[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Pages 19934-19935]
[FR Doc No: 2018-09636]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-1509]

Food Additives Permitted in Feed and Drinking Water of Animals;
Marine Microalgae

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of dried marine
microalgae as a source of docosahexaenoic acid (DHA) for use in
complete, dry foods for adult dogs. This action is in response to a
food additive petition filed by DSM Nutritional Products.

DATES: This rule is effective May 7, 2018. See section V of this
document for further information on the filing of objections. Submit
either electronic or written objections and requests for a hearing on
the final rule by June 6, 2018.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before June
6, 2018. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of June 6, 2018.
Objections received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-F-1509 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Marine Microalgae.'' Received objections, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies in total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of objections. The second copy, which
will have the claimed confidential information redacted/

blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your objections and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper objections received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224),
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of October 16, 2014
(79 FR 62090), FDA announced that we had filed a food additive petition
(animal use) (FAP 2288) submitted by DSM Nutritional Products, 45
Waterview Blvd., Parsippany, NJ 07054. The petition proposed that the
regulations for food additives permitted in feed and drinking water of
animals be amended to provide for the safe use of Schizochytrium sp.
dried marine microalgae as a source of DHA for use in complete, dry
foods for adult dogs.

II. Conclusion

    FDA concludes that the data establish the safety and utility of
Schizochytrium sp. dried marine microalgae as a source of DHA for use
in complete, dry foods for adult dogs and that the food additive
regulations should be amended as set forth in this document. This is
not a significant regulatory action subject to Executive Order 12866.

III. Public Disclosure

    In accordance with Sec.  571.1(h) (21 CFR 571.1(h)), the petition
and documents we considered and relied upon in reaching our decision to
approve the petition will be made available for inspection at the
Center for Veterinary Medicine by appointment with the information
contact person (see FOR FURTHER INFORMATION CONTACT). As provided in
Sec.  571.1(h), we will delete from the documents any materials that
are not available for public disclosure before making the documents
available for inspection.

IV. Analysis of Environmental Impact

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

V. Objections and Hearing Requests

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

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
573 is amended as follows:

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

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

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

0
2. Add Sec.  573.615 to subpart B to read as follows:

Sec.  573.615  Marine microalgae.

    The food additive, marine microalgae, may be safely used as a
source of docosahexaenoic acid (DHA) and other omega-3 fatty acids in
accordance with the following prescribed conditions:
    (a) The additive is dried whole cells of nonviable, nontoxigenic,
nonpathogenic Schizochytrium sp. algae grown as a pure culture.
    (b) The additive is used in complete, dry adult maintenance food
for dogs in accordance with good manufacturing and feeding practices
not to exceed 16.5 pounds per ton (7.5 kilograms (kg) per 1000 kg) of
complete, dry, adult maintenance dog food.
    (c) The additive consists of not less than 17.0 percent
(4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid
(docosahexaenoic acid or DHA).
    (d) The additive meets the following specifications:
    (1) Not less than 40 percent crude fat;
    (2) Not more than 12 percent ash;
    (3) Not more than 8 percent unsaponifiable matter;
    (4) Not more than 5 percent insoluble impurities;
    (5) Not more than 5 percent free fatty acids; and
    (6) Not more than 6 percent water.
    (e) To ensure the safe use of the additive, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and
complete feed, shall contain the name of the additive, marine
microalgae.
    (2) The label and labeling of the additive and any feed premix
shall also contain:
    (i) A statement to indicate that the maximum use level of the
additive shall not exceed 16.5 pounds per ton (7.5 kg per 1000 kg) of
complete, dry, adult maintenance dog food.
    (ii) Adequate directions for use.

    Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09636 Filed 5-4-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Rules and Regulations]
[Pages 30625-30630]
[FR Doc No: 2015-12938]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0303; FRL-9927-75]

Mesotrione; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
mesotrione in or on almond, hulls, fruit, citrus, group 10-10; fruit,
pome, group 11-10; fruit, stone, group 12-12; and nut, tree, group 14-
12. Syngenta Crop Protection, LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 29, 2015. Objections and
requests for hearings must be received on or before July 28, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0303, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0303 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 28, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0303, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online

instructions for submitting comments. Do not submit electronically any
information you consider to be CBI or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 2, 2014 (79 FR 44729) (FRL-
9911-67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8240) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR part 180.571 be amended by
establishing tolerances for residues of the herbicide, mesotrione, in
or on citrus fruit, crop group 10-10 at 0.01 parts per million (ppm);
pome fruit, crop group 11-10 at 0.01 ppm; stone fruit, crop group 12-12
at 0.01 ppm; tree nuts, crop group 14-12 at 0.01 ppm; and almond hulls
at 0.015 ppm. That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC the registrant, which is
available in the docket, http://www.regulations.gov. Comments were
received in response to the notice of filing. EPA's response to these
comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance for residues of mesotrione in or on fruit,
citrus, group 10-10 at 0.01 ppm; fruit, pome, group 11-10 at 0.01 ppm;
fruit, stone, group 12-12 at 0.01 ppm; nut, tree, group 14-12 at 0.01
ppm; and almond, hulls at 0.02 ppm. The reason for these changes are
explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    In subchronic and chronic oral studies in the rat, mouse, and dog,
mesotrione produced ocular (ocular discharge and corneal abnormalities
and lesions), kidney (increased organ weights), and liver effects
(increased organ weights and hepatocyte fat vacuolation), which are
consistent with the mammalian toxicity profile for
hydroxyphenylpyruvate dioxygenase (HPPD) inhibitors caused by high
tyrosine levels in the blood. Body-weight decrements and decreased food
consumption were also noted in mice and rats in multiple studies. Even
though the rat was found to be the most sensitive species for these
effects, the mouse was identified as a more appropriate model for
assessing human risk due to similar activity in mice and humans of an
enzyme involved in tyrosine catabolism. There was evidence of increased
quantitative susceptibility of rats and mice in the developmental and
reproduction toxicity studies. Offspring effects in the developmental
toxicity studies were evidenced by delayed ossification and ancillary
ribs and vertebrae at doses below or in the absence of maternal
toxicity in both species. In the reproduction toxicity studies,
tyrosinemia and ocular discharge were observed in offspring at doses
below those for parental toxicity, which was evidenced by increased
organ weights (liver in the rat and kidney in the mouse) and
tyrosinemia.
    Mesotrione was classified as having low acute toxicity via the
oral, dermal, and inhalation routes (Toxicity Categories III or IV). It
is classified as a mild eye irritant, but it is not a dermal sensitizer
or dermal irritant.
    There was no evidence of neurotoxicity, mutagenicity, carcinogenic
potential, or immunotoxicity in relevant studies. Specific information
on the studies received and the nature of the adverse effects caused by
mesotrione as well as the no-observed-adverse-effect-level (NOAEL) and
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies can be found at http://www.regulations.gov in document titled,
``Mesotrione. Human Health Risk Assessment in Support of the Section 3
Request for Use of Mesotrione on Pome Fruit, Stone Fruit, Citrus, and
Tree Nuts'', on page 26-29 in docket ID number EPA-HQ-OPP-2014-0303.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a

complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for mesotrione used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Mesotrione for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (all populations)..  Not applicable......  Not applicable.....  No adverse effects attributable to
                                                                               a single dose were observed. As a
                                                                               result, no hazard was identified
                                                                               and an endpoint was not selected.
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Chronic dietary (all populations)  LOAEL = 2.1 mg/kg/    Chronic RfD = 0.007  Reproduction study (mouse)
                                    day.                  mg/kg/day.          LOAEL = 2.1/2.4 mg/kg/day (M/F)
                                   UFA = 10x...........  cPAD = 0.007 mg/kg/   based on tyrosinemia and ocular
                                   UFH = 10x...........   day..                discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
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Incidental oral short-term (1 to   LOAEL = 2.1 mg/kg/    LOC for MOE = 300..  Reproduction study (mouse)
 30 days) and intermediate-term     day.                                      LOAEL = 2.1/2.4 mg/kg/day (M/F)
 (1 to 6 months).                  UFA = 10x...........                        based on tyrosinemia and ocular
                                   UFH = 10x...........                        discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
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Dermal short-term (1 to 30 days),  LOAEL = 2.1 mg/kg/    LOC for MOE = 300..  Reproduction study (mouse)
 intermediate-term (1 to six        day.                                      LOAEL = 2.1/2.4 mg/kg/day (M/F)
 months), and long-term (>6        UFA = 10x...........                        based on tyrosinemia and ocular
 months).                          UFH = 10x...........                        discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     LOAEL = 2.1 mg/kg/    LOC for MOE = 300..  Reproduction study (mouse)
 days), intermediate-term (1 to 6   day.                                      LOAEL = 2.1/2.4 mg/kg/day (M/F)
 months), and long-term (>6        UFA = 10x...........                        based on tyrosinemia and ocular
 months).                          UFH = 10x...........                        discharge. NOAEL not established.
                                   FQPA SF/UFL = 3x....
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)   Classified as ``not likely to be carcinogenic to humans'' based upon lack of
                                                    evidence of carcinogenicity in rats and mice.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mesotrione, EPA considered exposure under the petitioned-
for tolerances as well as all existing mesotrione tolerances in 40 CFR
180.571. EPA assessed dietary exposures from mesotrione in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
mesotrione; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA National
Health and Nutrition Examination Survey, What We Eat in America 2003-
2008. The chronic analysis assumed 100% crop treated (CT), Dietary
Exposure Evaluation Model (DEEM 7.81) default processing factors, and
tolerance-level residues for all foods. Drinking water was incorporated
directly into the dietary assessment using the groundwater
concentration and the PRZM-GW model. The chronic dietary risk
assessment shows that the chronic dietary risk estimates are not of
concern (i.e., <100% chronic population-adjusted dose (cPAD)). The
chronic dietary risk estimate for the highest exposed population
subgroup, all infants (<1 year old), is 17% of the cPAD.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that mesotrione does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for mesotrione. Tolerance level residues and/or 100%
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for mesotrione in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of mesotrione. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) for surface

water and with Screening Concentration in Ground Water (SCI-GROW) and
Pesticide Root Zone Model Ground Water (PRZM GW) for ground water, the
estimated drinking water concentrations (EDWCs) of mesiotrione for
chronic exposures for non-cancer assessments are estimated to be 5.1
ppb (1--10 year average) and 2.2 (30-year average) for surface water
and 18.4 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of
value 18.4 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Mesotrione is currently registered for the following uses that
could result in residential exposures: Golf course turf, home lawns,
and recreational turf. Both liquid and granular formulations are
registered, resulting in potential residential handler (dermal and
inhalation) and post-application (dermal and incidental oral)
exposures. Residential handler (dermal plus inhalation) exposures were
assessed for adults using various handheld equipment. Post-application
dermal exposure was assessed for adults, as well as children 11 to <16
years old, children 6 to <11 years old, and children 1 to <2 years old
performing various activities on turf. For children 1 to <2 years old,
incidental oral (hand-to-mouth) post-application exposure was also
assessed. These uses were assessed using the revised 2012 Residential
Standard Operating Procedures. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    There are marked differences among species in the ocular toxicity
associated with inhibition of HPPD. Ocular effects following treatment
with HPPD inhibitor herbicides are seen in the rat but not in the
mouse. Monkeys also seem to be recalcitrant to the ocular toxicity
induced by HPPD inhibition. One explanation for this species-specific
response in ocular opacity may be related to species differences in the
clearance of tyrosine. A metabolic pathway exists to remove tyrosine
from the blood that involves the liver enzyme TAT. In contrast to rats
where ocular toxicity is observed following exposure to HPPD-inhibiting
herbicides, mice and humans are unlikely to achieve the levels of
plasma tyrosine necessary to produce ocular opacities because the
activity of TAT in these species is much greater compared to rats.
    HPPD inhibitors (e.g., nitisinone) are used as an effective
therapeutic agent to treat patients suffering from rare genetic
diseases of tyrosine catabolism. Treatment starts in childhood but is
often sustained throughout patient's lifetime. The human experience
indicates that a therapeutic dose (1 mg/kg/day dose) of nitisinone has
an excellent safety record in infants, children, and adults and that
serious adverse health outcomes have not been observed in a population
followed for approximately a decade. Rarely, ocular effects are seen in
patients with high plasma tyrosine levels; however, these effects are
transient and can be readily reversed upon adherence to a restricted
protein diet. This observation indicates that an HPPD inhibitor in it
and of itself cannot easily overwhelm the tyrosine-clearance mechanism
in humans.
    Therefore, exposures to environmental residues of HPPD-inhibiting
herbicides are unlikely to result in the high blood levels of tyrosine
and ocular toxicity in humans due to an efficient metabolic process to
handle excess tyrosine. The Agency continues to study the complex
relationships between elevated tyrosine levels and biological effects
in various species. In the future, assessments of HPPD-inhibiting
herbicides may consider more appropriate models and cross species
extrapolation methods. Therefore, EPA has not conducted cumulative risk
assessment with other HPPD inhibitors.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was evidence of
increased quantitative susceptibility of rats and mice in the
developmental and reproduction toxicity studies. Offspring effects in
the developmental toxicity studies were evidenced by delayed
ossification and ancillary ribs and vertebrae at doses below or in the
absence of maternal toxicity in both species. In the reproduction
toxicity studies, tyrosinemia and ocular discharge were observed in
offspring at doses below those for parental toxicity, which was
evidenced by increased organ weights (liver in the rat and kidney in
the mouse) and tyrosinemia.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 3x for use of a LOAEL from the reproduction
toxicity study. That decision is based on the following findings:
    i. The toxicity database for mesotrione is adequate for FQPA
assessment.
    ii. There is no indication that mesotrione is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. The ocular discharge seen in the reproduction toxicity study
in mice provided a highly conservative endpoint. The LOAEL for this
study is currently the lowest dose tested. The incidence of ocular
discharge lacked a clear dose response, but an effect was evident at
the highest dose tested indicating that the choice of LOAEL in this
study may also be conservative.
    iv. There is low concern for susceptibility seen in the
developmental and reproduction toxicity studies because the doses and
endpoints selected are protective of effects seen in these studies. The
doses and endpoints are also protective of developmental effects
observed in the rat and rabbit developmental toxicity studies.
    v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to mesotrione in drinking water. The residential
exposure assessments are based upon

the Residential SOPs, which are based upon reasonable worst-case
assumptions. These assessments will not underestimate the exposure and
risks posed by mesotrione.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
mesotrione is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
mesotrione from food and water will utilize 17% of the cPAD for infants
(<1 year old) the population group receiving the greatest exposure.
Chronic aggregate risk consists only of food and water and does not
include residential post-application exposure. Chronic residential
exposure is not expected based on the residential use pattern of
mesotrione.
    3. Short- and intermediate-term risk. The short- and intermediate-
term toxicological PODs for mesotrione are the same for each route of
exposure. Therefore, for residential exposure scenarios, only short-
term exposures were assessed, and are considered to be protective of
intermediate-term exposure and risk.
    Short- and intermediate-term aggregate risk is made up of dietary
and non-dietary sources of exposure. Since mesotrione has residential
uses on turf, including golf courses, commercial, and residential
sites, handler and post-application residential exposure is expected.
Short- and intermediate-term aggregate risk is made up of average
dietary exposures from food and drinking water sources, dermal,
inhalation and oral (children only) residential exposures.
    Dietary (food + drinking water) exposure estimates are based on a
conservative, unrefined chronic dietary exposure assessment.
Residential exposure estimates are conservative estimates due to the
standard assumptions that were built into the calculations. For adults,
dermal plus inhalation exposures from handler activities were factored
into the aggregate risk calculations. For children (6 to <11 years old)
and children (11 to <16 years old, post-application dermal exposure
from activities on treated turf were factored into the aggregate risk
calculations. For children (1 to <2 years old), both dermal and
incidental oral exposures were factored into the short-and
intermediate-term aggregate risk calculations as incidental oral
exposure is possible for this population. All short-and intermediate-
term aggregate MOEs are not of concern (children 1 to <2 years, MOE =
1,400; children 6 to <11 years, MOE = 4,500; children 11 to <16 years,
MOE = 5,800; and adults, MOE = 3,200).
    4. Aggregate cancer risk for U.S. population. An aggregate cancer
risk was not calculated because mesotrione was classified as ``not
likely to be carcinogenic to humans''.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to mesotrione residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography method with fluorescence detection) is available to
enforce the tolerance expression.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for mesotrione.

C. Response to Comments

    On September 2, 2014, EPA published a notice of filing in the
Federal Register and two comments were received. The commenters noted
that pesticides and mesotrione pose a risk to pollinators and human
health. The Agency has determined that mesotrione poses no acute
contact risk to adult honey bees and there are no risk estimates of
concern for human health.

D. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance commodity definition for citrus, pome
fruit, stone fruit, and tree nuts are being revised to conform with EPA
preferred terms. In addition, based on the method LOQ of 0.01 ppm, EPA
is revising the petitioned-for tolerance in/on almond hull of 0.02 ppm
rather than 0.015 ppm.

V. Conclusion

    Therefore, tolerances are established for residues mesotrione in or
on almond, hulls at 0.02 ppm; fruit, citrus, group 10-10 at 0.01 ppm;
fruit, pome, group 11-10 at 0.01 ppm; fruit, stone, group 12-12 at 0.01
ppm; and nut, tree, group 14-12 at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income

Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 18, 2015.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.571, add in alphabetical order entries for ``Almond,
hulls'', ``Fruit, citrus, group 10-10'', ``Fruit, pome, group 11-10'',
``Fruit, stone, group 12-12'', and ``Nut, tree, group 14-12'' to the
table in paragraph (a) to read as follows:

Sec.  180.571  Mesotrione; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         0.02

                                * * * * *
Fruit, citrus, group 10-10.................................         0.01
Fruit, pome, group 11-10...................................         0.01
Fruit, stone, group 12-12..................................         0.01

                                * * * * *
Nut, tree, group 14-12.....................................         0.01

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

* * * * *
[FR Doc. 2015-12938 Filed 5-28-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53095]
[FR Doc No: 2021-20678]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4503-DR; Docket ID FEMA-2021-0001]

Alabama; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alabama (FEMA-4503-DR), dated March 29, 2020, and
related determinations.

DATES: This amendment was issued August 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
dated March 29, 2020 for the State of Alabama is hereby amended to
include the Hazard Mitigation Grant Program.

    All areas within the State of Alabama are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-20678 Filed 9-23-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Notices]
[Page 5788]
[FR Doc No: 2012-2576]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-50-001]

PetroLogistics Natural Gas Storage, LLC; Notice of Application

    Take notice that on January 27, 2012, PetroLogistics Natural Gas
Storage, LLC (PetroLogistics), 4470 Bluebonnet Blvd., Baton Rouge,
Louisiana 70809, filed in Docket No. CP11-50-001, an application
pursuant to section 7(c) of the Natural Gas Act (NGA) and Part 157 of
the Commission's regulations, to amend its previously filed application
in Docket No. CP11-50-000. Specifically, PetroLogistics request to
amend its certificate by removing Cavern 102 from the PetroLogistic's
proposed project in Iberville Parish, Louisiana. PetroLogistics states
that Cavern 102 has been removed from the project because the
Department of Energy has recently taken the cavern through a
condemnation proceeding. PetroLogistics states that, aside from the
removal of Cavern 102, only slight additional modifications are
necessary, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number, excluding the
last three digits, in the docket number field to access the document.
For assistance, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Allen Kirkley, PetroLogistics Natural Gas Storage, LLC, 4470 Bluebonnet
Blvd., Baton Rouge, Louisiana 70809, or by calling<PHONE_NUMBER>
(telephone) or<PHONE_NUMBER> (fax).
    Pursuant to section 157.9 of the Commission's regulations, 18 CFR
157.9, within 90 days of this Notice, the Commission's staff will
either complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission's staff issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to reach a final decision on a request
for federal authorization within 90 days of the date of issuance of the
Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link.
    Comment Date: February 21, 2012

    Dated: January 31, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-2576 Filed 2-3-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51512-51513]
[FR Doc No: 2016-18466]

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

[Investment Company Act Release No. 32195; 812-14635]

Investment Managers Series Trust and SilverPepper LLC; Notice of
Application

July 28, 2016.
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 Section 15(a) of
the Act and Rule 18f-2 under the Act, as well as from certain
disclosure requirements in Rule 20a-1 under the Act, Item 19(a)(3) of
Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of
Schedule 14A under the Securities Exchange Act of 1934, and Sections 6-
07(2)(a), (b), and (c) of Regulation S-X (``Disclosure Requirements'').
The requested exemption would permit an investment adviser to hire and
replace certain sub-advisers without shareholder approval and grant
relief from the Disclosure Requirements as they relate to fees paid to
the sub-advisers.

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

Applicants:  Investment Managers Series Trust (the ``Trust''), a
Delaware statutory trust registered under the Act as an open-end
management investment company with multiple series, and SilverPepper
LLC, a Delaware limited liability company registered as an investment
adviser under the Investment Advisers Act of 1940 (the ``Adviser,''
and, collectively with the Trust, the ``Applicants'').

Filing Dates:  The application was filed April 1, 2016, and amended on
April 7, 2016, and July 6, 2016.

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
August 22, 2016, and should be accompanied by proof of service on the
applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Pursuant to Rule 0-5 under the Act, hearing requests should
state the nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, 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:  Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: Trust: c/o John K.
Carter, Esq., Law Office of John K. Carter, 9455 Koger Blvd., Suite
102, St. Petersburg, Florida 33702 and Adviser: Patrick Reinkemeyer,
President, SilverPepper LLC, 570 Oakwood Avenue, Lake Forest, Illinois
60045.

FOR FURTHER INFORMATION CONTACT:  Emerson Davis, Senior Counsel, at
(202) 551-6868, or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

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>.

Summary of the Application

     1. The Adviser will serve as the investment adviser to the
Subabvised SP Series pursuant to an investment advisory agreement with
the Trust (the ``Investment Management Agreement'').\1\ The Adviser
will provide the Subabvised SP Series with continuous and comprehensive
investment management services subject to the supervision of, and
policies established by, each Subabvised SP Series' board of trustees
(``Board''). The Investment Management Agreement permits the Adviser,
subject to the approval of the Board, to delegate to one or more sub-
advisers (each, a ``Sub-Adviser'' and collectively, the ``Sub-
Advisers'') the responsibility to provide the day-to-day portfolio
investment management of each Subabvised SP Series, subject to the
supervision and direction of the Adviser. The primary responsibility
for managing the Subabvised SP Series will remain vested in the
Adviser. The Adviser will hire, evaluate, allocate assets to and
oversee the Sub-Advisers, including determining whether a Sub-Adviser
should be terminated, at all times subject to the authority of the
Board.
---------------------------------------------------------------------------

    \1\ Applicants request relief with respect to any existing and
any future series of the Trust and any other existing or future
registered open-end management company or series thereof that: (a)
Is advised by the Adviser or its successor or by a person
controlling, controlled by, or under common control with the Adviser
or its successor (each, also an ``Adviser''); (b) uses the manager
of managers structure described in the application; and (c) complies
with the terms and conditions of the application (any such series, a
``Subadvised SP Series'' and collectively, the ``Subadvised SP
Series''). For purposes of the requested order, ``successor'' is
limited to an entity that results from a reorganization into another
jurisdiction or a change in the type of business organization.
---------------------------------------------------------------------------

    2. Applicants request an exemption to permit the Adviser, subject
to Board approval, to hire certain Sub-Advisers pursuant to Sub-
Advisory Agreements and materially amend existing Sub-Advisory
Agreements without obtaining the shareholder approval required under
Section 15(a) of the Act and Rule 18f-2 under the Act.\2\ Applicants
also seek an exemption from the Disclosure Requirements to permit a
Subabvised SP Series to disclose (as both a dollar amount and a
percentage of the Subadvised SP Series' net assets): (a) The aggregate
fees paid to the Adviser; and (b) the aggregate fees paid to Non-
Affiliated Sub-Advisers; and (c) the fee paid to each Affiliated Sub-
Adviser (collectively, ``Aggregate Fee Disclosure'').
---------------------------------------------------------------------------

    \2\ The requested relief will not extend to any sub-adviser that
is an affiliated person, as defined in Section 2(a)(3) of the Act,
of a Subadvised SP Series or the Adviser, other than by reason of
serving as a sub-adviser to one or more of the Subadvised SP Series
(``Affiliated Sub-Adviser'').
---------------------------------------------------------------------------

    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the Application.
Such terms and conditions provide for, among other safeguards,
appropriate disclosure to Subadvised SP Series shareholders and
notification about sub-advisory changes and enhanced Board oversight to
protect the interests of the Subadvised SP Series' shareholders.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
any rule thereunder, if such relief is necessary or appropriate in the
public interest and consistent with the protection of investors and
purposes fairly intended by the policy and provisions of the Act.
Applicants believe that the requested relief meets this standard
because, as further explained in the Application, the Investment
Management Agreements will remain subject to shareholder approval,
while the role of the Sub-Advisers is substantially similar to that of
individual portfolio managers, so that requiring shareholder approval
of Sub-Advisory Agreements would impose unnecessary delays and expenses
on the Subadvised SP Series. Applicants believe that the requested
relief from the Disclosure Requirements meets this standard because it
will improve the Adviser's ability to negotiate fees paid to the Sub-
Advisers that are more advantageous for the Subadvised SP Series.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-18466 Filed 8-3-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: May 3, 2007 (Volume 72, Number 85)]
[Notices]
[Page 24579-24580]
[DOCID:fr03my07-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-405-000]

Williston Basin Interstate Pipeline Company; Notice of Tariff
Filing

April 26, 2007.
    Take notice that on April 23, 2007, Williston Basin Interstate
Pipeline Company (Williston Basin) tendered for filing to become a part
of its FERC Gas Tariff, Second Revised Volume No. 1, Fourteenth Revised
Sheet No. 375, to become effective April 23, 2007:
    Williston Basin has revised the above-referenced tariff sheet found
in Section 48 of the General Terms and Conditions of its FERC Gas
Tariff, Second Revised Volume No. 1 (Tariff), to rename Point ID No.
04840 (Kinder Morgan-Billy Creek) to Point ID No. 4840 (SourceGas-Billy
Creek).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or

protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-8411 Filed 5-2-07; 8:45 am]

BILLING CODE 6717-01-P