 1934 Act) with respect to the transactions
described in the application.
---------------------------------------------------------------------------

    \1\ Any other Adviser also will be registered under the Advisers
Act.
    \2\ Every existing entity that currently intends to rely on the
requested order is named as an applicant. Any existing or future
entity that relies on the order in the future will do so only in
accordance with the terms and condition in the application.
---------------------------------------------------------------------------

    3. Consistent with its fiduciary obligations under the Act, the
Trust's board of trustees will review the advisory fees charged by the
Fund of Funds' Adviser to ensure that they are based on services
provided that are in addition to, rather than duplicative of, services
provided pursuant to the advisory agreement of any investment company
in which the Fund of Funds may invest.

Applicants' Legal Analysis

    1. Section 12(d)(1)(A) of the Act provides that no registered
investment company (``acquiring company'') may acquire securities of
another investment company (``acquired company'') if such securities
represent more than 3% of the acquired company's outstanding voting
stock or more than 5% of the acquiring company's total assets, or if
such securities, together with the securities of other investment
companies, represent more than 10% of the acquiring company's total
assets. Section 12(d)(1)(B) of the Act provides that no registered
open-end investment company may sell its securities to another
investment company if the sale will cause the acquiring company to own
more than 3% of the acquired company's voting stock, or cause more than
10% of the acquired company's voting stock to be owned by investment
companies and companies controlled by them.
    2. Section 12(d)(1)(G) of the Act provides, in part, that section
12(d)(1) will not apply to securities of an acquired company purchased
by an acquiring company if: (i) The acquired company and acquiring
company are part of the same group of investment companies; (ii) the
acquiring company holds only securities of acquired companies that are
part of the same group of investment companies, government securities,
and short-term paper; (iii) the aggregate sales loads and distribution-
related fees of the acquiring company and the acquired company are not
excessive under rules adopted pursuant to section 22(b) or section
22(c) of the Act by a securities association registered under section
15A of the 1934 Act, or by the Commission; and (iv) the acquired
company has a policy that prohibits it from acquiring securities of
registered open-end investment companies or registered unit investment
trusts in reliance on section 12(d)(1)(F) or (G) of the Act.
    3. Rule 12d1-2 under the Act permits a registered open-end
investment company or a registered unit investment trust that relies on
section 12(d)(1)(G) of the Act to acquire, in addition to securities
issued by another registered investment company in the same group of
investment companies, government securities, and short-term paper: (i)
Securities issued by an investment company that is not in the same
group of investment companies, when the acquisition is in reliance on
section 12(d)(1)(A) or 12(d)(1)(F) of the Act; (ii) securities (other
than securities issued by an investment company); and (iii) securities
issued by a money market fund, when the investment is in reliance on
rule 12d1-1 under the Act. For the purposes of rule 12d1-2,
``securities'' means any security as defined in section 2(a)(36) of the
Act.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction from any provision of the Act, or
from any rule under the Act, if such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policies and
provisions of the Act.
    5. Applicants state that each Funds of Funds will comply with rule
12d1-2 under the Act, except to the extent it may invest a portion of
its assets in Other Investments. Applicants request an order under
section 6(c) of the Act for an exemption from rule 12d1-2(a) to allow
the Funds of Funds to invest in Other Investments while investing in
Underlying Funds. Applicants assert that permitting the Funds of Funds
to invest in Other Investments as described in the application would
not raise any of the concerns that the requirements of section 12(d)(1)
were designed to address.

Applicants' Condition

    Applicants agree that any order granting the requested relief will
be subject to the following condition:
    Applicants will comply with all provisions of rule 12d1-2 under the
Act, except for paragraph (a)(2) to the extent that it restricts any
Fund of Funds from investing in Other Investments as described in the
application.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-06639 Filed 3-21-13; 8:45 am]
BILLING CODE 8011-01-P