[Federal Register: January 31, 2007 (Volume 72, Number 20)]
[Notices]
[Page 4503-4505]
[DOCID:fr31ja07-49]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0007; FRL-8112-8]

Monocarbamide Dihydrogen Sulfate (Urea Sulfate); Tolerance
Reassessment Decision for Low Risk Pesticide; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's Tolerance
Reassessment Decision (TRED) for the pesticide monocarbamide dihydrogen
sulfate (Urea sulfate), and opens a public comment period on this
document, related risk assessments, and other support documents. EPA
has reviewed the low risk pesticide monocarbamide dihydrogen sulfate
(Urea sulfate) through a modified, streamlined version of the public
participation process that the Agency uses to involve the public in
developing pesticide tolerance reassessment and reregistration
decisions. Through the tolerance reassessment program, EPA is ensuring
that all pesticides meet current health and food safety standards.

DATES: Comments must be received on or before April 2, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0007, 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>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0007. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other

information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Bentley C. Gregg, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax number:
703-308-7070; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Registerdate and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA has reassessed the uses of monocarbamide dihydrogen sulfate
(Urea sulfate); also known as Enquik, reassessed one existing exemption
from the requirement for a tolerance, and on June 27, 2005, reached a
tolerance reassessment decision for this low risk pesticide. Urea
sulfate is used primarily as an active ingredient in herbicides and
desiccants on agricultural crops. The Agency has determined that urea
sulfate readily degrades to urea and sulfate ions in the environment
and in the human body. The Agency is now issuing for comment the
resulting Report on Food Quality Protection Act (FQPA) Tolerance
Reassessment Progress and Risk Management Decision for monocarbamide
dihydrogen sulfate (Urea sulfate), known as a TRED, as well as related
risk assessments and technical support documents.
    EPA developed the monocarbamide dihydrogen sulfate (Urea sulfate)
also known as Enquik, TRED through a modified, streamlined version of
its public process for making tolerance reassessment and reregistration
eligibility decisions. Through these programs, the Agency is ensuring
that pesticides meet current standards under the Federal Food, Drug,
and Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended by FQPA. EPA must review tolerances
and tolerance exemptions that were in effect when the FQPA was enacted,
to ensure that these existing pesticide residue limits for food and
feed commodities meet the safety standard established by the new law.
Tolerances are considered reassessed once the safety finding has been
made or a revocation occurs. EPA has reviewed and made the requisite
safety finding for the monocarbamide dihydrogen sulfate (Urea sulfate)
tolerances included in this notice.
    Although the monocarbamide dihydrogen sulfate (Urea sulfate) TRED
was signed on June 27, 2005, certain components of the document, which
did not affect the final regulatory decision, were undergoing final
editing at that time. These components, including the summary of
labeling changes, appendices, and other relevant information, have been
added to the monocarbamide dihydrogen sulfate (Urea sulfate) TRED
document. In addition, subsequent to signature, EPA identified several
minor errors and ambiguities in the document. Therefore, for the sake
of accuracy, the Agency also has included the appropriate error
corrections, amendments, and clarifications. None of these additions or
changes alter the conclusions documented in the June 27, 2005
monocarbamide dihydrogen sulfate (Urea sulfate) TRED. All of these
changes are described in detail in an errata memorandum which is
included in the public docket for monocarbamide dihydrogen sulfate
(Urea sulfate).
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register of May 14,
2004 (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, the Agency is tailoring its public participation process to
be commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
EPA can expeditiously reach decisions for pesticides like monocarbamide
dihydrogen sulfate (Urea sulfate), which pose no risk concerns, affect
few stakeholders, and require no risk mitigation. Once EPA assesses
uses and risks for such low risk pesticides, the Agency may go directly
to a decision and prepare a document summarizing its findings, such as
the monocarbamide dihydrogen sulfate (Urea sulfate) TRED.

    The tolerance reassessment program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public in finding ways to
effectively mitigate pesticide risks. Monocarbamide dihydrogen sulfate
(Urea sulfate), however, poses no risks that require mitigation. The
Agency therefore is issuing the monocarbamide dihydrogen sulfate (Urea
sulfate) TRED, its risk assessments, and related support documents
simultaneously for public comment. The comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the TRED. All comments should be submitted
using the methods in ADDRESSES, and must be received by EPA on or
before the closing date. These comments will become part of the Agency
Docket for monocarbamide dihydrogen sulfate (Urea sulfate). Comments
received after the close of the comment period will be marked ``late.''
EPA is not required to consider these late comments.
    EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the Docket
and regulations.gov. If any comment significantly affects the document,
EPA also will publish an amendment to the TRED in the Federal Register.
In the absence of substantive comments requiring changes, the decisions
reflected in the TRED will be implemented as presented.

B. What is the Agency's Authority for Taking this Action?

    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
was to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: January 23, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-1435 Filed 1-30-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Pages 19972-19976]
[FR Doc No: 2018-09649]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0249; FRL-9976-60]

Konjac Glucomannan; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of konjac glucomannan (CAS Reg. No. 37220-
17-0) when used as an inert ingredient on growing crops only at a
concentration not to exceed 1% by weight in a pesticide formulation.
Technology Services Group, on behalf of, Attune Agriculture, LLC,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of konjac
glucomannan resulting from use in accordance with the terms of this
exemption.

DATES: This regulation is effective May 7, 2018. Objections and
requests for hearings must be received on or before July 6, 2018, 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-2017-0249, 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: Michael Goodis, 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 protected].

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 40 CFR
part 180 through the Government Printing 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-2017-0249 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 6, 2018. 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-2017-0249, 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. Petition for Exemption

    In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11048) by Technology Services Group, on behalf of, Attune Agriculture,
LLC, 10552 Philadelphia Road, White Marsh, MD 21162. The petition
requested that 40 CFR 180.920 be amended by establishing an exemption
from the requirement of a tolerance for residues of konjac glucomannan
(also referred to as konjac mannan) (CAS Reg. No. 37220-17-0)

when used as an inert ingredient (thickener) in pesticide formulations
applied to growing crops only at a maximum use level of 1.0%. That
document referenced a summary of the petition prepared by Technology
Services Group, on behalf of, Attune Agriculture, LLC, the petitioner,
which is available in the docket, http://www.regulations.gov. A comment
was received on the notice of filing. EPA's response is discussed in
Unit V.C.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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 establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 konjac glucomannan including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with konjac glucomannan
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by konjac glucomannan as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    Konjac glucomannan is a non-digestible polysaccharide with a large
molecular weight (i.e., 200,000-2,000,000 daltons). A substance of this
size would be unlikely to penetrate intact human skin or
gastrointestinal tract. Because of its large molecular weight and the
body's inability to digest it, it is unlikely that the body will absorb
konjac glucomannan. This is supported by the studies below.
    Often in the literature, konjac flour and konjac glucomannan are
used interchangeably. The European Commission defines konjac flour as
the unpurified raw product from the root of the perennial plant
Amorphophallus konjac, and konjac glucomannan refers to the product
that has been washed and extracted using water-containing ethanol. The
majority of the studies refer to the use of konjac flour as the test
substance. EPA has concluded that it is appropriate to rely on those
studies since the two substances are essentially the same in molecular
weight and origin thus expected to present the same toxicological
profile.
    Konjac glucomannan exhibits low levels of acute toxicity. Acute
studies in rats and mice show oral LD50s of >2,800 mg/kg to
>5,000 mg/kg. The dermal LD50 in rabbits is >2,000 mg/kg.
Konjac glucomannan was not shown to be a skin irritant or dermal
sensitizer and shows minimal eye irritation.
    Asthmatic responses in humans (e.g., Konjac asthma or konnyaku
asthma) exposed to airborne powders produced during commercial
manufacture of konjac flour from konjac tubers has been reported. It
has been associated with the inhalation of dust produced during the
production of konjac flour to make konnyaku, a traditional jelly-like
Asian food prepared from glucomannan. An inhalation exposure study with
guinea pigs demonstrated that respiratory hypersensitivity to food
grade konjac flour can be induced following repeated inhalation
exposures. According to a more recent study, however, the antigen in
konjac flour responsible for respiratory sensitization is actually a
protein and not glucomannan.
    Several repeat-dose toxicity studies conducted on Sprague-Dawley
rats are available for konjac flour: A four-week dietary study, a
twelve-week feeding study, an 18-month dietary study, and an 8-week
oral study with pregnant cats. Two carcinogenicity studies are also
available.
    A four-week dietary exposure study was conducted with Sprague-
Dawley rats. Groups of four male rats were fed either 5% cellulose
(control), 10% cellulose, 10% pectin or 10% konjac (~5,000 mg/kg/day)
for 28 days. Compared to the control group, consumption of 10% konjac
in the diet decreased the digestion and absorption of protein in the
large intestine which resulted in a decrease in body weight gain.
Because of the high dosing it is not certain if the effect seen is the
result of excessive dosing or from the toxicity of chemical.
    In a twelve-week feeding study, groups of 12/sex, five week old
Sprague-Dawley rats received the basal diet (a 1% cholesterol) or
konjac meal

supplementation at 2.5, 5.0 or 10% of the diet (~1,250, 2,500, or 5,000
mg/kg/day). Changes were seen on gross examination of the liver. The
full study report was not available but according to the Food and
Agriculture Organization/World Health Organization (FAO/WHO) Joint
Expert Committee on Food Additives (JECFA) report, the author suggests
the reason for this is that konjac flour binds with bile acids and
depresses reabsorption in the intestines which consequently reduces the
accumulation of lipids in the liver. All treated groups had reduced
total cholesterol in comparison with the high-cholesterol control
group. Body-weight gain was slightly but statistically significantly
lower in males fed 10% refined konjac meal than in the other groups
during the first eight weeks. Food intake was also reduced in this
group. Therefore, the NOAEL is 5% of the diet (~2,500 mg/kg/day) with a
LOAEL of 10% (~5,000 mg/kg/day) based on decreased body weight gain in
males.
    An 18-month dietary study assessed groups of 15 Sprague-Dawley rats
fed a basal diet or a diet with 1.0% konjac flour (~500 mg/kg/day).
There was no difference in body weight gain, absolute or relative organ
weights or femur weights and no evidence of treatment-related
pathological changes or effects on calcium and phosphorus metabolism.
Treated male rats had significantly lower serum cholesterol levels at 9
and 18 months and lower triglycerides at 3 and 9 weeks but not 12
months. In female rats, the only difference from the control was a
lower triglyceride level at 18 months. The liver of treated rats had
smaller more lightly stained nuclei and reduced bile duct proliferation
in the portal area. Certain cells (not specified) of treated rats
displayed fewer signs of senescence compared to controls. There was no
evidence that 1% konjac flour in the diet (~500 mg/kg/day) was toxic to
rats.
    Two groups of 15 adult pregnant British short-hair cats were fed
diets containing either 2% carob gum or 2% konjac flour (0.98 to 3.08
mg/kg/day prior to parturition) for eight weeks. There were no
significant changes in body weight between controls and treated
animals. Biochemical and hematological parameters were reported to be
within normal ranges throughout the study. Mean birth weight of kittens
born to control cats was statistically significantly lower (p >0.01)
than kittens born to konjac fed cats; however, the standard deviation
was within the range of controls and therefore, these effects are not
considered adverse. All cats in the study completed lactation and
reared successfully.
    There is no evidence that konjac glucomannan suppresses or
otherwise harms immune function in mammalian systems. No signs of
neurotoxicity were reported in the studies of acute or repeat-dose oral
exposure to konjac glucomannan.
    Genotoxicity tests of konjac flour include an Ames test, a mouse
lymphoma assay, and an in vivo mouse micronucleus test. All
genotoxicity assays were negative. Konjac was not mutagenic in the Ames
test and did not induce mutations in cultured mouse lymphoma cells or
cause clastogenicity in the in vivo micronucleus study in the presence
or absence of S-9 activation.
    Konjac glucomannan is not expected to be carcinogenic. In addition
to showing negative results in genotoxicity and mutagenicity tests, a
20-week and a 1-year feeding study were conducted and no evidenced of
carcinogenicity was observed. In fact, the incidence of colon tumors in
1,2-dimethylhydrazine DMH treated animals was significantly reduced
with konjac glocomannan consumption. Similarly, spontaneous liver
tumors in C3H/He mice were inhibited by maintaining the mice on a diet
containing 10% glucomannan.

B. Toxicological Points of Departure/Levels of Concern

    No toxicological endpoint of concern has been identified for konjac
glucomannan. Based on the available information as discussed in Unit
IV.A., it is concluded that there is no end point of concern identified
and therefore, quantitative risk assessment is not warranted.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to konjac glucomannan, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from konjac glucomannan in food as follows:
    Dietary exposure (food and drinking water) to konjac glucomannan
may occur following ingestion of foods with residues from treated
crops. Additional dietary exposure may result from the use of konjac
glucomannan as a food additive; it has been used as a thickener,
texture stabilizer, emulsifier, and gelling agent in foods and
beverages, as well as agriculture and animal feed. However, a
quantitative dietary exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted, although exposures may be expected
from use on food crops.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Although currently, there are no uses for konjac glucomannan in
products that might result in residential exposure, it is possible that
some may be requested in the future. Additional non-dietary exposure
may occur from use of konjac glucomannan in pharmaceutical products and
cosmetics. Based on the discussion above, a quantitative residential
exposure assessment for konjac glucomannan was not conducted.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found konjac glucomannan to share a common mechanism of
toxicity with any other substances, and konjac glucomannan does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
konjac glucomannan does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) requires EPA to retain an additional tenfold
margin of safety in the case of threshold effects 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. As
noted in Unit IV.B., there is no indication of threshold effects being
caused by konjac glucomannan. Therefore, this requirement does not

apply to the present analysis. Moreover, due to the lack of any
toxicological endpoints of concern, EPA is conducting a qualitative
assessment of konjac glucomannan, which does not use safety factors for
assessing risk, and no additional safety factor is needed for assessing
risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on konjac
glucomannan, EPA has determined that there is a reasonable certainty
that no harm to any population subgroup will result from aggregate
exposure to konjac glucomannan. Therefore, EPA concludes that the
exemption from the requirement of a tolerance as requested by the
petitioner--for residues of konjac glucomannan on growing crops when
used as an inert ingredient (thickener), in pesticide formulations at a
concentration not to exceed 1.0% by weight of the pesticide formulation
is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
konjac glucomannan in or on any food commodities. EPA is establishing
limitations on the amount of konjac glucomannan that may be used in
pesticide formulations applied to growing crops. These limitations will
be enforced through the pesticide registration process under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136 et seq. EPA will not register any pesticide formulation for use on
growing crops for sale or distribution that exceeds 1% by weight of
konjac glucomannan.

B. Response to Comments

    One comment was received in response to the Notice of Filing. The
comment was received from a private citizen who opposed the
authorization to sell any pesticide that leaves a residue on food. The
Agency recognizes that some individuals believe that no residue of
pesticides should be allowed. However, under the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (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 the statute. EPA has evaluated all the available
data and concluded that there is a reasonable certainty of no harm from
the limited use of konjac glucomannan as inert ingredients in pesticide
formulations. The commenter has not provided any information supporting
a conclusion that this exemption would not be safe.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for konjac glucomannan (CAS Reg. No.
37220-17-0) when used as an inert ingredient (thickener) in pesticide
formulations applied to growing crops only at a concentration not to
exceed 1.0% by weight of the pesticide formulation.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance 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); Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 exemption 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).

VIII. 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: April 12, 2018.
Donna Davis,
Acting Division 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.  180.920, add alphabetically the inert ingredient ``Konjac
glucomannan (CAS Reg. No. 37220-17-0)'' to the table to read as
follows:

Sec.  180.920   Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------

                              * * * * * * *
Konjac glucomannan (CAS Reg. No.  Not to exceed 1.0%  Thickener.
 37220-17-0).                      by weight in
                                   pesticide
                                   formulation.

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

[FR Doc. 2018-09649 Filed 5-4-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Page 37200]
[FR Doc No: 2017-16753]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF17-2-000]

Bonneville Power Administration; Notice of Filing

    Take notice that on July 31, 2017, Bonneville Power Administration
submitted tariff filing per: BP-18 Power Rates Parts 1-3 to be
effective 10/1/2017.
    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, 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 on or before the comment date. On or
before the comment date, it is not necessary to 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 5 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 email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 30, 2017.

    Dated: August 2, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-16753 Filed 8-8-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Page 57095]
[FR Doc No: 2012-22794]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pediatric Oncology Subcommittee of the Oncologic
Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 4, 2012, from 8
a.m. to 5:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Minh Doan, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm.
2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area), to find out
further information regarding FDA advisory committee information. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The subcommittee will receive a presentation on pediatric
provisions mandated by the Food and Drug Administration Safety and
Innovation Act. This will be an awareness presentation and there will
not be a formal Committee discussion or recommendation. In addition,
information will be presented regarding pediatric development plans for
four products that are in development for an adult oncology indication.
The subcommittee will consider and discuss issues relating to the
development of each product for pediatric use and provide guidance to
facilitate the formulation of written requests for pediatric studies,
if appropriate. The four products under consideration are: (1)
Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302,
application submitted by Threshold Pharmaceuticals, Inc.; (3)
volasertib (BI 6727), application submitted by Boehringer Ingelheim
Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application
submitted by Amgen Inc.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 19, 2012. Oral presentations from the public will be scheduled
between approximately 9:15 a.m. to 9:30 a.m., 11:15 a.m. to 11:30 a.m.,
2:05 p.m. to 2:20 p.m., and 4:10 p.m. to 4:25 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before November 8, 2012.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by November 9, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Minh Doan at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 11, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-22794 Filed 9-14-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Rules and Regulations]
[Page 45857-45860]
[DOCID:fr07au08-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0837; Directorate Identifier 2008-CE-043-AD;
Amendment 39-15633; AD 2008-16-15]
RIN 2120-AA64

Airworthiness Directives; Eclipse Aviation Corporation Model
EA500 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is superseding emergency Airworthiness Directive (AD)
2008-13-51, which currently applies to all owners/operators of Eclipse
Aviation Corporation (Eclipse) Model EA500 airplanes that received the
emergency AD by letter issued June 12, 2008. Emergency AD 2008-13-51
requires owner/operators to insert temporary revisions into the
emergency and normal procedures sections of the airplane flight manual
(AFM), do a pilot evaluation of the throttles with replacement as
necessary, and report the evaluation results to the FAA. Emergency AD
2008-13-51 was the result of the throttle position exceeding its
maximum range. Since issuing that AD, Eclipse developed an FAA-approved
test procedure and issued Eclipse Aviation Alert Service Bulletin SB
500-76-001, REV B, dated July 22, 2008. The service bulletin provides a
standardized procedure for testing and modifying (as applicable) the
throttle lever with replacement as necessary. We are issuing this AD to
mandate the actions in this service bulletin to be done by a person
authorized to perform maintenance and reduce the likelihood of the
throttle position signal exceeding its maximum range, which could cause
loss of left and right engine control. This condition could result in
the inability to maintain desired airspeed and/or altitude with
consequent loss of control.

DATES: This AD becomes effective on August 7, 2008.
    On August 7, 2008, the Director of the Federal Register approved
the incorporation by reference of certain publications listed in this
AD.
    We must receive any comments on this AD by October 6, 2008.

ADDRESSES: Use one of the following addresses to comment on this AD.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    To get the service information identified in this AD, contact
Eclipse Aviation Corporation, 2503 Clark Carr Loop, SE., Albuquerque,
New Mexico 87106; telephone:<PHONE_NUMBER>.
    To view the comments to this AD, go to http://www.regulations.gov.
The docket number is FAA-2008-0837; Directorate Identifier 2008-CE-043-
AD.

FOR FURTHER INFORMATION CONTACT: Mitchell Soth, Aerospace Engineer,
FAA, Forth Worth Airplane Certification Office, 2601 Meacham Blvd.,
Fort Worth, Texas 76137; telephone:<PHONE_NUMBER>; fax: (817) 222-
5960.

SUPPLEMENTARY INFORMATION:

Discussion

    Following a wind shear encounter on final approach, the pilot of an
Eclipse Model EA500 airplane applied full throttle using enough force
against the forward stops to exceed the design throttle position signal
maximum range. The associated fault mode held the engine thrust
settings at the last known throttle position, which was maximum.
    Following the balked landing, the pilot elected to shutdown one
engine. Upon shutdown of the one engine, the opposite engine thrust
reduced to idle and was unresponsive to subsequent throttle lever
movement. The pilot was able to land the airplane with no injury or
substantial damage. Both main tires were blown during the event.
    Exceeding the throttle position signal maximum range could cause
loss of left and right engine control, which could result in the
inability to maintain desired airspeed and/or altitude with consequent
loss of control.
    On June 12, 2008, the FAA issued emergency AD 2008-13-51 to require
owner/operators to insert the following into emergency and normal
procedures sections of the EA500 pilots operating handbook (POH) and
airplane flight manual (AFM), as applicable:
     Temporary Revision No. 005 To EA500 POH and FAA-Approved
Airplane Flight Manual, L & R ENG CONTROL FAIL, AFM part number (P/N)
06-122204, dated June 12, 2008;
     Temporary Revision No. 006 To EA500 POH and FAA-Approved
Airplane Flight Manual, THROTTLE STOPS, AFM P/N 06-122204, dated June
12, 2008;
     Temporary Revision No. 007 To EA500 POH and FAA-Approved
Airplane Flight Manual, L & R ENG CONTROL FAIL, AFM P/N 06-121654,
dated June 12, 2008;
     Temporary Revision No. 008 To EA500 POH and FAA-Approved
Airplane Flight Manual, THROTTLE STOPS, AFM P/N 06-121654, dated June
12, 2008;
     Temporary Revision No. 013 To EA500 POH and FAA-Approved
Airplane Flight Manual, L & R ENG CONTROL FAIL, AFM P/N 06-100106,
dated June 12, 2008; and
     Temporary Revision No. 014 To EA500 POH and FAA-Approved
Airplane Flight Manual, THROTTLE STOPS, AFM P/N 06-100106, dated June
12, 2008.
    The emergency AD also required an evaluation of the throttles with

replacement as necessary and a report of the evaluation results to the
FAA.
    Emergency AD 2008-13-51 allowed the pilot to do the evaluation of
the throttle. The FAA has since determined that the throttles must be
inspected and modified (as applicable) by a person authorized to
perform maintenance as specified in 14 CFR section 43.3 of the Federal
Aviation Administration Regulations (14 CFR 43.3) following Eclipse
Aviation Alert Service Bulletin SB 500-76-001, REV B, dated July 22,
2008. The FAA has also determined the reporting requirement is no
longer necessary.

Relevant Service Information

    We reviewed Eclipse Aviation Alert Service Bulletin SB 500-76-001,
REV B, dated July 22, 2008. The service information describes
procedures for inspecting and modifying (as applicable) the throttles
with replacement as necessary.

FAA's Determination and Requirements of This AD

    We are issuing this AD because we evaluated all the information and
determined the unsafe condition described previously is likely to exist
or develop on other products of the same type design. This AD
supersedes emergency AD 2008-13-51 and requires the following:
     Inserting the above-mentioned temporary revisions into the
appropriate AFM; and
     Inspecting and modifying (as applicable) the throttles
with replacement as necessary.
    This is considered interim action. We may take future rulemaking
action.

FAA's Determination of the Effective Date

    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
public comment before issuing this AD are impracticable, and that good
cause exists for making this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and an opportunity for
public comment. We invite you to send any written relevant data, views,
or arguments regarding this AD. Send your comments to an address listed
under the ADDRESSES section. Include the docket number ``FAA-2008-0837;
Directorate Identifier 2008-CE-043-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the AD. We will consider
all comments received by the closing date and may amend the AD in light
of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive concerning this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket that contains the AD, the regulatory
evaluation, any comments received, and other information on the
Internet at http://www.regulations.gov; or in person at the Docket
Management Facility between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Docket Office (telephone<PHONE_NUMBER>)
is located at the street address stated in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding a new AD to read as follows:

2008-16-15 Eclipse Aviation Corporation: Amendment 39-15633; Docket
No. FAA-2008-0837; Directorate Identifier 2008-CE-043-AD.

Effective Date

    (a) This AD becomes effective on August 7, 2008.

Affected ADs

    (b) This AD supersedes emergency AD 2008-13-51, which was sent
by individual letter issued June 12, 2008, to owners/operators of
Eclipse Model EA500 airplanes.

Applicability

    (c) This AD affects Model EA500 airplanes, all serial numbers,
that are certificated in any category.

Unsafe Condition

    (d) This AD is the result of the throttle position exceeding its
maximum range. We are issuing this AD to reduce the likelihood of
the throttle position signal exceeding its maximum range, which
could cause loss of left and right engine control. This condition
could result in the inability to maintain desired airspeed and/or
altitude with consequent loss of control.

Compliance

    (e) To address this problem, you must do the following, unless
already done:

----------------------------------------------------------------------------------------------------------------
               Actions                             Compliance                            Procedures
----------------------------------------------------------------------------------------------------------------
(1) Insert the following into the     Before further flight after August    Under 14 CFR section 43.7 of the
 emergency and normal procedures       7, 2008 (the effective date of this   Federal Aviation Administration
 sections of the applicable EA500      AD). If you previously did this       Regulations (14 CFR 43.7), the
 pilots operating handbook (POH) and   action per compliance with            owner/operator holding at least a
 airplane flight manual (AFM):         emergency AD 2008-13-51, then you     private pilot certificate is
(i) For POH/AFM part number (P/N) 06-  may take ``unless already done''      allowed to insert the AFM temporary
 122204: Temporary Revision No. 005    credit for this portion of the AD.    revisions. Make an entry into the
 To EA500 POH and FAA-Approved                                               aircraft logbook showing compliance
 Airplane Flight Manual, L & R ENG                                           with this portion of the AD per
 CONTROL FAIL, dated June 12, 2008;                                          compliance with section 43.9 of the
 and Temporary Revision No. 006 To                                           Federal Aviation Regulations (14
 EA500 POH and FAA-Approved Airplane                                         CFR 43.9).
 Flight Manual, THROTTLE STOPS,
 dated June 12, 2008.
  (ii) For POH/AFM P/N 06-121654:     ....................................  ....................................
   Temporary Revision No. 007 To
   EA500 POH and FAA-Approved
   Airplane Flight Manual, L & R ENG
   CONTROL FAIL, dated June 12,
   2008; and Temporary Revision No.
   008 To EA500 POH and FAA-Approved
   Airplane Flight Manual, THROTTLE
   STOPS, dated June 12, 2008.
  (iii) For POH/AFM P/N 06-100106:    ....................................  ....................................
   Temporary Revision No. 013 To
   EA500 POH and FAA-Approved
   Airplane Flight Manual, L & R ENG
   CONTROL FAIL, dated June 12,
   2008; and Temporary Revision No.
   014, To EA500 POH and FAA-
   Approved Airplane Flight Manual,
   THROTTLE STOPS, dated June 12,
   2008.
(2) For POH/AFM P/N 06-122204,        Before further flight after August    Under 14 CFR section 43.7 of the
 inserting Section 3, Emergency        7, 2008 (the effective date of this   Federal Aviation Administration
 Procedures, Revision 1, dated June    AD).                                  Regulations (14 CFR 43.7), the
 25, 2008; and Section 4, Normal                                             owner/operator holding at least a
 Procedures, Revision 1, dated June                                          private pilot certificate is
 25, 2008, satisfies the requirement                                         allowed to insert the AFM temporary
 specified in paragraph (e)(1)(i) of                                         revisions. Make an entry into the
 this AD.                                                                    aircraft logbook showing compliance
                                                                             with this portion of the AD per
                                                                             compliance with section 43.9 of the
                                                                             Federal Aviation Regulations (14
                                                                             CFR 43.9).
(3) Inspect and modify (as            (i) If you have done all the actions  Follow the instructions in Eclipse
 applicable) the throttle quadrant     of emergency AD 2008-13-51 before     Aviation Alert Service Bulletin SB
 assembly (TQA).                       August 7, 2008 (the effective date    500-76-001, REV B, dated July 22,
                                       of this AD), an appropriately-        2008.
                                       licensed mechanic must do the
                                       inspection required by this AD at
                                       whichever of the following occurs
                                       first:
                                      (A) No later than the next            ....................................
                                       maintenance check; or
                                      (B) Within the next 60 days after     ....................................
                                       August 7, 2008 (the effective date
                                       of this AD).
                                      (ii) If you have not done all of the  ....................................
                                       actions of emergency AD 2008-13-51
                                       as of August 7, 2008 (the effective
                                       date of this AD), an appropriately-
                                       licensed mechanic must do the
                                       inspection required by this AD
                                       before further flight after August
                                       7, 2008 (the effective date of this
                                       AD). You may operate the airplane
                                       up to 10 hours time-in-service to
                                       reposition the airplane to the
                                       service center or maintenance
                                       facility doing the inspection
                                       provided the flight(s) occur(s)
                                       within 30 days after August 7, 2008
                                       (the effective date of this AD).
(4) If any TQA fails the inspection   Before further flight after the       Replace the TQA using FAA-approved
 required in paragraph (e)(3) of       inspection where any TQA failed.      procedures. Contact the FAA at the
 this AD, replace the TQA with a TQA                                         address in paragraph (f) of this AD
 that passes the test procedure set                                          for an FAA-approved procedure.
 forth in Eclipse Aviation Alert
 Service Bulletin SB 500-76-001, REV
 B, dated July 22, 2008.
----------------------------------------------------------------------------------------------------------------

    Note: To get copies of the temporary revisions specified in this
AD, contact Eclipse Aviation Corporation, 2503 Clark Carr Loop, SE.,
Albuquerque, NM 87105, fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
Alternative Methods of Compliance

    (f) The Manager, Fort Worth Airplane Certification Office, FAA,
ATTN: Mitchell Soth, FAA, 2601 Meacham Blvd, Fort Worth,

Texas 76137; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.

Material Incorporated by Reference

    (g) You must use Eclipse Aviation Alert Service Bulletin SB 500-
76-001, REV B, dated July 22, 2008, to do the actions required by
this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Eclipse Aviation Corporation, 2503 Clark Carr Loop, SE.,
Albuquerque, NM 87105, fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>    (3) You may review copies at the FAA, Central Region, Office of
the Regional Counsel, 901 Locust, Room 506, Kansas City, Missouri
64106; or at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-
register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on July 29, 2008.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-17786 Filed 8-6-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]
[Page 57759-57760]
[DOCID:fr22se10-48]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-87-000]

Great River Energy; Notice of Filing

September 14, 2010.
    Take notice that on September 10, 2010, Great River Energy (GRE)
filed its proposed updated Reactive Power revenue requirement and
supporting cost data for GRE's seven generation facilities located in
the Midwest Independent Transmission System Operator, Inc. region,
pursuant to the Commission's October 17 Order, Midwest Independent
Transmission System Operator, Inc., 113 FERC 61,046 (2005) (October 17
Order) at P 88 & n.13, rehg. denied, 114 FERC 61,192 (2006).
    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, 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 on or before the comment date. On or
before the comment date, it is not necessary to 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 (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on October 1, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23598 Filed 9-21-10; 8:45 am]
BILLING CODE 6717-01-P