[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70335-70337]
[FR Doc No: 2010-28986]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63308; File No. SR-MSRB-2010-15]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of Rule D-13, on a
Definition of ``Municipal Advisory Activities'', Rule D-14, on a
Definition of ``Appropriate Regulatory Agency'', and Amendments to Rule
D-11 (``Associated Persons''), Rule G-40 on Electronic Mail Contacts,
and Form G-40, on Electronic Mail Contacts

November 12, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``the Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 10, 2010, the Municipal Securities Rulemaking Board
(``Board'' or ``MSRB'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the MSRB. The Board has designated the proposed rule change as
concerned solely with the administration of the Board or other matters
which the Commission, by rule, consistent with the public interest and
the purposes of this subsection, may specify as without the provisions
of Section 19(b)(2) of the Act. 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 Substance
of the Proposed Rule Change

    The MSRB is filing a proposed rule change relating to municipal
advisors, consisting of: (i) Amendments to Rule D-11 (definition of
``associated persons''); (ii) new Rule D-13 (definition of ``municipal
advisory activities''); (iii) new Rule D-14 (definition of
``appropriate regulatory agency''); (iv) amendments to Rule G-40, on
electronic mail contacts, by municipal advisors; and (v) amendments to
Form G-40, on electronic mail contacts. The proposed rule change is
effective immediately upon filing.
    The text of the proposed rule change is available on the MSRB's Web
site at http://www.msrb.org/Rules-and-Interpretations/SEC-Filings/2010-Filings.aspx, at the MSRB's principal office, and at the Commission's
Public Reference Room.

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

    In its filing with the Commission, the MSRB 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. The Board 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
    The purposes of the proposed rule change are: (i) To complete the
rulemaking that is necessary for the registration of municipal advisors
with the MSRB (amended Rule G-40 and amended Form G-40) and (ii) to
define certain terms that are necessary to the MSRB rules governing
rulemaking concerning municipal advisors and the process of registering
municipal advisors with the MSRB. Specifically, the proposed rule
change consists of: (i) An amendment to Rule D-11 to provide that the
term ``municipal advisor'' in MSRB rules shall include the associated
persons of such municipal advisor unless otherwise specified, (ii) a
new Rule D-13 that defines ``municipal advisory activities'' with
respect to the activities of municipal advisors described in Section
15B(e)(4)(A)(i) and (ii) of the Act, (iii) a new Rule D-14 that defines
``appropriate regulatory agency'' to have the meaning set forth in
Section 3(a)(34) of the Act with respect to a broker, dealer, or
municipal securities dealer and to mean the Commission with respect to
a municipal advisor; (iv) amendments to Rule G-40 concerning the
provision of electronic mail contacts by municipal advisors, and (v)
amended Form G-40 concerning the provision of electronic mail contacts
by municipal advisors.
2. Statutory Basis
    The MSRB believes that the proposed rule change is consistent with
Section 15B(b)(2) of the Act, which provides that:

    The Board shall propose and adopt rules to effect the purposes
of this title with respect to transactions in municipal securities
effected by brokers, dealers, and municipal securities dealers and
advice provided to or on behalf of municipal entities or obligated
persons by brokers, dealers, municipal securities dealers, and
municipal advisors with respect to municipal financial products, the
issuance of municipal securities, and solicitations of municipal
entities or obligated persons undertaken by brokers, dealers,
municipal securities dealers, and municipal advisors.

    The proposed rule change is consistent with Section 15B(b)(2) of
the Act, because it: (i) Is essential to the registration with the MSRB
of the municipal advisors described in Section 15B(b)(2) of the Act and
(ii) defines certain terms that are necessary to the MSRB rules
governing such municipal advisors and the process of registering such
advisors with the MSRB.
    Section 15B(2)(L) of the Act requires that rules adopted by the
Board

    not impose a regulatory burden on small municipal advisors that
is not necessary or appropriate in the public interest and for the
protection of investors, municipal entities, and obligated persons,
provided that there is robust protection of investors against fraud.

    The proposed rule change does not impose a regulatory burden on
small advisors that is not necessary or appropriate in the public
interest and for the protection of investors, municipal entities, and
obligated persons and for the robust protection of investors against
fraud. Rule G-40, as amended by the proposed rule change, only requires
municipal advisors to submit basic contact information and to select
the categories of municipal advisors that best describe them. The MSRB
expects that municipal advisors will need no more than 15 minutes to
complete electronic Form G-40, but the MSRB will have staff ready to
assist them should they have any questions. Any burden on municipal
advisors is de minimis. The portion of the proposed rule change that
consists of definitions will impose no burden on any municipal advisor.
While the proposed rule change, at best, imposes only a de minimis
burden on municipal advisors, the proposed rule change is necessary for
the MSRB to have a record of the municipal advisors it regulates, so
that it may keep them abreast of regulatory developments, better target
its rulemaking and professional qualifications examinations to
different types of municipal advisors, and identify to the Commission
those municipal advisors who have reportedly violated MSRB rules.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The MSRB does not believe that the proposed rule change will impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, since it would apply equally to
all municipal advisors.

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

    Written comments were neither solicited nor received on the
proposed rule change.

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

    The MSRB represented that the proposed rule change qualifies for
immediate effectiveness pursuant to Section 19(b)(3)(A)(iii) of the Act
\3\ thereunder, because it: (i) Does not significantly affect the
protection of investors or the public interest; (ii) does not impose
any significant burden on competition; and (iii) does not become
operative for 30 days after filing or such shorter time as the
Commission may designate consistent with the protection of investors
and the public interest.\4\
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    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ In addition, Rule 19b-4(f)(6)(iii) requires a self-
regulatory organization to give the Commission written notice of its
intent to file the proposed rule change at least five business days
prior to the date of filing of the proposed rule change, or such
shorter time as designated by the Commission.
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    The MSRB provided the required written notice of its intention to
file the proposed rule change to the Commission on October 22, 2010.
    The MSRB has requested that the Commission designate a shorter time
period for the proposed rule change to become operative, that is, on
November 15, 2010, and has represented that the proposed rule change is
not controversial, that it is integrally related to SR-MSRB-2010-14,
which became effective November 9, 2010, and that it is necessary for
the completion of rulemaking related to the registration of municipal
advisors with the MSRB. The MSRB has stated that an earlier operative
date of November 15, 2010 will permit the MSRB to begin to register
municipal advisors and will provide municipal advisors with additional
time to complete their registration process with the MSRB by no later
than January 1, 2011. The Commission hereby grants the MSRB's request
and believes that waiving the 30-day operative delay is consistent with
the protection of investors and the public interest.\5\ The earlier
operative date will allow municipal advisors

additional time to register with the MSRB.
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    \5\ For the purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule
change's impact on efficiency, competition, and capital formation.
See 15 U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.\6\
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    \6\ See Section 19(b)(3)(C) of the Act, 15 U.S.C. 78s(b)(3)(C).
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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-MSRB-2010-15 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MSRB-2010-15. 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 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 Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE., Washington,
DC 20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the MSRB's offices. 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-MSRB-2010-15 and should be submitted on or before
December 8, 2010.

    For the Commission, by the Division of Trading and Markets,
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. 2010-28986 Filed 11-16-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Rules and Regulations]
[Pages 30762-30764]
[FR Doc No: 2013-12235]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0163]
RIN 1625-AA00

Safety Zone; 2013 Fish Festival Fireworks, Lake Erie, Vermilion,
OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Erie, Vermilion, OH. This safety zone is intended to restrict
vessels from a portion of Lake Erie during the 2013 Fish Festival
Fireworks display. This temporary safety zone is necessary to protect
spectators and vessels from the hazards associated with a fireworks
display.

DATES: This rule is effective from 9:30 p.m. until 11 p.m. on June 14,
2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0163]. To view documents

mentioned in this preamble as being available in the docket, go to
http://www.regulations.gov, type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this rulemaking. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Christopher Mercurio, Chief of Waterways Management,
U.S. Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Barbara Hairston, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
TFR Temporary Final Rule

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The final details for this event were
not known to the Coast Guard until there was insufficient time
remaining before the event to publish an NPRM. Thus, delaying the
effective date of this rule to wait for a comment period to run would
be both impracticable and contrary to the public interest because it
would inhibit the Coast Guard's ability to protect spectators and
vessels from the hazards associated with a maritime fireworks display,
which are discussed further below.
    Under 5 U.S.C. 553(d)(3), The Coast Guard finds that good cause
exists for making this temporary rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for a 30 day notice period to run
would be impracticable and contrary to the public interest.

B. Basis and Purpose

    Between 10 p.m. and 10:30 p.m. on June 14, 2013, a fireworks
display will be held on Lake Erie near the outer break wall of the
Vermilion River, Vermilion, OH. The Captain of the Port Buffalo has
determined that fireworks launched proximate to a gathering of
watercraft pose a significant risk to public safety and property. Such
hazards include premature and accidental detonations, dangerous
projectiles, and falling or burning debris.

C. Discussion of the Final Rule

    With the aforementioned hazards in mind, the Captain of the Port
Buffalo has determined that this temporary safety zone is necessary to
ensure the safety of spectators and vessels during the 2013 Fish
Festival Fireworks. This zone will be effective and enforced from 9:30
p.m. until 11 p.m. on June 14, 2013. This zone will encompass all
waters of Lake Erie, Vermilion, OH within a 560 foot radius of position
41[deg]25'44'' N and 82[deg]21'54'' W (NAD 83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS).
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, will not adversely alter the
budget of any grant or loan recipients, and will not raise any novel
legal or policy issues. The safety zone created by this rule will be
relatively small and enforced for relatively short time. Also, the
safety zone is designed to minimize its impact on navigable waters.
Furthermore, the safety zone has been designed to allow vessels to
transit around it. Thus, restrictions on vessel movement within that
particular area are expected to be minimal. Under certain conditions,
moreover, vessels may still transit through the safety zone when
permitted by the Captain of the Port.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that
this rule will not have a significant economic impact on a substantial
number of small entities. This rule will affect the following entities,
some of which might be small entities: The owners or operators of
vessels intending to transit or anchor in a portion of Lake Erie on the
evening of June 14, 2013.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
safety zone would be activated, and thus subject to enforcement, for
only 90 minutes late in the day. Traffic may be allowed to pass through
the zone with the permission of the Captain of the Port. The Captain of
the Port can be reached via VHF channel 16. Before the activation of
the zone, we would issue local Broadcast Notice to Mariners.

3. Assistance for Small Entities

    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 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 above.
    Small businesses may send comments on the actions of Federal
employees

who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    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 rule under that Order and determined
that this rule does not have implications for federalism.

6. 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

7. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

8. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

9. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

10. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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.

11. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

12. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

13. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have 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 rule involves the establishment of a safety zone and,
therefore it is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0163 to read as follows:

Sec.  165.T09-0163  Safety Zone; 2013 Fish Festival Fireworks, Lake
Erie, Vermilion, OH.

    (a) Location. This zone will encompass all waters of Lake Erie,
Vermilion, OH within a 560 foot radius of position 41[deg]25'44'' N and
82[deg]21'54'' W (NAD 83).
    (b) Effective and Enforcement Period. This regulation is effective
and will be enforced on June 14, 2013 from 9:30 p.m. until 11:00 p.m.
    (c) Regulations.
    (1) In accordance with the general regulations in Sec.  165.23 of
this part, entry into, transiting, or anchoring within this safety zone
is prohibited unless authorized by the Captain of the Port Buffalo or
his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: May 3, 2013.
S.M. Wischmann,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2013-12235 Filed 5-22-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: March 27, 2006 (Volume 71, Number 58)]
[Proposed Rules]
[Page 15098]
[DOCID:fr27mr06-31]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 51

[EPA-HQ-OAR-2005-0175; FRL-8049-7]

Extension of Public Comment Period for Proposed Rule on the
Transition to New or Revised Particulate Matter (PM) National Ambient
Air Quality Standards (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of public comment period.

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SUMMARY: The EPA is announcing a 90-day extension of the public comment
period for the proposed ``Transition to New or Revised Particulate
Matter (PM); National Ambient Air Quality Standards (NAAQS).'' As
initially published in the Federal Register on February 9, 2006 written
comments on the advance proposal for rulemaking were to be submitted to
EPA on or before April 10, 2006 (a 60-day public comment period). Since
publication, EPA has received several requests for additional time to
submit comments. Therefore, the public comment period is being extended
for 90 days and will now end on July 10, 2006. This extension is based
on the fact that the PM NAAQS will not be finalized until September 27,
2006.

DATES: The public comment period for this proposed rule is extended to
July 10, 2006.

FOR FURTHER INFORMATION CONTACT: For questions regarding PM
implementation issues, contact Ms. Barbara Driscoll, U.S. Environmental
Protection Agency, Office of Air Quality Planning and Standards, Mail
Code C504-05, Research Triangle Park, NC 27711, phone number (919) 541-
1051 or by e-mail at<EMAIL_ADDRESS>Questions regarding the
new source review issues contact Raj Rao, U.S. Environmental Protection
Agency, Office of Air Quality Planning and Standards, Mail Code C504-
03, Research Triangle Park, NC 27711, phone number<PHONE_NUMBER> or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Extension of Public Comment Period

    The proposed rule was signed by the Administrator on February 3,
2006 and published in the Federal Register on February 9, 2006 (71 FR
6718). The EPA has received several requests for additional time to
comment on the proposal. Since the 60-day public comment period would
have concluded on April 10, 2006, EPA has decided to extend the comment
period until July 10, 2006 based on the fact that the PM NAAQS will not
be promulgated until September 27, 2006.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2005-0175. Publicly available docket materials
are available either electronically through http://www.regulations.gov

or in hard copy at the EPA Docket Center, located at 1301 Constitution
Avenue, NW., Room B102, Washington, DC between 8:30 a.m. and 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 Docket is<PHONE_NUMBER>. A reasonable fee may be charged for
copying.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. Also, the advance notice of

proposed rulemaking was published in the Federal Register on February
9, 2006 and is available at http://www.epa.gov/air/particlepollution/actions.html
.

    Dated: March 14, 2006.
Jeffrey S. Clark,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. E6-4369 Filed 3-24-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Page 51880]
[FR Doc No: 2016-17922]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0242 and EPA-HQ-OPP-2016-0226; FRL-9949-39]

Guidance for Pesticide Registrants on Pesticide Resistance
Management Labeling and Guidance for Herbicide Resistance Management
Labeling, Education, Training, and Stewardship; Extension of Comment
Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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SUMMARY: EPA issued two notices in the Federal Register on June 3,
2016, each announcing the availability of a draft Pesticide
Registration Notice (PR Notice) for review and comment: One entitled
``Guidance for Pesticide Registrants on Pesticide Resistance Management
Labeling'' and the other entitled ``Guidance for Herbicide Resistance
Management Labeling, Education, Training, and Stewardship.'' In
response to requests received, this document extends the comment period
for 30 days, from August 2, 2016 to September 1, 2016. This is one of
the busiest times of year for pest control experts and this will allow
them extra time to complete their review and comment on the PRNs.

DATES: Comments must be received on or before September 1, 2016.

ADDRESSES: Follow the detailed instructions provided under ADDRESSES in
the Federal Register documents of June 3, 2016 (81 FR 35766) (FRL-9946-
52) and (81 FR 35767) (FRL-9946-53).

FOR FURTHER INFORMATION CONTACT: For the Guidance for Pesticide
Registrants on Pesticide Resistance Management Labeling; Notice of
Availability, contact Nikhil Mallampalli, Biological and Economic
Analysis Division (7503P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>For information on the Guidance for
Herbicide Resistance Management Labeling, Education, Training, and
Stewardship contact, Bill Chism, Biological and Economic Analysis
Division (7503P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  This document extends the public comment
period established in two Federal Register documents of June 3, 2016
(81 FR 35766) (FRL-9946-52) and (81 FR 35767) (FRL-9946-53), that each
announced the availability of a draft PR Notice: One entitled
``Guidance for Pesticide Registrants on Pesticide Resistance Management
Labeling'' and the other entitled ``Guidance for Herbicide Resistance
Management Labeling, Education, Training, and Stewardship.'' EPA is
hereby extending the comment period, which was set to end on August 2,
2016, to now end September 1, 2016.
    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES in the Federal Register
documents of June 3, 2016. If you have questions, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

    Authority:  7 U.S.C. 136 et seq.

    Dated: July 21, 2016.
Wynne F. Miller,
Acting Director, Biological and Economic Analysis Division, Office of
Pesticide Programs.
[FR Doc. 2016-17922 Filed 8-4-16; 8:45 am]
 BILLING CODE 6560-50-P


LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 14 1 14.0 Membrane Filtration 14.1 Introduction Microfiltration and ultrafiltration ( MF/ UF) are membrane processes which remove microorganisms and other contaminants by filtration. Contaminants larger than the pore size of the membrane are retained on the membrane and removed from the water. MF/ UF processes that meet the requirements for membrane filtration under the LT2ESWTR will receive Cryptosporidium removal credit.

EPA recently published the Membrane Filtration Guidance Manual for systems applying MF/ UF for removal of pathogens from public water supplies. The manual provides detailed guidance on applying membrane filtration to comply with the requirements of the LT2ESWTR. Readers interested in detailed information on membrane filtration should consult the Membrane Filtration Guidance Manual. This chapter will focus on the comparison of membrane filtration with other technologies for inactivation of Cryptosporidium.

14.2 Log Inactivation Requirements Most commercially available MF/ UF membranes designed for drinking water treatment, have been demonstrated to remove Cryptosporidium to detection limits, provided the membrane is intact. Systems that demonstrate membrane integrity through a challenge test before installation and through daily membrane integrity testing during operation will be eligible for 2.5 log additional credit for Cryptosporidium removal under the LT2ESWTR.

14.3 Toolbox Selection Considerations MF/ UF is a highly efficient technology for removing pathogens and other particulates from drinking water. Its main advantages are listed below:

° Essentially complete removal of all particles larger than the exclusion characteristic of the membrane ° Minimal installation effort when supplied as skid mounted package plants ° Minimal operator attention and training needed when supplied with fully automated controls ° Forms no disinfection byproducts because it is a physical removal process Chapter 14  Membrane Filtration LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 14 2 MF/ UF is an advanced technology and can be more expensive than conventional technologies. Its major disadvantages are:

° Total cost may exceed that of conventional technologies ° Membrane fouling may limit application in some cases ° Does not provide a disinfectant residual in the distribution system 14.4 Design Considerations Membrane systems are usually supplied in skid mounted packages. The package typically contains the membrane units, a pre filter for removal of large particles, low pressure feed pumps, high pressure backwash pumps, a chemical cleaning system, a chlorination system, and a backwash residuals handling and disposal system.

A major design variable for membrane systems is the permeate flux. MF/ UF membranes are designed to operate within a specific range of pressures and fluxes, and a membrane system must be designed to operate within these specifications. Pilot studies are often performed to find the optimal combination of flux, pressure, pretreatment, and cleaning interval for a particular application. Flux through a membrane is highly temperature dependent, so the average, minimum, and maximum temperature of the water to be treated must be considered when designing the system. The flux and the desired flow rate are used to determine the size and number of membrane units required. Water with high turbidity or high TOC levels can foul membranes, causing poor performance and shortening membrane life. If MF/ UF is installed after conventional treatment in the treatment train, high turbidity levels should not be a problem. TOC, however, may still be a problem, even after conventional filtration. If there are high TOC levels, pretreatment should be considered. If the membrane process is being relied upon to remove viruses as well as bacteria and protozoa, UF membranes will be needed. Considerations should also be made for treatment and/ or disposal of backwash residuals.

14.5 Operational Considerations In operating a membrane system, there are several factors that must be balanced. Operating at higher pressures will allow greater flow rates. It will also result in greater operating costs and increased cleaning and backwash frequency. Operating at lower pressures may result in reduced cleaning and backwash frequency but increased area requirements. To ensure the unit is working properly, regular integrity testing of the membrane should be conducted. While indicators such as turbidity can be useful, the integrity of the membrane should be directly tested at least daily. Even with pretreatment, membranes will eventually foul. Periodic cleaning of the membranes will improve membrane performance and life. The appropriate length of time between cleanings can be determined by monitoring the long term decrease in productivity and backwash efficiency. Chapter 14  Membrane Filtration LT2ESWTR Toolbox Guidance Manual Proposal Draft June 2003 14 3


[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Page 13663]
[FR Doc No: 2015-05893]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending February 21, 2015

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (see 14 CFR 302. 201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2015-0033.
    Date Filed: February 19, 2015.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: March 12, 2015.

Description

    Joint application of Southern Air Inc. (``Southern'') and Florida
West International Airways, Inc. (``Florida West'') requesting approval
of the de facto transfer of all international authority held by Florida
West to Southern.

    Docket Number: DOT-OST-2015-0037.
    Date Filed: February 20, 2015.

Due Date for Answers, Conforming Applications, or Motion To Modify
Scope

    March 13, 2015.

Description

    Application of Liberty Helicopters Inc. requesting authority to
engage in scheduled operations as a commuter air carrier and proposes
to operate flights between various New York City heliports, and the
following destinations: NYC Metro Airports, Mohegan Sun Casino,
Montauk, Southampton, and East Hampton (``Proposed Service'').

 Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Federal Register
Liaison.
[FR Doc. 2015-05893 Filed 3-13-15; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54453-54454]
[FR Doc No: 2021-21421]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1837]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic User Fee
Payment Request Forms

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Submit written comments (including recommendations) on the
collection of information by November 1, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0805. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Electronic User Fee Payment Request Forms--Form FDA 3913 and Form FDA
3914

OMB Control Number 0910-0805--Extension

    Form FDA 3913, User Fee Payment Refund Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment refund. The information collected includes the
organization, contact, and payment information. The information is used
to determine the reason for the refund, the refund amount, and who to
contact if there are any questions regarding the refund request. A
submission of the User Fee Payment Refund Request form does not
guarantee that a refund will be issued. FDA estimates an average of
0.40 hours per response, including the time to review instructions,
search existing data sources, gather and maintain the data needed, and
complete and review the collection of information. The estimated hours
are based on past FDA experience with the user fee payment refund
request.
    In fiscal year 2020, approximately 474 user fee refunds were
processed for cover sheets and invoices, including 0 for Animal Drug
User Fees, 0 for Animal Generic Drug User Fees, 1 for Biosimilar Drug
User Fees, 0 for Export Certificate Program fees, 0 for Freedom of
Information Act requests, 31 for Generic Drug User Fees, 200 for
Medical Device User Fees, 240 for Medical Device Federal Unified
Registration and Listing fees, 0 for Mammography inspection fees, 1 for
Prescription Drug User Fees, and 0 for Tobacco product fees.
    Form FDA 3914, User Fee Payment Transfer Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment transfer request. The information collected includes
payment and organization information. The information is used to
determine the reason for the transfer, how the transfer should be
performed, and who to contact if there are any questions regarding the
transfer request. A submission of the User Fee Payment Transfer Request
form does not guarantee that a transfer will be performed. FDA
estimates an average of 0.25 hours per response, including the time to
review instructions, search existing data sources, gather and maintain
the data needed, and complete and review the collection of information.
FDA estimated hours are based on past FDA experience with the user fee
payment transfer requests.
    In fiscal year 2020, approximately 194 user fee payment transfers
were processed for cover sheets and invoices, including 0 for Animal
Drug User Fees, 0 for Animal Generic Drug User Fees, 1 for Biosimilar
Drug User Fees, 34 for Generic Drug User Fees, 78 for Medical Device
User Fees, 80 for Medical Device Federal Unified Registration and
Listing fees, 0 for Mammography inspection fees, 1 for Prescription
Drug User Fees, and 0 for Tobacco product fees.
    Respondents for the electronic request forms include domestic and
foreign firms (including pharmaceutical, biological, medical device
firms, etc.). Specifically, refund request forms target respondents who
submitted a duplicate payment or overpayment for a user fee cover sheet
or invoice. Respondents may also include firms that withdrew an
application or submission. Transfer request forms target respondents
who submitted payment for a user fee cover sheet or invoice and need
that payment to be re-applied to another cover sheet or invoice
(transfer of funds).
    The electronic user fee payment request forms streamline the refund
and transfer processes, facilitate processing, and improve the tracking
of refund or transfer requests. The burden for this collection of
information is the same for all customers (small and large
organizations). The information being requested or required has been
held to the absolute minimum required for the intended use of the data.
Respondents

are able to request a user fee payment refund or transfer online at
https://www.fda.gov/forindustry/userfees/default.htm. This electronic
submission is intended to reduce the burden for customers to submit a
user fee payment refund and transfer request.
    In the Federal Register of April 29, 2021 (86 FR 22669), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
User Fee Payment Refund                    474               1             474  0.40 (24                     190
 Request--Form FDA 3913.                                                         minutes).
User Fee Payment Transfer                  194               1             194  0.25 (15                      49
 Request--Form FDA 3914.                                                         minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             239
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The current burden estimate shows a decrease of approximately 642
hours for this information collection over that reported previously.
The change reflects increased experience by the respondents to
correctly submit fee payments and increased sophistication in use of
the forms to request payments made in error. The use of the forms for
the user fee programs (e.g., Prescription Drug User Fees, Generic Drug
User Fees, Animal Drug User Fees, Animal Generic Drug User Fees,
Biosimilar Drug User Fees) are optional.
    In addition, new information technology applications have more
accurately calculated the number of registrants of drug facilities/food
facilities/medical device facilities/medicated feed facilities, and we
have therefore revised the number of respondents to the information
collection.

    Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21421 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Notices]
[Pages 376-377]
[FR Doc No: 2017-28343]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2984-037.
    Applicants: Merrill Lynch Commodities, Inc.
    Description: Notice of Non-Material Change in Status of Merrill
Lynch Commodities, Inc.

    Filed Date: 12/27/17.
    Accession Number: 20171227-5016.
    Comments Due: 5 p.m. ET 1/17/18.

    Docket Numbers: ER10-3254-003.
    Applicants: Cooperative Energy Incorporated (An Electric Membership
Corporation).
    Description: Updated Market Power Analysis of Cooperative Energy
Inc. (An Electric Membership Corporation).
    Filed Date: 12/22/17.
    Accession Number: 20171222-5299.
    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: ER18-540-000.
    Applicants: Westwood Generation, LLC.
    Description: Compliance filing: MBRA Tariff to be effective 2/28/
2018.
    Filed Date: 12/26/17.
    Accession Number: 20171226-5080.
    Comments Due: 5 p.m. ET 1/16/18.

    Docket Numbers: ER18-541-000.
    Applicants: Westwood Generation, LLC.
    Description: Compliance filing: Reactive Tariff to be effective 2/
28/2018.
    Filed Date: 12/27/17.
    Accession Number: 20171227-5000.
    Comments Due: 5 p.m. ET 1/17/18.

    Docket Numbers: ER18-542-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 642 5th Rev--NITSA with
General Mills Operations LLC to be effective 3/1/2018.
    Filed Date: 12/27/17.
    Accession Number: 20171227-5019.
    Comments Due: 5 p.m. ET 1/17/18.

    Docket Numbers: ER18-543-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 760 3rd Rev--NITSA with
Beartooth Electric Cooperative to be effective 3/1/2018.
    Filed Date: 12/27/17.
    Accession Number: 20171227-5020.
    Comments Due: 5 p.m. ET 1/17/18.

    Docket Numbers: ER18-544-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 666 5th Rev--NITSA with
Suiza Dairy Group LLC to be effective 3/1/2018.
    Filed Date: 12/27/17.
    Accession Number: 20171227-5021.
    Comments Due: 5 p.m. ET 1/17/18.

    Docket Numbers: ER18-545-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 767 4th Rev--NITSA with
Basin Electric Power Cooperative, Inc. to be effective 3/1/2018.
    Filed Date: 12/27/17.
    Accession Number: 20171227-5030.
    Comments Due: 5 p.m. ET 1/17/18.

    Docket Numbers: ER18-546-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 792 1st Rev--NITSA with
Big Horn County Electric Cooperative, Inc. to be effective 3/1/2018.
    Filed Date: 12/27/17.
    Accession Number: 20171227-5043.
    Comments Due: 5 p.m. ET 1/17/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 27, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-28343 Filed 1-2-18; 8:45 am]
 BILLING CODE 6717-01-P


                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                       APRIL 2015 PUBLIC MEETING AGENDA

               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.)
                  2777 S. Crystal Drive, Arlington, VA 22202

                           Wednesday, April 22, 2015

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone:<PHONE_NUMBER>
                  Docket Number: EPA - HQ - ORD - 2015 - 0145
                          Webcast of the HSRB Meeting
            The Webcast of the meeting is at the following website:
                     https://epa.connectsolutions.com/hsrb

1:00 PM*	Convene Public Meeting  -  Jim Downing, Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
            Introduction of Board Members  - Liza Dawson, Ph.D., HSRB Chair
	Welcome  -  Thomas A. Burke, PhD, MPH, Science Advisor, EPA

Session 1:	Completed Study and Monograph Report for Backpack and Handgun Application of Liquid Spray in Utility Rights of Way (Agricultural Handlers Exposure Task Force)

1:20 PM 	EPA Science Review  -  Mr. Mathew Crowley, (Health Effects Division, OPP, EPA)
2:05PM 	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, and Principal Investigator/Sponsor
2:30 PM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
2:45 PM	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, Principal Investigator/Sponsor
3:00 PM	Break
3:15 PM 	Public Comments
3:25 PM	Board Discussion

Charge to the Board - Science:

1.	Was the research reported in the Agricultural Handler Exposure Task Force (AHETF) completed monograph reports and associated field study report for AHE400 faithful to the design and objectives of the protocol, SOPs, and governing documents?

2. 	Has the Agency adequately characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating exposure of those who apply liquid pesticide sprays to utilities rights-of-way using backpack or handgun spray equipment?

Discussant: William Popendorf, Ph.D. (George Fernandez, Ph.D., statistics)

Charge to the Board - Ethics:

3.	Does available information support a determination that the studies were conducted in substantial compliance with subparts K and L of 40 CFR Part 26?

Discussant: Elizabeth Heitman, Ph.D.

4:50 PM 	Adjourn

                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                       APRIL 2015 PUBLIC MEETING AGENDA

               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.)
                  2777 S. Crystal Drive, Arlington, VA 22202

                           Thursday, April 23, 2015

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone:<PHONE_NUMBER>
                  Docket Number: EPA - HQ - ORD - 2015 - 0145
                          Webcast of the HSRB Meeting
            The Webcast of the meeting is at the following website:
                     https://epa.connectsolutions.com/hsrb

 9:00 AM*	Convene Public Meeting  -  Jim Downing, Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
            Introduction of Board Members  -  Liza Dawson, Ph.D., HSRB Chair
            Follow-up on Previous Day's Discussion  -  Ms. Kelly Sherman, OPP, Office of Chemical Safety and Pollution Prevention, EPA

Session 1:	Protocol for Field Testing of skin applied mosquito repellent products (SC Johnson)

9:10 AM 	EPA Science Review  -  Mr. Kevin Sweeney, (Registration Division, OPP, EPA)
9:30 AM	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, and Principal Investigator/Sponsor
10:00 AM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
10:20 AM	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, and Principal Investigator/Sponsor
10:45 AM	Public Comments
10:55 PM	Break
11:05 AM	Board Discussion

   If the SCJ study proposal is revised as suggested in EPA's science and ethics reviews and if the research is performed as described:

Charge to the Board - Science:

   * Is this research is likely to generate scientifically reliable data, useful for assessing the efficacy of these insect repellent pesticide products?

Discussant: Randy Maddalena, Ph.D. (Jun Zhu, Ph.D., statistics)

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?

Discussant: Gary Chadwick, Pharm.D., M.P.H, C.I.P.

12:05 PM 	Adjourn


COMPARATIVE EVALUATION OF VITELLOGENIN METHODS FOR FATHEAD MINNOW, MEDAKA AND ZEBRA FISH Photos : Biosense Laboratories Endocrine Disruptor Methods Validation Endocrine Disruptor Methods Validation Subcommittee Subcommittee August 2003 August 2003 EPA Work Assignments: 2 19 and 2 26 Presented by:

Michael L. Blanton and Dr. Irv Schultz 2 COMPARATIVE EVALUATION OF VITELLOGENIN METHODS FOR FATHEAD MINNOW, MEDAKA AND ZEBRA FISH COMPARATIVE EVALUATION OF VITELLOGENIN COMPARATIVE EVALUATION OF VITELLOGENIN METHODS FOR FATHEAD MINNOW, MEDAKA METHODS FOR FATHEAD MINNOW, MEDAKA AND ZEBRA FISH AND ZEBRA FISH WORK PERFORMED BY On behalf of the United States Environmental Protection Agency EPA CONTRACT NUMBER 68 W 01 023 3 Introduction Introduction Introduction Purpose of study: Survey of Methods for measurement of Vitellogenin ( VTG)

to conduct a survey of existing VTG analytical methods for suitability in a routine screening program.

Study was not intended to be a Method Validation

the comparison was not intended to be a validation of a given method, but an evaluation across methods to ascertain the qualitative and/ or quantitative comparability of the variety of methods currently available. 4 VTG Background VTG Background VTG Background VTG is a phospholipoglycoprotein precursor to egg yolk protein that normally occurs in sexually active female oviparous fishes, but can be induced to occur in males in response to estrogenic substances.

The measurement of a biochemical marker,

VTG in oviparous vertebrates is generally agreed to be a good indicator for estrogenic and anti estrogenic effects and is proposed as one of several endpoints in the fish screening assay. 5 Methods for Measuring VTG induction in fishes Methods for Measuring VTG Methods for Measuring VTG induction in fishes induction in fishes Enzyme Linked Immunosorbant Assays ( ELISA)

An enzyme immunoassay utilizing an enzymelabeled immunoreactant ( antigen/ antibody) and an immunosorbent ( antigen/ antibody bound to a solid support   i. e, a polystyrene microliter plate) 6 mRNA detection An alternative to measuring the VTG protein is to quantify the messenger ribonucleic acid ( mRNA) for VTG that codes for the protein.

Two methods for quantifying fish VTG mRNA have emerged,

the ribonuclease protection assay ( RPA)

the quantitative reverse transcriptionpolymerase chain reaction ( QRT PCR)

Methods for Measuring VTG induction in fishes cont.

Methods for Measuring VTG Methods for Measuring VTG induction in fishes cont.

induction in fishes cont. 7 Mass Spectrometry ( MALDI MS)

In general, MS approaches to protein quantification attempt to measure the protein largely in its intact form or rely on digestion procedures ( chemical or enzymatic) to reduce the size of the protein into smaller fragments.

The MS technique allows both the direct measurement of the VTG mass and generation of peptide fingerprinting data for further identification ( Wunschel and Wahl, 2002).

Methods for Measuring VTG induction in fishes Mass Spectrometry Methods for Measuring VTG Methods for Measuring VTG induction induction in fishes in fishes Mass Spectrometry Mass Spectrometry 8 Participants in the Fathead Minnow VTG Study Participants in the Participants in the Fathead Minnow VTG Study Fathead Minnow VTG Study WA 2 19 Fathead Minnow participants 1. University of Florida, USA 2. University of Idaho, USA 3. Oregon State University, USA 4. US EPA Duluth, USA 5. University of Exeter, USA 6. Brixham Environmental Laboratory, UK 7. Battelle Richland, USA 8. Battelle Sequin, USA 9. Molecular Light Technology, UK 10. Biosense, Norway 11. INERIS, France 12. Cemagref, France 13. University of Windsor, Canada 14. University of Southern Denmark, Denmark 15. Finnish Environmental Institute, Finland 9 Participants Zebrafish/ Medaka VTG Study ( contd)

Participants Participants Zebrafish/ Medaka VTG Study Zebrafish/ Medaka VTG Study ( contd)

( contd)

WA 2 26 Zebrafish/ Medaka Zebrafish/ Medaka Participants 1. Biosense Laboratories, Norway 2. Centre for Fish and Wildlife Health, University of Bern,

Switzerland 3. Department of Pathology, Vet. Medicine, Swedish University of Agricultural Sciences, Sweden 4. EnBioTec Laboratories, Ltd., Japan 5. Environmental and Symbiotic Sciences, Prefectural University of Kumamoto, Japan 6. Institute of Biology, University of Southern Denmark, Denmark 7. Los Angeles County Sanitation District, USA 8. National Institute for Environmental Studies ( NIES), Japan 9. Notox Safety & Environmental Research, the Netherlands 10. Phylonix Pharmaceuticals, Inc., USA 11. Unité d'Evaluation des Risques Ecotoxicologiques ( INERIS),

France. 10 Prepare standard series of plasma, liver and whole body homogenates of fathead minnow ( Pimephales promelas) to provide a range of VTG and mRNA concentrations produced in male and female fish ( plus a positive control) for evaluation by participating laboratories Determine the comparability of various methods for the analysis of vitellogenin in fathead minnows by means of statistical analysis of the results from eleven laboratories

The results from 8 ELISA laboratories, 3 mRNA laboratories and one Mass spectrometric ( MS) method are presented Objectives Fathead Minnow VTG Study Objectives Objectives Fathead Minnow VTG Study Fathead Minnow VTG Study 11 Objectives Zebrafish/ Medaka VTG Study Objectives Objectives Zebrafish/ Medaka VTG Study Zebrafish/ Medaka VTG Study Prepare standard series of liver and whole body homogenates of medaka and zebrafish for evaluation by participating laboratories; the series represents a range of vitellogenin concentrations in male and female fish, plus a positive control Determine the comparability of ELISA methods for the analysis of vitellogenin of the two species by means of statistical analysis of the results from eleven laboratories Photo:

Borg 2003 12 Methods Fathead Minnow VTG Study ( contd)

Methods Fathead Minnow VTG Study ( contd)

Methods Fathead Minnow VTG Study ( contd)

Sample Preparation ( Battelle)

Obtained approximately 600 Fathead minnows

Exposed subset of 100M and 190F to 300 ng/ L 17   estradiol in a 7

day static renewal treatment to induce vitellogenin production.

Remaining fish ( 210M and 190F remained unexposed).

Day 2 of exposure fish were sacrificed and liver tissue harvested for mRNA standard series ( 80 EM/ 80 UM and 160EF/ 160UF)

Prepared vitellogenin standard series from plasma collected from caudal vessels into heparinized hematocrit tubes.

whole body of exposed and unexposed, male and female fish by grinding tissue with ice cold ELISA assay buffer ( 1: 1 ratio, fish: buffer by wt), centrifuging, quick freezing supernatant on liquid nitrogen

Spiked unexposed male tissue of each species with known quantity of purified vitellogenin from corresponding species as positive control 13 Methods Zebrafish/ Medaka VTG Study ( contd)

Methods Methods Zebrafish/ Medaka Zebrafish/ Medaka VTG Study ( contd)

VTG Study ( contd)

Sample Preparation

Obtained approximately 400 zebrafish and 400 medaka

Exposed subset of each group to 300 ng/ L 17   estradiol in a 7 day static renewal treatment to induce vitellogenin production

Prepared vitellogenin standard series from liver and whole body of exposed and unexposed, male and female fish of each species by grinding tissue with ice cold ELISA assay buffer ( 1: 2 ratio, fish: buffer by wt),

centrifuging, quick freezing supernatant on liquid nitrogen

Spiked unexposed male tissue of each species with known quantity of purified vitellogenin from corresponding species as positive control ________________________

1Blood plasma was also collected, but its analysis was subsequently deleted from study. 14 Methods Fathead, Zebrafish/ Medaka VTG Study ( contd)

Methods Fathead,

Methods Fathead, Zebrafish/ Medaka Zebrafish/ Medaka VTG Study ( contd)

VTG Study ( contd)

 Shipment to participating labs ° Subsampled 20 µ L aliquots of homogenates and assembled triplicate vials of each sample type as standard series, each vial labeled with unique code for blind analysis:

° Shipped frozen at  80 ° C in super insulated packaging to elev participating labs 2 June 2003 with documentation, information, and standardized chainof custody and data reporting forms   Zebra fish   Zebra fish   W2   Zebra fish   L2   Zebra fish   S2 Standard Series: Whole Body, Liver ( W, L)

  uninduced male   uninduced female   induced male   induced female   positive control Purified vitellogenin as calibration standard for the species ( S) 15 Methods zebrafish Medaka VTG Study ( contd)

Methods zebrafish Medaka VTG Study ( contd)

Methods zebrafish Medaka VTG Study ( contd)

Sample analysis ( participating labs)

zebrafish  Sandwich enzyme immunoassay, VTG zebrafish antibody ( Biosense 2002) ( 6 labs)

 Sandwich ELISA, VTG zebrafish monoclonal antibody ( EnBio 2002; Nishi 2002) ( 1 lab)

 Direct noncompetitive sandwich ELISA, anti zebrafish lipovitellin,

polyclonal antibody ( Holbech et al. 2001) ( 1 lab)

 Modified Holbech et al. 2001 ( Borg 2003, unpublished) ( 1 lab)

 [ Competitive binding assay ( Brion et al. 2002) ( 1 lab); data received too late for inclusion in statistical analysis; see appendix] 16 Methods Zebrafish/ Medaka VTG Study ( contd)

Methods Methods Zebrafish/ Medaka VTG Study Zebrafish/ Medaka VTG Study ( contd)

( contd)

Sample analysis ( participating labs)

Medaka  Sandwich enzyme immunoassay, VTG medaka antibody ( Biosense 2003) ( 5 labs)

 Sandwich ELISA, VTG medaka monoclonal antibody ( EnBio 2002; Nishi 2002) ( 2 labs)

 Direct sandwich ELISA, VTG medaka monoclonal and biotinylated polyclonal antibodies ( Transgenic 2002) ( 1 lab)

 [ Competitive binding assay ( Brion et al. 2002) ( 1 lab); data received too late for inclusion in statistical analysis; see appendix] 17 Methods Fathead Minnow VTG Study ( contd)

Methods Methods Fathead Minnow VTG Study Fathead Minnow VTG Study ( contd)

( contd)

Sample analysis ( participating labs)

Fathead Minnow

ELISA ( 8 methods, 11 participating labs)

 Carp based polyclonal and monoclonal antibodies, sandwich ELISA ( Biosense 2002) ( 3 labs)

 Carp based polyclonal antibodies, competitive ELISA ( 1 lab)

 Carp based polyclonal and monoclonal antibodies, sandwich ELISA ( 1 lab)

 Trout based polyclonal antibodies in a competitive ELISA ( 2 labs)

 Fathead minnow based polyclonal antibodies, competitive, antibody capture ( 1 lab)

 Fathead minnow based, monoclonal antibody, direct ELISA ( 1 lab)

 Zebrafish based polyclonal antibodies, competitive ELISA ( 1 lab)

 Zebrafish based anti lipovitellin direct non competitive sandwich ELISA ( 1 lab)

mRNA ( 3 methods, 3 participating labs)

 mRNA  RT PCR  mRNA  qRT PCR TaqMan  mRNA  HPA ( hybridization protection assay)

Mass Spectrometric ( 1 method, 1 participating lab)

 Matrix assisted laser desorption/ ionization mass spectrometry ( MALDI MS) ( 1 lab) 18 C: Medaka liver D. Medaka whole body Results Zebrafish/ Medaka VTG Study Results Results Zebrafish/ Medaka VTG Study Zebrafish/ Medaka VTG Study Expected trend was as follows:

uninduced male< uninduced female< induced male< induced female>> positive control 1 10 100 1,000 10,000 100,000 1,000,000 10,000,000 100,000,000 0 1 2 3 4 5 6 Concentration Code Mean VTG Concentration Lab 1 Lab 2 Lab 4 Lab 5 Lab 7 Lab 8 Lab 9 Lab 10 Lab 12 Max Detection Limit 1 10 100 1,000 10,000 100,000 1,000,000 10,000,000 100,000,000 0 1 2 3 4 5 6 Concentration Code Mean VTG Concentration Lab 1 Lab 2 Lab 4 Lab 5 Lab 7 Lab 8 Lab 9 Lab 10 Lab 12 Max Detection Limit A: zebrafish liver B: zebrafish whole body 1 10 100 1,000 10,000 100,000 1,000,000 10,000,000 0 1 2 3 4 5 6 Concentration Code Mean VTG Concentration Lab 1 Lab 2 Lab 4 Lab 5 Lab 11 Lab 11 Lab 11 Lab 12 1 10 100 1,000 10,000 100,000 1,000,000 10,000,000 100,000,000 0 1 2 3 4 5 6 Concentration Code Mean VTG Concentration Lab 1 Lab 2 Lab 4 Lab 5 Lab 11 Lab 11 Lab 11 Lab 12   Results showed good relative tracking of trend,

particularly in medaka, but higher variability in absolute measured values Best fit: medaka liver results 19 Code 0 = Blank; Code 1 = Uninduced Male; Code 2 = Uninduced Female;

Code 3 = Induced male; Code 4 = Induced Female; Code 5 = Positive Control Homogenate 0.00 0.01 0.10 1.00 10.00 100.00 1000.00 10000.00 100000.00 0 1 2 3 4 5 6 Concentration Code VTG Concentr ation (

ug/

mL Lab 1 Lab 4 Lab 5 Lab 6 Lab 7 Lab 8 Lab 11 Lab 13 Max detection Limit Plasma 0.00 0.01 0.10 1.00 10.00 100.00 1000.00 10000.00 100000.00 1000000.00 0 1 2 3 4 5 6 Concentration Code VTG Concentration (

ug/

m Lab 1 Lab 4 Lab 5 Lab 6 Lab 7 Lab 11 Lab 13 Max detection Limit Results Fathead Minnow VTG Study Results Fathead Results Fathead Minnow VTG Study Minnow VTG Study Expected trend was as follows:

uninduced male< uninduced female< induced male< induced female>> positive control   Results showed good relative tracking of trend, particularly Plasma, but higher variability in absolute measured values 20 mRNA average for liver samples 0.1 1 10 100 1000 10000 100000 1000000 1 2 3 4 Lab 1 ( pg VTG mRNA / ug total RNA)

Lab 2 ( mRNA VTG / total RNA)

Lab 15 ( fmol VTG mRNA / ug total RNA)

All three methods distinguished between Uninduced and Induced fish mRNA Liver Results Code 1 = Uninduced Male; Code 2 = Uninduced Female;

Code 3 = Induced male; Code 4 = Induced Female;

Laboratory 1 RT PCR Laboratory 2 qRT PCR TaqMan Laboratory 15 HPA ( hybridization protection assay) 21 219PU18 Exposed Plasma:

Purified using microcon 100 with 60 ug BSA ( 6 ug injected)

 0 .005 0.005 0.015 0.025 0.035 0.045 1 5 75 1 14 9 172 3 229 7 2 8 71 3 44 5 4 01 9 459 3 516 7 5 7 41 6 3 15 6 88 9 7 46 3 803 7 8 6 11 9 1 85 9 75 9 Time ( 600/ min) Series1 BSA Vtg Rank Probability Z score Protein Information and Sequence Analyse Tools ( T) % pI + 1 1.0e+ 000 2.08 gi| 4572552| gb| AAD23878.1| AF130354_ 1 vitellogenin precursor [ Pimephales promelas] 17 9.0   gi| 15778562| gb| AAL07472.1| AF414432_ 1 vitellogenin [ Cyprinus carpio] 13 9.1 + 2 2.8e 005 0.14 T gi| 6006011| ref| NP_ 005492.1| ( NM_ 005501) integrin alpha 3, isoform b, [ Homo sapiens] 14 6.5 + 3 6.4e 007  T gi| 21362287| ref| NP_ 653099.1| RIKEN cDNA 2210402G22 [ Mus musculus] 25 9.1 4 2.3e 007  T gi| 20344336| ref| XP_ 111772.1| similar to put. gag and pol gene ( aa 1 814) [ Mus musculus] 19 9.6 + 5 9.8e 008  T gi| 16550881| dbj| BAB71072.1| ( AK056006) unnamed protein product [ Homo sapiens] 27 9.8 6 1.4e 008  T gi| 13385164| ref| NP_ 079982.1| RIKEN cDNA 4432405K22 [ Mus musculus] 17 5.2 + 7 1.1e 008  T gi| 14735371| ref| XP_ 027054.1| ( XM_ 027054) KIAA0674 protein [ Homo sapiens] 19 5.0 + 8 7.6e 009  T gi| 6005944| ref| NP_ 009058.1| ( NM_ 007127) villin 1; Villin 1 [ Homo sapiens] 15 6.0 9 6.8e 009  T gi| 21391472| gb| AAK58480.1| vitellogenin 1 [ Danio rerio] 12 8.9 kDa 146.26 148.24 118.74 66.13 85.00 64.01 76.51 92.49 92.68 128.02 Vtg Anion Exchange Fraction from treated plasma 219PT18:

database search with peptide masses 1000 1500 2000 2500 3000 219PU18 VTG AX fraction Digest 1000 1500 2000 2500 3000 Mass ( m/ z) 219PS18 VTG AX fraction Digest 1000 1500 2000 2500 3000 Standard curve 20ug Each Vtg & BSA:

VTG AX fraction digest Relative abundance Comparison of MALDI MS spectra from Vtg Digests vitellogenin precursor [ Pimephales promelas]

Rank: 1 Probability 1.0 e + 000 Z score: 1.98 % coverage: 17 vitellogenin precursor [ Pimephales promelas]

Rank: 1 Probability 1.0 e + 000 Z score: 1.67 % coverage: 25 vitellogenin precursor [ Pimephales promelas]

Rank: 1 Probability 1.0 e + 000 Z score: 1.51 % coverage: 15 Directly analyze VTG from fathead minnow plasma using a combination of liquid chromatography and mass spectrometry.

A membrane filtration pre purification step was coupled to an analytical scale anion exchange separation. This approach to MALDI MS analysis small plasma sample (< 10 µ l) MALDI MS 22 Summary Results Zebrafish/ Medaka VTG Study ( contd)

Summary Results Summary Results Zebrafish/ Medaka VTG Zebrafish/ Medaka VTG Study Study ( contd)

( contd)

Quantification of VTG was not absolute, but depended on method used and on the laboratory conducting the analysis ( one method can yield results thousands of times higher than those of another method,

but with similar relative trends)

Within run variability was typically low ( CVs< 10% for zebrafish, < 14%

for medaka) in 75% of results, with some higher outliers that accounted for a broader overall range of values Intra assay variability also covered broad range over all, but 75% of results were within a fairly tight distribution ( CVs< 30% zebrafish, < 41%

medaka); objective of detection of the standard series was generally met Little variation in values when two different standards were used for calibration for medaka for all three methods; similarly low for zebrafish VTG values for two methods, but high for one method 23 Summary Results Fathead Minnow ( contd)

Summary Results Summary Results Fathead Minnow Fathead Minnow ( contd)

( contd)

Quantification of VTG was not absolute, but depended on method used and on the laboratory conducting the analysis ( one method can yield results thousands of times higher than those of another method, but with similar relative trends)

Within run variability was relatively low for both Plasma and Homogenate CVs range 0 173% mean 32%, and 0  173% mean 34% respectively with some higher outliers that accounted for a broader overall range of values Intra assay variability also covered broad range for both sample types 75% of the CVs were less than 51%. This high level of intra assay variability indicates that the methods provide a high degree of variability when replicate samples are analyzed.

Detection of the standard series trend was generally met for Plasma and Homogenates mRNA levels were variable, with the labs reporting generally higher,

similar, or lower levels in the unexposed/ exposed males vs. the levels found in unexposed/ exposed females.

MALDI MS allowed detection of VTG confidently identifying VTG by matching experimental data with sequences in protein databases.

However, problems with sample degradation after thawing prevented quantitative estimates of VTG in plasma samples 24 Results Fathead Minnow,

Zebrafish/ Medaka VTG Study ( contd)

Results Fathead Minnow,

Results Fathead Minnow,

Zebrafish/ Medaka Zebrafish/ Medaka VTG Study VTG Study ( contd)

( contd)

Tukey's Honestly Significant Difference multiple comparison test of ranked average VTG concentrations: did neighboring means significantly differ?

Most methods could detect difference between uninduced males and other treatments;

differences were less clear cut among other groups.

There are biological reasons as well as differences in the chemical processes of the various methods that explain the results.

Positive controls were spiked at a specific, concentration; % recovery varied widely ( orders of magnitude)

Within lab variability low, but among laboratories and methods moderate ( medaka) to high ( zebrafish) For Fathead minnow both within and among laboratories the variability was relatively high. Results are typical of those seen in other studies ( e. g., Brion et al.

2002; Holbech et al. 2001) for variability of positive control spike recovery Sources of variability could not be precisely defined within the confines of this study. Variability due to the following factors not considered in this statistical analysis:

Shipping, storage, and handling of samples and other materials

Time and resource restrictions

Technical differences among protocols, such as method detection limits

Biological differences among fish ( e. g., reproductive status of fish during treatment) 25 Discussion and Recommendations Fathead minnow, Zebrafish/ Medaka VTG Study Discussion and Recommendations Discussion and Recommendations Fathead minnow,

Fathead minnow, Zebrafish/ Medaka Zebrafish/ Medaka VTG Study VTG Study Various studies have demonstrated utility of VTG as biomarker indicating endocrine disruption in fish Based on present results, most laboratories and methods considered are capable of distinguishing changes in VTG levels in Fathead minnow, zebrafish and/ or medaka Issues need to be resolved before VTG measurement could be used as reliable screening and testing tool Recommendations:

Develop specific performance criteria for VTG analytical methods

Use single, standardized protocol for each fish species to quantify VTG in interlaboratory validation trials


February 7, 2007

MEMORANDUM

FROM:  	Richard Cook

	   	Assessment and Standards Division

TO:	 	 Docket EPA-HQ-OAR-2005-0036

SUBJECT:	Data Files for National-Scale Modeling of Air Quality, Exposure
and Risk from Mobile Source Air Toxics; Final Mobile Source Air Toxics
Rule

The purpose of this memorandum is to transmit input and output
datafiles, and models from national-scale modeling of air toxics done to
support the final mobile source air toxics rule.  This modeling is
documented in the technical report, “National Scale Modeling of Air
Toxics for the Final Mobile Source Air Toxics Rule; Technical Support
Document,” Report Number EPA-454/R-07002, as well as Sections 2.2.1
and 3.2 of the Regulatory Impact Analysis.

These files are contained on 9 DVDs and one CD.  The CD contains README
files for the DVDs, a SAS program to convert Access files to SAS, and a
checklist of all files included on the DVDs.