[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]
[Page 58015]
[DOCID:fr23se10-121]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Criteria for
Internet Communications of Aviation Weather, NOTAM, and Aeronautical
Data

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. An Advisory Circular (AC) establishes criteria for
Qualified Internet Communications Providers (ICP), who provide access
to aviation weather, Notices to Airmen (NOTAM), and aeronautical data
via the Public Internet. The AC describes procedures for a provider to
become and remain an FAA approved QICP, and the information collected
is used to determine the provider's eligibility.

DATES: Written comments should be submitted by November 22, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0672.
    Title: Criteria for Internet Communications of Aviation Weather,
NOTAM, and Aeronautical Data.
    Form Numbers: There are no FAA forms associated with this
collection of information.
    Type of Review: Renewal of an information collection.
    Background: Any interested person or organization desiring to
become a QICP shall provide the FAA Aviation Weather and Policy
Requirements, AJP-B1 with a written application documenting their
capability to meet the QICP criteria. The purpose of the information is
to ensure the reliability, accessibility and security of aviation
weather data, NOTAM and aeronautical data accessed via the Internet as
well as to encourage data providers to identify the approval status
(e.g., experimental or operational) of aviation weather products.
    Respondents: Approximately 6 applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 40 hours.
    Estimated Total Annual Burden: 2,740 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Scott, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on September 17, 2010.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-23730 Filed 9-22-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Rules and Regulations]
[Pages 26610-26612]
[FR Doc No: 2014-10060]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0092; Directorate Identifier 2014-CE-002-AD;
Amendment 39-17846; AD 2014-09-11]
RIN 2120-AA64

Airworthiness Directives; GROB-WERKE Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
GROB-WERKE Models G115EG and G120A airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) issued by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as cracks in the left hand elevator flange. We are issuing
this AD to require actions to address the unsafe condition on these
products.

DATES: This AD is effective June 13, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of June 13, 2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0092; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact Grob
Aircraft AG, Customer Service, Lettenbachstrasse 9, 86874 Tussenhausen-
Mattsies, Germany, telephone: + 49 (0) 8268-998-105; fax; + 49 (0)
8268-998-200; email<EMAIL_ADDRESS>Internet: grob-
aircraft.com. You may view this referenced service information at the
FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816)

329-4090; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to add an AD that would apply to certain GROB-WERKE Models
G115EG and G120A airplanes. That NPRM was published in the Federal
Register on February 20, 2014 (79 FR 9661). That NPRM proposed to
correct an unsafe condition for the specified products and was based on
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country. The MCAI states:

    An operator of a G 115E aeroplane reported finding a crack
during scheduled maintenance on the left hand (LH) elevator flange,
part number (P/N) 115E-3761.06. The design of the right hand (RH)
elevator flange, P/N 115E-3762.07, is identical. A similar design is
used for the elevator flanges installed on G 120A and G-120A-I
aeroplanes, P/N 120A-3561.20(A) and P/N 120A-3562.20(A). Therefore,
the reported deficiency may also exist on G 120 aeroplanes.
    This condition, if not detected and corrected, could lead to
elevator failure, resulting in reduced control of the aeroplane.
    To address this potential unsafe condition, GROB Aircraft AG
issued Service Bulletins (SB) MSB1078-194 and SB MSB1121-140 to
provide instruction for inspection and corrective action.
    For the reasons described above, this AD requires repetitive
inspections of both elevator flanges on an aeroplane to detect any
crack, and, depending on findings, replacement of the affected part.

You may examine the MCAI on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0092-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 9661, February 20,
2014) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 9661, February 20, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 9661, February 20, 2014).

Costs of Compliance

    We estimate that this AD will affect 6 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $510, or $85 per product.
    In addition, we estimate that any necessary follow-on actions will
take about 8 work-hours and require parts costing approximately $306
for the left hand (LH) elevator flange and $365 for the right hand (RH)
elevator flange. We estimate a cost of $986 to replace the LH elevator
flange per product and $1,045 to replace the RH elevator flange per
product. We have no way of determining the number of products that may
need these actions.

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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-
2014-0092; or in person at the Docket Management Facility between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains the NPRM, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is 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

    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 the following new AD:

2014-09-11 GROB-WERKE: Amendment 39-17846; Docket No. FAA-2014-0092;
Directorate Identifier 2014-CE-002-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective June 13,
2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to GROB-WERKE Model G115EG airplanes, all serial
numbers, and Model G120A airplanes, serial numbers 85001 through
85007, 85026 through 85056, and 85058, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 55: Stabilizers.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI

describes the unsafe condition as cracks in the left hand elevator
flange. We are issuing this AD to detect and correct cracks in the
left hand and right hand elevator flanges, which could cause the
elevator to fail and could result in reduced control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(f)(3) of this AD:
    (1) Within the next 30 days after June 13, 2014 (the effective
date of this AD) and repetitively thereafter at intervals not to
exceed 100 hours time-in-service (TIS), inspect the left hand (LH)
and the right hand (RH) elevator flanges, part number (P/N) 115E-
3761.06 and P/N 115E-3762.07 or P/N 120A-3561.20(A) and P/N 120A-
3562.20(A), as applicable, for cracks. Do the inspections following
GROB Aircraft Service Bulletin No. MSB1078-194/1, dated December 3,
2013, or GROB Aircraft Service Bulletin No. MSB1121-140, dated
December 3, 2013, as applicable.
    (2) If any crack is found during any inspection required in
paragraph (f)(1) of this AD, before further flight, replace the
affected elevator flange with a serviceable part. Do the replacement
following GROB Aircraft Service Bulletin No. MSB1078-194/1, dated
December 3, 2013, or GROB Aircraft Service Bulletin No. MSB1121-140,
dated December 3, 2013, as applicable.
    (3) As of June 13, 2014 (the effective date of this AD), only
install an elevator flange P/N 115E-3761.06, P/N 115E-3762.07, P/N
120A-3561.20(A), or P/N 120A-3562.20(A), if it has been inspected
following GROB Aircraft Service Bulletin No. MSB1078-194/1, dated
December 3, 2013, or GROB Aircraft Service Bulletin No. MSB1121-140,
dated December 3, 2013, as applicable, and is free of any cracks.

(g) Credit for Actions Accomplished in Accordance With Previous Service
Information for Model G115EG Airplanes

    This paragraph provides credit for the initial inspection
required in paragraph (f)(1) of this AD and any replacement required
in paragraph (f)(2) based on the result of the initial inspection if
already done before June 13, 2014 (the effective date of this AD)
following GROB Aircraft Service Bulletin No. MSB1078-194, dated
November 26, 2013.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>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.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(i) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2014-0004, dated January 7, 2014; and GROB Aircraft Service Bulletin
No. MSB1078-194, dated November 26, 2013, for related information.
You may examine the MCAI on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0092-0002.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) GROB Aircraft Service Bulletin No. MSB1078-194/1, dated
December 3, 2013.
    (ii) GROB Aircraft Service Bulletin No. MSB1121-140, dated
December 3, 2013.
    (3) For GROB-WERKE service information identified in this AD,
contact Grob Aircraft AG, Customer Service, Lettenbachstrasse 9,
86874 Tussenhausen-Mattsies, Germany, telephone: + 49 (0) 8268-998-
105; fax; + 49 (0) 8268-998-200; email<EMAIL_ADDRESS>Internet: grob-aircraft.com.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference 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 April 25, 2014.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2014-10060 Filed 5-8-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Proposed Rules]
[Pages 12430-12431]
[FR Doc No: 2016-05221]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2013-N-0402]

Generic Drug User Fee Amendments of 2012; Regulatory Science
Initiatives; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing that will provide an overview of the
current status of regulatory science initiatives for generic drugs and
an opportunity for public input on research priorities in this area.
FDA is seeking this input from a variety of stakeholders--industry,
academia, patient advocates, professional societies, and other
interested parties--as it fulfills its commitment under the Generic
Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of
regulatory science initiatives specific to generic drugs. FDA will take
the information it obtains from the public hearing into account in
developing the fiscal year (FY) 2017 Regulatory Science Plan.

DATES:  The public hearing will be held on May 20, 2016, from 9 a.m. to
5 p.m. The public hearing may be extended or may end early depending on
the level of public participation.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
hearing participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Comments: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0402 for ``Generic Drug User Fee Amendments of 2012;
Regulatory Science Initiatives; Public Hearing; Request for Comments.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Thushi Amini, Center for Drug
Evaluation and Research, Food and

Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4728,
Silver Spring, MD 20993,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
or Robert Lionberger, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722,
Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, Congress passed GDUFA (Title III of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is
designed to enhance public access to safe, high-quality generic drugs
and modernize the generic drug program. To support this goal, FDA
agreed in the GDUFA commitment letter to work with industry and
interested stakeholders on identifying regulatory science research
priorities specific to generic drugs for each fiscal year covered by
GDUFA. The commitment letter outlines FDA's performance goals and
procedures under the GDUFA program for the years 2012-2017. The
commitment letter can be found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

II. Purpose and Scope of the Public Hearing

    The purpose of the May public hearing is to obtain input from
industry and other interested stakeholders on the identification of
regulatory science priorities for FY 2017. To help fulfill FDA's
mission, FDA is particularly interested in receiving input on the
following topics:
    1. Opportunities for scientific or technical advancements that
would help to overcome specific barriers for industry that currently
limit the availability of generic drug products.
    2. Innovative approaches to pre-approval development of generic
drugs, including new methodologies for product design and
manufacturing, and design and conduct of in vitro, ex vivo, and
clinical studies and identification of scientifically robust strategies
for demonstration of bioequivalence for various product classes.
    3. Innovation in scientific approaches to evaluating the
therapeutic equivalence of generic drug products throughout their
lifecycle.
    4. Identification of high-impact public health issues involving
generic drugs that can be addressed by the prioritized allocation of FY
2017 funding for regulatory science research.
    5. Identification of specific issues related to generic drug
products where scientific recommendations and/or clarifications are
needed in developing and/or revising FDA's guidance for industry.
    6. Strategies for enhancing quality and equivalence risk management
during generic drug product development, during regulatory review, and/
or throughout the drug product's lifecycle.
    FDA will consider all comments made at this hearing or received
through the docket (see ADDRESSES) as it develops its FY 2017 GDUFA
Regulatory Science Plan. Additional information concerning GDUFA,
including the text of the law and the commitment letter, can be found
at http://www.fda.gov/gdufa.
    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. If you wish to attend (either in
person or by Webcast (see Streaming Webcast of the Public Hearing))
and/or present at the hearing, please register for the hearing and/or
make a request for oral presentations or comments by email to
<EMAIL_ADDRESS>by April 29, 2016. The email should
contain complete contact information for each attendee (i.e., name,
title, affiliation, address, email address, and telephone number).
Those without email access can register by contacting Thushi Amini by
April 29, 2016 (see FOR FURTHER INFORMATION CONTACT).
    FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the topic, or topics, they wish to address. This will help FDA
organize the presentations. FDA will notify registered presenters of
their scheduled presentation times. The time allotted for each
presentation will depend on the number of individuals who wish to
speak. Once FDA notifies registered presenters of their scheduled
times, they are encouraged to submit an electronic copy of their
presentation to<EMAIL_ADDRESS>on or before May 6,
2016. Persons registered to make an oral presentation are encouraged to
arrive at the hearing room early and check in at the onsite
registration table to confirm their designated presentation time. An
agenda for the hearing and other background materials will be made
available 5 days before the hearing at http://www.fda.gov/GDUFARegScience.
    If you need special accommodations because of a disability, please
contact Thushi Amini (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the hearing.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live Webcast of the hearing. To join the
hearing via the Webcast, please go to https://collaboration.fda.gov/r7qyz2eds95.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov or at
http://www.fda.gov/GDUFARegScience. It may be viewed at the Division of
Dockets Management (see Comments). A transcript will also be available
in either hard copy or on CD-ROM, after submission of a Freedom of
Information request. The Freedom of Information office address is
available on the Agency's Web site at http://www.fda.gov.

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner and the
Center for Drug Evaluation and Research. Under Sec.  15.30(f), the
hearing is informal and the rules of evidence do not apply. No
participant may interrupt the presentation of another participant. Only
the presiding officer and panel members may pose questions; they may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (21 CFR part 10, subpart C). Under Sec.  10.205,
representatives of the media may be permitted, subject to certain
limitations, to videotape, film, or otherwise record FDA's public
administrative proceedings, including presentations by participants.
The hearing will be transcribed as stipulated in Sec.  15.30(b) (see
Transcripts). To the extent that the conditions for the hearing, as
described in this notice, conflict with any provisions set out in part
15, this notice acts as a waiver of those provisions as specified in
Sec.  15.30(h).

    Dated: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
 [FR Doc. 2016-05221 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Proposed Rules]
[Pages 31546-31547]
[FR Doc No: 2017-14213]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2017-0081; FRL-9964-50-Region 5]

Air Plan Approval; Wisconsin; Site-Specific Sulfur Dioxide
Requirements for USG Interiors, LLC

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve under the Clean Air Act a State Implementation Plan (SIP)
revision submitted by Wisconsin on January 31, 2017, and supplemented
on March 20, 2017. This SIP submittal consists of Wisconsin
Administrative Order AM-16-01, which imposes a requirement for a taller
cupola exhaust stack, a sulfur dioxide (SO2) emission limit
in conjunction with a minimum cupola stack flue gas flow rate, and
associated requirements on the mineral wool production process at the
USG Interiors LLC facility located in Walworth, Wisconsin (USG-
Walworth). Wisconsin submitted this SIP revision to enable the area
near USG-Walworth to qualify for being designated ``attainment'' of the
2010 primary SO2 National Ambient Air Quality Standards, a
matter that will be addressed in a separate future rulemaking. EPA is
approving AM-16-01 into the Wisconsin SIP, which makes the AM-16-01
requirements federally enforceable.

DATES: Comments must be received on or before August 7, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2017-0081 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jenny Liljegren, Physical Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal

Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: June 20, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-14213 Filed 7-6-17; 8:45 am]
 BILLING CODE 6560-50-P


Bluegill	LC50 (96-hr) = 5,000 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 2,800 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 2,000 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 234 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 5,200 µg/L	40.5% EC	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 3,360 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 13,000 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 15,000 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 45,000 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 40,000 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 6,800 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 9,600 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 8,100 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 2,350 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 2,250 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 2,250 µg/L	Technical	40098001	Supplemental

	Bluegill	LC50 (96-hr) = 1,050 µg/L	80% Wettable powder	40098001
Supplemental

	Bluegill	LC50 (96-hr) = 1,880 µg/L	Technical	40098001	Supplemental

	Largemouth bass	LC50 (96-hr) = 3,450 µg/L	Technical	40098001
Supplemental

	Yellow perch	LC50 (96-hr) = 3,450 µg/L	Technical	40098001	Supplemental

	Fathead minnow	LC50 (96-hr) = 110,000 µg/L	Technical

	65495	Supplemental

	Adequate for RQ calculation; No analytical verification was reported
for any of the bioassays.

Bluegill	LC50 (96-hr) = 3,800 µg/L

Goldfish	LC50 (96-hr) = 100,000 µg/L

Guppy	LC50 (96-hr) = 7,200 µg/L

Bluegill	LC50 (96-hr) = 2,200 µg/L	Technical	91766	Acceptable

	Rainbow trout	LC50 (96-hr) = 1,600 µg/L	Technical	91766	Acceptable

	Freshwater Fish (Chronic)

Rainbow trout	NOAEC = 110 µg a.i./L

LOAEC = 234 µg a.i./L	Technical	425717-01	Acceptable	Early life-stage
study; endpoint based on increased time to swim up

Estuarine/Marine Invertebrates (Acute)

Eastern oyster (Crassostrea virginica)	EC50 >114 mg a.i./L	Technical
444992-01	Acceptable	96-hr shell-deposition study; NOAEC = 83 mg a.i./L
(based on 16% decrease in shell deposition)

Estuarine/Marine Invertebrates (Chronic)

Mysid (Mysidopsis bahia)	NOAEC = 3.1 µg a.i./L

LOAEC = 6.7 µg a.i./L	Technical	444992-02	Acceptable	Flow-through,
life-cycle study; endpoints based on decreased number of neonates
produced, decreased survival, dreased weight, and decreased length

Thalassiosire pseudonana	LC50 = >50 mg a.i./L

TABLE A.2.  Summary of the Studies with the Most Sensitive Endpoints
from Submitted Toxicity Data for DDVP.

TAXON	ENDPOINT	FORMULATION	MRID	STUDY CLASS-IFICATION	COMMENTS

Birds (Acute)

Bobwhite quail (Colinus virginianus)	LD50 = 8.8 mg a.i./kg bw	Technical
40818301	Acceptable

	Birds (Sub-Acute)

Ring-necked pheasant (Phasianus colchicus)	LC50 =  568 mg a.i./kg-diet
Technical	0022923	Acceptable

	Birds (Chronic)

Mallard duck (Anas platyrhynchos)	NOAEC = 5 mg a.i./kg-diet

LOAEC = 15 mg a.i./kg-diet	Technical	44233401	Acceptable	Based on
reduced eggshell thickness, eggs laid, and number of viable embryos

Mammals  (Acute)

Laboratory rat (Rattus norvegicus)	LD50 = 56 mg a.i./kg-bw	Technical
0005467	Acceptable

	Mammals  (Chronic)

Laboratory rat (Rattus norvegicus)	NOAEC = 20 mg a.i./kg-diet

LOAEC = 80 mg a.i./kg-diet	Technical	42483901	Acceptable	Based on
reduced fertility and pup weight

Terrestrial Invertebrates

Honey bee (Apis mellifera)	LD50 = 0.5 µg a.i./bee (contact)	Technical
00036935	Acceptable

	Freshwater Invertebrates (Acute)

Water flea (Daphnia pulex)	EC50 = 0.066 µg a.i./L	Technical	40098001
Acceptable

	Freshwater Invertebrates (Chronic)

Water flea (Daphnia magna)	NOAEC = 0.0058 µg a.i./L

LOAEC = 0.0122 µg a.i./L	Technical	43890301	Acceptable	Based on reduced
egg production and growth (length and weight)

Freshwater Fish (Acute)

Cutthroat trout (Oncorhynchus clarki)	LC50 = 170 µg a.i./L	Technical
40098001	Acceptable

	Freshwater Fish (Chronic)

Rainbow trout (Oncorhynchus mykiss)	NOAEC = 5.2 µg a.i./L

LOAEC = 10.1 µg a.i./L	Technical	43788001	Acceptable	Based on decreased
post-hatch larval survival

Estuarine/Marine Invertebrates (Acute)

Mysid (Americamysis bahia)	EC50 = 19.1 µg a.i./L

	Technical	43571408	Acceptable

	Estuarine/Marine Invertebrates (Chronic)

Mysid (Americamysis bahia)	NOAEC = 1.48 µg a.i./L

LOAEC = 3.25 µg a.i./L	Technical	43854301	Acceptable	Based on reduced
growth (weight and length)

Estuarine/Marine Fish (Acute)

Sheepshead minnow (Cyprinodon variegates)	LC50 = 7,350 µg a.i./L
Technical	43571403	Acceptable

	Estuarine/Marine Fish (Chronic)

Sheepshead minnow (Cyprinodon variegates)	NOAEC = 960 µg a.i./L

LOAEC = 1840 µg a.i./L	Technical	43790401	Acceptable	Based on reduced
survival and length

 Appendix B. The Risk Quotient Method and Levels of Concern

The Risk Quotient Method is the means used by EFED to integrate the
results of exposure and ecotoxicity data. For this method, Risk
Quotients (RQs) are calculated by dividing exposure estimates by the
acute and chronic ecotoxicity values (i.e., RQ = EXPOSURE/TOXICITY).
These RQs are then compared to OPP's levels of concern (LOCs). These
LOCs are criteria used by OPP to indicate potential risk to non-target
organisms and the need to consider regulatory action. EFED has defined
LOCs for acute risk, potential restricted use classification, and for
endangered species.

The criteria indicate that a pesticide used as directed has the
potential to cause adverse effects on non-target organisms. LOCs
currently address the following risk presumption categories:

(1) acute - there is a potential for acute risk; regulatory action may
be warranted in addition to restricted use classification;

(2) acute restricted use - the potential for acute risk is high, but
this may be mitigated through restricted use classification;

(3) acute endangered species - the potential for acute risk to
endangered species is high, regulatory action may be warranted; and

(4) chronic risk - the potential for chronic risk is high, regulatory
action may be warranted.

Currently, EFED does not perform assessments for chronic risk to plants,
acute or chronic risks to non-target insects, or chronic risk from
granular/bait formulations to mammalian or avian species.

The ecotoxicity test values (i.e., measurement endpoints) used in the
acute and chronic RQs are derived from required studies. Examples of
ecotoxicity values derived from short-term laboratory studies that
assess acute effects are: (1) LC50 (fish and birds), (2) LD50 (birds and
mammals), (3) EC50 (aquatic plants and aquatic invertebrates), and (4)
EC25 (terrestrial plants). Examples of toxicity test effect levels
derived from the results of long-term laboratory studies that assess
chronic effects are: (1) the Lowest Observed Adverse Effect
Concentration (LOAEC) (birds, fish, and aquatic invertebrates), and (2)
the No Observed Adverse Effect Concentration (NOAEC) (birds, fish and
aquatic invertebrates). The NOAEC is generally used as the ecotoxicity
test value in assessing chronic effects. Risk presumptions, along with
the corresponding RQs and LOCs are summarized in Table B1.

Table B1.  Agency risk quotient (RQ) metrics and levels of concern (LOC)
per risk class.

Risk Class	Risk Description	RQ	LOC

Aquatic Animals (fish and invertebrates)

Acute	Potential for effects to non-listed animals from acute exposures
Peak EEC/LC501	0.5

Acute Restricted Use	Potential for effects to animals from acute
exposures

Risks may be mitigated through restricted use classification	Peak
EEC/LC501	0.1

Acute Listed Species	Listed species may be potentially affected by acute
exposures	Peak EEC/LC501	0.05

Chronic	Potential for effects to non-listed and listed animals from
chronic exposures 	60-day EEC/NOEC (fish)	1

21-day EEC/NOEC (invertebrates)

	Terrestrial Animals (mammals and birds)

Acute	Potential for effects to non-listed animals from acute exposures
EEC2/LC50 (Dietary)	0.5

EEC/LD50 (Dose)

	Acute Restricted Use	Potential for effects to animals from acute
exposures

Risks may be mitigated through restricted use classification	EEC2/LC50
(Dietary)	0.2

EEC/LD50 (Dose)

	Acute Listed Species	Listed species may be potentially affected by
acute exposures	EEC 2/LC50 (Dietary)	0.1

EEC/LD50 (Dose)

	Chronic	Potential for effects to non-listed and listed animals from
chronic exposures	EEC 2/NOAEC	1

Plants

Non-Listed 	Potential for effects to non-target, non-listed plants from
exposures	EEC/ EC25	1

Listed Plant	Potential for effects to non-target, listed plants from
exposures	EEC/ NOEC	1

EEC/ EC05

	1 LC50 or EC50. 2 Based on upper bound Kenaga values.

Appendix C.  Data Call-In Tables

The Environmental Fate and Effects Division (EFED) has completed a Data
Call-In (DCI) table for the trichlorfon (and DDVP) environmental fate
and effects data gaps identified in registration review.  The effects
data gaps may change if relevant toxicity data are identified from the
ECOTOX literature review.  The attached DCI tables, which include the
guideline number and study title for required data, also provides a
rationale for requiring the data, an explanation of how the data will be
used, and a brief description of how the data could impact the
Agency’s future decision-making.

Trichlorfon:

Guideline Number:  835.2120

Study Title:  Hydrolysis

Rationale for Requiring the Data

Acceptable data have not been provided to quantify the hydrolysis of
trichlorfon. According to Code of Federal Regulations 40 (CFR40 2007)
Part 158 Subpart D (data requirements for pesticides) hydrolysis data
are required for pesticides with terrestrial or aquatic uses. Since
trichlorfon uses are classified as terrestrial and aquatic, hydrolysis
data for trichlorfon should be submitted to fulfill OPPTS Guideline
835.2120.

Practical Utility of the Data

How will the data be used?

These data are used to estimate the degradation of trichlorfon in
aquatic systems and ultimately to derive aquatic EECs using PRZM/EXAMS.

How could the data impact the Agency’s future decision-making?

In the case that these data are unavailable at the time risk assessments
are conducted, it will be assumed that trichlorfon is stable to
hydrolysis. If trichlorfon does degrade due to hydrolysis, this
assumption will result in overestimates of the concentrations of
trichlorfon in the environment.

Guideline Number:  835.2410

Study Title:  Photodegradation in soil

Rationale for Requiring the Data

Acceptable data have not been provided to quantify the photolysis of
trichlorfon in water. According to Code of Federal Regulations 40 (CFR40
2007) Part 158 Subpart D (data requirements for pesticides) aqueous
photolysis data are required for pesticides with terrestrial or aquatic
uses. Since trichlorfon uses are classified as terrestrial and aquatic,
aqueous photolysis data for trichlorfon should be submitted to fulfill
OPPTS Guideline 835.2410.

Practical Utility of the Data

How will the data be used?

These data are used to characterize the degradation of trichlorfon in
soil.

How could the data impact the Agency’s future decision-making?

In the case that these data are not submitted, it will be assumed that
trichlorfon is stable to photolysis on soil.

Guideline Number:  835.4300

Study Title:  Aerobic Aquatic Metabolism

Rationale for Requiring the Data

Acceptable data have not been provided to quantify the metabolism of
trichlorfon under aerobic aquatic conditions. According to Code of
Federal Regulations 40 (CFR40 2007) Part 158 Subpart D (data
requirements for pesticides) aerobic aquatic metabolism are required for
pesticides with terrestrial or aquatic uses. Since trichlorfon uses are
classified as terrestrial and aquatic, aerobic aquatic metabolism data
for trichlorfon should be submitted to fulfill OPPTS Guideline 835.4300.

Practical Utility of the Data

How will the data be used?

These data are used to estimate the degradation of trichlorfon in
aquatic systems and ultimately to derive aquatic EECs using PRZM/EXAMS.

How could the data impact the Agency’s future decision-making?

In the case that these data are unavailable at the time risk assessments
are conducted, PRZM/EXAMS input parameter guidance default values will
be employed to account for aerobic aquatic metabolism.

Guideline Number:  835.4400

Study Title:  Anaerobic Aquatic Metabolism

Rationale for Requiring the Data

Acceptable data have not been provided to quantify the metabolism of
trichlorfon under anaerobic aquatic conditions. According to Code of
Federal Regulations 40 (CFR40 2007) Part 158 Subpart D (data
requirements for pesticides) anaerobic aquatic metabolism data are
required for pesticides with terrestrial or aquatic uses. Since
trichlorfon uses are classified as terrestrial and aquatic, anaerobic
aquatic metabolism data for trichlorfon should be submitted to fulfill
OPPTS Guideline 835.4400.

Practical Utility of the Data

How will the data be used?

These data are used to estimate the degradation of trichlorfon in
aquatic systems and ultimately to derive aquatic EECs using PRZM/EXAMS.

How could the data impact the Agency’s future decision-making?

In the case that these data are unavailable at the time risk assessments
are conducted, PRZM/EXAMS input parameter guidance default values will
be employed to account for anaerobic aquatic metabolism.

Guideline Number:  835.1240

Study Title:  adsorption/desorption

Rationale for Requiring the Data

Acceptable data have not been provided to quantify the
adsorption/desorption characteristics of trichlorfon in U.S. soils.
According to Code of Federal Regulations 40 (CFR40 2007) Part 158
Subpart D (data requirements for pesticides) adsorption/desorption data
are required for pesticides with terrestrial uses. Since trichlorfon
uses are considered to be terrestrial, an acceptable study should be
submitted to fulfill OPPTS Guideline 835.1240. This study should define
Kd and KOC values of trichlorfon in U.S. soils. It is preferred that
this study be conducted using a batch equilibrium method.

Practical Utility of the Data

How will the data be used?

These data are used to estimate the transport of trichlorfon from
treatment sites to aquatic systems and ultimately to derive aquatic EECs
using PRZM/EXAMS.

How could the data impact the Agency’s future decision-making?

In the absence of these data, EFED will assume that there is no sorption
of trichlorfon to soils or organic matter on the treatment site.  In
order to implement this in derivation of aquatic EECs, a KOC value of 0
will be used to parameterize PRZM/EXAMS.  Input of a KOC value >0 is
expected to result in lower aquatic EECs. If acceptable data are
provided, the uncertainties associated with this assumption will be
reduced.

Guideline Number:  835.6200

Study Title:  Aquatic Field Dissipation

Rationale for Requiring the Data

At this time, no acceptable studies are available to describe the
dissipation of trichlorfon under aquatic field conditions.  According to
Code of Federal Regulations 40 (CFR40 2007) Part 158 Subpart D (data
requirements for pesticides), aquatic field dissipation data are
required for pesticides with aquatic uses. Since trichlorfon uses are
classified as aquatic, aquatic field dissipation data for trichlorfon
should be submitted to fulfill OPPTS Guideline 835.6200.

Practical Utility of the Data

How will the data be used?

These data are used to characterize the fate of trichlorfon in the
aquatic environment resulting from direct applications to water.

How could the data impact the Agency’s future decision-making?

These data are useful to validate laboratory fate data of trichlorfon
with a field study that accounts for all of the fate processes studied
under laboratory conditions (e.g., hydrolysis, photolysis).

Guideline Number: 835.6100 (7), 835.6200 (7)

Study Title: Environmental Chemistry Methods

Rationale for Requiring the Data

Independently validated analytical methods for residues in soil and
water (environmental chemistry methods) submitted by the registrant are
used to evaluate analyses described in submitted environmental fate and
ecological effects studies.  Submitted analytical methods are also used
by various Federal, State, Tribal, and local agencies to detect and
monitor residues that are or are suspected to be in environmental
compartments due to outdoor uses and accidental releases.  Therefore,
availability of these analytical methods is necessary in order to
protect human health and the environment from trichlorfon residues in
the environment.  Independent laboratory validations for submitted
analytical methods are necessary to confirm the levels of detection and
quantitation reported in registrant-prepared validations.

Use of trichlorfon may impact surface water quality due to runoff of
rain water and drift of residues.  Therefore, analytical methods for are
necessary for detecting trichlorfon residues in water and in soil or
sediment.

Practical Utility of the Data

How will the data be used?

In the absence of independently validated environmental chemistry
methods, submitted environmental fate and ecological effects data may
not be reviewable and entities outside the Agency may lack
chemical-specific methods for analyses in environmental compartments.
Independently validated environmental chemistry methods will be used to
evaluate the submitted environmental fate and ecological effects data
and will be made available to the public to support monitoring for
trichlorfon residues.

How could the data change the Agency’s decision, or impact the
Agency’s future decision-making?

Risk assessment conclusions could be altered if they are not supported
by either study data or environmental monitoring detections that are
based on independently validated environmental chemistry methods.
Furthermore, while not directly related to Agency decision-making,
independently validated environmental chemistry methods are necessary in
order to protect human health and the environment from use of
trichlorfon.

Guideline Number:  850.2100

Study Title:  Avian Acute Oral Toxicity Test (mallard duck or bobwhite
quail and a passerine species)

Rationale for Requiring the Data

No acceptable acute avian oral toxicity data were submitted for
trichlorfon.  The new Part 158 data requirements [40 CFR Part 158 (CFR
40 2007)] specify that acute avian oral toxicity data be submitted for
either mallard duck or bobwhite quail and a passerine species. The
available chronic toxicity data for mallard ducks and bobwhite quails
demonstrate that trichlorfon can cause toxic effects in these birds. In
addition, avian data for other organophosphate (OP) insecticides,
including dimethoate, show that a passerine species, such as the
red-winged blackbird, are one order of magnitude more sensitive than
other tested bird species to acute OP insecticide exposure (USEPA 2008).
 Therefore, an avian oral toxicity test is required for passerine birds
and either the mallard duck or the bobwhite quail, as specified in 40
CFR Part 158. A passerine study protocol must be submitted for review by
the Agency prior to initiation of this study.

Practical Utility of the Data

How will the data be used?

Acute avian oral toxicity data will be used to identify potential risks
to birds from acute exposure to trichlorfon.  The data will reduce
uncertainties associated with the current risk assessment for birds and
will improve the Agency’s understanding of the potential effects of
trichlorfon on terrestrial species.  If oral acute toxicity data are not
submitted for any bird, than risk to birds from acute exposure to
trichlorfon will be assumed.

How could the data impact the Agency’s future decision-making?

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that trichlorfon “may
affect” listed birds directly (and listed species from other taxa
indirectly), and use of trichlorfon and its formulated products may need
to be restricted in areas where listed species could be exposed. The
lack of these data will limit the flexibility the Agency and registrants
have in coming into compliance with the Endangered Species Act and could
result in use restrictions for trichlorfon use that are unnecessarily
severe.

Guideline Number:  850.2200

Study Title:  Avian Dietary Toxicity Test (mallard duck and bobwhite
quail)

Rationale for Requiring the Data

No acceptable sub-acute avian dietary toxicity data were submitted for
trichlorfon.  The new Part 158 data requirements [40 CFR Part 158 (CFR
40 2007)] specify that avian dietary toxicity data be submitted for both
a waterfowl and upland game species. The available chronic toxicity data
for mallard ducks and bobwhite quails demonstrate that trichlorfon can
cause toxic effects in these birds.  Therefore, an avian dietary
toxicity test is required for mallard ducks and bobwhite quails as
specified in 40 CFR Part 158.

Practical Utility of the Data

How will the data be used?

Sub-acute avian dietary toxicity data will be used to identify potential
risks to birds from acute exposure to trichlorfon.  The data will reduce
uncertainties associated with the current risk assessment for birds and
will improve the Agency’s understanding of the potential effects of
trichlorfon on terrestrial species.  If dietary toxicity data are not
submitted for any bird, than risk to birds from dietary exposure to
trichlorfon will be assumed.

How could the data impact the Agency’s future decision-making?

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that trichlorfon “may
affect” listed birds directly (and listed species from other taxa
indirectly), and use of trichlorfon and its formulated products may need
to be restricted in areas where listed species could be exposed. The
lack of these data will limit the flexibility the Agency and registrants
have in coming into compliance with the Endangered Species Act and could
result in use restrictions for trichlorfon use that are unnecessarily
severe.

Guideline Number: 850.1075

Study Title:  Fish Acute Toxicity Test, Estuarine/Marine

Rationale for Requiring the Data

Acute toxicity data are not available for estuarine and marine fish.
The updated Part 158 data requirements, published in October 2007,
specify that acute toxicity data are required on one estuarine/marine
mollusk (guideline fulfilled), one estuarine/marine invertebrate
(guideline not fulfilled), and one estuarine/marine fish (guideline not
fulfilled) for terrestrial (food crop, feed crop, and nonfood), aquatic
food crop, and nonfood (outdoor), forestry, and residential outdoor
uses.  Trichlorfon has terrestrial (turf), aquatic nonfood
(ornamental/bait ponds) and residential outdoor uses registered, and
therefore, the acute estuarine/marine organism toxicity studies are
required.

In the absence of these data, an acute-to-chronic ratio (ACR) would
normally be derived; and the acute toxicity to estuarine and marine fish
would be estimated based on the ACR for freshwater fish.  However, there
are currently no toxicity data (acute or chronic) for estuarine/marine
fish, therefore, an ACR cannot be derived.  In addition, three of the
four reported ecological incidents associated with the use of
trichlorfon have involved fish kills.

Practical Utility of the Data

How will the data be used?

Estuarine/marine fish acute toxicity data will be used to determine the
potential for trichlorfon to affect fish species in estuarine/marine
environments. The data will reduce uncertainties associated with the
current risk assessment for estuarine/marine fish and will improve the
Agency’s understanding of the potential effects of trichlorfon on
aquatic animals.  In the absence of data specific for these fish, data
from freshwater fish species will be used as a surrogate for
estuarine/marine fish.

How could the data impact the Agency’s future decision-making?

Using toxicity data from a freshwater species as a surrogate for
estuarine/marine species increases the uncertainty for assessing risks
to estuarine/marine species in screening-level assessments.
Additionally, if future endangered species risk assessments are
performed without these data, the Agency would have to presume risk to
listed estuarine/marine fish species in the absence of such data for
trichlorfon. Therefore, the use of trichlorfon and its formulated
products may need to be restricted in areas where listed species could
be exposed. The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for trichlorfon that
are unnecessarily severe.

Guideline Number: 850.1035

Study Title:  Mysid Acute Toxicity Test

Rationale for Requiring the Data

Although, acute toxicity data are available for an estuarine/marine
mollusk, no acute data are currently available for a non-mollusk
estuarine/marine invertebrate.  The updated Part 158 data requirements,
published in October 2007, specify that acute toxicity data are required
on one estuarine/marine mollusk (guideline fulfilled), one
estuarine/marine invertebrate (guideline not fulfilled), and one
estuarine/marine fish (guideline not fulfilled) for terrestrial (food
crop, feed crop, and nonfood), aquatic food crop, and nonfood (outdoor),
forestry, and residential outdoor uses.  Trichlorfon has terrestrial
(turf), aquatic nonfood (ornamental/bait ponds) and residential outdoor
uses registered, and therefore, the acute estuarine/marine organism
toxicity studies are required.

In the absence of these data, an acute-to-chronic ratio (ACR) would
normally be derived; and the acute toxicity to estuarine/marine
invertebrates would be estimated based on the ACR for freshwater
invertebrates.  However, the freshwater invertebrate data necessary for
calculating the ACR are not available.  Chronic data are not available
for the most acutely sensitive freshwater species (Pteronarcella badia).

Practical Utility of the Data

How will the data be used?

Estuarine/marine invertebrate acute toxicity data will be used to
determine the potential for trichlorfon to affect non-mollusk
invertebrate species in estuarine/marine environments. The data will
reduce uncertainties associated with the current risk assessment for
estuarine/marine invertebrates and will improve the Agency’s
understanding of the potential effects of trichlorfon on aquatic
animals.  In the absence of data specific for these invertebrates, data
from freshwater invertebrate species will be used as a surrogate for
estuarine/marine invertebrates.

How could the data impact the Agency’s future decision-making?

Using toxicity data from a freshwater species as a surrogate for
estuarine/marine species increases the uncertainty for assessing risks
to estuarine/marine species in screening-level assessments.
Additionally, if future endangered species risk assessments are
performed without these data, the Agency would have to presume risk to
listed non-mollusk estuarine/marine invertebrate species in the absence
of such data for trichlorfon. Therefore, the use of trichlorfon and its
formulated products may need to be restricted in areas where listed
species could be exposed. The lack of these data will limit the
flexibility the Agency and registrants have in coming into compliance
with the Endangered Species Act and could result in use restrictions for
trichlorfon that are unnecessarily severe.

Guideline Number: 850.1400

Study Title:  Fish Early Life-Stage Toxicity Test, Estuarine/Marine

Rationale for Requiring the Data

Chronic toxicity data are not available for estuarine and marine fish.
In the absence of these data, an acute-to-chronic ratio (ACR) would
normally be derived; and the chronic toxicity to estuarine and marine
fish would be estimated based on the ACR for freshwater fish.  However,
there are currently no toxicity data (acute or chronic) for
estuarine/marine fish, therefore, an ACR cannot be derived.
Additionally, due to the potential use pattern of trichlorfon , exposure
to estuarine/marine environments is possible.  Therefore, an early
life-stage toxicity study is required for estuarine/marine fish, as
specified in 40 CFR Part 158.

Practical Utility of the Data

How will the data be used?

Estuarine/marine fish chronic toxicity data will be used to determine
the potential for trichlorfon to affect fish species in estuarine/marine
environments. The data will reduce uncertainties associated with the
current risk assessment for estuarine/marine fish and will improve the
Agency’s understanding of the potential effects of trichlorfon on
aquatic animals.  In the absence of data specific for these fish, data
from freshwater fish species will be used as a surrogate for
estuarine/marine fish.

How could the data impact the Agency’s future decision-making?

Using toxicity data from a freshwater species as a surrogate for
estuarine/marine species increases the uncertainty for assessing risks
to estuarine/marine species in screening-level assessments.
Additionally, if future endangered species risk assessments are
performed without these data, the Agency would have to presume risk to
listed estuarine/marine fish species in the absence of such data for
trichlorfon. Therefore, the use of trichlorfon and its formulated
products may need to be restricted in areas where listed species could
be exposed. The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for trichlorfon that
are unnecessarily severe.

Guideline Number:  850.4100, 850.4150

Study Title:  Terrestrial Plant Toxicity Test, Tier I (Seedling
Emergence and Vegetative Vigor)

Rationale for Requiring the Data

Toxicity data for terrestrial plants are not available for trichlorfon.
The current 40 CFR Part 158 data requirements, require Tier I level
seedling emergence and vegetative vigor terrestrial plant data for all
insecticides.  Additionally, other OPs are known to be phytotoxic (e.g.,
tribufos, a plant defoliant).  Therefore, Tier I plant toxicity studies
(seedling emergence and vegetative vigor) are required for terrestrial
plants, as specified in 40 CFR Part 158.

Practical Utility of the Data

How will the data be used?

Vegetative vigor and seedling emergence data for terrestrial plants will
be used to determine the potential for trichlorfon to affect non-target
plant species in the terrestrial environment. The data will reduce
uncertainties associated with the current risk assessment for
terrestrial plants and will improve the Agency’s understanding of the
potential effects of trichlorfon on terrestrial plants.  In the absence
of data specific for these plants, risk to terrestrial plants will be
assumed.

How could the data impact the Agency’s future decision-making?

Because terrestrial plants form the basis of the food chain in many
terrestrial habitats, a solid understanding of the potential risks to
terrestrial plants is essential for sound environmental risk management
decision-making.  Without terrestrial plant data for trichlorfon, the
Agency cannot determine if the current application rates for trichlorfon
may result in direct adverse effects to terrestrial plants and/or
indirect effects resulting from reduction in the prey base and/or loss
of habitat/cover.  If future endangered species risk assessments are
performed without these data, the Agency would have to presume risk to
non-target terrestrial plants from use of trichlorfon. Therefore, use of
trichlorfon and its formulated products may need to be restricted in
areas where listed species could be exposed. The lack of these data will
limit the flexibility the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for trichlorfon that are unnecessarily severe.

Guideline Number:  850.4400

Study Title:  Aquatic plant toxicity (Tier I)

Rationale for Requiring the Data

Trichlorfon toxicity data for vascular and non-vascular aquatic plants
are not available.  Based on the 40 CFR Part 158 data requirements, Tier
I level non-target aquatic plant data are required for all insecticides.
 Additionally, other OPs are known to be phyotoxic (e.g., tribufos,
which is a defoliant).  Therefore, non-target aquatic plant data for
algae and vascular plants are required for trichlorfon at the Tier I
level.

Practical Utility of the Data

How will the data be used?

Data from Tier I aquatic plant toxicity studies will be used to estimate
potential risks to aquatic vascular and non-vascular plants associated
with the use of trichlorfon.  The data will reduce uncertainties
associated with the current risk assessment for aquatic plants and will
improve the Agency’s understanding of the potential effects of
trichlorfon on aquatic plants.  In the absence of Tier I data, risks for
both vascular and non-vascular aquatic plants will be presumed.

How could the data impact the Agency’s future decision-making?

Because aquatic vascular and non-vascular plants form the basis of the
food chain for aquatic habitats and significantly contribute to overall
water quality, a solid understanding of the potential risks to aquatic
plants is essential for sound environmental risk management
decision-making.  Without aquatic plant data for trichlorfon, the Agency
cannot determine if the current application rates for trichlorfon may
result in direct adverse effects to aquatic plants and/or indirect
effects resulting from reduction in the prey base and/or loss of
habitat/cover.  If future endangered species risk assessments are
performed without these data, the Agency would have to assume that
trichlorfon “may affect” aquatic plants directly (and listed species
from other taxa indirectly via reduction in prey base and/or habitat),
and use of trichlorfon may need to be restricted in areas where listed
species could be exposed.  The lack of these data will limit the
flexibility the Agency and registrants have in coming into compliance
with the Endangered Species Act and could result in use restrictions for
trichlorfon which are unnecessarily severe.

DDVP:

Guideline Number:  850.2100

Study Title:  Avian Acute Oral Toxicity Test

Rationale for Requiring the Data

Acceptable acute avian oral toxicity data were submitted for exposures
of bobwhite quail to DDVP; however, data are not available for
passerines, which are required under the new 40 CFR Part 158 (CFR 40
2007) data requirements for conventional pesticides (72 FR 60934; USEPA
2007c).  The available data for bobwhite quails show that DDVP is
classified as very highly toxic to birds on an acute exposure. In
addition, avian data for other organophosphate (OP) insecticides,
including dimethoate, show that a passerine species, such as the
red-winged blackbird, are one order of magnitude more sensitive than
other tested bird species to acute OP insecticide exposure.  Therefore,
an avian oral toxicity test is required for passerine birds, as
specified in 40 CFR Part 158. A passerine study protocol must be
submitted for review by the Agency prior to initiation of this study.

Practical Utility of the Data

How will the data be used?

Acute avian oral toxicity data will be used to identify potential risks
to birds from acute exposure to DDVP from the use of trichlorfon.  The
data will reduce uncertainties associated with the current risk
assessment for birds and will improve the Agency’s understanding of
the potential effects of trichlorfon on terrestrial species.  If oral
acute toxicity data are not submitted for passerines, than risk to
passerines from acute exposure to DDVP from the use of trichlorfon will
be assumed.

How could the data impact the Agency’s future decision-making?

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that trichlorfon “may
affect” listed passerine species directly (and listed species from
other taxa indirectly), and use of trichlorfon and its formulated
products may need to be restricted in areas where listed species could
be exposed. The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for trichlorfon use
that are unnecessarily severe.

Guideline Number:  850.4100, 850.4150

Study Title:  Terrestrial Plant Toxicity Test, Tier I (Seedling
Emergence and Vegetative Vigor)

Rationale for Requiring the Data

Toxicity data for terrestrial plants are not available for DDVP.  The
current 40 CFR Part 158 data requirements, require Tier I level seedling
emergence and vegetative vigor terrestrial plant data for all
insecticides.  Additionally, other OPs are known to be phytotoxic (e.g.,
tribufos, a plant defoliant).  Therefore, Tier I plant toxicity studies
(seedling emergence and vegetative vigor) are required for terrestrial
plants, as specified in 40 CFR Part 158.

Practical Utility of the Data

How will the data be used?

Vegetative vigor and seedling emergence data for terrestrial plants will
be used to determine the potential for DDVP (from the use of
trichlorfon) to affect non-target plant species in the terrestrial
environment. The data will reduce uncertainties associated with the
current risk assessment for terrestrial plants and will improve the
Agency’s understanding of the potential effects of trichlorfon on
terrestrial plants.  In the absence of data specific for these plants,
risk to terrestrial plants will be assumed.

How could the data impact the Agency’s future decision-making?

Because terrestrial plants form the basis of the food chain in many
terrestrial habitats, a solid understanding of the potential risks to
terrestrial plants is essential for sound environmental risk management
decision-making.  Without terrestrial plant data for DDVP, the Agency
cannot determine if the current application rates for trichlorfon may
result in direct adverse effects to terrestrial plants and/or indirect
effects resulting from reduction in the prey base and/or loss of
habitat/cover.  If future endangered species risk assessments are
performed without these data, the Agency would have to presume risk to
non-target terrestrial plants from use of trichlorfon. Therefore, use of
trichlorfon and its formulated products may need to be restricted in
areas where listed species could be exposed. The lack of these data will
limit the flexibility the Agency and registrants have in coming into
compliance with the Endangered Species Act and could result in use
restrictions for trichlorfon that are unnecessarily severe.

Guideline Number:  850.4400

Study Title:  Aquatic plant toxicity (Tier I)

Rationale for Requiring the Data

DDVP toxicity data for vascular and non-vascular aquatic plants are not
available.  Based on the 40 CFR Part 158 data requirements, Tier I level
non-target aquatic plant data are required for all insecticides.
Additionally, other OPs are known to be phyotoxic (e.g., tribufos, which
is a defoliant).  Therefore, non-target aquatic plant data for algae and
vascular plants are required for DDVP at the Tier I level.

Practical Utility of the Data

How will the data be used?

Data from Tier I aquatic plant toxicity studies will be used to estimate
potential risks to aquatic vascular and non-vascular plants from DDVP
exposure associated with the use of trichlorfon.  The data will reduce
uncertainties associated with the current risk assessment for aquatic
plants and will improve the Agency’s understanding of the potential
effects of trichlorfon on aquatic plants.  In the absence of Tier I
data, risks for both vascular and non-vascular aquatic plants will be
presumed.

How could the data impact the Agency’s future decision-making?

Because aquatic vascular and non-vascular plants form the basis of the
food chain for aquatic habitats and significantly contribute to overall
water quality, a solid understanding of the potential risks to aquatic
plants is essential for sound environmental risk management
decision-making.  Without aquatic plant data for DDVP, the Agency cannot
determine if the current application rates for trichlorfon may result in
direct adverse effects to aquatic plants and/or indirect effects
resulting from reduction in the prey base and/or loss of habitat/cover.
If future endangered species risk assessments are performed without
these data, the Agency would have to assume that trichlorfon “may
affect” aquatic plants directly (and listed species from other taxa
indirectly via reduction in prey base and/or habitat), and use of
trichlorfon may need to be restricted in areas where listed species
could be exposed.  The lack of these data will limit the flexibility the
Agency and registrants have in coming into compliance with the
Endangered Species Act and could result in use restrictions for
trichlorfon which are unnecessarily severe.

 PAGE

 PAGE   9  of   NUMPAGES  74

Ingestion

Birds / Amphibians

Wet/dry deposition

Root uptake

Long range atmospheric transport

Dermal uptake/Ingestion

Ingestion

Ingestion

Ingestion

Ingestion

Soil

Exposure

Media

Mammals

Runoff

Terrestrial/riparian plants

grasses/forbs, fruit, seeds (trees, shrubs)

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Food chain

Reduction in prey

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Terrestrial

insects

Birds / Terrestrial-phase amphibians / reptiles / mammals

Juvenile

Adult

Spray drift

Direct

application

Trichlorfon applied to use site

Trichlorfon degrading to DDVP

Attribute

Change

Receptors

Source

Stressor

Riparian plant terrestrial exposure pathways see Figure 3

Uptake/cell,

roots, leaves

Aquatic Plants

Non-vascular

Vascular

Uptake/gills

or integument

Ground water

Soil

Wet/dry deposition

Long range atmospheric transport

Ingestion

Ingestion

Uptake/gills

or integument

Exposure

Media

Aquatic Animals

Invertebrates

Vertebrates

Runoff

Surface water/

Sediment

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Food chain

Reduction in algae

Reduction in prey

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Fish/aquatic-phase amphibians

Eggs

Larvae

Juveniles / Adults

Spray drift

Trichlorfon applied to use site

Trichlorfon degrading to DDVP

Attribute

Change

Receptors

Source

Stressor


[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16012-16013]
[FR Doc No: 2022-05914]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4533-DR; Docket ID FEMA-2022-0001]

Alaska; Amendment No. 7 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security (DHS).

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alaska (FEMA-4533-DR), dated April 9, 2020, and
related determinations.

DATES: This change occurred on March 4, 2022.

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 Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order

12148, as amended, Willie G. Nunn, of FEMA is appointed to act as the
Federal Coordinating Officer for this disaster.
    This action terminates the appointment of Vincent J. Maykovich as
Federal Coordinating Officer for this disaster.

    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. 2022-05914 Filed 3-18-22; 8:45 am]
BILLING CODE 9111-23-P