[Federal Register: December 28, 2006 (Volume 71, Number 249)]
[Notices]
[Page 78174-78175]
[DOCID:fr28de06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-33-000]

Kinder Morgan Interstate Gas Transmission LLC; Notice of
Application

December 19, 2006.
    Take notice that on December 13, 2006, Kinder Morgan Interstate Gas
Transmission LLC (KMIGT), 370 Van Gordon Street, Lakewood, Colorado
80228-8304, filed in Docket No. CP07-33-000 an application pursuant to
section 7(b) of the Natural Gas Act (NGA) for permission and approval
to abandon, by removal, the Otis Compressor Station located in Rush
County, Kansas, all as more fully set forth in the application.
    Copies of this filing are on file with the Commission and are
available for public inspection. This 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, please contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>.
    Any questions concerning this request may be directed to Skip
George, Manager of Regulatory, Kinder Morgan Interstate Gas
Transmission LLC, P.O. Box 281304, Lakewood, Colorado 80228-8304, or
call<PHONE_NUMBER>.
    Specifically, KMIGT proposes to abandon One 660 hp Worthington
SLHC-7 compressor unit and one 300 hp Worthington LCE-8 compressor
unit, with appurtenances.
    KMIGT states that the Otis Compressor Station has not been utilized
since 1994 and it is uneconomical for KMIGT to continue to operate this
Compressor Station. KMIGT states further that the abandonment would
have no material impact on KMIGT's cost of service nor would it result
in or cause any interruption, reduction, or termination of the
transportation service presently rendered by KMIGT.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    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 commenters 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 commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters 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 filings of comments, protests
and interventions electronically via the Internet in lieu of paper.
See, 18 CFR385.2001(a)(1)(iii) and the instructions on the Commission's
web site under the ``e-filing'' link.
    If the Commission decides to set the application for a formal
hearing before an Administrative Law Judge, the Commission will issue
another notice describing that process. At the end of the Commission's
review process, a final Commission order approving or denying a
certificate will be issued.
    Comment Date: January 8, 2007.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-22227 Filed 12-27-06; 8:45 am]

BILLING CODE 6717-01-P


Table 4: Aggregate Burden Table for Burden Identified on Tables 2 and 3 Activity Person hours per responden t per year Respondent s per year Total Hours Per Year Total Cost Per year Batch Vapor or In Line Cleaning Machines ( subtotal) 154.00 1,180.00 44,956.20 $ 1,787,900.10 Batch Cold Cleaning Machines ( subtotal) 1.00 251.00 251.00 $ 9,982.25 Capital/ Operations and Maintenance Cost $ 4,091,060.00 TOTAL ANNUAL COST BURDEN( Labor/ Capital O& M Cost) 155.00 1,431.00 45,207.00 $ 5,888,942.30


[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74775-74777]
[FR Doc No: 2020-25730]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90439; File No. SR-C2-2020-017]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Interpretations and Policies to Rule 6.13 in Connection With
Market-Makers' Complex Orders, Quoting Obligations and Volume

November 17, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 3, 2020, Cboe C2 Exchange, Inc. (the ``Exchange'' or
``C2'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposal pursuant to Section 19(b)(3)(A)(iii) of the
Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2'') proposes to
amend its Interpretations and Policies to Rule 6.13 in connection with
Market-Makers' complex orders, quoting obligations and volume. The text
of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, 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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to adopt new Interpretation and Policy .02 to
Rule 6.13 which provides that complex strategies are included when
determining whether a Market Maker exceeds the 25% volume threshold in
its non-appointed classes pursuant to Rule 8.6(f).\5\ The Exchange also
proposes to make clarifying, nonsubstantive updates to Interpretation
and Policy .01 to Rule 6.13.
---------------------------------------------------------------------------

    \5\ As a result of the proposed Interpretation and Policy, the
proposed rule change accordingly updates the subsequent
Interpretation and Policy numbering.
---------------------------------------------------------------------------

    Rule 6.13 governs trading of complex orders on the Exchange and,
currently, Interpretation and Policy .01 to Rule 6.13 specifically
provides that Market-Makers are not required to quote on the COB.
Complex strategies are not subject to any quoting requirements that
apply to Market-Makers in the simple market. Interpretation and Policy
[sic] to Rule 6.13 also states that the Exchange does not take into
account Market-Makers' volume executed in complex strategies when
determining whether Market-Makers meet their quoting obligations in the
simple market. The proposed rule change updates Interpretation and
Policy .01 to Rule 6.13 in order to provide additional clarity and
consistency with the rules that provide for a Market-Maker's quoting
requirements and obligations. Specifically, pursuant to Rule 8.6, a
Market-Maker must satisfy quoting obligations in each of its appointed
classes. As such, the proposed updates to Interpretation and Policy .01
to Rule 6.13 to [sic] make it clear that a Market-Maker's orders in
complex strategies are not subject to a Market-Maker's quoting
requirements in its appointed classes nor are considered in determining
whether a Market-Maker has satisfied its quoting obligations in its
appointed classes. Also, the proposed rule change also updates
Interpretation and Policy .01 to Rule 6.13 as it inadvertently refers
to volume executed rather than orders, as ``quoting'' obligations
relate to the submission of quotes and orders rather than executed
volume. More specifically, pursuant to Rule 8.6, a Market-Maker's bids
and offers entered in the simple market are considered in determining
whether a Market-Maker satisfies its quoting obligations, therefore,
the proposed rule change amends Interpretation and Policy .01 to Rule
6.13 to more appropriately reflect this. The proposed change also
updates the language in Interpretation and Policy .01 to Rule 6.13 to
read in plain English.
    Current Rule 8.6(f) provides that a Market-Maker is considered an
order entry firm (``OEF'') \6\ under the Rules in all classes in which
the Market-Maker has no appointment, and limits the total number of
contracts a Market-Maker may execute in classes in which it has no
appointment to 25% of the total number of all contracts the Market-
Marker executes on the Exchange in any calendar quarter. The Exchange
does not currently include executed complex order volume when
determining whether a Market-Maker has exceeded this threshold. The
Exchange's affiliated options exchange, Cboe Exchange, Inc. (``Cboe
Options'') has a rule in place that is substantially the same as C2
Rule 8.6(f); however, Cboe Options currently considers a Market Maker's
executed complex order volume as well as a Market Maker's executed
simple order volume in determining whether a Market-Maker has exceeded
the 25%

volume threshold in its non-appointed classes.\7\ In order to harmonize
this practice across the affiliated options exchanges,\8\ the Exchange
now proposes to change its current interpretation and adopt proposed
Interpretation and Policy .02 to Rule 6.13 to provide that a Market-
Maker's orders for complex strategies executed in classes in which it
has no appointment are included in the total number of all contracts
the Market-Maker executes on the Exchange in any calendar quarter in
determining whether the Market-Maker exceeds the 25% threshold pursuant
to Rule 8.6(f). The Exchange notes that Rule 8.6(f) is designed to
prevent a Market-Maker from executing volume in non-appointed option
classes in an amount disproportionate to volume executed in its
appointed option classes, potentially in derogation of the performance
of its obligations and provision of liquidity in its appointed option
classes. As such, the proposed rule change is consistent with and
supports the purposed [sic] of Rule 8.6(f) by including complex orders
in this calculation. Therefore, the proposed rule change considers a
Market-Maker's orders executed in complex strategies representative of
a Market-Maker's total volume on the Exchange.
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    \6\ See Rule 1.1., which defines an ``Order Entry Firm'' or
``OEF'' as a Trading Permit Holder that represents as agent customer
orders on the Exchange or that is a non-Market-Maker conducting
proprietary trading.
    \7\ The Exchange notes too that Cboe Options intends to
simultaneously submit a rule filing to codify its current practice
in calculating its Market-Makers' simple and complex volume in non-
appointed classes in its corresponding Interpretations and Policies
to Rule 6.13.
    \8\ The Exchange's affiliated options exchange, Cboe EDGX
Exchange, Inc. (``EDGX Options'') intends to simultaneously submit a
substantively identical rule filing to clarify that it will
calculate its Market Makers' simple and complex volume in non-
appointed classes pursuant to Cboe Options' current practice.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\9\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \10\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, 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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \11\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed rule change will
remove impediments to and perfect the mechanism of a free and open
market and a national market system by providing that the Exchange
considers a Market-Maker's complex order volume when calculating the
25% threshold of volume in non-appointed classes pursuant to Rule
8.6(f) and thereby harmonizing the Exchange's rules with that of the
corresponding rules of its affiliated options exchanges.\12\
Specifically, Rule 8.6(f) is designed to prevent a Market-Maker from
executing volume in non-appointed option classes in an amount
disproportionate to volume executed in its appointed option classes,
potentially in derogation of the performance of its obligations and
provision of liquidity in its appointed option classes. As stated
above, the Exchange believes that a Market-Maker's orders executed in
complex strategies are representative of a Market-Maker's total volume
on the Exchange. Thus, including such in its calculation of volume in
non-appointed classes will help to ensure that Market-Makers perform
their obligations and provide liquidity in appointed classes in an
appropriate manner as compared to non-appointed classes, and is thereby
consistent with and supports the purpose of Rule 8.6(f). The Exchange
also believes that codifying that a Market-Maker's complex order volume
counts towards its Market-Maker's total volume on the Exchange may
mitigate any potential confusion regarding this calculation so that
Market-Makers have more clarity regarding their obligations in
appointed classes in an appropriate manner as compared to non-appointed
classes. As such, the Exchange believes the proposed rule change will
contribute to the protection of investors and the public interest by
adding transparency and clarity to the Exchange's Rules by codifying
its affiliated options exchange's current interpretation of how to a
Market-Maker's executed volume on the Exchange is calculated. In
addition, the Exchange believes the proposed changes to Interpretation
and Policy .01 of Exchange Rule 6.13 will add clarity by revising the
Rule to provide that orders entered in appointed classes, rather than
volume executed, is considered in connection with determining whether a
Market-Maker meets it quoting obligations pursuant to Rule 8.6 in its
appointed classes as well as updating the language to read in plain
English.
---------------------------------------------------------------------------

    \12\ See supra notes 7 and 8.
---------------------------------------------------------------------------

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 purposes of the Act. The Exchange reiterates that
the proposed rule change is intended to codify in new Interpretation
and Policy .02 to Rule 6.13 that the Exchange will consider a Market-
Maker's complex strategy execution volume in calculating its volume per
quarter pursuant to Rule 8.6(f) and harmonize this calculation with the
manner in which the exchange's affiliated options exchange, Cboe
Options, currently calculates Market-Maker executed volume in non-
appointed classes. The proposed rule change also corrects an
inadvertent error in Interpretation and Policy .01 to 6.13 indicating
that executed volume rather than entered orders are considered when
determining compliance with a Market-Maker's quoting obligations. Thus,
the Exchange believes this proposed rule change will benefit Exchange
participants by providing specific guidance and additional clarity
within the Exchange Rules, as well as between the rules of the
affiliated options exchanges.
    Additionally, the Exchange believes that the proposed rule change
regarding the applicability of Rule 8.6(f) to a Market-Maker's
executions in the COB does not impose any burden on intramarket
competition because it applies to all Market-Makers in the same manner.
The proposed rule change codifies its affiliated options exchange's
existing interpretation of such calculation in its corresponding rules.
It does not modify any existing Market-Maker obligations. The Exchange
believes that the proposed rule change does not impose any burden on
intermarket competition because it relates to an obligation regarding
Market-Maker executed volume only on the Exchange.
    The Exchange believes that the proposed rule change will relieve
any burden on market participants because it serves to provide Market-
Makers with rules that ensure that Market-Makers are performing their
obligations in appointed options classes in an appropriate manner as
compared to

non-appointed classes. Ensuring that Market-Makers execute a certain
amount of their volume in appointed classes will contribute to
sufficient liquidity in those classes, which benefits the market and
investors as a whole.
    Additionally, the proposed nonsubstantive updates to Interpretation
and Policy .01 to Rule 6.13 are not competitive in nature and, instead,
are intended to correct an inadvertently used term and provide clarity
and consistency within the Rules.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \13\ and
Rule 19b-4(f)(6) \14\ thereunder. At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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-C2-2020-017 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-C2-2020-017. 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-C2-2020-017, and should be submitted on
or before December 14, 2020.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-25730 Filed 11-20-20; 8:45 am]
BILLING CODE 8011-01-P


%
1
.6%
1
.3%
3391
15, Ophthalmic goods
manufacturing
3
1,121,083
0.
004
%
0
.6%
0
.4%
6219
91 Blood and organ
banks 4,281,172
0.
001
%
0
.1%
0
.1%
1
Source: Table 4 of 2002 Economic Census for NAICS 325411, 325412, 325414, 339112, 339113, 339114, 339115,
and 621991.
2
Averages based on the sum of data for establishments with 1 to 4 employees and 5 to 9 employees. For
establishments with 1 to 4 employees, recordkeeping costs equal less than 0.02 percent of average annual shipments
for all NAICS categories. It is unlikely that entities with 1 to 4 employees would incur compliance costs for a
labeling revision or a request for exception or alternative to requirements of the proposed rule. Nevertheless, for
these smallest entities, as a percentage of average annual shipments, a labeling revision equals less than 2.6 percent
and a request for exemption or alternative equals less than 2.0 percent for all NAICS categories.
3
No information for establishments with 1 to 4 employees.
Besides the one-time compliance burden that a few small entities might incur, most
affected small manufacturers would incur minor new compliance costs for recordkeeping.  For
small manufacturers and small importers of record, these annual costs would equal about $45, a
negligible amount for even the smallest entities.  Table 5 shows that these incremental
recordkeeping costs for establishments with less than 10 employees would equal less than 0.02
percent of their average annual value of shipments..
FDA lacks the data required to estimate the number of requests, the distribution of one-
time labeling costs, and the new annual recordkeeping burden on small entities.  We anticipate,

97
however, that the potential costs might represent a very small percentage of their annual
revenues and would not be a significant economic impact on affected small entities.
Nevertheless, the agency requests detailed data on small business impacts from affected firms.
As discussed in section VIII. F. of this document,  FDA considered other regulatory
options.  The proposed rule is the least burdensome option that meets FDA’s goal of minimizing
human and ruminant exposure to materials that scientific studies have demonstrated are likely to
contain the BSE agent in cattle infected with the disease.
IX.  Paperwork Reduction Act Analysis
This proposed rule contains information collection requirements that are subject to
review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
A description of these provisions is given below with an estimate of the annual reporting and
recordkeeping burden.  Included in the estimate is the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on the following 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.

98
Title:  Use of Materials Derived from Cattle in Medical Products Intended for Use in
Humans and Drugs Intended for Use in Ruminants
Description:  As discussed previously in this document, we are proposing to prohibit the
use of certain cattle material in medical products for humans and drugs for ruminants because of
the risk of BSE and related human disease. The rulemaking contains reporting and
recordkeeping requirements that are subject to review by OMB.
Reporting.  Under proposed §§ 300.200(b)(2)(i) and (b)(2)(ii) for drugs for humans,
500
.200
(b)(2)(i) and (b)(2)(ii) for drugs for ruminants, 600.16(b)(2)(i) and (b)(2)(ii) for
biological products, 895.102(b)(2)(i) and (b)(2)(ii) for human medical devices that are intended
for use in or on the body, and 1271.470(b)(2)(i) and (b)(2)(ii) for HCT/Ps, applicants and
manufacturers could request permission for an exception or alternative to the requirements in
proposed §§ 300.200(b)(1), 500.200(b)(1), 600.16(b)(1), 895.102(b)(1), and 1271.470(b)(1) that
no medical product for humans or drug for ruminants be manufactured from or otherwise contain
prohibited cattle materials obtained from cattle slaughtered on or after the effective date of the
regulation.  To obtain written permission from FDA for an exception or alternative to the
requirements, applicants and manufacturers would send a written request to the director of the
Center having jurisdiction over the relevant product.  Any request would contain the following:
•
A statement of the reasons why an exception or alternative is needed;
•
A description of the product, including the type of prohibited cattle materials used in its
manufacturing, its manufacturing and purification processes, and its route of
administration;
•
A description of the source of the prohibited cattle materials, including information on
the location where the cattle were born, raised, and slaughtered, and any other

99
information relevant to the likelihood of the cattle having ingested material prohibited
under  589.2000;
•
A description, if applicable, of how the requirements that pertain to their product in
proposed §§ 300.200(b)(1), 600.16(b)(1), 895.102(b)(1), or 1271.470(b)(1) are not
necessary based on the risks of the prohibited cattle materials in the product and the
benefits of the product, or how such restrictions are not necessary to ensure the safety of
the product;
•
A description, if applicable, of:  (1) How the requirements that pertain to their product in
proposed § 500.200(b)(1) are not necessary: (i) Based on the risks of the prohibited cattle
materials in the product to the target animal and the benefits of the product to the target
animal and (ii) to ensure a reasonable certainty of no harm to humans from any food
derived from the target animal to which the product was administered, or (2) how such
restrictions are not necessary to ensure the safety of the product with respect to both the
target animal and any food derived from the target animal to which the product is
administered; and
•
Any other relevant information.
As discussed in the Analysis of Impacts (see section VIII of this document), we
estimate that a request for an exception or alternative to the requirements would take between 60
and 120 hours to complete and submit to FDA. For purposes of this information collection
analysis, we estimate, as indicated in table 6 of this document, that each request would take
approximately 120 hours.  We estimate that only three requests would be submitted to FDA in
the first year by applicants and manufacturers of medical products for humans and drugs for
ruminants because only a small number of such products are currently manufactured with cattle

10
0
materials that would be prohibited under this rule.  We expect that applicants and manufacturers
would seek, and obtain, alternatives to prohibited cattle materials, eliminating the need for future
requests for an exception or alternative to the requirements of the proposed rule.  We request
comments on our estimates of the number of exception/alternative requests, the time for
preparation and submission of the request, and the likelihood of requests beyond the first year
after the rule would be in effect.
Under proposed §§ 300.200(c)(5), 500.200(c)(5), 600.16(c)(5), 895.102(c)(5), and
127
1.47
0(c)(5), when filing entry with the U.S. Customs and Border Protection, importers of
record of a medical product for humans or a drug for ruminants that was manufactured from, or
otherwise contains, cattle material would be required to affirm that the product was
manufactured from or otherwise contained cattle material and affirm that the product was
manufactured in accordance with the requirements in this proposed rule.  If a product was
manufactured from, or otherwise contains, cattle material, then importers of record would also, if
requested, have to provide to FDA within 5 days records that would be sufficient to demonstrate
that the product was not manufactured from, and does not contain, prohibited cattle material.  As
discussed in the Analysis of Impacts (see section VIII of this document), we estimate that 3,787
importers of record would be subject to this affirmation and potential record submission and that
it would take each of them between 1 and 5 hours annually to process.  For purposes of this
information collection analysis, we estimate, as indicated in table 6 of this document, that this
proposed provision would take each importer of record approximately 2.5 hours annually to
process.
Under proposed § 530.42, FDA would require that labels for drugs prohibited from
extralabel use in ruminants by proposed § 530.41(c) bear or be accompanied by the statement

10
1
“Federal law prohibits the extralabel use of this product in ruminants.” This labeling statement is
not subject to review by OMB because it is “originally supplied by the Federal Government to
the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)) and, therefore,
does not constitute a “collection of information” under the PRA.
Recordkeeping. Under proposed §§ 300.200(c), 500.200(c), 600.16(c), 895.102(c), and
127
1.47
0(c), applicants and manufacturers of medical products for humans and drugs for
ruminants that are manufactured from, or otherwise contain, material from cattle would be
required to establish and maintain records demonstrating that their products have not been
manufactured from and do not otherwise contain, prohibited cattle materials and make such
records available to FDA for inspection and copying.  These proposed requirements are
necessary because, once materials are separated from an animal, it may not be possible without
records to know the following:  (1) Whether the cattle material contains SRMs, (2) whether the
material was sourced from an animal that was inspected and passed for human consumption, (3)
whether the material was sourced from a nonambulatory disabled animal, and (4) whether the
product contains mechanically separated beef.  Under the proposed rule, applicants and
manufacturers must retain records the varying periods of time consistent with the applicable
CGMP or CGTP requirements (e.g., for drugs for humans, it would be at least 1 year after the
expiration date of the drug; for drugs for humans lacking an expiration date, it would be at least 3
years after distribution of the last lot of the drug).  These records would be required to be
maintained at the applicant’s or manufacturer’s establishment or another reasonably accessible
location.
Recordkeeping requirements currently exist for applicants and manufacturers of medical
products for humans and drugs for ruminants under FDA’s CGMP and CGTP regulations.  For

10
2
drugs and biological products for humans and drugs for ruminants, these requirements are at part
210
(21 CFR part 210) and part 211 (CGMP), and the information collection requirements for
these regulations are already approved by OMB under OMB Control Number 0910-0139 until
September 30, 2008.  For blood and blood components, these requirements are at 21 CFR part
606
(CGMP), and the information collection requirements for these regulations are already
approved by OMB under OMB Control Number 0910-0116 until December 31, 2008.  For Type
A medicated articles, these requirements are at part 226 (CGMP), and the information collection
requirements for these regulations are already approved by OMB under OMB Control Number
091
0-015
4 until December 31, 2007.  For medical devices for humans, these requirements are at
21 CFR part 820 (CGMP/quality system regulations), and the information collection
requirements for these regulations are already approved by OMB under OMB Control Number
091
0-007
3 until September 30, 2007.  For HCT/Ps, these requirements are at part 1271, subpart
D (CGTP regulations), and the information collection requirements for these regulations are
already approved by OMB under OMB Control Number 0910-0559 until November 30, 2007.
In accordance with the previously mentioned CGMP and CGTP regulations, applicants and
manufacturers of medical products for humans and drugs for ruminants would be responsible for
maintaining records regarding use of cattle materials in, or in the manufacture of, their products.
However, FDA estimates that, in accordance with this rulemaking, applicants and manufacturers
would expend a small amount of additional effort to comply with the proposed recordkeeping
requirements.  FDA has determined, as indicated in table 7 of this document, that there are 1,278
applicants and manufacturers of a medical product for humans or drug for ruminants that would
be responsible for recordkeeping. This would include verifying records and storing records that
contain information on sources of cattle materials that are to be used in medical products for

10
3
humans and drugs for ruminants. As discussed in the Analysis of Impact (see section VIII of this
document), we estimate that this recordkeeping burden will be about 1 to 3 hours per year.  For
purposes of this document, we estimate, as indicated in table 7, that this burden would take about
2 hours/year. Therefore, the total annual burden will be 2 hrs x 1,278 = 2,556 hours, as shown in
table 7 of this document.
Description of Respondents: Applicants and manufacturers of medical products for
humans and drugs for ruminants that are manufactured from, or otherwise contain, material from
cattle slaughtered on or after the effective date of the regulation.
Table 6.--Estimated Reporting Burden
1
21
CFR Section
Number of
Respondents
Frequency per
Response
Total
Responses
Hours per
Response
Total
Hours
300.
200(b)(2)(i) and (b)(2)(ii),
500.
200(b)(2)(i) and (b)(2)(ii),
600.
16(b)(2)(i) and (b)(2)(ii),
895.
102(b)(2)(i) and (b)(2)(ii), and
127
1
.
470
(b)(2)(i) and (b)(2)(ii)
3 1
3 120 360
300.
200(c)(5), 500.200(c)(5), 600.16(c)(5),
895.
102(c)(5), and 1271.470(c)(5)
3
7
87 1
3
7
87 2.5 9467.5
Total
98
27.5
<s>1</s>
There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 7.--Estimated Annual Recordkeeping Burden
1
21 CFR Section
Number of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Hours
300.
200(c), 500.200(c), 600.16(c),
895.
102(c), and 1271.470(c)
1,278 1 1,278 2 2,556
<s>1</s>
There are no capital costs or operating and maintenance costs associated with this collection of information.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the
agency has submitted the information collection provisions of this proposed rule to OMB for
review.  Interested persons are requested to send comments regarding information collection to
OMB (see DATES and ADDRESSES).
X.  Environmental Impact Analysis
FDA has carefully considered the potential environmental effects of this proposed rule
(i.e., ban use of prohibited cattle materials in medical products for humans and drugs for
Deleted:
requirements
Deleted:
fax
Deleted:
the Office of Information and
Regulatory Affairs,
Deleted:
, Attn: FDA Desk Officer,
FAX: 202
¶974

10
4
ruminants, unless a request for exception or alternative to the requirements has been granted) and
of two possible alternative actions:  (1) No action and (2) in addition to the requirements
proposed in this rule, ban use in medical products for humans and drugs for ruminants of all
neural material from cattle from countries with a high or medium risk of BSE if the cattle were
slaughtered when over 6 months old, unless a request for exception or alternative to the
requirements has been granted.  In doing so, the agency focused on the environmental impacts of
its action, specifically, disposal of unused cattle byproducts (e.g., dead animals and slaughter
byproducts) that can no longer be used in medical products for humans or drugs for ruminants
after the rule becomes effective.
The environmental assessment (EA) considered each of the alternatives in terms of the
need to provide maximum reasonable protection of human health without resulting in a
significant impact on the environment. The EA considered environmental impacts related to
landfill, incineration, composting, and land burial.  The additional waste that might result from
the selected action would be an extremely small amount compared to the total amount of waste
generated by the cattle industry.
The agency has concluded that the proposed rule will not have a significant impact on
the human environment and that an environmental impact statement is not required.  FDA's
finding of no significant impact (FONSI) and the evidence supporting that finding, contained in
an EA prepared under 21 CFR 25.40, may be seen in the Dockets Management Branch (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. FDA invites comments and
submission of data concerning the EA and FONSI.

10
5
XI.  Federalism
We have analyzed this proposed rule in accordance with the principles in Executive
Order 13132.  We have determined that the proposed rule does not contain policies 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. Accordingly, we have concluded that the proposed rule does not contain policies
that have federalism implications as defined in the Executive order and, consequently, a
federalism summary impact statement has not been prepared.
XII.  References
The following references have been placed on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4
p.m
., Monday through Friday.  (FDA has verified the Web site address, but we are not
responsible for subsequent changes to the Web site after this document publishes in the Federal
Register.)
1
.  Johnson, R. T. and C. J. Gibbs, Jr., “Creutzfeldt-Jakob
Disease and Related Transmissible Spongiform Encephalopathies,”
New England Journal of Medicine, 339(27):1994-2004, 1998.
2
.  Herzog, C., N. Sales, N. Etchegaray, et al., “Tissue
Distribution Of Bovine Spongiform Encephalopathy Agent in
Primates After Intravenous or Oral Infection,” Lancet,
363
(9407):422-28, 2004.
3
.
Wells, G. A. H., S. A. C. Hawkins, R. B. Green, et al.,
“Preliminary Observations on the Pathogenesis of Experimental

10
6
Bovine Spongiform Encephalopathy (BSE):  An Update,”
Veterinary Record, 142:103-106, 1998.
4
.
Wells, G. A. H., M. Dawson, S. A. C. Hawkins, et al.,
“Infectivity in the Ileum of Cattle Challenged Orally With Bovine
Spongiform Encephalopathy,”  Veterinary Record, 135:40-41,
199
4.
5
.
Wells, G. A. H., S. A. C. Hawkins, R. B. Green, et al.,
“Limited Detection of Sternal Bone Marrow Infectivity in the
Clinical Phase of Experimental Bovine Spongiform
Encephalopathy (BSE),” Veterinary Record, 144:292-294, 1999.
6
.
Brown, K. L, D. L. Ritchie, P. A. McBride, and M. E.


TECHNICAL SUPPORT DOCUMENT (TSD)

FOR THE STATE OF WEST VIRGINIA 111(d)/129 PLAN

REVISION #1 FOR THE CONTROL OF EMISSIONS FROM

HOSPITAL/MEDICAL/INFECTIOUS WASTE SOLID WASTE

INCINERATOR (HMIWI) UNITS

Submitted By the West Virginia Department of Environmental Protection on
May 11, 2009

TSD Prepared by James B. Topsale, P.E.

Air Quality Analysis Branch, 3AP22

U.S. Environmental Protection Agency, Region 3

1650 Arch Street

Philadelphia, Pennsylvania 19103

(215) 814-2190

/s/

___________________________________

Reviewed by Walter Wilkie, Chief

Air Quality Analysis Branch

__July 8, 2009___

Date Signed

                                                                  TABLE
OF CONTENTS

                 Page

I.     General provisions . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .       3

       A.   What action is EPA approving?  . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .       3

       B.   What pollutant(s) will this action control? . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .      3

       C.   What are the expected environmental and public health
benefits from controlling

              hospital/medical infectious solid waste incinerator
(HMIWI) emissions?  . . . . . . . . .      3

II.   Federal requirements the West Virginia (WV) 111(d)/129 Plan
revision must meet

       for approval . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  3

                   A.	 What general requirements must the WV Department
of Environmental Protection

                         meet in order to receive approval of its HMIWI
111(d)/129 plan revision ?  . . . . . . . .      3

       B.   What does the WV plan revision contain? . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . .    3

                   C.   Does the WV plan revision meet all EPA
requirements for approval?  . . . . . . . . . . . .  .   4

            III.   Requirements for affected HMIWI unit owners/operators
 . . . . . . . . . . . . . . . . . . . . . . . . . .  14

        A.   What general requirements must I meet under the approved
plan revision?  . . . . . .  . .   14

        B.    Is there a requirement for obtaining a Title V permit?  .
. . . . . . . . . . . . . . . . . . . . . . . .   14

IV. Conclusion  . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14

        WEST VIRGINIA HOSPITAL/MEDICAL/INFECTIOUS SOLID WASTE

INCINERATOR (HMIWI) 111(d)/129 PLAN REVISION #1

I. General Provisions

Q. What action is EPA approving?

A.  The West Virginia Department of Environmental Protection, Division
of Air Quality (DAQ) has streamlined its regulatory structure for Clean
Air Act, Section 129, incinerator units by consolidating all applicable
requirements (WV45CSR6,18, and 24) into one state rule, WV45CSR18.  On
May 11, 2009  the DAQ forwarded to EPA a revision to its approved
111(d)/129 plan ( the “plan”) for existing HMIWI units, 40 CFR 62,
Subpart XX.  The scope of EPA’s plan revision approval is limited to
Part 60 and 62 provisions relevant to existing HMIWI units, and the
related new source performance standard provisions, subpart Ec, as
referenced in the emission guidelines, subpart Ce.  Other types of
Section 129 incinerator rules are not included in this approval action.

Q. What pollutant(s) will this action control?

A. The pollutants are dioxins/furans, carbon monoxide, metals (cadmium,
lead, mercury, particulate matter), opacity, and acid gases (hydrogen
chloride, sulphur dioxide, and nitrogen oxides).

Q. What are the expected environmental and public health benefits from
controlling HMIWI emissions?

A. The benefits are explained in the original EPA plan approval
technical support document dated May 23, 2000.

II. Federal Requirements the WV HMIWI 111(d)/129 plan revision must meet
for approval

Q. What general requirements must the DAQ meet to receive approval of
its 111(d)/129 plan revision?

A.  The West Virginia plan must meet the requirements of 1) 40 CFR Part
60, Subpart B, Sections 60.23 through .26, except the provisions
relating to electric generating units; 2) 40 CFR Part 60, Subpart Ce,
Sections 60.30e through 60.39e.; and 3) 40 CFR Part 62, Subpart A

Q. What does the WV plan revision contain?

The revision contains a modified DAQ rule, 45 CSR18 that streamlines the
state’s regulatory structure by incorporating all 40 CFR Part 60
requirements for existing Section 129 solid waste combustion units into
one rule.  The submitted plan revision contains all the required
elements as listed in EPA’s WV plan approval Federal Register notice
of June 13, 2000.  (65 FR37046).

Q.  Does the WV 111(d)/129 plan revision meet all EPA requirements for
approval?

A. Yes. The completeness and approvability of the WV plan revision in
the context of 40 CFR Part 60, Subparts B, and Ce; and 40 CFR Part 62,
section 62.09 are discussed in the narrative and tables below.

How WV45CSR18, as amended, meets EPA(s Hospital/Medical Infectious
Waste Incinerator (HMIWI) EG, Subpart Ce (((60.30e through 60.39e) Model
Rule Requirements

HMIWI RULE (WV45CSR18, as amended )

Subpart Ce – Federal Requirements, Rule Section.	    State Rule Series
	Series 18, as Amended, Meets

subpart Ce  Requirements	    Comment(s)

	  Series 24	Related Series 18, as amended

60.30e, Scope	4.3  and 4.4	6.3 and 6.4*	Yes

	60.31e, Definitions	2	2	Yes	Subparts A & B definitions referenced in
Sec.18, 2.42

60.32e, Designated facilities	3.1, 3.2; and  4.3,  4.4	6.1, 6.3, 6.4*,
and 13.1	Yes

	60.32e, T5 Permit	6.1	10.1	Yes

	60.33e, MACT emission limits.	4.3.a and g,

Table 1

4.4.i (opacity)*	6.3.a and g, 6.4.a, Table 18-A*

6.4.i (opacity)*	Yes

	60.34e, and 60.39e(e), Operator Training & Certif.	4.3.b and 4.4.b
6.3.c and 6.4.b*	Yes

	60.35e, Waste Mang’mt plan	4.3.c and 4.4.c	6.3.d and 6.4.c*	Yes

	60.36e, Rural Unit Inspections	4.4.d*	6.4.d*	Yes 	* - Indicates
inclusion of rural unit requirements

60.37e, Compliance,Perf. Test’g, and Mont’g	4.3.d & e, 4.4.e & f*
6.3.e and 6.3.f

6.4.e & f*	Yes

	60.38e, Reporting & Recordkeeping	4.3.f and 4.4.g and h*	6.3.g, 11

6.4.g and h*	Yes

	60.39e, Compliance

 Time	7	12	Yes

Evaluation of the West Virginia Plan Revision #1 against the
requirements of 40 CFR Parts 60, Subpart B, Sections 60.23 through
60.26, excluding electric generating unit provisions, and Part 62,
Section 62.09

40 CFR 60.23 - Adoption and submittal of State plan revision; public
hearings.

Federal Requirements

DAQ Submittal

(60.23(a)(1) Within nine months after notice of the availability of a
final guideline document is

published under (60.22(a), each State shall adopt and submit to the
Administrator, in accordance with ( 60.4, a plan for the control of the
designated pollutant to which the guideline document applies.

See EPA’s 5/23/00 technical support document (TSD).

(2) Within nine months after notice of the availability of a final
revised guideline document is published as provided in (60.22(d)(2),
each State shall adopt and submit to the Administrator any plan revision
necessary to meet the requirements of this subpart.

Not applicable; the plan revision is not an EPA requirement.

(60.23(b) If no designated facility is located within a State, the
State shall submit a letter of certification to that effect to the
Administrator within the time specified in paragraph (a) of this
section.  Such  certification shall exempt the State from the
requirements of this subpart for that designated pollutant.

Not applicable.

(60.23(c)(1)  Except as provided in paragraphs (c)(2) and (c)(3) of this
section, the State shall, prior to the adoption of any plan or revision
thereof, conduct one or  more public hearings within the State on such
plan or plan revision.

Public hearings were held in Charleston, WV on July 21, 2008 and April
21, 2009 for the plan revision.

( 60.23(d) Any hearing required by paragraph (c) of this section shall
be held only after reasonable notice. Notice shall be given at

least 30 days prior to the date of such hearing.

A certified copy of the required public notices was provided.  The
requirements of Part 62, ( 62.09 were met.

( 60.23(e)  The State shall prepare and retain, for a minimum of 2
years, a record of each hearing for inspection by any interested party.
The record shall contain, as a minimum, a list of witnesses together
with the text of each presentation.

A copy of records from the public hearings were submitted with the plan,
and amendment.

( 60.23(f)  The State shall submit with the plan or revision:

(1)  Certification that each paragraph (c) of this section was held in
accordance with the notice required by paragraph (d) of this section;
and

           (2)  A list of witnesses and their organizational
affiliations, if any, appearing at the hearing and a brief written
summary of each presentation or written submission.

The State submitted the required certification and list of witnesses.

( 60.23(g) provides for alternate procedures to insure public
participation.

Not applicable.

40 CFR 60.24  --  Emission standards and compliance schedules

( 60.24(a)  Each plan shall include emission standards and compliance
schedules.

The Series 18 regulation incorporates by reference (IBR) the required
emission standards.

( 60.24(b)(1) Emission standards shall prescribe allowable rates of
emissions except when it is clearly impracticable.  Such cases will be
identified in the guideline documents issued under ( 60.22.  Where
emission standards prescribing equipment specification are established,
the plan shall, to the degree possible, set forth the emission
reductions achievable by implementation of such specifications, and may
permit compliance by the use of equipment determined by the State to be
equivalent to that prescribed.

Not applicable.

         (2) Test methods and procedures for determining compliance with
the emission standards shall be specified in the plan.  Methods other
than those specified in Appendix A to this part may be specified in the
plan if shown to be equivalent or alternative methods are defined in (
60.2(t) and (u).

The plan IBR the required test methods and procedures specified in the
EG and related NSPS.

(3)  Emission standards shall apply to all designated facilities within
the State.  A plan may contain emission standards adopted by local
jurisdictions provided that the standards are enforceable by the State.

   See EPA’s 5/23/00 TSD.

( 60.24(c)  Except as provided in paragraph (f) of this section where
the Administrator has determined that a designated pollutant may cause
or contribute to endangerment or public health, emission standards,
shall be no less stringent than the corresponding emission guideline(s)
specified in Subpart C of this part, and final compliance shall be
required as expeditiously as practicable but no later than the
compliance times specified in Subpart C of this part.

The emission limits remain as stringent and protective as required by
the EG.

( 60.24(d)  Where the Administrator has determined that a designated
pollutant may cause or contribute to endangerment of public welfare but
that adverse effects on public health have not been demonstrated, States
may balance the emission guidelines, compliance times, and other
information provided in the applicable guideline document against other
factors of public concern in establishing emission standards, compliance
schedules, and variances.  Appropriate consideration shall be given to
the factors specified in ( 60.22(b) and to information presented at the
public hearing(s) conducted under ( 60.23(c).

Not applicable.

( 60.24(e)(1)  Any compliance schedule extending more than 12 months
from the date required for submittal of the plan shall include legally
enforceable increments of progress to achieve compliance for each
designated facility or category of facilities.  Increments of progress
shall include, where practicable, each increment of progress specified
in ( 60.21(h) and such additional increments of progress as may be
necessary to permit close and effective supervision of progress toward
final compliance.

See EPA’s 5/23/00 TSD.

(2)  A plan may provide that compliance schedules for individual sources
or categories of sources will be formulated after plan submittal.  Any
such schedule shall be the subject of a public hearing held accordingly
to ( 60.23 and shall be submitted to the Administrator within 60 days
after the date of adoption of the schedule but in no case later than the
date prescribed for submittal of the first semiannual report required by
( 60.25(e).

Not applicable.

( 60.24(f)  On a case-by-case basis for particular designated
facilities, or classes of facilities, States may provide for the
application of less stringent emission standards or longer compliance
schedule than those otherwise required by paragraph (c) of this section,
provided that the State demonstrated with respect to each facility (or
class of facilities):

(1)  Unreasonable cost of control resulting from plant age, location or
basic process design:

(2)  Physical impossibility of installing necessary control equipment;
or

(3)  Other factors specific to the facility (or class of facilities)
that make application of a less stringent standard or final compliance
time significantly more reasonable.

The WV plan revision is no less stringent than the Federal requirements.

( 60.24(g)  Nothing in this subpart shall be construed to preclude any
State or political subdivision thereof from adopting or enforcing

(1)  emission standards more stringent than emission guidelines
specified in Subpart C of this part or in applicable guideline
documents or

(2)  compliance schedules requiring final compliance at earlier times
than those specified in Subpart C or in applicable guideline documents.

Not applicable

40 CFR 60.25  --  Emission inventories, source surveillance, reports.

( 60.25(a)  Each plan shall include an inventory of all designated
facilities, including emission data for the designated pollutants and
information related to emissions as specified in Appendix D to this
part.  Such data shall be  summarized in the plan, and emission rates of
designated facilities shall be correlated with applicable emission
standards.  As used in this subpart, "correlated" means presented in
such a manner as to show the relationship between measured or estimated
amounts of emissions and the amounts of such emissions allowable under
applicable emission standards.

See EPA’s 5/23/00 TSD.

( 60.25(b)  Each plan shall provide for monitoring the status of
compliance with applicable emission standards.  Each plan shall, as a
minimum, provide for:

Included in plan narrative section on legal authority.

(1)  Legally enforceable procedures for requiring owners and operators
of designated facilities to maintain records and periodically report to
the State information on the nature and amount of emissions from such
facilities, and/or such information as may be necessary to enable the
State to determine whether such facilities are in compliance with
applicable portions of the plan.

See EPA’s 6/12/08 plan revision comment letter to DAQ relating to
Retention of Federal Authority.  The EPA Administrator retains authority
for several tasks, as stipulated in (45-18-9.1, including the granting
of waivers for initial and annual compliance testing requirements.  ??

            (2)  Periodic inspection and, when applicable, testing of
designated facilities.

( 60.25(c)  Each plan shall provide that information obtained by the
State under paragraph (b) of this section shall be correlated with
applicable emission standards (see ( 60.25(a)) and made available to the
general public.

DAQ has the authority to make emissions data available to the public.

( 60.25(d)  The provisions referred to in               paragraphs (b)
and (c) of this section shall be specifically identified.  Copies of
such be submitted with the plan unless:

      (1) They have been approved as portions of a preceding plan
submitted under this subpart or as portions of an implementation plan
submitted under Section 110 of the Act, and

      (2) The State demonstrates:

    (i) That the provisions are applicable                  to the
designated pollutant(s) for                   which the plan is
submitted, and

                (ii) That the requirements of (60.26
      are met.

Copies of the HMIWI plan revision,

including applicable rules (WV45CSR18), were made available during the
public comment periods.

(60.25(e)  The State shall submit reports on progress in plan
enforcement to the Administrator on an annual (calendar year) basis,
commencing with the first full report period after approval of a plan or
after promulgation of a plan by the Administrator.  Information required
under this paragraph must be included in the annual report required by (
51.321 of this chapter.

The DAQ will submit on an annual basis a report which details the
progress in enforcement of the 111(d)/129 plan in accordance with 40 CFR
60.25. The first progress report will be submitted to EPA one year after
the approval of the State plan.

( 60.25(f)  Each progress report shall include:

(1) Enforcement actions initiated against designated facilities during
the reporting period, under any emission standard or compliance schedule
of the plan.

(2) Identification of the achievement of any increment of progress
required by the applicable plan during the reporting period.

(3) Identification of designated facilities that have ceased operation
during the report period.

(4) Submission of emission inventory data as described in paragraph (a)
of this section for designated facilities that were not in operation at
the time of plan development but began operation during the reporting
period.

Same as above.

(5)  Submission of additional data as necessary to update the
information submitted under paragraph (a) of this section or in previous
progress reports.

            (6)  Submission of copies of technical reports on all
performance testing on designated facilities conducted under paragraph
(b)(2) of this section, complete with concurrently recorded process
data.

( 60.26  --  Legal authority

( 60.26(a)  Each plan shall show that the State has legal authority to
carry out the plan, including authority to:

(1)  Adopt emission standards and compliance schedules applicable to
designated facilities.

(2)  Enforce applicable laws, regulations, standards, and compliance
schedules, and seek injunction relief.

(3)  Obtain information necessary to determine whether designated
facilities are in compliance with applicable laws, regulations,
standards, and compliance schedules, including authority to require
recordkeeping and to make inspections and conduct tests of designated
facilities.

(4)  Require owners or operators of designated facilities to install,
maintain, and use emission monitoring devices and to make periodic
reports to the State on the nature and amounts of emissions from such
facilities; also authority for the State to make such data available to
the public as reported and as correlated with applicable emission
standards.

See EPA’s 5/23/00 TSD.

( 60.26(b)  The provisions of law or regulations which the State
determines provide the authorities required by this section shall be
specifically identified.  Copies of such laws or regulations shall be
submitted with the plan unless:

(1)  They have been approved as portions of a preceding plan submitted
under this subpart or as portions of an implementation plan submitted
under section 110 of the Act, and

(2)  The State demonstrates that the laws or regulations are applicable
to the designated pollutant(s) for which the plan is submitted.

Same as above. EPA has approved previous WV 111(d)/129 plans – CISWI,
HMIWIs and landfills.

( 60.26(c) The plan shall show that the legal authorities specified in
this section are available to the State at the time of submission of the
plan.  Legal authority adequate to meet the requirements of paragraphs
(a)(3) and (4) of this section may be delegated to the State under
section 114 of the Act.

Same as above. Legal authority cited in the submitted plan.

( 60.26(d)  A State governmental agency other than the State air
pollution control agency may be assigned responsibility for carrying out
a portion of a plan if the plan demonstrates to the Administrator's
satisfaction that the State governmental agency has the legal authority
necessary to carry out that portion of the plan.

Not applicable.

( 60.26(e)  The State may authorize a local agency to carry out a plan
or portion thereof, within the local agency's jurisdiction if the plan
demonstrates to the Administrator's satisfaction that the local agency
has the legal authority necessary to implement the plan or portion
thereof, and that the authorization does not relieve the State of
responsibility under the Act for carrying out the plan or portion
thereof.

Not applicable.

III. Requirements affected HMIWI owners/operators must meet

Q. What general requirements must an owner/operator meet under the
approved EPA 111(d)/129 plan revision?

A. An owner/operator must meet the same applicability, emission limits,
operating, testing, monitoring, recordkeeping, reporting, compliance
schedules, and other requirements as the initial EPA 111(d)/129 HMIWI
plan approval of June 13, 2000.  This plan revision approval does not
negate or void any of the original state HMIWI rule, WV45CSR24,
requirements.

Q. Is there a requirement for obtaining a Title V permit revision?

A. Yes, as a result of the rule streamlining, an affected facility will
need to submit a Title V permit application revision.  Accordingly, the
DAQ will complete the Title V permit revision as soon as practicable.

IV. Conclusion

The West Virginia HMIWI plan revision for streamlining and consolidating
its regulatory requirements for section 129 pollutants is approvable.
The 111(d)/129 plan revision approval does not negate or void any of the
initial EPA plan approval requirements for any affected facility.  The
scope of the plan revision approval is limited to the provisions of 40
CFR Parts 60 and 62 for existing HMIWI units, as defined in the emission
guidelines, subpart Ce, and the related new source performance standard
provisions, subpart Ec.  Other types of Section 129 incinerator rules
are not included in this plan approval action.

The EPA Administrator continues to retain authority for several tasks,
as stipulated in 45 CSR 18, (45-18-9.1; this retention of federal
authority also includes the granting of waivers for initial and annual
compliance testing requirements.

 PAGE

 PAGE  14


[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51825-51826]
[FR Doc No: 2017-24276]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD18-2-000]

White River Electric Association, Inc.; Notice of Preliminary
Determination of a Qualifying Conduit Hydropower Facility and
Soliciting Comments and Motions To Intervene

    On October 31, 2017, White River Electric Association, Inc., filed
a notice of intent to construct a qualifying conduit hydropower
facility, pursuant to section 30 of the Federal Power Act (FPA), as
amended by section 4 of the Hydropower Regulatory Efficiency Act of
2013 (HREA). The proposed Town of Meeker Hydro Project would have an
installed capacity of up to 180 kilowatts (kW), and would be located
along the existing Meeker Power Canal near the Town of Meeker, Rio
Blanco County, Colorado.
    Applicant Contact: Trina Zagar-Brown, General Counsel, 233 6th
Street, P.O. Box 958, Meeker, CO 81641, Phone No.<PHONE_NUMBER>.
    FERC Contact: Christopher Chaney, Phone No.<PHONE_NUMBER>, email:
[email protected].
    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) Up to two low head turbines with a total
generating capacity not to exceed 180 kW; (2) two approximately 20-
foot-long, 44-inch-diameter penstocks exiting an existing 25-foot by
50-foot forebay structure; (3) a small controls structure; and (4)
appurtenant facilities. The proposed project would have an estimated
annual generating capacity of up to 500,000 kilowatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

      Table 1--Criteria for Qualifying Conduit Hydropower Facility
------------------------------------------------------------------------
                                                               Satisfies
      Statutory provision                 Description            (Y/N)
------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by   The conduit the facility              Y
 HREA.                            uses is a tunnel, canal,
                                  pipeline, aqueduct, flume,
                                  ditch, or similar manmade
                                  water conveyance that is
                                  operated for the
                                  distribution of water for
                                  agricultural, municipal, or
                                  industrial consumption and
                                  not primarily for the
                                  generation of electricity.
FPA 30(a)(3)(C)(i), as amended   The facility is constructed,          Y
 by HREA.                         operated, or maintained for
                                  the generation of electric
                                  power and uses for such
                                  generation only the
                                  hydroelectric potential of
                                  a non-federally owned
                                  conduit.
FPA 30(a)(3)(C)(ii), as amended  The facility has an                   Y
 by HREA.                         installed capacity that
                                  does not exceed 5 megawatts.
FPA 30(a)(3)(C)(iii), as         On or before August 9, 2013,          Y
 amended by HREA.                 the facility is not
                                  licensed, or exempted from
                                  the licensing requirements
                                  of Part I of the FPA.
------------------------------------------------------------------------

    Preliminary Determination: The proposed addition of the
hydroelectric project along the existing irrigation canal will not
alter its primary purpose.\1\ Therefore, based upon the above
information and criteria, Commission staff preliminarily determines
that the proposal satisfies the requirements for a qualifying conduit
hydropower facility, which is not required to be licensed or exempted
from licensing.
---------------------------------------------------------------------------

    \1\ White River Electric Association, Inc. states in its Notice
of Intent that the Meeker Power Canal was constructed in 1912 to
supply water to a hydroelectric facility, which was decommissioned
in the 1960's. Since then, the Meeker Power Canal has been
continuously operated to provide water for irrigation and
agricultural use, which is now its primary purpose.
---------------------------------------------------------------------------

    Comments and Motions To Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the COMMENTS CONTESTING QUALIFICATION FOR A
CONDUIT HYDROPOWER FACILITY or MOTION TO INTERVENE, as applicable; (2)
state in the heading the name of the applicant and the project number
of the application to which the filing responds; (3) state the name,
address, and telephone number of the person filing; and (4) otherwise
comply with the requirements of sections 385.2001 through 385.2005 of
the Commission's regulations.\2\ All comments contesting Commission
staff's preliminary determination that the facility meets the
qualifying criteria must set forth their evidentiary basis.
---------------------------------------------------------------------------

    \2\ 18 CFR 385.2001-2005 (2017).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at [email protected],<PHONE_NUMBER> (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (i.e., CD18-2) in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or email [email protected]. For TTY, call
(202) 502-8659.

    Dated: November 2, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-24276 Filed 11-7-17; 8:45 am]
 BILLING CODE 6717-01-P