[Federal Register: January 25, 2010 (Volume 75, Number 15)]
[Notices]
[Page 3960-3961]
[DOCID:fr25ja10-104]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Peninsula Corridor Joint Powers Board-Caltrain

[Waiver Petition Docket Number FRA-2009-0124]

    The Peninsula Corridor Joint Powers Board (JPB) seeks a waiver of
compliance from certain provisions of Title 49 CFR Part 238 Passenger
Equipment Safety Standards. Specifically, JPB is considering purchasing
non-FRA compliant high-efficiency electric multiple unit (EMU)
vehicles, constructed to European safety standards for its Caltrain
commuter rail service between San Francisco, CA, and Gilroy, CA. JPB
seeks relief from the requirements of Sec.  238.204 Static End
Strength; Sec.  238.205 Anti-Climbing Mechanism; Sec.  238.207 Link
Between Coupling Mechanism; Sec.  238.211 Collision Posts; and Sec.
238.213 Corner Posts.
    JPB, which owns and operates the Caltrain commuter rail service
between San Francisco, CA, and Gilroy, CA [MilePost (MP) 51.9], is
currently considering a program that increases system capacity by
removing constraints within the system. This program, referred to as
``Caltrain 2025,'' will allow Caltrain to expand service and reduce
costs while providing a measurably safer transportation network. Along
with electrification of mainline tracks and implementation of an
enhanced positive train control system, a key component of this program
involves the operation of some non-FRA compliant high-efficiency EMU
vehicles constructed to European safety standards that feature Crash
Energy

Management capabilities. Also, Caltrain will temporally separate
freight operations from passenger operations between San Francisco, CA,
and Santa Clara (MP 44.6), by limiting freight movements to the
exclusive freight period hours of midnight-5 a.m. Only from MP 44.6-MP
51.9 will freight service commingle with Caltrain commuter equipment
during revenue service.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0124) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http:// www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR 19477) or at
http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on January 19, 2010.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. 2010-1226 Filed 1-22-10; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Pages 58808-58809]
[FR Doc No: 2011-24369]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9470-1]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; Request for public comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA''), 42 U.S.C. 7413(g), notice is hereby given of a
proposed partial consent decree, to address a lawsuit filed by Sierra
Club in the United States District Court for the District of Columbia:
Sierra Club v. EPA, No. 1: 10-cv-1541 (CKK). Plaintiff filed a
complaint alleging that EPA failed to perform mandatory duties under
sections 110(c)(1) and (k)(2) of the CAA, 42 U.S.C. 7410(c)(1), (k)(2),
to: (1) Promulgate a federal implementation plan (``FIP'') for the
State of Texas that meets the requirements of CAA section
110(a)(2)(D)(i) for the 1997 fine particulate matter (``PM2.5'') and
the 1997 8-hour ozone national ambient air quality standards
(``NAAQS''); (2) promulgate a FIP for the State of Texas that meets the
requirements of CAA Section 110(a)(2) for the 1997 8-hour ozone NAAQS;
and (3) take final approval/disapproval action pursuant to CAA section
110(k)(3) on the state implementation plan (``SIP'') that Texas
submitted for implementation of the 1997 PM2.5 NAAQS. The partial
proposed consent decree establishes deadlines for EPA to take these
actions.

DATES: Written comments on the proposed consent decree must be received
by October 24, 2011.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2011-0785, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>mailed to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Geoffrey L. Wilcox, Air and Radiation
Law Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    The partial proposed consent decree would resolve a lawsuit seeking
to compel the Administrator to take various actions under sections
110(c)(1) and 110(k) of the CAA with respect to the State of Texas.
These required actions are: (1) To take an action or actions in
accordance with section 110(c)(1) to promulgate a federal
implementation plan (``FIP''), or an unconditional approval of a SIP,
that meets certain specified requirements of CAA section 110(a)(2) for
the 1997 8-hour ozone NAAQS; (2) to take an action or actions in
accordance with section 110(c) to promulgate a FIP, or an unconditional
approval of a SIP, that meets the requirements of section
110(a)(2)(D)(i)(II) concerning interference with prevention of
deterioration of air quality for the 1997 PM2.5 NAAQS; (3)
to take an action or actions in accordance with section 110(k)
approving or disapproving a SIP submission regarding certain specified
requirements of section 110(a)(2) for the 1997 PM2.5 NAAQS;
and (4) to take an action or actions in accordance with section 110(c)
to promulgate a FIP, or an unconditional approval of a SIP, that meets
the requirements of section 110(a)(2)(D)(i)(II) concerning interference
with measures required in other states related to protection of

visibility for 1997 8-hour ozone NAAQS and 1997 PM2.5 NAAQS.
Sierra Club and EPA have jointly moved to stay Plaintiff's claim with
respect to EPA's obligation to promulgate a FIP for the State of Texas
that satisfies the requirements of CAA section 110(a)(2)(D)(i)(I) for
the 1997 8-hour ozone NAAQS and the 1997 PM2.5 NAAQS.
    The proposed consent decree provides various dates by which EPA
must take action on the claims that are not stayed. No later than 10
business days following signature of a final rule or determination as
described in the proposed consent decree, EPA is required to send the
notice to the Office of the Federal Register for review and publication
in the Federal Register. The proposed consent decree also states that
after EPA fulfills its obligations, this case shall be dismissed with
prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines, based on any comment submitted, that consent to
this consent decree should be withdrawn, the terms of the decree will
be affirmed.

 II. Additional Information About Commenting On the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC- 2011-0785) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use the http://www.regulations.gov
to submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, key in the appropriate docket identification number then select
``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or CD
ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: September 16, 2011.
Kevin W. McLean,
Acting Associate General Counsel.
[FR Doc. 2011-24369 Filed 9-21-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 16, 2006 (Volume 71, Number 32)]
[Notices]
[Page 8290]
[DOCID:fr16fe06-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-208-000]

Columbia Gas Transmission Corporation; Notice of Tariff Filing
and Service Agreements

February 9, 2006.
    Take notice that on February 2, 2006, Columbia Gas Transmission
Corporation (Columbia) tendered for filing as part of its FERC Gas
Tariff, Second Revised Volume No. 1, Thirteenth Revised Sheet No. 500B,
and the following Service Agreements for consideration and approval:
    FTS Service Agreement No. 85892 between Columbia Gas Transmission
Corporation and Amerada Hess Corporation dated January 23, 2006.
    FTS Service Agreement No. 85893 between Columbia Gas Transmission
Corporation and Amerada Hess Corporation dated January 23, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 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 in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-2248 Filed 2-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: January 8, 2007 (Volume 72, Number 4)]
[Notices]
[Page 766-767]
[DOCID:fr08ja07-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-52-000; Downeast Pipeline, LLC, Docket Nos. CP07-53-
000, CP07-54-000, CP07-55-000]

Downeast LNG, Inc.; Notice of Applications for Certificates of
Public Convenience and Necessity and Section 3 Authorization

December 29, 2006.
    Take notice that on December 22, 2006, Downeast LNG, Inc. (Downeast
LNG), 748 U.S. Route 1, Robbinston, Maine 04671, filed an application
in Docket No. CP07-52-000 pursuant to section 3(a) of the Natural Gas
Act (NGA), and Parts 153 and 380 of the regulations of the Federal
Energy Regulatory Commission (Commission), 18 CFR Parts 153 and 380,
for authorization to site, construct and operate a liquefied natural
gas (LNG) receiving terminal and associated facilities to be located in
Washington County, Maine as a place of entry for the importation of
LNG.
    Also take notice that on December 22, 2006, Downeast Pipeline, LLC
(Downeast Pipeline), 748 U.S. Route 1, Robbinston, Maine 04671, filed
pursuant to Section 7(c) of the NGA and the Commission's regulations;
(1) an application in Docket No. CP07-53-000 for a certificate of
public convenience and necessity; (i) authorizing Downeast Pipeline to
construct, own and operate the Downeast Pipeline under Part 157,
Subpart A of the Commission's regulations, (ii) approving the pro forma
Tariff submitted as Exhibit P of the application, and (iii) approving
the proposed initial rates for pipeline transportation services; (2) an
application in Docket No. CP07-54-000, for a blanket certificate
authorizing Downeast Pipeline to engage in certain self-implementing
routine activities under Part 157, Subpart F, of the Commission's
regulations; and (3) an application in Docket No. CP07-55-000, for a
blanket certificate authorizing Downeast Pipeline to transport natural
gas, on an open access and self-implementing basis, under Part 284,
Subpart G of the Commission's regulations.
    Any questions regarding these applications should be directed to
Dean Girdis, Downeast LNG, Inc., 748 U.S. Route 1, Robbinston, ME 04671
or Lisa M. Tonery, King & Spalding LLP, 1185 Avenue of the Americas,
New York, NY 10036.
    These filings are available for review at the Commission's
Washington, DC offices or may be viewed on the Commission's Web site at
http://www.ferc.gov/ using the ``e-Library'' link. Enter the docket

number, excluding the last three digits, in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or Telephone:<PHONE_NUMBER>; Toll-free: 1-
866-208-3676; or for TTY, contact<PHONE_NUMBER>.
    On January 25, 2006, the Commission Staff granted Downeast LNG's
request to utilize the Pre-Filing process and assigned Docket No. PF06-
13-000 to Staff activities involving the Downeast LNG import terminal
project and Downeast Pipeline's proposed pipeline. Now, as of the
filing of this application on December 22, 2006, the Pre-Filing Process
for this project has ended. From this time forward, these proceedings
will be conducted in Dockets No. CP07-52-000, CP07-52-000, CP07-54-000,
and CP07-55-000 as noted in the caption of this Notice.
    Downeast LNG is seeking authorization pursuant to Section 3(a) of
the NGA to site, construct and operate: (1) An LNG receiving facility
(including docking facilities and associated piping appurtenances); and
(2) an LNG storage and vaporization facility (including two LNG storage
tanks, each with a storage capacity of 160,000 cubic meters,
vaporization units with an average capacity of 500,000 Mcf/d and peak
capacity 625,000 Mcf/d, and associated piping and control equipment).
    Downeast Pipeline proposes to construct about 31 miles of single
30-inch diameter pipeline. The proposed Pipeline will originate at the
Import Terminal site boundary and terminate in the vicinity of the
Maritimes and Northeast Pipeline at the existing Baileyville Compressor
Station in Baileyville, Maine. The proposed Pipeline facilities will
include pig launcher and receiver traps, mainline valves and
interconnection and metering facilities, and will be designed for
maximum allowable operating pressure of 1,580 psig and capacity of up
to 625,000 Mcf/d, as more fully described in the filing.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9
and to ensure compliance with the Energy Policy Act of 2005, the
Commission Staff will issue a Notice of Schedule for Environmental
Review within 90 days of the date of this Notice. The Notice of
Schedule for Environmental Review will indicate, among other
milestones, the anticipated date for the Commission Staff's issuance of
the final environmental impact statement (FEIS)

for the Downeast LNG's and Downeast Pipeline's proposals. The Notice of
Schedule for Environmental Review will also alert other agencies of the
requirement to complete necessary reviews and authorizations within 90
days of the date of issuance of the Commission Staff's FEIS.
    There are two ways to become involved in the Commission's review of
this Project. First, any person wishing to obtain legal status by
becoming a party to the proceeding for this project should file with
the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, a motion to intervene in accordance with the
requirements of the Commission's Rules of Practice and Procedure (18
CFR Sec. Sec.  385.214 or 385.211) and the Regulations under the NGA
(18 CFR 157.10) by the comment date, below. A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    However, a person does not have to intervene to have comments
considered. The second way to participate is by filing with the
Secretary of the Commission, as soon as possible, an original and two
copies of comments in support of or in opposition to this project and/
or associated pipeline. The Commission will consider these comments in
determining the appropriate action to be taken, but the filing of a
comment alone will not serve to make the filer a party to the
proceeding. The Commission's rules require that persons filing comments
in opposition to the project provide copies of their protests only to
the party or parties directly involved in the protest.
    Protests and interventions may be filed electronically via the
Internet in lieu of paper; see 18 CFR 285.2001(a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-filing'' link.
The Commission strongly encourages electronic filings.
    The Commission may issue a preliminary determination on non-
environmental issues prior to the completion of its review of the
environmental aspects of the project and associated pipeline. This
preliminary determination typically considers such issues as the need
for the project and its economic effect on existing customers of the
applicant, on other pipelines in the area, and on landowners and
communities. For example, the Commission considers the extent to which
the applicant may need to exercise eminent domain to obtain rights-of-
way for the proposed pipeline and balances that against the non-
environmental benefits to be provided by the project.
    If the Commission decides to set the application for a formal
hearing before an Administrative Law Judge, the Commission will issue
another notice describing that process. At the end of the Commission's
review process, a final Commission order approving or denying a
certificate will be issued.
    Comment Date: January 22, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E6-22691 Filed 1-5-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Page 58597]
[FR Doc No: 2013-23225]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: National Air
Tour Safety Standards

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. A final rule published on February 13, 2007 (72 FR 6883)
set safety and oversight rules for a broad variety of sightseeing and
commercial air tour flights. This final rule improved the overall
safety of commercial air tours by requiring all air tour operators to
abide by the safety provisions found in 14 CFR part 136.

DATES: Written comments should be submitted by November 25, 2013.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0717
    Title: National Air Tour Safety Standards
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: This final rule set safety and oversight rules for a
broad variety of sightseeing and commercial air tour flights. The FAA
uses the information it collects and reviews to ensure compliance and
adherence to regulations and, if necessary, take enforcement action on
violators of the regulations.
    Respondents: 3,480 pilots and air tour operators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 10 minutes.
    Estimated Total Annual Burden: 30,321 hours.
    Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on September 18, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-23225 Filed 9-23-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Rules and Regulations]
[Pages 7706-7708]
[FR Doc No: 2016-02959]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2015-0670; FRL-9942-31-Region 8]

Approval and Promulgation of Air Quality Implementation Plans;
2008 Ozone NAAQS Interstate Transport for Colorado, Montana, North
Dakota and South Dakota

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving State
Implementation Plan (SIP) submissions from the states of Colorado,
Montana, North Dakota and South Dakota that are intended to demonstrate
that the SIP for each respective state meets certain interstate
transport requirements of the Clean Air Act (Act or CAA) for the 2008
8-hour ozone National Ambient Air Quality Standards (NAAQS). These
submissions address the requirement that each SIP contain adequate
provisions prohibiting air emissions that will have certain adverse air
quality effects in other states. The EPA is approving these SIPs for
all four states as containing adequate provisions to ensure that air
emissions in the states do not significantly contribute to
nonattainment or interfere with maintenance of the 2008 8-hour ozone
NAAQS in any other state.

DATES: This final rule is effective on March 17, 2016.

ADDRESSES: EPA has established a docket for this action under Docket
Identification Number EPA-R08-OAR-2015-0670. All documents in the
docket are listed on the http://www.regulations.gov index. Although
listed in the index, some information may not be publicly available,
e.g., Confidential Business Information or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street,
Denver, Colorado, 80202-1129. EPA requests that you contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section to
view the hard copy of the docket. You may view the hard copy of the
docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding federal
holidays.

FOR FURTHER INFORMATION CONTACT: Adam Clark, Air Program, U.S.
Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595
Wynkoop, Denver, Colorado 80202-1129,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 23, 2015, the EPA proposed to approve submittals from
Colorado, Montana, North Dakota and South Dakota as meeting the
interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for
the 2008 ozone NAAQS (80 FR 72937). An explanation of the CAA
requirements, a detailed analysis of the states' submittals, and the
EPA's rationale for approval of each submittal were all provided in the
notice of proposed rulemaking, and will not be restated here. The
public comment period for this proposed rule ended on December 23,
2015. The EPA received no comments on the proposal.

II. Final Action

    The EPA is approving the following submittals as meeting the
interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for
the 2008 8-hour ozone NAAQS: Colorado's December 31, 2012 submission;
Montana's January 3, 2013 submission; North Dakota's March 8, 2013
submission; and South Dakota's May 30, 2013 submission. This action is
being taken under section 110 of the CAA.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state actions,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law provisions as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP does not apply on any Indian reservation land
or in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 18, 2016. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: January 25, 2016. Signed:
Debra H. Thomas,
Acting Regional Administrator, Region 8.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart G--Colorado

0
2. Section 52.352 is amended by adding paragraph (d) to read as
follows:

Sec.  52.352  Interstate transport.

* * * * *
    (d) Addition to the Colorado State Implementation Plan of the
Colorado Interstate Transport SIP regarding 2008 Ozone Standards for
both of the CAA section 110(a)(2)(D)(i)(I) requirements submitted to
EPA on December 31, 2012.

Subpart BB--Montana

0
3. Section 52.1393 is amended by adding paragraph (c) to read as
follows:

Sec.  52.1393  Interstate transport requirements.

* * * * *
    (c) EPA is approving both elements of CAA section
110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS, which was submitted to EPA
on January 3, 2013.

Subpart JJ--North Dakota

0
4. Section 52.1833 is amended by adding paragraph (e) to read as
follows:

Sec.  52.1833  Section 110(a)(2) infrastructure requirements.

* * * * *
    (e) EPA is approving both elements of CAA section
110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS, which was submitted to EPA
on March 8, 2013.

Subpart QQ--South Dakota

0
5. Section 52.2170, paragraph (e), is amended by adding the entry
``XIX. Section 110(a)(2)(D)(i)(I) Infrastructure Requirements for the
2008 8-hour Ozone NAAQS'' to read as follows:

Sec.  52.2170  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                                                        Final rule
           Rule title             State effective     EPA Effective     citation,             Comments
                                        date               date            date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
XIX. Section 110(a)(2)(D)(i)(I)            5/21/13             3/2/15  80 FR 4799,  ............................
 Interstate Transport                                                   1/29/15
 Requirements for the 2008 8-
 hour Ozone NAAQS.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-02959 Filed 2-12-16; 8:45 am]
 BILLING CODE 6560-50-P


March 28, 2012

EPA-HSRB-12-01

Lek Kadeli, Acting Assistant Administrator

Office of Research and Development

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Subject: January 26, 2012 EPA Human Studies Review Board Meeting Report

Dear Mr. Kadeli,

	The United States Environmental Protection Agency (EPA or Agency)
requested that the Human Studies Review Board (HSRB) provide scientific
and ethics reviews of one new protocol for a study involving intentional
exposure of human subjects to pesticides: a proposed Agricultural
Handler Exposure Task Force, LLC (AHETF) scenario measuring dermal and
inhalation exposure of workers who perform mixing, loading and
application of pesticides using powered (gasoline or electric)
handgun/hand wand equipment in greenhouses and nurseries (AHE-600).

	The Agency also requested that the HSRB review a completed study of
dermal and inhalation exposure of professional janitorial workers who
clean indoor surfaces with an antimicrobial pesticide product using
hand-held pressurized aerosol canisters, conducted by the Antimicrobial
Exposure Assessment Task Force II (AEATF II). This study (AEA-04) was
conducted after publication of the EPA’s expanded final rule for
protection of subjects in human research. The data will be posted to the
Biocide Handlers Exposure Database (BHED®), and used generically to
estimate daily dermal and inhalation exposures of those who wipe indoor
surfaces with antimicrobial pesticides.

	The enclosed report provides the Board’s response to EPA charge
questions presented at the January 26, 2012 meeting.

Assessment of Proposed AHETF Research Study AHE-600: Mixing, Loading,
and Applying Liquid Pesticides in Managed Horticultural Facilities Using
Powered Handgun Equipment.

Science

The Board concluded that the protocol submitted for review, if modified
in accordance with EPA (Evans, Sarkar and Sherman 2011) and HSRB
recommendations, is likely to generate high quality, reliable and useful
data for assessing worker’s pesticide exposures in horticultural
settings.

The Board provided several additional comments or suggestions with
respect to the use of personal protective equipment (PPE), the potential
effect of unanticipated incidental exposures and other variables on
proportionality, and the utility of existing European Crop Protection
Association (ECPA) data.

Ethics

The Board concluded that the protocol submitted for review, if modified
in accordance with EPA and HSRB recommendations, is likely to meet the
applicable requirements of 40 CFR 26, subparts K and L.

Assessment of Completed AEATF II Research Study AEA-04: Measurement of
Potential Dermal and Inhalation Exposure During Application of a Liquid
Antimicrobial Pesticide Product Using a Pressurized Aerosol Can for
Indoor Surface Disinfecting.

Science

The Board concurred with the Agency’s assessment that this study
provides scientifically valid results for estimating the dermal and
inhalation exposure of those who apply liquid antimicrobial pesticide
products for indoor surface disinfecting using a pressurized aerosol
can, but noted several issues, limitations and concerns with the data
and proposed analyses.

Ethics

The Board concurred with the Agency’s assessment that the study
submitted for review was conducted in substantial compliance with
subparts K and L of 40 CFR 26.

Sincerely,

Sean Philpott, PhD, MSBioethics

Chair

EPA Human Studies Review Board

NOTICE

This report has been written as part of the activities of the EPA Human
Studies Review Board, a Federal advisory committee providing advice,
information and recommendations on issues related to scientific and
ethical aspects of human subjects research.  This report has not been
reviewed for approval by the Agency and, hence, the contents of this
report do not necessarily represent the view and policies of the
Environmental Protection Agency, nor of other agencies in the Executive
Branch of the Federal government, nor does the mention of trade names or
commercial products constitute a recommendation for use.  You may obtain
further information about the EPA Human Studies Review Board from its
website at   HYPERLINK "http://www.epa.gov/osa/hsrb"
http://www.epa.gov/osa/hsrb .  You may also contact the HSRB Designated
Federal Officer, via e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
	In preparing this document, the Board carefully considered all
information provided and presented by the Agency presenters, as well as
information presented by public commenters.  This document addresses the
information provided and presented within the structure of the charge by
the Agency.

US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

Chair

Sean Philpott, PhD, MSBioethics, Director for Research Ethics, The
Bioethics Program of Union Graduate College and the Mount Sinai School
of Medicine, Schenectady, NY

Vice Chair

Rebecca Parkin, PhD, MPH, Professorial Lecturer (EOH), School of Public
Health and Human Services, The George Washington University, Washington,
DC

Members

Janice Chambers, PhD, DABT, Fellow ATS, William L. Giles Distinguished
Professor, Director, Center for Environmental Health Sciences, College
of Veterinary Medicine, Mississippi State University, Mississippi State,
MS

George Fernandez, PhD, Professor of Applied Statistics, Director of the
University of Nevada-Reno Center for Research Design and Analysis,
University of Nevada-Reno, Reno, NV

Vanessa Northington Gamble*, MD, PhD, University Professor of Medical
Humanities, Professor of Health Policy and American Studies, The George
Washington University, Washington, DC

Sidney Green, Jr., PhD, Fellow of the ATS, Professor, Department of
Pharmacology, Howard University College of Medicine, Washington, DC

Jewell H. Halanych, MD, Assistant Professor, Department of Preventative
Medicine, University of Alabama at Birmingham, Birmingham, AL

Dallas E. Johnson, PhD, Professor Emeritus, Department of Statistics,
Kansas State University, Manhattan, KS

Michael D. Lebowitz†, PhD, FCCP, Retired Professor of Public Health &
Medicine, University of Arizona, Tucson, AZ

José E. Manautou*, PhD, Associate Professor of Toxicology, Department
of Pharmaceutical Science, University of Connecticut School of Pharmacy,
Storrs, CT

Jerry A. Menikoff, MD, JD, Director, Office for Human Subjects Research,
Office of the

Secretary, Department of Health and Human Services, Rockville, MD

William Popendorf, PhD, MPH, Professor Emeritus, Department of Biology,
Utah State University, Logan, UT

Leonard Ritter*, PhD, Professor Emeritus, School of Environmental
Sciences, University of Guelph, Guelph, ON, Canada

Virginia Ashby Sharpe, PhD, Medical Ethicist, National Center for Ethics
in Health Care, Veterans Health Administration, Washington, DC

Bernard A. Schwetz*, DVM, PhD, Director (Retired), Office of Human
Research Protections, Department of Health and Human Services, Cadott,
WI

Linda J. Young, PhD, Professor, Department of Statistics, Institute of
Food and Agricultural Sciences, University of Florida, Gainesville, FL

Human Studies Review Board Staff

Jim Downing, Executive Director, Human Studies Review Board Staff,
Office of the Science Advisor, United States Environmental Protection
Agency, Washington, DC

* Not present on January 26, 2012.

† Participated in the January 26, 2012 meeting via telepresence.

INTRODUCTION

On January 26, 2012, the United States Environmental Protection
Agency’s (EPA or Agency) Human Studies Review Board (HSRB) met to
address scientific and ethical issues concerning one new protocol for
research involving human participants: a study measuring dermal and
inhalation exposures associated with the mixing, loading and application
of pesticides using powered (gasoline or electric) handgun/hand wand
equipment in greenhouses and nurseries. In accordance with 40 CFR
26.1601, EPA sought HSRB review of this proposed study. This study is
discussed more fully below.

	In addition, the Agency has data from one completed study measuring
dermal and inhalation exposure of professional janitorial workers who
clean indoor surfaces with an antimicrobial pesticide product using
hand-held pressurized aerosol canisters. In accordance with 40 CFR
26.1602, EPA sought HSRB review of this completed study. This study is
discussed more fully below.

REVIEW PROCESS

On January 26, 2012, the Board conducted a public face-to-face meeting
in Arlington, Virginia. Advance notice of the meeting was published in
the Federal Register as “Human Studies Review Board; Notice of Public
Meeting” (76 Federal Register 248, 80938).

Following welcoming remarks from Agency officials, the Board heard
presentations from EPA on the following topics: one new study protocol
to measure dermal and inhalation exposures associated with the mixing,
loading and application of pesticides using powered (gasoline or
electric) handgun/hand wand equipment in greenhouses and nurseries, and
one completed study measuring dermal and inhalation exposure of
professional janitorial workers who clean indoor surfaces with an
antimicrobial pesticide product using hand-held pressurized aerosol
canisters.

The Board also asked clarifying questions of several study sponsors
and/or research investigators, including:

Ms. Megan Boatwright, Analytical Coordinator, Golden Pacific
Laboratories.

Dr. Victor Cañez, Technical Chair, Agricultural Handler Exposure Task
Force.

Dr. Richard Collier, Administrative Committee Chair, Agricultural
Handler Exposure Task Force.

Mr. William McCormick III, Clorox, on behalf of the Antimicrobial
Exposure Assessment Task Force II.

Mr. Robert Testman, Vice-President, Golden Pacific Laboratories.

Public oral comments were provided by:

Dr. Victor Cañez, Technical Chair, Agricultural Handler Exposure Task
Force

Dr. Richard Collier, Administrative Committee Chair, Agricultural
Handler Exposure Task Force.

Mr. Robert Testman, Vice-President, Golden Pacific Laboratories.

One written public comment from a New Jersey resident was submitted, but
the substance of that comment was not directly related to the two
studies under review by the HSRB at the January 26, 2012 meeting.

For their deliberations, the Board considered the materials presented at
the meeting, oral comments, and Agency background documents (e.g.,
published literature, sponsor and investigator research reports, study
protocols, data evaluation records, and Agency science and ethics
reviews of proposed protocols and completed studies). A comprehensive
list of background documents is available online at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov .

CHARGE TO THE BOARD AND BOARD RESPONSE

Assessment of Proposed AHETF Research Study AHE-600: Mixing, Loading,
and Applying Liquid Pesticides in Managed Horticultural Facilities Using
Powered Handgun Equipment.

Overview of the Study

	This proposal presents an agricultural handler exposure scenario
involving mixing, loading and application of pesticides using powered
(gasoline or electric) handgun/hand wand equipment in greenhouses and
nurseries. Pesticides can be formulated as either liquids or as wettable
powders.

	A total of 30 participants (described in the protocol as “Monitoring
Units” [MUs]) will be observed; three volunteers from each of ten
geographically distinct growing regions will be enrolled using a
purposive sampling method (with some elements of random selection). For
each scenario, volunteers will be randomized to mix and load a defined
amount of active ingredient within one of three strata: 0.5 to 1.6
pounds, 1.6 to 4.8 pounds of active ingredient, or 4.8 to 15 pounds of
active ingredient. After mixing and loading the pesticide, participants
will use powered equipment to treat ornamentals and nonbearing fruit
trees in nurseries, or ornamentals and vegetables grown in greenhouses,
using spray patterns that include downward, outward and upward
directions.

	For this protocol, all participants will wear long sleeved shirts, long
pants, and shoes plus socks. In addition, all participants will wear
chemical resistant gloves. Additional personal protective equipment
(PPE) may be required depending on product labeling directions,
including the use of chemical-resistant aprons when mixing and loading
the pesticide, and chemical-resistant headgear when making overhead
applications.

	Dermal exposure will be measured by a whole body dosimeter worn beneath
the subject’s outer clothing. Hand wash and face/neck wipe samples
will also be collected prior to, during, and after completion of
pesticide loading and mixing procedures. For study participants wearing
chemical-resistant headgear, patches placed inside and outside of the
headgear will be employed to estimate dermal exposure of the protected
portions of the body covered by these garments.

	Airborne concentrations of the surrogate will be monitored in the
participant’s breathing zone using an OSHA Versatile Sampler (OVS)
tube connected to a personal sampling pump. Additional measures will
also record environmental conditions at the time of monitoring, and
observers will make field notes, photographs and videos of participant
activity throughout the monitoring event.

	The results of sample analysis under the powered handgun scenario will
be posted to the Agricultural Handlers Exposure Database (AHED®), where
they will be available to the EPA and other regulatory agencies for
statistical analysis. The proposed documentation will report a
confidence interval-based approach to determine the relative accuracy
for the arithmetic mean and 95th percentile of unit exposures. The
Agency proposes to use these data to estimate daily dermal and
inhalation exposures of agricultural handlers who mix, load and apply
pesticides using powered handgun equipment.

Science

Charge to the Board

	If the AHETF proposal is revised as suggested in EPA’s review and if
the research is performed as described, is the research likely to
generate scientifically reliable data, useful for assessing the exposure
of workers mixing, loading and applying pesticides in managed
horticultural facilities using powered handgun equipment?

Board Response to the Charge

HSRB Recommendation

	The Board concluded that the protocol submitted for review, if modified
in accordance with EPA (Evans, Sarkar and Sherman 2011) and HSRB
recommendations, is likely to generate high quality, reliable and useful
data for assessing worker’s pesticide exposures in horticultural
settings.

	Several comments or suggestions were made by the Board with respect to
the use of PPE, the potential effect of unanticipated incidental
exposures and other variables on proportionality, and the utility of
existing European Crop Protection Association (ECPA) data.

HSRB Detailed Recommendations and Rationale

This protocol, a study designed to measure dermal and inhalation
exposure of agricultural workers who mix, load and apply pesticides in
nurseries or greenhouses using a hand-held sprayer or gun, was well
thought out and well designed.  The study sponsors (Collier 2011) found
no suitable existing information that could constitute some of the MUs
for this particular scenario; consequently, the entire scenario has to
be conducted. The design requires ten (10) regions with three (3) MUs
per region, for a total of 30 MUs. The rationale for this design is that
there are relatively few nurseries and greenhouses that would be
suitable for this scenario in most, if not all, regions of the United
States. Similarity restrictions will be imposed to assure diversity. The
investigators consulted several information sources to identify
locations with suitable nurseries or greenhouses that could be venues
for the conduct of this scenario. The areas of the country selected
represent a variety of climatic and geographic conditions, likely
providing the representativeness and diversity sought for the scenario.
Given these factors and considerations, the Board determined that the
proposed study design is reasonable.

The scenario will include several tasks: mixing/loading of the pesticide
product, open pouring of the formulated product, application of the
product to the plants, and potentially some cleaning. The objective is
to demonstrate proportionality between the amount of active ingredient
handled (AaiH) and exposure level.  One concern that was raised by the
Board was that proportionality may not be observed due to the high
variability of unanticipated incidental exposures (e.g., accidentally
touching a treated plant or contaminated part of spray equipment in some
settings but not others), and these sources may contribute substantially
to participants’ exposure levels. Because workers may be close to some
of the sprayed plants in a setting such as a nursery, it seems likely
that unintended contact of workers with these plants might easily occur.
In scenarios where unanticipated incidental exposures are likely to
occur, it will be important for researchers to observe and document all
unintentional contacts with treated plants or other events that might
contribute to the exposure levels. However, even if proportionality is
not seen -- particularly if the results are attributable to observed
unanticipated exposures -- this scenario will still provide valid
information about worker exposure when using a powered handgun or hand
wand in a horticultural setting.

The Board provided additional recommendations and advice to the Agency
about personal protective equipment (e.g., chemical-resistant headgear),
respirators, the many sources of diversity, and analysis of data. For
example, the Agency was reminded that, should chemical-resistant
headgear be worn, the use of patches inside the headgear should yield
valid estimates of exposure for those participants wearing such a hat
(an issue previously raised at the April 2011 HSRB meeting [EPA HSRB
2011]).  However, this method may underestimate exposures if attempts
were made to extrapolate these data to those not wearing such headgear.
Such extrapolation may not be an explicit intent, but the Agency states
its plans to use the head exposure data to develop mitigation strategies
(e.g. Evans, Sarkar and Sherman 2011, 11).  The effect of the protection
afforded by the brim of the chemical-resistant headgear would negatively
affect that use. Thus, the Board suggested that the sponsors consider:
1) having study participants use chemical-resistant headgear without a
brim (but only if this is allowed by the Worker Protection Standards);
or 2) add a third patch dosimeter against the head below the brim, as
the density of deposition (µg/cm2) onto this patch could be compared to
the deposition onto the rest of the face to estimate the magnitude of
protection afforded by such a brim.

The Board also discussed the use of respirators and half-masks in the
scenario, and how to handle the impact that use of such PPE might have
on dermal exposure levels.  For example, the Board raised concerns about
whether the measured skin exposure to the face would be adjusted upward
in proportion to the area of the face/neck covered by a respirator.
Although the Agency responded affirmatively, this adjustment was not
stated in the protocol or the Agency’s review of the protocol.

Several Board members noted that there are many sources of diversity in
this scenario.  As a result, it may be difficult to test the numerous
variables to the degree the Agency intends for identifying statistically
significant differences. Variables that may influence the proposed
exposure data include:

The predominant direction of spray (downward, outward, or upward);

Whether or not the MU does “minor clean-up”;

Whether the MU uses a handgun or a hand wand;

Whether the MU applies the pesticide indoors or outdoors;

The width of the path through which the applicator must pass, as
determined by facility type (i.e., ornamental greenhouse, vegetable
greenhouse, nursery), which may or may not be a surrogate for the
proximity of foliage;

The formulation type mixed (liquid or solid/wettable powder); and

The mixing sequence (pre-mix or tank mix).

The Board also considered issues related to the Agency’s
recommendation to include wettable powder by at least one participant in
each cluster (Evans, Sarkar and Sherman 2011, 4).  In particular,
concerns were raised about the use of two formulation types (wettable
powder and liquid) in the scenario; this could be seen as akin to
conducting two studies. The lack of clarity as to how many participants
would use the wettable powder in each cluster is problematic for
assessing the recommended study design and field conduct. The number of
MUs who would handle the powder versus liquid formation is critical for
statistical and analytical questions to be fully answered. If both
formulations are to be used, the Board recommended that the Agency
conduct a separate analysis of each type before combining all of the
data for analysis. If the intent is to maximize the power of detecting a
difference attributable to this variable, then the sponsor could have 15
MUs use the powder formulation and 15 MUs use the liquid formulation.
Alternatively, all MUs could use the wettable powder, as that
formulation type is more likely to generate more conservative exposure
data.

Finally, the Board cautioned the Agency and the sponsors that the
justification for the study may be weak.  In particular, the Board
raised a question about the utility of ECPA data.  The Agency’s
rationale for not using those data was that the proposed AHETF scenario
involves individual workers performing both mixing/loading and
application activities, whereas the ECPA exposure data was collected
from agricultural handlers involved only in the application of
pesticides.  The Board was not convinced, however, that this difference
precludes the use of existing ECPA data.  While there may be other
scenario or data quality issues with the ECPA data, the Board
recommended that the Agency consider the viability of combining the ECPA
application-only exposure data with the Task Force’s
mixing/loading-only exposure data to satisfy the Agency’s registration
needs without further human exposure studies. Despite this, the Board
noted that the amount of active ingredient handled might be very
different for the proposed scenario and the existing ECPA data set; if
true, then the existing data sets might not be useful in assessing
worker exposure in this horticultural scenario.

Ethics

Charge to the Board

	If the AHETF proposal is revised as suggested in EPA’s review and if
the research is performed as described, is the research likely to meet
the applicable requirements of 40 CFR part 26, subparts K and L?

Board Response to the Charge

HSRB Recommendation

	The Board concluded that the protocol submitted for review, if modified
in accordance with EPA (Evans, Sarkar and Sherman 2011) and HSRB
recommendations, is likely to meet the applicable requirements of 40 CFR
26, subparts K and L.

HSRB Detailed Recommendations and Rationale

The submitted documents assert that the study will be conducted in
accordance with the ethical and regulatory standards of 40 CFR 26,
Subparts K and L, as well as the requirements of the US EPA’s Good
Laboratory Practice (GLP) Standards described at 40 CFR 160, and, for
research conducted in California, the California State EPA Department of
Pesticide Regulation study monitoring (California Code of Regulations
Title 3, Section 6710) (Collier 2011). Requirements of FIFRA
§12(a)(2)(P) also apply. Researchers who participate in the study and
interact with study participants will be required to undergo ethics
training.  The training will include the successful completion of the
course from the National Institutes of Health (Protecting Human Research
Participants) and/or the Basic Collaborative IRB Training Initiative
Course.

	The protocol was reviewed and approved by an independent human subjects
review committee, IIRB, Inc. of Plantation, FL, prior to submission.
IIRB, Inc. is fully accredited by the Association for the Accreditation
of Human Research Protection Programs (AAHRPP). IIRB, Inc. is also
listed as an active Institutional Review Board (IRB) on the Office of
Human Research Protection (OHRP) website (Reg. #IORG0002954). Copies of
all correspondence with IIRB, Inc. (Collier 2011) and a copy of IIRB,
Inc. policies and membership roster were provided (IIRB, Inc. 2010;
2011). These documents indicate that IIRB, Inc. reviewed this protocol
pursuant to the standards of the Common Rule (45 CFR Part 46, Subpart
A).

1.	The Board concurred with the conclusions and factual observations of
the ethical strengths and weaknesses of the study, as detailed in the
EPA’s Ethics Review (Evans, Sarkar and Sherman 2011). The proposed
study is likely to meet the applicable ethical requirements for research
involving human subjects, in accordance with the following criteria:

a. 	Societal value of the proposed research. The clearly stated purpose
of the proposed monitoring study is to develop data to determine the
potential exposure for workers who mix, load, and apply liquid
pesticides using powered handgun equipment in managed horticultural
facilities in the United States. This mixing/loading/applying method is
applicable to a large variety of commercially important crops associated
with the nursery and greenhouse industry across the US and Canada, and
the existing exposure data are likely inadequate. This study will
provide a partial answer to the question of what dermal and inhalation
exposures are likely for workers who mix/load and apply pesticide
products using handguns and hand wands in nurseries and greenhouses. EPA
will use the results of this study to estimate the dermal and inhalation
exposure likely for a wide range of agricultural pesticides mixed,
loaded, and applied under this exposure scenario.

b.	Subject selection and informed consent.  The inclusion/exclusion
criteria are complete and appropriate. Pregnant or nursing women are
excluded from participation. Pesticide company employees and contractors
to the AHETF are also excluded from participation. Protections are
adequate even if a subject were from a vulnerable population. Informed
consent will be obtained from each prospective subject and appropriately
documented in the language (Spanish or English) preferred by the
subject. Recruitment materials and interactions with potential subjects
will be conducted in English or Spanish, depending on subject
preference. The Board agrees with EPA’s suggestion that it is
preferable for recruitment discussions to take place away from the work
site, to minimize the potential for coercion and that the protocol
should describe the types of locations where recruitment discussions
between researchers and potential subjects will take place, clarifying
whether these discussions will take place at the work site or at
locations that are away from the work site. The proposed monetary
compensation is not so high as to unduly influence participation.
Candidates and subjects will be repeatedly informed that they are free
to decline to participate or to withdraw at any time for any reason,
without penalty.

	Depending on the number of employees and size of the grower’s
facility, the Study Director or researcher may contact employees using
an informational recruitment flyer posted in a common work area.
Alternatively, or subsequent to the use of a flyer, the Study Director
or researcher will arrange a meeting with the grower’s employees who
express interest in participation. Such recruitment meetings will always
occur without supervisors being present. The Study Director or
researcher will describe the AHETF Exposure Monitoring Program, the
goals of this specific study, the procedures to be used in exposure
monitoring, and the risks and benefits to participants. The subject
eligibility factors listed in the consent form and SOP AHETF-11.B.6 are
appropriate. Candidates who attend an individual interview will be paid
$20 whether or not they agree to participate; enrolled subjects who put
on the whole-body dosimeter will be paid $80 in addition to their usual
pay, whether or not they complete participation.

c.	Risks to subjects. The proposed test materials are EPA-registered
products registered for nursery and/or greenhouse use and the specific
application planned by the grower, and will be used in full compliance
with the approved labels. All identified risks are characterized as of
low probability, and risks are further minimized by exclusion of
candidates who self-report that they are in less than “good” health;
alerting subjects to signs and symptoms of heat stress; monitoring heat
index with associated stopping rules; close observation of subjects;
training of experienced technicians to minimize embarrassment;
incorporation of procedures to keep results of pregnancy testing private
and to permit discrete withdrawal; provision of appropriate work
clothing and PPE. Provision is made for discrete handling of the
pregnancy testing that is required of female subjects on the day of
testing.

	Five kinds of risks to subjects are discussed in the protocol, along
with specific steps proposed to minimize them: the risk of heat-related
illness; the risk associated with scripting of field activities;
psychological risk; the risk of exposure to surfactants, and; the risk
of exposure to surrogate chemicals.  In this study, risks to subjects
are classified as ‘greater than minimal’ since the likelihood of
harm or discomfort is greater than what is encountered in ordinary daily
life. In particular, the risk of heat-related illness (resulting from
wearing an extra layer of clothing to trap the chemical) will be
increased due to study participation. AHETF has adopted an extensive
program to minimize these risks. Appropriate provision is made for
safety and medical monitoring. The protocol also incorporates procedures
to keep results of pregnancy testing private and to permit discrete
withdrawal of a study subject.  Finally, the protocol incorporates
procedures to ensure that no photographs or videos will be taken in
which a worker can be readily identified.

d. 	Benefits to participants. This research offers no direct benefits to
the subjects. The principal benefit of this research is likely to be
reliable data about the dermal and inhalation exposure of people mixing,
loading and application of pesticides using powered handgun equipment.
These data are intended to be used by EPA and other regulatory agencies
to support exposure assessments for a wide variety of antimicrobial
products and their uses.

e.	Risk/benefit balance. Risks to subjects have been thoughtfully and
thoroughly minimized in the design of the research. The low residual
risk is reasonable, in light of the likely benefits to society from new
data supporting more accurate exposure assessments for antimicrobial
products.

2.	In addition to this analysis, the Board recommended a few edits to
improve the clarity of the Informed Consent Form. These are listed
below, organized according to the section within the Informed Consent
Form in which they appear. In particular, in the past the Agency and the
Board have suggested that protocols and consent forms clarify the steps
that participants should take if participants have an adverse reaction
within 24 hours. This was not included in the materials provided by the
AHETF, and the Board recommends that such information be included on the
consent form.

Introduction and Purpose:

“If you do In order to take part in this study, you must read and sign
this consent form” (Line 4).

Procedures Before the Start of the Study:

Modify the language per the protocol (p. 248/SOP II.D.2) to clarify that
the pregnancy test will be taken prior to the start of the study:

8. If you are female, within 24 hours of prior to starting the study you
will perform an over-the-counter pregnancy test. If there is a delay in
the start of the study of more than 24 hours, another pregnancy test may
be needed. The negative results of your pregnancy test will be verified
by a female member of the study.

Injury to Participants:

Add a line indicating the name and contact information of the Study
Director or other individual to be contacted if the participant
experiences an adverse event within 24 hours.

3.	The Board agreed with the Agency that information about potential
psychological and social harms related to unwanted disclosure of test
results and breach of confidentiality associated with photographs or
video may be included in the protocol (Evans, Sarkar and Sherman 2011).
However, the Board recommended that this information not be included in
the informed consent form as it might give participants the erroneous
impression that these risks are particularly significant or that
appropriate steps have not been taken to mitigate them.

Assessment of Completed AEATF II Research Study AEA-04: Measurement of
Potential Dermal and Inhalation Exposure During Application of a Liquid
Antimicrobial Pesticide Product Using a Pressurized Aerosol Can for
Indoor Surface Disinfecting.

Overview of the Study

	AEATF II aerosol spraying scenario was designed to measure a typical
occupational handler’s daily exposure to an antimicrobial spray
(containing C14 alkyl dimethyl benzyl ammonium chloride [ADBAC])
packaged in a commercially-available pressurized aerosol spray can.

	Eighteen (18) professional janitors were enrolled in the study, and
applied (but did not wipe) the product on surfaces at one of three
motels in the Fresno, CA area. Study participants were randomized to
apply different amounts of product, from one (1) to four (4) cans of
product in 1/2-can increments (i.e., 1 to 1.5 cans, 1.5 to 2 cans, and
so on up to 3.5 to 4 cans).

	Participants wore a variety of clothing combinations, ranging from
short pants and short sleeved shirts with shoes plus socks, to long
pants and long sleeved shirts with shoes plus socks. No participant wore
gloves, but participants were given the option of wearing a respirator
during product application; all 18 subjects elected to wear respirators
during monitoring. All participants wore inner and outer sets of
whole-body dosimeters that were sectioned and analyzed separately.

	Dermal exposures were measured using whole-body dosimeters (inner and
outer), and hand and face washes.  Dermal unit exposures (reported in
mg/lb AaiH) were calculated by dividing the summed total exposure by
AaiH. The study sponsor report normalized the dermal exposures by
milligrams (mg) of active ingredient applied, but these exposure data
were recalculated by the Agency and expressed as mg/lb of active
ingredient applied.

	Inhalation exposures were measured using a personal air sampling pump
and OVS tubes plus a separate pump used to run a RespiCon™ Particle
Sampler. This allows for collection and analysis of inhalation exposure
monitoring results as total particles, as inhalable particles (<100
μm), as thoracic particles (<10 μm), and as respirable particles (<2.5
μm). Inhalation unit exposures (reported in mg/m3/lb AaiH) were
calculated by dividing the air concentrations by AaiH.

	The data will be posted to the Biocide Handlers Exposure Database
(BHED®). The Agency plans to use these data generically to estimate
dermal and inhalation exposures and risks for other antimicrobial
ingredients where the applied product is packaged in a pressurized
aerosol spray can. Although the scenario as performed did not include
the subsequent wiping of the aerosol spray solution, the Agency believes
that dermal and inhalation exposure that results from the subsequent
wiping of sprayed antimicrobial solutions can be determined by combining
the results of this study with the results of the previously AEATF II
conducted ready-to-use (RTU) wipe study (favorably reviewed at the April
2011 HSRB meeting; EPA HSRB 2011).

Science

Charges to the Board

	Was the research reported in the AEATF II completed aerosol study
report faithful to the design and objectives of the protocol and
governing documents of the AEATF?

	Has EPA adequately characterized, from a scientific perspective, the
limitations on these data that should be considered when using the data
in estimating the exposure of professional janitorial workers who apply
liquid antimicrobial pesticide products to indoor surfaces using
pressurized aerosol cans?

Board Response to the Charge

HSRB Recommendation

	 The Board concluded that the research reported in the completed
monograph, associated field study reports, and associated supplemental
documents was conducted in a manner that was reasonably faithful to the
design and objectives of the protocol and governing documents of the
AEATF.

The Board also concluded that the Agency has adequately, but not
completely, considered the limitations in this study when using the data
in estimating the dermal and inhalation exposure of those who apply
liquid antimicrobial pesticide products for indoor surface disinfecting
using a pressurized aerosol can.  In particular, the Board noted several
issues, limitations and concerns with the data and analyses. These are
described in greater detail below.

HSRB Detailed Recommendations and Rationale

The Board concluded that the study (Testman and Boatwright 2011) was
done thoroughly, yielding detailed and helpful data that appear to be
reliable.  Some data trends were not explained in the accompanying
Agency analysis, but overall the diversity of subjects and settings were
strengths of the study.

The Board agreed with the Agency that the number of participants was
adequate to achieve the primary benchmark accuracy goal.  The Board also
agreed that the modest diversity of application settings was a
reasonable attempt to offset the practical limitation of recruiting and
assessing all exposures within one geographic area. The documented
diversity in application behaviors indicates the robust nature of the
resulting exposure data.

The Agency's analyses of protocol deviations and of the blank, fortified
field, and lab samples were acceptable.  In addition to the deviations
noted in the final report (Testman and Boatwright 2011, 1033-104) or by
the Agency (Leighton 2012, 9), however, the Board identified a few more.
For example, subject AE4 was apparently observed to be applying the
product to surfaces at much heavier rates than usual. About 20% of the
way into the sampling time, the study director instructed this subject
to “lighten up” in their application (Testman and Boatwright 2011,
488).  This intervention comprises an unknown limitation that may have
had a large effect on reducing a potentially high exposure.
Alternatively, it may have had no significant effect and was unjustified
in terms of protecting the subject.  Although no specific prohibition
against such interventions was found in the protocol, such instructions
regarding applicator behavior were counter to the intent of the protocol
(i.e., that the study participants “spray surfaces as they would
normally do” [Testman and Boatwright 2011, 18]). Thus, it is unclear
whether this event actually qualifies as a protocol deviation. However,
the lack of an explicit prohibition of study director intervention
raised issues in this study’s analysis and interpretation. Guidance
about how to handle interventions should be incorporated into future
protocols and standard operating procedures (SOPs).

Subject AE18 (in cluster #1) was a borderline outlier without any
indication in the field notes of intervention by the researchers.  The
Board did not disagree completely with the Agency’s conclusion that
AE18’s data was not an outlier (Leighton 2012, 15), but believed that
one particular combination of these data -- application rate -- reflects
the characteristics of an outlier.  However, the Board did not advocate
excluding this data point from subsequent analyses. Rather, these
sometimes substantial differences provide additional support for the
diverse and therefore broadly representative nature of the subjects and
the qualitatively robust nature of the study results.

The Board also discussed outliers in laboratory recovery data.  These
data were not used by the Agency to correct field samples; the Board
agreed with the EPA’s approach.  However, the lack of explicit
procedures for handling outliers raised questions among Board members.
Explicit discussions about when data should or should not be excluded
should be incorporated into future protocols and SOPs.

The Board raised concerns that the 20% higher flow rates (or discharge
rates) from the batch of aerosol cans used in the first four MEs, as
compared with the flow rates from those cans used in the last 14 MEs,
could cause an appreciable difference in exposure (Leighton 2012, 9).
Typically, a faster discharge rate through a given nebulizer produces
smaller droplets.  An analysis of variance for data in this study found
a statistically significant difference between the average fraction of
the a.i. <10 µm in the first four RespiCon™ samples and the last 14
samples (44% versus 55%, respectively; p < 0.00001).  This difference is
consistent with the expectation that the first batch of canisters may
have produced particles with a mass median aerodynamic diameter just
over 10 μm and the last batch particles with a mass median aerodynamic
diameter just under 10 μm. The difference in particle size is more
likely to have been due to the reported difference between flow rates
than the difference in ADBAC concentration in the product.  Notably, the
impact of this probable shift to slightly smaller droplets is small in
comparison to the much wider variation in flow rates and particle sizes
among the many other products these studies are intended to represent.

The Board also raised concerns that the ventilation data presented were
unclear, inadequately recorded, and inadequately interpreted (Testman
and Boatwright 2011, 119-20).  For example, “fresh air” was
presented using different metrics (e.g., %, total fan cubic feet per
minute [CFM], and CFM fresh air).  Furthermore, the reported air changes
per hour seem to differ from separately calculated values by factors of
1.5- to 3-fold. Analyses by one Board member suggest that the overall
effect of the deficiencies may have been small; the amount of time that
participants spent in each room was so short that airborne ABDAC was
just beginning to accumulate by the time the subjects left the space,
limiting the effect of ventilation on overall rates of exposure.
However, the Board recommended that the Agency consider the potential
limitations associated with the heating, ventilation and air
conditioning systems in the test facilities.

The Agency requested the Board’s advice on the use of RespiCon™
versus OVS results. The major advantage of the RespiCon™ air samples
is their ability to look at the data by size ranges. A disadvantage of
collecting RespiCon™ samples is the challenge of confronting the
difference inherent in the entrance losses of any two air samplers.
Such losses are a characteristic primarily of entrance diameters and
flow rates, but also of the shape of those entrances and their
orientation, and the air velocity and particle diameters in any given
setting.  These characteristics affect both the RespiCon™ and OVS
samples.  Unfortunately, it appears that no tests could be found in the
literature comparing the OVS with the RespiCon™ sampler (e.g.,
Leighton 2012, 35-7).  Thus, there is no reliable basis upon which to
correct the RespiCon™ to the OVS data. For the purposes of calculating
dose via inhalation, however, the Board recommends that the <10
micron-size results from RespiCon™ monitors be used because this size
range represents the fraction that enters the respiratory tract and thus
provides a more conservative estimate of inhalation exposure.

The Board suggested that the dermal and inhalation exposure data be
combined to obtain total exposure results. The Board also questioned
whether a slope of 1.5, with a confidence interval (CI) including one
(1), should be considered as evidence of proportionality. Furthermore, a
CI that does not include one may not provide adequate protection. The
Board thus recommended that the Agency always clarify coefficients over
one. Finally, the Board recommended that the Agency and the Task Force
refrain from using the word ‘proportional’ without preceding it by
an adjective such as 1:1 proportional or 1:2 proportional.

Ethics

Charge to the Board

	Does available information support a determination that the study was
conducted in substantial compliance with subparts K and L of 40 CFR Part
26?

Board Response to the Charge

HSRB Recommendation

The Board concurred with the Agency’s assessment (Sherman 2012) that
the study submitted for review was conducted in substantial compliance
with subparts K and L of 40 CFR Part 26.

HSRB Detailed Recommendation and Rationale

The documents prepared by Golden Pacific Laboratories, LLC, and
submitted by American Chemistry Council Antimicrobial Exposure
Assessment Task Force II under Project No. AEA-04, state that the study
was conducted in compliance with the requirements of the EPA’s Good
Laboratory Practice (GLP) Standards; FIFRA §12(a)(2)(P); and the
applicable subparts of 40 CFR 26 (Testman and Boatwright 2011).

The protocol was reviewed and approved by an independent human subjects
review committee, IIRB, Inc. of Plantation, FL prior to submission.
Minutes of IIRB, Inc. meetings and a copy of IIRB, Inc. policies and
procedures were provided. This IRB is fully accredited by AAHRPP and
registered with OHRP (see details above). Documentation provided to the
EPA indicated that IIRB, Inc. reviewed this study pursuant to the
standards of the Common Rule (45 CFR Part 46, Subpart A) and found it in
compliance (IIRB, Inc. 2010; 2011).

1.	The Board concurred with the conclusions and factual observations
relating to the study, as detailed in the EPA’s Ethics Review (Sherman
2012). Specifically:

a. 	Prior HSRB and Agency Review. The requirements of 40 CFR §26.1125
for prior submission of the protocol to EPA and of §26.1601 for HSRB
review of the protocol were satisfied. The study (Testman and Boatwright
2011) was conducted in accordance with the protocol previously reviewed
by the Agency (Leighton, Walls and Sherman 2009) and by the HSRB (EPA
HSRB 2009). Neither the Agency’s nor the HSRB’s ethics reviews
identified any significant deficiencies requiring correction relative to
40 CFR 26, subparts K and L, or to FIFRA § 12(a)(2)(P) (Leighton, Walls
and Sherman 2009). Because the study was conducted in California, the
approval of the California Department of Pesticide Regulation (CDPR) was
also required before the study could be initiated. CDPR granted final
approval of the amended protocol and supporting documents on April 19,
2010.

b.	Responsiveness to HSRB and Agency Reviews. Following HSRB review, the
protocol and consent form were modified to incorporate changes
responsive to the all of the comments of EPA (Leighton, Walls and
Sherman 2009) and the HSRB (EPA HSRB 2009). Additional corrections and
amendments were also requested by CDPR. IIRB, Inc. granted approval to
the amended protocol and supporting documents on April 6 and April 7-9,
2010, respectively (Testman and Boatwright 2011; Sherman 2012).

c.	Substantial Compliance with Reporting Requirements (40 CFR Part 26
subpart M). The AEATF II’s submission (Testman and Boatwright 2011),
along with the separately submitted documents describing the procedures
and roster of the IRB (IIRB, Inc. 2010; 2011), fully meet the
requirements of 40 CFR §26.1303 to document the ethical conduct of the
research.

2.	The Board concluded that this study, as conducted, met all applicable
ethical requirements for research involving human participants, in
accordance with the following criteria that had been stated in the
Board’s prior review of this study protocol (EPA HSRB 2009):

a.	Acceptable risk-benefit ratio. The risks to study participants were
minimized appropriately and were justified by the potential societal
benefits, particularly data on the dermal and inhalation exposure of
professional janitorial workers to antimicrobial compounds as they
sprayed indoor surfaces with aerosolized pesticides. These data could be
used to develop mechanisms to protect future users of these
antimicrobial pesticides.

Minors and pregnant or lactating women were excluded from participation,
with pregnancy confirmed by over-the-counter pregnancy testing on the
day of study or by opt-out. The potential of stigma resulting from study
exclusion was also appropriately minimized.

Clear stopping rules and medical management procedures were in place,
and no adverse events or other incidents of concern related to product
exposure were reported.

The study was designed to minimize the risks of exposure to the test
compounds.

b.	Voluntary and informed consent of all participants.

The study protocol included several mechanisms designed to minimize
coercive recruitment and enrollment.

Monetary compensation was not so high as to unduly influence
participation. Minors and pregnant or lactating women were excluded from
participation, with pregnancy confirmed by over-the-counter pregnancy
testing on the day of study or by opt-out. The potential of stigma
resulting from study exclusion was also appropriately minimized.

Although the first study participants were enrolled in April 2010 and
monitoring began in June 2010, shortly thereafter the study was placed
on ‘hold’ as the result of an issue raised by CDPR. In response to a
request from some participants to wear a respirator while engaged in
study related tasks, the AEATF II decided to offer all study subjects
the option of wearing a half-mask respirator fitted with organic vapor
cartridges. This decision was made after consulting with the Agency and
with the IRB, and the amended protocol and informed consent forms were
reviewed and approved by the IRB. Upon receipt of the approved protocol
amendment, CDPR requested that the study be halted temporarily until
Golden Pacific Laboratories could conduct an additional review of its
procedures for respirator use. CDPR granted approval for the amended
protocol on May 11, 2011.

This hold is unlikely to have affected the integrity of the research or
the safety of participants. In fact, by allowing subjects to wear a
respirator, the researchers further minimized potential risks to study
participants. All 18 monitored subjects used a respirator, which was
fitted by a trained study investigator and worn under the supervision of
a registered study nurse.

Several minor deviations from GLP were reported by the study sponsors
(Testman and Boatwright 2011, 3), but these were unlikely to have
affected the integrity of the research or the safety of participants.
Only one of these deviations bears further discussion, namely the
enrollment of a participant who self-reported that his health was only
“fair,” despite the requirement that all participants be in “good
health” (Testman and Boatwright 2011, 227). This same issue was
discussed by the HSRB during its October 2010 and April 2011 meetings
(EPA HSRB 2010; 2011), at which time the Board recommended that the
study sponsors clarify the criteria used to establish participants’
health status prior to enrollment. Enrollment of this particular
participant, however, happened prior to those two Board meetings.
Furthermore, although formally enrolled in the study, this participant
was not one of the 18 subjects monitored. Thus, the Board concluded that
this deviation did not put the participant at increased risk.

REFERENCES

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湡条摥䠠牯楴畣瑬牵污䘠捡汩瑩敩⁳獵湩潐敷敲慈
摮畧煅極浰湥⁴䄨䕈䙔匠畴祤丠⹯䄠䕈〶⤰慄整
捏潴敢⁲㐲〲ㄱ湕異汢獩敨潤畣敭瑮瀠敲慰敲
潦⁲桴䡁呅ⱆ㐠㐷瀠മ

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&

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