Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual e-cigarette user to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises many significant issues and questions that are important and relevant to me, as a user of products proposed for regulation under this Proposed Rule. The Proposed Rule asks dozens of questions I wish to respond to. I want to provide my thoughts, comments and scientific research about these issues, but my time to devote to researching and providing thoughtful comments on these vital questions is limited. I have already spent many hours researching and dissecting these issues, but will need more time. I know that the FDA took many years to even come up with the Proposed Rule, so it seems reasonable to me that the public be allowed at least six months to comment on it. This is our only opportunity to provide you with consumer feedback.

I am passionate about e-cigarette use. Quite frankly, I firmly believe that they have enhanced the quality of my life. I wish to provide you with my personal story, as well as specific science- and evidence-based responses so that you can take my comments into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders, particularly consumers who use products purchased via the massive entrepreneurial business network that actually generated and grew this industry, have the opportunity to share their thoughts regarding this proposed regulation.

I appreciate your consideration of my request and would be happy to discuss this issue with you further.


[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Notices]
[Page 18253]
[DOCID:fr09ap10-142]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending March 27,
2010

    The following Agreements were filed with the Department of
Transportation under the Sections 412 and 414 of the Federal Aviation
Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.
    Docket Number: DOT-OST-2010-0077.
    Date Filed: March 26, 2010.
    Parties: Members of the International Air Transport Association.
    Subject: Mail Vote 630--Resolution 010t, Composite Resolutions 300,
301, Baggage Allowance Weight System, Baggage Allowance Piece System
(Memo 1565).
    Intended Effective Date: 1 April 2010.

Renee V. Wright,
 Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2010-8110 Filed 4-8-10; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: April 7, 2006 (Volume 71, Number 67)] [Corrections]                [Page 17960] [DOCID:fr07ap06-146]

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53522; File No. SR-ISE-2006-09]

  Self-Regulatory Organizations; International Securities Exchange,  Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule  Change and Amendment No. 1 Thereto Relating to Session/API Fees

Correction

    In notice document E6-4274, beginning on page 14975 in the issue of  March 24, 2006, make the following correction:     On page 14976, in the third column, in the last paragraph, in the  last line, ``April 17, 2006 '' should read ``April 14, 2006''.

[FR Doc. Z6-4274 Filed 4-6-06; 8:45 am]

BILLING CODE 1505-01-D


[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Proposed Rules]
[Page 39035]
[FR Doc No: 2018-16905]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2017-0699; FRL-9981-42--Region 6]

Air Plan Approval; Arkansas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is proposing to approve portions
of the revisions to the Arkansas State Implementation Plan (SIP)
submitted by the Arkansas Department of Environmental Quality (ADEQ) on
March 24, 2017. Most of the revisions are administrative in nature and
make the SIP current with Federal rules. The EPA is also proposing to
make ministerial changes to the Code of Federal Register (CFR) to
reflect SIP actions pertaining to the Arkansas Prevention of
Significant Deterioration (PSD) program.

DATES: Written comments should be received on or before September 7,
2018.

ADDRESSES: Submit your comments, identified by EPA-R06-OAR-2017-0699,
at http://www.regulations.gov or via email to [email protected]. For
additional information on how to submit comments see the detailed
instructions in the ADDRESSES section of the direct final rule located
in the rules section of this issue of the Federal Register.

FOR FURTHER INFORMATION CONTACT: Ms. Carrie Paige,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In the final rules section of this issue of
the Federal Register, the EPA is approving the State's SIP submittal as
a direct rule without prior proposal because the Agency views this as
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
action no further activity is contemplated. If the EPA receives
relevant adverse comments, the direct final rule will be withdrawn and
all public comments received will be addressed in a subsequent final
rule based on this proposed rule. The EPA will not institute a second
comment period. Any parties interested in commenting on this action
should do so at this time.
    For additional information, see the direct final rule, which is
located in the rules section of this issue of the Federal Register.

    Dated: July 31, 2018.
Anne Idsal,
Regional Administrator, Region 6.
[FR Doc. 2018-16905 Filed 8-7-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Page 32275]
[FR Doc No: 2014-12936]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-56-000]

LoneStar Wind Power Company, NorthStar Wind Power Company,
WindStar Power Company v. South Texas Electric Co-Operative; Notice of
Petition for Enforcement

    Take notice that on May 27, 2014, LoneStar Wind Power Company,
NorthStar Wind Power Company, and WindStar Power Company filed a
Petition for Enforcement, pursuant to section 210(h) of the Public
Utility Regulatory Policies Act of 1978 (PURPA), requesting the Federal
Energy Regulatory Commission (Commission) to exercise its authority and
initiate enforcement action against the South Texas Electric Co-
Operative to ensure that PURPA regulations are properly and lawfully
implemented.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on June 17, 2014.

    Dated: May 29, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-12936 Filed 6-3-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62739-62746]
[FR Doc No: 2020-21952]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1602]

Revocation of Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection of Antibodies Against SARS-CoV-2, the
Virus That Causes Coronavirus Disease 2019 (COVID-19)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocations of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Autobio Diagnostics Co. Ltd. (``Autobio'')
for the Anti-SARS-CoV-2 Rapid Test (``Autobio's Test'') and to
Manufacturers and Other Stakeholders (``Stakeholders'') for certain in
vitro diagnostic SARS-CoV-2 Antibody Tests. FDA revoked Autobio's
Authorization on August 6, 2020, and the Stakeholders' Authorization on
July 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C
Act). The revocations, which include an explanation of the reasons for
each revocation, are reprinted in this document.

DATES: Autobio's Authorization is revoked as of August 6, 2020. The
Stakeholders' Authorization is revoked as of July 21, 2020.

ADDRESSES: Submit written requests for single copies of the revocations
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocations may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. On April 24, 2020, FDA issued an EUA for Autobio's Anti-
SARS-CoV-2 Rapid Test, subject to the terms of the Authorization. On
April 28, 2020, FDA issued an EUA to Stakeholders, for certain in vitro
diagnostic SARS-CoV-2 Antibody Tests (lateral flow or enzyme-linked
immunosorbent assay tests to detect IgG only, IgG and IgM, or total
antibodies in human plasma and/or serum) for use at laboratories
certified under the Clinical Laboratory Improvement Amendments of 1988,
42 U.S.C. 263a, to perform moderate or high complexity tests. Notice of
the issuance of the Authorizations was published in the Federal
Register on July 14, 2020 (85 FR 42407), as required by section
564(h)(1) of the FD&C Act. Subsequent to the issuance of the
Authorization for Autobio's Test, FDA considered new information,
including from an independent evaluation of Autobio's Test from the
National Institute of Health's Frederick National Laboratory for Cancer
Research, part of the National Cancer Institute (the ``NCI study''),
demonstrating performance below the performance information submitted
in Autobio's original EUA request and reflected in the authorized
labeling for Autobio's Test. Subsequent to the Stakeholders'
Authorization, FDA considered that no device had been listed under the
EUA and that FDA may issue individual EUAs instead.

II. EUA Criteria for Issuance No Longer Met and Other Circumstances
Make Revocation Appropriate To Protect the Public Health or Safety

    Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary
of HHS may revoke an EUA if, among other things, the criteria for
issuance are no longer met or other circumstances make such revocation
appropriate to protect the public health or safety. On August 6, 2020,
FDA revoked the EUA for Autobio's Test because the criteria for
issuance were no longer met and other circumstances make such
revocation appropriate to protect the public health or safety. Under
section 564(c)(2) of the FD&C Act, an EUA may be issued only if FDA
concludes that, based on the totality of scientific evidence available,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that the product may be
effective in diagnosing, treating, or preventing such disease or
condition and that the known and potential benefits of the product,
when used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product.
    Given the poor device performance observed in the NCI study since
the issuance of the Authorization for Autobio's Test, FDA has concluded
it is not reasonable to believe the product may be effective in
detecting antibodies against SARS-CoV-2 or that the known and potential
benefits of the device outweigh its known and potential risks. In
addition, based on the same information and the risks to public health
from false test results, FDA has concluded under section 564(g)(2)(C)
of the FD&C Act that other circumstances make revocation appropriate to
protect the public health or safety. Accordingly, FDA has revoked
EUA200349 for Autobio's Anti-SARS-CoV-2 Rapid Test, pursuant to section
564(g)(2)(B) and (C) of the FD&C Act. On July 21, 2020, FDA revoked the
EUA for Stakeholders' certain in vitro diagnostic SARS-CoV-2 Antibody
Tests because other circumstances make such revocation appropriate to
protect the public health or safety (section 564(g)(2)(C) of the FD&C
Act), considering that no device has been listed under the EUA, and FDA
can issue individual EUAs instead.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet

at https://www.regulations.gov/, https://www.fda.gov/media/140351/download and https://www.fda.gov/media/140908/download.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g) of the FD&C Act are met, FDA has
revoked the EUAs for Autobio's Anti-SARS-CoV-2 Rapid Test and
Stakeholders' certain in vitro diagnostic SARS-CoV-2 Antibody Tests.
The revocations in their entirety follow and provide an explanation of
the reasons for each revocation, as required by section 564(h)(1) of
the FD&C Act.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN05OC20.066

[GRAPHIC] [TIFF OMITTED] TN05OC20.067

[GRAPHIC] [TIFF OMITTED] TN05OC20.068

[GRAPHIC] [TIFF OMITTED] TN05OC20.069

[GRAPHIC] [TIFF OMITTED] TN05OC20.070

[GRAPHIC] [TIFF OMITTED] TN05OC20.071

[GRAPHIC] [TIFF OMITTED] TN05OC20.072

    Dated: September 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21952 Filed 10-2-20; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 74, Number 102 (Friday, May 29, 2009)]
[Notices]
[Page 25796]
[FR Doc No: E9-12576]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending May 16,
2009

    The following Agreements were filed with the Department of
Transportation under the Sections 412 and 414 of the Federal Aviation
Act, as amended (49 U.S.C. 1383 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.
    Docket Number: DOT-OST-2009-0113.
    Date Filed: May 11, 2009.
    Parties: Members of the International Air Transport Association.
    Subject: CSC/31/Meet/005/09 dated April 8, 2009. Finally Adopted
Resolutions: Resolution 623 and Recommended Practice 1630. Intended
effective date: 1 October 2009.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. E9-12576 Filed 5-28-09; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 83, Number 206 (Wednesday, October 24, 2018)]
[Notices]
[Page 53632]
[FR Doc No: 2018-23250]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[CERCLA-04-2018-3759; FRL-9985-73-Region 4]

Armstrong World Industries Site, OU2, Macon, Macon-Bibb County,
Georgia; Notice of Settlement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of settlement.

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

SUMMARY: Under 122(h) of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), the United States
Environmental Protection Agency (EPA) has entered into a settlement
with Armstrong World Industries, Macon-Bibb County, Macon Water
Authority, Honeywell International Inc., Reynolds Metals Company, LLC
and The Unimax Corporation concerning the Armstrong World Industries
Site, OU2, located in Macon, Macon-Bibb County, Georgia. The settlement
addresses recovery of CERCLA costs for a cleanup action performed by
the EPA at the Site. EPA will only be accepting comments on the cost
recovery portion of the settlement.

DATES: The Agency will consider public comments on the settlement until
November 23, 2018. The Agency will consider all comments received and
may modify or withdraw its consent to the proposed settlement if
comments received disclose facts or considerations which indicate that
the proposed settlement is inappropriate, improper, or inadequate.

ADDRESSES: Copies of the settlement are available from the Agency by
contacting Ms. Paula V. Painter, Program Analyst, using the contact
information provided in this notice. Comments may also be submitted by
referencing the Site's name through one of the following methods:
    Internet: https://www.epa.gov/aboutepa/about-epa-region-4-southeast#r4-public-notices.
     U.S. Mail: U.S. Environmental Protection Agency, Superfund
Division, Attn: Paula V. Painter, 61 Forsyth Street SW, Atlanta,
Georgia 30303.
     Email: [email protected].

FOR FURTHER INFORMATION CONTACT: Paula V. Painter at 404/562-8887.

    Dated: October 4, 2018.
Maurice L. Horsey, IV,
Chief, Enforcement and Community Engagement Branch, Superfund Division.
[FR Doc. 2018-23250 Filed 10-23-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Notices]
[Page 35415-35416]
[DOCID:fr23jn08-71]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0038]

Electrical Reliability Services, Inc. (Formerly Electro-Test,
Inc.); Denial of Renewal of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: This notice announces the Occupational Safety and Health
Administration's final decision to deny the renewal of recognition of
Electrical Reliability Services, Inc. (formerly Electro-Test, Inc.)
(ETI) as a Nationally Recognized Testing Laboratory under 29 CFR
1910.7.

DATES: The denial of recognition is effective on June 23, 2008.

FOR FURTHER INFORMATION CONTACT: MaryAnn Garrahan, Director, Office of
Technical Programs and Coordination Activities, NRTL Program,
Occupational Safety and Health Administration, U.S. Department of
Labor, 200 Constitution Avenue, NW., Room N-3655, Washington, DC 20210,
or phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    The Occupational Safety and Health Administration (OSHA) is giving
notice of the denial of renewal of recognition of Electrical
Reliability Services, Inc. (formerly Electro-Test, Inc.) (ETI) as a
Nationally Recognized Testing Laboratory (NRTL). OSHA is taking this
action following its requirements under Subsection I.B. of Appendix A
to 29 CFR 1910.7.
    OSHA recognition of an NRTL signifies that the organization has met
the legal requirements in Section 1910.7 of Title 29, Code of Federal
Regulations (29 CFR 1910.7), OSHA's NRTL Program regulations.
Recognition is an acknowledgment that the organization can perform
independent safety testing and certification of the specific products
covered within its scope of recognition and is not a delegation or
grant of government authority. As a result of recognition, employers
may use products in the workplace that are properly approved by the
NRTL to meet OSHA standards that require testing and certification.
    Subsection I.B describes the procedures that OSHA must use in
deciding an NRTL's application for renewal of recognition. In order to
approve such an application, the NRTL must meet all of the requirements
for recognition in 29 CFR 1910.7. Subsection I.B sets out the steps
OSHA must follow in reviewing each renewal application and provides the
NRTL opportunities to correct or respond to any perceived failures to
meet the requirements.
    OSHA followed the process set forth in Subsection I.B and is
denying renewal of ETI as an NRTL. OSHA found that ETI's ownership by
Emerson Electric Company resulted in ETI's failure to satisfy the
requirement of 29 CFR 1910.7 that NRTLs be independent of the
manufacturers and vendors of the products for which OSHA requires
certification. This failure constitutes a cause for non-renewal under
OSHA's NRTL Program regulations.
    OSHA has notified ETI of its final decision to deny its application
for renewal. The effective date of non-renewal is shown in the DATES
section above. As of this date, the Agency no longer accepts product
certifications done by ETI.
    Docket No. OSHA-2007-0038 contains all public materials in the
record concerning the recognition of ETI. You may obtain or review
copies of these documents by contacting the Docket Office, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue, NW., Room N-2625, Washington, DC 20210.

    Signed at Washington, DC, this 13th day of June, 2008.
Edwin G. Foulke, Jr.
Assistant Secretary of Labor for Occupational Safety and Health.
 [FR Doc. E8-14072 Filed 6-20-08; 8:45 am]

BILLING CODE 4510-26-P


Antidegradation discussion with Environmental Law and Policy Center (ELPC)

Thursday, July 15, 2010, 4:30-5:30 pm

EPA Headquarters

Attendees:

EPA OW - Janita Aguirre, Heather Goss

EPA OGC - Peter Ford

Outside groups - Albert Ettinger (Environmental Law and Policy Center), Matt Roda (Gulf Restoration Network-LA), and Kris Sigford (MN Enviro Advocacy-MN).

Topics covered:

Issue of coverage of "high quality waters"

Issue of triggers for Tier 2 review (related to permit limits)

Update on Minnesota from Kris Sigford

Update on Louisiana from Mat Roda


[Federal Register Volume 88, Number 190 (Tuesday, October 3, 2023)]
[Proposed Rules]
[Pages 68031-68033]
[FR Doc No: 2023-21753]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2023-0530]
RIN 1625-AA09

Drawbridge Operation Regulation; Long Creek, Nassau County, NY

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to temporarily modify the operating
schedule that governs the Loop Parkway Bridge across Long Creek, mile
0.7, Nassau County, NY. The bridge owner, New York State Department of
Transportation (NYSDOT), submitted a request to operate the bridge
under single leaf openings to perform bridge deck replacement. We
invite your comments on this proposed rulemaking.

DATES: Comments and related material must reach the Coast Guard on or
before November 2, 2023.

ADDRESSES:  You may submit comments identified by docket number USCG-
2023-0530 using Federal Decision Making Portal at https://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Ms. Stephanie E. Lopez, First Coast Guard District,
Project Officer, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of proposed rulemaking (advance, supplemental)
Sec.  Section
U.S.C. United States Code
NYSDOT New York State Department of Transportation

II. Background, Purpose, and Legal Basis

    The Loop Parkway Bridge across Long Creek, mile 0.7, Nassau County,
NY, has a vertical clearance of 21 feet at mean high water and a
horizontal clearance of 75.5 feet at mean high water. Waterway

users include recreational and commercial vessels, including fishing
vessels.
    The existing drawbridge operating regulations are listed at 33 CFR
117.799(f). NYSDOT is requesting a temporary rulemaking to operate
under single leaf openings while they perform bridge deck replacements.
NYSDOT has reached out to local mariners and notified them of the
proposed temporary rulemaking as well as outlined an alternate route
for larger vessels that may not be able to make passage under the
bridge with single leaf openings.

III. Discussion of Proposed Rule

    The Loop Parkway Bridge will continue to operate under its regular
operating schedule found in 33 CFR 117.799(f). However, this proposed
rule will allow the bridge to operate under single leaf openings from
September 15, 2023, through May 15, 2024. For vessels that are too
large for single leaf openings, NYSDOT has set an alternate route.
Vessels that can pass without requesting a bridge opening may do so.
NYSDOT has reached phase 2 of the project which requires replacing the
bridge deck. The reason for this request is to allow the project to
progress while minimizing impact on mariners.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on these statutes and Executive orders.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This proposed rule has not been designated a
``significant regulatory action,'' under section 3(f) of Executive
Order 12866, as amended by Executive Order 14094 (Modernizing
Regulatory Review). This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the ability of
vessels to still transit the bridge under singe leaf openings or may
transit through an alternate route.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section IV.A.
above, this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rulemaking would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule promulgates the
operating regulations or procedures for drawbridges. Normally such
actions are categorically excluded from further review, under paragraph
L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental
Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this proposed rule. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material

received during the comment period. Your comment can help shape the
outcome of this rulemaking. If you submit a comment, please include the
docket number for this rulemaking, indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0530 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION
CONTACT section of this document for alternate instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. Also, if you click on the ``Dockets'' tab and then
the proposed rule, you should see a ``Subscribe'' option for email
alerts. Selecting this option will enable notifications when comments
are posted, or if/when a final rule is published.
    We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
in response to this document, see DHS's eRulemaking System of Records
notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No.
00170.1, Revision No. 01.3.

0
2. Section 117.799 is amended as follows:
0
a. Stay paragraph (f).
0
b. Add paragraph (j).
    The addition reads as follows:

Sec.  117.799  Long Island, New York Inland Waterway from East Rockaway
Inlet to Shinnecock Canal.

* * * * *
    (j) The draw of the Loop Parkway Bridge across Long Creek, mile
0.7, shall operate on single leaf openings until May 15, 2024. The draw
will open for commercial vessels engaged in commerce and shall open
Monday thru Friday from 6:20 a.m. to 9:50 a.m. and 3:20 p.m. to 7:20
p.m. on signal at 20 and 50 minutes after the hour, and on signal at
all other times. For all other vessels, the draw shall open on Monday
through Friday from 6:20 a.m. to 7:20 p.m. on signal at 20 and 50
minutes after the hour, and the draw shall open on Saturday, Sunday,
and Federal holidays from 7:20 a.m. to 8:20 p.m. on signal at 20 and 50
minutes after the hour, and on signal at all other times.

    Dated: August 21, 2023.
J.W. Mauger,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2023-21753 Filed 9-28-23; 4:15 pm]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Page 69719]
[FR Doc No: 2011-28987]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-39-001]

Gregory R. Swecker and Beverly F. Swecker v. Midland Power
Cooperative and State of Iowa; Notice of Filing

    Take notice that on October 27, 2011, Gregory R. Swecker and
Beverly F. Swecker (Complainants) filed a notice of disconnection of
back-up power to Complainant's QF and residence by Midland Power
Cooperative (Respondent) and request for an expedited order for
reconnection. In addition, on October 31, 2011 Complainants filed a
second request for expedited order for reconnection.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 8, 2011.

    Dated: November 1, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-28987 Filed 11-8-11; 8:45 am]
BILLING CODE 6717-01-P


     1    21 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: May 9, 2005 Subj: Study Review: GUTHION ® 50 WP  Biological Monitoring of Post Application Workers During Manual Harvesting of Walnuts MRID#: 463164 05 DP Barcode: D307561 PC Code( s) : 058001 From: Steven Weiss, Industrial Hygienist Health Effects Division/ Reregistration Branch 3 ( 7509C)

Through: Seyed Tadayon, Chemist Health Effects Division/ Reregistration Branch 3 ( 7509C)

To: Catherine Eiden, Chief Health Effects Division/ Reregistration Branch 3 ( 7509C)

Attached is a review of the study entitled, GUTHION ® 50 WP  Biological Monitoring of Post Application Workers During Manual Harvesting of Walnuts. A primary review of the study was performed by Versar, Inc. under the supervision of HED. It has undergone secondary review in HED and has been revised to reflect Agency policies.      2    21 STUDY TYPE: Biological and breathing zone air monitoring during postapplication activities.

TEST MATERIAL: Azinphos methyl SYNONYMS: GUTHION ® ; S( 3,4 dihydro 4 oxobenzo[ d][ 1,2,3] trizin 3 ylmethyl) O, O dimethyl phosphorodithioate; O, O dimethyl S[( 4 oxo 1,2,3 benzotriazin 3( 4H) yl) methyl] phosphorodithioate CITATION: Study Author: D. R. Fischer Title: GUTHION ® 50 WP  Biological Monitoring of Post Application Workers During Manual Harvesting of Walnuts Report Date: July 8, 2004 Analytical Laboratories: Bayer CropScience Environmental Research Bayer Research Park 17745 South Metcalf Avenue Stilwell, KS 66085 9104 Identifying Codes: MRID: 463164 05 Report No.: 201044 Study Number: GU264703 PSI Number: RCGUX004 SPONSOR: Bayer CropScience Product Safety Management 2 T. W. Alexander Drive Research Triangle Park, NC 27709 COMPLIANCE: Signed and dated GLP, Data Confidentiality statements, and Quality Assurance statements were provided in the Study Report. The Study Report states that it meets FIFRA Good Laboratory Practices 40 CFR part 160 with the following exceptions: weather data, maintenance chemical applications, pesticide history data, irrigation records, and cultural practices were not collected under GLP. Other exceptions included: ( 1) not all data entries were made promptly, ( 2) sample receipt dates and weight values were recorded into a LIMS system which was not validated, ( 3) and the bathroom scale used to weigh the workers was not maintained/ calibrated in accordance with GLP. The GLP statement also noted that the storage containers of test material were not retained for the duration of the study as required due to the nature of the GUTHION ® 50 WP Solupack packaging system. The statement noted that none of these exceptions negatively impacted the integrity of the study.      3    21 GUIDELINE OR PROTOCOL FOLLOWED: The Bayer CropScience Protocol was provided in the Study Report and included a list of deviations from the protocol. The Study Report states that the data requirements were U. S. EPA OPPTS Harmonized Test Guidelines, Series 875 Occupational and Residential Exposure.

I. MATERIALS AND METHODS A. MATERIALS Formulation: GUTHION ® 50 WP  water soluble packets ( GUTHION ® Solupak) EPA Reg. No. 264 733 Lot/ Batch # formulation: 3144145 Purity: The purity of the batch was verified at 51.69% azinphos methyl with an expiration date of May 20, 2005.

CAS #( s): CAS 86 50 0 Packaging: The product was supplied in bags containing the water soluble packets.

B. STUDY DESIGN There were 6 amendments to the protocol and 8 deviations from the protocol. The amendments included:

( 1) A statement was added to the protocol indicating that the workers participating in the study will have had experience harvesting walnuts. ( 2) An explanation was added to the protocol for the use of MSMB as a urinary biomarker for azinphos methyl. ( 3) A statement was added to the protocol indicating that the type of clothing worn by the workers will be documented. ( 4) Additional information was added to the protocol regarding the packing and storing conditions for the blood samples. ( 5) The additive ` NIS' which will be used during application was further defined (` NIS' stands for non ionic surfactant). ( 6) The  3,  1, and 4 day time point blood samples will be shipped via two overnight express carriers to increase the probability of safe receipt of the samples at the laboratory for cholinesterase testing within the required time from sample collection.

These deviations included: ( 1) At times during collection, the urine samples were maintained cold using a freezer rather than      4    21 a refrigerator. Also, only limited temperature data were available for the urine samples during collection. Each refrigerator and freezer was equipped with a Hobo temperature recorder, but some of the Hobo units did not operate properly due to a problem during launch of the units. In addition, the urine sample storage temperatures may have occasionally been below freezing. Field fortification samples, stored with the field samples, were used to monitor the stability of the analytes of interest during storage, collection, and shipping. Also, while subsampling the bulk urine samples, the bulk containers were maintained in coolers with frozen gel packs ( rather than refrigerators) to keep the samples cool, and temperature data were not recorded for the samples during this period of time. ( 2) The data and time for transfer of the control and fortified urine samples from the freezer to the refrigerators used for storing the workers' urine samples during collection was recorded on paper, but not in FieldNotes. ( 3) Following collection, the OVS tube samples from the workers were not placed directly into a freezer, but were maintained on dry ice until storage in a freezer. The samples were maintained in a frozen condition at all times, since dry ice was always present with the samples. ( 4) Additional information was given for the analysis of the duplicate blood samples described in a protocol amendment. Upon successful receipt and analysis of one set of the duplicate blood samples, the second set was discarded. ( 5) The protocol indicated that sweeping/ vacuuming would be one of the tasks for which biomonitoring would be conducted. Biomonitoring was conducted for the sweeping activity, but not conducted for the vacuuming activity. Vacuuming usually takes much less time than the shaking, raking, and sweeping activities and so was not included as part of the study. ( 6) Other than during agricultural harvest, the activities of the workers were not recorded during the sample collection period as required int the protocol. However, the workers were sequestered during the sample collection period, and the activities of the workers were monitored to insure that they followed the study procedures and did not receive any exposure to other pesticides. ( 7) Each worker individually chose and wore clothing typical of that they normally wore when working. This clothing may not have necessarily been ` single layer' as stated in the protocol or ` long sleeves' or ` sleeves not rolled up' as stated in the AHETF Worker Clothing Acceptability Criteria document. All aspects of this study were conducted in accordance with the Guthion Solupak ( GUTHION 50WP) label ( application rates, application intervals, re entry intervals, etc were followed) and the Worker Protection Standard 40 CFR part 170. The objective was to conduct the study as close as possible to normal agricultural and worker practice to give the most realistic measurement of the exposure that workers may receive while harvesting walnuts in an area treated with GUTHION 50 WP. ( 8) To increase the probability of having 15 worker participants available for the day of harvest control urine and blood samples were collected from two additional workers up until beginning harvest. Since 15 workers were available at the time of harvest, the extra workers were not needed and were released from the study just prior to the start of harvest.

These deviations from the protocol were reported to not have any adverse effects on the study.

1. Test Site: The test site was a single walnut tree grove plot located near Poplar, California in Tulare County ( EPA Region 10). For the trial, 23.6 acres of walnut trees were dedicated to the reentry monitoring events. The maintenance chemicals applied during the growing season included Roundup, Basic Copper, Kocide 20/ 20, Lorsban 4E, and Omite 30WS. Except for Lorsban 4E, none of these maintenance chemicals are organophosphate or carbamate pesticides. Lorsban 4E, an organophosphate pesticide, was applied on 7/ 8/ 03 and on 8/ 20/ 03 ( 41 days prior to reentry      5    21 activities). Typical cultural and irrigation practices were employed at the site.

The variety of walnuts used was Serr. The distance between rows and trees within a row was reported to be 25 feet. The approximate density was 69 trees/ A.

2. Meteorology: Meteorological conditions were recorded during the application. This information is provided in Table 1. The Study Report also noted that rainfall between the first application and the reentry activity was 0.17 inches. There was no irrigation applied between the application and reentry activity.

Table 1. Meteorological Conditions During Application on 9/ 30/ 04 Air Temp 74 F Wind Speed ( mph) 0 to 1.6 Wind Direction NW Percent Cloud Cover 0 Rainfall Within 24 Hours of Application ( inches) None 3. Number and type of workers: Fifteen male workers were monitored for this study. The Study Report stated that all participants were experienced agricultural workers who had recently been harvesting walnuts. The Study Report also stated that the workers were not exposed to azinphos methyl or any other organophosphate or carbamate chemicals for at least 10 days prior to harvest. The workers ranged in age from 18 years to 35 years. The weight of the workers ranged from 56.7 kg to 108 kg. The workers' years of experience ranged from 0.5 years to > 10 years.

Two spare workers were added to the study on the day before reentry to increase the probability of 15 workers being available on the day of reentry. These workers were ultimately not used, as 15 workers were available on the day of reentry.

4. Replicates: Harvesting activities took place 30 days after the airblast application of 2.01 lb ai/ A of azinphosmethyl to the test site. The workers harvested walnuts from the designated trees in the treated plot for 8 hours ( including breaks). The workers entered the grove at the same time ( 7: 30 AM), took a 30 minute lunch break and two 15 minute breaks, and ended the work day at the same time ( 3: 30 PM). Table 6 of the Study Report provides observations of the workers recorded during the study.

Workers 1 and 2 ( called ` shakers') operated the two shaker machines used during the reentry activity. The shaker machine was a 3 wheeled unit that had a set of large pinchers attached to a hydraulic arm. After the shaker machine was driven in position near a tree, the pinchers were affixed to the trunk or a major limb of the tree and used to rapidly shake the tree for      6    21 approximately 10 seconds, causing the walnuts ( and also small tree limbs) to fall from the tree. The shaker machine was driven from tree to tree, while alternating back and forth between two tree rows. While operating the shaker machines, the workers were enclosed within a cab.

Workers 3 and 4 ( called ` sweepers') operated the two sweeper machines used during the reentry activity. The sweeper machine was a 3 wheeled unit with a large brush roller in front that was angled slightly to the right side of the unit. As the sweeper machine was driven between the tree rows, the fallen walnuts ( and also small tree limbs) were swept from one half of the row into the center of the row by the rotating brush. During the return pass on that same row, the walnuts on the other half of the row were also swept into the center, leaving a single windrow in the center of the row. The sweeper machine was also equipped with a blower on the left side of the unit that was used to blow the walnuts on the berms of the tree rows into the neighbouring row as the unit proceeded down the row. The workers were not enclosed within a cab while operating the sweeper machines.

Workers 5 to 15 ( called ` rakers') used rakes and also their hands to move small tree limbs from the rows prior to sweeper machine driving down the row. Tree limbs were also removed from the windrow and placed on the berms of the tree rows. Using rakes, these workers moved walnuts near the trunks of the trees that were not blown by the sweeper machine, so that these walnuts could subsequently be swept into a windrow by the sweeper machine.

5. Protective clothing: The Study Report states that the workers wore clothing typical of what they would normally wear when performing agricultural work. The workers clothing was listed in Table 6 of the Study Report, and typically included long sleeve shirts and long work pants. One worker wore a short sleeve shirt and two workers wore a short sleeve shirt underneath a long sleeve shirt. Each worker wore a hat, plastic hair cover, or bandana on the head, except for one worker who did not wear any head protection. Type N95 dust masks were made available to each worker just prior to beginning harvest and each worker was allowed to make their own decision regarding the use of a mask. All workers wore a dust mask; however, the mask was not necessarily worn for the entire exposure period.

6. Application Method and Rate:

Application rate( s): A single foliar application was made at 2.01 lb ai/ A on September 30, 2003.

Application Equipment: Application was made with a tractor drawn Air O Fan airblast sprayer, Model GB 36. Five nozzles were located on one side of the sprayer. The sprayer had a 500 gallon tank.

Spray Volume: The actual spray volume was reported as 202 gal/ A. According to the product label, the test substance should be applied in a maximum spray volume of 400 gal/ A.

Equipment Calibration: The authors reported that the sprayers were calibrated prior to the application.

7. Exposure monitoring methodology:      7    21 Urine Samples Total urine output was collected from each worker during each 24 hour period starting 1 day prior to reentry through 4 days after reentry. Day  1 samples were those collected starting after the first void of the bladder in the morning on the day prior to reentry and ending after the first void on the day of reentry. Day 0 samples were those collected during the 24 hour period starting when the workers began the reentry activities. Samples were collected in individually labeled 4 L Urisafe ® bulk containers. Samples were kept in refrigerators during the 24 hour collection time, except for the Day 0 samples which were kept cool using a freezer powered by a portable generator. After collection of each 24 hour bulk sample, the total volume of each sample was recorded. The samples were mixed by shaking, and duplicate 25 mL aliquots were transferred to 90 mL urine specimen containers. The bulk samples and aliquots were kept frozen and the aliquots were shipped frozen to Bayer Research Park. The bulk samples were kept frozen until notification by Bayer, at which time they were discarded.

Blood Samples Blood samples were collected from each worker at the following time intervals: ( 1) 3 days prior to reentry, ( 2) 1 day prior to reentry; and ( 3) on the day of reentry after a full work day, and ( 4) 4 days following reentry. The control samples collected 3 days and 1 day prior to the reentry activity for each worker were used to establish baseline cholinesterase activity. The samples were collected into individually labelled collection tubes containing EDTA K3 as an additive. Prior to sample collection, the skin was thoroughly cleaned to eliminate possible contamination of pesticide residue that may have been on the skin. Blood samples were packaged in compliance with International Air Transport Association Packaging Instructions 650 and were maintained cool during transport in a styrofoam cooler containing frozen gel packs. Samples were shipped to Bayer Research Park on the day of collection.

Breathing Zone Air Samples Breathing zone air samples were taken using OVS tubes, containing XAD 2 sorbent, and a personal air sampling pump attached to the worker's belt. The OVS tubes consisted of a glass fiber filter, secured with a Teflon ® holding ring, covering a 270 mg layer of XAD 2 sorbent in the top, primary bed and a 140 mg layer of XAD 2 sorbent in the bottom, backup bed. The OVS tube was connected to the pump using Tygon ® tubing and clipped onto the worker's outer clothing, with the inlet positioned in the breathing zone of the worker. The air samples were collected by operating the pumps over the entire workday ( including breaks). Just prior to monitoring the reentry activity, the air sampling pumps were calibrated at a rate of approximately 2 L/ min. The pump flow rates were collected before and after the monitoring period and the pumps were checked throughout the monitoring period to ensure continual operation. At the end of the work day, the OVS tube was disconnected and caps were fitted onto the ends. A label was placed on the tube, which was placed into a pre labeled plastic bag. The samples were stored and then shipped frozen to Bayer Research Park.

C. ANALYTICAL METHODOLOGY:

1. Sample Extraction/ Detection:

Urine Samples Extraction method: 0.100 mL of [ 2H3] MSMB internal standard solution ( 0.300 µ g/ mL) was added to a 10 mL      8    21 aliquot of urine. The sample was added to a 10 mL Chem Elut cartridge and the cartridge was eluted with three 20 mL portions of methylene chloride into a 60 mL vial. A TurboVap was used to evaporate the methylene chloride at 35C for 45 minutes. The residue was dissolved in 0.10 mL of methanol, a 0.9 mL aliquot of 0.1% formic acid was added and the sample was mixed. An aliquot of the sample was then analyzed using high pressure liquid chromatography triple stage quadrupole mass spectrometry.

The method for urine creatinine analysis was reported to be based on the Jaffe/ Alkaline Picrate/ Kinetic method.

Detection methods: See Table 2.

Table 2. Summary of HPLC and MS Conditions for Urine HPLC Conditions GC Column: Zorbax SB Aq, 5 µ m, 50 mm x 2.1 mm Solvents: 0.1% aqueous formic acid ( solvent A) and methanol ( solvent B) Solvent Program: Time ( min) Solvent A(%) Solvent B(%) Flow ( mL/ min) Initial 68 32 0.200 2.5 68 32 0.200 2.85 15 85 0.200 2.90 68 32 0.300 5.00 68 32 0.300 5.05 68 32 0.200 Injection Volume: Autosampler with a 20 µ L loop MS Conditions Collision cell pressure: 1.5 mTorr Spray Voltage: 1900 kV Capillary temperature: 390C Sheath: 90 psi Auxilary gas: 20 Ionization mode: Positive ion Divert valve: On from 0.60 minutes to 2.60 minutes ( HPLC effluent enters the LC/ MS)

Instrument performance and calibration: Calibration curves were prepared for each calibration run. The relative response of the detector in the lc/ ms ms chromatographic system to MSMB in solvent was linear over the range of 0.05 ng/ mL to 10 ng/ mL. The correlation of coefficients were all > 99%. The limit of quantitation ( LOQ) for urine samples was reported to be 0.10 ng/ mL of MSMB. The limit of detection ( LOD) for the urine samples was reported to be 0.08 ng/ mL.

Quantification: The MSMB residue level in urine was determined by comparing the LC/ MS measurement of MSMB to the measurement of the MSMB internal standard.

Blood Samples      9    21 Extraction/ Detection method: Blood samples were analyzed for plasma and red blood cell cholinesterase activity. The method was reported to be a modification of the method described by Ellman ( Ellman, M. L., K. D. Cortney, V. Andres, and R. M. Featherston. 1961. A New and Rapid Colorimetric Determination of Acetylcholinesterase Activity. Biochemical Pharmocology 7: 88 95).

Breathing Zone Air Samples Extraction method: The top and bottom sections of the OVS tubes were analyzed separately. The top portion of the OVS tube ( including the Teflon ® ring, filter, upper layer of XAD 2 resin, and the upper foam ring) was disassembled and placed into a labeled 40 mL vial. The bottom portion of the OVS tube ( lower layer of XAD 2 resin and lower foam plug) was disassembled and placed into a separate, labeled 40 mL vial. Each sample received 10 mL of acetonitrile and 0.100 mL of an internal standard solution, which contained a mixture of [ 2H6] azinphos methyl ( 10.0 µ g/ mL) and [ 2H6] azinphos methyl oxon ( 2.0 µ g/ mL). Each sample was then sonicated for 2 minutes and a 0.25 mL aliquot was removed and diluted with 0.75 mL of water. The diluted samples were analyzed by high pressure liquid chromatography triple stage quadrupole mass spectrometry.

Detection methods: See Table 3 Table 3. Summary of HPLC and MS Conditions for Breathing Zone Air Samples HPLC Conditions GC Column Xterra MS C18, 3.5 µ m, 50 mm x 4.6 mm Solvents 0.1% aqueous formic acid ( solvent A) and methanol ( solvent B) Solvent Program Isocratic at 38% Solvent A and 62% Solvent B Flow Rate 1.00 mL/ min Injection Volume Autosampler with a 20 µ L loop MS Conditions Instrument Setup LC MS/ MS with electrospray interface and 1: 4 split Collision cell pressure 1.5 m Torr Spray voltage 5.900 kV Capillary temperature 235C Sheath gas 100 psi Auxiliary gas 30 Ionization mode Positive ion Divert valve On from 0.5 min to 2.50 min ( HPLC effluent enters LC/ MS)

Instrument performance and calibration: Calibration curves were prepared for each calibration run. The relative response of the detector in the lc/ ms ms chromatographic system to MSMB in solvent was linear over the range of 30 ng to 30,000 ng. The correlation of coefficients were all > 99%. The limit of quantitation for both azinphos methyl and azinphos methyl oxon was reported to be 100 ng. The limit of detection for azinphos methyl and azinphos methyl oxon were reported as 5 ng and 9 ng, respectively.      10    21 Quantification: The azinphos methyl or azinphos methyl oxon residue level in the air samples was determined by comparing the LC/ MS measurement of azinphos methyl or azinphos methyl oxon to the measurement of the azinphos methyl or azinphos methyl oxon internal standard.

2. Quality Control:

Lab Recovery: Concurrent laboratory recoveries were performed for both urine samples and for the inhalation exposure analysis. Urine samples were fortified at the 0.50 ng/ mL level and OVS tubes were fortified at the 0.50 ng level. The results provided in the Study Report were verified and these are presented in Tables 4 and 5. The recoveries were corrected for residues found in blank samples.

Table 4. Urine Sample Concurrent Laboratory Recoveries a Sample No. Fortification Level ( ng/ mL) Measured residue ( ng/ mL) Average Blank Sample Residue ( ng/ mL) Corrected residue b ( ng/ mL) Recovery (%) Average Recovery (%)

0.5 0.495 0.466 93 GUO18 03D 1H 0.5 0.477 0.029 0.448 90 91 0.5 0.476 0.4625 93 GUO18 03D+ 0H 0.5 0.506 0.0135 0.4925 99 96 0.5 0.45 0.4315 86 GUO18 03D+ 1H 0.5 0.504 0.0185 0.4855 97 92 0.5 0.527 0.5185 104 GUO18 03D+ 2H 0.5 0.46 0.0085 0.4515 90 9 0.5 0.438 0.4305 86 GUO18 03D+ 3H 0.5 0.507 0.0075 0.4995 100 93 0.5 0.527 0.516 103 GUO18 03D+ 4H 0.5 0.567 0.011 0.556 111 107 a Recoveries calculated using raw data provided in Appendix 3 of the Study Report. b Corrected residue is the measured residue minus the average blank residue.

Table 5. OVS Tubes Concurrent Laboratory Recoveries a Analyte Fortificatio n Level ( ng) Measured Bottom Residue ( ng) Bottom Blank Residues ( ng) Corrected Bottom Residue b ( ng) Measured Top Residue ( ng) Top Blank Residues ( ng) Corrected Top Residue ( ng) Total Residue ( top + bottom) ( ng) Percent recovery (%)

AZM c 500 12.1 17.5  5.4e 417.8 17.5 400.3 402.8 81 AZMoxon d 500 4.5f 4.5f 0e 510.2 4.5f 505.7 510.2 102 a Recoveries calculated using raw data provided in Appendix 3 of the Study Report.      11    21 b Corrected residue is the measured residue minus the average blank residue. c AZM = azinphos methyl d AZM oxon = azinphos methyl oxon e Since the corrected bottom residue was less than the LOD, ½ the LOD was used in subsequent calculations. f Residues < LOD are shown as 1/ 2 LOD.      12    21 Field recovery:

Urine Samples Field fortification samples were prepared at 0.50 ng/ mL and 10.0 ng/ mL for urine samples. The fortification samples were prepared from two 200 mL aliquots of control urine. One aliquot received 0.1 mL of a 1.00 µ g/ mL fortification solution, while the other received two mL of the fortification solution. The solutions were then mixed well and three 50 mL aliquots were removed and placed in separate containers. A summary of the results were verified and are provided in Table 6. The recoveries were corrected for residues found in blank samples. The average low level fortification recovery was 106% and the average high level fortification recovery was 96%.

Table 6. Urine Sample Field Fortification Recoveries a Fortification Level ( ng/ mL) Measured residue ( ng/ mL) Blank Samples ( ng/ mL) Corrected residue b ( ng/ mL) Recovery (%) Average Percent recovery (%)

0.471 0 0.471 94 0.537 0 0.537 107 Low fortification level 0.5 0.579 0 0.579 116 106 9.356 0 9.356 94 9.367 0 9.367 94 High fortification level 10 10.138 0 10.138 101 96 a Recoveries calculated using raw data provided in Appendix 3 of the Study Report. b Corrected residue is the measured residue minus the average blank residue. Breathing Zone Air Samples Field fortification samples were prepared at 500 ng and 10,000 ng for OVS tubes. 0.050 mL of a fortification solution containing 10 µ g/ mL azinphos methyl and 10 µ g/ mL azinphos methyl oxon were added to blank laboratory control OVS tubes for the low field fortification samples. 0.050 mL of a fortification solution containing 200 µ g/ mL azinphos methyl and 200 µ g/ mL azinphosmethyl oxon were added to blank laboratory control OVS tubes for the high field fortification samples. Air was then drawn through the tubes for 10 minutes at a rate of 3 mL/ min to evaporate the solvent. The tubes were then capped and labeled. The results provided in the Study Report were verified and are presented in Table 7. The recoveries were corrected for residues found in blank samples. For azinphos methyl, the average low level fortification recovery was 96% and the average high level fortification recovery was 99%. For azinphos methyl oxon, the average low level fortification recovery was 113% and the average high level fortification recovery was 101%.      13    21 Table 7. OVS Tubes Field Fortification Recoveries a Analyte Fortificatio n Level ( ng/ mL) Measure d Bottom Residue ( ng) Bottom Blank Residue s ( ng) Correcte d Bottom Residue ( ng) Measured Top Residue ( ng) Top Blank Residue s ( ng) Correcte d Top Residue b ( ng) Total Residue ( top + bottom) ( ng) Recovery (%) Overall Average Recovery (%)

2.5 f  7.5 e 515 21.4 494 497 99 5  2.5 e 516 21.4 494.8 497 99 500 2.5 f  7.5 e 470 21.4 448.9 451 90 96 16.7 9.2 10,516 21.4 10494.3 10,504 105 2.5 f  7.5 e 8,995 21.4 8973.8 8,976 90 AZM c 10,000 2.5 f 7.5  7.5 e 10,104 21.4 10082.9 10,085 101 99 4.5 f 0 e 562 4.5 f 557.7 562 112 4.5 f 0 e 562 4.5 f 557.6 562 112 500 4.5 f 0 e 576 4.5 f 571.6 576 115 113 4.5 f 0 e 10,282 4.5 f 10277.2 10,282 103 4.5 f 0 e 10,170 4.5 f 10165.2 10,170 102 AZMoxon d 10000 4.5 f 4.5 f 0 e 9,845 4.5 f 9840.8 9,845 98 101 a Recoveries calculated using raw data provided in Appendix 3 of the Study Report. b Corrected residue is the measured residue minus the average blank residue. c AZM = azinphos methyl d AZM oxon = azinphos methyl oxon e Since the corrected bottom residue was less than the LOD, ½ the LOD was used in subsequent calculations. f Residues < LOD are shown as 1/ 2 LOD.

Tank mix: No information on tank mix analysis was provided in the Study Report.

Travel Recovery: Travel recovery was not assessed in the Study Report.

Storage Stability: All samples were stored frozen prior to analysis. Urine samples were held for a maximum of 3 months ( 89 days) prior to extraction and all extracts were analyzed within 3 days after extraction. OVS tube samples were held for a maximum of 2.8 months ( 83 days) prior to extraction and all extracts were analyzed within 1 day after extraction. The Study Report states that the acceptable recoveries from the field fortification samples indicate that the field samples would be stable over the period of collection, storage, and shipping through sample analysis. A separate storage stability study was not performed.

II. RESULTS AND CALCULATIONS:

A. EXPOSURE CALCULATIONS:

Internal Dose The AZM dose estimates calculated from urinary MSMB residues in this study represent the internal exposure. The worker replicates wore dust/ mist respirators during all/ most of the exposure period. Therefore, dose estimates may underestimate exposure via the inhalation route.      14    21 Using the raw data provided in the Study Report, azinphos methyl internal dose estimates in mg/ kg body weight were calculated for each worker and each worker type by sampling interval and as a cumulative total over the 4 sampling days ( 120 hrs). The results corrected for background ( day  1) residue. The background residues were < LOD in eleven of the workers and ranged from 0.0945 to 0.358 ng/ mL in four workers ( Nos. 4, 5, 8, and 15). The measured residues were corrected to 100% recovery based on recoveries of the associated field fortification samples. Residues < LOD were set to 1/ 2 LOD for all calculations. The measured residues were adjusted for the volume of urine collected and the internal dose was calculated by adjusting the MSMB excreted during each sampling interval for the cumulative percent of the absorbed dose excreted 120 hours after exposure ( as determined from a previous study   86.3%) and the percent of the urine activity attributed to MSMB ( determined from a previous study  9.2%).

The internal azinphos methyl dose was determined from the residues measured in 24 hour urine samples collected from each worker for the time period of 120 hours after reentry ( 5 days, including the day of reentry) . MSMB residue levels are presented in this report as µ g equivalents of parent azinphos methyl. Equivalents were calculated using a molecular weight conversion factor of 1.328. The total MSMB excreted for each worker over the 120 hour sampling period following exposure to arrive at an estimated dose. Table 8 provides the azinphos methyl dose ( over 120 hrs) for shakers, sweepers, and rakers based on mg per kg body weight. The total average azinphos methyl doses for shakers, sweepers, and rakers ( with background correction) are 0.00019, 0.00034, and 0.00089 mg/ kg body weight, respectively. Table 9 provides individual daily residue values and total azinphos methyl doses for each worker.

Breathing Zone Air Samples Air samples were collected in the breathing zone of workers using OVS sampling tubes. Residues of both azinphos methyl and azinphos methyl oxon were measured on the top and bottom portions of the sampling tubes and combined for a total azinphos methyl residue.

All field samples were adjusted for field fortification recoveries. Residues that were reported as < LOD were included in calculations as ½ LOD. The inhalation exposure concentration for shakers averaged 2.2 µ g/ m3, 2.8 µ g/ m3 for sweepers, and 8.6 µ g/ m3 for all rakers.

Cholinesterase Activity Cholinesterase activity ( both plasma and red blood cells) was monitored through blood sampling prior to reentry ( on days  3 and  1), on day 0 ( immediately following reentry) and day 4. The depression of cholinesterase activity was then determined by comparing the background activity to the activity measured on days 0 and 4. These results are provided in Table 12. The percent decrease in plasma cholinesterase on day 0 ranged from  1.7% to 18.4% for shakers, 1.80% to 3.25% for sweepers, and 0.91% to 10.47% for rakers. The percent decrease in plasma cholinesterase on day 4 ranged from  11.73% to 3.46% for shakers, 1.53% to 2.17% for sweepers, and  9.98% to 7.41% for rakers. The percent decrease in red blood cell cholinesterase on day 0 ranged from 2.91% to 4.20% for shakers,  2.08% to 4.18% for sweepers, and  5.05% to 8.69% for rakers. The percent decrease in red blood cell cholinesterase on day 4 ranged from  0.352% to  1.56% for shakers,  0.39% to 2.84% for sweepers, and  2.33% to 5.89% for rakers.

The average percent change in plasma cholinesterase ( ChE) immediately following the day of      15    21 entry was negative five percent with a range of ± 5 percent. One worker ( out of 15) experienced an 18 percent drop in plasma ChE levels. The data indicate that by day 4 following exposure, the average plasma ChE levels returned to baseline levels with average plasma ChE change at positive one percent with a range of ± five percent. The average percent change in red blood cell ( RBC) cholinesterase levels immediately following the day entry was negative two percent with a range of ± 4 percent. That remained about constant on day 4.

III DISCUSSION:

A. LIMITATIONS OF THE STUDY:

Major issues of concern in evaluation of the study include:

  The baseline cholinesterase levels for workers was established by taking a sample 3 days prior and another sample one day prior to the day where the workers were exposed to AZM residues while performing postapplication tasks. Most guidelines recommend that baseline blood samples be taken at a time when the worker has not been exposed to organophosphates or n methyl carbamates for at least 30 days. Workers in the study stated that they had not been exposed to organophosphates or n methyl carbamates for at least 10 days prior to the study, but that could not be independently verified. Guidelines generally also recommend that establishing a stable baseline requires a minimum of two pre exposure tests taken at least 3 days, but not more than 14 days, apart. Considering these factors, the baseline ChE levels in the study may not reflect actual baseline levels in unexposed workers. The baseline ChE levels measured in the study fall within the normal range of ChE levels in the blood.

  Since the blood cholinesterase data reflect a single day of exposure, it would be expected that successive days of exposure would result in additional depression of ChE that could be cumulative. The data do not permit estimating the slope of recovery for ChE plasma and RBC levels back to normal levels, therefore it is difficult to predict the cumulative effect of successive days of exposure.

This study met most of the Group B 875.2500 ( inhalation exposure) and 875.2600 ( biological monitoring) Guidelines. The major issues of concern are:

  The guideline states that samples should be stored in a manner that will minimize deterioration and loss of analytes between collection and analysis; biological monitoring samples ( e. g., serum, plasma and urine) should be refrigerated or stored frozen prior to analysis ; whole blood should not be frozen; and information on storage stability should be provided. The Study Report states that samples were stored frozen prior to analysis and that field fortification samples and recoveries were used to demonstrate storage stability. A separate storage stability study was not mentioned.

  The guideline states that data should be corrected if any appropriate field fortified, laboratory fortified or storage stability recovery is less than 90 percent. The Study Report states that corrections were made even if field fortification recoveries were above 90%. Field samples were corrected for all field fortification recoveries.      16    21   The guideline states that for urine monitoring, there should also be a sufficient time period between exposures to the test substance or structurally related compounds and participation in the study to ensure adequate urinary clearance of the compound and its metabolites, based on pharmacokinetic data. The Study Report stated that workers were not exposed to azinphos methyl or any other organophosphate and carbamate chemicals for at least 10 days prior to harvest. However, it should be noted that MSMB residues were detected at or above the LOQ in the background urine samples of four workers.

  The guideline states that a trapping efficiency test for the monitoring media chosen must be documented. A trapping efficiency test was not reported. However, method validation data exhibited recoveries of 103 107% for azinphos methyl and 94 101% for azinphosmethyl oxon.

  The guideline states that air samples should also be tested for breakthrough to ensure that collected material is not lost from the medium during sampling and it is recommended that at least one test be carried out where the initial trap contains 10X the highest amount of residue expected in the field. A breakthrough test was not mentioned in the Study Report.

  The guideline states that the extraction efficiency of laboratory fortified controls is considered acceptable if the lower limit of the 95% confidence interval is greater than 75%, unless otherwise specified by the Agency. At a minimum, the guideline states that seven determinations should be made at each fortification level to calculate the mean and standard deviation for recovery and that the total recovery from field fortified samples must be greater than 50% for the study. One laboratory fortified sample yielded recoveries of 81% for azinphos methyl and 102% for azinphos methyl oxon. There were 3 fortification samples at each of 2 levels, with all recoveries greater than 96%.

  The guideline states that if trapping media or extracts from field samples are to be stored after exposure, a stability test of the compound of interest must be documented and the media must be stored under the same conditions as field samples. Storage stability samples should be extracted and analyzed immediately before and at appropriate periods during storage and the time periods for storage should be chosen so that the longest corresponds to the longest projected storage period for field samples. There was no information in storage stability included in the study report; however, field fortification samples were collected, stored and analyzed with the field samples.      17    21 Table 8. Total Azinphos methyl Dose Estimates by Task Shakers Sweepers Rakers Arithmetic Mean Geometric Mean Standard Deviation Arithmetic Mean Geometric Mean Standard Deviation Arithmeti c Mean Geometric Mean Standard Deviation mg/ kg/ day 0.00019 0.00017 0.0001 0.00034 0.00034 0.000038 0.00089 0.00073 0.0006 NOTE: Worker replicates wore dust/ mist respirators during all/ most of the exposure period.      18    21 Table 9 Azinphos methyl Internal Doses in Workers Worker Number Sampling Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

Shakers 0 day 0.1 0.69 83.6 9.2 8.98 77.11 0.00012 1 day 0.219 2 day 0.15 3 day 0.161 1 4 day 0.062g 0 day 0.257 2.09 83.6 9.2 27.1 105.23 0.00026 1 day 1.313 2 day 0.276 3 day 0.142 2 4 day 0.098g Sweepers 0 day 0.17 2.2 83.6 9.2 28.6 90.72 0.00032 1 day 1.461 2 day 0.287 3 day 0.129 3 4 day 0.153 0 day 0.326 2.51 83.6 9.2 32.7 88.45 0.00037 1 day 1.191 2 day 0.41 3 day 0.476 4 4 day 0.109 Rakers 0 day 0.64 2.83 83.6 9.2 36.8 88.45 0.00042 1 day 1.144 2 day 0.938 3 day 0.106 5 4 day  0.146h 0 day 0.543 2.37 83.6 9.2 30.8 56.7 0.00054 1 day 1.012 2 day 0.462 3 day 0.233 6 4 day 0.122 0 day 1.199 7.22 83.6 9.2 93.9 71.67 0.00131 1 day 4.465 2 day 1.158 3 day 0.225 7 4 day 0.173 0 day 1.337 9.12 83.6 9.2 118.6 95.26 0.00124 1 day 4.793 2 day 1.126 3 day 1.457 8 4 day 0.407 0 day 0.49 10.26 83.6 9.2 133.4 58.06 0.0023 1 day 5.253 9 2 day 2.937      19    21 Table 9 Azinphos methyl Internal Doses in Workers Worker Number Sampling Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

3 day 1.225 4 day 0.355 0 day 0.771 8.57 83.6 9.2 111.5 99.79 0.00112 1 day 3.813 2 day 1.595 3 day 1.614 10 4 day 0.782 0 day 0.537 3.29 83.6 9.2 42.8 96.16 0.00045 1 day 1.699 2 day 0.513 3 day 0.38 11 4 day 0.165 0 day 0.768 4.27 83.6 9.2 55.6 88.45 0.00063 1 day 2.014 2 day 0.966 3 day 0.31 12 4 day 0.216 0 day 1.506 9.01 83.6 9.2 117.1 107.96 0.00109 1 day 4.548 2 day 1.264 3 day 1.207 13 4 day 0.486 0 day 0.346 2.23 83.6 9.2 29 78.93 0.00037 1 day 0.721 2 day 0.58 3 day 0.332 14 4 day 0.252 0 day 0.399 1.59 83.6 9.2 20.6 64.86 0.00032 1 day 0.625 2 day 0.355 3 day 0.147 15 4 day 0.060g NOTE: Worker replicates wore dust/ mist respirators during all/ most of the exposure period. a Total MSMB excreted ( ug) =[( measured MSMB ( AZM equivalents) ng/ mL / field fortification recovery correction factor)   background residue ( 1 day residue) ng/ mL x 24 hour urine volume ( mL)] 1 ug/ 1000 ng. This amount was calculated for each day ( 0 4) and then summed to give a 120 hour total residue estimate. Field fortification recovery values used for correction: 105.8% when residue < 2.2 ng 96.2 % when residue > 2.2 ng b Total AZM Dose ( µ g) = Total MSMB excreted ( µ g) * % of absorbed dose excreted in urine after 120 hours/ 100 * % of total AZM dose represented by MSMB/ 100 c Total AZM Dose ( mg/ kg BW) = (( Total AZM Dose ( µ g))/ 1000) / Body Weight ( kg)      20    21 Table 11. Azinphos methyl Inhalation Exposures Worker Type Worker No. Total Residuea ( ng) Air Conc ( µ g/ m3)

1 2942 3.07 2 1324 1.38 Average 2133 2.22 Geo Mean 2025 2.06 Shaker St. Dev. 1145 1.19 3 1606 1.7 4 3786 3.94 Average 2696 2.81 Geo Mean 2540 2.57 Sweeper St. Dev. 1542 1.61 5 5060 5.27 6 3746 3.9 7 14534 15.14 8 16142 16.81 9 10022 10.44 10 9989 10.41 11 8831 9.2 12 5809 6.05 13 7109 7.41 14 4757 4.95 15 4852 5.05 Average 8259 8.6 Geo Mean 7419 8.08 Raker St. Dev. 4120 4.29 a Total Residue is the sum of the azinphos methyl and azinphos methyl oxon residues corrected for field fortification recovery values of:. For AZM samples: 94% when residue < 2,250 ng and for AZM samples: 86% when residue > 2,250 ng For AZM oxon samples: 97% when residue < 2,250 ng and for AZM oxon samples: 88% when residue > 2,250 ng a Total AZM Residue is the sum of the azinphos methyl and azinphos methyl oxon residues in both top and bottom tube sections. 1/ 2 LOD was used in calculations for residues < LOD. Data were corrected for AZM and AZM oxon field fortification recovery values of 96% and 113% , respectively were used when residues were < 2,250 ng. When residue values were > 2,250 ng recovery values of 99% and 101% were used for AZM and AZM oxon, respectively.

b Air Concentration ( µ g/ m3) = Total Residue ( µ g) [( Flow Rate ( 2 L/ min) * Sampling Time ( 480 min)) / 1000 L/ m3]      21    21 Table 12. Percent Depression of Cholinesterase Activity Average Cholinesterase Activity Determined on Days  1 and  3 Cholinesterase Activity and % Depression on Sampling Day 0 Cholinesterase Activity and % Depression on Sampling Day 4 Worker Type Worker Number Plasma Red Blood Cells Plasma % Depressio n Red Blood Cells % Depression Plasma % Depressio n Red Blood Cells % Depression 1 3.8 11.78 3.86  2 11.28 4 4.24  12 12.19  4 2 3.33 11.87 2.71 18 11.52 3 3.21 3 12.05  2 Shaker Average 3.56 11.82 3.29 8 11.4 4 3.73  4 12.12  3 3 3.69 13.39 3.57 3 12.83 4 3.61 2 13.01 3 4 3.61 8.88 3.54 2 9.06  2 3.55 2 8.91 0 Sweeper Average 3.65 11.13 3.56 3 10.95 1 3.58 2 10.96 1 5 3.73 10.98 3.6 3 11.15  2 3.48 7 10.89 1 6 2.81 12.99 2.61 7 12.87 1 2.93  4 12.28 5 7 2.76 14.68 2.73 1 14.13 4 3.03  10 13.81 6 8 4.69 12.94 4.47 5 13.52  5 4.8  2 12.94 0 9 3.24 12.87 3.17 2 13.52  5 3.19 2 13.17  2 10 4.39 15.19 4.08 7 14.61 4 4.06 7 14.59 4 11 3.62 14.56 3.57 1 13.29 9 3.74  3 13.91 4 12 2.71 10.32 2.59 4 9.7 6 2.75  1 10.31 0 13 3.9 12.93 3.59 8 12.76 1 3.91 0 12.65 2 14 3.82 13.81 3.42 10 14.04  2 3.77 1 13.74 1 15 3.85 14.72 3.71 4 14.07 4 3.95  3 14 5 Raker Average 3.59 13.27 3.41 5 12.56 2 3.6  1 12.94 2


[Federal Register: April 10, 2007 (Volume 72, Number 68)]
[Notices]
[Page 17961-17962]
[DOCID:fr10ap07-119]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55570; File No. SR-CBOE-2007-15]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change To Amend CBOE's
Membership Application Procedures To Incorporate Individuals Who Are
Acting in an Exchange Trading Floor Capacity

April 2, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 14, 2007, The Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange''), filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by CBOE. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend its membership application
procedures to incorporate those individuals who are acting in an
Exchange trading floor capacity. Set forth below are the proposed
changes to the rule text with additions in italic.
Chicago Board Options Exchange, Incorporated
Rules
* * * * *
Rule 3.9. Application Procedures and Approval or Disapproval

    (a)-(f) No Change.
    (g) Any person applying pursuant to paragraph (a) of this Rule to
have an authorized trading function is required to have completed the
Exchange's Member Orientation Program and to have passed an Exchange
Trading Member Qualification Exam. Additionally, any person who has
completed the Member Orientation Program and taken and passed the
applicable Trading Member Qualification Exam and who then does not
possess an authorized trading function or Exchange trading floor
capacity for more than 1 year is required to complete the Member
Orientation Program and to re-pass the applicable Trading Member
Qualification Exam in order to once again become eligible to have an
authorized trading function. A person must score 75% or better on the
applicable Trading Member Qualification Exam in order to pass the Exam.
Any person who fails the applicable Trading Member Qualification Exam
must wait 30 days to re-take the Exam after failing the Exam for the
first time, must wait 60 days to re-take the Exam after failing the
Exam for the second time, and must wait 120 days to re-take the Exam
after failing the Exam for a third or subsequent time. The Exchange may
not waive any of the requirements set forth in this paragraph (g).
    (h)-(l) No Change.
    * * * Interpretations and Policies:
    .01 No Change.
    .02 No Change.
    .03 For purposes of this rule, ``Exchange trading floor capacity''
means any person who is acting on behalf of the Exchange in an Exchange
trading floor capacity, such as a PAR Official, Order Book Official, or
other similar function.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, CBOE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. CBOE has prepared summaries, set forth in Sections A, B,
and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Exchange Rule 3.9, entitled ``Application Procedures and Approval
or Disapproval,'' outlines, among other things, the application
procedures for an individual who desires to become a member of the
Exchange. Paragraph (g) of Exchange Rule 3.9 currently requires any
person applying to the Exchange to (i) have completed the Exchange's
Member Orientation Program (``Orientation Program'') and (ii) passed an
Exchange Trading Member Qualification Exam (``Qualification Exam'').
However, a person who has completed the Orientation Program and taken
and passed the Qualification Exam but does not possess an authorized
trading function for more than one year must again complete the
Orientation Program and re-pass the Qualification Exam.
    This filing proposes to amend CBOE's rules to provide that PAR
Officials and Order Book Officials, as described in CBOE's rules and
discussed below, as well as others acting in a similar capacity (i.e.,
an Exchange trading floor capacity), shall be included in the rule, in
addition to those who possess an authorized trading function, since
both functions are similar.
    On November 18, 2005, the Commission approved a filing which

created a new category of market participant called ``PAR Officials.''
\3\ The PAR Official was established in response to the elimination of
CBOE's rules as applied to Designated Primary Market-Makers (``DPMs'')
executing orders as agents or Floor Brokers in their allocated option
classes. The PAR Official is responsible for operating the PAR
workstation trading stations, including handling and executing orders
that are routed to the PAR workstation.
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    \3\ See Securities Exchange Act Release No. 52798 (November 18,
2005), 70 FR 71344 (November 28, 2005) (SR-CBOE-2005-46).
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    Specifically, the PAR Official is an Exchange employee or
independent contractor designated by the Exchange to be responsible for
(i) operating the PAR workstation; (ii) when applicable, maintaining
the customer limit order book for the assigned option classes; \4\ and
(iii) effecting proper executions of orders placed with him.
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    \4\ This provision will not apply to option classes that are on
the CBOE's Hybrid System.
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    In addition to PAR Officials, the Exchange also employs ``Order
Book Officials'' (``OBOs'') whose responsibilities include, among other
things, (i) maintaining the book with respect to the classes of options
assigned to him, (ii) effecting proper executions of orders placed with
him, (iii) displaying bids and offers, and (iv) monitoring the market
for the classes of options assigned to him.
    The Exchange may employ former members, who previously acted in the
capacity of a DPM before the initiation of the PAR Official, to act on
behalf of the Exchange in a trading floor capacity. If these PAR
Officials and OBOs become members of the Exchange after working for the
Exchange in a trading floor capacity for longer than one year, these
individuals would have to again complete the Orientation Program and
re-pass the Qualification Exam under current CBOE Rule 3.9, since they
would have not possessed an authorized trading function for longer than
one year.
    These PAR Officials and OBOs, while acting in an Exchange trading
floor capacity, are ultimately acting in the same capacity as when they
were operating in a DPM capacity prior to the initiation of the PAR
Official trading floor capacity. Therefore, the Exchange feels that it
is appropriate to amend its procedures to allow for the one year period
under CBOE Rule 3.9(g) to be applied to not only an individual who has
possessed an authorized trading function, but also to an individual who
has acted in an Exchange trading floor capacity, since both functions
are similar.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\5\ in general and furthers the objectives
of Section 6(b)(5) of the Act,\6\ in particular, in that it should
promote just and equitable principles of trade, serve to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and protect investors and the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding, or (ii) as to
which CBOE consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-15 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2007-15. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2007-15 and should be submitted on or before May 1,
2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-6671 Filed 4-9-07; 8:45 am]

BILLING CODE 8010-01-P