	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2009-0506; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans;
Commonwealth of Pennsylvania; Determination of Clean Data for the 1997
Fine Particulate Matter Standard

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to determine that the Johnstown (Cambria and
Indiana Counties), Lancaster (Lancaster County), Reading (Berks County)
and York (York County), Pennsylvania nonattainment areas for the 1997
fine particulate matter (PM2.5) National Ambient Air Quality Standard
(NAAQS) have clean data for the 1997 PM2.5 NAAQS.  This proposed
determination is based upon quality assured, quality controlled, and
certified ambient air monitoring data showing that these areas have
monitored attainment of the 1997 PM2.5 NAAQS based on the 2006 – 2008
data.  In addition, quality controlled and quality assured monitoring
data for 2009 that are available in the EPA Air Quality System (AQS)
database, but not yet certified, show that these areas continue to meet
the 1997 PM2.5 NAAQS.  If this proposed determination is made final, the
requirements for these areas to submit an attainment demonstration,
associated reasonably available measures, a reasonable further progress
plan, contingency measures, and other planning State Implementation
Plans (SIPs) related to attainment of the standard shall be suspended
for so long as each of these areas continue to meet the 1997 PM2.5
NAAQS.

DATES:  Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2009-0506 by one of the following methods:

www.regulations.gov.  Follow the on-line instructions for submitting
comments.

B.    	E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    	Mail:  EPA- R03-OAR-2009-0506, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.   	Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket’s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2009-0506.  EPA's policy is that all comments received will
be included in the public docket without change, and may be made
available online at   HYPERLINK "http://www.regulations.gov"
www.regulations.gov , including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.  Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov website is an “anonymous access” system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment.  If you send an
e-mail comment directly to EPA without going through   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov ., your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet.  If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit.  If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA may
not be able to consider your comment.  Electronic files should avoid the
use of special characters, any form of encryption, and be free of any
defects or viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT:  Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:  Throughout this document whenever “we,”
“us,” or “our” is used, we mean EPA.

Organization of this document.  The following outline is provided to aid
in locating information in this preamble.

I.    What Action is EPA Taking?

II.   What is the Effect of This Action?

III.  What is the Background for This Action?

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

V.   What is EPA’s Proposed Action?

VI.  What are the Statutory and Executive Order Reviews?

I.  What Action is EPA Taking?

EPA is proposing to determine that the Johnstown, Lancaster, Reading and
York, Pennsylvania PM2.5 nonattainment areas have clean data for the
1997 PM2.5 NAAQS.  This determination is based upon quality assured,
quality controlled, and certified ambient air monitoring data showing
that these areas have monitored attainment of the 1997 PM2.5 NAAQS based
on the 2006 – 2008 data.  In addition, quality controlled and quality
assured monitoring data for 2009 that are available in the EPA AQS
database, but not yet certified, show that these areas continue to meet
the 1997 PM2.5 NAAQS.

II.  What is the Effect of This Action?

If this determination is made final, under the provisions of EPA’s
PM2.5 implementation rule (see 40 CFR section 51.1004(c)), the
requirements for the Johnstown, Lancaster, Reading and York,
Pennsylvania PM2.5 nonattainment areas to submit an attainment
demonstration, associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and any other
planning SIPs related to attainment of the 1997 PM2.5 NAAQS would be
suspended for so long as each area continues to meet the 1997 PM2.5
NAAQS.

As further discussed below, the proposed determination would:  (1) for
the Johnstown, Lancaster, Reading and York, Pennsylvania PM2.5
nonattainment areas, suspend the requirements to submit for each area an
attainment demonstration, associated reasonably available control
measures (RACM) (including reasonably available control technologies
(RACT)), a reasonable further progress (RFP) plan, contingency measures,
and any other planning SIPs related to attainment of  the 1997 PM2.5
NAAQS; (2) continue until such time, if any, that EPA subsequently
determines that each area have violated the 1997 PM2.5 NAAQS; (3) be
separate from, and not influence or otherwise affect, any future
designation determination or requirements for the Johnstown,  Lancaster,
Reading and York, Pennsylvania PM2.5 nonattainment areas based on the
2006 PM2.5 NAAQS; and (4) remain in effect regardless of whether EPA
designates these areas as  nonattainment areas for purposes of the 2006
PM2.5 NAAQS.  Furthermore, as described below, any such final
determinations would not be equivalent to the redesignation of these
areas to attainment based on the 1997 PM2.5 NAAQS.

If this rulemaking is finalized and EPA subsequently determines, after
notice-and-comment rulemaking in the Federal Register, that these areas
have violated the 1997 PM2.5 NAAQS, the basis for the suspension of the
specific requirements, set forth at 40 CFR section 51.1004(c), would no
longer exist, and these areas would thereafter have to address the
pertinent requirements.

The determination that EPA proposes with this Federal Register notice,
that the air quality data show attainment of the 1997 PM2.5 NAAQS, is
not equivalent to the redesignation of these areas to attainment.  This
proposed action, if finalized, would not constitute a redesignation to
attainment under section 107(d)(3) of the Clean Air Act (CAA), because
we would not yet have an approved maintenance plan for these areas as
required under section 175A of the CAA, nor a determination that these
areas have met the other requirements for redesignation.  The
designation status of these areas would remain nonattainment for the
1997 PM2.5 NAAQS until such time as EPA determines that these areas meet
the CAA requirements for redesignation to attainment.

This proposed action, if finalized, is limited to a determination that
the Johnstown, Lancaster, Reading and York, Pennsylvania PM2.5
nonattainment areas have clean data for the 1997 PM2.5 NAAQS.  The 1997
PM2.5 NAAQS became effective on July 18, 1997 (62 FR 36852) and are set
forth at 40 CFR section 50.7.  The 2006 PM2.5 NAAQS, which became
effective on December 18, 2006 (71 FR 61144) are set forth at 40 CFR
section 50.13.  EPA is currently in the process of making designation
determinations, as required by CAA section 107(d)(1), for the 2006 PM2.5
NAAQS.  At this point, EPA has not made any designation determination
for the Johnstown, Lancaster, Reading and York, Pennsylvania PM2.5
nonattainment areas based on the 2006 PM2.5 NAAQS.  This proposed
determination, and any final determination, will have no effect on, and
is not related to, any future designation determination that EPA may
make based on the 2006 PM2.5 NAAQS for these Pennsylvania PM2.5
nonattainment areas.  Conversely, any future designation determination
of these Pennsylvania PM2.5 nonattainment areas based on the 2006 PM2.5
NAAQS, will not have any effect on the determination proposed by this
notice.

If this proposed determination is made final and the Johnstown,
Lancaster, Reading and York, Pennsylvania PM2.5 nonattainment areas
continue to demonstrate attainment with the 1997 PM2.5 NAAQS, the
requirements for these Pennsylvania PM2.5 nonattainment areas to submit
an attainment demonstration, associated reasonably available control
measures, a reasonable further progress plan, contingency measures, and
any other planning SIPs related to attainment of the 1997 PM2.5 NAAQS
would remain suspended, regardless of whether EPA designates these areas
as nonattainment areas for purposes of the 2006 PM2.5 NAAQS.  Once these
areas are designated for the 2006 NAAQS, they will have to meet all
applicable requirements for that designation.

III.  What is the Background for This Action?

On July 18, 1997 (62 FR 36852), EPA established a health-based PM2.5
NAAQS at 15.0 micrograms per cubic meter (µg/m3) based on a 3-year
average of annual mean PM2.5 concentrations, and a twenty-four hour
standard of 65 µg/m3 based on a 3-year average of the 98th percentile
of 24-hour concentrations.  EPA established the standards based on
significant evidence and numerous health studies demonstrating that
serious health effects are associated with exposures to particulate
matter.  The process for designating areas following promulgation of a
new or revised NAAQS is contained in section 107(d)(1) of the CAA.  EPA
and State air quality agencies initiated the monitoring process for the
1997 PM2.5 NAAQS in 1999, and developed all air quality monitors by
January 2001.  On January 5, 2005 (70 FR 944), EPA published its air
quality designations and classifications for the 1997 PM2.5 NAAQS based
upon air quality monitoring data from those monitors for calendar years
2001 – 2003.  These designations became effective on April 5, 2005.
The Johnstown, Lancaster, Reading and York, Pennsylvania nonattainment
areas were designated nonattainment for the 1997 PM2.5 NAAQS (see 40 CFR
part 81).

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

EPA has reviewed the ambient air monitoring data for PM2.5 consistent
with the requirements contained in 40 CFR part 50 and recorded in the
EPA AQS database for the Johnstown, Lancaster, Reading and York,
Pennsylvania PM2.5 nonattainment areas from 2006 through the present
time.  On the basis of that review, EPA has concluded that these areas
meet the 1997 PM2.5 NAAQS based on the 2006 – 2008 data.  In addition,
quality controlled and quality assured monitoring data for 2009 that are
available in the EPA AQS database, but not yet certified, show that
these areas continue to attain the 1997 PM2.5 NAAQS.

Under EPA regulations at 40 CFR Part 50, section 50.7:

(1) The annual primary and secondary PM2.5 standards are met when the
annual arithmetic mean concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 15.0 µg/m3.

(2) The 24-hour primary and secondary PM2.5 standards are met when the
98th percentile 24-hour concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 65 µg/m3.

Table 1 shows the design values for the 1997 24-hour PM2.5 NAAQS for
Johnstown, Lancaster, Reading and York, Pennsylvania PM2.5 nonattainment
area monitors for the years 2006 – 2008. Table 2 shows the design
values for the 1997 annual PM2.5 NAAQS for these same monitors and the
same three-year period.

Table 1 - Design Values for the 1997 24-Hour PM2.5 NAAQS for Johnstown,
Lancaster, Reading and York, Pennsylvania in micrograms per cubic meter
(µg/m3)

Location	AQS site ID	1997 24-Hour Attainment Standard	2006 – 2008

Design Values

Cambria County (Johnstown, PA)	42-021-0011	65	35

Lancaster County (Lancaster, PA)	42-071-0007	65	37

Berks County (Reading, PA)	42-011-0011	65	34

York County (York, PA)	42-133-0008	65	35

Table 2 - Design Values for the 1997 Annual PM2.5 NAAQS for Johnstown,
Lancaster, Reading and York, Pennsylvania in micrograms per cubic meter
(µg/m3)

Location	AQS site ID	1997 Annual Attainment Standard	2006 – 2008

Design Values

Cambria County (Johnstown, PA)	42-021-0011	15.0	14.4

Lancaster County (Lancaster, PA)	42-071-0007	15.0	14.5

Berks County (Reading, PA)	42-011-0011	15.0	13.6

York County (York, PA)	42-133-0008	15.0	14.6

EPA’s review of these data indicate that the Johnstown, Lancaster,
Reading and York, Pennsylvania PM2.5 nonattainment areas have met and
continue to meet the 1997 PM2.5 NAAQS. EPA is soliciting public comments
on the issues discussed in this document.  These comments will be
considered before taking final action.  Please note that if EPA receives
adverse comment on an amendment, paragraph, or section of this rule and
if that provision may be severed from the remainder of the rule, EPA may
adopt as final those provisions of the rule that are not the subject of
an adverse comment.

V.   What is EPA’s Proposed Action?

EPA is proposing to determine that the Johnstown, Lancaster, Reading and
York, Pennsylvania nonattainment areas for the 1997 PM2.5 NAAQS have
clean data for the 1997 PM2.5 NAAQS.  As provided in 40 CFR section
51.1004(c), if EPA finalizes this determination, it would suspend the
requirements for these areas to submit an attainment demonstration,
associated reasonably available control measures, a reasonable further
progress plan, contingency measures, and any other planning SIPs related
to attainment of the 1997 PM2.5 NAAQS so long as these areas continue to
meet the 1997 PM2.5 NAAQS.

VI.  What are the Statutory and Executive Order Reviews?

Under the CAA, the Administrator is required to approve a SIP submission
that complies with the provisions of the CAA and applicable Federal
regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in reviewing
SIP submissions, EPA’s role is to approve state choices, provided that
they meet the criteria of the CAA.  Accordingly, this action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

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 (Public Law 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
CAA; and

does not provide 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, this proposed rule pertaining to the determination of the
1997 fine particle standard for the Johnstown, Lancaster, Reading and
York, Pennsylvania PM2.5 nonattainment areas, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part

Environmental protection, Air pollution control, Particulate matter.

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

            Judith M. Katz, Acting for

            William C. Early

__July 24, 2009____________
____________________________

Dated:
William C. Early,

 Acting Regional Administrator,

 Region III.

 PAGE

 PAGE   2

 PAGE  12


[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Page 25774]
[FR Doc No: 2011-10996]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

International Standards on the Transport of Dangerous Goods;
Public Meeting

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation.

ACTION: Notice of public meeting.

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SUMMARY: This notice is to advise interested persons that PHMSA will
conduct a public meeting in preparation for the 39th session of the
United Nations Sub-Committee of Experts on the Transport of Dangerous
Goods (UNSCOE TDG) to be held June 20-24, 2011, in Geneva, Switzerland.
During this meeting, PHMSA is also soliciting comments relative to
potential new work items which may be considered for inclusion in its
international agenda.

Information Regarding the UNSCOE TDG Meeting

    Date: Wednesday, June 8, 2011; 9:30 a.m.-12:30 p.m.
    Address: The meeting will be held at the DOT Headquarters, West
Building, Oklahoma City Conference Room, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
    Registration: Pre-registration for this meeting is not required.
Participants are encouraged to arrive early to allow time for security
checks necessary to obtain access to the building.
    Conference Call Capability/Live Meeting Information: Conference
call-in and ``live meeting'' capability will be provided for this
meeting. Specific information on call-in and live meeting access will
be posted when available at http://www.phmsa.dot.gov/hazmat/regs/international.

FOR FURTHER INFORMATION CONTACT: Mr. Shane Kelley, Senior International
Transportation Specialist, Office of Hazardous Materials Safety,
Department of Transportation, Washington, DC 20590;<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The primary purpose of this meeting will be
to prepare for the 39th session of the UNSCOE TDG. The 39th session of
the UNSCOE TDG is the first of four meetings scheduled for the 2011-
2012 biennium. The UNSCOE will consider proposals for the 18th Revised
Edition of the United Nations Recommendations on the Transport of
Dangerous Goods Model Regulations which will be implemented within
relevant domestic, regional, and international regulations from January
1, 2015. Copies of proposals and the meeting agenda may be obtained
from the United Nations Transport Division's Web site at: http://www.unece.org/trans/main/dgdb/dgsubc/c32011.html.
    General topics on the agenda for the UNSCOE TDG meeting include:
     Explosives and related matters.
     Listing, classification and packing.
     Electric storage systems.
     Electronic data interchange (EDI) for documentation
purposes.
     Cooperation with the International Atomic Energy Agency
(IAEA).
     Global harmonization of transport of dangerous goods
regulations.
     Guiding principles for the Model Regulations.
     Globally Harmonized System of Classification and Labeling
of Chemicals (GHS).
    In addition, PHMSA is soliciting comments on how to further enhance
harmonization for international transport of hazardous materials. PHMSA
has finalized a broad international strategic plan and welcomes input
on items which stakeholders believe should be included as specific
initiatives within this plan. PHMSA's Office of International Standards
Strategic Plan can be accessed at: http://www.phmsa.dot.gov/hazmat/regs/international.
    Following the 39th session of the UNSCOE TDG, PHMSA will place a
copy of the Sub-Committee's report and a summary of the results on
PHMSA's Hazardous Materials Safety Web site at http://www.phmsa.dot.gov/hazmat/regs/international.
    PHMSA's site at http://www.phmsa.dot.gov/hazmat/regs/international
provides additional information regarding the UNSCOE TDG and related
matters such as summaries of decisions taken at previous sessions of
the UNSCOE TDG.

    Issued in Washington, DC, on May 2, 2011.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 2011-10996 Filed 5-4-11; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40720-40722]
[FR Doc No: 2020-14494]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89197; File No. SR-NYSEArca-2020-56]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change To Amend NYSE Arca Rules 5.2-E(j)(3), 5.2-
E(j)(8), 5.5-E(g)(2), 8.600-E and 8.900-E

June 30, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on June 18, 2020, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') a proposed rule change described in Items I and II
below, which Items have been prepared by the Exchange. 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\ 15 U.S.C. 78a.
    \3\ 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 Exchange proposes to amend NYSE Arca Rules 5.2-E(j)(3)
(Investment Company Units), 5.2-E(j)(8) (Exchange-Traded Fund Shares),
5.5-E(g)(2), 8.600-E (Managed Fund Shares) and 8.900-E (Managed
Portfolio Shares) to (1) remove the listing requirement that, following
the initial twelve-month period after commencement of trading of a
series of Investment Company Units, Exchange-Traded Fund Shares,
Managed Fund Shares, and Managed Portfolio Shares, respectively, on the
Exchange that the applicable fund has at least 50 beneficial holders,
and (2) require that a series of Investment Company Units, Exchange-
Traded Fund Shares, Managed Fund Shares, and Managed Portfolio Shares,
respectively, have at least one creation unit outstanding on an initial
and continued listing basis. The proposed change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, 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 self-regulatory organization
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 those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend NYSE Arca Rules 5.2-E(j)(3)
(Investment Company Units), 5.5 E(g)(2), 5.2-E(j)(8) (Exchange-Traded
Fund Shares),\4\ 8.600-E (Managed Fund Shares) and 8.900-E (Managed
Portfolio Shares) (collectively, ``Fund Shares'') to (1) remove the
listing requirement that, following the initial twelve-month period
after commencement of trading of a series of Investment Company Units,
Exchange-Traded Fund Shares, Managed Fund Shares or Managed Portfolio
Shares, respectively, on the Exchange, such series have at least 50
beneficial holders, and (2) require that a series of Fund Shares have
at least one creation unit outstanding on an initial and continued
listing basis.\5\
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    \4\ A series of Exchange-Traded Fund Shares listed pursuant to
NYSE Arca Rule 5.2-E (j)(8) is required to be eligible to operate in
reliance on Rule 6c-11 under the Investment Company Act of 1940, as
amended (``1940 Act''). See NYSE Arca Rule 5.2-E (j)(8)(e)(1).
    \5\ The term creation unit would have the same meaning as
defined in Rule 6c-11(a)(1) (i.e., a specified number of exchange-
traded fund shares that the exchange-traded fund will issue to (or
redeem from) an authorized participant in exchange for the deposit
(or delivery) of a basket and a cash balancing amount if any).
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    The Exchange believes that the requirement that a series of Fund
Shares listed on the Exchange must have at least 50 beneficial
shareholders is no longer necessary. Exchange-Traded Fund Shares are
currently subject to the conditions of Rule 6c-11 under 1940 Act \6\
and Investment Company Units and Managed Fund Shares will be required
to operate in compliance with Rule 6c-11 by December 23, 2020.\7\ The
Exchange believes that the requirements of Rule 6c-11 and, in
particular, the website disclosure requirements of Rule 6c-11(c),
together with the existing creation and redemption process, serve to
mitigate the risks of manipulation and lack of liquidity that the
shareholder requirement was intended to address. The Exchange believes
that requiring at least one creation unit to be outstanding at all
times, together with the enhanced disclosure requirements of Rule 6c-
11, will facilitate an effective arbitrage mechanism that, for
Investment Company Units, Managed Fund Shares and Exchange-Traded Fund
Shares, will provide investors with sufficient transparency into the
holdings of the underlying portfolio and help ensure that the trading
price in the secondary market remains in line with the value per share
of a fund's portfolio.
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    \6\ See Release No. 33-10695; IC-33646; File No. S7-15-18
(Exchange-Traded Funds) (September 25, 2019), 84 FR 57162 (October
24, 2019) (``ETF Adopting Release'').
    \7\ As of December 23, 2020, the Commission is rescinding those
portions of prior Commission ETF exemptive orders that grant relief
related to the formation and operation of an ETF. See ETF Adopting
Release, note 39 and accompanying text.
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    For example, Rule 6c-11(c)(1)(vi), which requires additional
disclosure if the premium or discount is in excess of 2% for more than
seven consecutive days, as well as the related website disclosure and
discussion requirements,\8\ provides additional transparency to
investors in the event that the trading value and the underlying
portfolio deviate for an extended period of time, which could indicate
an inefficient arbitrage mechanism.\9\
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    \8\ Rule 6c-11(c)(1)(vi) provides that ``[i]f the exchange-
traded fund's premium or discount is greater than 2% for more than
seven consecutive trading days, a statement that the exchange-traded
fund's premium or discount, as applicable, was greater than 2% and a
discussion of the factors that are reasonably believed to have
materially contributed to the premium or discount, which must be
maintained on the website for at least one year thereafter.''
    \9\ The Commission discussed the importance of an effective and
efficient arbitrage mechanism in the ETF Adopting Release at 84 FR
57165 and 57209-57211 (``Secondary Market Trading, Arbitrage and ETF
Liquidity)''.
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    With respect to Managed Portfolio Shares, while these securities do
not publicly disclose their portfolio holdings daily and are not
eligible to rely on Rule 6c-11, the Commission, in approving exchange
rules accommodating listing and trading of Managed Portfolio Shares,
stated that the Verified Intraday Indicative Value (``VIIV'') and other
information required to be disseminated in connection with such trading
ensures transparency of key values and information for such
securities.\10\ The Exchange believes that such information is
sufficient to support an effective arbitrage process, independent of
any minimum shareholder requirement.
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    \10\ See Securities Exchange Act Release No. 87759 (December 16,
2019) 84 FR 70223 (December 20, 2019) (SR-CboeBZX-2019-047) (Notice
of Filing of Amendment Nos. 4 and 5, and Order Granting Accelerated
Approval of a Proposed Rule Change, as Modified by Amendment Nos. 4
and 5, to Adopt BZX Rule 14.11(k) to Permit the Listing and Trading
of Managed Portfolio Shares). In that order, the Commission stated:
``Although the portfolio holdings of the Managed Portfolio Shares
are not publicly disclosed on a daily basis, the Commission believes
that the proposed continued listing standards and trading rules
under proposed BZX Rule 14.11(k) are adequate to ensure transparency
of key values and information regarding the securities. The
Commission notes that, for continued listing of each series of
Managed Portfolio Shares, the VIIV will be widely disseminated by
the Reporting Authority and/or one or more major market data vendors
in one second intervals during Regular Trading Hours, and will be
disseminated to all market participants at the same time. Further,
transactions in Managed Portfolio Shares would be permitted only
during Regular Trading Hours, when one second VIIVs would be
available. In addition, like all other registered management
investment companies, each series of Managed Portfolio Shares would
be required to publicly disclose its portfolio holdings information
on a quarterly basis, within at least 60 days following the end of
every fiscal quarter.'' [footnotes omitted]. See also, Securities
Exchange Act Release No. 88648 (April 15, 2020) 85 FR 22200 (April
21, 2020) (SR-NYSEArca-2020-32) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change to Adopt NYSE Arca Rule 8.900-
E).
---------------------------------------------------------------------------

    The Exchange notes that, as of June 9, 2020, the median creation
unit size for a series of Fund Shares listed on the Exchange is 50,000
shares and the mean creation unit size is approximately 58,012 shares.
As of June 9, 2020, of the approximately 1,368 series of Fund Shares
listed on the Exchange, the median number of creation units outstanding
is approximately 71, approximately 214 series have fewer than 10
creation units outstanding, and approximately 13 series have one
creation unit outstanding.\11\
---------------------------------------------------------------------------

    \11\ NYSE Arca internal data as of June 9, 2020.
---------------------------------------------------------------------------

    The arbitrage mechanism relies on the fact that Fund Shares can be
created and redeemed and that Fund Shares are able to flow into the
market when the price of a series of Fund Shares is lower than the net
asset value per share of the portfolio. The resulting buying and
selling of Fund Shares, as well as the underlying portfolio components,
generally causes the market price and the net asset value per share to
align. The functioning of the arbitrage mechanism helps to ensure that
the trading price in the secondary market is at fair value.
    The existence of the creation and redemption process, as well as
the proposed requirement that at least one creation unit is always
outstanding, would ensure that market participants are able to redeem
Fund Shares and, thereby, allow the arbitrage mechanism to function
properly. The Exchange believes, therefore, that such arbitrage
mechanism would obviate the need for a minimum shareholder requirement
to support a fair and orderly market in Fund Shares. In addition, the
Exchange's surveillance procedures for Fund Shares and its ability to
halt trading in Fund Shares in specified

circumstances provide for additional investor protections by further
mitigating any abnormal trading that would affect the Fund Shares'
prices.\12\
---------------------------------------------------------------------------

    \12\ See, e.g., NYSE Arca Rule 7.18-E(d)(2); NYSE Arca Rule
8.900-E(d)(2).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposal is consistent with Section
6(b) of the Act \13\ in general and Section 6(b)(5) of the Act \14\ in
particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Exchange-Traded Fund Shares are currently subject to the conditions
of Rule 6c-11 under 1940 Act \15\ and Investment Company Units and
Managed Fund Shares will be required to operate in compliance with Rule
6c-11 by December 23, 2020.\16\ The Exchange believes that the
requirements of Rule 6c-11 and in particular the website disclosure
requirements of Rule 6c-11(c), together with the existing creation and
redemption process and proposed requirement that at least one creation
unit is always outstanding, would serve to mitigate the risks of
manipulation and the lack of liquidity that the shareholder requirement
was intended to address. More specifically, the Exchange believes that
requiring at least one creation unit to be outstanding at all times,
together with the enhanced disclosure requirements of Rule 6c-11, would
facilitate an effective arbitrage mechanism that, for Investment
Company Units, Managed Fund Shares and Exchange-Traded Fund Shares,
would provide investors with sufficient transparency into the holdings
of the underlying portfolio and help ensure that the trading price in
the secondary market remains in line with the value per share of a
fund's portfolio.
---------------------------------------------------------------------------

    \15\ See note 6, supra.
    \16\ See note 7, supra.
---------------------------------------------------------------------------

    With respect to Managed Portfolio Shares, the Commission, in
approving exchange rules accommodating listing and trading of Managed
Portfolio Shares, stated that the VIIV and other information required
to be disseminated in connection with such trading ensures transparency
of key values and information for such securities.\17\ The Exchange
believes that such information is sufficient to support an effective
arbitrage process, independent of any minimum shareholder requirement.
---------------------------------------------------------------------------

    \17\ See note 10, supra.
---------------------------------------------------------------------------

    Reliance on the conditions of Rule 6c-11 (for Investment Company
Units, Exchange-Traded Fund Shares and Managed Fund Shares) or the VIIV
and other requirements applicable to Managed Portfolio Shares, together
with the existing creation and redemption process, as well as the
presence of at least one creation unit, would serve to work together to
mitigate the risks of manipulation and the lack of liquidity that the
shareholder requirement was intended to address. By further aligning
the listing requirements with the operational relationship between
investors, market participants and ETF issuers, the proposal
facilitates greater transparency for investors and issuers resulting in
a more efficient market and increased investor protections.
    For the above reasons, the Exchange believes that the proposed rule
change is consistent with the requirements of Section 6(b)(5) of the
Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. The Exchange believes that
the proposed rule change will facilitate growth in development of new
issues of Fund Shares, to the benefit of investors and the marketplace.

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

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

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

    Within 45 days of the date of publication of this notice in the
Federal Register or such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2020-56 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2020-56. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEArca-2020-56 and should be submitted
on or before July 28, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-14494 Filed 7-6-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Pages 64957-64958]
[FR Doc No: 2011-27071]

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

Federal Emergency Management Agency

Docket ID FEMA-2011-0017; OMB No. 1660-0040]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request, Standard Flood Hazard Determination Form

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before November 18, 2011.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 1800 South Bell Street, Arlington, VA
20598-3005, facsimile number<PHONE_NUMBER>, or e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Standard Flood Hazard Determination Form.
    Type of information collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0040.
    Form Titles and Numbers: FEMA Form 086-0-32 (previously FEMA Form
81-93), Standard Flood Hazard Determination Form (SFHDF).
    Abstract: FEMA Form 086-0-32 (previously FEMA Form 81-93), SFHDF is
used by regulated lending institutions, federal agency lenders, related
lenders/regulators, and the Government. Federally regulated lending
institutions complete this form when making, increasing, extending,
renewing or purchasing each loan for the purpose is of determining
whether flood insurance is required and available. The form may also be
used by property owner, insurance agents, realtors, community officials
for flood insurance related documentation.
    Affected Public: Business or other for-profit.
    Estimated Number of Respondents: 46,456,460.
    Frequency of Response: On occasion.
    Estimated Average Hour Burden per Respondent: Standard Flood Hazard
Determination Form (SFHDF), 20 minutes.
    Estimated Total Annual Burden Hours: 15,330,632 hours.
    Estimated Cost: There are no operation and maintenance, or capital
and start-up costs associated with this collection of information.

    Dated: October 13, 2011.
Gary L. Anderson,
Acting Chief Administrative Officer, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2011-27071 Filed 10-18-11; 8:45 am]
BILLING CODE 9110-11-P


[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51278-51280]
[FR Doc No: 2015-20760]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0564]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Dietary Supplement Labeling Requirements and
Recommendations Under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment. This notice
solicits comments on the information collection provisions of the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
(the DSNDCPA) and the guidance document entitled, ``Guidance for
Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.''

DATES: Submit either electronic or written comments on the collection
of information by October 23, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Dietary Supplement Labeling Requirements and Recommendations Under the
Dietary Supplement and Nonprescription Drug Consumer Protection Act

OMB Control Number 0910-0642--Extension

    In 2006, the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (the DSNDCPA) amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) with respect to serious adverse event
reporting for dietary supplements and nonprescription drugs marketed
without an approved application. The DSNDCPA also amended the FD&C Act
to add section 403(y) (21 U.S.C. 343(y)), which requires the label of a
dietary supplement marketed in the United States to include a domestic
address or domestic telephone number through which the product's
manufacturer, packer, or distributor may receive a report of a serious
adverse event associated with the dietary supplement.
    In the Federal Register of September 1, 2009 (74 FR 45221), we
announced the availability of a guidance document entitled ``Guidance
for Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.'' The guidance document contains
questions and answers related to the labeling requirements in section
403(y) of the FD&C Act and provides guidance to industry on the use of
an explanatory statement before the domestic address or telephone
number. The guidance document provides our interpretation of the
labeling requirements for section 403(y) of the FD&C Act and our views
on the information that should be included on the label. We believe
that the guidance will enable persons to meet the criteria for labeling
that are established in section 403(y) of the FD&C Act.
    We estimate the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual   Average burden
            Activity                respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
----------------------------------------------------------------------------------------------------------------
Domestic address or phone number           1,700            3.27           5,560             0.2           1,112
 labeling requirement (21 U.S.C.                                                    (12 minutes)
 343(y))........................
FDA recommendation for label               1,700            3.27           5,560             0.2           1,112
 statement explaining purpose of                                                    (12 minutes)
 domestic address or phone
 number.........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,224
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The labeling requirements of section 403(y) of the FD&C Act became
effective on December 22, 2007, although we exercised enforcement
discretion until September 30, 2010, to enable all firms to meet the
labeling requirements for dietary supplements. At this time, therefore,
we expect that all labels required to include the domestic address or
telephone number pursuant to section 403(y) of the FD&C Act have been
revised accordingly. Thus our current burden estimate for this
information collection applies only to new product labels.

    In row 1 of table 1 we estimate the total annual hourly burden
necessary to comply with the requirement under section 403(y) of the
FD&C Act to be 1,112 hours. Using historical A.C. Nielson Sales Scanner
Data, we estimate the number of dietary supplement stock keeping units
for which product sales are greater than zero to be 55,600. Assuming
that the flow of new products is 10 percent per year, then each year
approximately 5,560 new dietary supplement products are projected to
enter the market. Estimating that there are 1,700 dietary supplement
manufacturers, re-packagers, re-labelers, and holders of dietary
supplements subject to the information collection requirement (using
the figure 1,460 as provided in our final rule of June 25, 2007 (72 FR
34752), on the ``Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements,''
and factoring for a 2 percent annual growth rate), we calculate an
annual disclosure burden of 3.27 disclosures (labels) per firm. Last,
we expect that firms prepare the required labeling for their products
in a manner that takes into account at one time all information
required to be disclosed and therefore believe that less than 0.2 hours
(12 minutes) per product label would be expended to fulfill this
requirement.
    In row 2 of table 1 we estimate the total burden associated with
the recommendation to include an explanatory statement on dietary
supplement product labels letting consumers know the purpose of the
domestic address or telephone number to be 1,112 hours. Based upon our
knowledge of food and dietary supplement labeling, we estimate it would
require less than 0.2 hours (12 minutes) per product label to include
such a statement.

    Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20760 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P


36476 Federal Register / Vol. 68, No. 117 / Wednesday, June 18, 2003 / Rules and Regulations Commodity Parts per million * * * * * Corn, field, forage .................................................................................................... 6.0 * * * * * Grain, aspirated fractions ........................................................................................ 100.0 * * * * *

* * * * *

[ FR Doc. 03   15128 Filed 6   17   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0113; FRL   7301   1]

Bacillus Pumilus Strain QST2808; Temporary Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the Bacillus pumilus strain QST2808 in or on all agricultural commodities when applied/ used in accordance with label directions. AgraQuest, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus pumilus strain QST2808. The temporary tolerance exemption will expire on June 30, 2006. DATES: This regulation is effective June 18, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0113, must be received by EPA on or before August 18, 2003. ADDRESSES: Written objections and hearing requests may be submitted by mail or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and Pollution Prevention Division ( 7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8077 ; e mail address: cerrelli. susanne@ epa. gov.

SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production/ Agriculture ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0113. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 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/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title _ 40/ 40cfr180 _ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ 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. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of May 3, 2001 ( 66 FR 22225) ( FRL   6773   9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide tolerance petition ( PP 1G6240), submitted by AgraQuest, Inc., 1530 Drew Avenue, Davis, CA 95616. This notice included a summary of the petition prepared by the petitioner AgraQuest, Inc. There were no comments received in response to the notice of filing. The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Bacillus pumilus strain QST2808. Section 408( c)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA VerDate Jan< 31> 2003 15: 35 Jun 17, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 18JNR1. SGM 18JNR1 36477 Federal Register / Vol. 68, No. 117 / Wednesday, June 18, 2003 / Rules and Regulations determines that the exemption is `` safe.'' Section 408( c)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Additionally, section 408( b)( 2)( D) of the FFDCA requires that the Agency consider `` available information concerning the cumulative effects of a particular pesticide's residues'' and `` other substances that have a common mechanism of toxicity.'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

III. Toxicological Profile Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Bacillus pumilus is a ubiquitous and naturally occurring bacteria found in soil. The results of the acute toxicology and pathogenicity studies required of the petitioner under section 408( d)( 2)( A) of the FFDCA in support of its petition for a temporary exemption from the requirement of a tolerance for Bacillus pumilus strain QST2808 indicate negligible to no mammalian toxicity. In addition, no pathogenicity was observed in any of the tests conducted with the Bacillus pumilus strain QST2808 Technical product. The toxicology and pathogenicity data generated by AgraQuest, Inc in support of this temporary exemption from the requirement of a tolerance are summarized below. 1. Acute oral toxicity and pathogenicity rats ( OPPTS Harmonized Guideline 885.3050; Master Record Identification Number ( MRID) 451366   04). Fifteen male and fifteen female rats each were administered 4.1 x 109 cfu of Bacillus pumilus strain QST2808 Technical and observed for 14 days. Based on the data, Bacillus pumilus strain QST2808 does not appear to be toxic, infective, and/ or pathogenic in rats, when dosed at 4.1 x 109 cfu/ animal. Classification: Acceptable; Toxicity Category IV. ( C. Etsitty's Memorandum to John L. Kough, dated 1/ 7/ 02 ( hereinafter referred to as `` BPPD Review  1/ 7/ 02'')). 2. Acute dermal toxicity ( OPPTS Harmonized Guideline 885.3100; MRID 451366   05). Five male and five female rabbits were dermally treated with 2g/ kg body weight Bacillus pumilus strain QST2808 Technical for 24 hours and observed for the following 14 days. The acute lethal dose ( LD50) is greater than 2,000 mg/ kg. Classification: Acceptable; Toxicity Category III. ( BPPD Review  1/ 7/ 02). 3. Primary eye irritation ( OPPTS Harmonized Guideline 870.2400; MRID 452679   01). Three male rabbits each were administered 0.1 mL of QST2808 Technical in the everted lower lid of one eye and then observed for 72 hours. Based on the data, QST2808 Technical showed minimal effects to the eye. Classification: Acceptable; Toxicity Category IV. ( BPPD Review  1/ 7/ 02). 4. Acute injection toxicity/ pathogenicity ( OPPTS Harmonized Guideline 885.3200; MRID 451366   07). Eighteen male and eighteen female rats each were dosed at 1.6 x 108 cfu Bacillus pumilus strain QST2808 Technical intravenously and monitored over a period of 28 days. A gross necropsy was performed on all rats. Based on the data, the test organism was not toxic, infective, or pathogenic to rats. Classification: Acceptable. ( BPPD Review  1/ 7/ 02). 5. Acute pulmonary toxicity/ pathogenicity ( OPPTS Harmonized Guideline 885.3150; MRID 451366   06). Eighteen male and eighteen female rats each were administered 1.6 x 108 cfu Bacillus pumilus strain QST2808 Technical by a single intratracheal dosage and monitored over a period of 35 days for clinical signs of toxicity. Necropsy studies showed no significant signs of abnormalities due to the test organism. Based on the data, Bacillus pumilus strain QST2808 was not toxic, infective, and/ or pathogenic to rats when dosed at 1.6 x 108 cfu/ animal. Classification: Acceptable. ( BPPD Review  1/ 7/ 02). 6. Acute Inhalation toxicity ( OPPTS Harmonized Guideline 870.1300). Results of the acute pulmonary toxicity/ pathogenicity ( MRID 451366   06) performed with Bacillus pumilus strain QST2808 Technical indicate that it is not toxic, infective, and/ or pathogenic to rats when dosed at 1.6 x 108 cfu/ animal. For the purposes of this specific action, the Agency has determined that the acute pulmonary toxicity/ pathogenicity data are adequate to support and/ or fulfill this particular data requirement. 7. Primary dermal irritation ( OPPTS Harmonized Guideline 870.2500; MRID 452679   02). Each of three male adult rabbits were treated dermally with 0.5 mL QST2808 Technical for 4 hours and observed for the following 72 hours. Based on the data, no abnormal clinical signs were noted. Approximately 60 minutes after patch removal, very slight erythema was noted on one of the three rabbits with resolution by 24 hours. When dosed with QST2808 Technical at 0.5 mL/ animal, QST2808 Technical was essentially non irritating. Classification: Acceptable; Toxicity Category IV. ( BPPD Review  1/ 7/ 02). 8. Hypersensitivity incidents ( OPPTS Harmonized Guideline 885.3400). The registrant reported ( November 1, 2000) no incidents to date. 9. Immune response. There is no information to suggest that Bacillus pumilus strain QST2808 has an effect on the immune system. The submitted toxicity/ pathogenicity studies in rodents indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient ( MRID 451366   04; 451366   06, and 451366   07). Based on the data generated in accordance with the Tier I data requirements set forth in 40 CFR § 158.740( c), the Tier II and Tier III data requirements were not triggered and, therefore, not required in connection with this action. In addition, because the Tier II and Tier III data requirements were not required, the residue data requirements set forth in 40 CFR § 158.740( b) also were not required.

IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or VerDate Jan< 31> 2003 15: 35 Jun 17, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 18JNR1. SGM 18JNR1 36478 Federal Register / Vol. 68, No. 117 / Wednesday, June 18, 2003 / Rules and Regulations buildings ( residential and other indoor uses).

A. Dietary Exposure Humans and animals are commonly exposed to Bacillus pumilus, a ubiquitous microorganism that inhabits soil. No toxicological endpoints were identified for Bacillus pumilus strain QST2808. The low toxicity and nonpathogenicity infectivity of Bacillus pumilus strain QST2808 is demonstrated by the data summarized in Unit III of this action. 1. Food. While the proposed use pattern may result in dietary exposure with possible residues in or on agricultural commodities, negligible to no risk is expected for the general population, including infants and children, or animals because Bacillus pumilus strain QST2808 technical demonstrated no pathogenicity or oral toxicity at the maximum doses tested, as noted above in ( Unit III). 2. Drinking water exposure. Most importantly, there is no evidence of adverse effects from oral, dermal, or inhalation exposure to this microbial agent. ( See `` Unit III. Toxicological Profile'' above.) In addition, the potential for transfer of Bacillus pumilus strain QST2808 to surface or ground water during run off associated with intended use applications is considered minimal to non existent, due in part to its percolation through and resulting capture in soil. Accordingly, the use of this microbial pest control agent on terrestrial plants is not anticipated to negatively impact the quality of drinking water.

B. Other Non Occupational Exposure Based on the proposed use patterns, the potential of non dietary exposures to Bacillus pumilus strain QST2808 pesticide residues for the general population, including infants and children, is unlikely. Accordingly, the Agency believes that the potential aggregate non occupational exposure, derived from dermal and inhalation exposure through the application of Bacillus pumilus strain QST2808, should fall well below the currently tested microbial safety levels. 1. Dermal exposure. The potential for dermal exposure to Bacillus pumilus strain QST2808 pesticide residues for the general population, including infants and children, is unlikely because potential use sites are agricultural and horticultural. However, since Bacillus pumilus strain QST2808 is a naturally occurring bacteria in soil, there is a great likelihood of prior exposure for most, if not all individuals. Accordingly, the increase in exposure due to this proposed product would be negligible. Furthermore, and as demonstrated in Unit III of this action, the organism is of low dermal toxicity, the acute lethal dose ( LD50) is greater than 2,000 mg/ kg, and the QST2808 Technical was essentially non irritating ( Toxicity Category IV). Accordingly, the risks anticipated for this route of exposure are considered minimal. 2. Inhalation exposure. The potential for inhalation exposure to Bacillus pumilus strain QST2808 pesticide residues for the general population, including infants and children is unlikely because potential use sites are agricultural and horticultural. However, since Bacillus pumilus is a natural occurring bacteria in soil, there is a great likelihood of prior exposure for most, if not all individuals. Accordingly, the increase in exposure due to this proposed product would be negligible. Furthermore, and as demonstrated in Unit III of this action, the acute pulmonary toxicity/ pathogenicity testing performed on the technical formulation did not demonstrate pathogenicity or toxicity of Bacillus pumilus strain QST2808. ( See Unit III above.) Accordingly, the risks anticipated for this route of exposure are considered minimal.

V. Cumulative Effects The Agency has considered the potential for cumulative effects of Bacillus pumilus strain QST2808 and other substances in relation to a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Bacillus pumilus strain QST2808 is practically non toxic to mammals. Because no mechanism of pathogenicity or toxicity in mammals has been identified for this organism ( see Unit III above), no cumulative effects from the residues of this product with other related microbial pesticides is anticipated.

VI. Determination of Safety for U. S. Population, Infants and Children There is a reasonable certainty that no harm to the U. S. population, including infants and children, will result from aggregate exposure to residues of Bacillus pumilus strain QST2808 due to its use as a microbial pest control agent. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previously, Bacillus pumilus strain QST2808 is not pathogenic or infective and is practically non toxic to mammals. ( See Unit III above.) Accordingly, exempting Bacillus pumilus strain QST 2808 from the requirement of a tolerance should be considered safe and pose no significant risk. FFDCA section 408( b)( 2)( C) provides that EPA shall apply an additional tenfold margin of exposure ( safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure, unless EPA determines that a different margin of exposure ( safety) will be safe for infants and children. Margins of exposure ( safety) are incorporated into EPA risk assessments either directly through the use of a margin of exposure analysis or by using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. Due to the ubiquitous nature of Bacillus pumilus, residues of this microbial pesticide in or on agricultural commodities are not expected to significantly increase exposure to the U. S. population, including infants and children. Here, EPA concludes that the toxicity and exposure data are sufficiently complete to adequately address the potential for additional sensitivity of infants and children to residues of Bacillus pumilus strain QST2808 and that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to Bacillus pumilus strain QST2808 residues.

VII. Other Considerations A. Endocrine Disruptors EPA is required under section 408( p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) `` may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.'' Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there is no scientific basis for including, as part of the screening program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone VerDate Jan< 31> 2003 15: 35 Jun 17, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 18JNR1. SGM 18JNR1 36479 Federal Register / Vol. 68, No. 117 / Wednesday, June 18, 2003 / Rules and Regulations systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, Bacillus pumilus strain QST2808 may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption. To date, the Agency has no information to suggest that Bacillus pumilus strain QST2808 has an effect on the endocrine systems. Moreover, as is expected from a non pathogenic microorganism that is practically nontoxic to mammals, the submitted toxicity/ pathogenicity studies in rodents indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. ( BPPD Review  1/ 7/ 02).

B. Analytical Method The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above, including Bacillus pumilus strain QST2808' s lack of mammalian toxicity. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purpose for Bacillus pumilus strain QST2808.

C. Codex Maximum Residue Level There is no Codex Alimentarius Commission Maximum Residue Level for Bacillus pumilus strain QST2808.

VIII. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d), as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0113 in the subject line on the first page of your submission. All objections and requests for hearings must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 18, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0113, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VerDate Jan< 31> 2003 15: 35 Jun 17, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 18JNR1. SGM 18JNR1 36480 Federal Register / Vol. 68, No. 117 / Wednesday, June 18, 2003 / Rules and Regulations IX. Statutory and Executive Order Reviews This final rule establishes a temporary exemption from the tolerance requirement for Bacillus pumilus strain QST2808 under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects 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.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

X. Congressional Review Act 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 rule 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 this final rule in the Federal Register. This final rule is not a `` major rule '' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: June 3, 2003. James Jones, Director, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 371.

 2. Section 180.1226 is added to subpart D to read as follows:

§ 180.1226 Bacillus pumilus strain QST2808; temporary exemption from the requirement of a tolerance. A temporary exemption from the requirement of a tolerance is established for residues of the microbial pesticide Bacillus pumilus strain QST2808 when used in or on all agricultural commodities when applied/ used in accordance with label directions.

[ FR Doc. 03   15129 Filed 6   17   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0196; FRL   7311   2]

Azoxystrobin; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues of azoxystrobin, methyl ( E) 2[[ 6( 2 cyanophenoxy) 4 pyrimidinyl] oxy]  ( methoxymethylene) benzeneacetate, and its Z isomer, methyl ( Z) 2[[ 6( 2 cyanophenoxy) 4 pyrimidinyl] oxy]  ( methoxymethylene) benzeneacetate, in or on artichoke, globe; asparagus; brassica, head and stem, subgroup 5A; herb subgroup 19A, ( dried) except chive; and herb subgroup 19A, ( fresh) except chive. Interregional Research Project Number 4 ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA).

VerDate Jan< 31> 2003 15: 35 Jun 17, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 18JNR1. SGM 18JNR1


[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11111-11112]
[FR Doc No: 2020-03806]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2020-0002]

National Advisory Committee on Occupational Safety and Health
(NACOSH); Request for Nominations

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

ACTION: Request for nominations to serve on NACOSH.

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

SUMMARY: The Secretary of Labor requests nominations for membership on
NACOSH.

DATES: Nominations for NACOSH membership must be submitted (postmarked,
sent or received) by April 27, 2020.

ADDRESSES: You may submit nominations for NACOSH, which must include
the docket number for this Federal Register notice (Docket No. OSHA-
2020-0002), by one of the following methods:
    Electronically: You may submit nominations, including attachments,
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the online instructions for making
submissions.
    Facsimile: If your nomination, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Regular mail, express delivery, hand delivery, messenger/courier
service (hard copy): You may submit your materials to the OSHA Docket
Office, Docket No. OSHA-2020-0002, Room N-3653, U.S. Department of
Labor, 200 Constitution Avenue NW, Washington, DC 20210; telephone
(202) 693-2350, TTY number is<PHONE_NUMBER>. OSHA's Docket Office
accepts deliveries (hand deliveries, express mail, and messenger/
courier service) from 10 a.m. to 3 p.m., ET.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Mr. Frank
Meilinger, Director, OSHA Office of Communications, U.S. Department of
Labor; telephone:<PHONE_NUMBER>, TTY<PHONE_NUMBER>); email:
<EMAIL_ADDRESS>    For general information: Ms. Michelle Walker, Director, OSHA
Technical Data Center, Directorate of Technical Support and Emergency
Management; telephone:<PHONE_NUMBER>, TTY<PHONE_NUMBER>); email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Secretary of Labor (Secretary) invites
interested individuals to submit nominations for membership on NACOSH.
    The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C.
651, 656) established NACOSH to advise, consult with, and make
recommendations to the Secretary and the Secretary of Health and Human
Services (HHS Secretary) on matters relating to the administration of
the OSH Act. NACOSH is a continuing advisory committee of indefinite
duration.
    NACOSH operates in accordance with the Federal Advisory Committee
Act (FACA) (5 U.S.C. App. 2), implementing regulations (41 CFR part
102-3), the OSH Act, and OSHA's regulations on NACOSH (29 CFR part
1912a).
    NACOSH is comprised of 12 members, all of whom the Secretary
appoints. The terms of six NACOSH members expire on July 31, 2020, and
the terms of the other six members expire on July 31, 2021. NACOSH
members serve staggered terms, unless the member becomes unable to
serve, resigns, ceases to be qualified to serve, or is removed by the
Secretary. Accordingly, the Secretary will appoint six members to a
two-year term. If a vacancy occurs before a term expires, the Secretary
may appoint a new member who represents the same interest as the
predecessor to serve the remainder of the unexpired term. The Committee
shall meet at least two times a year (29 U.S.C. 656(a)(2)).
    OSHA invites nominations for the following NACOSH positions:
     Two (2) public representatives;

     One (1) management representative;
     One (1) labor representative;
     One (1) occupational safety professional representative;
and
     One (1) occupational health professional representative.
    Pursuant to 29 CFR 1912a.2, the HHS Secretary designates both of
the occupational health professional representatives and two of the
four public representatives for the Secretary's consideration and
appointment. OSHA will provide to HHS all nominations and supporting
materials for the membership categories the HHS Secretary designates.
    Any individual or organization may nominate one or more qualified
persons for membership on NACOSH. Nominations must include:
     The nominee's name and contact information;
     The nominee's occupation or current position;
     The categories that the nominee is qualified to represent;
     The nominee's resume or curriculum vitae;
     Membership in relevant organizations and associations;
     A summary of the nominee's background, experience, and
qualifications to serve on NACOSH;
     A list of articles or other documents the nominee has
authored that indicates the nominee's experience in worker safety and
health;
     A statement that the nominee has no conflicts of interest
that would preclude membership on NACOSH; and
     A statement that the nominee is aware of the nomination
and is willing to serve and regularly attend NACOSH meetings.
    The Secretary will appoint NACOSH members on the basis of their
experience and competence in the field of occupational safety and
health (29 CFR 1912a.2). The information OSHA receives through this
nomination process, in addition to other relevant sources of
information, will assist the Secretary in appointing members to serve
on NACOSH. In appointing NACOSH members, the Secretary will consider
individuals nominated in response to this Federal Register notice, as
well as other qualified individuals.
    The U.S. Department of Labor (Department) is committed to equal
opportunity in the workplace and seeks a broad-based and diverse NACOSH
membership. The Department will conduct a public records check of
nominees before their appointment using publicly available sources.

I. Public Participation, Submissions and Access to Public Record

    You may submit nominations using one of the methods listed in the
ADDRESSES section. Your submission must include the agency name and
docket number for this Federal Register notice (Docket No. OSHA-2020-
0002). Due to security-related procedures, receipt of submissions by
regular mail may experience significant delay. Please contact the OSHA
Docket Office for information about security procedures for making
submissions by hand, express delivery, or messenger/courier service.
    OSHA posts submissions without change at http://www.regulations.gov. Therefore, OSHA cautions interested parties about
submitting personal information, such as social security numbers and
birth dates. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through the
website. All submissions, including copyrighted material, are available
for inspection and copying, if permissible, at the OSHA Docket Office.
Information on using http://www.regulations.gov to submit comments and
access the docket is available on the website. Please contact the OSHA
Docket Office for information about materials not available through the
website and for assistance in using the internet to locate docket
submissions.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, also are available on OSHA's web page at
http://www.osha.gov.

Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this notice
under the authority granted by 29 U.S.C. 656; 5 U.S.C. App. 2; 29 CFR
part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order No. 1-
2012 (77 FR 3912 (1/25/2012)) and 04-2018 (6/1/2018).

    Signed at Washington, DC, on February 20, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2020-03806 Filed 2-25-20; 8:45 am]
BILLING CODE 4510-26-P