[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Notices]
[Page 52068-52071]
[DOCID:fr01se06-36]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0693; FRL-8090-3]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review the Studies Evaluating the Impact of Surface
Coatings on the Level of Dislodgeable Arsenic, Chromium and Copper from
Chromated Copper Arsenate (CCA)-Treated Wood.

DATES:  The meeting will be held on November 14-16, 2006, from 8:30
a.m. to approximately 5 p.m, eastern time.
    Comments: For the deadline for submission of requests to present
oral comments and submission of written comments, see Unit I.C. of the
SUPPLEMENTARY INFORMATION.

     Nominations: Nominations of scientific experts to serve as ad hoc
members of the FIFRA SAP for this meeting should be provided on or
before September 13, 2006.
     Special Accommodations: For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the Designated Federal Official (DFO) listed
under FOR FURTHER INFORMATION CONTACT at least 10 business days prior
to the meeting, to give EPA as much time as possible to process your
request.

ADDRESSES:  The meeting will be held at the Environmental Protection
Agency, Conference Center - Lobby Level, One Potomac Yard (South Bldg.)
2777 S. Crystal Drive, Arlington, Virginia 22202.
     Comments: Submit your comments, identified by docket ID number
EPA-HQ-OPP-2006-0693, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
     Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0693. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
     Docket: All documents in the docket are listed in the docket index
that is available at http://www.regulations.epa.gov. Although, listed

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

copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket telephone number
is<PHONE_NUMBER>.
     Nominations or requests to present oral comments.: See Unit I.C.
of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail addresses:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under FIFRA and the Federal
Food, Drug, and Cosmetic Act (FFDCA). Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the DFO listed under FOR FURTHER INFORMATION CONTACT.

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

    Tips for preparing your comments. When preparing and submitting
comments, remember to use these tips:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    2. 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.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

C. How May I Participate in this Meeting?

     You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2006-0693 in the subject line
on the first page of your submission.
    1. Oral comments: Oral comments presented at the meetings should
not be repetitive of previously submitted oral or written
comments.Although requests to present oral comments are accepted until
the date of the meeting (unless otherwise stated), to the extent that
time permits, the Chair of the FIFRA SAP may permit the presentation of
oral comments at the meeting by interested persons who have not
previously requested time. However, each individual or group wishing to
make brief oral comments to FIFRA SAP is strongly advised to submit
their request to the DFO listed under FOR FURTHER INFORMATION CONTACT
no later than noon, eastern standard time, November 8, 2006, in order
to be included on the meeting agenda. The request should identify the
name of the individual

making the presentation, the organization (if any) the individual will
represent, and any requirements for audiovisual equipment (e.g.,
overhead projector, 35 mm projector, chalkboard). Oral comments before
FIFRA SAP are limited to approximately 5 minutes unless prior
arrangements have been made. In addition, each speaker should bring 30
copies of his or her comments and presentation slides for distribution
to FIFRA SAP at the meeting.
    2. Written comments: Although submission of written comments are
accepted until the date of the meeting, unless otherwise stated, the
Agency encourages that written comments be submitted using the
instructions in ADDRESSES, no later than noon, eastern standard time,
November 1, 2006, to provide FIFRA SAP the time necessary to consider
and review the written comments. It is requested that persons
submitting comments directly to the docket also notify the DFO listed
under FOR FURTHER INFORMATION CONTACT. Persons wishing to submit
written comments at the meeting should bring 30 copies. There is no
limit on the extent of written comments for consideration by FIFRA SAP.
    3. Seating at the meeting: Seating at the meeting will be on a
first-come basis. Individuals requiring special accommodations at this
meeting, including wheelchair access, should contact the DFO at least
10 business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT so that appropriate arrangements can be
made.
    4. Request for nominations to serve as ad hoc members of the FIFRA
SAP for this meeting. As part of a broader process for developing a
pool of candidates for each meeting, the FIFRA SAP staff routinely
solicit the stakeholder community for nominations of prospective
candidates for service as ad hoc members of the FIFRA SAP. Any
interested person or organization may nominate qualified individuals to
be considered as prospective candidates for a specific meeting.
Individuals nominated for the meeting announced in this notice should
have expertise in one or more of the following areas: Wood technology
and wood preservatives, statistics, exposure and risk assessment and
children's health. Nominees should be scientists who have sufficient
professional qualifications, including training and experience, to be
capable of providing expert comments on the issues for this meeting.
Nominees should be identified by name, occupation, position, address,
and telephone number. Nominations should be provided to the DFO listed
under FOR FURTHER INFORMATION CONTACT on or before September 13, 2006.
The Agency will consider all nominations of prospective candidates for
this meeting that are received on or before this date. However, final
selection of ad hoc members for this meeting is a discretionary
function of the Agency.
     The selection of scientists to serve on FIFRA SAP is based on the
function of the panel and the expertise needed to address the Agency's
charge to the panel. No interested scientists shall be ineligible to
serve by reason of their membership on any other advisory committee to
a Federal department or agency or their employment by a Federal
department or agency (except EPA). Other factors considered during the
selection process include availability of the potential panel member to
fully participate in the panel's reviews, absence of any conflicts of
interest or appearance of lack of impartiality, independence with
respect to the matters under review, and lack of bias. Though financial
conflicts of interest, the appearance of lack of impartiality, lack of
independence, and bias may result in disqualification, the absence of
such concerns does not assure that a candidate will be selected to
serve on FIFRA SAP. Numerous qualified candidates are identified for
each panel. Therefore, selection decisions involve carefully weighing a
number of factors including the candidates' areas of expertise and
professional qualifications and achieving an overall balance of
different scientific perspectives on the panel. In order to have the
collective breadth of experience needed to address the Agency's charge
for this meeting, the Agency anticipates selecting approximately 12 ad
hoc scientists.
     If a prospective candidate for service on FIFRA SAP is considered
for participation in a particular session, the candidate is subject to
the provisions of 5 CFR part 2634, Executive Branch Financial
Disclosure, as supplemented by EPA in 5 CFR part 6401. As such, the
FIFRA SAP candidate is required to submit a Confidential Financial
Disclosure Form for Special Government Employees Serving on Federal
Advisory Committees at the U.S. Environmental Protection Agency (EPA
Form 3110-48 5-02) which shall fully disclose, among other financial
interests, the candidate's employment, stocks and bonds, and where
applicable, sources of research support. The EPA will evaluate the
candidate's financial disclosure form to assess that there are no
financial conflicts of interest, no appearance of lack of impartiality,
and no prior involvement with the development of the documents under
consideration including previous scientific peer review before the
candidate is considered further for service on FIFRA SAP.
     Those who are selected from the pool of prospective candidates
will be asked to attend the public meetings and to participate in the
discussion of key issues and assumptions at these meetings. In
addition, they will be asked to review and to help finalize the meeting
minutes. The list of FIFRA SAP members participating at this meeting
will be posted on the FIFRA SAP Web site or may be obtained by
contacting the OPP Regulatory Public Docket at the address or telephone
number listed under ADDRESSES.

II. Background

A. Purpose of the FIFRA SAP

    Amendments to FIFRA enacted November 28, 1975 (7 U.S.C. 136w(d),
include a requirement under section 25(d) of FIFRA that notices of
intent to cancel or reclassify pesticide regulations pursuant to
section 6(b)(2) of FIFRA, as well as proposed and final forms of
regulations pursuant to section 25(a) of FIFRA, be submitted to a SAP
prior to being made public or issued to a registrant. In accordance
with section 25(d) of FIFRA, the FIFRA SAP is to have an opportunity to
comment on the health and environmental impact of such actions. The
FIFRA SAP also shall make comments, evaluations, and recommendations
for operating guidelines to improve the effectiveness and quality of
analyses made by Agency scientists. Members are scientists who have
sufficient professional qualifications, including training and
experience, to be capable of providing expert comments as to the impact
on health and the environment of regulatory actions under sections 6(b)
and 25(a) of FIFRA. The Deputy Administrator appoints seven individuals
to serve on the FIFRA SAP for staggered terms of 4-years, based on
recommendations from the National Institutes of Health and the National
Science Foundation.
    Section 104 of Food Quality Protection Act of 1996 (FQPA) (Public
Law 104-170) established the FQPA Science Review Board (SRB). These
scientists shall be available to the FIFRA SAP on an ad hoc basis to
assist in reviews conducted by the FIFRA SAP.

B. Public Meeting

     Chromated Copper Arsenate (CCA) is a preservative that is
impregnated under pressure into wood to protect it from decay and
insect damage. In October

2001, the U.S. Environmental Protection Agency (EPA) requested guidance
from the FIFRA Scientific Advisory Panel (SAP) about risk mitigation
measures, such as the application of surface coatings, for CCA-treated
wood (SAP Report No. 2001-12). The SAP Panel made ``recommendations
regarding the need for additional studies in this area...'' because the
``weight-of evidence from available studies indicates that certain
coatings can substantially reduce dislodgeable and leachable CCA
chemicals.'' The Panel also recommended that ``EPA inform the public of
the ability of certain coatings to substantially reduce leachable and
dislodgeable CCA chemicals...''
     In response to these recommendations, EPA and the Consumer Product
Safety Commission (CPSC) staff (Interagency Agreement  CPSC-I-
03-1235), conducted studies evaluating the ability of selected coatings
to reduce the amount of dislodgeable chemicals on CCA-treated wood
surfaces under natural weather conditions for 2 years, August 2003-
August, 2005. The data presented are final data from the studies;
interim one-year data from the studies were reviewed through a letter
peer review process previously.
     On November 14-16, 2006, the FIFRA SAP will meet to review and
consider the EPA and CPSC staff studies of the impact of surface
coatings on the levels of dislodgeable arsenic, chromium, and copper
from treated wood. The review will focus on the design and methodology
employed in the studies, extrapolation of the results, and areas for
future research.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's position paper, charge/questions to FIFRA SAP, FIFRA SAP
composition (i.e., members and consultants for this meeting), the
meeting agenda and the EPA and CPSC staff studies will be available by
early October 2006. In addition, the Agency may provide additional
background documents as the materials become available. You may obtain
electronic copies of these documents, and certain other related
documents that might be available electronically, from the
regulations.gov Web site and the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap
.

     The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency in approximately 90 days after the
meeting. The meeting minutes will be posted on the FIFRA SAP Web site
or may be obtained by contacting the OPP Regulatory Public Docket at
the address or telephone number listed under ADDRESSES.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 23, 2006.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.

[FR Doc. E6-14537 Filed 8-31-06; 8:45 am]

BILLING CODE 6560-50-S


PWSS Program ICR 2040 0090 Cap Dev V& E's Primacy Reg CCRs State Primacy Activities Stage 1 TTHMs Chems LCR ' 76 Rads ' 00 Rads IESWTR SWTR LT1 LT2 FBRR TCR GWR Arsenic UCMR Stage 2 Radon Red = Activities covered in stand alone ICRs Green = Activities covered by PWSS Program ICR Purple = Activities not covered in current ICRs Gray = Future ICRs Needs Survey Class V ICR Florida ICR UIC Program ICR DW SRF SWAP Op Cert PN Figure 1. Previous Structure of OGWDW ICRs PWSS Program ICR 2040 0090 DBP/ Chem/ Rads ICR 2040 0204 Cap Dev V& E's Primacy Reg PN CCRs State Primacy Activities Stage 1 TTHMs Chems LCR ' 76 Rads ' 00 Rads IESWTR SWTR LT1 LT2 Microbial ICR 2040 0205 FBRR TCR GWR Arsenic Stage 2 UCMR Radon Yellow = Activities moving via ICW Red = Activities not moving between ICRs Green = Activities moving during restructuring Blue = Activities moving out of expiring ICRs Purple = Activities not covered in current ICRs Pink = Activities that will move when they expire Gray = Future amendments UIC Program ICR 2040 0042 Needs Survey 2040 0198 Class V Florida UIC Program DW SRF 2040 0185 SWAP 2040 0197 Op Cert Lab QA Figure 2. Restructure of OGWDW ICRs


[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Notices]
[Pages 72491-72492]
[FR Doc No: 2022-25643]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2782]

Antimicrobial Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Antimicrobial Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held virtually on January 24, 2023, from 9
a.m. to 4:30 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions about FDA advisory committee meetings may be accessed
at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-2782. Please note that late, untimely
filed comments will not be considered. The docket will close on January
23, 2023. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of January 23,
2023. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or
before that date.
    Comments received on or before January 9, 2023, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2022-N-2782 for ``Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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.'' FDA 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 https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information 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 the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Joyce Frimpong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7973, [email protected], or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last-minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss new drug application 217417, for rezafungin lyophilized
powder for injection, submitted by Cidara Therapeutics, Inc., for
treatment of candidemia and invasive candidiasis in adults.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before January 9, 2023, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before December 29, 2022.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by December 30, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Joyce Frimpong (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25643 Filed 11-23-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 5, 2009 (Volume 74, Number 23)]
[Notices]
[Page 6212-6213]
[DOCID:fr05fe09-76]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2000-7363; FMCSA-2000-7918; FMCSA-2002-13411]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
11 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent
to, or greater than, the level of safety maintained without the
exemptions for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective March 7, 2009. Comments must be
received on or before March 9, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2000-7363; FMCSA-2000-7918;
FMCSA-2002-13411, using any of the following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://DocketInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers

of CMVs in interstate commerce, for a two-year period if it finds
``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 11 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 11 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Henry Ammons, Jr., Michael D. Archibald, David S. Carman, Cedric E.
Foster, Glen T. Garrabrant, Alan L. Johnston, Dennis I. Nelson, Rance
A. Powell, Shannon E. Rasmussen, Garfield A. Smith, Henry L. Walker.
    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 11 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (65 FR 45817; 65 FR 77066; 68 FR 10300; 70 FR 7546; 65 FR
66286; 66 FR 13825; 67 FR 76439; 68 FR 10298; 70 FR 7545). Each of
these 11 applicants has requested renewal of the exemption and has
submitted evidence showing that the vision in the better eye continues
to meet the standard specified at 49 CFR 391.41(b)(10) and that the
vision impairment is stable. In addition, a review of each record of
safety while driving with the respective vision deficiencies over the
past two years indicates each applicant continues to meet the vision
exemption standards. These factors provide an adequate basis for
predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of two years is
likely to achieve a level of safety equal to that existing without the
exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by March 9, 2009.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 11 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all of these drivers, are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: January 29, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-2454 Filed 2-4-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Notices]
[Page 26203]
[FR Doc No: 2017-11769]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a closed meeting on Thursday, June 8,
2017 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matter at the closed meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Consideration of amici participation; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed; please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: June 1, 2017.
Lynn M. Powalski,
Deputy Secretary.
[FR Doc. 2017-11769 Filed 6-2-17; 11:15 am]
BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date:		August 19, 2004

Subject:	Occupational and Residential Risk Assessment to Support Request for a Section 3 Registration of Pyraclostrobin on a Variety of Crops and Residential Turf

DP Barcode:

PC Code:

Trade Names:

EPA Reg#s

MRID#s

PRAT Case

Class

D298017

099100

Headline®

Cabrio® EG

Insignia®

7969-186

7969-187

7969-184

N/A

N/A

Fungicide

To:		Barry O’Keefe, Risk Assessor

Health Effects Division

Registration Action Branch 3 (7509C)

From:		Kelly O’Rourke, Biologist

Health Effects Division

Registration Action Branch 3 (7509C)

Thru:		Stephen Dapson, Branch Senior Scientist

and

Jack Arthur, Occ. & Res. Exposure Team Leader

Health Effects Division

Registration Action Branch 3 (7509C)

Introduction

The registrant, BASF Corporation, requests the establishment of tolerances for residues of the fungicide pyraclostrobin on Brassica, citrus, corn, hops, leafy vegetables, mint, pome fruit, soybeans, succulent peas and beans, and sunflower, as well as registration on sod and residential/ recreational turf.  This memorandum addresses risk from occupational and residential exposure only; an aggregate human risk assessment for pyraclostrobin is included as a separate HED memorandum.

1.0  Executive Summary

Pyraclostrobin is a fungicidal active ingredient (ai) currently registered on berries, bulb vegetables, cucurbit vegetables, fruiting vegetables, grapes, pistachios, root vegetables, tree nuts, stone fruits, citrus, dried peas and beans, grass grown for seed, peanuts, potatoes, sugarbeets, tuberous and corm vegetables, barley, rye, and wheat, as well as golf course turf.  The formulated end use products evaluated in this assessment are labeled under the trade names Headline®, Cabrio® EG, and Insignia®.  In this memorandum, the name pyraclostrobin will be used for the active ingredient (ai) in these products.

The agricultural formulations of pyraclostrobin evaluated in this assessment are a water dispersible granule product, also called dry flowable, (i.e., Cabrio® EG 20% ai) and an emulsifiable concentrate (i.e., Headline® 2.09 lb ai/gallon).  The registrant proposes multiple foliar sprays using ground, aerial, or chemigation equipment.  Applications are proposed to begin prior to disease development and continue throughout the season, with PHIs ranging from 0 to 21 days.  Proposed use rates are 0.15-0.20 lb ai/A/application, with seasonal maximums of up to 1.2 lbs ai/A  The target crops may receive from 2 to 6 applications during a season (with limits for sequential applications), at intervals ranging from 7 to 21 days.

A non-agricultural water dispersible granule product (Insignia® 20% ai) is proposed for use on turfgrass including residential, institutional, commercial, and municipal lawns, parks, recreational areas, cemeteries, and sod farms at use rates ranging from 0.28 to 0.5 lb ai/A, at intervals of 14 to 28 days; the maximum seasonal application rate is 3 lb ai/A.

Occupational Exposure

There is potential for occupational exposure to pyraclostrobin during mixing, loading, application, and postapplication activities.   For short-/intermediate-term dermal and inhalation exposure, the Hazard Identification Assessment Review Committee (HIARC) selected an endpoint from a rabbit prenatal developmental toxicity study (NOAEL = 5 mg/kg/day), based on developmental toxicity findings of increased resorptions at 10 mg/kg/day.  Because this is an oral study, daily dermal doses were adjusted to account for 14% dermal absorption and, daily inhalation doses were calculated assuming 100% absorption.  Resulting dermal and inhalation MOEs were combined into Total MOEs because the same endpoint was chosen to evaluate both routes of exposure.  The target MOE for short-/intermediate-term exposure is 100.  Chronic exposures are not expected for handlers or postapplication workers for the proposed use patterns associated with pyraclostrobin.

The Cancer Assessment Review Committee (CARC) concluded that pyraclostrobin should be classified into the category “data are inadequate to assess the human carcinogenic potential” because the female mice were not tested at adequate dose levels in the carcinogenicity study.  In the absence of a complete data base for carcinogenicity, HED management decided that a Margin of Exposure (MOE) method to assess cancer would be appropriate.  In an ad hoc meeting which occurred on August 10, 2004, this decision was reaffirmed, along with the conclusion that this approach is applicable to long-term exposure only, for the following reasons: 1) genotoxicity data indicate that pyraclostrobin is not mutagenic; 2) there was no treatment related increase in tumors in male and female rats, or in male mice; and 3) two structural analogs of pyraclostrobin were found “not likely to be carcinogenic to humans”.  Because there is no long-term non-dietary exposure associated with the use of pyraclostrobin, occupational/residential cancer assessments were not conducted.

No chemical-specific handler exposure data were submitted in support of this registration.  It is the policy of the HED to use data from the Pesticide Handlers Exposure Database (PHED) Version 1.1 as presented in PHED Surrogate Exposure Guide (8/98) to assess handler exposures for regulatory actions when chemical-specific monitoring data are not available (HED Science Advisory Council for Exposure Standard Operating Procedure (SOP) #7, dated 1/28/99).  The handgun sprayer exposure data used in this assessment are from the Outdoor Residential Exposure Task Force (ORETF) submission of proprietary data for hose-end sprayers, push-type granular spreaders, and handgun sprayers (MRID # 44972201).

The results of the handler occupational exposure and risk assessment indicate that risks are not of concern when gloves are used to mitigate exposure.  The Total short-/intermediate-Term MOEs with this PPE range from 280 to 6,400; which exceed the target of 100, and are not of concern.

Chemical-specific dislodgeable foliar residue (DFR) data had previously been submitted by the registrant to support earlier registration requests for food crops.  The studies were conducted on peaches, peanuts, strawberries, grapes (MRID#s: 45118727, 45118724, 45118726, and 45118728, respectively), and one study comparing the effect of two different formulations of pyraclostrobin on grape DFR (MRID#: 45118729).  Turf transferrable residue (TTR) data (MRID#: 45118725) are also available from an earlier submission in support of a request for use on golf course turf.  In addition to these residue data, the interim transfer coefficient policy developed by HED’s Science Advisory Council for Exposure, which includes proprietary data from the Agricultural Re-entry Task Force (ARTF) database (policy # 3.1), was used in estimating postapplication exposures.

The results of the postapplication exposure and risk assessment indicate that Target MOEs are met (i.e., reach or exceed 100) on Day 0 for all crops except sweet corn, for which an REI of 7 days was calculated.  The pyraclostrobin technical material has been classified in Toxicity Category III for acute dermal, primary eye irritation, and primary skin irritation.  Per the Worker Protection Standard (WPS), a 12-hr restricted entry interval (REI) is required for chemicals classified under Toxicity Category III or IV.  The Headline® and Cabrio® labels indicate an REI of 12 hours, and therefore, are in compliance with the WPS.  The Insignia® label is for non-agricultural use sites to which the WPS does not apply, it appropriately contains language cautioning unprotected persons to keep out of treated areas until sprays have dried.

Residential Exposure

Residential handler exposure was not evaluated because the registrant indicated that turf applications are intended to be made by professional pest control operators (PCOs) only (although the label does not state this).

Residential postapplication exposure via the dermal route is likely for adults and children entering treated lawns.  Toddlers may also experience exposure via incidental non-dietary ingestion (i.e., hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) during postapplication activities on treated turf.  The postapplication risk assessment is based on generic assumptions as specified by the Recommended Revisions to the Residential SOPs and recommended approaches by HED’s Science Advisory Council for Exposure (ExpoSAC).

Residential short-/intermediate-term dermal exposure was assessed using the NOAEL (5 mg/kg/day) from the rabbit developmental study that was selected for occupational exposure.  While the developmental effect of increased resorptions is not applicable to toddlers, it should be noted that the maternal NOAEL from this study is also 5 mg/kg/day, and is based on reduced body weight gain, food consumption, and food efficiency at the LOAEL of 10 mg/kg/day;  this more relevant endpoint was used to assess toddler dermal exposure.  For incidental ingestion, exposure was assessed using the endpoint from a 13-week feeding study in the dog.  The NOAEL from this study is 5.8 mg/kg/day, based on increased incidence of diarrhea, clinical chemistry changes, duodenum mucosal hypertrophy, and decreased body weight and food intake/efficiency at the LOAEL of 12.9 mg/kg/day.  A common effect (i.e., decreased body weight gain and food efficiency) was seen in the studies selected to evaluate toddler dermal and incidental ingestion exposure; therefore, route-specific MOEs were combined into a Total MOE for toddlers.

On December 17, 2002, the HIARC reevaluated the potential for increased susceptibility of infants and children according to the 2002 OPP FQPA 10X Guidance Document, and recommended that the special FQPA factor should be removed [1X] for all potential exposure scenarios for pyraclostrobin because there are no residual uncertainties for pre- and/or postnatal toxicity.  Therefore, the target MOE for residential exposure is 100.

Residential short-/intermediate-term postapplication MOEs were estimated for “Day 0" exposure (i.e., the day of application).  The Total short-/intermediate-term MOE is 140, which is greater than the target of 100 on the day of application, and therefore, is not of concern.

2.0  Hazard Profile

On April 5, 2001, the Health Effects Division (HED) Hazard Identification Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for pyraclostrobin with regard to the acute and chronic Reference Doses (RfDs) and the toxicological endpoint selection for use as appropriate in occupational/residential exposure risk assessments.  The potential for increased susceptibility of infants and children from exposure to pyraclostrobin  was also evaluated as required by the Food Quality Protection Act (FQPA) of 1996.  On October 1, 2001, the FQPA Committee met and confirmed that the safety factor of 3X, applicable to females ages 13 to 50, is appropriate to address the potential for increased susceptibility.  However, on December 17, 2002, the HIARC reevaluated the potential for increased susceptibility of infants and children according to the 2002 OPP FQPA 10X Guidance Document, and recommended that the special FQPA factor should be removed [1X] for all potential exposure scenarios to pyraclostrobin because there are no residual uncertainties for pre- and/or postnatal toxicity.  The acute toxicity data for the pyraclostrobin technical formulation are presented in Table 1.  The doses and toxicological endpoints selected by the HIARC for various exposure scenarios are summarized in Table 2.

On October 24, 2001, the Cancer Assessment Review Committee (CARC) concluded that pyraclostrobin should be classified into the category “data are inadequate to assess the human carcinogenic potential” because of inadequate dose levels for female rats and mice in the carcinogenicity studies.  On September 10, 2003, the CARC reevaluated the carcinogenicity data and reaffirmed the cancer classification based on the determination of inadequate dose levels in the carcinogenicity study for female mice only.  The CARC now considers the doses tested in both sexes of the rat carcinogenicity study adequate, and confirmed that the tumor data from the combined results of carcinogenicity and chronic toxicity studies (in rats) showed neither a significant increasing trend nor a significant difference in the pari-wise comparison of the dosed groups with the controls.  In the absence of a complete data base for carcinogenicity, HED management decided that a Margin of Exposure (MOE) method to assess cancer risk would be appropriate.  In an ad hoc meeting with HED senior scientists, which occurred on August 10, 2004, this decision was reaffirmed, along with the conclusion that this approach is applicable to long-term exposure only, for the following reasons: 1) genotoxicity data indicate that pyraclostrobin is not mutagenic; 2) there was no treatment related increase in tumors in male and female rats, or in male mice; and 3) two structural analogs of pyraclostrobin were found “not likely to be carcinogenic to humans”.  Because there is no long-term non-dietary exposure associated with the use of pyraclostrobin, occupational/residential cancer assessments were not conducted.

Table 1.  Acute Toxicity Data on Pyraclostrobin Technical

Guideline

 No.

Study Type

MRID #

Results

Toxicity Category

870.1100

Acute Oral

45118302

LD50 =  > 5000 mg/kg

IV

870.1200

Acute Dermal

45118305

LD50 =  > 2000 mg/kg

III

870.1300

Acute Inhalation

45118308

0.31< LC50 < 1.07  mg/L

II

870.2400

Primary Eye Irritation

45118311

minimal eye irritation; MAS 4.6/110

III

870.2500

Primary Skin Irritation

45118314

moderate skin irritation; MAS 2.2/8.0

III

870.2600

Dermal Sensitization

45118317

not a dermal sensitizer

N/A

Table 2.  Summary of Toxicological Doses and Endpoints for Pyraclostrobin for Use in Human Risk Assessment

Exposure

Scenario

Dose

(mg/kg/day)

Endpoint

Study

Incidental Oral, Short and Intermediate-Term

NOAEL= 5.8

Increased incidence of diarrhea, clinical chemistry changes, duodenum mucosal hypertrophy, and decreased body weight and food intake/efficiency at 12.9 mg/kg/day (LOAEL).

13-Week Feeding Dog Study (MRID 45118323)

Dermal, Short- and Intermediate-Term

Oral NOAEL= 5.0

Developmental toxicity findings of increased resorptions at 10.0 mg/kg/day (LOAEL).1

Rabbit Prenatal Developmental Toxicity (MRID 45118326)

Dermal, Long-Term

Oral NOAEL= 3.4

Decreased body weight/gain, kidney tubular casts and atrophy in both sexes; increased incidence of  liver necrosis and erosion/ulceration of the glandular stomach and forestomach in males in addition to hemolymphoreticular tumors in males and mammary adenocarcinoma in females at 9.2 mg/kg/day (LOAEL).1

Rat Oral Carcinogenicity (MRID 45118331)

Inhalation, Short- and Intermediate-Term

Oral NOAEL= 5.0

Developmental toxicity findings of increased resorptions at 10.0 mg/kg/day (LOAEL).2

Rabbit Prenatal Developmental Toxicity (MRID 45118326)

Inhalation, Long-Term

Oral NOAEL= 3.4

Decreased body weight/gain, kidney tubular casts and atrophy in both sexes; increased incidence of  liver necrosis and erosion/ulceration of the glandular stomach and forestomach in males in addition to hemolymphoreticular tumors in males and mammary adenocarcinoma in females at 9.2 mg/kg/day (LOAEL).2

Rat Oral Carcinogenicity2 (MRID 45118331)

Cancer

(MOE Approach)

NOAEL = 32.8

Mortality, clinical signs, body weight, body weight gain, food consumption, food efficiency, hematology, organ weights, and gross and microscopic findings for both sexes at all doses were unaffected by treatment.  The highest tested dose was 32.8 mg/kg/day in females.1, 2

Mouse Oral Carcinogenicity (MRID 45118330)

1 The dermal absorption factor of 14% should be applied to extrapolate from the oral route to the dermal route.

2 100% absorption rate (default value) should be used to extrapolate from the oral route to the inhalation route.

3.0  Use Profile

Pyraclostrobin is currently registered on berries, bulb vegetables, cucurbit vegetables, fruiting vegetables, grapes, pistachios, root vegetables, tree nuts, stone fruits, citrus, dried peas and beans, grass grown for seed, peanuts, potatoes, sugarbeets, tuberous and corm vegetables, barley, rye, and wheat, as well as golf course turf.  The proposed uses evaluated in this assessment are summarized in Table 3.

Table 3.  Summary of Use Patterns/Formulation Information Relevant to Occupational and Residential Exposure/Risk Assessment

Formulation Type (% ai)

Application Method

Use Site

Maximum

Application Rate

(lb ai/A)

Frequency of Application

(at max rate)*

Application Interval

Headline® Emulsifiable Concentrate

(2.09 lb ai/gal)

Groundboom, Aerial, and Chemigation

corn

0.2

6 applications

7 to 14 days

mint

0.2

4 applications

soybean

0.2

2 applications

succulent shelled

peas & beans,

edible podded legumes

0.15

2 applications

sunflower

0.2

2 applications

Cabrio®

Water Dispersible Granule

(i.e., Dry Flowable)

(20% ai)

Groundboom, Aerial, and Chemigation

Brassica, head & stem vegetables

0.2

4 applications

7 to 14 days

Brassica, leafy greens

0.2

4 applications

7 to 10 days

leafy vegetables

 0.2

4 applications

7 to 14  days

leaves of root & tuber vegetables

 0.2

3 applications

7 to 14  days

Airblast, Aerial

hops

0.2

3 applications

10 to 21 days

pome fruit

0.15

4 applications

7 to 10 days

Insignia®

Water Dispersible Granule

(i.e., Dry Flowable)

(20% ai)

Groundboom, Handgun, Low-pressure Handwand, and Backpack Sprayer

turf

(residential lawns, recreational areas, and sod farms)

0.28 - 0.50

6 applications

14 to 28 days

  * The label recommends no more than 2 (or 3, in the case of some diseases on turf) sequential applications.

4.0  Occupational Exposure

4.1   Handler Exposure and Risk

There is a potential for exposure to pyraclostrobin during mixing, loading, and application  activities.  An exposure/risk assessment using applicable endpoints was performed.  Handler’s exposure and risk were estimated for the following scenarios:  (1 and 2) mixing/loading emulsifiable concentrate formulation (i.e., liquids) for aerial/chemigation and groundboom application, respectively, (3, 4, and 5) mixing/loading water dispersible granule formulation (i.e., dry flowable) for aerial/chemigation, groundboom, and airblast application, respectively, (6) applying sprays with fixed-wing aircraft, (7) applying sprays with a groundboom sprayer, (8) applying sprays with an airblast sprayer, (9) mixing/loading dry flowable formulation and applying sprays with a handgun sprayer, (10 and 11) mixing/loading/applying liquids with a low-pressure handwand and backpack sprayer, respectively, and (12) flagging for aerial spray operations.

Flaggers for aerial application are assessed for a maximum of 350 acres per day, because a larger area would likely require pilot-activated mechanical flagging or global positioning systems (GPS), rather than human flaggers.

No chemical-specific handler exposure data were submitted in support of this registration.  It is the policy of the HED to use data from the Pesticide Handlers Exposure Database (PHED) Version 1.1 as presented in PHED Surrogate Exposure Guide (8/98) to assess handler exposures for regulatory actions when chemical-specific monitoring data are not available (HED Science Advisory Council for Exposure Standard Operating Procedure #7, dated 1/28/99).  There are two scenarios (mixing/loading/applying dry flowable with a low pressure handwand and mixing/loading/applying dry flowable with a back pack sprayer) for which no PHED unit exposure data exists.  Because the dry flowable unit exposure data for mixing/loading is lower than the unit exposure data for mixing/loading for liquids, it is assumed that the exposure from mixing/loading/applying a dry flowable for both the backpack and the low pressure handwand would be less than the exposure from mixing/loading/applying liquids for both the backpack sprayer and the low pressure handwand.  Thus, the use of the data for the liquid formulation would not be underprotective.  The handler exposure data for the handgun sprayer scenario are from the Outdoor Residential Exposure Task Force (ORETF), rather than from PHED.  The task force recently submitted proprietary data to the Agency on hose-end sprayers, push-type granular spreaders, and handgun sprayers (MRID # 44972201).  The ORETF data were designed to replace the present PHED data with higher-confidence, higher quality data that contain more replicates than the PHED data for those scenarios.

For short-/intermediate-term dermal and inhalation exposure, the HIARC selected an endpoint from a rabbit prenatal developmental toxicity study (NOAEL = 5 mg/kg/day), based on developmental toxicity findings of increased resorptions at the LOAEL of 10 mg/kg/day.  Because this is an oral study, daily dermal doses were adjusted to account for 14% dermal absorption and, daily inhalation doses were converted to oral equivalent doses, assuming 100% absorption.  Resulting dermal and inhalation MOEs were combined into Total MOEs because the same endpoint was chosen to evaluate both routes of exposure.  The target MOE for short-/intermediate-term exposure is 100.  Chronic exposures are not expected for handlers or postapplication workers for the proposed use patterns associated with pyraclostrobin.

The results of the handler occupational exposure and risk assessment indicate that risks are not of concern when gloves are used to mitigate exposure.  The Total Short-/Intermediate-Term MOEs with this PPE range from 280 to 6,400; which exceed the target of 100, and are not of concern.  Exposure assumptions and MOE estimates for occupational handlers are summarized in Table 4.

It is feasible for the same individual to mix/load and apply formulations, especially for groundboom and airblast applications, however, appropriate data are not available in PHED for which unit exposure values for these combined activities can be derived.  HED does not recommend simply adding the unit exposure values for each job function because any extrapolation error (i.e., exposure from the amount ai handled in the study to that of a real-life application) would be magnified, leading to greater uncertainty.  For information and characterization purposes, even with the over-estimation uncertainty, the MOEs for these combined activities for groundboom and airblast application of pyraclostrobin would be well above the target MOE of 100 (i.e., 1,100 and 2,000, respectively).

The minimum level of PPE for handlers is based on acute toxicity for the end-use products.  The Registration Division (RD) is responsible for ensuring that PPE listed on the label is in compliance with the Worker Protection Standard (WPS).

	Table 4.  Summary of  MOEs for Occupational Handlers of Pyraclostrobin

Exposure Scenario (Scenario #)

Dermal Unit Exposure (mg/lb ai) 1

Inhalation Unit Exposure   (μg/lb ai) 2

Application

Rate

(lb ai/A) 3

Amount Treated

(A/day) 4

Total Short-/Intermediate-term MOE 5

Baseline

PPE

(gloves)

Baseline

PPE

(gloves)

Mixer/Loader

Mixing/Loading Liquids for Aerial/Chemigation application (1)

2.9

0.023

1.2

0.20

1200

3.1

280

350

11

970

Mixing/Loading Liquids for Groundboom application (2)

2.9

0.023

1.2

0.20

200

18

1,700

80

46

4,200

Dry Flowables for Aerial/Chemigation (3)

0.066

0.066

0.77

0.20

350

430

-

Dry Flowables for Groundboom application (4)

0.066

0.066

0.77

0.50

80

750

-

Dry Flowables for Airblast application (5)

0.066

0.066

0.77

0.20

40

3,700

-

Applicator

Sprays for Aerial application (6)

0.005

-

0.068

0.20

1200

1,600

-

350

5,600

-

Sprays for Groundboom application (7)

0.014

0.014

0.74

0.20

200

2,800

-

0.50

80

2,800

-

Sprays for Airblast application (8)

0.36

0.24

4.5

0.20

40

680

-

Mixer/Loader/Applicator

Mixing/Loading Dry Flowables and Applying with Handgun Sprayer (9)

no data

0.59

2.2

0.5

5

no data

1,400

Mixing/Loading Dry Flowables and Applying with Low-Pressure Handwand (10)

100

0.43

30

0.0031

(lb ai/gal)

40

(gal/day)

170

-

Mixing/Loading Dry Flowables and Applying with Backpack Sprayer (11)

no data

2.5

30

0.0031

(lb ai/gal)

40

(gal/day)

no data

6,400

Flagger

Flagging for Sprays application (12)

0.011

-

0.35

0.20

350

2,300

-

1 Baseline dermal unit exposure values represent long pants, long sleeved shirts, shoes, and socks; PPE values represent the addition of chemical-resistant gloves; for aerial spray application, the unit exposure for closed cockpit was used because reliable data for open cockpit are not available.  Values are reported in the PHED Surrogate Exposure Guide dated August 1998, except for the handgun value which was obtained from ORETF..

2 Inhalation unit exposure values represent no respirator; for aerial spray application, the unit exposure for closed cockpit was used because reliable data for open cockpit are not available.  Values are reported in the PHED Surrogate Exposure Guide dated August 1998.

3 Application rates are based on maximum values found in pyraclostrobin labels Headline® (Reg No:  7969-186), Cabrio® EG (Reg No:  7969-187), and Insignia® (Reg No:  7969-184).

4 Amount treated is the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern, based on the application method and formulation/packaging type. (standard EPA/OPP/HED values).

5 Short-/Intermediate-Term MOE = NOAEL (5 mg/kg/day) / Total Daily Absorbed Short-/Intermediate-Term Dose.  The Target MOE is 100.

Total Daily Absorbed Dose (mg/kg/day) = {[(Dermal unit exposure * 14% Dermal absorption) + (Inhalation unit exposure * 100% absorption)] * Application rate * Area treated} / 60-kg Body weight.

4.2   Post-Application Exposure and Risk

This Section 3 action for pyraclostrobin involves foliar applications.  Therefore, postapplication exposure is possible for workers entering treated fields to tend or harvest crops.  Chemical-specific dislodgeable foliar residue (DFR) data had previously been submitted by the registrant to support earlier registration requests for food crops.  The studies were conducted on peaches, peanuts, strawberries, grapes (MRID#s: 45118727, 45118724, 45118726, and 45118728, respectively), and one study comparing the effect of two different formulations of pyraclostrobin on grape DFR (MRID#: 45118729).  An overview of each study was provided in a previous assessment (D269670, K. O’Rourke, 9/30/2002); a summary of the results is provided in Table 5.  Turf transferrable residue (TTR) data (MRID#: 45118725) are also available from an earlier submission in support of a request for use on golf course turf; the results are summarized below:

Turf Transferrable Residue (TTR) Study:

BAS 500 00 F( formulated as an emulsifiable concentrate containing 23.4% pyraclostrobin was applied six times to turf, with a 14-day application interval, at three test sites (California, North Carolina, and Pennsylvania) at the maximum label application rate of 0.5 lbs ai per acre using ground application equipment.  Transferable turf residues (TTR) were collected using the modified California Roller Technique.  The application method and frequency (number and timing) were relevant to the use pattern proposed by the product label.  Triplicate samples were collected at each sampling interval.  At all three sites, the maximum average TTR values occurred immediately after the application of the test substance (0.035 µg ai/cm2 for California, 0.011 µg ai/cm2 for North Carolina, and 0.013 µg ai/cm2 for Pennsylvania).  The estimated half-life values were 1.9 days (r2=0.84), 1.4 days (r2=0.82), and 3.8 days (r2=0.73) for turf at the California, North Carolina, and Pennsylvania sites, respectively.

The DFR data were used to estimate restricted entry intervals (REIs) for the proposed crops by extrapolating, where possible, to corresponding general crop groups (i.e., peach DFR data were considered representative of other tree fruit).  In order to estimate REIs for the other crops, an average percent initial DFR value was calculated (i.e., the average of the calculated initial DFR percentages for each crop, presented in Table 5) and used to estimate surrogate residue values for those crops.  An average daily dissipation rate was also estimated based on the individual daily dissipation rates for each of the crops tested.  It was found that the type of formulation used influences the DFR profile; therefore, separate average DFR percentages were calculated for the water dispersible granular and emulsifiable concentrate formulations.  Although uncertainties are introduced into the assessment when crop-specific residues are used to estimate residues from other types of crops, it is believed to be more realistic than using default assumptions.  These results are also shown in Table 5, and the assignment of the DFR data to crops is included in Table 6.

Table 5.  Summary of DFR Study Results

Crop

Location

(state)

Formu-lation

Application Rate

(lb ai/A)

Number

of Apps.

Interval

r2

Initial DFR

(% of

Appl. Rate)

Dissipation

(% per day)

Half-life (days)

peaches

CA

WDG

0.12

5

7 days

0.84

22

2

27.8

peaches

GA

WDG

0.12

5

7 days

0.97

15

11

6

peaches

PA

WDG

0.12

5

7 days

0.94

22

9

7.7

Peaches Average

20

7

strawberries

NC

WDG

0.18

5

7 days

0.77

26

15

4.2

strawberries

CA

WDG

0.18

5

7 days

0.98

25

15

4.4

strawberries

OR

WDG

0.18

5

7 days

0.91

12

13

4.9

      Strawberry Average

21

14

peanuts

NC

EC

0.25

5

14 days

0.91

18

26

2.3

peanuts

GA

EC

0.25

5

14 days

0.77

17

61*

0.74

peanuts

TX

EC

0.25

5

14 days

0.91

18

24

2.5

  Peanuts Average

18

25*

grapes

CA

WDG

0.18

3

14 days

0.97

22

6

11.1

grapes

WA

WDG

0.18

3

14 days

0.94

25

6

11.8

grapes

PA

WDG

0.18

3

14 days

0.82

14

4

15.6

      Grapes WDG Average

20

5

grapes

CA

EC

0.18

3

14 days

0.95

14

9

7.4

grapes

WA

EC

0.18

3

14 days

0.9

22

9

7.5

grapes

PA

EC

0.18

3

14 days

0.79

12

5

13.9

grapes

CA

EC

0.15

6

10 days

0.9

6

6

12

grapes

NY

EC

0.15

6

10 days

0.92

28

6

11.2

grapes

WA

EC

0.15

6

10 days

0.9

24

4

17.3

      Grapes EC Average

18

7

EC Average

18

13

    WDG Average

20

9

WDG = water dispersible granule

EC = emulsifiable concentrate

* The results from the Georgia site reflect uncharacteristically high rainfall during the monitoring period.  This is not representative of typical conditions, therefore, the dissipation from this site was not included in the average.

Regarding the turf data, there is a slight data gap in that the study used an emulsifiable concentrate formulation, rather than the water dispersible granule formulation that is proposed in this action.  The effect of formulation type on residue values can be significant.  Based on data from the grape DFR study mentioned previously, residues associated with the water dispersible granule formulation can be as much as two times higher than those associated with the emulsifiable concentrate formulation.  Thus, using the results from the TTR study (even when the residues from California, which had the highest values, are used as a screen) may be underprotective.  Because of this uncertainty, the assessment was conducted with the SOP default assumption for the initial fraction of residue available.

In addition to these residue data, transfer coefficients (Tc) are used to relate the foliage residue values to activity patterns (e.g., harvesting) to estimate potential human exposure.  The transfer coefficients used in this assessment are from an interim transfer coefficient policy developed by HED’s Science Advisory Council for Exposure using proprietary data from the Agricultural Re-entry Task Force (ARTF) database (policy # 3.1).

Table 6 reports the transfer coefficients used to estimate potential exposure levels for all crops treated with pyraclostrobin to determine the margin of exposure (MOE).  Low transfer coefficients generally represent low contact activities such as weeding, scouting, and irrigating.  High transfer coefficients generally represent activities with more foliar contact such as thinning, hand harvesting, etc.  The estimated short-/intermediate-term MOEs are presented in Table 6.

The Short-/Intermediate-term Target MOE was met on reentry Day 0 for all crops except sweet corn (hand harvesting or detasseling), for which an REI of 7 days was calculated.  In the case where two REIs have been estimated for the same crop (e.g., corn - 7 days for hand harvesting activity, and day 0 for irrigating), the longer, more protective, estimate should be used to establish the REI for that crop (i.e., 7 days).   Please note that the minimum REI required under the Worker Protection Standard (WPS), based on the acute toxicity categories for pyraclostrobin, is 12 hours for crops for which MOEs are not 景挠湯散湲漠敲湥牴⁹慄⁹⸰఍名扡敬㘠匠浵慭祲 漠獅楴慭整䕒獉慂敳湯匠潨瑲⼭湉整浲摥慩整 吭牥位獅܇倍特捡潬瑳潲楢匍数楣楦牃灯ݳ匍畴 楤獥甠敳琍獅楴慭整䐍剆ㄠഇ䅄⁔ܲ䐍剆㌠

(μg/cm2)

TC 4

(cm2/hr)

Activity 4

MOE 5

Short-/ Int-

Term

Brassica, head and stem

WDG

average

0

0.45

2,000

Irrigation, scouting, thinning, weeding immature plants

300

0

5,000

Hand harvesting, irrigation, pruning, topping, tying mature plants

120

Brassica, leafy greens

Leafy Vegetables

WDG

average

0

0.45

500

Irrigation, scouting, thinning, weeding immature plants

1,200

0

2,500

Hand harvesting, pruning, and thinning mature plants

240

Corn

Sunflower

EC

average

0

0.40

100

Scouting, weeding  immature/low foliage plants

6,600

0

1,000

Scouting, irrigation, weeding mature/full foliage plants

660

0

17,000

Sweetcorn hand harvest or detasseling

39

7

0.13

100

Hops

WDG

average

0

0.34

100

Irrigation, scouting immature/low foliage plants

8,000

0

2,000

Training, mechanical harvest

400

Pome fruit

Peach

average

0

0.45

100

Propping

6,000

0

1,500

Harvesting

400

0

3,000

Thinning

200

Mint,

Soybean

EC

average

0

0.40

100

Irrigation, scouting, thinning, weeding  immature/low foliage

6,600

0

1,500

Hand harvesting

440

Succulent Shelled

Peas & Beans

EC

average

0

0.30

100

Irrigation, scouting, thinning, weeding  immature/low foliage

8,900

0

2,500

Hand harvesting

350

Sod

Turf &

default

0

0.28

3,400

Mowing

280

0

6,800

	Transplanting, harvesting

140

1 Studies from which Dislodgeable Foliar Residue (DFR) data were used as surrogate DFR values for the crop group - see Table 5 for values.

2 DAT = Days after treatment needed to reach the Target MOE; DAT 0 = The day of treatment, after sprays have dried; assumed to be approximately 12 hours.

3 DFR (ug/cm2) = Application rate (lb ai/A) x CF (4.54E+8 ug/lb) x CF (2.47E-8 A/cm2) x Initial Fraction of ai Retained on the Foliage (see Table 5) x [(1- Fraction of Residue That Dissipates Daily - see Table 5) Postapplication day].  See Table 3 for application rate.

4 TC (cm2/hr) = transfer coefficients and associated activities from ExpoSAC Policy Memo #003.1 “Agricultural Transfer Coefficients”, 8/17/2000.

5 MOE = MOE on the corresponding DAT.  MOE = NOAEL / Daily Dose.

Daily Dose = [(DFR x  TC x 14% Dermal absorption  x  8-hr Exposure Time)] / [(CF: 1000 ug/mg) x 60-kg Body weight

The Short-/Int-term NOAEL is 5 mg/kg/day, with a Target MOE of 100.

5.0  Non-Occupational/Residential Exposure

A product containing pyraclostrobin (i.e., Insignia®) is proposed for application to residential turfgrass and recreational sites.  It may be applied to turf at rates ranging from 0.28 to 0.5 lb ai/A, at intervals of 14 to 28 days; the maximum seasonal application rate is 3 lb ai/A.

The registrant indicated that turf applications are intended to be made by professional pest control operators (PCOs) only (although the label does not state this).  Therefore, residential handler exposure was not evaluated.  Residential postapplication exposure via the dermal route is likely for adults and children entering treated lawns.  Toddlers may also experience exposure via incidental non-dietary ingestion (i.e., hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) during postapplication activities on treated turf.  The postapplication risk assessment is based on generic assumptions as specified by the Recommended Revisions to the Residential SOPs and recommended approaches by HED’s Science Advisory Council for Exposure (ExpoSAC).

Residential short-/intermediate-term dermal exposure was assessed using the NOAEL (5 mg/kg/day) from the rabbit developmental study that was selected for occupational exposure.  While the developmental effect of increased resorptions is not applicable to toddlers, it should be noted that the maternal NOAEL from this study is also 5 mg/kg/day, and is based on reduced body weight gain, food consumption, and food efficiency at the LOAEL of 10 mg/kg/day; this more relevant endpoint was used to assess toddler dermal exposure.  For incidental ingestion, exposure was assessed using the endpoint from a 13-week feeding study in the dog.  The NOAEL from this study is 5.8 mg/kg/day, based on increased incidence of diarrhea, clinical chemistry changes, duodenum mucosal hypertrophy, and decreased body weight and food intake/efficiency at the LOAEL of 12.9 mg/kg/day.  A common effect (i.e., decreased body weight gain and food efficiency) was seen in the studies selected to evaluate toddler dermal and incidental ingestion exposure; therefore, route-specific MOEs were combined into a Total MOE for toddlers.

On December 17, 2002, the HIARC reevaluated the potential for increased susceptibility of infants and children according to the 2002 OPP FQPA 10X Guidance Document, and recommended that the special FQPA factor should be removed [1X] for all potential exposure scenarios for pyraclostrobin because there are no residual uncertainties for pre- and/or postnatal toxicity.  Therefore, the target MOE for residential exposure is 100.

5.1   Residential Handler Exposure and Risk

As mentioned previously, the registrant indicated that turf applications are intended to be made by professional pest control operators (PCOs) only (although the label does not state this).  Therefore, residential handler exposure was not evaluated.

5.2   Residential Postapplication Exposure and Risk

The following postapplication exposure scenarios resulting from lawn treatment were assessed: (1) adult and toddler postapplication dermal exposure, (2) toddlers’ incidental ingestion of pesticide residues on lawns from hand-to-mouth transfer, (3) toddlers’ object-to-mouth transfer from mouthing of pesticide-treated turfgrass, and (4) toddlers’ incidental ingestion of soil from pesticide-treated residential areas.

Turf transferrable residue (TTR) data (MRID#: 45118725) are available from an earlier submission in support of a request for use on golf course turf.  However, the study used an emulsifiable concentrate formulation, rather than the water dispersible granule formulation that is proposed in this action.  Using the results from the TTR study may be underprotective, for the reason discussed previously, as well as the fact that the study was conducted using a modified version of the California roller, which was found to have a much lower transfer efficiency than the original version.  Therefore, these TTRs are not compatible with the transfer coefficients used in this assessment (which were derived using the original method).  Because of these uncertainties, the assessment was conducted with the SOP default assumption for the initial fraction of residue available for turf, in addition to other generic assumptions presented in the Recommended Revisions to the Residential SOPs.

The exposure and risk estimates for the residential exposure scenarios are assessed for the day of application (day “0") because it is assumed that adults and toddlers could contact the lawn immediately after application.  The equations used for the exposure calculations and the results are presented in Tables 7 through 10.

The exposure estimates are based on some upper-percentile (i.e., maximum application rate, initial amount of transferrable residue and duration of exposure) and some central tendency (i.e., surface area and body weight) assumptions and are considered to be representative of high-end exposures.  The uncertainties associated with this assessment stem from the use of an assumed amount of pesticide available from turf, and assumptions regarding transfer of chemical residues and hand-to mouth activity.  The estimated exposures are believed to be reasonable high-end estimates based on observations from chemical-specific field studies and professional judgement.

The short-/intermediate-term MOEs for each scenario are above the target of 100, and are not of concern.  As mentioned previously, a common effect (i.e., decreased body weight gain and food efficiency) was observed in the studies selected for the endpoints for all routes of exposure; therefore, the MOEs were combined.  The Total short-/intermediate-term MOE resulting from the combined MOEs for children (shown in Table 11) is 140, which is also above the target of 100, and not of concern.

Table 7.  Postapplication Dermal Exposure and Risk From Treated Lawns

Subgroup Exposed

Application Rate

 (lb ai/A)

Dislodgeable

Foliar Residue

(ug/cm2)

Dermal Transfer Coefficient

(cm2/hr)

Body Wt

(kg)

 Daily Dose2

(mg/kg/day)

Dermal MOE3

Short-/ Int-term

Short-/Int-term

Adults

0.50

0.28

14,500

60 / 70

0.019

260

Children

5,200

15

0.027

180

1 Dislodgeable Foliar Residue Postapplication day zero (ug/cm2) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage (0.05) x [(1- Fraction of Residue That Dissipates Daily (0.1)] Postapplication day x  4.54E+8  µg/lb x 2.47E-8 A/cm2

2 Daily Dose = [Dislodgeable Foliar Residue x  Absorption Factor (0.14) x 0.001 mg/ug  x Dermal Transfer Coefficient x Exposure Time (2 hrs/day)]/Body weight

3 Dermal MOE = Dermal NOAEL/Daily Dose; where Short-/Intermediate-term NOAEL = 5 mg/kg/day.

Table 8.  Postapplication Oral Hand-to-Mouth Exposure and Risk for Children from Treated Lawns

Application Rate

 (lb ai/A)

Post-application day (t)

Fraction of ai Retained on the Foliage

Saliva Extraction Factor

Dislodgeable Foliar Residue

(ug/cm2)

Hand Surface Area

(cm2/event)

 Frequency

(events/ hr)

Body Weight

(kg)

 Daily Dose2

(mg/kg/day)

Oral MOE3

Short/Int-term

0.50

0

0.05

50%

0.28

20

20

15

0.0075

780

1 Dislodgeable Foliar Residue Postapplication day (ug/cm2)=App.lication rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That Dissipates Daily, 0.1) Postapplication day x  4.54E+8  µg/lb x 2.47E-8 A/cm2

2 Daily Dose = (Dislodgeable Foliar Residue (ug/cm2) x Hand Surface Area (cm2/event) x Extraction factor x Frequency (events/hr) x 0.001 mg/ ug  x  Exposure time (2 hrs/day)] / [Body Weight (kg)]

3 Oral MOE = Oral NOAEL/Daily Dose; where Short-/Intermediate-term NOAEL = 5.8 mg/kg/day.

Table 9. Postapplication Oral Object-to-Mouth (Turfgrass) Exposure and Risk for Children from Treated Lawns

Application Rate

 (lb ai/A)

Post-

application day

(t)

Fraction of ai Retained on the Foliage

Grass

Residue 1

(ug/cm2)

Ingestion Rate

(cm2/day)

Body

Weight

(kg)

 Daily Dose2

(mg/kg/day)

Oral MOE3

Short/Int-term

0.50

0

0.20

1.1

25

15

0.0019

3,100

1Grass residue Postapplication day (ug/cm2) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That Dissipates Daily) Postapplication day x  4.54E+8  µg/lb x 2.47E-8 A/cm2

2 Daily Dose  = [Grass reside (ug/cm2) x Ingestion rate (cm2/day) x 0.001 mg/ug] / [Body Weight (kg)]]

3Oral MOE = Oral NOAEL/Daily Dose; where Short-/Intermediate-term NOAEL = 5.8 mg/kg/day.

Table 10. Postapplication Incidental Soil Ingestion Exposure and Risk for Children from Treated Lawns

Application Rate

 (lb ai/A)

Post-

application day (t)

Fraction of ai Retained in the Soil

Soil

Residue 1

(ug/g)

Ingestion Rate

(mg/day)

Body

Weight

(kg)

 Daily Dose2

(mg/kg/day)

Oral MOE3

Short/Int-term

0.50

0

1

3.8

100

15

0.000025

230,000

1 Soil residue Postapplication day (ug/cm2) = Application rate (lb ai/A) x Fraction of ai Retained on the Soil x (1- Fraction of Residue That Dissipates Daily) Postapplication day x  4.54E+8  µg/lb x 2.47E-8 A/cm2 x 0.67 cm3/g soil

2 Daily Dose  = [Soil reside (ug/g) x Ingestion rate (mg/day) x 0.000001 g/ug] / [Body Weight (kg)]]

3 Oral MOE = Oral NOAEL/Daily Dose; where Short-/Intermediate-term NOAEL = 5.8 mg/kg/day.

	Table 11.  Children’s Aggregate Exposure and Risk Estimates from Residential Lawns

Children’s Scenarios

TTR/GR/SR0 (ug/cm2 or g) 1

PDR0-norm

(mg/kg/day) 2

Short-/

Int-Term

 MOE

Total

Short-/

Int-Term

 MOE 3

(1) Dermal Contact

0.28

0.027

180

140

(2) Hand-to-Mouth

0.28

0.0075

780

(3) Mouthing Grass

1.1

0.0019

3,100

(4) Soil Ingestion

3.8

0.000025

230,000

	1 TTR=turf transferable residue on day “0"; GR=grass residue on day “0"; SR0=soil residue on day “0".

2 PDR0norm=potential dose rate on day “0”.

3 Total MOE = 1/ [(1/MOEDermal) + (1/MOEHand-to-Mouth) + (1/MOEGrass) + (1/MOESoil)]

5.3   Recreational Postapplication Exposure and Risk

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Recreational exposures to turf are expected to be similar to, or in many cases less than, those evaluated in section 5.2 Residential Postapplication Exposure and Risk; therefore, a separate recreational exposure assessment was not included.

5.4   Off Target Non-Occupational Exposure

Spray drift is always a potential source of exposure to residents nearby to spraying operations.  This is particularly the case with aerial applications, but, to a lesser extent, could also be a potential source of exposure from ground application methods.   As indicated in this assessment, pyraclostrobin is directly applied to residential turf and does not result in exposures of concern.  Based on this assessment, HED believes that it is unlikely that there is a higher potential for risk of exposure to spray drift from agricultural uses of this chemical.

CC:     RAB3 RF

SignOff Date: 8/19/2004

DP Barcode: D298017

 PAGE  19


[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Notices]
[Pages 55801-55802]
[FR Doc No: 2022-19599]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD22-9-000]

New England Winter Gas-Electric Forum; Supplemental Notice of New
England Winter Gas-Electric Forum

    As first announced in the Notice of Forum issued in the above-
referenced proceeding on May 19, 2022, the Federal Energy Regulatory
Commission (Commission) will convene a Commissioner-led forum on
Thursday, September 8, 2022, from approximately 9:00 a.m. to 5:00 p.m.
Eastern Time, to discuss the electricity and natural gas challenges
facing the New England Region. The forum will be open to the public and
held in the Emerald I & II Ballroom at the DoubleTree by Hilton
Burlington Vermont, 870 Williston Rd, South Burlington, VT, 05403.
    The agenda for this forum is attached, which includes the final
forum panelists.
    The purpose of the forum is to bring together stakeholders in New
England to

discuss the challenges faced historically during New England winters
and discuss the stakeholders' differing expectations of challenges for
future winters. The objectives of the forum are to achieve greater
consensus or agreement among stakeholders in defining the electric and
natural gas system challenges in New England and identify what, if any,
steps are needed to better understand those challenges before
identifying solutions.
    While the forum is not for the purpose of discussing any specific
matters before the Commission, some forum discussions may involve
issues raised in proceedings that are currently pending before the
Commission. These proceedings include, but are not limited to, the
dockets listed below. Dockets that were added subsequent to the
Commission's August 22, 2022 supplemental notice appear in italics.

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

----------------------------------------------------------------------------------------------------------------
Constellation Mystic Power LLC.........................  Docket Nos. ER18-1639-000, ER18-1639-001, ER18-1639-
                                                          002, ER18-1639-003, ER18-1639-004, ER18-1639-005, ER18-
                                                          1639-006, ER18-1639-014, ER18-1639-015, ER18-1639-017,
                                                          ER22-1192-000.
ISO New England Inc....................................  Docket Nos. ER19-1428-000, ER19-1428-001, ER19-1428-
                                                          002, ER19-1428-003, ER19-1428-004.
RENEW Northeast and American Clean Power Association     Docket No. EL22-42-000.
 vs. ISO New England Inc.
NextEra Energy Seabrook, LLC...........................  Docket No. EL21-3-000.
NECEC Transmission LLC and Avangrid, Inc. v. NextEra     Docket No. EL21-6-000.
 Energy Resources, LLC.
----------------------------------------------------------------------------------------------------------------

    Only Commissioners and panelists will participate in the panel
discussions. The forum will be open to the public for listening and
observing, and written comments may be submitted in Docket No. AD22-9-
000.
    Registration for in-person attendance is required, and there is no
fee for attendance. A link to attendee registration is available on the
New England Winter Gas-Electric Forum event page. Due to space
constraints, seating for this event will be limited and registrants
that get a confirmed space will be contacted via email. Only confirmed
registrants can be admitted to the forum given the maximum occupancy
limit at the venue (as required by fire and building safety code).
Therefore, the Commission encourages members of the public who wish to
attend this event in person to register at their earliest convenience.
Online registration will be open, as long as attendance capacity is
available, until the day before the forum (September 7). Once
registration has reached capacity, registration will be closed.
However, those interested in attending after capacity has been reached
can join a waiting list (using the same registration link) and be
notified if space becomes available. Those who are unable to attend in
person may watch the free webcast.
    The webcast will allow persons to listen and observe the forum
remotely but not participate. Information on this forum, including a
link to the webcast, will be posted prior to the event on this forum's
event page on the Commission's website. A recording of the webcast will
be made available after the forum in the same location on the Calendar
of Events. The forum will be transcribed. Transcripts of the forum will
be available for a fee from Ace-Federal Reporters, Inc.<PHONE_NUMBER>).
    Additionally, please note that the Commission will be implementing
health and safety restrictions, as appropriate, associated with the
Centers for Disease Control and Prevention (CDC) COVID Community Level
mitigations. This may include requiring all participants to wear cloth
face covers or masks as well as further limiting venue occupancy if
Chittenden County is designated as having a high-community level in
data expected to be released on the evening of Thursday, September 1.
The CDC Community Level tracker may be found at the CDC COVID Data
Tracker site.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected], call toll-free<PHONE_NUMBER>
(voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    For more information about this forum, please contact
[email protected] for technical or logistical questions.

    Dated: September 6, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-19599 Filed 9-9-22; 8:45 am]
BILLING CODE 6717-01-P