[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Notices]
[Pages 53798-53799]
[FR Doc No: 2014-21519]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72986; File No. SR-CBOE-2014-017]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Approving a Proposed Rule Change, as Modified by
Amendment 1, To Amend Its Rules Related to Complex Orders

September 4, 2014.

I. Introduction

    On February 19, 2014, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend its rules relating to
complex orders. On March 3, 2014, the Exchange filed Amendment No. 1 to
the proposed rule change. The proposed rule change, as modified by
Amendment No. 1 thereto, was published for comment in the Federal
Register on March 10, 2014.\3\ On April 23, 2014, the Commission
extended the time period in which to either approve the proposal,
disapprove the proposal, or to institute proceedings to determine
whether to approve or disapprove the proposal, to June 6, 2014.\4\ On
June 5, 2014, the Commission instituted proceedings to determine
whether to approve or disapprove the proposed rule change.\5\ The
Commission then received two comment letters on proposal.\6\ This order
approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 71648 (March 5,
2014), 79 FR 13359 (``Notice'').
    \4\ See Securities Exchange Act Release No. 72008, 79 FR 24032
(April 29, 2014).
    \5\ See Securities Exchange Act Release No. 72329, 79 FR 33627
(June 11, 2014).
    \6\ See letter to Kevin M. O'Neill, Deputy Secretary,
Commission, from John Kinahan, Interim-CEO, Group One Trading, L.P.,
dated July, 7, 2014 (``Group One Letter''); and letter to the Office
of the Secretary, Commission, from Martha Redding, Chief Counsel and
Assistant Corporate Secretary, NYSE, Inc., dated July 10, 2014
(``NYSE Letter'').
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II. Description of Proposed Rule Change

    Under current CBOE Rule 6.53C(d)(ii), a Trading Permit Holder
representing a COA-eligible order may request that the Exchange
initiate a complex order auction (``COA'') for the COA-eligible order
before such order enters the complex order book (``COB'').\7\ In this
proposed rule change, the Exchange proposes to require all complex
orders with three or more legs to be subject to a COA prior to entering
the COB.\8\ Specifically, the Exchange proposes to amend Rule
6.53C(d)(ii) to provide that CBOE's Hybrid Trading System \9\ (the
``System'') will initiate a COA on receipt of: (1) A COA-eligible order
with two legs and request from the Trading Permit Holder representing
the order that it initiate a COA; or (2) a complex order with three or
more legs, regardless of the order's routing parameters (e.g., a
request to route directly to the COB) or handling instructions (except
for orders routed for manual handling).\10\ Thus, as proposed, all
complex orders in Hybrid classes with three or more legs would
automatically be subject to a COA (other than those routed for manual
handling) prior to entering the COB where they can leg into the
market.\11\
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    \7\ Under current CBOE Rule 6.53C(d)(i)(2), the Exchange may
determine on a class-by-class basis which complex orders are
eligible for a COA, including by complex order type and origin type.
The Exchange notes that currently, in all Hybrid classes, customer,
firm and broker-dealer complex orders are eligible for a COA, and
all complex order types except for immediate-or-cancel (``IOC'')
orders are eligible for a COA in all Hybrid classes. See Notice,
supra note 3, n.8. Additionally, only marketable orders and
``tweeners'' (limit orders bettering the same side of the derived
net market) are eligible for a COA. For Hybrid 3.0 classes (i.e.
SPX), all complex order types (including IOC orders) are eligible
for a COA, but only customer complex orders are eligible for a COA.
See id. (citing CBOE Regulatory Circulars RG06-73, RG08-38, and
RG08-97).
    \8\ The Exchange explains that this proposed change applies to
Hybrid classes only, and not Hybrid 3.0 classes. See Notice, supra
note 3, n.7. In this regard, the proposed rule change proposes to
amend CBOE Rule 6.53C, Interpretation and Policy .10 to indicate
that complex orders in Hybrid 3.0 classes, regardless of the number
of legs, will initiate a COA in the same manner they currently do.
See id.
    \9\ The proposed rule change proposes to amend CBOE Rule
6.53C(d)(ii) to say that the System, rather than the Exchange, will
send the RFR message. See id. at n.9. Because the System will
automatically send the RFR message when the conditions set forth in
CBOE Rule 6.53C(d)(ii) are met, the Exchange believes using the term
``System'' in the rule text is appropriate. See id.
    \10\ The Exchange explains that if a complex order with three or
more legs contains an instruction to route for manual handling, such
as to PAR, and through such manual handling routes to the COB, the
proposed rule change would provide that such order will initiate a
COA prior to entry on the COB, even if the PAR operator requests
that the order not initiate a COA. See Notice, supra note 3, n.10.
    \11\ The Exchange states that this automatic initiation of a COA
does not apply to stock-option orders. See id. at n.11.
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    The Exchange proposes to amend CBOE Rule 6.53C(d)(ii) to provide
that CBOE's System will reject back to a Trading Permit Holder any
complex order with three or more legs that includes a request pursuant
to CBOE Rule 6.53C, Interpretation and Policy .04 \12\ that the order
not initiate a COA.\13\ The Exchange also proposes to amend CBOE Rule
6.53C(d)(ii), which currently provides that only a Trading Permit
Holder representing an order may request that the order initiate a COA,
to also provide that PAR operators handling an order may request that a
COA-eligible order initiate a COA.\14\
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    \12\ CBOE Rule 6.53C, Interpretation and Policy .04 provides
that Trading Permit Holders routing complex orders directly to the
COB may request that the complex orders initiate a COA on a class-
by-class basis and Trading Permit Holders with resting complex
orders on PAR may request that complex orders initiate a COA on an
order-by-order basis.
    \13\ See Notice, supra note 3, at 13362.
    \14\ CBOE believes that permitting orders resting on PAR to
initiate a COA is consistent with other CBOE rules. See id. at n. 15
and accompanying text (citing to CBOE Rule 6.53C(d), which,
according to the Exchange, states that complex orders may be subject
to a COA once on PAR, and CBOE Rule 6.53C, Interpretation and Policy
.04(a), which, according to the Exchange, states that Trading Permit
Holders with resting complex orders on PAR may request that complex
orders initiate a COA).
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    According to the Exchange, this proposed rule change will address
the concern that market makers may reduce the size of their quotations
in the leg markets because of the presence of certain complex orders
that are designed to circumvent the ``Quote Risk Monitor Mechanism''
(``QRM'') settings established by market makers.\15\ CBOE describes the
QRM as a functionality designed to help market makers provide liquidity
across most series in their appointed classes without being at risk of
executing the full cumulative size of all their quotes before being
given adequate opportunity to adjust their quotes.\16\
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    \15\ See Notice, supra note 3, at 13363.
    \16\ See id. at 13361.
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    The QRM, according to CBOE, generally operates by allowing market
makers to set a variety of parameters, which, if triggered, will cause
the System to cancel a market maker's quotes in all series in an
appointed class after executing the order that triggered the
parameter.\17\ CBOE states that the System performs the QRM parameter
calculations to determine if the QRM has been triggered after each
execution against a market maker's quotes.\18\ According to the
Exchange, when a complex order legs into the regular market (i.e.,
executes against individual quotes for each of the legs in the regular
market), all of the legs of a complex order are considered as a single
execution for purposes of the QRM, and

not as a series of individual transactions, because each leg of the
complex order is contingent on the other leg.\19\ Thus, the System
performs the QRM parameter calculations after the entire complex order
executes against interest in the regular market. In contrast, if the
legs of the complex order had been submitted to the regular market
separately and without any complex order contingency, the System would
perform the QRM parameter calculations after each leg executed against
interest in the regular market. According to the Exchange, this
differential treatment may result in market makers exceeding their risk
parameters by a greater number of contracts when complex orders leg
into the regular market.\20\
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    \17\ See id. at 13360-61. CBOE states that the System performs
the parameter calculations after an execution against a market maker
quote occurs in order to assure that all quotations are firm for
their full size. See id. at 13361.
    \18\ See id.
    \19\ See id.
    \20\ See id.
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    The Exchange believes that the potential risk to market makers of
complex orders legging into the regular market limits the amount of
liquidity that market makers are willing to provide in the regular
market.\21\ In particular, according to the Exchange, market makers may
reduce the size of their quotations in the regular market because of
the presence of these complex orders that are designed to circumvent
QRM and risk the execution of the cumulative size of market makers'
quotations across multiple series without market makers' being aware of
these complex orders or having an opportunity to adjust their
quotes.\22\ Accordingly, the Exchange believes that reducing market
maker risk in the regular market by requiring complex orders in Hybrid
classes with three or more legs to be subject to a COA--which will
allow market makers to react accordingly, including adjusting their
quotes to avoid the circumvention of their QRM parameter settings--will
benefit investors by encouraging market makers to provide additional
liquidity in the regular market and enhance competition in those
classes.\23\ According to the Exchange, this potential benefit to
investors far exceeds any ``perceived detriment'' to requiring certain
complex orders to be subject to a COA prior to potential interaction
with the leg markets.\24\ The Exchange notes that complex orders with
three or more legs will still have opportunities for execution through
a COA, in the COB or in the leg markets if they do not execute at the
end of the COA.\25\
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    \21\ See Notice, supra note 3, at 13362.
    \22\ See id.
    \23\ See id.
    \24\ See id.
    \25\ See id.
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    In the Notice, the Exchange states that it will announce the
implementation date of the proposed rule change in a Regulatory
Circular to be published no later than 90 days following the effective
date of this proposed rule change.\26\ The Exchange also states that
the implementation date will be no later than 180 days following the
effective date of this proposed rule change.\27\
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    \26\ See Notice, supra note 3, at 13363.
    \27\ See id.
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III. Summary of Comment Letters

    As noted above, the Commission received two comments, both
expressing support for the proposed rule change.\28\ One commenter
stated that it believes CBOE's proposal is a reasonable response to the
problem of complex orders circumventing market makers QRM
parameters.\29\ The other commenter stated that it believes that the
proposal will allow market makers to better rely on the Exchange's QRM
to remove quotes when a market makers risk tolerance is exceed, which,
according to the commenter, will allow market makers to provide
quotations with large sizes and tight spreads.\30\
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    \28\ See supra note 6.
    \29\ See NYSE Letter, supra note 6, at 2.
    \30\ See Group One Letter, supra note 6, at 2.
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IV. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\31\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\32\ which
requires, among other things, that the rules of a national securities
exchange be 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. The Commission notes that participating in a COA will
provide complex orders with three or more legs an opportunity for price
improvement through the auction mechanism. The Commission also notes
that both commenters expressed support for the proposal.
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    \31\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \32\ 15 U.S.C. 78f(b)(5).
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\33\ that the proposed rule change (SR-CBOE-2014-017) is approved.
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    \33\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
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    \34\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21519 Filed 9-9-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Page 10682]
[FR Doc No: 2015-04125]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-86-000]

El Paso Natural Gas Company, L.L.C.; Notice of Request Under
Blanket Authorization

    Take notice that on February 12, 2015, El Paso Natural Gas Company,
L.L.C. (EPNG), P.O. Box 1087, Colorado Springs, Colorado, 80944 filed a
prior notice request pursuant to sections 157.205 and 157.213 of the
Commission's regulations under the Natural Gas Act for authorization to
construct and operate certain natural gas storage field facilities
within EPNG's existing Washington Ranch Storage Field located in Eddy
County, New Mexico. Specifically, EPNG proposes to: (i) Drill and
connect two new injection/withdrawal wells, (ii) construct two
appurtenant six-inch outside diameter storage pipelines totaling up to
2,400 feet, and (iii) install new well pad measurements. The project is
referred to as the Washington Ranch Project. EPNG states that the two
new wells and associated laterals are designed to better access
existing working capacity, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this Application should be directed to
Francisco Tarin, Director, Regulatory Affairs Department, El Paso
Natural Gas Company, LLC, P.O. Box 1087, Colorado Springs, Colorado,
80944, or by calling<PHONE_NUMBER>.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: February 23, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-04125 Filed 2-26-15; 8:45 am]
BILLING CODE 6717-01-P


June 3, 1998 Robert Hodanbosi, Chief Division of Air Pollution Control Ohio Environmental Protection Agency 1800 WaterMark Drive Columbus, Ohio 43215 Dear Mr. Hodanbosi:

I am writing to express our concerns about the periodic monitoring requirements in utility Title V permits recently processed by your office. The Title V permits for two utilities, Conesville Power Plant ( Conesville) and Ohio Valley Electric Corporation, Kyger Creek Station ( Kyger Creek), did not receive any comments from our agency during their draft or proposed stages and have been finalized. However, concerns about certain terms in these permits have been brought up in light of the developing periodic monitoring guidance and out of concern for national consistency. The Title V permits for two other facilities, DP& L, Killen Generating Station ( Killen) and Department of Public Utilities in the City of Orrville, Ohio ( Orrville), did receive comments from our office during their draft stage and have not yet reached the proposed stage.

Section 70.6( a)( 3)( B) requires each Title V permit to contain periodic monitoring sufficient to yield reliable data from the relevant time period that are representative of the source's compliance with the permit, if the underlying applicable requirements do not otherwise specify such monitoring. In order to meet this " gap filling" provision, the periodic monitoring terms for each emission unit in the permit must include not only the appropriate method for monitoring, but also the minimum frequency at which the monitoring must be done in order to yield sufficient data to represent the source's compliance with the permit. If a Title V permit's monitoring requirements do not specify a frequency, the monitoring methods they institute cannot be considered periodic.

The four Title V permits require Part 60 Method 9 testing for many of the emission units, but they do not specify the frequency at which Method 9 must be performed. The Ohio Environmental Protection Agency ( OEPA) has argued that the frequency does not need to be specified because the emission units either have 1) continuous opacity monitoring systems ( COMS) which will provide monitoring data for direct compliance with opacity limits, or 2) inherently clean emissions and infrequent periods of operation. In accordance with our November 10, 1997 letter to you, the United States Environmental Protection Agency ( USEPA) believes that such explanations belong in a statement of basis for each permit. We understand that OEPA is working on including statements of basis in future Title V permits. USEPA also believes that, regardless of operating history, the emission units for which COMS data is not required must have a frequency for Method 9 testing specified in the permits in order to meet the gap filling requirement. USEPA recommends that OEPA consider the guidance written by Region 7 on periodic monitoring for opacity and the periodic monitoring guidance being developed by the Office of Air Quality Planning and Standards at USEPA.

USEPA has commented that OEPA's utility permits appear to lack adequate requirements for periodic monitoring of particulate emissions, and for proper operation and maintenance of particulate control equipment. OEPA has explained that the actual particulate emissions will be well below the allowable limits, that the emissions will be parametrically monitored through the COMS, and that the COMS will provide adequate information to ensure proper operation and maintenance of control equipment. USEPA believes that these justifications, as well as a technical explanation of the correlation between COMS data and particulate matter emission limit compliance, also belong in a statement of basis for each permit.

The four permits allow the sources to be deemed in compliance if less than 1.5% of their nonexempt 6 minute average opacity values during a calendar quarter exceed the 20% opacity limit. USEPA has commented that this appears to be an unnecessary limit on enforcement authority. OEPA has argued that the 1.5% leeway is considered necessary based on experience in enforcing the 20% standard and on the Pacific Environmental Services study of continuous emission data, and that the COMS data will still be used for direct compliance. USEPA understands the need to practice enforcement discretion, but opposes putting such discretion in writing in any air pollution permit. USEPA will object to the incorporation of enforcement discretion in the federally enforceable section of proposed Title V permits, and requests that the Conesville and Kyger Creek permits be administratively amended to correct this problem as soon as possible.

Finally, the four utility permits contain a clause that contradicts the Credible Evidence rule. The permits state that in case of a discrepancy between COMS data and Method 9 data for a particular emission unit, the Method 9 data will take precedence. USEPA believes that the Credible Evidence rule prohibits preferring one monitoring method over another by default in a permit, and will object to any proposed Title V permit that contains such anti credible evidence language. USEPA requests that the Conesville and Kyger Creek permits be administratively amended to correct this problem as soon as possible. USEPA understands that OEPA will be adding a Credible Evidence rule provision in the General Terms and Conditions section of their Title V permits, but does not believe this provision nullifies the problem of rejecting one type of possibly accurate monitoring data in favor of another.

In addition to making the administrative amendments to the Conesville and Kyger Creek permits prescribed above, we request that OEPA revise the Killen and Orrville permits to correct the problems mentioned in this letter before those permits reach the proposed stage. We also recommend that OEPA examine all other Title V permits for similar language and correct them appropriately.

We appreciate OEPA's consideration of our comments and efforts to improve the periodic monitoring requirements in their Title V permits. If you have any questions regarding this letter, please contact Kaushal Gupta, of my staff, at ( 312) 886 6803.

Sincerely yours,

/ s/

Cheryl Newton, Chief Permits and Grants Section ( IL/ IN/ OH)


[Federal Register Volume 74, Number 99 (Tuesday, May 26, 2009)]
[Proposed Rules]
[Pages 24753-24757]
[FR Doc No: E9-12105]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2008-0020; Internal Agency Docket No. FEMA-B-1047]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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SUMMARY: Comments are requested on the proposed Base (1% annual-chance)
Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this notice is to
seek general information and comment regarding the proposed regulatory
flood elevations for the reach described by the downstream and upstream
locations in the table below. The BFEs and modified BFEs are a part of
the floodplain management measures that the community is required
either to adopt or show evidence of having in effect in order to
qualify or remain qualified for participation in the National Flood
Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents, and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before August 24, 2009.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community are available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1047, to
William R. Blanton, Jr., Chief, Engineering Management Branch,
Mitigation Directorate, Federal Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-mail)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-3151, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own, or pursuant to policies established
by other Federal, State, or regional entities. These proposed
elevations are used to meet the floodplain management requirements of
the NFIP and are also used to calculate the appropriate flood insurance
premium rates for new buildings built after these elevations are made
final, and for the contents in these buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                feet (NAVD)
                                                                  Depth in feet above
         Flooding source(s)            Location of referenced       ground  [caret]        Communities affected
                                            elevation **          Elevation in meters
                                                                         (MSL)
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                  Harvey County, Kansas, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Sand Creek..........................  Approximately 865 feet         +1436        +1434  City of North Newton.
                                       upstream of Northeast
                                       24th Street.
                                      Approximately 1,590            +1437        +1435
                                       feet upstream of
                                       Northeast 24th Street.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of North Newton
Maps are available for inspection at 2601 North Main Street, North Newton, KS 67117.
----------------------------------------------------------------------------------------------------------------

                               Dukes County, Massachusetts, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Atlantic Ocean......................  Along the shoreline of            +7          +11  Town of Chilmark.
                                       the Atlantic Ocean
                                       between Gilberts Cove
                                       and Quenames Cove.
Atlantic Ocean......................  Along the shoreline of          None           +9  Town of Edgartown.
                                       the Atlantic Ocean
                                       between Paqua Pond and
                                       Jobs Neck Pond.
Atlantic Ocean......................  Along the shoreline of          None           +9  Town of West Tisbury.
                                       the Atlantic Ocean
                                       between Long Cove and
                                       Homer Road.
Vineyard Sound......................  Along the shoreline of            +8           +9  Town of Aquinnah.
                                       Vineyard Sound
                                       approximately 300 feet
                                       East of the
                                       intersection of
                                       Lobsterville Road and
                                       West Basin Road.
Vineyard Sound......................  Along the shoreline of          None          +12  Town of Oak Bluffs.
                                       Vineyard Sound between
                                       Farm Pond and Hamlin
                                       Pond.
Vineyard Sound......................  Along the shoreline of          None          +12  Town of Tisbury.
                                       Vineyard Sound between
                                       Algonquin Avenue to
                                       Yacht Club Lane.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Town of Aquinnah
Maps are available for inspection at the Town Hall, 65 State Road, Aquinnah, MA 02535.

Town of Chilmark
Maps are available for inspection at the Town Hall, 401 Middle Road, Chilmark, MA 02535.

Town of Edgartown
Maps are available for inspection at the Town Hall, 70 Main Street, Edgartown, MA 02539.

Town of Oak Bluffs
Maps are available for inspection at the Town Hall, 56 School Street, Oak Bluffs, MA 02557.

Town of Tisbury
Maps are available for inspection at the Town Hall, 51 Spring Street, Vineyard Haven, MA 02568.

Town of West Tisbury
Maps are available for inspection at the Town Hall, 1059 State Road, West Tisbury, MA 02575.
----------------------------------------------------------------------------------------------------------------

                                 Kennebec County, Maine, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
China Lake..........................  Along the entire                None         +199  Town of Albion.
                                       shoreline.
China Lake..........................  Along the entire                None         +199  Town of Vassalboro.
                                       shoreline.
Kezar Brook.........................  At the mouth of                 None         +169  Town of Winthrop.
                                       Cobboseecontee Lake.

                                      Just downstream of              None         +169
                                       South Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Town of Albion
Maps are available for inspection at the Town Office, 22 Main Street, Albion, ME 04910.

Town of Vassalboro
Maps are available for inspection at the Town Hall, 682 Main Street, North Vassalboro, ME 04989.

Town of Winthrop
Maps are available for inspection at the Town Hall, 17 Highland Avenue, Winthrop, ME 04364.
----------------------------------------------------------------------------------------------------------------
                                Pike County, Mississippi, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Tangipahoa River....................  Approximately 0.68              None         +233  Town of Osyka.
                                       miles downstream of
                                       Highway 575.
                                      Approximately 1,100             None         +236
                                       feet downstream of
                                       Highway 575.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Town of Osyka
Maps are available for inspection at 215 West Liberty Street, Osyka, MS 39648.
----------------------------------------------------------------------------------------------------------------
                                 Muskingum County, Ohio, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Moxahala Creek......................  Approximately 1,300             None         +734  Unincorporated Areas of
                                       feet downstream of                                 Muskingum County.
                                       Ransbottom Road.
                                      Approximately 500 feet          None         +735
                                       downstream of East 1st
                                       Street.
Muskingum River.....................  Approximately 0.4 mile          +714         +718  Village of Dresden.
                                       downstream of E
                                       Muskingum Avenue
                                       (State Route 208).
                                      At confluence with              +716         +720
                                       Wakatomika Creek.
Muskingum River.....................  Approximately 0.6 mile          None         +683  Village of Philo.
                                       downstream of
                                       confluence with Salt
                                       Creek.
                                      Approximately 0.5 mile          None         +685
                                       upstream of confluence
                                       with Salt Creek.
Wakatomika Creek....................  Approximately 0.5 mile          +719         +720  Unincorporated Areas of
                                       downstream of Main                                 Muskingum County.
                                       Street.
                                      Approximately 1,400             +719         +725
                                       feet downstream of
                                       Frazeysburg Road.
Wakatomika Creek....................  Approximately 0.6 mile          None         +745  Unincorporated Areas of
                                       downstream of Shannon                              Muskingum County,
                                       Road.                                              Village of
                                                                                Frazeysburg.
                                      Just downstream of              None         +751
                                       Canal Road.
Wakatomika Creek....................  Approximately 0.5 mile          None         +720  Village of Dresden.
                                       downstream of Main
                                       Street.
                                      Approximately 0.4 mile          None         +725
                                       downstream of
                                       Frazeysburg Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

                                    Unincorporated Areas of Muskingum County
Maps are available for inspection at 401 Main Street, Zanesville, OH 43701.

Village of Dresden
Maps are available for inspection at 904 Chestnut Street, Dresden, OH 43821.

Village of Frazeysburg
Maps are available for inspection at 7 West Second Street, Frazeysburg, OH 43822.

Village of Philo
Maps are available for inspection at 300 Main Street, Philo, OH 43771.
----------------------------------------------------------------------------------------------------------------
                                 Macon County, Tennessee, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Salt Lick Creek.....................  Approximately 1,965             None         +778  Unincorporated Areas of
                                       feet upstream of State                             Macon County.
                                       Highway 151.
                                      Approximately 1,624             None         +778
                                       feet upstream of State
                                       Highway 151.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

                                      Unincorporated Areas of Macon County
Maps are available for inspection at 201 County Courthouse, Lafayette, TN 37083.
----------------------------------------------------------------------------------------------------------------
                                   Ector County, Texas, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Flooding Effects of Eastside Channel  Just downstream of the          None        +2887  Unincorporated Areas of
 and its Split Flow.                   Pacific Union Railroad.                            Ector County, City of
                                                                                Odessa.
                                      Just downstream of              None        +2906
                                       Pueblo Avenue.
                                      Approximately 200 feet          None        +2912
                                       upstream of the
                                       intersection of Custer
                                       Avenue and Eastside
                                       Channel.
Flooding Effects of Monahans Draw...  Just upstream of                None        +2842  Unincorporated Areas of
                                       Grandview Road.                                    Ector County.
                                      Just upstream of South          None        +2878
                                       Crane Avenue.
                                      Just upstream of West           None        +2884
                                       County Road.
                                      Just upstream of                None        +3009
                                       Westcliff Drive.
                                      Just upstream of State          None        +3043
                                       Highway 866.
Flooding effects of Far East Channel  At the confluence of            None        +2857  Unincorporated Areas of
 and its subsidiary channels.          East Side Channel.                                 Ector County, City of
                                                                                Odessa.
                                      Approximately 450 feet          None        +2899
                                       upstream of the
                                       intersection of
                                       Caliche Road.
                                      Just upstream of Maple          None        +2907
                                       Avenue.
Flooding effects of West Side         At the confluence of            None        +2896  City of Odessa.
 Drainage Channel.                     Monahans Draw.
                                      Just upstream of West           None        +2909
                                       16th Street.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of Odessa
Maps are available for inspection at 411 West 8th Street, Odessa, TX 79761.

                                      Unincorporated Areas of Ector County
Maps are available for inspection at 521 North Texas Street, Odessa, TX 79761.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: May 14, 2009.
Deborah S. Ingram,
Acting Deputy Assistant Administrator for Mitigation, Mitigation
Directorate, Department of Homeland Security, Federal Emergency
Management Agency.
 [FR Doc. E9-12105 Filed 5-22-09; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Pages 4038-4039]
[FR Doc No: 2023-01143]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0042]

TUV Rheinland of North America, Inc.: Grant of Expansion of
Recognition

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

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for TUV Rheinland of North America, Inc. as a
Nationally Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
January 23, 2023.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2110 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of TUV Rheinland of North America, Inc. (TUVRNA), as a
NRTL. TUVRNA's expansion covers the addition of two recognized testing
and certification sites to the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
approved by the NRTL to meet OSHA standards that require product
testing and certification.
    The agency processes applications by a NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including TUVRNA, which details that

NRTL's scope of recognition. These pages are available from the OSHA
website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    TUVRNA submitted an application, dated February 8, 2018 (OSHA-2007-
0042-0061), to expand recognition as a NRTL to include two additional
test sites located at: 295 Foster Street, Suite 100, Littleton,
Massachusetts 01460 (TUVRNA Littleton) and 710 Resende Road, Bldg. 199,
Webster, New York 14580 (TUVRNA Webster). OSHA staff performed an on-
site review of TUVRNA's testing facilities at TUVRNA Littleton on July
12, 2022, and at TUVRNA Webster on July 14, 2022, in which assessors
found some nonconformities with the requirements of 29 CFR 1910.7.
TUVRNA addressed these issues sufficiently, and OSHA staff
preliminarily determined that OSHA should grant the application.
    OSHA published the preliminary notice announcing TUVRNA's expansion
application in the Federal Register on December 9, 2022 (87 FR 75667).
The agency requested comments by December 27, 2022, but it received no
comments in response to this notice. OSHA now is proceeding with this
notice to grant expansion of TUVRNA's scope of recognition.
    To obtain or review copies of all public documents pertaining to
the TUVAM expansion application, go to www.regulations.gov or contact
the Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>). Docket No.
OSHA-2007-0042 contains all materials in the record concerning TUVRNA's
recognition.

II. Final Decision and Order

    OSHA staff examined TUVRNA's expansion application, conducted a
detailed on-site assessment, and examined other pertinent information.
Based on review of this evidence, OSHA finds that TUVRNA meets the
requirements of 29 CFR 1910.7 for expansion of recognition, subject to
the specified limited and conditions. OSHA, therefore, is proceeding
with this final notice to grant TUVRNA's scope of recognition. OSHA
limits the expansion of TUVRNA's recognition to include the sites at
Littleton, Massachusetts and Webster, New York as listed above. OSHA's
recognition of these two sites limits TUVRNA to performing product
testing and certifications only to the test standards for which the
site has the proper capability and programs, and for test standards in
TUVRNA's scope of recognition. This limitation is consistent with the
recognition that OSHA grants to other NRTLs that operate multiple
sites.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
TUVRNA also must abide by the following conditions of the recognition:
    1. TUVRNA must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. TUVRNA must meet all the terms of its recognition and comply
with all OSHA policies pertaining to this recognition; and
    3. TUVRNA must continue to meet the requirements for recognition,
including all previously published conditions on TUVRNA's scope of
recognition, in all areas for which it has recognition.

III. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2),
Secretary of Labor's Order No. 8-2020 (85 FR 58393; Sept. 18, 2020),
and 29 CFR 1910.7.

    Signed at Washington, DC, on January 17, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-01143 Filed 1-20-23; 8:45 am]
BILLING CODE 4510-26-P


USEPA 2002a 1 Compilation of National Research Council ( NRC) Recommendations on Biosolids NRC Recommendation ( OA= overarching,, OACS= overarching chemical standards, OACP= overarching chemical/ pathogen standards, OAPS= overarching pathogen standards, OAHE= overarching health effects, OACP= overarching chem, ical/ pathogen , CH##= chapter#

recommendation #) Category Survey OA 2. Conduct a new national survey of chemicals and pathogens in sewage sludge. The committee endorses the recommendation of a previous NRC committee that a new national survey of chemicals be performed. The committee further recommends a survey of pathogen occurrence in raw and treated sewage sludges. The survey should include a careful examination of management practices to ensure that risk assessment principles are effectively translated into practice. Data from the survey should be used to provide feedback for continuous improvement in the science and technology of biosolids applied to land. Survey Risk Assessment OAPS 1. EPA should conduct a national survey of pathogen occurrence in raw and treated sewage sludges. Important elements in conducting the survey include use of consistent sampling methods, analysis of a broad spectrum of pathogens that could be present in sewage sludge, and use of the best available ( preferably validated) pathogen measurement techniques. Survey OACS 2. As recommended by an earlier NRC committee, a new national survey of chemicals in biosolids should be conducted. EPA should review available databases from state programs in designing a new survey. Other elements that should be included in the survey are an evaluation of the adequacy of detection methods and limits to support risk assessment; consideration of chemical categories, such as odorants and pharmaceuticals, that were not previously evaluated; and assessment of the presence of multiple species of certain metals, such as mercury and arsenic, that have different toxicity end points. Data from this survey should be used to identify any additional chemicals for potential regulation. Survey Risk Assessment CH5 3. The committee endorses the recommendation of the previous NRC committee ( NRC 1996) that a new national survey of chemicals in biosolids be conducted. It recognizes that more recent survey data are available through many state programs and recommends that EPA consider those databases in the course of designing a new national survey. Other elements that should be included in a new survey are the following: evaluation of the adequacy of analytical methods and detection limits to support risk assessment; consideration of categories of chemicals of current concern that were not previously evaluated ( e. g., odorants, surfactants, and pharmaceuticals); and assessment of the possible presence of multiple species of mercury, arsenic, and other metals that have different toxic end points. Survey Risk Assessment CH5 8. In addition to the recommendations above for a new biosolids survey and chemical selection process, it is recommended that a research program be developed for pharmaceuticals and other chemicals likely to be present in biosolids that are not currently included in routine monitoring programs. This included chemicals eliminated from Round 1 and Round 2 evaluations because of data gaps. The research program should have the goal of identifying additional chemicals that should be included in routine biosolids surveys, and in future risk assessments. For odorants, research is needed to identify the odorants present in various kinds of biosolids. For odorants commonly present in biosolids, EPA should move more aggressively to develop acute toxicity values for use in assessing the risks posed by these chemicals and should support research on the interaction between these chemicals and pathogens in causing human disease. Survey Exposure Risk Assessment USEPA 2002a 2 CH6 1. EPA should conduct a national survey of pathogen occurrence in raw and treated sewage sludges. Important elements in conducting the survey include use of consistent sampling methods, analysis of a broad spectrum of pathogens that could be in sewage sludge, and use of the best available ( preferably validated) pathogen measurement techniques. Survey Exposure OACS 3. Aggregate exposure assessments should be performed. A conceptual site model should be used to identify major and minor exposure pathways for various application scenarios. Special consideration should be given to identifying the application practices and environmental conditions that are likely to result in the greatest human exposure. Risks from long term low level exposures, as well as short term episodic exposures, such as those that can occur with volatile chemicals should be evaluated. Exposure OACS 4. An RME individual, rather than an HEI, should be evaluated for each exposure pathway. Use of the RME is a more informed and reasonable estimate of exposure than the HEI because it reduces reliance on the subjective application of default assumptions and reflects improved methods of characterizing population exposure. When the RME individual is likely to be exposed by more than one pathway, exposures should be added across pathways. Exposure OACS 5. Fate and transport models and exposure parameter assumptions used in the risk assessment should be updated to reflect the most current information on the RME individual for each exposure pathway. Exposure CH3 2. Biosolids exposure assessment studies. Such studies should characterize the exposures of workers, such as biosolids appliers and farmers, and the general public who come into contact with constituents of biosolids either directly or indirectly. The studies would require identification of microorganisms and chemicals to be measured, selection of measurement methods for field samples, and collection of adequate samples in appropriate scenarios. A possible exposureassessment study would be to measure endotoxin exposure of workers at biosolids production and application sites and of communities nearby. Exposure Human Health Studies CH5 5. A new risk assessment should include separate exposure scenarios that represent substantial differences in exposure potential ( e. g., land reclamation and forestry applications). For each scenario, a conceptual site model approach should be used to identify major and minor exposure pathways and routes of exposure. Risks from short term episodic exposures should also be evaluated for volatile chemicals, such as odorants. Exposure CH5 6. A comparable reasonable maximum exposure ( RME) should be evaluated for each exposure pathway in each exposure scenario, and where the same receptor is likely to be exposed to more than one pathway, exposures should be added across pathways. Such considerations are applicable for both deterministic and probabilistic exposure assessment approaches. Multiple highly conservative assumptions should be avoided; however, care should be taken to ensure that the risks are assessed for the high end population and that the most sensitive conditions for biosolids application are considered. For example, for the groundwater infiltration pathway, if biosolids application is likely to occur in areas of sandy soil or karst topography with shallow groundwater, those conditions should be used in the risk assessment. Exposure CH5 7. The most recent EPA reviews and new studies reported in the literature should be used to identify updated assumptions for exposure parameters for use in risk assessment. Updated fate and transport models should be used to estimate exposure point concentrations. For each exposure pathway, fate and transport models and exposure parameter assumptions should be selected so that pathway exposures reflect the RME. Exposure Risk Assessment USEPA 2002a 3 CH6 5. As recommended in Chapter 5 for chemicals, EPA should develop a conceptual site model to identify the major and minor exposure pathways ( including secondary transmission) by which humans might come into contact with pathogens in biosolids. Exposure CH7 2. Research should be conducted to synthesize existing information on potential interaction of chemicals and pathogens that might be associated with biosolids exposures and lead to an increased susceptibility to infection, particularly by inhalation. Exposure Risk Assessment Risk Assessment OA 1. Use improved risk assessment methods to better establish standards for chemicals and pathogens. Risk assessment methods for chemicals and pathogens have advanced over the past decade to the extent that ( 1) new risk assessments should be conducted to update the scientific basis of the chemical limits, and ( 2) risk assessments should be used to supplement technological approaches to establishing regulatory criteria for pathogens in biosolids. Risk Assessment OACS 1. Using current risk assessment practices, EPA should reassess the standards for the regulated chemicals and conduct another chemical selection process to determine whether additional chemicals should be considered for regulation. On the basis of the revised risk assessments and chemical selection, EPA can determine whether the standards or risk management process should be revised and whether additional chemicals should be regulated. Because the landapplication standards are to be relevant nationally, it is important that the revised risk assessments reflect regional variations in climate, hydrology, and biosolids use and characteristics, and that standards are protective of populations reflecting reasonable estimates of maximum exposure. The chemical standards should be reevaluated and updated periodically to ensure that they are supported by the best available scientific data and methods. B, C Risk Assessment OAPS 2. QMRAs should be developed and used to establish regulatory criteria ( treatment requirements, use restrictions, and monitoring) for pathogens in biosolids. For example, EPA could stipulate an acceptable risk level for a particular pathogen. QMRA could then be used to estimate the concentration of that pathogen in biosolids either at the point of application ( where there is immediate potential for exposure) or following any required holding period. EPA could then determine experimentally based relationships between the maximum acceptable pathogen concentration and the process conditions ( e. g., time, temperature, pH, chemical doses, and holding times) and/ or the pathogen indicator concentrations ( either density or reduction through treatment). On the basis of those relationships, regulatory criteria and monitoring for land application can be updated or developed to ensure consistent attainment of target pathogen concentrations. To conduct QMRAs, a conceptual site model should be used to identify all potential routes of exposure; additional input data ( e. g., dose response and pathogen survival data) should be collected; and consideration should be given to potential secondary transmission of infectious disease. QMRAs also can be used to analyze sensitivity and to ascertain what critical information is needed to reduce uncertainty about the risks from exposure to pathogens in biosolids. The pathogen standards should be reevaluated and updated periodically to ensure that they are supported by the best available scientific data and methods and to ensure that anecdotal information is not being used for the predication of past, current, or future regulations. Risk Assessment Pathogens Regulatory Activities OACS 6. Representatives of stakeholders should be included in the risk assessment process to help identify exposure pathways, local conditions that could influence exposure, and possible adverse health outcomes. Risk Assessment Exposure USEPA 2002a 4 CH4 1. Because of the significant changes in risk assessment methods and policies over the last decade, EPA should revise and update the Part 503 rule risk assessments. Important developments include recognition of the need to include stakeholders throughout the risk assessment process, improvements in measuring and predicting adverse health effects, advances in measuring and predicting exposure, explicit treatment of uncertainty and variability, and improvements in describing and communicating risk. EPA should consider how the updated risk assessments would change the risk management process. A similar approach can be taken with the issue of biological agent risks. Risk Assessment CH4 4. Because there are no guidelines to ensure that conditions assumed in the risk assessment actually transpire, the committee recommends that the Part 503 rule provide guidance for periodic reassessments that will be used to ensure that the demographic and operational conditions of biosolids land application are consistent with the assumptions of the applicable risk assessment. Risk Assessment Regulatory Activities CH5 1. A revised multipathway risk assessment should be performed for the currently regulated pollutants, with particular attention paid to arsenic and to indirect exposure pathways for cadmium and mercury. Additionally, new survey data should be used to identify any additional inorganic or organic pollutants that might need to be included in a risk assessment. Risk Assessment CH5 2. Risk based standards for land application of biosolids should be reevaluated on a regular basis to take into account new information regarding the identity and properties of chemicals present in these mixtures and current approaches to evaluating the risks of exposure to such mixtures. Stakeholders should be included in the process, particularly in the development of the exposure assessments. Risk Assessment Exposure CH5 4. Selected persistent, bioaccumulative, and highly toxic chemicals should be retained in the risk assessment even if they are detected relatively infrequently or if some chemical specific fate and transport parameters are missing. An uncertainty assessment should be performed to evaluate the significance of eliminating chemicals from the risk assessment because of lack of toxicity data or other parameters. Risk Assessment CH6 7. QMRAs should be developed and used to establish ( or validate) regulatory criteria ( treatment processes, use restrictions, and monitoring) for pathogens in biosolids. They can also be used for sensitivity analyses and identifying critical information that is needed to reduce uncertainty about the risks from pathogens in biosolids. To conduct these risk assessments, consideration must be given to assessing risks from all potential routes of exposure ( e. g., bioaerosols, groundwater), dose response relationships, pathogen survival, and secondary transmission of disease. In some cases, research will be needed to fill gaps in knowledge of those inputs. As additional information is gathered on exposure, dose response relationship, and pathogen survival, the risk assessments should be reviewed and updated as necessary. Risk Assessment Survey Pathogens Regulatory Activities CH7 3. As outlined in Chapters 5 and 6, future risk assessments of biosolids components should be conducted using the most current methods and data. For pathogens, it is important that risk assessments include an evaluation of the potential for secondary transmission of disease. Representatives from all stakeholders should be included in future risk assessments. Stakeholders can provide information and insights into the use of biosolids in practice and the potential health problems, which are particularly important in the development of exposure assessment. Involving stakeholders throughout the risk assessment process provides opportunities to bridge gaps in understanding, language, values, and perspectives. Risk Assessment Pathogens Methods Development OAPS 3. EPA should foster development of standardized methods for measuring pathogens in biosolids and bioaerosols. Methods Development USEPA 2002a 5 OAPS 4. EPA should promote research that uses improved pathogen detection technology to better establish the reliability of its prescribed pathogen treatment processes and biosolids use controls to achieve and maintain minimal exposure over time. In setting pathogen treatment requirements, it might be useful to establish metrics for typical ( mean) treatment performance and concentrations not to be exceeded. Methods Development CH4 2. Many of the measures of risk used in developing the Part 503 rule guidelines cannot be monitored. Because of that inability to monitor, the committee acknowledges that EPA must perform theoretical risk assessments. Nevertheless, there is a continuing need to provide some measures of performance that can be monitored ( e. g., concentrations of selected chemicals in exposure media, such as indoor air, house dust, or tap water of residences near land application sites; and exposure biomarkers in the blood or urine of nearby residents). Recent improvements in health surveillance and exposure monitoring provide new opportunities for EPA to develop more explicit and measurable metrics of performance for biosolids land application practices. Methods Development Survey CH6 6. EPA should foster development of standardized methods for measurement of pathogens in biosolids and bioaerosols. EPA should include round robin laboratory testing to establish method accuracies and precisions at the various pathogen concentrations expected in raw sewage sludge and partially and fully treated biosolids. These new detection methods should be used to verify that EPA's prescribed pathogen reduction techniques are reliable in achieving their intended goals. Mechanisms should be developed for incorporating new methodologies into the verification process as they become available. Methods Development Pathogens OAPS 5. Research should be conducted to assess whether other indicator organisms, such as Clostridium perfringens, could be used in regulation of biosolids. Such indicators, along with traditional indicators and operational parameters, may be suitable for monitoring day to day regulatory compliance. Pathogens CH2 5. The PEC should be funded, supported, and officially sanctioned as an integral part of the federal biosolids program. The following are important in supporting the PEC: ° The PEC members should have a formal portion of their time allocated to PEC responsibilities. ° Travel funds should be put at the disposal of the PEC to enable meeting attendance and visits to selected sites of petitioners. ° There is a perception on the part of PEC members that EPA's Cincinnati laboratories do not include biosolids as a formal part of their mission statement. This needs to be clarified and rectified. ° A formal procedure for designation of backup members should be devised. Pathogens Biosolids Management CH2 8. Provisions for allowing distribution Class A biosolids in bags or other containers ( weighing less than 1 metric ton) should not be allowed when they do not meet pollutant concentration limits ( i. e., all biosolids sold or given away should be EQ). Pathogens Regulatory Activities CH2 10. EPA should conduct national field and laboratory surveys to verify that Class A and Class B treatment processes perform as assumed by their engineering and design principles. Determinations should be made of pathogen density and elimination across the various accepted treatment processes and in the biosolids or environmental media over time. Pathogens Survey CH2 13. EPA should support development, standardization, and validation of detection and quantification methods for pathogens and indicator organisms regulated under the Part 503 rule. The sufficiency of these methods and their results should be considered in conducting and interpreting future risk assessments and used to develop applicable risk management technologies. Pathogens Methods Development USEPA 2002a 6 CH2 15. Research is needed on the following topics: ° Pathogen survival in processing or emissions during the treatment process. ° Vectors carrying pathogens and toxins. ° Bioaerosols and other chemical aerosols. ° Test method development and validation for various organisms in sewage sludge and biosolids. ° Field verification of efficacy of Class A and Class B treatment processes ( including data to directly relate process controls to initial and final pathogen and indicator densities). ° Development of indicator pathogens for assessment of impact and attenuation in field situations. Pathogens Survey Risk Assessment CH6 2. Additional indicator organisms, such as Clostridium perfringens, should be considered for potential use in regulation of land applied biosolids. Such indicators and other operational parameters ( e. g., time, temperature, pH, and chemical dose) may be suitable for assessing day today compliance with the regulations. Pathogens CH6 3. Site restrictions, buffer zones, and holding periods for land applied Class B biosolids, should consider geographic and site specific conditions that affect pathogen fate and transport. Pathogens CH6 4. Studies should be conducted to determine whether the site restrictions specified for Class B biosolids in the Part 503 rule actually achieve their intended effect with regard to pathogen levels. Pathogens Human Health Studies Human Health Studies OAHE 1. Although routine human health surveillance of all populations exposed to biosolids is impractical, the committee recommends that EPA promote and support response investigations, targeted exposure surveillance studies, and a few well designed epidemiological investigations of exposed populations. This recommendation is intended to provide a means of documenting whether health effects exist that can be linked to biosolids exposure. The committee recommends the following types of studies:

Studies in response to unusual exposures and unusual occurrences of disease. Occasionally, the occurrence of unusual events can provide information on the agents of disease. For example, an outbreak or a symptom of disease might occur following a known exposure or an unusual exposure scenario. In both instances, exposure and health outcomes should be determined.

Preplanned exposure assessment studies. Such studies should characterize the exposures of workers, such as biosolids appliers and farmers, and the general public who come into contact with constituents of biosolids either directly or indirectly. The studies would require identification of microorganisms and chemicals to be measured, selection of measurement methods for field samples, and collection of adequate samples in appropriate scenarios. A possible exposureassessment study would be to measure endotoxin exposure of workers at biosolids production and application sites and of communities nearby.

Complete epidemiological studies of biosolids use. These studies should be conducted to provide evidence of a causal association, or a lack thereof, between biosolids exposure and adverse human health effects. They should include an assessment of the occurrence of disease and an assessment or measurement of potential exposures. An example of a longitudinal epidemiological study would be Human Health Studies Exposure USEPA 2002a 7 an evaluation of health effects in a cohort of biosolids appliers These workers should be characterized by duration and level of exposure, and given appropriate follow up. Because complete epidemiological studies are expensive and require extensive data analysis, priority should be given to studies that can address serious or widespread problems and help reduce uncertainty.

CH3 1. Studies in response to unusual exposure and unusual occurrence of disease. On occasion, unplanned events occur that can provide information on the agents of disease. An example might be an outbreak or a symptom of disease following a known exposure or an unusual exposure scenario. In both instances, exposure and health outcomes should be determined. Human Health Studies CH3 3. Complete epidemiological studies of routine biosolids use. These studies should be conducted to provide evidence of a causal association, or a lack thereof, between biosolids exposure and adverse human health effects. They should include an assessment of the occurrence of disease and an assessment or measurement of potential exposures. An example of a longitudinal epidemiological study would be an evaluation of health effects in a cohort of biosolids appliers; these workers should be characterized by duration and level of exposure, with appropriate followup Human Health Studies Regulatory Activities CH2 6. Studies should be conducted to determine whether the management practices specified in the Part 503 rule ( e. g., 10 meter setback from waters) achieve their intended effect. Regulatory Activities CH2 7. Additional risk management practices should be considered in future revisions to the Part 503 rule, including setbacks from residences or businesses, setbacks from private and public water supply wells, slope restrictions, soil permeability and depth to groundwater or bedrock, and reexamination of whether a greater setback distance to surface water is warranted. Regulatory Activities CH2 9. Exemptions from nutrient management and site restrictions for land application of bulk EQ biosolids should be eliminated. Regulatory Activities CH2 11. Standard treatment design criteria should be adopted nationally to ensure compliance with existing biosolids regulations. Regulatory Activities CH2 12. Stabilization controls need to be further refined and directly correlated to metabolic techniques ( e. g., SOUR test, carbon dioxide metabolic release, methane metabolic release). Regulatory Activities Pathogens CH2 14. As part of the process of revising the Part 503 rule, EPA should review biosolids protocols used by other nations. This could provide valuable new perspectives and insights into the scientific, technical, and societal bases for the development and implementation of biosolids regulations. Regulatory Activities Biosolids Management OA 3. Establish a framework for an approach to implement human health investigations. A procedural framework should be established to implement human health investigations, including short term investigations of unusual episodes of release, exposure, or disease and large scale preplanned studies of exposures and their association, if any, with disease. The framework should have mechanisms to document state of the art successes, both technological and administrative, in preventing or remediating exposure to pathogens and toxicants and their adverse health outcomes. Further, the framework should include a means for tracking allegations and sentinel events ( compliance, management, or health based), investigations, and conclusions. Such tracking should be systematic and developed in cooperation with states. Biosolids Management USEPA 2002a 8 OA 4. Increase the resources devoted to EPA's biosolids program. To remedy the deficiencies and to implement the recommendations described in this report, more funding and staff resources are needed for EPA's biosolids program. EPA should support and facilitate greater delegation of authority to states to administer the federal biosolids regulation. Resources are also needed for conducting needed research and to revise the regulation as appropriate and in a timely fashion. Biosolids Management Regulatory Activities OACP 1. EPA should expand its biosolids oversight activities to include procedures for ( 1) assessing the reliability of the biosolids treatment processes, ( 2) monitoring compliance with the chemical and pathogen standards, ( 3) conducting environmental hazard surveillance, and ( 4) studying human exposure and health. The committee recommends that Figure S 1 be used by EPA as a framework for establishing such a program. The central part of the figure presents the general process by which biosolids are produced and used for land application. Depicted on the left side of the figure are opportunities for conducting environmental hazard surveillance. At these stages, biosolids or environmental samples should be collected and analyzed to verify that ( 1) treatment technologies for pathogen control are effective ( quality control), ( 2) chemical standards are met ( compliance audits), and ( 3) unanticipated hazards are identified. An important part of this verification process is a review of the management practices required for land application, because the practices are predicated on the assumption that exposure to hazardous agents is further reduced by the implementation of such practices. Studies should be conducted to determine whether the management practices specified in the Part 503 rule achieve their intended effect. Additional riskmanagement practices should be considered in revising the Part 503 rule. Considerations should include setbacks to residences or businesses, setbacks to private and public water supplies, limitations on holding or storage practices, slope restrictions, soil permeability and depth to groundwater or bedrock, and greater distance to surface water. Biosolids Management Regulatory Activities CH2 1. EPA should strengthen its biosolids oversight program by increasing the amount of funding and staff ( technical and administrative) devoted to it. Biosolids Management CH2 2. EPA should provide additional funds ( not diverted funds) to states to implement biosolids programs and facilitate delegation of authority to states to administer the federal biosolids regulations. Biosolids Management CH2 3. Resources are also needed for conducting research into emerging issues and to revise the regulations as appropriate and in a timely fashion ( e. g., molybdenum standards should be proposed). Biosolids Management Regulatory Activities CH2 4. A process should be established to track allegations and sentinel events ( compliance, management, or health based), investigations, and conclusions. Such tracking should be systematic, developed in cooperation with states, and document both positive and negative outcomes. Biosolids Management CH4 3. In making revisions to the Part 503 rule risk assessment, EPA must strike a balance between expending resources to carry out site specific data collection and expending resources to model and assess risk using existing information. In light of improvements in exposure and health monitoring, the committee encourages EPA to consider options carefully for collecting new data in support of risk assessment assumptions before resorting to another risk assessment that relies only on existing data, models, and default assumptions. Among the data that would be of value are data on proximity of receptors to land application sites; surveys of activities that could increase direct and indirect exposures; and samples of biosolids, air, vegetation, runoff, groundwater, and soil in environments surrounding land application sites. In addition, EPA should conduct site specific surveys of performance ( e. g., monitor the extent to which rates and depth of application are consistent with risk assessment assumptions) and scientifically relevant studies of health complaints. Biosolids Management Risk Assessment USEPA 2002a 9 CH7 1. Figure 7 1 should be used by EPA as a framework for managing the risks from exposure to biosolids. The framework includes audits of treatment process performance and management practices, periodic hazard surveillance, and studies of health outcomes, including preplanned studies and studies in response to episodic events. For example, as recommended in Chapters 2 and 6, surveys should be conducted to verify that Class A and Class B treatment processes perform as assumed by engineering principles, and determinations of pathogen density and destruction across the treatment process and in the soil over time should be completed. Recommendations contained in Chapter 5 also address the need for process performance measures that can be monitored and used in site specific surveys of performance. In Chapter 3, the nature and objectives of hazard surveillance studies and studies of health outcomes of exposed populations are described more fully. All the recommendations reflect the committee's concern that the complex risk assessment task posed by biosolids cannot serve as a useful and reliable guide without an ongoing effort to ensure that the assumptions underlying the assessment are valid and that the risk management procedures put in place in response to the assessment are being routinely implemented. Broad scale and sitespecific feedback, graphically depicted in Figure 7 1, is needed. Biosolids Management Pathogens Survey