[Federal Register: September 10, 2009 (Volume 74, Number 174)]
[Notices]
[Page 46589-46591]
[DOCID:fr10se09-57]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0492; FRL-8955-2]

Release of Draft Documents Related to the Review of the National
Ambient Air Quality Standards for Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Availability of draft documents for public comment.

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SUMMARY: On or about September 4, 2009, the Office of Air Quality
Planning and Standards (OAQPS) of EPA is making available for public
comment two draft assessment documents: Risk Assessment to Support the
Review of the PM Primary National Ambient Air Quality Standards--
External Review Draft and Particulate Matter Urban-Focused Visibility
Assessment--External Review Draft. These draft documents describe the
quantitative analyses that are being conducted as part of the review of
the National Ambient Air Quality Standards (NAAQS) for particulate
matter (PM).

DATES: Comments should be submitted on or before October 15, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0492, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail: Comments may be sent by electronic mail (e-mail)
to<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-OAR-2007-
0492.
     Fax: Fax your comments to<PHONE_NUMBER>, Attention Docket
ID. No. EPA-HQ-OAR-2007-0492.
     Mail: Send your comments to: Air and Radiation Docket and
Information Center, Environmental Protection Agency, Mailcode: 2822T,
1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID
No. EPA-HQ-OAR-2007-0492.
     Hand Delivery or Courier: Deliver your comments to: EPA
Docket Center, 1301 Constitution Ave., NW., Room 3334, Washington, DC.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0492. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be 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 http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
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 http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other

material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the Air
Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. This Docket Facility is open from 8:30 a.m.
to 4:30 p.m. Monday through Friday, excluding legal holidays. The
Docket telephone number is<PHONE_NUMBER>; fax<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For questions related to the draft
document titled, Risk Assessment to Support the Review of the PM
Primary National Ambient Air Quality Standards: External Review Draft
(September 2009), please contact Dr. Zachary Pekar, Office of Air
Quality Planning and Standards (Mail code C504-06), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
    For questions related to the draft document titled, Particulate
Matter Urban-Focused Visibility Assessment--External Review Draft
(September 2009), please contact Ms. Vicki Sandiford, Office of Air
Quality Planning and Standards (Mail code C504-06), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711; e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
    For questions related to the preliminary draft document, Policy
Assessment for the Review of the Particulate Matter National Ambient
Air Quality Standards: Preliminary Draft (September 2009), please
contact Ms. Beth Hassett-Sipple, Office of Air Quality Planning and
Standards (Mail code C504-06), U.S. Environmental Protection Agency,
Research Triangle Park, NC 27711; e-mail<EMAIL_ADDRESS>
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

General Information

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

    1. Submitting CBI. Do not submit this information to EPA through
http://www.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:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     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.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Make sure to submit your comments by the comment period
deadline identified.

SUPPLEMENTARY INFORMATION: Under section 108(a) of the Clean Air Act
(CAA), the Administrator identifies and lists certain pollutants which
``cause or contribute to air pollution which may reasonably be
anticipated to endanger public health or welfare.'' The EPA then issues
air quality criteria for these listed pollutants, which are commonly
referred to as ``criteria pollutants.'' The air quality criteria are to
``accurately reflect the latest scientific knowledge useful in
indicating the kind and extent of all identifiable effects on public
health or welfare which may be expected from the presence of [a]
pollutant in the ambient air, in varying quantities.'' Under section
109 of the CAA, EPA establishes primary (health-based) and secondary
(welfare-based) NAAQS for pollutants for which air quality criteria are
issued. Section 109(d) of the CAA requires periodic review and, if
appropriate, revision of existing air quality criteria. The revised air
quality criteria reflect advances in scientific knowledge on the
effects of the pollutant on public health or welfare. The EPA is also
required to periodically review and revise the NAAQS, if appropriate,
based on the revised criteria.
    Air quality criteria have been established for PM and NAAQS have
been established for PM2.5 and PM10, to provide
protection from fine and coarse particles, respectively. Presently, EPA
is reviewing the air quality criteria and NAAQS for PM. The EPA's
overall plan and schedule for this review is presented in the
Integrated Review Plan for the National Ambient Air Quality Standards
for Particulate Matter.\1\ A draft of the integrated review plan was
released for public review and comment in October 2007 and was the
subject of a consultation with the CASAC on November 30, 2007 (72 FR
63177; November 8, 2007). Comments received from that consultation and
from the public were considered in finalizing the plan and in beginning
the review of the air quality criteria.
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    \1\ EPA 452R-08-004; March 2008; Available: http://www.epa.gov/
ttn/naaqs/standards/pm/s_pm_2007_pd.html.
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    As part of EPA's review of the primary (health-based) and secondary
(welfare-based) PM NAAQS, the Agency is conducting quantitative
assessments characterizing (1) the health risks associated with
exposure to ambient PM and (2) urban visibility impairment associated
with PM. The EPA's plans for conducting these assessments, including
the proposed scope and methods of the analyses, were presented in two
planning documents titled, Particulate Matter National Ambient Air
Quality Standards: Scope and Methods Plan for Health Risk and Exposure
Assessment and Particulate Matter National Ambient Air Quality
Standards: Scope and Methods Plan for Urban Visibility Impact
Assessment (henceforth, Scope and Methods Plans).\2\ These documents
were released for public comment in February 2009 and were the subject
of a consultation with the CASAC on April 2, 2009 (74 FR 11580; March
18, 2009). Comments received from the CASAC consultation (Samet, 2009)
\3\ as well as public comments on the Scope and Methods Plans have been
considered in developing the draft assessment documents being released
at this time.
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    \2\ EPA-452/P-09-001 and -002; February 2009; Available: http://
www.epa.gov/ttn/naaqs/standards/pm/s_pm_2007_pd.html.
    \3\ See http://yosemite.epa.gov/sab/sabproduct.nsf/
4620a620d0120f93852572410080d786/
350899ec134552948525746600691de5!OpenDocument.
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    The draft documents announced today convey the approaches taken to
assess exposures to ambient PM and to characterize associated health
risks or urban visibility impairment, as well as present the initial
key results, observations, and related uncertainties associated with
the quantitative analyses performed. These draft

documents will be available on or about September 4, 2009, through the
Agency's Technology Transfer Network (TTN) Web site at http://
www.epa.gov/ttn/naaqs/standards/pm/s_pm_index.html. These documents
may be accessed in the ``Documents from Current Review'' section under
``Risk and Exposure Assessments.'' The EPA is soliciting advice and
recommendations from the CASAC by means of a review of the draft
documents at an upcoming public meeting of the CASAC scheduled in
Chapel Hill, NC. Information about this public meeting, including the
date and location, will be published as a separate notice in the
Federal Register. Following the CASAC meeting, EPA will consider
comments received from the CASAC and the public in preparing revisions
to these assessment documents.
    In addition, on or about September 15, 2009, EPA will make
available a third draft document: Policy Assessment for the Review of
the National Ambient Air Quality Standards: Preliminary Draft. The
development of this document is a result of recent changes to the NAAQS
review process. On May 21, 2009, Administrator Jackson called for key
changes to the NAAQS review process including reinstating a policy
assessment document that contains staff analyses of the scientific
bases for alternative policy options for consideration by senior Agency
management prior to rulemaking. This document, which builds upon the
historical ``Staff Paper,'' will serve to ``bridge the gap'' between
the scientific information and the judgments required of the
Administrator in determining whether it is appropriate to retain or
revise the standards. In conjunction with this change, EPA will no
longer issue a policy assessment in the form of an Advance Notice of
Proposed Rulemaking (ANPR).\4\
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    \4\ See http://www.epa.gov/ttn/naaqs/review.html for a copy of
Administrator Jackson's May 21, 2009 memorandum and for additional
information on the NAAQS review process.
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    The preliminary draft Policy Assessment (PA) builds upon
information presented in the Integrated Science Assessment for
Particulate Matter (Second External Review Draft) \5\ and the two draft
assessment documents described above. This preliminary draft PA will
include several chapters but is not intended to be a complete draft PA
document in that it will not include staff conclusions on a range of
policy options that could be appropriate for the Administrator to
consider concerning whether, and if so how, to revise the primary and
secondary PM NAAQS. It is instead being released for informational
purposes to facilitate a discussion with CASAC on the overall
structure, areas of focus, and level of detail to be included in an
external review draft of the document, which EPA plans to release for
CASAC review and public comment later this year.
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    \5\ EPA/600/R-08/139B; July 2009; Available: http://www.epa.gov/
ttn/naaqs/standards/pm/s_pm_2007_isa.html.
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    The preliminary draft PA may be accessed online through EPA's TTN
Web site at http://www.epa.gov/ttn/naaqs/standards/pm/s_pm_
index.html. This document may be accessed in the ``Documents from
Current Review'' section under ``Policy Assessments.'' The discussion
with CASAC on this preliminary draft PA will be held at the same
meeting that CASAC will review of the second draft ISA and the two
draft assessment documents described above.
    The draft documents briefly described above do not represent and
should not be construed to represent any final EPA policy, viewpoint,
or determination. The EPA will consider any public comments submitted
in response to this notice when revising the documents.

    Dated: September 2, 2009.
Jeffrey S. Clark,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. E9-21822 Filed 9-9-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Pages 7839-7841]
[FR Doc No: 2017-01188]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0825]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket Approval of
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 22, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0231.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Approval of Medical Devices--OMB Control Number 0910-0231--
Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360e) all devices placed into class III by FDA are
subject to premarket approval (PMA) requirements. PMA is the process of
scientific and regulatory review to ensure the safety and effectiveness
of class III devices. An approved PMA is, in effect, a private license
granted to the applicant for marketing a particular medical device. A
class III device that fails to meet PMA requirements is considered to
be adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f))
and cannot be marketed. PMA requirements apply differently to
preamendments devices, postamendments devices, and transitional class
III devices.
    Manufacturers of class III preamendments devices, devices that were
in commercial distribution before May 28, 1976, are not required to
submit a PMA until 30 months after the issuance of a final
classification regulation or until 90 days after the publication of a
final regulation requiring the submission of a PMA, whichever period is
later. FDA may allow more than 90 days after issuance of a final rule
for submission of a PMA.
    A postamendments device is one that was first distributed
commercially on or after May 28, 1976. Postamendments devices
determined by FDA to be substantially equivalent to preamendments class
III devices are subject to the same requirements as the preamendments
devices. FDA determines substantial equivalence after reviewing an
applicant's premarket notification submitted in accordance with section
510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices
determined by FDA to be not substantially equivalent to either
preamendments devices or postamendments devices classified into class I
or II are ``new'' devices and fall automatically into class III. Before
such devices can be marketed, they must have an approved PMA
application or be must reclassified into class I or class II.
    The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115) was enacted on November 21, 1997, to implement revisions to the
FD&C Act by streamlining the process of bringing safe and effective
drugs, medical devices, and other therapies to the U.S. market. FDAMA
added section 515(d)(6) to the FD&C Act (21 U.S.C. 360e(d)(6)), which
provided that PMA supplements were required for all device changes that
affect safety and effectiveness unless such changes are modifications
to manufacturing procedures or method of manufacture. That type of
manufacturing change will require a 30-day notice, or where FDA finds
such notice inadequate, a 135-day PMA supplement.
    The implementing regulations, contained in part 814 (21 CFR part
814), further specify the contents of a PMA for a medical device and
the criteria FDA will employ in approving, denying, or withdrawing
approval of a PMA and supplements to PMAs. The regulations' purpose is
to establish an efficient and thorough procedure for FDA's review of
PMAs and supplements to PMAs for class III medical devices. The
regulations facilitate the approval of PMAs and supplements to PMAs for
devices that have been shown to be reasonably safe and effective and
otherwise meet the statutory criteria for approval. The regulations
also ensure the denial of PMAs and supplements to PMAs for devices that
have not been shown to be reasonably safe and effective and that do not
otherwise meet the statutory criteria for approval.
    The industry-wide burden estimate for PMAs is based on an FDA
average fiscal year (FY) annual rate of receipt of PMA submissions data
FYs 2013 through 2015 and our expectation of submissions to come in the
next few years. The burden data for PMAs is based on data provided by
applicants by device type and cost element in an earlier study.
    Reporting Burden: The reporting burden can be broken out by certain

sections of the PMA regulations and the FD&C Act as follows:
    Sec.  814.15(b)--Research Conducted Outside the United States. Each
foreign study should be performed in accordance with the ``Declaration
of Helsinki'' or the laws and regulations of the country in which the
study was conducted. If the study was conducted in accordance with the
laws of the country, the PMA applicant is required to explain to FDA in
detail the differences between the laws of the country and the
``Declaration of Helsinki.'' Based on the number of PMAs received that
contained studies from overseas, FDA estimates that the burden estimate
necessary to meet this requirement is 50 hours.
    Sec.  814.20--Application. Included in this requirement is the
conduct of laboratory and clinical trials, as well as the analysis,
review, and physical preparation of the PMA application. FDA estimates
that 35 applicants, including hospital remanufacturers of single-use
devices, will be affected by these requirements which are based on the
actual average of FDA receipt of new PMA applications in FYs 2013
through 2015. FDA's estimate of the hours per response (668) was
derived through FDA's experience and consultation with industry and
trade associations. In addition, FDA also based its estimate on the
results of an earlier study that accounts for the bulk of the hourly
burden for this requirement, which is identified by applicants.
    Sec.  814.37(a) through (c) and (e)--PMA Amendments and Resubmitted
PMAs. As part of the review process, FDA often requests the PMA
applicant to submit additional information regarding the device
necessary for FDA to file the PMA or to complete its review and make a
final decision. The PMA applicant may, also on their own initiative,
submit additional information to FDA during the review process. These
amendments contain information ranging from additional test results and
re-analysis of the original data set to revised device labeling. Almost
all PMAs received by the Agency have amendments submitted during the
review process.
    Sec.  814.39(a)--PMA Supplements. This information collection
includes the requirements for the range of PMA supplements (panel
track, 180-day fee-based, 180-day non fee-based, and real-time
supplements).
    Sec.  814.39(d)--Special PMA Supplements--Changes Being Affected.
This type of supplement is intended to enhance the safety of the device
or the safe use of the device. The number of PMA supplements received
that fit this category averaged 88 per year based on the numbers
received from FYs 2013 through 2015. Because of the minimal data
required to be included in this type of supplement, FDA estimates that
the number of burden hours necessary to satisfy this requirement is
528.
    Sec.  814.39(f)--30-Day Notice. Under section 515(d) of the FD&C
Act, modifications to manufacturing procedures or methods of
manufacture that affect the safety and effectiveness of a device
subject to an approved PMA do not require submission of a PMA
supplement under paragraph (a) of this section and are eligible to be
the subject of a 30-day notice. A 30-day notice shall describe in
detail the change, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The applicant may
distribute the device 30 days after the date on which FDA receives the
30-day notice, unless FDA notifies the applicant within 30 days from
receipt of the notice that it is not adequate.
    Sec.  814.82(a)(9)--Postapproval Requirements. Postapproval
requirements concerns approved PMAs that were not reclassified and
require a periodic report. After approval, all PMAs require a
submission of an annual report. A majority of the submitted PMAs
require associated post-approval studies, i.e., followup of patients
used in clinical trials to support the PMA or additional preclinical
information that is labor-intensive to compile and complete; the
remaining PMAs require minimal information.
    Sec.  814.84(b)--Periodic Reports. Postapproval requirements
described in Sec.  814.82(a)(7) require submission of an annual report
for each approved PMA. FDA estimates that respondents will average
about 10 hours in preparing their reports to meet this requirement.
This estimate is based on FDA's experience and consultation with
industry.
    Expedited or Priority Review--Section 515(d)(5) of the FD&C Act.
FDA will provide special review, which can include expedited processing
of a PMA application, for certain devices intended to treat or diagnose
life threatening or irreversibly debilitating diseases or conditions.
To receive special review, the devices must meet one of the following
criteria:
     The device represents a breakthrough technology;
     There are no approved alternatives;
     The use of the device offers significant advantages over
existing approved alternatives; or
     Availability is in the best interest of the patients.
    Agreement Meeting--Section 520(g)(7) of the FD&C Act (21 U.S.C.
360j(g)(7)). Applicants planning to submit a PMA may submit a written
request to reach agreement with FDA on the key parameters of the
investigational plan.
    Determination Meeting--Section 513(a)(3)(D) of the FD&C Act (21
U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a
written request to FDA for a meeting to determine the type of
information (valid scientific evidence) necessary to support the
effectiveness of their device.
    Panel of Experts--Section 515(c)(3) of the FD&C Act. An original
PMA or panel track PMA supplement is taken to an advisory panel of
experts unless FDA determines that the information in the application
substantially duplicates information which has previously been reviewed
by the panel.
    Day 100 Meeting--Section 515(d)(3) of the FD&C Act. FDA must, upon
the written request of the applicant, meet with that party within 100
days of receipt of the filed PMA application to discuss the review
status of the application. With the concurrence of the applicant, a
different schedule may be established. Prior to this meeting, FDA must
inform the applicant in writing of any identified deficiencies and what
information is required to correct those deficiencies. FDA must also
promptly notify the applicant if FDA identifies additional deficiencies
or of any additional information required to complete Agency review.

Recordkeeping

    Sec.  814.82(a)(5) and (a)(6)--Maintenance of Records. The
recordkeeping burden under this section requires the maintenance of
records, used to trace patients and the organization and indexing of
records into identifiable files to ensure the device's continued safety
and effectiveness. These records are required of all applicants who
have an approved PMA.
    PMAs have been required since 1976, and there are 725 active PMAs
that could be subject to these requirements, based on actual FDA data,
and approximately 30 new PMAs are approved every year. The aggregate
burden for the estimated 422 PMA holders of approved original PMAs for
the next few years is estimated to be 7,174 hours.
    The applicant determines which records should be maintained during
product development to document and/or substantiate the device's safety
and effectiveness. Records required by the

current good manufacturing practices for medical devices regulation (21
CFR part 820) may be relevant to a PMA review and may be submitted as
part of an application. In individual instances, records may be
required as conditions of approval to ensure the device's continuing
safety and effectiveness.
    In the Federal Register of October 19, 2016 (81 FR 72063), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Activity/21 CFR or FD&C Act       Number of     responses per   Total annual     burden per      Total hours
             section                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Research conducted outside the                25               1              25               2              50
 United States (814.15(b))......
PMA application (814.20)........              35               1              35             668          23,380
PMA amendments and resubmitted             1,222               1           1,222             167         204,074
 PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a)).....             695               1             695              60          41,700
Special PMA supplement--changes               88               1              88               6             528
 being affected (814.39(d)).....
30-day notice (814.39(f)).......           1,710               1           1,710              16          27,360
Postapproval requirements                    340               1             340             135          45,900
 (814.82(a)(9)).................
Periodic reports (814.84(b))....             695               1             695              10           6,950
Agreement meeting (520(g)(7))...               1               1               1              50              50
Expedited review request                       6               1               6              10              60
 (515(d)(5) of the FD&C Act)....
Determination Meeting                          1               1               1              50              50
 (513(1)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the                9               1               9              30             270
 FD&C Act)......................
Day 100 meeting (515(d)(3) of                 19               1              19              10             190
 the FD&C Act)..................
                                 -------------------------------------------------------------------------------
Total...........................  ..............  ..............  ..............  ..............         350,562
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      Activity/21 CFR section                           Number of       records per      Total annual   Average  burden    Total hours
                                                                      recordkeepers     recordkeeper      responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (a)(6))...................             422                1              422               17            7,174
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01188 Filed 1-19-17; 8:45 am]
 BILLING CODE 4164-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA, Office of Prevention, Pesticides & Toxic Substances 2. OMB control number b. G None a. 2 0 7 0  0 0 1 2 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. O Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. O Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes O No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. O Three years from approval date b. G Other Specify: / /___

7. Title Pre Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances 8. Agency form number( s) ( If applicable) EPA Forms 7710 25 and 7710 56; EPA ICR # 574.11 9. Keywords Environmental Protection; Hazardous Substances; Reporting Requirements 10. Abstract: TSCA requires businesses to notify the Agency 90 days prior to the manufacture or import of a new chemical substance or an existing chemical substance for a significant new use. EPA reviews the information to evaluate the effects of the chemical on human health and the environment. The submitter is free to manufacture or import the new chemical substance if the Agency takes no further regulatory action within 90 days of receipt of the notification. Submitters can also apply for certain exemptions with shorter review times.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 443 b. Total annual responses 1,674 1. Percentage of these responses collected electronically % c. Total hours requested 184,608 d. Current OMB inventory 226,547 e. Difference  41,939 f. Explanation of difference 1. Program Change 2. Adjustment  41,939 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment OPPT 2003 0038 0001 RECEIVED OPPT NCIC 2003 July 25 11: 04AM 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. O Recordkeeping b. G Third party disclosure c. O Reporting 1. O On occasion 2. G Weekly 3. G Monthly 4. G Quarterly 5. G Semi annually 6. G Annually 7. G Biannually 8. G Other ( describe)

17. Statistical methods Does this information collection employ statistical methods? G Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angela F. Hofmann, Director, Regulatory Coordination Staff, OPPTS Phone: 202 260 2922 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Angela F. Hofmann, Director Regulatory Coordination Staff Office of Prevention, Pesticides and Toxic Substances ( OPPTS) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95


[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56978-56979]
[FR Doc No: 2021-22162]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2170]

Proposed Flood Hazard Determinations

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

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before January 11, 2022.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2170, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities

with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           Pottawatomie County, Kansas and Incorporated Areas
  Project: 15-07-0283S Preliminary Date: January 31, 2020 and June 18,
                                  2021
------------------------------------------------------------------------
City of St. Marys......................  City Hall, 200 South 7th
                                          Street, St. Marys, KS 66536.
City of Wamego.........................  City Hall, 430 Lincoln Avenue,
                                          Wamego, KS 66547.
Unincorporated Areas of Pottawatomie     Pottawatomie County Courthouse,
 County.                                  108 North Main Street,
                                          Westmoreland, KS 66549.
------------------------------------------------------------------------
              Leelanau County, Michigan (All Jurisdictions)
 Project: 13-05-4238S Preliminary Date: September 30, 2020 and April 30,
                                  2021
------------------------------------------------------------------------
Charter Township of Elmwood............  Elmwood Township Hall, 10090
                                          East Lincoln Road, Traverse
                                          City, MI 49684.
City of Traverse City..................  Governmental Center, 400
                                          Boardman Avenue, Traverse
                                          City, MI 49684.
Grand Traverse Band of Ottawa and        Grand Traverse Band of Ottawa &
 Chippewa Indians.                        Chippewa Indians Tribal
                                          Government, 2605 North West
                                          Bay Shore Drive,
                                          Peshawbestown, MI 49682.
Township of Bingham....................  Bingham Township Office, 7171
                                          South Center Highway, Traverse
                                          City, MI 49684.
Township of Centerville................  Centerville Township Office,
                                          5001 South French Road, Cedar,
                                          MI 49621.
Township of Cleveland..................  Cleveland Township Hall, 955
                                          East Harbor Highway, Maple
                                          City, MI 49664.
Township of Empire.....................  Township Hall, 10088 West Front
                                          Street, Empire, MI 49630.
Township of Glen Arbor.................  Township Hall, 6394 West
                                          Western Avenue, Glen Arbor, MI
                                          49636.
Township of Leelanau...................  Leelanau Township Hall, 119
                                          East Nagonaba Street,
                                          Northport, MI 49670.
Township of Leland.....................  Leland Township Hall, 123 North
                                          Saint Joseph Street, Lake
                                          Leelanau, MI 49653.
Township of Suttons Bay................  Township Office, 95 West Fourth
                                          Street, Suttons Bay, MI 49682.
Village of Empire......................  Village Office, 11518 South
                                          LaCore Street, Empire, MI
                                          49630.
Village of Northport...................  Village Office, 116 West
                                          Nagonaba Street, Northport, MI
                                          49670.
Village of Suttons Bay.................  Village Hall, 420 North Front
                                          Street, Suttons Bay, MI 49682.
------------------------------------------------------------------------
           Blue Earth County, Minnesota and Incorporated Areas
   Project: 07-05-0439S Preliminary Date: December 09, 2009, April 20,
              2011, September 12, 2018 and August 28, 2020
------------------------------------------------------------------------
City of Eagle Lake.....................  City Hall, 705 Parkway Avenue,
                                          Eagle Lake, MN 56024.
------------------------------------------------------------------------

[FR Doc. 2021-22162 Filed 10-12-21; 8:45 am]
BILLING CODE 9110-12-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division Contact: Tony Kish<PHONE_NUMBER>

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[MITSUI CHEMICALS AGRO, INC.]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
MITSUI CHEMICALS AGRO, INC. c/o Landis International, Inc., P. O. Box
5126 Valdosta, GA  31603-5126 proposing, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180 by establishing  tolerances for residues of
Penthiopyrad,
(RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-py
razole-4-carboxamide in or on the raw agricultural commodities fruit,
pome, group 11 at 0.4 parts per million (ppm); apple, wet pomace at 1.0
ppm; fruit, stone, group 12 at 3.0 ppm; low growing berry, subgroup
13-07G at 3.0 ppm; vegetable, bulb, group 3 at 4.0 ppm; vegetable,
brassica leafy, group 5 TBD; vegetable, fruiting, group 8 at 2.5 ppm;
tomato, paste at 5.0 ppm; vegetable, cucurbit, group 9 at 1.0 ppm;
vegetable, leafy, except brassica, group 4 at 20 ppm; vegetable, root
and tuber, group 1 TBD; potato at 0.06 ppm; vegetable, legume, group 6
TBD; pea and bean, dried shelled, except soybean, subgroup 6C at 0.2
ppm; peanut at 0.04 ppm; grain, cereal, group 15 TBD; barley at 0.2 ppm
(for import); wheat at 0.1 ppm (for import); nut, tree, group 14 at 0.05
ppm; almond, hulls at 6.0 ppm; canola at 0.6 ppm; sunflower at 0.03 ppm
(for import); cotton TBD; pea, field, hay at 45 ppm; pea, field, vines
at 30 ppm; peanut, hay at 30 ppm; grain, cereal, forage, fodder and
straw, group 16 TBD, alfalfa TBD,  and establishing tolerances for
residues of Penthiopyrad,
(RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-py
razole-4-carboxamide and its major metabolite PAM
(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide) in animal
commodities  hog, meat at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver at
0.01 ppm; hog, kidney at 0.01 ppm; hog, meat byproducts at 0.01 ppm;
cattle, meat at 0.01; cattle, fat at 0.02 ppm; cattle, liver at 0.05
ppm; cattle, kidney at 0.02 ppm; cattle, meat byproducts at 0.05 ppm;
sheep, meat at 0.01 ppm; sheep, fat at 0.02 ppm; sheep, liver at 0.05
ppm; sheep, kidney at 0.02 ppm; sheep, meat byproducts at 0.05 ppm; milk
at 0.01 ppm; milk, fat at 0.01 ppm; poultry, meat at 0.01 ppm; poultry,
fat at 0.01 ppm; poultry, liver at 0.01 ppm; poultry, meat byproducts at
0.01 ppm; poultry, eggs at 0.01 ppm. [TBD: to be determined in June 2010
submission]. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of
FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.

Residue Chemistry

1. Plant Metabolism. The metabolic fate of penthiopyrad in plants is
adequately understood.  The metabolism of penthiopyrad was studied in
five crops using penthiopyrad labeled with carbon 14 in both rings.  The
following metabolic processes were observed in all studies:

1.	Hydroxylation of the alkyl side chain leading to 753-A-OH and its
isomers. Conjugates of these metabolites were observed in all crops at
higher amounts than the free metabolites.

2.	Oxidation of the thienyl ring leading to 753-T-DO, which is further
oxidized to the lactone 753-F-DO.  Neither 753-T-DO nor 753-F-DO
persists in plant matrices.

3.	Oxidative degradation of 753-F-DO leading to the cleavage of the
two-ring structure and the formation of PAM; PAM is then hydrolyzed to
form PCA.

The major metabolism pathways are consistent in all five crops studied,
which represent fruiting vegetables, fruits, leafy crops, cereals and
oil seeds as well as the various commodity types: watery, acidic, dry
and oily.  In grape, tomato, cabbage and wheat the major residue in all
crop parts used for human food or animal fodder was penthiopyrad.  In
canola forage, while penthiopyrad was a major component of the residue,
the various conjugated metabolites were present at higher levels. In
canola seed, penthiopyrad was observed only at very low level. The main
cleavage products identified in all crops were PAM and PCA.

Penthiopyrad was the major residue in most matrices, followed by PAM and
PCA. Lower amounts of 753-F-DO were found in leaves. Conjugates of
753-A-OH were significant residues in many crop matrices especially in
canola forage.

2. Analytical method. Adequate enforcement methods are available to
enforce the proposed tolerances.  Samples of plant matrices from field
residue trials were analyzed for penthiopyrad and its metabolites using
a validated residue method, which involves the extraction of analytes
from crops, hydrolysis of conjugates, partition of analytes, followed by
LC-MS/MS detection.  The limit of quantification (LOQ) is 0.01 mg/kg
for most matrices except for very dry matrices, e.g., pea hay, for which
the LOQ is 0.05 mg/kg.

An LC-MS/MS residue method has been used in the animal feeding studies
and is proposed for enforcement purposes.  The method involves the
extraction of analytes from animal matrices and LC-MS/MS detection.
This method has been validated for the determination of penthiopyrad and
its metabolites in chicken tissues, eggs, ruminant tissues and milk.
The limit of quantification is 0.01 mg/kg for all animal matrix groups.

3. Magnitude of residues. Penthiopyrad and its plant metabolites PCA,
PAM, 753-A-OH, and 753-F-DO, were quantified in the field residue trials
along with DM-PCA, the major soil metabolite.  Penthiopyrad (parent) was
found to be the major component of the residue in raw agricultural crop
matrices following post-emergence applications of penthiopyrad.
High-temperature hydrolysis data showed that penthiopyrad is stable
under various processing conditions.

The field trials data for representative processed food commodities of
apples, tomatoes, potatoes, plums, cereals, and oilseeds indicate that
metabolite residues were detected in only a few end-processed
commodities and were always significantly lower than the parent.
Therefore exposure to the metabolites relative to exposure to parent
penthiopyrad from raw and processed commodities will be low.

DM-PCA, the major soil metabolite, is the predominant component of the
residue in raw agricultural crop matrices in succeeding crops; however,
DM-PCA has been shown to be not toxicologically significant and minimal
exposure is expected through the diet.

The main residue in the crops with significance for human dietary
exposure is penthiopyrad (parent).  For commodities where there are
higher relative metabolite residues, the total magnitude of residues is
quite low and does not significantly contribute to human exposure.

A harmonized residue definition for food of crop origin for
monitoring/enforcement and risk assessment is therefore proposed as
penthiopyrad.

Crop Rotation Study

Penthiopyrad residues in succeeding crops grown under realistic field
conditions are very low with less than 0.010 mg/kg in leafy vegetables,
cereal grains and wheat forages/grains for all plant back intervals and
less than 0.10 mg/kg in vegetable root crops. No residues greater than
0.01 mg/kg are anticipated in any edible tissues, milk, or egg products
following consumption by livestock of rotational crop commodities.

Cow and Hen Feeding Studies

The metabolic fate of penthiopyrad in livestock is adequately
understood.  Penthiopyrad is extensively metabolized in and excreted
from livestock and residues do not accumulate in milk, egg or tissues.
PAM was the major component of the residue in meat, milk and eggs.
Total radioactive residues were very low in fat, where penthiopyrad was
present at higher levels than PAM or the other identified metabolites.
Along with low levels of penthiopyrad, PAM, PCA, and 753-A-OH, numerous
low level metabolites were observed in hen and goat liver and goat
kidney. These were identified mainly as cysteine conjugates of 753-F-DO
and 753-T-DO and their hydroxylated analogues.

Residues of penthiopyrad and its metabolites PAM, PCA and 753-A-OH were
measured in the cow and hen feeding studies. Residues were very low and
were generally less than LOQ (0.01 mg/kg). Penthiopyrad was the
predominant component in fat and PAM was predominant in liver, kidney,
meat, milk and eggs.

Therefore, the proposed definition of the residue for risk assessment
and monitoring for food of animal origin is penthiopyrad plus PAM.

B. Toxicological Profile

1.  Acute Toxicity. Penthiopyrad was found to be of a low order of acute
toxicity following exposure via oral (gavage), dermal and inhalation
routes of administration, non-irritating to the skin and to the eye and
not sensitizing.

Acute Toxicology Study Results - Penthiopyrad, Proposed EPA Tox
Categories

Acute Oral - III

Acute Dermal - III

Acute Inhalation - IV

Acute Eye Irritation - IV

Acute Dermal Irritation - IV

Dermal Sensitization - Not a sensitizer (MKMM)

Overall Category - III

2.  Genotoxicity. Penthiopyrad has been evaluated in a comprehensive
battery of 6 genotoxicity assays comprising in vitro bacterial and
mammalian gene mutation, in vitro mammalian cytogenetics, DNA repair and
UDS assays and in vivo clastogenicity.  The in vitro assays were
performed with and without exogenous metabolic activation.  All assays
were OPPTS and/or OECD and Japan MAFF guideline studies and all were
considered to be valid assays based on sensitivity to known positive
control substances.  The results of these studies indicate that
penthiopyrad has no genotoxic potential at relevant doses in these
assays at the DNA, gene and chromosome levels of genetic organization.

3.  Reproductive and developmental toxicity. Guideline pre-natal
developmental oral (gavage) toxicity studies in rats and rabbits and a
dietary 2-generation reproductive toxicity study have been performed on
penthiopyrad.

Penthiopyrad did not produce any effects in the rat on prenatal fetal
growth and development at maternal dose levels up to 1000 mg/kg/day.  At
that dose level there was a minimal and transient reduction in maternal
weight gain.  Litter effects at this dose level were confined to an
increase in the number of early resorptions, leading to slightly reduced
gravid uterus weight, litter weight and litter number.  There were no
adverse maternal or embryo-fetal effects at the 250 mg/kg/day dose
level.  Therefore, maternal and embryo-fetal NOAEL values were
established as 250 mg/kg/day.

In the rabbit developmental toxicity study, a maternal high dose level
of 225 mg/kg/day produced one abortion, which was considered to be
treatment-related.  At 225 mg/kg/day fetal weight was slightly reduced
but there were no effects on fetal growth and development.  Therefore,
maternal and embryo-fetal NOAEL values were established as 75 mg/kg/day.
 This NOAEL, with an adjustment factor of 100, is proposed as the basis
for an Acute Reference Dose (aRfD) of 0.75 mg/kg.

Penthiopyrad is not a reproductive toxin in the rat 2-generation study
at any parental dose level, the highest of which elicited slightly
reduced weight gain prior to mating in the F1 parental animals, and in
intermediate dose F1 males.  No functional reproductive and fertility
effects or histopathological alterations in the reproductive organs
occurred at the highest dose level employed.  Therefore, the NOAEL for
reproductive effects was established as > 278 mg/kg/day (highest dose
tested - HDT) for both sexes.  In the parental and F1 generation,
increased liver, thyroid and adrenal weights were evident at the HDT.
Increased relative liver weight also occurred in females of both
generations at 54.0 - 95.6 mg/kg/day.  These effects and the effect on
F1 male pre-mating weight gain resulted in a parental NOAEL value of
11.0 mg/kg/day.  Reduced pre-weaning weight gain occurred only at the
HDT in both sexes and in both the F1 and F2 generations.  The NOAEL for
offspring effects was established as 54.0 mg/kg/day.

These data indicate that penthiopyrad is not a morphological
developmental toxin in rats and rabbits, is not a reproductive toxin in
rats, and does not produce enhanced sensitivity to penthiopyrad on
embryo-fetal and/or neonatal exposure.

4.  Subchronic toxicity. 28-day dietary dose range finding studies were
conducted in the rat, mouse and dog to establish appropriate dose levels
to be used in the 90-day studies. 90-day dietary studies were conducted
in the same 3 species, as well as a 52-week feeding study in dog and a
28-day dermal study in rat.

The liver was a common target organ in all 3 species in the 28-day and
13-week studies.  The thyroid gland in mice and dogs, and the adrenal
gland in dogs, were also target organs after 13 weeks treatment.
Hematological perturbations also occurred at high dose levels in all
three species after 28 and/or 90 days treatment and in the dog after 52
weeks.  However, the changes
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ഠ

Male rats treated at dose levels ≥100 mg/kg/day showed significantly
reduced motor activity during a quantitative assessment.  However, there
were no effects at dose levels up to 625 mg/kg/day on a battery of
functional observations performed towards the end of the 13-week
treatment period.

The lowest relevant NOAEL determined in the short-term toxicity
evaluation was 40 mg/kg/day, established in the male rat and based on
histomorphological alterations in the liver and reduced motor activity
at 100 mg/kg/day.

Although there were other, lower NOEL values in the 28-day studies in
the rat and mouse because these effects were not adverse, were
transient, or occurred in only one animal of each sex, none of these
were considered an appropriate basis for short-term risk assessment.

In the 28-day dermal study, a no observed adverse effect level (NOAEL)
was established as 1000 mg/kg/day, based on the absence of adverse
findings at the highest dose level evaluated.

5.  Chronic toxicity.  Three guideline long-term toxicity studies have
been performed on penthiopyrad: a rat 52-week dietary toxicity study,
and 104-week and 78-week oncogenicity studies in the rat and the mouse,
respectively.  In addition, three non-guideline studies were performed
to investigate the thyroid follicular cell proliferation potential of
penthiopyrad in rats and hepatic enzyme induction potential in rats and
mice.  The investigative studies were designed to provide evidence to
support the contention that excess incidences of thyroid adenoma in male
rats and hepatic adenomas in male mice had non-genotoxic etiologies
based on threshold mechanisms of action.

In the rat 52-week study, the liver, adrenal, thyroid gland and ovary
were identified as target organs.  Increased prothrombin time at 400
mg/kg/day and increased plasma enzyme activities and lipid
concentrations at 100 or 400 mg/kg/day were suggestive of hepatic
dysfunction.  These effects occurred in the presence of increased liver
weight and hepatocyte hypertrophy in both sexes, and periportal fat
vacuolation, cell swelling and single cell necrosis in male rats only.
Adrenal cortical lipid vacuolation and hypertrophy of the zona
glomerulosa, diffuse follicular hypertrophy in the thyroid and ovarian
interstitial cell hypertrophy were also apparent.

In addition to liver, adrenal, thyroid and ovary effects identified in
13- and/or 52-week studies, further non-neoplastic effects seen in the
rat 104-week study comprised increased incidences of alveolar
macrophages and interstitial inflammation in the lungs of females and
chronic progressive nephropathy in males.

The numbers of rats with neoplasms, the multiplicity of tumors and the
latency period for tumor formation did not distinguish treated animals
from the controls.  There were no excess incidences of neoplasia in any
tissue, with the exception of the male thyroid in which the incidence of
follicular adenoma was slightly, but significantly, increased in males
at the highest dose level, 250 mg/kg/day, surviving to termination.  The
incidence of follicular carcinoma was unaffected by treatment.  The
increased incidence of follicular adenoma is considered to be an effect
of treatment, but a secondary effect to prolonged metabolic adaptation
et seq.  Therefore, penthiopyrad is considered not to be a primary
carcinogen in the rat at dose levels up to 250 mg/kg/day.

In the 78-week mouse carcinogenicity study, lung was identified as a
target organ for non-neoplastic alterations in which an increased
incidence of alveolar foamy cells occurred at the highest dose level
only (600 mg/kg/day).  The thyroid follicular epithelial hypertrophy
noted after 13 weeks of treatment was accompanied by further changes
comprising altered colloid and lipofuscin deposits.  Marked hepatomegaly
at dose levels of 200 or 600 mg/kg/day was accompanied by increased
incidences of hepatocellular adenoma, and adenoma plus carcinoma in male
mice surviving to termination.  Although the incidences remained within
the laboratory historical control ranges, the changes are considered,
conservatively, to be treatment-related but secondary to marked and
prolonged hepatomegaly.

Two mechanistic studies were performed in the rat to investigate the
effects of penthiopyrad on hepatic drug metabolizing enzymes and cell
proliferation.  Based on the results of the first study, it was
concluded that penthiopyrad is likely to be a phenobarbital-type enzyme
inducer.  At 1000 ppm, penthiopyrad produced effects similar to, but
milder than, those seen with phenobarbital, including enhanced hepatic
cell proliferation during the early stages of treatment and increased
hepatic microsomal cytochrome P450 isozymes, POD and UDPGT activities.
There were no effects of treatment on any parameter at 100 ppm.
Therefore, an NOEL for enzyme induction was established as 100 ppm
(equivalent to a dose level of 6.47 mg/kg/day penthiopyrad).

In the second study in the rat, penthiopyrad at dietary concentrations
of 4000 and/or 16000 ppm elicited a similar pattern of effects that were
fully reversible on withdrawal of treatment for 28 days.  Based on these
results it was postulated that penthiopyrad is a phenoparbital-type
enzyme inducer which results in an increase in circulating TSH through
negative feedback leading to thyroid follicular cell hypertrophy.
Furthermore, prolonged follicular cell hypertrophy under the influence
of increased TSH is considered to be a rational, non-genotoxic basis for
the development of a slightly increased number of thyroid adenomas in
the 104-week study.  In addition, it is concluded that the effects of
penthiopyrad on thyroid function, and thus on neoplasia in the long-term
study, have a threshold below which thyroid neoplasia will not occur.  A
clear NOAEL for the postulated mechanism was established as 400 ppm,
equivalent to a dose level of 37.5 mg/kg/day penthiopyrad.

A mechanistic study was performed in the mouse to investigate the
effects of penthiopyrad on hepatic drug metabolizing enzymes and cell
proliferation in order to support a putative mechanism for the low
incidence of hepatocellular adenoma in this species.  The effects of
penthiopyrad were compared with the effects of an established hepatic
enzyme-inducer, phenobarbital.  Phenobarbital administration produced a
pattern of effects comprising increases in liver weight, microsomal
protein and P450 content, microsomal ECOD and PROD activities, hepatic
P450 Cyp1A, 2B and 3A isozyme content and hepatic BrdU labeling index,
associated with histological evidence of centrilobular hepatic
hypertrophy.  A similar pattern of effects occurred in response to 600
mg/kg/day penthiopyrad and at 200 mg/kg/day penthiopyrad, but to a
lesser extent. Long-term administration of penthiopyrad to mice produced
a very marked increase in liver weight (> 150%) at dose levels of 200 or
600 mg/kg/day, but had no effect on liver weight at dose levels
≤ 60 mg/kg/day.

The lowest NOAEL in these long-term toxicity and carcinogenicity studies
was 25 mg/kg/day (LOEL 100 mg/kg/day) established in the 52-week rat
study.  However, the NOAEL of 27 mg/kg/day, established in the 104-week
rat study, based on a LOAEL of 83 mg/kg/day, is proposed for use in
long-term risk assessments since dose spacing in this study provided a
more accurate NOAEL. This NOAEL, with an adjustment factor of 100, is
proposed as the basis for a chronic RfD of 0.27 mg/kg bw/day.

6.  Animal metabolism.  The pathways of metabolism in the rat, ruminant
and hen are consistent. Primary metabolism of penthiopyrad proceeds in
rat, ruminant and hen by three major pathways which proceed in parallel.

N-demethylation of the pyrazole ring to form DM-penthiopyrad which can
enter pathways 2 and or 3.   N-demethylation may also occur after
hydroxylation.

Hydroxylation on one or more of several positions on the alkyl moiety to
form 753-A-OH analogs and dihydroxy compounds which can be further
oxidized to carboxylic acids or conjugated.

Sequential oxidation of the thienyl ring of penthiopyrad to yield
753-T-DO and 753-F-DO and their hydroxy and desmethyl forms which are
degraded to PAM and DM-PAM either before or after conjugation with
glutathione.

753-T-DO and 753-F-DO (and their hydroxylated and demethylated
derivatives) are conjugated with glutathione in rat, ruminant and hen.
Subsequent catabolism to yield a complex range of cysteine conjugates
was observed in the rat, ruminant and hen.  In a supplementary study in
rat, additional intermediate metabolites were identified in bile (0-6
hours after administration).   These were notably the
cysteine-glutamate conjugates of 753-F-DO and to a lesser extent the
glycine-cysteine conjugates which are intermediates in the pathway
between the glutathione conjugates and the cysteine conjugates.
Acetylation of some of the cysteine conjugates was also observed in this
study.

Hydroxy-penthiopyrad and/or it’s demethyl analogs can be sequentially
oxidized on the thienyl ring or be transformed by glucuronidation of the
side chain hydroxyl group. Alternatively these hydroxyl groups can be
further oxidized to yield the carboxylic acids 753-A-COOH and
DM-753-A-COOH respectively.  These acids were major metabolites in rat
urine and feces.

Following cleavage of the two ring structure, PAM is the most abundant
metabolite in rat, goat and hen together with DM-PAM and PCA (mainly in
rat and goat urine). Metabolites containing the thienyl moiety after
cleavage were not observed in any significant amounts.

7.  Metabolite toxicology. The metabolites DM-PCA, PCA, PAM, 753-A-OH
and 753-T-DO were evaluated for toxicity.

All acute oral LD50 estimates were > 2000 mg/kg, except for PAM which
was 300 - 2000 mg/kg. In a 13-week oral rat study, the NOAEL for DM-PCA
was 258 mg/kg/day based on reduced weight gain in males. In a 4-week
oral rat study the NOAEL for the metabolite PCA was 1000 mg/kg/day based
on no effects.

In Ames studies, in vitro chromosome aberrations and mouse lymphoma
assays on DM-PCA, 753-A-OH and 753-T-DO were all clearly negative.
Mammalian cell gene mutation assay (mouse lymphoma) for PCA was an
equivocal positive, but an in vivo mouse micronucleus test was clearly
negative. The in vitro chromosome aberration test and mouse lymphoma
assays for PAM were positive, but the in vivo mouse micronucleus test
was clearly negative.

On the basis of the toxicity studies and genotoxicity tests performed
with DM-PCA, PCA, PAM, 753-A-OH and 753-T-DO, it is concluded that these
metabolites are not of toxicological concern.

8.  Endocrine disruption. Penthiopyrad does not belong to a class of
chemicals known or suspected of having adverse effects on the endocrine
system. There is no evidence that penthiopyrad has any effect on
endocrine function in developmental, reproduction or developmental
neurotoxicity studies.  Furthermore, histological investigation of
endocrine organs in chronic dog, rat and mouse studies did not indicate
that the endocrine system is targeted by penthiopyrad.

C. Aggregate Exposure

The following exposure analysis was completed for the US.

	1. Dietary exposure. It can be concluded with reasonable certainty that
residues of penthiopyrad in food will not result in unacceptable human
health risk since both the acute and chronic dietary exposure
assessments result in exposures that are well below the EPA level of
concern.

	i. Food.

The chronic dietary exposure assessment was determined with the Dietary
Exposure Evaluation Model software with Food Commodity Intake Database
(DEEM-FCID(TM)), version 2.14, from Exponent, Inc.  This model
incorporates nationwide food consumption data as reported by respondents
in the U.S. Department of Agriculture (USDA) 1994-1996, 1998 Continuing
Surveys of Food Intake by Individuals (CSFII).  The chronic exposure
assessment used conservative residue values as generated from supervised
residue trials and adjustments for processing; no adjustment for percent
crop treated was made (100% crop treated was assumed).  Thus, the actual
chronic dietary exposure will be much less than that determined here.

The chronic exposure to penthiopyrad for the overall U.S. population in
this very conservative analysis is less than 1% of the Chronic Reference
Dose (cRfD = ADI = 0.27 mg/kg bw/day).  The chronic exposure of the most
highly exposed subgroup, Children 1-2 years, is 1% of the cRfD.  There
are large margins of safety for all population groups.

The acute dietary exposure assessment was determined with the Dietary
Exposure Evaluation Model software with Food Commodity Intake Database
(DEEM-FCID(TM)), version 2.14, from Exponent, Inc.  This model
incorporates nationwide food consumption data as reported by respondents
in the U.S. Department of Agriculture (USDA) 1994-1996, 1998 Continuing
Surveys of Food Intake by Individuals (CSFII).  The acute exposure
assessment used conservative residue values as generated from supervised
residue trials and adjustments for processing. No adjustment for percent
crop treated was made (100% crop treated was assumed).  Thus, the actual
acute dietary exposure will be much less than that determined here.

The acute exposure to penthiopyrad at the 95th percentile, calculated in
a conservative deterministic assessment, for the overall
U.S. population is 2% of the aRfD (0.75 mg/kg bw/day).  The acute
exposure of the most highly exposed subgroup, Children 1-2 years, is 3%
of the aRfD.  There are large margins of safety for all population
groups.

	ii. Drinking water.

To assess the aggregate dietary exposure to food and drinking water,
water residue values were included in the acute and chronic dietary
assessment described above for food only.  Worst-case concentrations of
penthiopyrad in groundwater were modeled using Screening Concentration
in Ground Water (SCI-GROW, v2), and worst-case surface water
concentrations were modeled using The Pesticide Root Zone Model (PRZM
v3.12.2) and Exposure Analysis Modeling System (EXAMS v<IP_ADDRESS>)
coupled with the input shell PE Version 5.0. The groundwater
concentrations for penthiopyrad are less than those in surface water.
The highest 1 in 10 year peak penthiopyrad concentration was 19.1 ppb in
surface water; the 1 in 10 year annual mean penthiopyrad value for
surface water was 1.15 ppb. When the higher surface water concentrations
were included in the acute and chronic dietary risk assessments, there
was little change from the food-only dietary risk assessments.  For the
acute assessment which included drinking water as a point estimate the
predicted exposure at the 95th percentile for the general U.S.
population was 0.013044 mg/kg/day which corresponds to 2% of the aRfD;
the most sensitive subpopulation, children 1-2 years, had an estimated
exposure of 0.026236 mg/kg/day, 4% of the aRfD.  For the chronic
assessment which included drinking water the predicted exposure for the
general population was 0.001340 mg/kg/day, <1% of the cRfD; the most
sensitive subpopulation, children 1-2 years, had an estimated exposure
of 0.003140 mg/kg/day, 1% of the cRfD.  Thus, the aggregate acute and
chronic dietary exposure of penthiopyrad, including the contribution of
drinking water, clearly meets the standard of reasonable certainty of no
harm.

2. Non-dietary exposure.  Penthiopyrad product registrations for
residential turf uses have been submitted.  Residential exposure
(non-occupational, non-dietary exposure to consumers) was conservatively
assessed for dermal post-application exposure (children and adults), and
for children the oral exposures via hand-to-mouth, object-to-mouth, and
incidental ingestion of soil were also assessed.  The margins of
exposure (MOE) greatly exceed the 100-fold MOE required for these routes
and from the combined children’s incidental oral ingestion.
Therefore, residential non-dietary exposure is not a concern.

D. Cumulative Effects

Penthiopyrad is classified as a succinate dehydrogenase inhibitor (SDHI)
fungicide (FRAC Group #7).  The mode of action of penthiopyrad is
different from that of most other fungicides presently on the market.
There is no cross resistance to other non-carboxamide fungicides.

E. Safety Determination

	1. U.S. population. The toxicity database for penthiopyrad is complete.
The chronic exposure to penthiopyrad for the overall U.S. population in
this very conservative analysis is less than 1% of the Chronic Reference
Dose (cRfD = ADI = 0.27 mg/kg bw/day).  The acute exposure to
penthiopyrad at the 95th percentile, calculated in a conservative
deterministic assessment, for the overall U.S. population is 2% of the
aRfD (0.75 mg/kg bw/day).  There are large margins of safety for all
population groups, thus there is reasonable certainty that no harm to
the U.S. population will result from the proposed uses of penthiopyrad.

	2. Infants and children. The toxicity database for penthiopyrad is
complete.  The database includes acute, subchronic, chronic,
mutagenicity, genotoxicity, developmental, reproduction, neurotoxicity
and immunotoxicity studies on penthiopyrad and acute mutagenicity and
genotoxicity studies on main metabolites.  The chronic exposure of the
most highly exposed subgroup, children 1-2 years, is 1% of the cRfD.
The acute exposure of the most highly exposed subgroup, children 1-2
years, is 3% of the aRfD.  There are large margins of safety for all
population groups.

F. International Tolerances.

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=; tops of root and tuber vegetables at 0.01 ppm; legume vegetables at
0.01 ppm; roots of root and tuber vegetables at 0.01 ppm; legume
oilseeds at 0.01 ppm; cereal grains at 0.01 ppm; tree nuts at 0.01 ppm;
oilseed at 0.01 ppm; legume animal feeds at 0.01 ppm; straws, fodder and
forage of cereal grains and grasses at 0.01 ppm.  Global tolerances are
simultaneously being sought in the United States of America, Canada and
the European Union.  Codex tolerances have not yet been established but
penthiopyrad is in the process of being scheduled for review by JMPR.

 PAGE

 PAGE   2


BEFORE THE

UNITED STATES DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

____________________________________

Notice of					)

						)

VANGUARD AIRLINES, INC.	)

					)		OST – 2001-10711-1

Termination of scheduled service		)

Kansas City – Myrtle Beach			)

___________________________________	)

NOTICE OF VANGUARD AIRLINES, INC.

Communications with respect to this document should be addressed to:

Robert M. Rowen

Vice President and General Counsel

Vanguard Airlines, Inc.

533 Mexico City Avenue

Kansas City, Missouri  64153

October 2, 2001

BEFORE THE

UNITED STATES DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

____________________________________

Notice of					)

						)

VANGUARD AIRLINES, INC.	)

					)		OST – 2001-10711-1

Termination of scheduled service		)

Kansas City – Myrtle Beach			)

___________________________________	)

NOTICE OF VANGUARD AIRLINES, INC.

Vanguard Airlines, Inc. (“Vanguard”) hereby provides notice that it is terminating scheduled airline service between Kansas City, Missouri and Myrtle Beach, South Carolina, effective October 4, 2001.  Such service had been provided four times a week, using 737-200 aircraft seating 120 passengers.  Vanguard publicly announced the termination of such service on September 21, 2001.

Vanguard intends to consider reintroducing such service in early 2002.

						Respectfully Submitted.

/s/ Robert M. Rowen___________________

Date:	October 2, 2001			Robert M. Rowen

Vice President and General Counsel

Vanguard Airlines, Inc.

533 Mexico City Avenue

Kansas City, Missouri  64153

(816) 243 2995

fax:<PHONE_NUMBER>

CERTIFICATE OF SERVICE

	I hereby certify that on October 2, 2001, a copy of Application of Vanguard Airlines, Inc. was served upon the parties on the attached service list.

						/s/ Julia King

						Julia L. King

SERVICE LIST

Myrtle Beach International Airport

1100 Jetport Road

Myrtle Beach, SC  29577	Continental Airlines

1100 Jetport Road

Myrtle Beach, SC  29577

AirTran

1100 Jetport Road

Myrtle Beach, SC  29577

Delta Airlines

1100 Jetport Road

Myrtle Beach, SC  29577

ASA

1100 Jetport Road

Myrtle Beach, SC  29577

Spirit

1100 Jetport Road

Myrtle Beach, SC  29577

ComAir

1100 Jetport Road

Myrtle Beach, SC  29577

US Air

1100 Jetport Road

Myrtle Beach, SC  29577

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